| Page Range | 67261-67620 | |
| FR Document |
| Page and Subject | |
|---|---|
| 80 FR 67619 - National College Application Month, 2015 | |
| 80 FR 67617 - National Alzheimer's Disease Awareness Month, 2015 | |
| 80 FR 67615 - National Adoption Month, 2015 | |
| 80 FR 67421 - Government In the Sunshine Act Meeting Notice | |
| 80 FR 67421 - Government in the Sunshine Act Meeting Notice | |
| 80 FR 67399 - Public Water System Supervision Program Revision for the State of Oklahoma | |
| 80 FR 67413 - Notice To Propose the Redesignation of the Service Delivery Area for the Wampanoag Tribe of Gay Head (Aquinnah) | |
| 80 FR 67416 - Notice on Outer Continental Shelf Oil and Gas Lease Sales | |
| 80 FR 67277 - Organization; Mergers, Consolidations, and Charter Amendments of Banks or Associations | |
| 80 FR 67277 - Farm Credit Administration Board Policy Statements | |
| 80 FR 67400 - Proposed Information Collection Request; Comment Request; Tips and Complaints Regarding Environmental Violations (Renewal) | |
| 80 FR 67399 - Notice of Public Meeting of the Interagency Steering Committee on Radiation Standards (ISCORS) | |
| 80 FR 67398 - Proposed CERCLA Administrative Cost Recovery Settlement; Ashue Road Site, Wapato, Yakima County, WA | |
| 80 FR 67481 - Qualification of Drivers; Exemption Applications; Vision | |
| 80 FR 67397 - Notice of a Public Meeting of the National Drinking Water Advisory Council | |
| 80 FR 67476 - Qualification of Drivers; Exemption Applications; Vision | |
| 80 FR 67472 - Agency Information Collection Activities; Extension of a Currently-Approved Information Collection: Annual Report of Class I and Class II Motor Carriers of Property (OMB 2139-0004) | |
| 80 FR 67472 - Qualification of Drivers; Exemption Applications; Vision | |
| 80 FR 67423 - President's Committee on the International Labor Organization Charter Renewal | |
| 80 FR 67469 - South Carolina Disaster Number SC-00032 | |
| 80 FR 67416 - Wind Energy Research Lease Issuance on the Atlantic Outer Continental Shelf Offshore Virginia | |
| 80 FR 67471 - Fine Arts Committee Notice of Meeting | |
| 80 FR 67346 - Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2015 Gulf of Alaska Pollock Seasonal Apportionments | |
| 80 FR 67470 - Contingent Waiver of Certain Sanctions Related to the Joint Comprehensive Plan of Action | |
| 80 FR 67315 - Visas: Procedures for Issuing Visas | |
| 80 FR 67415 - The Performance Review Board | |
| 80 FR 67412 - Agency Information Collection Activities; Proposed Collection; Public Comment Request | |
| 80 FR 67406 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 80 FR 67415 - 30-Day Notice of Proposed Information Collection: Supplement to Application for Federally Assisted Housing | |
| 80 FR 67437 - Clarification of Licensee Actions in Support of Enforcement Guidance for Tornado-Generated Missiles | |
| 80 FR 67435 - SHINE Medical Technologies, Inc.; Notice of Hearing | |
| 80 FR 67264 - Cyber Security Event Notifications | |
| 80 FR 67386 - Endangered and Threatened Species; Recovery Plans | |
| 80 FR 67404 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 80 FR 67404 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 80 FR 67403 - Notice of Termination, 10461 First East Side Savings Bank, Tamarac, Florida | |
| 80 FR 67403 - Notice of Termination, 10466 Hometown Community Bank, Braselton, Georgia | |
| 80 FR 67396 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Servicing of Motor Vehicle Air Conditioners (Renewal) | |
| 80 FR 67470 - SOUTH CAROLINA Disaster Number SC-00031 | |
| 80 FR 67382 - Export Verification Program: Microbiological Testing of Ready-To-Eat Products Destined for Canada | |
| 80 FR 67434 - President's Committee on the Arts and the Humanities: Meeting #71 | |
| 80 FR 67394 - Combined Notice of Filings | |
| 80 FR 67392 - Combined Notice of Filings #2 | |
| 80 FR 67392 - Combined Notice of Filings #1 | |
| 80 FR 67408 - The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy; Updated Guidance for Industry, Availability | |
| 80 FR 67395 - Baker County, Oregon; Notice of Availability of Environmental Assessment | |
| 80 FR 67384 - Caribbean Fishery Management Council; Public Hearings; Correction | |
| 80 FR 67490 - The Long Island Rail Road Company-Abandonment Exemption-in Queens County, NY | |
| 80 FR 67401 - Agency Information Collection Activities: Submission for OMB Review; Comment Request (3064-0072, -0093, -0095, -0117, -0145, -0152 & -0161) | |
| 80 FR 67383 - New England Fishery Management Council; Public Meetings | |
| 80 FR 67489 - CSX Transportation, Inc.-Abandonment Exemption-in Floyd County, KY | |
| 80 FR 67407 - Proposed Information Collection Activity; Comment Request | |
| 80 FR 67389 - North Pacific Fishery Management Council; Public Meeting | |
| 80 FR 67437 - New Postal Product | |
| 80 FR 67438 - New Postal Product | |
| 80 FR 67386 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting | |
| 80 FR 67384 - New England Fishery Management Council; Public Meeting | |
| 80 FR 67439 - Agency Forms Submitted for OMB Review, Request for Comments | |
| 80 FR 67483 - Notice of Receipt of Petition for Decision That Nonconforming 2006 Mercedes-Benz SL Passenger Cars (Manufactured Before September 1, 2006) Are Eligible for Importation | |
| 80 FR 67428 - Petitions for Modification of Application of Existing Mandatory Safety Standards | |
| 80 FR 67427 - Proposed Extension of Information Collection; Fire Protection (Underground Coal Mines) | |
| 80 FR 67432 - Preparations for the 30th Session of the UN Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS) | |
| 80 FR 67423 - Petitions for Modification of Application of Existing Mandatory Safety Standards | |
| 80 FR 67405 - Submission for OMB Review; Subcontract Consent | |
| 80 FR 67411 - Information To Support a Claim of Electromagnetic Compatibility of Electrically Powered Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 80 FR 67313 - Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay | |
| 80 FR 67409 - Bioequivalence Recommendations for Progesterone; Draft Guidance for Industry; Availability | |
| 80 FR 67420 - Certain Electric Skin Care Devices, Brushes and Chargers Therefore, and Kits Containing the Same: Notice of a Commission Determination Not To Review an Initial Determination Granting-in-Part Complainant's Motion for Leave To Amend the Amended Complaint and Notice of Investigation | |
| 80 FR 67414 - National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting | |
| 80 FR 67414 - Center for Scientific Review; Notice of Closed Meetings | |
| 80 FR 67414 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings | |
| 80 FR 67416 - Certain Vision-Based Driver Assistance System Cameras, Components Thereof, and Products Containing the Same: Notice of the Commission's Determination Finding No Violation of Section 337; Termination of the Investigation | |
| 80 FR 67492 - Proposed Collection; Comment Request for Consumer Tipping Survey Study | |
| 80 FR 67491 - Advisory Council to the Internal Revenue Service; Meeting | |
| 80 FR 67491 - Proposed Collection; Comment Request for Form 4506-A | |
| 80 FR 67302 - Standards for Business Practices of Interstate Natural Gas Pipelines; Coordination of the Scheduling Processes of Interstate Natural Gas Pipelines and Public Utilities | |
| 80 FR 67394 - Cave Run Energy, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 80 FR 67393 - El Dorado Irrigation District; Notice of Availability of Environmental Assessment | |
| 80 FR 67395 - Tennessee Gas Pipeline Company, L.L.C.; Notice of Application | |
| 80 FR 67452 - Submission for OMB Review; Comment Request | |
| 80 FR 67464 - Submission for OMB Review; Comment Request | |
| 80 FR 67467 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Provide Additional Details Regarding the Requirement That Participants Participate in Annual Testing of Business Continuity and Disaster Recovery Plans | |
| 80 FR 67464 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Certificate of Incorporation and Bylaws of its Parent Company | |
| 80 FR 67461 - Self-Regulatory Organizations; C2 Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Certificate of Incorporation and Bylaws of Its Parent Company | |
| 80 FR 67450 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Provide Additional Details Regarding the Requirement That Members Participate in Annual Testing of Business Continuity and Disaster Recovery Plans | |
| 80 FR 67443 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule Change Deleting Rule 410B Governing Reporting Requirements for Off-Exchange Transactions | |
| 80 FR 67454 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change Deleting Rule 410B Equities Governing Reporting Requirements for Off-Exchange Transactions | |
| 80 FR 67446 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing of a Proposed Rule Change Relating to Complex Orders, as Modified by Amendment No. 1 | |
| 80 FR 67457 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing of a Proposed Rule Change Relating to Complex Orders, as Modified by Amendment No. 1 | |
| 80 FR 67440 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Unify Procedures for the Handling of Resting Orders in a Security Subject to a Trading Halt, Pause or Suspension on the Exchange | |
| 80 FR 67319 - Revisions to Air Plan; Arizona; Stationary Sources; New Source Review | |
| 80 FR 67485 - Hazardous Materials: Explosive Approvals-Compliance With Special Provision 347 | |
| 80 FR 67335 - Approval of Air Quality State Implementation Plans (SIP); State of Iowa; Infrastructure SIP Requirements for the 2008 Lead National Ambient Air Quality Standard (NAAQS) | |
| 80 FR 67439 - Product Change-Priority Mail Negotiated Service Agreement | |
| 80 FR 67390 - Agency Information Collection Activities; Comment Request; Perkins Discretionary Grant Performance Report | |
| 80 FR 67391 - Agency Information Collection Activities; Comment Request; Mathematics and Science Partnerships Program | |
| 80 FR 67389 - Joint Statement of Principles on Student Loan Servicing | |
| 80 FR 67316 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, South Branch of the Elizabeth River, Portsmouth and Chesapeake, VA | |
| 80 FR 67351 - Energy Labeling | |
| 80 FR 67285 - Energy Labeling Rule | |
| 80 FR 67261 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Direct Grant Programs | |
| 80 FR 67421 - Notice of Lodging of Proposed Consent Decree Under The Clean Air Act, Emergency Panning and Community Right-To-Know Act, Clean Water Act, and The Resource Conservation and Recovery Act | |
| 80 FR 67435 - SES Performance Review Board | |
| 80 FR 67422 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine DEA Form 488 | |
| 80 FR 67317 - Safety Zone; Grounded Vessel, Atlantic Ocean, Port St. Lucie, FL | |
| 80 FR 67337 - Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions; Channel Sharing by Full Power and Class A Stations Outside the Broadcast Television Spectrum Incentive Auction Context | |
| 80 FR 67401 - SES Performance Review Board-Appointment of Members | |
| 80 FR 67348 - Airworthiness Directives; Airbus Airplanes | |
| 80 FR 67576 - Medicaid Program; Methods for Assuring Access to Covered Medicaid Services | |
| 80 FR 67377 - Medicaid Program; Request for Information (RFI)-Data Metrics and Alternative Processes for Access to Care in the Medicaid Program | |
| 80 FR 67417 - Wooden Bedroom Furniture From China; Institution of a Five-Year Review | |
| 80 FR 67433 - Distribution of 2014 DART Sound Recordings Fund Royalties (Copyright Owners and Featured Artists Subfunds) | |
| 80 FR 67344 - Channel Sharing by Full Power and Class A Stations Outside the Broadcast Television Spectrum Incentive Auction Context | |
| 80 FR 67422 - Meeting of the Coordinating Council on Juvenile Justice and Delinquency Prevention | |
| 80 FR 67496 - Pesticides; Agricultural Worker Protection Standard Revisions |
Food Safety and Inspection Service
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
Indian Health Service
National Institutes of Health
Coast Guard
Ocean Energy Management Bureau
Justice Programs Office
Mine Safety and Health Administration
Occupational Safety and Health Administration
Copyright Royalty Board
National Endowment for the Arts
Federal Aviation Administration
Federal Motor Carrier Safety Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
Surface Transportation Board
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Department of Education.
Final regulations.
The Secretary adopts as final regulations of the Department the interim final regulations that were published on December 19, 2014. This action adopts the OMB guidance in title 2 of the CFR as final regulations of the Department. The Secretary amends the interim final regulations to correct technical errors contained in the amendments.
These regulations are effective December 2, 2015.
Phillip Juengst, U.S. Department of Education, 400 Maryland Avenue SW., Room 6056, PCP, Washington, DC 20202-4450. Telephone: (202) 245-8030 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
On December 19, 2014, the Secretary published an IFR for these amendments in the
Except for minor editorial and technical revisions, there are no differences between the IFR and these final regulations.
The Secretary makes two amendments to the interim final regulations to correct errors made in the adoption of the Uniform Guidance. First, in amending § 75.135 to reference the Uniform Guidance, the Department failed to amend paragraph (b) of that section to reference the correct requirement in part 200. Second, in amending 34 CFR part 75, the Department inadvertently removed § 75.263 when we should have just revised the cross references in that section to refer to the appropriate citation in the Uniform Guidance. These two errors are corrected in these final regulations.
LEAs that engage in pilot trials of educational technologies or instructional materials that then wish to “scale up” are not exempted from competitive procurement. Procurement transactions must be conducted in a manner providing full and open competition, as described in 2 CFR 200.319. If an LEA wants to experiment with a new educational technology or instructional strategy or material, it may do so without violating conflict of interest requirements by holding an open procurement competition, identifying the specifications for the technology, strategy, or material and stating the initial contract would be for a pilot of that product with an option to “scale up” the product if the pilot proves successful.
After consideration of all the comments regarding the IFR, the Secretary makes no changes to the regulations adopting the Uniform Guidance that were published on December 19, 2014 except for the two technical amendments discussed earlier in this preamble.
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.
This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed these regulations under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only on a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing these final regulations only on a reasoned determination that their benefits justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that these final regulations are consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action does not unduly interfere with State, local, or tribal governments in the exercise of their governmental functions.
In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs associated with this regulatory action are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
These regulations do not contain any information collection requirements.
These regulations are subject to the requirements of Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.
This document provides early notification of our specific plans and actions for these regulations.
In the IFR we requested comments on whether the proposed regulations would require transmission of information that any other agency or authority of the United States gathers or makes available.
Based on the response to the IFR and on our review, we have determined that these final regulations do not require transmission of information that any other agency or authority of the United States gathers or makes available.
You may also access documents of the Department published in the
For the reasons discussed in the preamble, and under the authority of 5 U.S.C. 301 and the authorities listed below, the interim rule amending chapter XXXIV of 2 CFR and subtitle A and chapter I of title 34 of the Code of Federal Regulations, which was published at 79 FR 75871 on December 19, 2014, is adopted as a final rule with the following changes:
20 U.S.C. 1221e-3 and 3474, unless otherwise noted.
A grantee may, notwithstanding any requirement in 2 CFR part 200, incur pre-award costs as specified in 2 CFR 200.308(d)(1) unless—
(a) ED regulations other than 2 CFR part 200 or a statute prohibit these costs; or
(b) The conditions of the award prohibit these costs.
Nuclear Regulatory Commission.
Final rule.
The U.S. Nuclear Regulatory Commission (NRC) is adopting new cyber security regulations that govern nuclear power reactor licensees. This final rule codifies certain reporting activities associated with cyber security events contained in security advisories issued by the NRC. This rule establishes new cyber security event notification requirements that contribute to the NRC's analysis of the reliability and effectiveness of licensees' cyber security programs and plays an important role in the continuing effort to provide high assurance that digital computer and communication systems and networks are adequately protected against cyber attacks, up to and including the design basis threat.
Please refer to Docket ID NRC-2014-0036 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
Robert H. Beall, Office of Nuclear Reactor Regulation, telephone: 301-415-3874, email:
On July 9, 2008, in SECY-08-0099, “Final Rulemaking—Power Reactor Security Requirements” (Agencywide Documents Access and Management System (ADAMS) Accession No. ML081650474), the NRC staff recommended the Commission approve a final rule amending the NRC's Power Reactor Security Requirements. The NRC staff also recommended removing sections in the Power Reactor Security Requirements rule on new and revised security notification requirements in § 73.71 and appendix G of part 73 of title 10 of the
On June 27, 2010, in SECY-10-0085, “Proposed Rule: Enhanced Weapons, Firearms Background Checks and Security Event Notifications” (ADAMS Accession No. ML101110121), the NRC staff recommended delegating to the Office of the Executive Director for Operations the authority to issue new cyber security notification changes in the proposed enhanced weapons rule for publication in the
In SECY-12-0125, “Interim Actions to Execute Commission Preemption Authority Under Section 161A of the Atomic Energy Act of 1954, as Amended,” dated September 20, 2012 (ADAMS Accession No. ML12171A089), the NRC staff reported their discussions with the U.S. Department of Justice on the need to revise the Firearms Guidelines to limit the firearms background check requirement to only licensees that apply for preemption authority. Subsequently in SRM—SECY-12-0125, dated November 12, 2012 (ADAMS Accession No. ML12326A653), the Commission directed the NRC staff to revise the Firearms Guidelines accordingly, and publish a supplemental proposed enhanced weapons rule for public comment as soon as possible.
On December 20, 2013, in COMSECY-13-0031, “Bifurcation of the Enhanced Weapons, Firearms Background Checks, and Security Event Notifications Rule” (ADAMS Accession No. ML13280A366), the NRC staff informed the Commission of its plan to bifurcate the cyber security event notifications from the Enhanced Weapons rule due to delays resulting from the Firearms Guidelines revision. The bifurcation would allow the NRC staff to prepare a separate final rule for cyber security event notifications, therefore avoiding any further delay associated with the aforementioned Firearms Guidelines revision. In addition, this action would supplement the existing cyber security requirements (
As part of the 2011 proposed enhanced weapons rule, the NRC received comments on the proposed cyber security event notification requirements. Changes between the proposed rule and this final cyber security event notifications rule reflect those public comments. Additionally, Draft Regulatory Guide (DG)-5019, Revision 1, “Reporting and Recording Safeguards Events” (ADAMS Accession No. ML100830413), was published for public comment on February 3, 2011 (76 FR 6085). The portions of the DG related to cyber security event notifications were also separated out from the original draft guide, and are now included in a new final regulatory guide (RG) (RG 5.83, “Cyber Security Event Notifications,” ADAMS Accession No. ML14269A388). Changes between DG-5019, Revision 1, and RG 5.83 reflect public comment. This approach (
The NRC is adding cyber security event notification requirements for nuclear power reactor facilities. These additions are necessary because cyber security event notification requirements were not included in the NRC's final rule that added § 73.54, “Protection of Digital Computer and Communication Systems and Networks,” to the NRC's regulations (74 FR 13926; March 27, 2009). Section 73.54 requires power reactor licensees to establish and maintain a cyber security program that provides high assurance that digital computer and communication systems and networks are adequately protected against cyber attacks, up to and including the design basis threat as described in § 73.1. Cyber security event notification requirements will contribute to the NRC's analysis of the reliability and effectiveness of licensees' cyber security programs and play an important role in the continuing effort to protect digital computer and communication systems and networks associated with: Safety-related and important-to-safety functions; security functions; emergency preparedness functions, to include offsite communications; and support systems and equipment which, if compromised, would adversely impact safety, security, and emergency preparedness (SSEP) functions. Notifications conducted and written reports generated by licensees will be used by the NRC to respond to emergencies, monitor ongoing events, assess trends and patterns, identify precursors of more significant events, and inform other NRC licensees of cyber security-related events, enabling them to take preemptive actions, if necessary (
The terrorist attacks of September, 11, 2001, demonstrated that adversaries were capable of simultaneously attacking multiple sectors of critical infrastructure. After those attacks, the NRC issued several Security Orders, as well as the Design Basis Threat (DBT) final rule (72 FR 12705; March 19, 2007) and the Power Reactor Security final rule (74 FR 13926; March 27, 2009). These Orders and final rules were steps taken by the NRC to ensure adequate protection of the public health and safety and common defense and security. The DBT final rule, in § 73.1, “Purpose and Scope,” describes in general terms the types of attacks licensees must protect against in order to prevent radiological sabotage and to prevent theft or diversion of strategic special nuclear material. An adversary attribute included under the DBT for radiological sabotage is a cyber attack, which is a type of attack that adversaries could remotely launch against multiple targets (
Separating the cyber security event notification requirements from the Power Reactor Security proposed rule narrowed the applicability to licensees subject to the requirements of § 73.54, which applies to operating nuclear power plants after the effective date of the final cyber security rule. Under the original proposed rule published on October 26, 2006 (71 FR 62664), cyber security event notifications were included with other event notifications (physical security, enhanced weapons, etc.) requiring a broader range of applicability (
The NRC considered other options for licensees to report cyber attacks to the NRC. The NRC considered taking no additional regulatory actions and relying upon the continuation of voluntary reporting initiatives currently in place through security advisories. These voluntary reporting initiatives have allowed the NRC to identify certain cyber security-related events that might have had a negative impact upon licensees (
As part of its comprehensive assessment of the NRC's cyber security event notification regulations and guidance development for this rule, the NRC staff held two meetings with internal and external stakeholders.
On June 1, 2011, staff held a public meeting to discuss the proposed Enhanced Weapons, Firearms Background Checks, and Security Event Notifications rulemaking, which included the cyber security event notification requirements. The meeting was in workshop format, and was held at the NRC Headquarters in Rockville, Maryland; it was attended by more than 50 people. Additional individuals remotely participated in the meeting through audio teleconferencing and webinar. Presenters at the meeting included NRC staff, the Bureau of Alcohol, Tobacco, Firearms and Explosives, and the Federal Bureau of Investigations (FBI). Since the NRC was not accepting public comments, the meeting was not transcribed; however, a meeting summary and the handouts from the meeting are available in ADAMS under Accession No. ML111720007.
The NRC staff also met with internal and external stakeholders on July 31, 2014. This public meeting was to discuss the draft final rule implementation date for the cyber security event notification requirements. The public meeting was held at the NRC Headquarters in Rockville, Maryland, and it was attended by six individuals in person and eight individuals remotely through audio teleconferencing and webinar. The NRC staff presented the current status of the draft final cyber security event notifications rule and the draft final implementation date. The NRC transcribed the meeting in order to capture public input on the draft final implementation date. The feedback from this meeting, as well as all the previous interactions, informed the NRC's schedule for the implementation of the new cyber security event notification requirements. The meeting summary, handouts, and a transcript of the meeting are available in ADAMS under Accession No. ML14240A404.
The proposed rule was published in the
The proposed enhanced weapons rule was published February 03, 2011 (76 FR 6199), and the public comment period closed on August 04, 2011. On the same day the NRC also published a separate notice requesting comment on DG-5019, Revision 1, “Reporting and Recording Safeguards Events.”
The NRC received 14 submittals on the proposed rule and draft guidance. The NRC also received one comment on the proposed implementation date during the July 31, 2014, public meeting. Comments specific to cyber security event notifications in the proposed enhanced weapons rule and DG-5019, Revision 1, were identified and are addressed in this final rule. The comments specific to the proposed rule on Enhanced Weapons, Firearms Background Checks, and Security Event Notifications (76 FR 6200) are not addressed in this final rule and will be addressed in a subsequent rulemaking. In addition, certain event notification comments in the proposed rule that were generic (
Prompt notification of a cyber attack could be vital to the NRC's ability to take immediate action in response to a cyber attack and, if necessary, to notify other NRC licensees, Government agencies, and critical infrastructure facilities, to defend against a multiple sector (
The final rule will become effective 30 days after publication in the
(a) Any failure, degradation, or discovered vulnerability in a safeguards system, had compensatory measures not been established, that could . . . (2) Degrade the effectiveness of the licensee's or certificate holder's cyber security program that would allow unauthorized or undetected access to any systems, networks, or equipment that fall within the scope of § 73.54 of this part.
The following section-by-section analysis discusses the final revisions to the NRC's regulations regarding cyber security, and explains how the final rule differs from the language in the proposed rule. This final rule adds a new section (§ 73.77) to 10 CFR part 73 and revises three existing sections (§§ 73.8, 73.22, and 73.54) to make conforming changes.
The NRC is amending § 73.8 to add § 73.77 to paragraph (b) that provides the approved information collection requirements contained in 10 CFR part 73 under control number 3150-0002. In addition, the NRC is amending § 73.8 to add § 73.77 to paragraph (c)(1) that provides that NRC Form 366 is approved under control number 3150-0104.
The NRC is amending § 73.22(f)(3) to add the sentence, “Cyber security event notifications required to be reported pursuant to § 73.77 are considered to be extraordinary conditions” to the end of the paragraph.
The NRC is amending § 73.54 to add a new paragraph (d)(4) that reads, “Conduct cyber security event notifications in accordance with the provisions of § 73.77.” This new requirement guides the licensee to the correct 10 CFR part 73 section for conducting cyber security event notifications.
The NRC has moved cyber security event notifications requirements that were proposed to be added to § 73.71 and appendix G to a newly created section (§ 73.77) within 10 CFR part 73.
Section 73.77(a)(1) requires licensees to notify the NRC within one-hour after discovery of a cyber attack that adversely impacted safety-related or important-to-safety functions, security functions, or emergency preparedness functions (including offsite communications); or that compromised support systems and equipment resulting in adverse impacts to safety, security, or emergency preparedness functions within the scope of § 73.54. This requirement differs from the proposed rule language, it has been revised to more closely align with § 73.54 and to remove the term “uncompensated cyber security events” because it was unclear and not defined within the CSP.
Section 73.77(a)(2) requires licensees to notify the NRC within four-hours.
Section 73.77(a)(2)(i) after discovery of a cyber attack that could have caused an adverse impact to safety-related or important-to-safety functions, security functions, or emergency preparedness functions (including offsite communications); or that could have compromised support systems and equipment, which if compromised, could have adversely impacted safety, security, or emergency preparedness functions within the scope of § 73.54. This requirement differs from the proposed rule; it has been revised to more closely align with § 73.54. In addition, the final rule distinguishes between four-hour and eight-hour notifications.
Section 73.77(a)(2)(ii) after discovery of a suspected or actual cyber attack initiated by personnel with physical or electronic access to digital computer and communication systems and networks within the scope of § 73.54. This requirement differs from the proposed rule; it has been revised to capture cyber attacks (
Section 73.77(a)(2)(iii) after notification of a local, State, or other Federal agency (
Section 73.77(a)(3) requires licensees to notify the NRC within eight-hours after receipt or collection of information regarding observed behavior, activities, or statements that may indicate intelligence gathering or pre-operational planning related to a cyber attack against digital computer and communication systems and networks within the scope of § 73.54. Requirements for “suspicious cyber events” have been revised and moved from four-hour notifications in the proposed rule to eight-hour notifications in the final rule. This requirement now captures activities that are associated with precursors to a cyber attack (
Section 73.77(b) requires licensees to record certain cyber security events in their site corrective action program (CAP) within 24-hours of their discovery. The proposed rule required licensees to use a Safeguards Event Log; to prevent duplication of effort, the final rule requires licensees to use their site CAP.
Section 73.77(b)(1) requires licensees to use their site CAP to record vulnerabilities, weaknesses, failures, and deficiencies in their § 73.54 cyber security program. This requirement has been revised to align with NRC physical protection program requirements in § 73.55(b)(10) regarding the use of the site CAP to track, trend, correct, and prevent recurrence of failures and deficiencies.
Section 73.77(b)(2) requires licensees to record notifications made under paragraph (a) of § 73.77.
Section 73.77(c) provides the process for conducting cyber security event notifications.
Section 73.77(c)(1) has been revised from the proposed rule to include the Emergency Notification System (ENS) as the primary means for conducting notifications, instead of any available telephone system. Using the ENS is consistent with existing NRC regulations for conducting notifications (
Section 73.77(c)(3) in the final rule was revised to remove a reference to paragraph III in appendix A of 10 CFR part 73 that provided instructions on requesting a transfer to a secure phone. The current appendix A in 10 CFR part 73 does not contain a paragraph III and conforming changes to appendix A are not part of this final rule. Section 73.77(c)(3) was revised to reference appendix A and request transfer to a secure phone.
Sections 73.7(c)(6), “Declaration of emergencies,” and 73.77(c)(7), “Elimination of duplication,” were moved in the final rule from the “Written Security Follow-up Reports” section into the “Notification Process” section because they contain notification-specific information. In addition, due to the narrowed scope of this final rule, the proposed rule referenced several sections of the NRC's regulations (
Section 73.77(d), “Written security follow-up reports,” establishes the necessary regulatory framework to facilitate consistent application of Commission requirements for written security follow-up reports for cyber security event notifications.
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC certifies that this rule does not have a significant economic impact on a substantial number of small entities. This final rule affects only the licensing and operation of nuclear power plants. The companies that own these plants do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810).
The NRC has prepared a final regulatory analysis for this final rule. The analysis examines the costs and benefits of the alternatives considered by the NRC. The regulatory analysis is available as indicated in Section XVII., “Availability of Documents,” of this document.
The final rule imposing new cyber security event notifications affects information collection and reporting requirements and is not considered to be a backfit, as presented in the charter for NRC's Committee to Review Generic Requirements. Therefore, a backfit analysis has not been completed for any of the provisions of this final rule.
While the proposed rule was issued prior to the formal CER requirements promulgated by SRM-SECY-0032, the intent of CER was still met. For example, the draft guidance was issued for comment concurrent with the proposed rule, a public meeting was conducted during the development of the proposed rule, a public meeting on implementation was conducted during the final rule stage, and the final guidance will be issued with the final rule.
The NRC staff engaged external stakeholders at public meetings and by soliciting public comments on the proposed rule and draft guidance documents. A public meeting was held at NRC Headquarters on June 1, 2011, to discuss the proposed rule, the draft implementation plan, and draft guidance.
In addition, on July 31, 2014, a public meeting was held at the NRC Headquarters on the draft final implementation plan for the final rule (a type of meeting specifically contemplated by the NRC's CER effort). Prompt notification of a cyber attack is vital to the NRC's ability to take immediate action in response to a cyber attack, which contributes to protecting the public health and safety or the common defense and security. The NRC's strategic communications mission and the feedback from the public meetings informed the staff's recommended schedule for the final implementation date in the CSEN final rule.
A fundamental CER process improvement is to publish the final guidance with the final rule so as to support effective implementation. This final rulemaking accomplishes this by ensuring that final guidance is complete and available concurrent with this final rule publication in the
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).
The NRC has determined that this final rule is the type of action described in 10 CFR 51.22(c)(3)(iii). Therefore, neither an environmental impact statement nor environmental assessment has been prepared for this final rule.
This final rule contains new or amended information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The burden to the public for these information collections is estimated to average 39.4 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. Send comments on any aspect of these information collections, including suggestions for reducing the burden, to the Freedom of Information Act, Privacy, and Information Collections Branch (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by email to
The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.
In accordance with the Congressional Review Act of 1996 (5 U.S.C. 801-808), 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 OMB.
For the purposes of Section 223 of the Atomic Energy Act of 1954, as amended
Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs,” approved by the Commission on June 20, 1997, and published in the
The NRC is issuing implementation guidance for this rule, RG 5.83, “Cyber Security Event Notifications” (Docket ID NRC-2014-0036). The guidance is available in ADAMS under Accession No. ML14269A388. Regulatory Guide 5.83 is intended to describe a proposed method that the NRC staff considers acceptable for use in complying with the NRC's regulations on cyber security event notifications. Because the regulatory analysis for the final rule provides sufficient explanation for the rule and the implementing guidance, a separate regulatory analysis was not prepared for the regulatory guide.
The documents identified in the following table are available to interested persons through the following methods, as indicated.
Criminal penalties, Exports, Hazardous materials transportation, Incorporation by reference, Imports, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Security measures.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR part 73.
Atomic Energy Act of 1954, secs. 53, 147, 149, 161, 170D, 170E, 170H, 170I, 223, 229, 234, 1701 (42 U.S.C. 2073, 2167, 2169, 2201, 2210d, 2210e, 2210h, 2210i, 2273, 2278a, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.
Section 73.37(b)(2) also issued under Sec. 301, Public Law 96-295, 94 Stat. 789 (42 U.S.C. 5841 note).
(b) The approved information collection requirements contained in this part appear in §§ 73.5, 73.20, 73.21, 73.24, 73.25, 73.26, 73.27, 73.37, 73.38, 73.40, 73.45, 73.46, 73.50, 73.54, 73.55, 73.56, 73.57, 73.58, 73.60, 73.67, 73.70, 73.71, 73.72, 73.73, 73.74, 73.77 and appendices B, C, and G to this part.
(c) * * *
(1) In §§ 73.71 and 73.77, NRC Form 366 is approved under control number 3150-0104.
(f) * * *
(3) * * * Cyber security event notifications required to be reported pursuant to § 73.77 are considered to be extraordinary conditions.
(d) * * *
(4) Conduct cyber security event notifications in accordance with the provisions of § 73.77.
(a) Each licensee subject to the provisions of § 73.54 shall notify the NRC Headquarters Operations Center via the Emergency Notification System (ENS), in accordance with paragraph (c) of this section:
(1) Within one hour after discovery of a cyber attack that adversely impacted safety-related or important-to-safety functions, security functions, or emergency preparedness functions (including offsite communications); or that compromised support systems and equipment resulting in adverse impacts to safety, security, or emergency preparedness functions within the scope of § 73.54.
(2) Within four hours:
(i) After discovery of a cyber attack that could have caused an adverse impact to safety-related or important-to-safety functions, security functions, or emergency preparedness functions (including offsite communications); or that could have compromised support systems and equipment, which if compromised, could have adversely impacted safety, security, or emergency preparedness functions within the scope of § 73.54.
(ii) After discovery of a suspected or actual cyber attack initiated by personnel with physical or electronic access to digital computer and communication systems and networks within the scope of § 73.54.
(iii) After notification of a local, State, or other Federal agency (
(3) Within eight hours after receipt or collection of information regarding observed behavior, activities, or statements that may indicate intelligence gathering or pre-operational planning related to a cyber attack against digital computer and communication systems and networks within the scope of § 73.54.
(b)
(2) The licensee shall use the site corrective action program to record notifications made under paragraph (a) of this section within twenty-four hours of their discovery.
(c)
(2) Notifications required by this section that contain Safeguards Information may be made to the NRC Headquarters Operations Center without using secure communications systems under the exception in § 73.22(f)(3) for emergency or extraordinary conditions.
(3) Notifications required by this section that contain Safeguards Information and/or classified national security information and/or restricted data must be made to the NRC Headquarters Operations Center using secure communications systems appropriate to the sensitivity/classification level of the message. Licensees making these types of telephonic notifications must contact the NRC Headquarters Operations Center at the commercial numbers specified in appendix A to this part and request a transfer to a secure telephone.
(i) If the licensee's secure communications capability is unavailable (
(ii) Licensees using a non-secure communications capability may be directed by the NRC Emergency Response management to provide classified information to the NRC over the non-secure system, due to the significance of the ongoing security event. In such circumstances, the licensee must document this direction and any information provided to the NRC over a non-secure communications capability in the written security follow-up report required in accordance with paragraph (d) of this section.
(4) For events reported under paragraph (a)(1) of this section, the NRC may request that the licensee maintain an open and continuous communication channel with the NRC Headquarters Operations Center.
(5) Licensees desiring to retract a previous security event report that has been determined to not meet the threshold of a reportable event must telephonically notify the NRC Headquarters Operations Center and indicate the report being retracted and basis for the retraction.
(6)
(7)
(d)
(1) Licensees are not required to submit a written security follow-up report following a telephonic notification made under § 73.77(a)(2)(iii) or (a)(3).
(2) Each licensee shall submit to the NRC written security follow-up reports that are of a quality that will permit legible reproduction and processing.
(3) Licensees shall prepare the written security follow-up report on NRC Form 366.
(4) In addition to the addressees specified in § 73.4, the licensee shall also provide one copy of the written security follow-up report addressed to the Director, Office of Nuclear Security and Incident Response, or the Director's designee. Any written security follow-up reports containing classified information shall be transmitted to the NRC Headquarters' classified mailing address as specified in appendix A to this part.
(5) The written security follow-up report must include sufficient information for NRC analysis and evaluation.
(6) Significant supplemental information which becomes available after the initial telephonic notification to the NRC Headquarters Operations Center or after the submission of the written security follow-up report must be telephonically reported to the NRC Headquarters Operations Center under paragraph (c) of this section and also
(7) Errors discovered in a written security follow-up report must be corrected in a revised written security follow-up report with the revision(s) indicated.
(8) The revised written security follow-up report must replace the previous written security follow-up report; the update must be complete and not be limited to only supplementary or revised information.
(9) If the licensee subsequently retracts a telephonic notification made under this section as not meeting the threshold of a reportable event, and has not yet submitted a written security follow-up report then submission of a written security follow-up report is not required.
(10) If the licensee subsequently retracts a telephonic notification made under this section as not meeting the threshold of a reportable event after it has submitted a written security follow-up report required by this paragraph, then the licensee shall submit a revised written security follow-up report in accordance with this paragraph.
(11) Each written security follow-up report submitted containing Safeguards Information or Classified Information must be created, stored, marked, labeled, handled, and transmitted to the NRC according to the requirements of §§ 73.21 and 73.22 or with part 95 of this chapter, as applicable.
(12) Each licensee shall maintain a copy of the written security follow-up report of an event submitted under this section as a record for a period of three years from the date of the report or until the Commission terminates the license for which the records were developed, whichever comes first.
For the Nuclear Regulatory Commission.
Farm Credit Administration.
Notice of effective date.
The Farm Credit Administration (FCA or our) amended our regulations related to mergers and consolidations of Farm Credit System banks and associations to clarify the merger review and approval process and incorporate existing practices in the regulations. In accordance with the law, the effective date of the rule is no earlier than 30 days from the date of publication in the
The Farm Credit Administration (FCA or our) amended our regulations related to mergers and consolidations of Farm Credit System banks and associations to clarify the merger review and approval process and incorporate existing practices in the regulations. In accordance with 12 U.S.C. 2252, the effective date of the final rule is no earlier than 30 days from the date of publication in the
Farm Credit Administration.
Notice of policy statements and index.
The Farm Credit Administration (FCA), as part of its annual public notification process, is publishing for notice an index of the 18 Board policy statements currently in existence. Most of the policy statements remain unchanged since our last
November 2, 2015.
A list of the 18 FCA Board policy statements is set forth below. FCA Board policy statements may be viewed online at
On August 18, 2015, the FCA Board updated FCA-PS-62 on, “Equal Employment Opportunity and Diversity.” The policy was published in the
On August 31, 2015, the FCA Board updated FCA-PS-44 on, “Travel” and FCA-PS-64 on, “Rules for the Transaction of Business of the Farm Credit Administration Board.” Those were not previously published in the
EFFECTIVE DATE: August 31, 2015
EFFECT ON PREVIOUS ACTIONS: Originally adopted 13-JUN-91; amended 12-NOV-92; amended 08-JUL-11; amended 31-AUG-15.
SOURCE OF AUTHORITY: 5 U.S.C. 7351, 7353; 5 U.S.C. App. (Ethics in Government Act of 1978); E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. 215, as modified by E.O. 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306; 12 U.S.C. 2242 (Section 5.8 of the Farm Credit Act of 1971, as amended), 41 CFR Part 301.
Members of the Farm Credit Administration (FCA or Agency) Board are not subject to the same requirements regarding allowances for travel and subsistence that generally apply to officers and employees of the United States (§ 5.8 of the Farm Credit Act of 1971, as amended). Nevertheless, it is the general policy of the FCA Board (Board) that Board members will travel on official business in the most economical fashion reasonable under the circumstances.
FCA Board members are subject to Federal laws, rules, and Executive Orders relating to conflicts of interest that may result from accepting gifts, including travel related expenses, from outside sources. Generally, Board members may not accept anything of value from:
• A person seeking official action from, doing business with, or conducting activities regulated by the FCA, or
• A person whose interests may be substantially affected by the performance or nonperformance of our official duties.
The gift rule under the standards of ethical conduct and the Agency's gift acceptance authority at 31 U.S.C. § 1353 outline the limited circumstances in which government officials may accept gifts and the payment of travel expenses from outside sources. Unless an exception applies, ethics rules prevent Board members from accepting gifts offered because of their official positions. Under no circumstances may Board members accept anything of value in return for being influenced in the performance of an official act. The aim of these rules is to prevent an actual conflict of interest or the appearance of a conflict and to uphold public confidence in the integrity of the Government and the Agency.
Except as noted above, third parties may not pay for official Agency expenditures. Because the Agency is responsible for the cost of conducting official business, Board members will ensure that the Agency is billed directly for travel expenses whenever possible (for example, by using a Government issued credit card for travel expenses). On those occasions when direct Agency payment is impossible or impractical (for example, a large group business dinner arranged and paid for in advance by the organizer), Board members will promptly notify the Agency of the obligation and ensure that the payer is promptly reimbursed. Board Members recognize that it is important not to create the impression that a third party, particularly a prohibited source, is paying for their expenses.
Board members will use less than first-class accommodations for all modes of transportation except in circumstances where:
1. A Board member must use first-class accommodations because no other space accommodations are reasonably available or where other practical considerations exist (such as to accommodate a disability or other special need);
2. Exceptional security circumstances require it;
3. The conduct of Agency business requires it; or
4. A Board member receives first-class travel benefits on an unsolicited basis from a carrier (such as free first-class coupons) and the benefit cannot be used by the Agency either in the present or the future, cannot be redeemed for cash value, and does not require the redemption of official miles. Under these circumstances, Board members can use the first-class benefit for either official or personal travel.
Board members will use a commercial charter flight at Agency expense only when no commercially scheduled flights are available in time to meet the requirements of the travel or when the charter flight would be more economical than a commercial flight. Board members will avoid the use of private aircraft whenever possible and use them only where commercial or charter flights are not reasonably available or would impose undue hardships. When reporting travel expenses, Board members must adequately justify the use of a commercial charter flight, private aircraft, or first-class accommodations.
When available and practical, Board members will book lodging at the Government rate or another available reduced rate at hotels and motels. When attending a convention, meeting, or other official activity, Board members will ordinarily obtain lodging at the hotel or motel holding the activity even if reduced rates are available elsewhere. Board members may also book more than one room when necessary for the conduct of official business on the premises.
The Agency will not ordinarily reimburse Board members for lodging in the metropolitan Washington, DC, area unless they have relocated in a holdover status. However, lodging may be necessary to take full advantage of a conference.
The FCA will reimburse Board members for the usual and reasonable expenses incurred as a consequence of official activities in the Washington, DC, metropolitan area and in other locations. The Agency will allow the repayment of expenses for:
1. Transportation costs;
2. Meal costs;
3. Registration fees or other fees assessed for attendance or participation;
4. The cost of miscellaneous supplies needed to participate in a particular function or activity; and
5. Other costs we incur by participating in official activities.
The Agency will
Board members will arrange for official travel using the Agency's travel management system whenever possible. Although Board members may use cash to pay for official travel expenses and seek repayment from the Agency afterwards, whenever possible, the preferred method of payment will be the use of the Government-issued credit card for all official travel expenses.
When filing claims for reimbursement of travel expenses, Board members will provide receipts for expenses as normally required of other FCA employees under the Federal Travel Regulation, which currently requires receipts for all lodging and travel expenses over $75. However, failure to provide a receipt as normally required is not grounds for denial of a claim. If a receipt is not available, Board members will provide a statement explaining the nature and amount of the expense and the reason for not having a receipt.
Although it is permissible to engage in personal activities while on official travel, the purpose of the trip must always be the need to conduct official business. The Agency pays for travel and related expenses incurred in performing official business. However, the Agency may
The Board is aware that, in certain circumstances, engaging in personal activities while on official travel could create an appearance that personal activities, not official business, prompted the trip. When Board members take a trip to conduct official business, it is usually clear from the nature of the business that the trip is proper and necessary. If there are concerns that personal activities during the trip might suggest otherwise, Board members will consult the DAEO to avoid a possible appearance of impropriety. The Board understands that engaging in official travel that involves a given destination (for example, our home state) on a disproportionate basis may raise questions about whether the travel truly is necessary. Again, Board members will consult with the DAEO about such concerns.
DATED THIS 31st DAY OF AUGUST, 2015
BY ORDER OF THE BOARD
EFFECTIVE DATE: August 31, 2015
EFFECT ON PREVIOUS ACTION: Originally adopted by NV-94-05 (07-FEB-94)[FCA-PS-58]; corrected by memo 09-FEB-94; amended by NV-95-03 (13-JAN-95)[FCA-PS-64]; amended by NV-95-18 (20-MAR-95); amended by NV-95-46 (9-AUG-95); amended by BM-24-OCT-95-02; amended by NV-95-69 (02-JAN-96).
SOURCE OF AUTHORITY: Sections 5.8, 5.9, 5.10, 5.11 and 5.17 of the Farm Credit Act of 1971, as amended.
“
“
“
“
“
“
“
“
“
“
“
Article I. Board Meetings.
Article II. Board Action.
Article III. Board and Chairman Delegations.
(a)
(b)
(1) By the Chairman; or
(2) By the other two Board Members; or
(3) If there is at the time a vacancy on the Board, by a single Board Member.
Any call for a Special Meeting will specify the business to be transacted and state the place and time of such meeting. No business will be brought before a Special Meeting that has not been specified in the notice of call of such meeting without the unanimous consent of all Board Members.
(c)
(a)
(b)
(a)
(b)
(a)
(b)
(a) Nothing in these Rules precludes the transaction of business by the circulation of written items (notational votes) to the Board Members.
(b) The Board may use notational voting procedures to decide any matter that may come before it. Any Board Member may submit a motion to the Secretary for distribution as a notational vote. However, in view of the public policy of openness reflected in the Sunshine Act and the desire to allow any Board Member to present viewpoints to the other Board Members, any Board Member can veto the use of the notational voting procedure for the consideration of any particular matter by voting “not appropriate for notational vote.”
(c) Upon submission of an item for notational vote, the Secretary will provide each Board Member a complete package of all relevant information and a notational vote ballot specifying the Board Member making the motion, the motion itself, and the deadline for return of the ballot. Within ten business days of receipt, or earlier if the motion requires, each Board Member will act on the matter by returning the ballot to the Secretary. Each Board Member is to indicate his/her position in writing on the ballot in the following manner: (1) Approve, (2) disapprove, (3) abstain, or (4) not appropriate for notational vote.
(d) No partial concurrences or amendments are permitted; however, a Board Member may suggest a revision to the proponent of the motion, subject to compliance with the Sunshine Act, and the proponent may withdraw his or her motion at any time before receipt by the Secretary of all the ballots of all Board Members or the end of the time period provided for on the ballot.
(e) A Board Member who is absent from the office may authorize a staff member to initial the ballot for him/her, provided that the Board Member has a designation memorandum on file with the Secretary.
(a) The approval of actions of the Farm Credit System (System) institutions that are required by statute, regulations or otherwise to be approved by the FCA or its Board;
(b) The exercise of all powers of enforcement granted to the FCA by statute, including but not limited to, the authorities contained in 12 U.S.C. 2154, 2154a, 2183, 2202a, and 2261-2274; and
(c) Any actions or approvals required in connection with the conduct of a receivership or conservatorship of a System institution.
Authorities delegated by this Section may be re-delegated, in writing, at the discretion of the remaining Board Member, to other FCA officers or employees.
(a) Member of the Board of the Chairman's political party;
(b) If there is no other Board Member from the Chairman's political party, the Board Member serving the longest on the Board;
(c) General Counsel.
The Chairman or Acting Chairman will ensure that FCA has an alternative location for its headquarters functions in the event a national security emergency renders FCA's headquarters inoperative. The Chairman or Acting Chairman may establish such branch office or offices of the FCA as are necessary to coordinate its operations with those of other government agencies.
Article I. Board Governance.
Article II. Staff Governance.
The Board recognizes that for the Agency to run efficiently, the Chairman/CEO must have sufficient latitude and discretion to direct the implementation of Board policies and run the Agency's day-to-day affairs. Notwithstanding such latitude, the other Board Members must have access to staff and must be able to request information from staff that they find necessary to fulfill their policy- and rulemaking responsibilities under the Act.
The Chairman/CEO is always free to bring to the Board issues that do not require Board action. Conversely, the Board may involve itself in operational matters ordinarily reserved for the Chairman/CEO if it concludes that they rise to the level of policy due to their sensitivity, seriousness, or controversial nature.
The Chairman, in carrying out policies as directed by the Board, acts as spokesperson for the Board and represents the Board and the FCA in official relations within the Federal Government. Under policies adopted by the Board, the Chairman must consult on a regular basis with the Secretary of the Treasury concerning the exercise of the System's powers under § 4.2 of the Act; the Board of Governors of the Federal Reserve System concerning the effect of System lending activities on national monetary policy; and the Secretary of Agriculture concerning the effect of System policies on farmer, ranchers, and the agricultural economy. As to third persons, all acts of the Chairman will be conclusively presumed to be in compliance with general policies and regulatory decisions, findings, and determinations of the Board.
The Chairman enforces the rules, regulations, and orders of the Board. The Chairman designates attorneys to represent the Agency in any civil proceeding or civil action brought in connection with the administration of conservatorships and receiverships and in civil proceedings or civil actions when so authorized by the Attorney General under provisions of title 28 of the United States Code. The Chairman, subject to the approval of the Board, may establish one or more advisory committees in accordance with the Federal Advisory Committee Act.
The Chairman may not delegate any of the foregoing powers without prior Board approval.
The Chairman also exercises those powers conferred on the Head of the Agency, including the power to make certain designations.
“Consultation with the Board” is achieved when the Chairman/CEO makes a good faith attempt to seek advice, guidance, and input from the Board before taking significant action on matters related to the execution of administrative functions or duties.
The Chairman as CEO runs the day-to-day operations of the Agency. This includes the power to implement the policies and regulations adopted by the Board, appoint personnel as necessary to carry out Agency functions, set staff pay and benefits and direct staff. As provided in § 5.11(b) of the Act, the Chairman/CEO appoints heads of major administrative divisions subject to the approval of the Board. In accordance with the IG Act, the IG is appointed by the FCA Board.
The Chairman as CEO may designate to other FCA officers and employees the authority to exercise and perform those powers necessary for the day-to-day management of the Agency.
Subject to the approval of the Board, the Chairman/CEO appoints and removes the “heads of major administrative divisions.” The Board defines the “heads of major administrative divisions” as all Office Directors who are career appointees. The Board must approve the conversion of an existing career position to a non-career (political) position. In accordance with the IG Act, a removal of the IG may only be made upon the written concurrence of a 2/3 majority of the FCA Board.
Article I. Committee and Financial Operations, and Other Activities.
Article II. Board Member Travel and Related Expenses.
Each Committee Chair will be designated by the Chairman. Each committee will be comprised of the Board Members' Executive Assistants and such Agency staff as determined by the Committee Chair. The Committee
(a)
(b)
(c)
The IG, in accordance with the IG Act, transmits a budget estimate specifying an aggregate amount for OIG operations, OIG training needs, and amounts for support of the Council of the Inspectors General on Integrity and Efficiency.
(a)
(b)
(c)
(1)
The Board must approve all documents published in the
The issuance of a “no action” letter is a policy matter requiring Board approval. For the purposes of this statement, a “no action” letter is a statement to a Farm Credit institution that, notwithstanding any other provision of law or regulation, the Board will take no action against a System institution solely because it engaged in conduct specified in the letter.
Authority to promulgate internal administrative issuances, including FCA Policies and Procedures Manual (PPM) issuances, rests with the Chairman and may be delegated to the Chief Operating Officer. The Chairman will provide the Board with final drafts of PPM issuances and other administrative issuances for an appropriate consultative period if those issuances relate to examination and supervision, audits, internal controls, the budget, the strategic planning process, regulation development, or personnel matters relating strictly to promotion or pay.
(2)
(3)
(4)
• Statements authenticating copies of, or excerpts from official records and files of the FCA;
• Effective periods of regulations, orders, instructions, and regulatory announcements on the basis of the records of the FCA;
• Appointment, qualification, and continuance in office of any officer or employee of the FCA, or any conservator or receiver acting in accordance with the FCA receivership regulations at 12 CFR part 627 on the basis of the records of the FCA.
The Chairman may further empower the designated official(s) to sign official documents and to affix the seal of the FCA thereon for the purpose of attesting the signature of officials of the FCA.
Travel that may result in substantial benefit to the FCA could include meetings, briefings, conferences, or other similar encounters between the nominee and FCA Board Members, office directors, the Chief Operating Officer, or other senior congressional and executive branch officials, for the purpose of developing substantive knowledge about the FCA, its role, its interaction with other Government entities, or the institutions that it regulates. Meetings or briefings of this nature may enable a nominee to more quickly and effectively assume leadership at the Agency after confirmation by the Senate and could thus substantially benefit the Agency.
Board Members will be reimbursed by FCA for travel and transportation expenses incurred in connection with relocation to their first official duty station. Reasonable expenses for which reimbursement, as approved by the Chairman/CEO, will be allowed generally include, but are not limited to the following:
(a) Travel and per diem for the Board Member.
(b) Travel, but not per diem, for immediate family of the Board Member.
(c) Mileage if privately owned vehicle is used in travel; and
(d) Transportation and temporary storage of household goods.
Each relocation will be considered separately and all rates and allowances will be determined at the time of authorization, notwithstanding the limitations of 5 U.S.C., Chapter 57 and the Federal Travel Regulations, as provided in § 5.8(d) of the Act. Reimbursement of additional expenses may be authorized if warranted by specific circumstances. Board Members will be issued a specific prior written authorization by the Chief Operating Officer detailing the expenses that may be reimbursed.
It is in the Agency's best interest to maintain a full complement of Board Members. The Agency is sensitive to the uncertainty and extra expenses often incurred by Board Members that serve past the expiration of their official appointment and prior to their successor's appointment. In accordance with § 5.8(b) of the Act, a Board Member “shall continue to serve as such after the expiration of the member's term until a successor has been appointed and qualified.” To that end, a Board Member, not serving as FCA Chairman, in a holdover status may prefer to perform their official duties from another U.S. location outside of the Washington, DC area, recognizing that they still have an obligation to devote their full time and attention to the business of the Board as required by § 5.8(d) of the Act. In such a case, the Board Member's duty station may be changed from FCA headquarters to a new location. Such a Board Member will be reimbursed for regularly scheduled official travel to headquarters upon authorization by the Chief Operating Officer. For other official travel, Board Members that serve in continuation will be reimbursed subject to the Board travel policy outlined in PS-44.
In addition, Board Members serving as a holdover who change their duty station will be reimbursed by FCA for travel and transportation expenses incurred in connection with relocation to their new location. Reimbursement for reasonable expenses, as approved by the Chief Operating Officer, will be limited to:
(a) Travel and per diem for the Board Member.
(b) Travel, but not per diem, for immediate family of the Board Member.
(c) Mileage if privately owned vehicle is used in travel; and
(d) Transportation and temporary storage of household goods.
Board Members will be issued a specific prior written authorization by the Chief Operating Officer detailing the expenses that may be reimbursed.
“Official functions” include meetings and other contacts with the public to explain or further the Agency's mission and typically are activities of the FCA Board, individual Board Members, or other FCA officials acting for the Board. For example, while extending official courtesies to the public on occasions associated with the mission of the Agency, FCA staff may use the R&R Fund to cover catering services, rental of facilities, receptions, coffee, snacks, refreshments, supplies, services and tips. Consistent with opinions of the Comptroller General, the FCA Board has determined, as a matter of policy, that it will not permit the R&R Fund to be used for events or functions in which attendance is restricted to Agency employees.
Similarly, the R&R Fund may not be used for activities relating solely to “personal entertainment” (interpreted by the Comptroller General to include attendance at a sporting event or
The FCA Board has determined, as a matter of policy, that the R&R Fund shall be a fund of last resort and shall not be used for expenses that can properly be classified as another type of Agency expense.
The FCA Board will decide how much to budget for the R&R Fund. The FCA Board will approve any amount available for R&R expenses for the Chairman and each Board Member, and an amount available for general R&R expenses. The amount approved for use by the Chairman and each Board Member will be maintained in their budget code. The amount approved for general R&R will be maintained in a separate budget class code by the Secretary.
DATED THIS 31st DAY OF AUGUST, 2015
BY ORDER OF THE BOARD
Part 1—
1. Issuances or revisions to:
• The FCA Examination Manual, examination criteria, and examination procedures;
• The FCA Uniform Call Report instructions;
• Examination plans and general guidance provided to examiners, except those relating to Agency positions not previously approved by the Board.
2. Requests for information on:
• Call Reports, LARS, or similar data requests;
• Young, beginning, and small farmers and ranchers reports;
• Other reports as required by statute or determined necessary by the Board (consistent with Board instruction).
3. Information that is being provided on:
• Fraudulent activities;
• Removals/suspensions/prohibitions;
• Other related activities.
4. Documents that have been issued by other Federal agencies including regulations, official staff commentary on regulations, and forms;
5. FCA Handbook updates;
6. Annual Report of Assessments and Expenses under 12 CFR 607.11;
7. Office of Inspector General mailings for official purposes;
8. Vacancy Announcements;
9. PPM mailings.
1. Agency policy;
2. Agency legal interpretations;
3. Substantive Agency positions on examination, corporate or accounting;
4. No-action positions;
5. Any communication listed in Part 1 containing any of the matters listed in Part 2 would also require review by the FCA Board prior to distribution.
1. The FCA Board delegates to the Chairman the authority to:
a. Sign letters notifying the Chairman of the Boards of Farm Credit System institutions of final approval for
b. Execute and issue under the FCA seal the new charter or charter amendment document for such institutions; and
c. Sign certificates of charter after new charters and charter amendments are executed.
The Chairman may re-delegate the authority in item “a” to other FCA officers or employees as needed.
2. The FCA Board delegates to the Chairman the authority to approve (preliminary and final) corporate applications from associations requesting to merge or consolidate provided the applications are deemed noncomplex, noncontroversial, and low risk.
Applications for mergers or consolidations approved under authority of § 7.8 of the Act will be considered noncomplex, noncontroversial, and low risk if they meet all of the following criteria:
a. The applicant association(s) has a current FIRS rating of 1, 2, or 3 (with no 3-rated association having a formal enforcement action);
b. The continuing or resulting association(s) has a gross loan volume of $500 million or less;
c. The application(s) is consistent with the Act and regulations governing its approval, and
d. There are no policy or precedent-setting decisions embedded in the request.
3. The FCA Board delegates to the Chairman the authority to approve, execute, and issue under the seal of the FCA, amendments to charters requested by Farm Credit associations, limited to name changes and/or headquarters relocations. The Chairman may redelegate this authority to other FCA officers or employees. However, all official charters or charter amendments must be signed by the Chairman and the Secretary and may not be delegated to other staff.
Federal Trade Commission (“FTC” or “Commission”).
Final rule.
The Commission issues final amendments to expand coverage of the Lighting Facts label, require room air conditioner labels on packaging instead of the units themselves, enhance the durability of appliance labels, and improve plumbing disclosure requirements. This Notice completes the Commission's recent regulatory review of the Energy Labeling Rule.
The amendments published in this document are effective on December 2, 2015, except for the amendments to § 305.11, which become effective November 2, 2016, and §§ 305.3(z), 305.8, 305.15, 305.20, and Appendix L, which become effective November 2, 2017.
Relevant portions of this proceeding, including this document, are available at
Hampton Newsome, (202) 326-2889, Attorney, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580.
The Commission issued the Energy Labeling Rule (“Rule”) in 1979,
The Rule requires manufacturers to attach yellow EnergyGuide labels for many of the covered products and prohibits retailers from removing the labels or rendering them illegible. In addition, the Rule directs sellers, including retailers, to post label information on Web sites and in paper catalogs from which consumers can order products. EnergyGuide labels for covered products contain three key disclosures: Estimated annual energy cost (for most products); a product's energy consumption or energy efficiency rating as determined from Department of Energy (DOE) test procedures; and a comparability range displaying the highest and lowest energy costs or efficiency ratings for all similar models. For energy cost calculations, the Rule specifies national average costs for applicable energy sources (
In a March 15, 2012
On June 18, 2014 (79 FR 34642), the Commission published a Supplemental Notice of Proposed Rulemaking (SNPRM) seeking comments on a broad array of issues raised over the course of the review proceeding and proposing related amendments.
In the present Notice, the Commission concludes the regulatory review by issuing final amendments for expanded light bulb labeling, improvements to appliance and room air conditioner labels, and updates to plumbing requirements. In a separate Notice, the Commission proposes several amendments on issues that have arisen recently or require additional consideration, including a new online database, revised central air conditioner labels, refrigerator ranges, new ceiling fan labels, and revised labels for heating and cooling equipment in response to recent DOE efforts.
The 2014 SNPRM sought comment on labeling for specialty bulb types with energy use or light output similar to the general service bulbs already covered by the Lighting Facts label. The proposal set specific wattage and light output thresholds and excluded bulbs with shapes or uses not generally sought by typical consumers (
The National Electrical Manufacturers Association (NEMA) supported the proposed labeling for most lamps under the proposed coverage,
The final rule sets specific thresholds for wattage and light output for covered bulbs and excludes certain bulbs for which labeling is not likely to provide substantial consumer benefit. The new rule includes special marking provisions for some bulbs and provides a smaller, single-label option for smaller packages. For consumer bulbs not covered by the requirements, manufacturers may use the Lighting Facts label if they follow the Rule's content and format requirements.
The new requirements are consistent with EPCA's directive to develop labels that help consumers with their purchasing decisions.
The Commission addresses the following specific issues raised during the proceeding: Product coverage, exclusions, package size, product markings, testing, voluntary labeling, compliance period, watt-equivalence claims, and color appearance.
The final rule meets the statute's directive to provide labels that will assist consumers in purchasing the most efficient bulbs among common bulb types on store shelves. Specifically, the new labels will provide a means for consumers to compare the energy use, brightness, and other attributes of commonly available bulb types and technologies that are likely to appear side-by-side on store shelves with general service bulbs. The record suggests that the newly-covered bulbs have a significant market presence, are available in models that have light output or energy use ratings similar to general service bulbs, and often come in different technologies (with their different energy costs).
A-shape:—Often available in medium bases; used in residential applications, including ceiling fans; used for incandescent rough service and shatter proof bulbs at high wattages;
B-shape:—Decorative “torpedo” shaped bulbs used in residential applications; available in CFL and LED versions; previous NEMA comments suggest that 40-watt or fewer B-shape lamps account for about 7% of the incandescent market;
BA and CA shape:—Bent tip decorative lamps used in residential settings; available with medium and candelabra bases; wattages as a high as 60; available in incandescent and LED versions; represents between 6-7% of the incandescent market according to NEMA comments;
F-Shape:—Decorative flame-shaped bulb; use as much as 40 watts; available in CFL and LED versions;
G-Shape:—Often used in residential bathrooms; available in CFL and LED versions; according to comments, G16
Spiral shape:—Commonly used for CFLs with intermediate screw bases and GU-24 pin-based bulbs; increasingly used in new construction.
In response to comments about small specialty bulb packages, the final rule also contains a special provision for very small blister packs that cannot accommodate the required label on the front. The final rule states that, if the required disclosures (
The Rule currently permits manufacturers of refrigerators, dishwashers, and clothes washers to
Concerned that hang tags may be less secure and more prone to detachment than adhesive labels, the Commission, in its March 15, 2012 NPRM, proposed prohibiting hang tags for clothes washers, dishwashers, and refrigerators.
In the 2014 SNPRM, the Commission, recognizing the legitimate concerns raised in the comments, did not propose eliminating hang tags altogether. Instead, it proposed requiring that hang tags be affixed to products using cable ties (
The Joint Commenters agreed that hang tags should be more durable but recommended the Rule require reinforced punch holes on all hang tag labels, independent of the attachment method. They also argued that this would improve the uniformity of labels' appearance. Though the California Utilities supported the proposal, they noted that adhesive labels on the inside panels of products would address manufacturer concerns about damage to stainless steel products.
In contrast, appliance industry members opposed the proposal because, in their view, it would increase manufacturers' costs without accomplishing the goal of decreasing the incidence of missing labels. The Association of Home Appliance Manufacturers (AHAM) asserted that the SNPRM did not provide adequate evidence that the proposal will increase label durability or, more importantly, that increased label durability will reduce the incidence of missing labels. It stated that, because the attaching material (cable tie, double string, etc.) is stronger than the reinforced paper used for the label, a determined consumer (or retailer) can easily remove the tag. In addition, some refrigerators, particularly those lacking a wire shelf or door handle, have no location to affix a cable or string hang tag without taping the string or cable tie to the shelf. Instead of new labeling requirements, AHAM urged the Commission to find ways for retailers to display labels in such a way that consumers do not try to detach them (or that retailers themselves do not feel compelled to remove them to effectively display the product). According to AHAM, retailers are in the best position to display labels in a way that prevents removal.
Both Alliance Laundry Systems and AHAM also repeated earlier requests to limit the Rule's label requirements to display models. They explained that most labels never appear on the showroom floor because retailers only use a handful of units as display models. For most units, consumers view the labels only upon delivery in their home. At that point, consumers generally want to remove the label from the products. Alliance therefore recommended that the Commission consider options that remove the burden associated with affixing physical labels on every unit.
Similarly, AHAM urged the Commission to consider eliminating physical labels on every unit sold and, instead, rely on electronic labels on Web sites. The Joint Commenters disagreed, arguing that, even though consumers may conduct online research prior to purchase, labels in showrooms are still necessary to allow consumers to examine multiple competing products.
As discussed in earlier notices, more durable hang tag labels should increase the likelihood that labels remain affixed to products in showrooms. The Commission understands that determined consumers can remove labels from showroom products. However, the new requirements are not intended to prevent such deliberate actions. Rather, by their nature, the stronger labels should increase the likelihood that labels will remain on products during shipping and handling through the retail chain and during normal examination and inspection by consumers.
While the final rule increases the durability of labels, it provides manufacturers flexibility to use label methods most suited to their products. In recent informal visits to retail stores, the FTC staff has observed that manufacturers currently use a variety of means to attach labels on refrigerators, dishwashers, and clothes washers including conventional adhesive labels affixed to an interior or exterior surface, labels attached with wide pieces of reinforced tape on the top and bottom, hang tags attached with cable ties, hang tags attached with string, and hang tags made of laminated paper or plastic. Labels taped onto models across the entire top and bottom edge of the label appear to provide durability similar to a traditional adhesive label. Likewise, hang tags made of laminated paper or plastic provide durability similar to a
Finally, as explained above, the Commission does not propose abandoning physical labels. Notwithstanding the growing availability of Internet access, physical labels, especially those displayed at the point-of-sale, likely help a substantial number of consumers. Not all consumers have convenient online access, and not all of those who do conduct online research before making purchase decisions in stores. Moreover, even consumers who research products online are likely to benefit from viewing the physical labels in the store as they make final decisions and compare products at the point-of-purchase.
The Commission also proposed two changes related to recent DOE regulatory actions. First, it proposed to amend the room air conditioner label to replace Energy Efficiency Ratio (EER) ratings with Combined Energy Efficiency Ratio (CEER) ratings consistent with recent DOE changes for these products. The Commission indicated that the differences between EER and CEER should be minor. The Commission also proposed conforming changes to the label's capacity description for room air conditioners in section 305.7 and ratings on Sample Label 4. Second, the Commission proposed requiring EnergyGuide labels for portable air conditioners, in light of a recent DOE proposal to designate portable air conditioners as covered products under EPCA.
The Joint Commenters repeated their earlier recommendation to require labels on both room air conditioner boxes and on the units themselves because a substantial portion (21%) of the models observed by FTC staff were displayed only outside of their boxes. The commenters explained that their own observations indicate the practice is even more common, though they did not provide specifics. They also argued the operating cost information on the room air conditioner label is particularly important because most households that rely on one or more room air conditioners have an annual household income below $40,000. Additionally, they noted that room air conditioner labels can provide important information to renters who pay for equipment operation but do not purchase the units themselves.
Finally, the Joint Commenters urged the Commission to consider creating an affirmative labeling requirement for retailers who chose to display their room air conditioner without boxes. The commenters explained that, even if FTC does not require manufacturers to label both the room air conditioner and its packaging, EPCA grants the Commission authority to “require disclosure, in any printed matter displayed or distributed at the point-of-sale of such product.” 42 U.S.C. 6294(c)(4).
AHAM indicated it did not object to requiring EnergyGuide labels on room air conditioner boxes as long as Natural Resources Canada (NRCAN) harmonizes its EnerGuide requirements with the Commission's. Absent such harmonization, AHAM strongly opposes the proposal because it would impose substantial burdens by forcing manufacturers to create labels for both the product (to meet Canadian requirements) and the box (to meet U.S. requirements). Accordingly, AHAM recommended that FTC work on such harmonization, consistent with the President's directive regarding international regulatory cooperation. AHAM also recommended a two year period to implement the changes.
The comments also supported the proposal to replace the EER reference on the room air conditioner label with CEER. AHAM, which proposed this change in earlier comments, explained that the switch would make the label consistent with the efficiency metric manufacturers currently report to DOE. The California Utilities also supported the proposal but further recommended disclosures for all efficiency metrics specified in the DOE energy conservation standards. Specifically, they reiterated their recommendation to require reporting of energy factor for water heaters, in addition to the cost and energy use. They stressed the importance of efficiency performance information to consumers and other market actors, particularly in the implementation of various national, regional, state, and utility programs. The commenters further recommended that the labels disclose any performance metric required for compliance with energy efficiency standards, including regulated performance metrics for room ACs, central ACs, and water heaters.
The final rule provides manufacturers with flexibility. Specifically, manufacturers have the flexibility to choose a background color for the label, thus avoiding full redesign of some boxes. In addition, manufacturers may use stickers on the box itself, allowing easy label updates in response to test procedure or range changes. With the notice provided by this proceeding, manufacturers should be able to incorporate the label on packaging without additional burden. The labels must appear on the package's principal display panel, that part of a label most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale.
In the SNPRM, the Commission explained that it is not proposing to require labels on both the product and the box. Over the years, retailers have shifted away from displaying most room air conditioner models outside of packaging. Given this trend, the Commission expects that retailers will continue to display the vast majority of these products in boxes. While some retailers may display some models outside the packaging, the label's absence is mitigated in those limited situations by recent provisions increasing the labels' availability to consumers online.
Finally, given concerns raised by commenters about coordinating with Canadian labeling, the Commission will not announce a final compliance date for these new requirements until NRCAN implements conforming regulatory changes. Such coordination will prevent the burden of labeling units in two places (
In addition, the California Utilities recommended that the Commission require disclosures such as water heater energy factor (EF) information to help consumers and aid in compliance with state building code standards. The Commission declines to change the Rule at this time. The labels for heating and cooling equipment already display metrics applicable to federal standards, including SEER, EER, and AFUE where appropriate. For central air conditioners, the Commission recently required EnergyGuide labels on product packaging for many models and these labels include SEER information as the primary disclosure. 78 FR 8362 (Feb. 6, 2013). For water heaters, the current label includes yearly energy cost as the primary disclosure. It is unclear whether the inclusion of EF information would be helpful because we have no evidence that most consumers are familiar with the term. In addition, state code enforcers can obtain such EF information from DOE's Compliance Certification Management System (CCMS) database.
The Notice also indicated that the FTC staff would continue to consider providing full-fuel cycle and greenhouse gas information to consumers, on labels or elsewhere, and keep track of DOE's efforts to incorporate full-fuel-cycle analysis into their decision-making.
The comments explained that “site” energy disclosures only provide information about the energy an appliance consumes in the home. According to AGA, such “site” energy information is not only inadequate, but can be misleading to consumers who may assume that a higher “site” efficiency rating means that an appliance uses less energy and emits fewer greenhouse gases overall. “Full‐fuel‐cycle” energy information addresses this shortfall by including not only energy consumption in the consumer's home, but also the losses that occur in the transportation and distribution of the fuel or its generation, as well as the energy consumed in its production or extraction. In AGA's view, full‐fuel‐cycle disclosures enable a more accurate analysis of the total energy usage and environmental impacts.
These commenters also argued that source-based energy information would allow utilities, state regulators, and consumers to understand the environmental benefits or costs, including the greenhouse gas emissions associated with appliance use.
APGA also noted that DOE, the National Academy of Sciences, and the ENERGY STAR program have recognized the shortcomings of site-based analysis. It explained that labels derived using a source based approach will fully identify the emissions reduction through the entire energy cycle. AGA agreed, arguing that the label or other required disclosures should include information reflecting the energy use, life‐cycle cost, and associated emissions on a full‐fuel‐cycle basis. AGA recommended consideration of full‐fuel‐cycle energy use and emissions information on a regional basis.
The commenters urged the Commission to expedite interaction with DOE on this issue. According to AGA, DOE already has all the information available through the existing residential furnace efficiency test procedure on full-fuel-cycle and emissions data. DOE agreed to work with the Commission to improve existing online databases, to increase consumer access to energy use and emissions data through web‐based information tools, and to collaboratively determine if changes to the Energy Guide labeling requirements would be beneficial to consumers. 76 FR 51281 (Aug. 18, 2011).
The comments raise concerns about the failure of “site” efficiency rating disclosures (
In contrast, several comments supported the five-year update schedule. Alliance Laundry Systems argued the current approach maintains certainty, allowing manufacturers to plan for label changes, lowers scrap costs of the printed labels, and reduces disruption to the manufacturing process. It also reduces consumer confusion in the marketplace because more frequent fuel energy rate and range changes would yield energy labels with differing descriptors on the same model manufactured on different dates. AHAM argued that frequent updates could also impact label information during the transition periods and make it difficult for consumers to compare old and new labels. AHAM, therefore, argued that the existing five-year schedule strikes the proper balance between maintaining consistent labels and providing updates to the cost and range information.
In establishing the current five-year schedule, the Commission sought to strike a balance between maintaining consistent labels and providing updates to cost and range information.
In the 2014 SNPRM, the Commission explained its plans to pursue improvements in label design to increase label presence on display models before imposing new responsibilities for retail stores. The Commission reasoned that it was premature to impose costs on retailers when better label requirements and greater availability of online labels may alleviate the problem.
In contrast, the Direct Marketing Association (DMA), which represents retailers, encouraged the Commission to refrain from imposing affirmative duties on retailers. In DMA's view, the Commission can best ensure increased information to consumers by pursuing label attachment improvements without imposing new burdens at the point-of-sale. DMA also argued that an affirmative retailer requirement, in its opinion, could increase mislabeling inadvertently because retailers are not well-positioned to identify the correct labels and do not have readily available access to a library of substitute or replacement labels. A new retailer requirement would force sales personnel to halt customer service and verify correct product labels, attempt to locate proper labels, and attach a substitute label whenever a missing label was noticed. DMA also argued that a new requirement would penalize retailers for situations beyond their control (
Those amendments do not cover Web sites that serve solely as platforms for sellers by performing functions such as hosting sellers' advertising, matching buyers' searches to sellers' products, and processing payment and shipment directions.
The Direct Marketing Association disagreed and supported the Commission's proposal. DMA argued that the Rule's current requirements appropriately place responsibility for
DMA argued that additional requirements on marketplace Web sites would create “secondary” or duplicate coverage, as this information is already provided to consumers elsewhere. At present, in its view, the burdens of imposing the requirement far outweigh any benefit to consumers from providing information that would be, at best, redundant.
However, the Joint Commenters urged the Commission to revisit the issue. They asserted that the SNPRM did not provide adequate evidence to demonstrate that the benefits of clothes dryer labels would be minimal. First, they argued that high-efficiency dryers are likely to populate the market soon. According to the comments, one manufacturer has unveiled plans to introduce a heat pump dryer and another has introduced new efficient models. In addition, according to the Joint Commenters, dryers already exist that meet the new ENERGY STAR specifications, which require, on average, approximately 20% less energy use than allowed under DOE's 2015 minimum efficiency standards. This is a larger energy use spread than the new ENERGY STAR specifications for refrigerators. The Joint Commenters also stated that, according to DOE energy data, dryer labels may help some consumers choose between gas and electric dryers because a substantial number of consumers currently use gas for cooking but electricity for clothes drying.
The Joint Commenters also took issue with the Commission's interpretation of EPCA's test for requiring clothes dryer labels. They explained that EPCA requires clothes dryer labels as long as labeling is “technologically and economically feasible.” In their view, EPCA does not allow the Commission to consider whether the costs of labeling outweigh the benefit.
Finally, the Joint Commenters noted that DOE currently allows manufacturers to use two alternative test procedures.
However, in the meantime, the existence of two separate DOE test procedures raises serious complications for creating labeling requirements. Given the existence of two DOE tests, the Commission does not plan to require one DOE version over another because, by doing so, the Commission would, in essence, circumvent DOE's efforts to resolve the conflicts in its own testing requirements. The resolution of this technical issue is best left to DOE. The Commission will consider revisiting this after DOE resolves the testing issue.
Consistent with the proposal in the SNPRM, the final amendments include two minor changes related to plumbing products.
The current Rule contains recordkeeping, disclosure, testing, and reporting requirements that constitute information collection requirements as defined by 5 CFR 1320.3(c), the definitional provision within the Office of Management and Budget (OMB) regulations that implement the Paperwork Reduction Act (PRA). OMB has approved the Rule's existing information collection requirements through May 31, 2017 (OMB Control No. 3084 0069). The amendments make changes in the Rule's labeling requirements that will increase the PRA burden as detailed below.
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires that the Commission provide an Initial Regulatory Flexibility Analysis (IRFA) with a Proposed Rule, and a Final Regulatory Flexibility Analysis (FRFA) with the final Rule, unless the Commission certifies that the Rule will not have a significant economic impact on a substantial number of small entities.
The Commission does not anticipate that the final amendments will have a significant economic impact on a substantial number of small entities. The Commission recognizes that many affected entities may qualify as small businesses under the relevant thresholds. The Commission does not expect, however, that the economic impact of implementing the amendments will be significant because the Commission plans to provide businesses with ample time to implement the requirements, and the amendments involve simple information disclosures that do not impose substantial burdens.
The Commission estimates that the amendments will apply to about 75 light bulb manufacturers and an additional 150 online and paper catalog sellers of covered products. The Commission expects that approximately 150 of these entities qualify as small businesses.
Although the Commission certified under the RFA that the amendments would not, if promulgated, have a significant impact on a substantial number of small entities, the Commission has determined, nonetheless, that it is appropriate to publish an FRFA in order to explain the impact of the amendments on small entities as follows:
The Commission initiated this rulemaking to increase the availability of energy labels to consumers while minimizing burdens on industry, and generally improve existing requirements.
The Commission did not receive any comments specifically related to the impact of the final amendments on small businesses. No comments were filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule amendments. Comments that involve impacts on all entities are discussed above.
Under the Small Business Size Standards issued by the Small Business Administration, appliance manufacturers qualify as small businesses if they have fewer than 1,000 employees (for other household appliances the figure is 500 employees). Catalog sellers qualify as small businesses if their sales are less than $8.0 million annually. The Commission estimates that there are approximately 150 entities subject to the proposed rule's requirements that qualify as small businesses.
As discussed above, the changes would slightly increase reporting or recordkeeping requirements associated with the Commission's labeling rules. The amendments likely will increase compliance burdens by extending the labeling requirements to new types of light bulbs. The Commission assumes that the label design change will be implemented by graphic designers.
The Commission has not identified any other federal statutes, rules, or policies that would duplicate, overlap, or conflict with the proposed Rule.
The Commission sought comment and information on the need, if any, for alternative compliance methods that would reduce the economic impact of the Rule on such small entities. In particular, the Commission sought comments on whether it should time the Rule's effective date to provide additional time for small business compliance and whether to reduce the amount of information catalog sellers must provide. As discussed in this Notice, the Commission received no comments suggesting shorter compliance periods for requirements. However, to minimize the impacts on manufacturers and retailers in posting the required labels, the Commission has set effective dates for the new requirements to minimize burden on manufacturers as they implement them.
Advertising, Energy conservation, Household appliances, Labeling, Reporting and recordkeeping requirements.
For the reasons discussed above, the Commission amends part 305 of title 16, Code of Federal Regulations, as follows:
42 U.S.C. 6294.
(j)
(r)
(z)
(1) Any lamp that:
(i) Is not included under the definition of general service lamp in this part;
(ii) Has a lumen range between 310 lumens and no more than 2,600 lumens or a rated wattage between 30 and 199;
(iii) Has one of the following bases:
(A) A medium screw base;
(B) A candelabra screw base;
(C) A GU-10 base; or
(D) A GU-24 base; and
(iv) Is capable of being operated at a voltage range at least partially within 110 and 130 volts.
(2)
(i) vibration-service lamps as defined at 42 U.S.C. 6291(30)(AA);
(ii) rough service lamps as defined at 42 U.S.C. 6291(30)(X);
(iii) appliance lamps as defined at 42 U.S.C. 6291(30)(T); and
(iv) shatter resistant lamps (including a shatter proof lamp and a shatter protected lamp) as defined in 42 U.S.C. 6291(30)(Z).
(3)
(i) A black light lamp;
(ii) A bug lamp;
(iii) A colored lamp;
(iv) An infrared lamp;
(v) A left-hand thread lamp;
(vi) A marine lamp;
(vii) A marine signal service lamp;
(viii) A mine service lamp;
(ix) A sign service lamp;
(x) A silver bowl lamp;
(xi) A showcase lamp;
(xii) A traffic signal lamp;
(xiii) A G-shape lamp with diameter of 5 inches or more;
(xiv) A C7, M-14, P, RP, S, or T shape lamp;
(xv) A intermediate screw-base lamp; and
(xvi) A plant light lamp.
(d)
(a) * * *
(4) This section does not require reports for general service light-emitting diode (LED or OLED) lamps or specialty consumer lamps.
(d) Label types. The labels must be affixed to the product in the form of an adhesive label or a hang tag as follows:
(1)
(2)
(b)
(c)
(2)
(i) The principal display panel of the product package shall be labeled clearly and conspicuously with the following information consistent with the Prototype Labels in Appendix L:
(A) The light output of each lamp included in the package, expressed as “Brightness” in average initial lumens rounded to the nearest five;
(B) The estimated annual energy cost of each lamp included in the package, expressed as “Estimated Energy Cost” in dollars and based on usage of 3 hours per day and 11 cents ($0.11) per kWh; and
(C) The life, as defined in § 305.2(w), of each lamp included in the package, expressed in years rounded to the nearest tenth (based on 3 hours operation per day).
(ii)(A) If the lamp contains mercury, the principal display panel shall contain the following statement in minimum 10 point font:
“Contains Mercury For more on clean up and safe disposal, visit epa.gov/cfl.”
(B) The manufacturer may also print an “Hg[Encircled]” symbol on package after the term “Contains Mercury.”
(iii) If the lamp contains mercury, the lamp shall be labeled legibly on the product with the following statement: “Mercury disposal: epa.gov/cfl” in minimum 8 point font.
(iv) If the required disclosures for a lamp covered by paragraph (c)(2) of this section will not be legible on the front panel of a single-card, blister package due to the small size of the panel, the manufacturer or private labeler may print the statement “Lighting Facts see back” on the principal display panel consistent with the sample label in Appendix L as long as the Lighting Facts label required by paragraph (b)(3) of this section appears on the rear panel.
(v) No marks or information other than that specified in this part shall appear on the Lighting Facts label.
(3)
(i) The Lighting Facts information shall be set off in a box by use of hairlines and shall be all black or one color type, printed on a white or other neutral contrasting background whenever practical.
(ii) All information within the Lighting Facts label shall utilize:
(A) Arial or an equivalent type style;
(B) Upper and lower case letters;
(C) Leading as indicated in the Prototype Labels in Appendix L of this part;
(D) Letters that never touch;
(E) The box and hairlines separating information as illustrated in the Prototype Labels in appendix L of this part; and
(F) The minimum font sizes and line thicknesses as illustrated in Prototype Labels in Appendix L of this part.
(iii) For small package labels covered by (c)(2)(iv) of this section, the words “Lighting Facts see back” shall appear on the primary display panel in a size and format specified in appendix L of this part.
(4)
(d) For lamps that do not meet the definition of general service lamp or specialty consumer lamp, manufacturers and private labelers have the discretion to label with the Lighting Facts label as long as they comply with all requirements applicable to specialty consumer lamps in this part.
(f) * * *
(1) The required disclosures of any covered product that is a general service lamp or specialty consumer lamp shall be measured at 120 volts, regardless of the lamp's design voltage. If a lamp's design voltage is 125 volts or 130 volts, the disclosures of the wattage, light output, energy cost, and life ratings shall in each instance be:
(4) For any covered product that is a general service lamp or specialty consumer lamp and operates at discrete, multiple light levels (
(5) A manufacturer or private labeler who distributes general service fluorescent lamps, general service lamps, or specialty consumer lamp without labels attached to the lamps or without labels on individual retail-sale packaging for one or more lamps may meet the package disclosure requirements of this section by making the required disclosures, in the manner and form required by those paragraphs, on the bulk shipping cartons that are to be used to display the lamps for retail sale.
(6) Any manufacturer or private labeler who makes any representation, other than those required by this section, on a package of any covered product that is a general service fluorescent lamp, general service lamp, or specialty consumer lamp regarding the cost of operation or life of such lamp shall clearly and conspicuously disclose in close proximity to such representation the assumptions upon which it is based, including,
(a) * * *
(1)
(ii)
The additions read as follows:
By direction of the Commission.
Federal Energy Regulatory Commission.
Final rule.
The Federal Energy Regulatory Commission (Commission) is amending its regulations to incorporate by reference the latest version (Version 3.0) of seven business practice standards adopted by the Wholesale Gas Quadrant of the North American Energy Standards Board (NAESB) applicable to interstate natural gas pipelines. These updated business practice standards contain and supplement the revisions to the NAESB scheduling standards accepted by the Commission in Order No. 809 as part of the Commission's efforts to harmonize gas-electric scheduling coordination, and are required to be implemented on April 1, 2016, the same date as the regulations adopted in Order No. 809. In addition, the updated standards revise
This rule will become effective December 2, 2015. Implementation of these standards is required on April 1, 2016. The incorporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register as of December 2, 2015.
Stanley Wolf (technical issues), Office of Energy Policy and Innovation, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, Telephone: (202) 502-6841, Email:
Oscar F. Santillana (technical issues), Office of Energy Market Regulation, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, Telephone: (202) 502-6392,Email:
Gary D. Cohen (legal issues), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, Telephone: (202) 502-8321,Email:
1. In this final rule, the Federal Energy Regulatory Commission (Commission) amends its regulations at 18 CFR 284.12 to incorporate by reference the latest version (Version 3.0) of seven business practice standards applicable to interstate natural gas pipelines adopted by the Wholesale Gas Quadrant (WGQ) of the North American Energy Standards Board (NAESB). Interstate natural gas pipelines are required to implement these standards April 1, 2016.
2. The NAESB WGQ Version 3.0 package of standards includes standards governing coordination of the scheduling processes of interstate natural gas pipelines and public utilities that the Commission incorporated by reference in Docket No. RM14-2-000.
3. In addition, the Commission terminates, as moot, the proceeding in Docket No. RM14-2-003, as the standard corrections NAESB filed in Docket No. RM14-2-003 are included as part of the Version 3.0 standards that the Commission is incorporating by reference here, with the same implementation date of April 1, 2016.
4. Since 1996, the Commission has adopted regulations to standardize the business practices and communication methodologies of interstate natural gas pipelines to create a more integrated and efficient pipeline grid. These regulations have been promulgated in the Order No. 587 series of orders,
5. On July 23, 2013, as corrected on July 25, 2013, NAESB filed a report informing the Commission that it had adopted and ratified Version 2.1 of its business practice standards applicable to natural gas pipelines. NAESB reported that the WGQ reviewed, at the request of the industry, the necessity of maintaining the current location common codes system to determine if the system provides a significant benefit to the industry and should be continued.
6. NAESB reported that, after extensive discussions, the WGQ reached the conclusion that the NAESB WGQ Standards should no longer support the location common codes system, as the NAESB membership concluded that the system provided little commercial benefit to the industry at large. Consistent with this determination, the Version 2.1 Standards added seven new standards, modified six standards, and deleted three standards to match up with a transition from common codes to the proprietary codes used by interstate pipelines to identify points.
7. Additionally, as requested by the Commission in Order No. 587-V,
8. On November 14, 2014, NAESB filed a report informing the Commission that it had adopted and ratified Version 3.0 of its business practice standards applicable to natural gas pipelines. NAESB reported that all of the modifications made in the Version 2.1 Standards are included in the Version 3.0 Standards and thus no action is needed on the Version 2.1 Standards.
9. On July 7, 2015, NAESB filed a report informing the Commission that it made errata corrections to the WGQ Version 3.0 Business Practice Standards.
10. On July 16, 2015, the Commission issued a Notice of Proposed Rulemaking (Version 3.0 NOPR) proposing to amend its regulations to incorporate by reference, with certain enumerated exceptions, the NAESB Version 3.0 business practice standards (referenced above) applicable to natural gas pipelines.
11. In response to the Version 3.0 NOPR, comments were filed by three commenters. All three commenters express support for the Commission's proposal to incorporate by reference NAESB's Version 3.0 business practice standards. Tennessee Valley Authority (TVA) comments that it fully supports the full package of revisions reflected in the NAESB Version 3.0 Standards that are subject to the NOPR. Interstate Natural Gas Association of America (INGAA) comments that it “supports the Commission's proposal to amend its regulations to incorporate by reference Version 3.0 of the business practice standards adopted by [NAESB's WGQ] applicable to natural gas pipelines,” subject to a few suggested modifications.
12. The NAESB WGQ Version 3.0 Business Practice Standards made a number of changes to the earlier version of those standards that the Commission previously incorporated by reference in 2012 in Order No. 587-V.
13. Additionally, as requested by the Commission in Order No. 587-V,
14. NAESB used its consensus procedures to develop and approve the Version 3.0 Standards. As the Commission found in Order No. 587, the adoption of consensus standards is appropriate because the consensus process helps ensure the reasonableness of the standards by requiring that the standards draw support from a broad spectrum of industry participants representing all segments of the industry. Moreover, since the industry itself has to conduct business under these standards, the Commission's regulations should reflect those standards that have the widest possible support. In section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTT&AA), Congress affirmatively requires federal agencies to use technical standards developed by voluntary consensus standards organizations, like NAESB, as means to carry out policy objectives or activities determined by the agencies unless an agency determines that the use of such standards would be inconsistent with applicable law or otherwise impractical.
15. In the Version 3.0 NOPR, the Commission proposed to incorporate by reference, in its regulations, Version 3.0 of the NAESB WGQ's consensus business practice standards, with the exception of NAESB's standards specifying the terms of optional model contracts and its eTariff-related standards.
16. As explained above, all of the commenters supported the Commission's proposal to incorporate by reference the NAESB WGQ Version 3.0 business practice standards as proposed in the Version 3.0 NOPR.
17. After a review of the comments filed in response to the Version 3.0 NOPR, the Commission is amending Part 284 of its regulations to incorporate by reference seven of the NAESB WGQ's Version 3.0 business practice standards. Further, as explained in the Version 3.0 NOPR, we are not incorporating by reference the NAESB WGQ's optional model contracts and eTariff-related
18. To implement the standards we are incorporating by reference in this Final Rule, we will require each interstate natural gas pipeline to file a separate tariff record reflecting the changed standards by February 1, 2016, to take effect on April 1, 2016, and the natural gas pipelines will be required to comply with these standards on and after April 1, 2016.
19. As explained in the Version 3.0 NOPR, at industry's request, NAESB reviewed the location common codes system and concluded that the NAESB WGQ Business Practice Standards should no longer support the location common codes system, as the NAESB membership concluded that the system provided little commercial benefit to the industry at large.
20. In the Version 3.0 NOPR, the Commission proposed to incorporate by reference the standards that revised the prior standards to introduce the use of proprietary codes to identify the location of points of receipt and delivery and that included requirements for the pipelines to post on their Web sites information on each of the proprietary points that can be used to determine which points are interconnecting points between pipelines.
21. Southern Star & INGAA both support the Commission's proposal to use the term “location code,” rather than “industry common code” to identify the location of receipt and delivery points.
22. We will incorporate by reference NAESB's standards requiring interstate pipelines to refer to location points using their own proprietary code, together with a posting of information regarding these codes on the pipelines' Web site, rather than requiring the pipelines to maintain a common code database implemented by a third party. Given the ability of the Commission and customers to continue to identify interconnection points referenced in the Index of Customers through the Web site postings, the Commission also will revise its regulations governing the filing of the Index of Customers and other regulations requiring the specification of location point codes to align with the NAESB standards.
23. We also will adopt Southern Star and INGAA's recommendations to modify the regulations to create a separate requirement at 18 CFR 284.13(f) for the posting of information regarding the location points to make cross-reference easier. Consistent with the proposal in the Version 3.0 NOPR, we are requiring interstate pipelines to file their Index of Customers using the new location names and codes for all active points. In addition, as proposed in the Version 3.0 NOPR, we are requiring pipelines to maintain and post on their Web sites a complete listing of all inactive points. Finally, for the convenience of those reviewing past Index of Customers filings, or those wishing to compare past Index of Customers filings to newer Index of Customers filings, we will post the old common code file for past indices on the Commission's Web site prior to April 1, 2016.
24. In the Version 3.0 NOPR, we explained that pipelines currently file the Index of Customers using a tab-delimited file format consistent with Form No. 549B—Index of Customers Instruction Manual.
[b]ecause tab-delimited file formats can be difficult and can result in errors that impose burdens both on Commission and pipeline staff to correct, we also are adding the Index of Customers form to the list of forms that are being updated as part of the Commission's forms refresh project in Docket No. AD15-11-000 (Forms Project). Adding the Index of Customers to the Forms Project will move the Commission towards the use of a standard approach for all Commission forms that will result in more efficient filing and processing of forms.
25. TVA comments that, while it was neutral in the past, it has come to appreciate that a user-friendly format for the Index of Customers is extremely beneficial to TVA in long-range planning. TVA asserts that, with growing staff to support the growth of gas-fired generation at TVA and counterparties, a user-friendly format for locations codes is a beneficial tool to
26. The transition from the current tab delimited file format for the Index of Customers information reported on Form No. 549B to a more up-to-date format will improve the efficient filing and processing of this information. As we explained in the Version 3.0 NOPR, the Commission issued an order (Forms Project Order) initiating a proceeding in Docket No. AD15-11-000 to consider the transition to a new filing format for a number of other Commission forms and has enlisted the assistance of NAESB in this endeavor.
27. In the Version 3.0 NOPR, the Commission proposed to post on the Commission's Web site a revised instruction manual for the filing of Form No. 549B—Index of Customers.
28. Southern Star and INGAA both suggest that three changes are needed to the proposed instruction manual for the Index of Customers:
29. Second, for Item yj (the Point identification Code Qualifier), the commenters suggest that the instructions should simply read “Enter 95” as all location codes will now be assigned by the pipeline (the Transportation Service Provider).
30. Third, for Item yk (the Point Identification Code), the commenters suggest that the instructions should simply read “Enter the Transportation Service Provider's Location (LOC)” as there is no longer an industry common code to enter. INGAA asserts that this item should read “Enter the pipeline's location code.” It makes this suggestion because “Pipeline” is the term utilized throughout the Instruction Manual.
31. As to the suggestion to revise the instruction manual to delete references to references to G1 and G2 in the instructions for Item yh (the Point Identifier Code), we find this suggestion reasonable and will make this change.
32. As to the suggestion to revise the instruction manual to revise the instructions for Item yj, we see merit in this suggestion, but believe the suggested language would be clearer if it read “Enter 95 whenever item yk is the Transmission Service Provider's Location (LOC)” and will revise the instruction manual accordingly.
33. As to the suggestion to revise the instruction manual to revise the instructions for Item yk to read “Enter the Transmission Service Provider's Location (LOC),” we find this suggestion reasonable and will make this change.
34. As to the suggestion to revise the instruction manual to revise the instructions for Item yj to substitute the term “Pipeline” in lieu of the term “Transmission Service Provider,” we are not persuaded to make this revision, as the term “Transmission Service Provider” matches the terminology in the standards we are incorporating. As we did after we issued the Version 3.0 NOPR, we will post a link to the revised instruction manual on our Web site after issuance of this Final Rule.
35. Finally, our review of the comments also brought to our attention that Item yi (Point Name) also needs revision to reflect the transition to the use of proprietary location codes in the Version 3.0 standards. Thus, the Instructions for Item ID yi will now read as follows: “Enter the Location Name (LOC Name) of the point or facility.”
36. In the Version 3.0 NOPR, the Commission proposed conforming changes to reference the new location names and codes at 18 CFR 157.14 and 18 CFR 157.18 (dealing with exhibits), in 18 CFR 260.8 (dealing with system flow diagrams), and in 18 CFR 284.13 (dealing with reporting requirements for interstate pipelines).
37. Along with their comments suggesting that the Commission move its proposed regulation at § 284.13(c)(2)(6) into a new subsection § 284.13(f), the commenters point out the Commission missed two references to common codes in § 284.13(b) and suggest revisions to the accompanying cross references proposed in the Version 3.0 NOPR.
38. Given the Commission's determination that, as proposed by the commenters, the proper provision in which to place the requirement for pipelines to use “location code” rather than “industry common code” to identify the location of receipt and delivery points is at 18 CFR 284.13(f), we will make appropriate cross-references. We agree with INGAA that the inclusion of Exhibit H(iv) in the regulatory text of proposed § 157.14(a) is in error. Reference to this exhibit was deleted in Order No. 699 as an erroneous or outdated reference.
39. Finally, as a result of the INGAA comment that we needed to make additional conforming changes that were overlooked, we also will make a conforming change to 18 CFR 284.126 to remove the reference to common codes. Intrastate pipelines filing Form No. 549D should identify their location codes and names in their list of jurisdictional points of receipt and delivery.
40. In the Version 3.0 NOPR, the Commission stated that we anticipated acting on the proposed rule in order to permit these standards to become effective April 1, 2016 at the same time as the Gas-Electric Harmonization standards, with compliance filings due February 1, 2016.
41. None of the comments took issue with the Commission's proposed implementation schedule. Nor did the comments take issue or seek clarification with regard to the Commission's explanation of its policies on tariff filings and on waiver requests. We are not modifying these policies in this Final Rule and stand by the explanation of those policies we made in the Version 3.0 NOPR. The Commission will require interstate natural gas pipelines to comply with the revised NAESB standards that we are incorporating by reference in this Final Rule beginning on April 1, 2016. Thus, among other requirements, when pipelines make their Index of Customers filing for the second quarter of 2016 and thereafter they should do so using the new location names and codes for all active points. We are requiring this implementation schedule to give the interstate natural gas pipelines subject to these standards adequate time to implement these changes. In addition, the interstate natural gas pipelines must file tariff records to reflect the changed standards by February 1, 2016.
42. In addition, consistent with the requirements in Order Nos. 587-V and 809,
(1) The pipelines must designate a single tariff record under which every NAESB standard currently incorporated by reference by the Commission is listed.
(2) For each standard, each pipeline must specify in the tariff record a list of all the NAESB standards currently incorporated by reference by the Commission:
(a) whether the standard is incorporated by reference;
(b) for those standards not incorporated by reference, the tariff provision that complies with the standard;
(c) a statement identifying any standards for which the pipeline has been granted a waiver, extension of time, or other variance with respect to compliance with the standard.
(3) If the pipeline is requesting a continuation of an existing waiver or extension of time, it must include a table in its transmittal letter that states the standard for which a waiver or extension of time was granted, and the docket number or order citation to the proceeding in which the waiver or extension was granted.
43. Office of Management and Budget Circular A-119 (section 11) (February 10, 1998) provides that federal agencies should publish a request for comment in a NOPR when the agency is seeking to issue or revise a regulation proposing to adopt a voluntary consensus standard or a government-unique standard. In this Final Rule, the Commission is amending its regulations to incorporate by reference voluntary consensus standards developed by NAESB's WGQ. In section 12(d) of NTT&AA, Congress affirmatively requires federal agencies to use technical standards developed by voluntary consensus standards organizations to carry out policy objectives or activities determined by the agencies unless use of such standards would be inconsistent with applicable law or otherwise impractical.
44. In section 12(d) of NTT&AA, Congress affirmatively requires federal agencies to use technical standards developed by voluntary consensus standards organizations to carry out policy objectives or activities determined by the agencies unless use of such standards would be inconsistent with applicable law or otherwise impractical.
45. The Office of the Federal Register requires agencies incorporating material by reference in final rules to discuss, in the preamble of the final rule, the ways that the materials it incorporates by
• Additional Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015). These standards cover general areas or standards applicable to multiple business activities, such as creditworthiness and gas/electric operational communications.
• Nominations Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015). These standards define the business processes used to schedule natural gas service on pipelines.
• Flowing Gas Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015). These standards define the business processes related to the communication of entitlement rights to flowing gas at a location, the entitlement rights on a contractual basis, the management of imbalances, and the measurement and gas quality information of the actual flow of gas.
• Invoicing Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015). These standards define the business process for the communication of charges for services rendered (Invoice), communication of details about funds rendered in payment for services rendered (Payment Remittance), and communication of the financial status of a customer's account (Statement of Account).
• Quadrant Electronic Delivery Mechanism Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015). These standards establish the framework for the electronic dissemination and communication of information between parties in the North American wholesale gas marketplace for EDI/EDM transfers, batch flat file/EDM transfers, informational postings Web sites, EBB/EDM and interactive flat file/EDM.
• Capacity Release Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015). These standards define the business processes for communication of information related to the release or transfer of any portion of a transmission service requester's contract rights for transportation on pipelines.
• Internet Electronic Transport Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015). These standards define the implementation of various technologies necessary to communicate transactions and other electronic data using standard protocols for electronic commerce over the internet between NAESB trading partners.
46. Our regulations provide that copies of the NAESB standards incorporated by reference may be obtained from the North American Energy Standards Board, 801 Travis Street, Suite 1675, Houston, TX 77002, Phone: (713) 356-0060. NAESB's Web site is at
47. The collections of information for this Final Rule are being submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the Paperwork Reduction Act of 1995
48. The Commission solicits comments from the public on the Commission's need for this information, whether the information will have practical utility, the accuracy of the burden estimates, recommendations to enhance the quality, utility, and clarity of the information to be collected, and any suggested methods for minimizing respondents' burden, including the use of automated information techniques. The burden estimates are for implementing the information collection requirements of this Final Rule. The Commission asks that any revised burden estimates submitted by commenters include the details and assumptions used to generate the estimates.
49. The collections of information related to this Final Rule fall under FERC-545 (Gas Pipeline Rates: Rate Change (Non-Formal))
OMB regulations require OMB to approve certain information collection requirements imposed by agency rule. The Commission is submitting notification of this Final Rule to OMB. These information collections are mandatory requirements.
OMB Control Nos.: 1902-0154, 1902-0174
50.
51. Interested persons may obtain information on the reporting requirements by contacting the following: Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426 [Attention: Ellen Brown, Office of the Executive Director, email:
52. Comments concerning the collections of information and the associated burden estimates should be sent to the Commission and to the Office of Management and Budget, Office of Information and Regulatory Affairs, Washington, DC 20503 [Attention: Desk Officer for the Federal Energy Regulatory Commission, telephone: (202) 395-0710, fax: (202) 395-4718]. For security reasons, comments to OMB should be submitted by email to:
53. The Commission concludes that neither an Environmental Assessment nor an Environmental Impact Statement is required for this Final Rule under section 380.4(a) of the Commission's regulations, which provides a categorical exemption for actions that are clarifying, corrective, or procedural, or that do not substantively change the effect of legislation or regulations being amended, for information gathering, analysis, and dissemination, or for the
54. The Regulatory Flexibility Act of 1980 (RFA)
55. This Final Rule applies only to interstate natural gas pipelines, most of which are not small businesses. The Commission estimates that approximately 165 interstate pipeline entities are potential respondents subject to the data reporting requirements of FERC-545 and also are subject to data collection FERC 549-C reporting requirements. For the year 2012 (the most recent year for which information is available), only eleven companies not affiliated with larger companies had annual revenues of less than $25.5 million and are defined by the SBA as “small entities.” These companies constitute about seven percent of the total universe of potential respondents. The Commission estimates that the one-time implementation cost of the proposals in this Final Rule is $441,778 (or $2,677 per entity, regardless of entity size).
56. In addition to publishing the full text of this document in the
57. From FERC's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.
58. User assistance is available for eLibrary and the FERC's Web site during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
59. These regulations are effective December 2, 2015. The Commission has determined (with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of OMB) that this rule is not a “major rule” as defined in section 351 of the Small Business Regulatory Enforcement Fairness Act of 1996. This Final Rule is being submitted to the Senate, House, and Government Accountability Office.
Natural gas, Reporting and recordkeeping requirements.
Incorporation by reference, Natural gas, Reporting and recordkeeping requirements.
By the Commission.
In consideration of the foregoing, the Commission amends parts 157, 260, and 284, chapter I, title 18,
15 U.S.C. 717-717z.
(a)
(c) Exhibit V—Flow diagram showing daily design capacity and reflecting operation of applicant's system after abandonment. Receipt and delivery point information required in various exhibits must be labeled with a location point name and code in accordance with the location name and code the pipeline has adopted in conformance with § 284.13(f) of this chapter. A flow diagram showing daily design capacity and reflecting operating conditions of applicant's system after abandonment of facilities on that segment of the system affected by the abandonment, including the following:
15 U.S.C. 717-717z, 3301-3432; 42 U.S.C. 7101-7352.
(a) Each Major natural gas pipeline company, having a system delivery capacity in excess of 100,000 Mcf per day (measured at 14.73 p.s.i.a. and 60° F), shall file with the Commission by June 1 of each year five (5) copies of a diagram or diagrams reflecting operating conditions on its main transmission system during the previous twelve months ended December 31. For purposes of system peak deliveries, the heating season overlapping the year's end shall be used. Facilities shall be those installed and in operation on December 31 of the reporting year. All volumes shall be reported on a uniform stated pressure and temperature base. Receipt and delivery point information required in various exhibits must be labeled with a location point name and code in accordance with the location name and code adopted by the pipeline in accordance with § 284.13(f) of this chapter.
15 U.S.C. 717-717z, 3301-3432; 42 U.S.C. 7101-7352; 43 U.S.C. 1331-1356.
(a) * * *
(1) An interstate pipeline that transports gas under subparts B or G of this part must comply with the business practices and electronic communications standards as promulgated by the North American Energy Standards Board, as incorporated herein by reference in paragraphs (a)(1)(i) thru (vii) of this section.
(i) Additional Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015);
(ii) Nominations Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015);
(iii) Flowing Gas Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015);
(iv) Invoicing Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015);
(v) Quadrant Electronic Delivery Mechanism Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015);
(vi) Capacity Release Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015); and
(vii) Internet Electronic Transport Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015).
(b) * * *
(1) * * *
(vi) The receipt and delivery points and the zones or segments covered by the contract, including the location name and code adopted by the pipeline in conformance with paragraph (f) of this section for each point, zone or segment;
(2) * * *
(iv) The receipt and delivery points and the zones or segments covered by the contract, including the location name and code adopted by the pipeline in conformance with paragraph (f) of this section for each point, zone or segment;
(c) * * *
(2) * * *
(vi) The receipt and delivery points and the zones or segments covered by the contract, including the location name and code adopted by the pipeline in conformance with paragraph (f) of this section for each point, zone or segment;
(f)
(b) * * *
(1) * * *
(iv) The primary receipt and delivery points covered by the contract, identified by the list of points that the pipeline has published with the Commission;
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
This order is effective November 2, 2015. The classification was applicable January 14, 2013.
Andrew Grove, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301-796-6198.
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device.
In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on January 03, 2013 automatically classifying the xTAG® Gastrointestinal Pathogen Panel (GPP) in class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, nor to a device that was subsequently reclassified into class I or class II. On January 10, 2013, Luminex Molecular Diagnostics, submitted a request for de novo classification of the xTAG® GPP under section 513(f)(2) of the FD&C Act.
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request for de novo classification in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on January 14, 2013, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.3990 (§ 866.3990).
Following the effective date of this final classification administrative order, any firm submitting a premarket notification (510(k)) for a gastrointestinal microorganism multiplex nucleic acid-based assay will need to comply with the special controls named in this final administrative order.
The device is assigned the generic name gastrointestinal microorganism multiplex nucleic acid-based assay, and it is identified as a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.
FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks in table 1:
FDA believes that the measures set forth in the special controls guideline entitled “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens” are necessary, in addition to general controls, to mitigate the risks to health described in table 1.
A gastrointestinal microorganism multiplex nucleic acid-based assay is a prescription device. Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this type of device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the gastrointestinal microorganism multiplex nucleic acid-based assay they intend to market.
We have determined under 21 CFR 25.34(b) that this action is of type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final administrative order establishes special controls that refer to previously approved collections of information found in other 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, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality systems have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.
Biologics, Laboratories, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
(a)
(b)
Department of State.
Final rule.
The Department of State is updating its regulations regarding nonimmigrant visa format, and records retention procedures. These updates reflect changes in technology, including the current practice of issuing machine-readable visas and the planned future practice of issuing visas electronically. The Department is also removing an obsolete records retention provision and a visa review provision, both of which are now addressed in the Foreign Affairs Manual.
This rule is effective November 2, 2015.
Lauren A. Boquin, Legislation and Regulations Division, Visa Services, Department of State, 600 19th St NW., Washington, DC 20006, (202) 485-7638.
Currently, 22 CFR 41.113 provides for the placement of a stamp in a visa holder's passport. The Department is amending paragraphs (a) and (c) to reflect the current practice of issuing machine-readable visas on adhesive foils that are affixed to passports, and the planned future practice of issuing such visas as electronic visas. An electronic visas is a machine readable tamper-resistant visa format, as required by 8 U.S.C. 1732, in that the U.S. Customs and Border Protection officers at the port of entry are expected to scan the machine readable zone of the visa holder's passport to verify the biometrics and identity of the individual and to authenticate the visa's validity by accessing information stored in the Department's electronic records database.
Conforming changes and minor nonsubstative edits were made to paragraphs (b) and (d) through (h). Paragraph (i) was revised to remove visa review and file retention instructions that are internal Department procedures addressed in Volume 9 of the Foreign Affairs Manual.
This regulation amends certain “rules of agency organization, procedure, or practice”, which are not subject to the notice-and-comment rulemaking procedures set forth in 5 U.S.C. 553. See 5 U.S.C. 553(b). Therefore, the Department is issuing this amendment as a final rule.
Because this final rule is exempt from notice and comment rulemaking under 5 U.S.C. 553, it is exempt from the regulatory flexibility analysis requirements set forth by the Regulatory Flexibility Act (5 U.S.C. 603 and 604). Nonetheless, consistent with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Department certifies that this rule will not have a significant economic impact on a substantial number of small entities. This regulates individual aliens who seek consideration for nonimmigrant visas and does not affect any small entities, as defined in 5 U.S.C. 601(6).
Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532, generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in any such expenditure, nor will it significantly or uniquely affect small governments.
This rule is not a major rule as defined by 5 U.S.C. 804. The Department is aware of no monetary effect on the economy that would result from this rulemaking, nor will there be any increase in costs or prices; or any effect on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and import markets.
The Department of State has reviewed this rule to ensure its consistency with the regulatory philosophy and principles set forth in Executive Orders 12866 and 13563, and has determined that the benefits of this regulation,
This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. The rule will not have federalism implications warranting the application of Executive Orders 12372 and 13132.
The Department has reviewed the regulation 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 or revise information collection requirements under the provisions of the Paperwork Reduction Act, 44 U.S.C. Chapter 35.
Aliens, Foreign Officials, Immigration, Documentation of Nonimmigrants, Passports and Visas.
For the reasons stated in the preamble, the Department of State amends 22 CFR Part 41 as follows:
22 U.S.C. 2651a; 8 U.S.C. 1104; 8 U.S.C. 1182(d) ; 8 U.S.C. 1185 note (section 7209 of Pub. L. 108-458, as amended by section 546 of Pub. L. 109-295); 112 Stat. 2681-795.
(a)
(b)
(1) The alien's passport was issued by a government with which the United States does not have formal diplomatic relations, unless the Department has specifically authorized the placing of the visa in such passport;
(2) The passport requirement has been waived; or
(3) In other cases as authorized by the Department.
(c)
(1) Full name of the applicant;
(2) Visa type/class;
(3) Location of the visa issuing office;
(4) Passport number;
(5) Sex;
(6) Date of birth;
(7) Nationality;
(8) Number of applications for admission authorized, or the letter “M” for multiple applications for admission authorized;
(9) Date of issuance;
(10) Date of expiration;
(11) Visa control number.
(d)
(2) If the visa is being issued upon the basis of a petition approved by the Secretary of Homeland Security, the number of the petition, if any, the period for which the 'alien's admission has been authorized, and the name of the petitioner shall be reflected in the annotation field on the visa.
(3) In the case of an alien who derives status from a principal alien, the name of the principal alien and of the petitioner shall be reflected in the annotation field of the visa.
(e)
(f)
(g)
(h)
(i)
Coast Guard, DHS.
Notice of deviation from drawbridge regulations.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Belt Line Railroad Bridge across the South Branch of the Elizabeth River, mile 2.6, between Portsmouth and Chesapeake, VA. This deviation allows the bridge to remain in the closed-to-navigation position to facilitate a tie replacement project.
This deviation is effective without actual notice from November 2, 2015 until 7 p.m. on November 5, 2015. For the purposes of enforcement, actual notice will be used from 11 a.m. on October 29, 2015, until November 2, 2015.
The docket for this deviation, [USCG-2015-0980], is available at
If you have questions on this temporary deviation, call or email Mr. Hal R. Pitts, Bridge Administration Branch Fifth District, Coast Guard; telephone (757) 398-6222, email
The Norfolk and Portsmouth Belt Line Railroad Company, who owns and operates the Belt Line Railroad Bridge, has requested a temporary deviation from the current operating regulations to facilitate a tie replacement project on the bridge. The bridge is a vertical lift draw bridge and has a vertical clearance in the closed position of 6 feet above mean high water.
The current operating schedule is set out in 33 CFR 117.997(a). Under this temporary deviation, the bridge will remain in the closed-to-navigation position from 11 a.m. to 7 p.m., except for scheduled daily openings at 2 p.m. and 5 p.m., from October 29, 2015 through November 5, 2015. During this temporary deviation, the bridge will operate per 33 CFR 117.997(a) from 7 p.m. to 11 a.m. The South Branch of the Elizabeth River is used by a variety of vessels including deep draft ocean-going vessels, U.S. government vessels, small commercial vessels, recreational vessels and tug and barge traffic. The Coast Guard has carefully coordinated the restrictions with commercial and recreational waterway users.
Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no alternate route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridge so that vessels
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone in the waters of the Atlantic Ocean, east of the Port St. Lucie Inlet. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a grounded vessel outside the Port St. Lucie Inlet. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Miami.
This rule is effective without actual notice from November 2, 2015] until November 15, 2015. For purposes of enforcement, actual notice will be used from October 27, 2015 through November 2, 2015.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Petty Officer Benjamin R. Colbert, Sector Miami Waterways Management Division, U.S. Coast Guard; telephone 305-535-4317, email
In the evening of October 26, 2015, the Coast Guard was notified that a 60 foot motorized vessel was taking on water in the vicinity of the Port St. Lucie Inlet. Over the next several hours attempts to refloat the vessel were unsuccessful and the grounded vessel settled on the bottom. Local, state, and federal agencies are now engaged in emergency salvage operations.
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because this rule is being established in response to an ongoing emergency situation. Delay in publishing this rule would be impracticable because the grounded vessel poses an immediate risk public safety. In addition, any delay in the publishing of this rule would be contrary to public interest. This rule is needed immediately in order to ensure safety of life on the navigable waters surrounding this ongoing emergency situation.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Miami (COTP) has determined that potential hazards associated with the grounded vessel will be a safety concern for anyone within a 100-yard radius of the vessel and equipment engaged in salvage operations. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while emergency salvage operations take place.
This rule establishes a safety zone from October 27, 2015 through November 15, 2015. COTP may cease enforcement of the zone if emergency salvage operations end before November 15, 2015. The safety zone will cover all navigable waters within 100 yards of vessels and machinery being used by personnel to conduct emergency salvage operations. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while emergency salvage operations are conducted. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.
E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, and duration. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Atlantic Ocean for a limited duration during emergency salvage operations. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves an emergency safety zone implemented to protect persons and vessels in the vicinity of a grounded vessel. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the regulated area by contacting the Captain of the Port Miami by telephone at 305-535-4472, or a designated representative via VHF radio on channel 16. If authorization is granted by the Captain of the Port Miami or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Miami or a designated representative.
(d)
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing a limited approval and limited disapproval of, and other actions on, revisions to the Arizona Department of Environmental Quality (ADEQ) portion of the applicable state implementation plan (SIP) for the State of Arizona (State or Arizona) under the Clean Air Act (CAA or Act). These revisions submitted by Arizona are primarily intended to serve as a replacement of ADEQ's existing SIP-approved rules for the issuance of New Source Review (NSR) permits for stationary sources, including review and permitting of major and minor sources under the Act. After a lengthy stakeholder process, the State submitted a NSR program for SIP approval that satisfies most of the applicable CAA and NSR regulatory requirements, and which will significantly update ADEQ's existing SIP-approved NSR program. It also represents an overall strengthening of ADEQ's SIP-approved NSR program by clarifying and enhancing the NSR requirements for major and minor stationary sources. This final action updates the applicable plan while allowing ADEQ to remedy certain deficiencies in ADEQ's rules.
This rule is effective December 2, 2015.
EPA has established docket number EPA-R09-OAR-2015-0187 for this action. Generally, documents in the docket for this action are available electronically at
Lisa Beckham, EPA Region 9, (415) 972-3811,
For the purpose of this document, we are giving meaning to certain words or initials as follows:
(i) The words or initials
(ii) The initials
(iii) The initials
(iv) The initials
(v) The initials
(vi) The initials
(vii) The initials
(viii) The words
(ix) The initials
(x) The initials
(xi) The initials
(xii) The initials
(xiii) The initials
(xiv) The initials
(xv) The initials
(xvi) The initials
(xvii) The initials
(xviii) The initials
(xix) The initials
(xx) The initials
(xxi) The initials
(xxii) The initials
(xxiii) The initials
(xxiv) The initials
(xxv) The initials
(xxvi) The initials
(xxvii) The initials
(xxviii) The words
(xxix) The initials
(xxx) The initials
On March 18, 2015, the EPA provided notice of, and requested public comment on, our proposed CAA rulemaking to revise certain portions of the Arizona SIP for ADEQ. See 80 FR 14044 (Mar. 18, 2015). We proposed action on SIP submittals that comprise ADEQ's updated program for preconstruction review and permitting of new or modified stationary sources under ADEQ's jurisdiction in Arizona.
As a component of its NSR SIP submittal, ADEQ also requested the removal from the Arizona SIP of numerous older rules, as well as one Arizona statutory provision, which are mostly superseded by the newer provisions that are the subject of this action or by newer provisions that have already been approved into the Arizona SIP. Accordingly, our action also will remove certain provisions from the Arizona SIP.
The EPA's rulemaking action on the ADEQ NSR SIP submittal is intended to update the applicable SIP consistent with ADEQ's requests, while allowing ADEQ to remedy certain deficiencies in
The ADEQ NSR SIP submittal was extensive in scope. We prepared a comprehensive Evaluation of the submittal in light of the requirements of the CAA and its implementing regulations, and provided a detailed discussion of our findings in the Technical Support Document (TSD) for our proposed action. Both the Evaluation and the TSD were available in the docket for our rulemaking during the public comment period. Our proposed rule discussed our analysis and findings, but focused primarily on the issues that formed the basis for our limited approval/limited disapproval of the ADEQ NSR SIP submittal, and referenced the TSD for additional information concerning our analysis. The Evaluation was an attachment to the TSD.
The EPA is finalizing a SIP revision for the ADEQ portion of the Arizona SIP for the rules and statutory provision listed in Table 1. The SIP revision will be codified in 40 CFR 52.120 by incorporating by reference the rules and statutory provision in ADEQ's NSR SIP submittal as listed in Table 1.
In addition, this final action removes the rules and appendices listed in Table 2 from the ADEQ portion of the Arizona SIP.
In summary, this action is primarily a limited approval and limited disapproval of a SIP submittal from Arizona for the ADEQ portion of the Arizona SIP that governs preconstruction review and the issuance of preconstruction permits for stationary sources, including the review and permitting of new major sources and major modifications under parts C and D of title I of the CAA as well as review of new and modified minor sources. The intended effect of our final limited approval and limited disapproval action is to update the applicable SIP with current ADEQ regulations, while allowing ADEQ to remedy the identified deficiencies in these regulations. We are also removing at ADEQ's request certain rules and appendices from the Arizona SIP, which are outdated and which are mostly being superseded by this action. In addition, we are finalizing a partial disapproval of one provision in ADEQ's NSR program that has been vacated by the courts. We are finalizing a limited approval of ADEQ's NA-NSR program for certain nonattainment areas based on requirements under section 189 of the Act related to PM
We are finalizing the above-described action because, although we find that the new and amended rules submitted by ADEQ meet most of the applicable CAA requirements for preconstruction review programs and other CAA requirements, and that overall the SIP revisions improve and strengthen the existing SIP, we have found certain deficiencies that prevent full approval, as explained in our proposed action and in the TSD for this rulemaking, and in this final action and our Response to Comments document.
We reviewed the ADEQ NSR SIP submittal in accordance with applicable CAA requirements, primarily including those that apply to: (1) General preconstruction review programs, including for minor sources, under section 110(a)(2)(C) of the Act; (2) PSD permit programs under part C of title I of the Act; and (3) NA-NSR permit programs under part D of title I of the Act. For the most part, ADEQ's submittal satisfies the applicable CAA requirements, including those for these preconstruction review programs, and our approval will strengthen the applicable SIP by updating the
We are largely finalizing our action as proposed. However, in response to public comments we received, our final action differs in some respects from our proposed action. For certain deficiencies identified in our proposal as bases for limited disapproval, we have changed our determination and no longer find that these are bases for our limited disapproval. In addition, we have changed our determination concerning one of the ADEQ rule provisions for which we had proposed partial disapproval; we are not finalizing our partial disapproval of this provision.
Specifically, the following issues that had been identified in our proposed action as bases for limited disapproval are not a basis for our final limited disapproval: (1) ADEQ's use of the term “proposed final permit” in its rules for the minor NSR, PSD and NA-NSR programs; (2) a question concerning whether ADEQ rule R18-2-334(E) requires ADEQ to review potential impacts on the attainment and maintenance of the National Ambient Air Quality Standards (NAAQS) for all minor sources subject to new source review under ADEQ rule R18-2-334;
In addition, we are making three technical corrections to address typographical errors, as noted by commenters: (1) Correction of SIP submittal dates listed in Table 1 (listing the rules and statutory provisions that we are approving into the SIP) so that “10/29/2012” is listed instead of “10/29/2014,” (2) correction of Table 2 (the list of rules and appendices that we are removing from the SIP) to exclude subsection (20) from the provisions of ADEQ rule R9-3-101 that we are removing from the SIP, and (3) the addition of ADEQ rules R9-3-310 and R9-3-312 to the list of rules in Table 2. Additional detail regarding these technical corrections is provided in response to comments 13 through 15 in our Response to Comments document.
Our March 18, 2015 proposed rule included a 30-day public comment period that ended on April 17, 2015. We received 3 written comments, one each from the Office of Robert Ukeiley, the Salt River Project Agricultural Improvement and Power District (SRP), and ADEQ. Copies of each comment have been added to the docket for this action and are accessible at
The
In the EPA's March 18, 2015
ADEQ states that its methodology for establishing minor NSR thresholds was valid for all areas under ADEQ's jurisdiction. The CAA does not impose strict, specific requirements on NSR programs for minor sources, as it does for major NSR. Rather, section 110(a)(2)(C) generally requires that each state include a program regulating the modification and construction of any stationary source
Citing the EPA's proposed Tribal NSR Rule, ADEQ states that in the past, the EPA has asserted that threshold levels are appropriate where “sources and modifications with emissions below the thresholds are inconsequential to attainment and maintenance of the NAAQS.”
ADEQ set an adequate, yet cost-effective threshold level of one half the significant emission rate (SER) for nonattainment areas. Just as the EPA did in the Tribal Minor NSR Rule, ADEQ identified the level at which a lower threshold merely creates a larger pool of regulated minor sources without
ADEQ illustrated this statement through a figure provided in its comments showing a comparison of potential threshold levels and relative impact, by pollutant.
As noted by ADEQ, CAA section 110(a)(2) generally requires that each state include a program regulating the modification and construction of any stationary source as necessary to assure achievement of the NAAQS. While we appreciate ADEQ's comments on this issue, to date, ADEQ has not provided sufficient information about the nature, scope and emissions that are contributing to nonattainment in the areas subject to ADEQ's jurisdiction to change our proposed determination that ADEQ has not provided an adequate basis for its NSR exemption thresholds as applied in such nonattainment areas.
The implementing regulations for the minor NSR program make clear that SIPs must include legally enforceable procedures that enable the decisionmaking authority to determine whether the construction or modification of stationary sources will result in a violation of applicable portions of the control strategy or interfere with attainment or maintenance of the NAAQS, and that such procedures include means by which the decisionmaking authority can prevent such construction or modification if it will result in such violation or interference. 40 CFR 51.160(a) and (b). Further, 40 CFR 51.160(e) provides:
The procedures must identify types and sizes of facilities, buildings, structures or installations which will be subject to review under this section. The plan must discuss the basis for determining which facilities will be subject to review.
Under CAA section 110(a)(2) and 40 CFR 51.160(e), we agree with ADEQ that States are not necessarily required to regulate all stationary sources under the minor NSR program. States can exempt from review those stationary sources with emissions that they can demonstrate would not pose a threat to the attainment or maintenance of the NAAQS, thereby satisfying the requirement in CAA section 110(a)(2)(C) that their minor NSR program regulate the modification and construction of any stationary source within the areas covered by the plan as necessary to ensure that the NAAQS are achieved. The EPA's interpretation was discussed in the proposal for our Tribal Minor NSR Rule:
A review of several State minor NSR programs indicated that a number of State programs have established cutoff levels or minor NSR thresholds, below which sources are exempt from their minor NSR rules. We believe that such an approach is also appropriate in Indian country. Section 110(a)(2)(C) of the Act requires minor NSR programs to assure that the NAAQS are attained and maintained. Applicability thresholds are proper in this context provided that the sources and modifications with emissions below the thresholds are inconsequential to attainment and maintenance of the NAAQS. For each pollutant, only around 1 percent (or less) of total emissions would be exempt under the minor NSR program.
In our proposed action on ADEQ's NSR SIP submittal, we found deficiencies in the basis ADEQ provided for determining which sources would be subject to review under its minor NSR program under 40 CFR 51.160(e), applying the statutory and regulatory standard discussed above. 80 FR at 14049. These deficiencies provided a basis (among other bases) for our proposed limited disapproval of ADEQ's minor NSR program. As stated in our proposal, we found ADEQ's general approach to meeting 40 CFR 51.160(e) acceptable. However, we proposed a limited disapproval for three aspects of ADEQ's minor NSR program under 40 CFR 51.160(e): The adequacy of ADEQ's NSR exemption thresholds for nonattainment areas; certain exemptions for agricultural and fuel burning equipment; and the lack of any basis for the PM
ADEQ's comments focus largely on the argument that expanding its minor
We recognize that the reference that the EPA made in its proposed action to ADEQ's submittal not providing a clear basis for concluding that its NSR exemption thresholds would ensure that a “sufficient percentage of minor sources” would be subject to review in nonattainment areas, rather than referring to a “sufficient percentage of minor source emissions,” was imprecise and may have led to confusion about the nature of the EPA's concern. As such, we are clarifying that our disapproval is related to ensuring that ADEQ's NSR program exempts from review only those sources with emissions that do not pose a threat to attainment and maintenance of the NAAQS because they are inconsequential to attainment or maintenance. The particular percentage of stationary sources that are being regulated would generally not be an adequate basis under 40 CFR 51.160(e) for determining the sizes and types of stationary sources that will be subject to NSR review as necessary to ensure compliance with CAA section 110(a)(2) and 40 CFR 51.160(a) and (b). As noted, the Tribal NSR Rule exempted as many as 76 percent of the
As stated in our proposal, in addressing this deficiency, ADEQ does not necessarily have to consider overall lower NSR exemption thresholds in nonattainment areas, see 80 FR 14049 n. 13, although, as noted, the Tribal NSR Rule established lower thresholds for nonattainment areas. 76 FR at 38758. For example, ADEQ could provide further analysis to demonstrate that the adopted thresholds are protective of the NAAQS in nonattainment areas, or ADEQ could consider a different approach, such as requiring minor sources in nonattainment areas subject to a pre-existing SIP requirement for the nonattainment pollutant, or its precursors, to be subject to review under ADEQ's registration program. In addressing this limited disapproval issue, we recommend that ADEQ focus its consideration on the contribution that emissions from minor stationary sources with emissions below its currently adopted NSR exemption thresholds are expected to make with respect to attainment and maintenance of the NAAQS in nonattainment areas.
In addition, we wish to clarify that while the EPA's proposed rulemaking for the Tribal NSR program discussed cost-effectiveness and attempted to strike a “balance between environmental protection and economic growth,” it also recognized the need for exemption thresholds to ensure “that sources with emissions below the proposed minor NSR thresholds will be inconsequential to attainment and maintenance of the NAAQS.” 71 FR at 48703. See also 76 FR at 38758. The EPA recognized the overarching need for standards stringent enough to ensure NAAQS protection, and agreed to “consider changing the minor NSR thresholds as appropriate” to ensure that they are sufficiently protective. 76 FR at 38759. Thus, cost-effectiveness is not a relevant criterion for determining whether a minor NSR program's exemption thresholds will assure attainment and maintenance of the NAAQS, and the test is not whether the benefits of the program outweigh the burdens of regulation, but whether the state's program meets the requirement in CAA section 110(a)(2)(C) to “assure that national ambient air quality standards are achieved.”
SRP and ADEQ state that the EPA may not substitute its policy preferences for ADEQ's in proposing to disapprove ADEQ's minor NSR program with respect to nonattainment areas. There are no regulatory provisions or CAA statutory provisions that specify that a State must regulate a “sufficient percentage” of minor sources in nonattainment areas. The EPA's objection appears to be based on its own policy preferences, and the EPA simply lacks authority to substitute its preferences for those of the State. The EPA points to no flaws in the reasoning behind the analysis, nor does the EPA provide an alternative analysis demonstrating that modifications or construction of minor sources of a certain size or type have caused air quality concerns within ADEQ's jurisdiction.
Further, each state, region, and control area encounters unique circumstances that contribute to air quality issues, as well as the strategies necessary to comply with the requirements of the CAA. At page 14049 n. 12 of the proposal, which accompanied a generalized comparison to other states, the EPA referenced threshold levels for Sacramento, California. It is erroneous for the EPA to compare Arizona's minor NSR program with that of California, due to the extraordinary severity of the nonattainment problems in California. The EPA's implication that ADEQ should create a minor source NSR program that looks and functions like other states, and particularly California, is an improper basis for disapproval.
ADEQ also asserts that the EPA has advanced no reason for concluding that ADEQ's analysis is any less valid for nonattainment areas than it is for attainment areas.
Contrary to the commenters' assertions, our proposed limited disapproval of ADEQ's program concerning the NSR exemption threshold for nonattainment areas was not based on a policy preference by the EPA to regulate “more” sources in nonattainment areas. As explained in detail in our response to comment 2, the EPA's proposed disapproval based on 40 CFR 51.160(e) stemmed in part from the lack of sufficient justification in ADEQ's NSR submittal to support its chosen thresholds for coverage of the minor NSR program in nonattainment areas as required by 40 CFR 51.160(e) and CAA section 110(a)(2). It is the State's obligation to demonstrate that emissions from sources exempt under its chosen NSR exemption threshold will not pose a threat to attainment or maintenance of the NAAQS. We found at the time of our proposal that ADEQ had not done so with respect to the NSR exemption thresholds in nonattainment areas, and we continue to find that this is the case.
Our March 18, 2015 proposed action made clear that ADEQ could consider various options for addressing this deficiency and we did not mandate that ADEQ adhere to a particular policy choice of the EPA in this regard. 80 FR at 14049 and n. 13. See also response to comment 2. The EPA agrees with the commenters that ADEQ has the discretion to determine the types and sizes of sources that need to be regulated under its NSR program to attain and maintain the NAAQS. But ADEQ, like other States, must provide a reasoned basis for the scope of emissions (and stationary sources of such emissions) regulated under its program that demonstrates that exemption of such emissions from NSR review will not threaten the attainment and maintenance of the NAAQS in nonattainment areas.
Air quality concerns in nonattainment areas differ from those in attainment areas and thus the measures necessary to attain and maintain the NAAQS may be more stringent in nonattainment areas than in attainment areas. When an area is already in nonattainment with a NAAQS for a particular pollutant, it is logical to conclude that relatively low levels of emissions increases of that nonattainment pollutant may well contribute to nonattainment and interfere with achievement of the NAAQS, while a source with the same level of emissions in an attainment area may pose little threat to maintaining the NAAQS. Thus, SIPs may need to provide greater or more detailed justification for exempting smaller sources of emissions from NSR review in nonattainment areas, depending on the particular air quality concerns in the area at issue. Indeed, as noted, the EPA's Tribal NSR Rule established more stringent thresholds for minor NSR in nonattainment areas, in most cases at 50% of the thresholds for attainment areas. 76 FR 38758 (Table).
ADEQ's jurisdiction covers both attainment and nonattainment areas, and ADEQ's analysis supporting its NSR exemption thresholds made no distinction between these types of areas nor did it provide additional information to support the thresholds in nonattainment areas under ADEQ's jurisdiction. For example, ADEQ's analysis indicated that it would exempt approximately 65% of CO emissions, 78% of SO
In the case of attainment areas, the EPA is approving the basis provided by ADEQ for its selected NSR exemption thresholds. We find it reasonable to conclude, based on the information and analysis provided by ADEQ, that expanding the NSR program to cover more emissions in areas that are already attaining the NAAQS will ensure that those areas will continue to attain and maintain the NAAQS. We cannot reach the same conclusion for nonattainment areas where the minor sources in a particular nonattainment area may, in fact, significantly contribute to nonattainment in that area.
The reference in our proposal to the approaches taken by other permitting programs, including a California agency, with respect to NSR exemption thresholds in nonattainment areas is not an indication that the EPA believes that such approaches or thresholds are required for ADEQ, but simply information showing that it is common for agencies in nonattainment areas to find it necessary to regulate more emissions. In providing this information, the EPA was not suggesting that there was a particular percentage of emissions that should be regulated, but that other nonattainment areas have found it necessary to exempt fewer emissions from their programs (including Maricopa County, Arizona, Colorado, and the EPA's Tribal Minor NSR rule, which were also referenced in our proposed action).
In sum, the EPA did not conclude that ADEQ's NSR exemption thresholds are necessarily deficient, or suggest that some other agency's threshold must be applied. The EPA's proposed limited disapproval for ADEQ's NSR exemption thresholds for nonattainment areas under 40 CFR 51.160(e) relates only to the fact that ADEQ had not provided an adequate basis for the thresholds that were set for these areas. As discussed in response to comment 2, our final limited disapproval is also based on this finding.
ADEQ submitted comments related to the EPA's proposed limited disapproval of ADEQ's NSR SIP submittal for its use of the term “proposed final permit.” ADEQ explains that the purpose of allowing sources to construct after issuance of a proposed final permit—the version of the permit that ADEQ
ADEQ specifically takes issue with the EPA's proposed determination that the program does not provide ADEQ with clear authority to prevent construction or modification before it issues a final decision on the request for authority to construct as is required per 40 CFR 51.160(a) and (b). 80 FR at 14048. ADEQ states that this objection is invalid for two reasons. First, 40 CFR 51.160(b) does not require a minor NSR program to include authority to prevent construction “before [an agency] issues a final decision.” It requires only that the program include procedures by which the agency “will prevent . . . construction or modification.” The Arizona program manifestly includes such procedures: ADEQ can prevent construction of a source that threatens the NAAQS or control strategy by denying the permit application before a proposed final permit is issued. No more is required. Second, by “final” the EPA appears to mean subject to administrative and judicial review. See 80 FR at 14053. The EPA maintains that although ADEQ has issued guidance stating that it “will treat [a] proposed final permit as a final, appealable agency action,” the rule itself is not sufficiently clear to be fully approved. 80 FR at 14048.
The EPA, however, has mischaracterized ADEQ's guidance. ADEQ did not state that it “will treat” proposed final permits” as appealable agency actions. Rather, the Department stated that it “must” do so. Under Arizona administrative law, an “appealable agency action” is defined as “an action that determines the legal rights, duties or privileges of a party.” A.RS. § 41-1092(3). Because a proposed final permit or permit revision under the revised rules determines the applicant's right to construct, it must be treated as an appealable agency action separate from the issuance of the final permit or permit revision. ADEQ must therefore issue a notice of appealable agency action under A.R.S § 41-1092.03 for both the proposed final permit or permit revision, as well as the final permit or permit revision.
ADEQ states that there is no ambiguity under Arizona law (which mirrors the administrative law of most states). Under the clear terms of ADEQ's regulations, a proposed final permit confers a right to construct and is therefore appealable.
The EPA appreciates ADEQ's comments concerning the question of whether ADEQ's NSR program provides for the issuance of a final NSR decision prior to sources being allowed to begin construction. Our proposed action on ADEQ's NSR SIP submittal stated that certain sources were allowed to begin construction upon issuance of a proposed final permit, and that we believed that ADEQ's regulations were ambiguous as to whether issuance of a “proposed final permit” was a final NSR decision. As a result, we proposed to find that ADEQ's NSR SIP submittal did not satisfy several related CAA requirements, and those deficiencies provided some of the bases for our proposed limited disapproval of ADEQ's PSD program, NA-NSR program, and minor NSR program.
The EPA continues to believe that the CAA and its implementing regulations require that PSD and NA-NSR programs must provide for the issuance of final NSR permit decisions imposing permit conditions necessary to ensure compliance with the applicable NSR program requirements before sources subject to those programs may begin construction. We also interpret the CAA to require that PSD programs provide an opportunity for judicial review of PSD permit decisions. See generally CAA sections 110(a)(2)(C), 165, 172(c)(5), 173; 40 CFR 51.165(a)(2), 51.166(a)(7)(iii), 166(q)(2)(vii).
The CAA and its implementing regulations also require that minor NSR programs provide for legally enforceable procedures including means by which the Agency responsible for final decisionmaking on an application for approval to construct or modify has authority to prevent such construction or modification if such construction or modification will result in a violation of applicable portions of the control strategy or will interfere with the attainment or maintenance of a NAAQS. CAA section 110(a)(2)(C), 40 CFR 51.160(a)-(b). We continue to believe that decisionmaking authorities must make final NSR decisions for minor sources, as well as major sources, subject to their NSR program prior to allowing sources to begin construction in order to satisfy this requirement that the plan provide for such “legally enforceable procedures.”
The EPA acknowledges the interpretation that ADEQ recently provided to clarify that ADEQ
We therefore conclude that ADEQ's NSR program provides, in all instances, for the issuance of a final NSR decision prior to sources being allowed to begin construction, thus this issue no longer provides a basis for our limited disapproval of the ADEQ NSR SIP submittal. Specifically, we agree that: (1) ADEQ's NSR program provides ADEQ with clear authority to prevent construction or modification before it issues a final decision on the request for authority to construct as required by 40 CFR 51.160(a) and (b); (2) ADEQ's PSD
However, we continue to recommend that ADEQ revise its regulations to clarify that a proposed final permit is a final, enforceable, and appealable NSR permit decision in order to minimize confusion among the public and the regulated community. We reiterate that such a revision is not a requirement for approval of ADEQ's NSR program into the SIP.
ADEQ disagrees with the EPA's proposed limited disapproval of ADEQ's program under 40 CFR 51.160(a)(2) and (b)(2) because rule R18-2-334 does not require ADEQ to evaluate whether the project under review will interfere with attainment or maintenance of the NAAQS in all cases, and instead allows sources to apply reasonably available control technology (RACT) in lieu of such an evaluation. ADEQ also takes issue with the EPA's determination that R18-2-334(E) allows for too great of Director's discretion when determining when to require a NAAQS analysis. ADEQ believes this objection is fundamentally at odds with the EPA's own approach to air quality impact analysis (AQIA) in the Tribal Minor NSR Rule. The tribal rule initially imposes a case-by-case control technology requirement, but gives the “reviewing authority” (which may be the EPA or a tribe with delegated authority) discretion to conduct an AQIA. 40 CFR 51.154(c) and (d). ADEQ also cites to the EPA's response to comments for the Tribal Minor NSR Rule where the EPA indicated that reviewing authorities implementing the Tribal Minor NSR Rule should be allowed the discretion to determine when an AQIA might be needed from the applicant. See 76 FR 38761. Further, ADEQ argues that ADEQ's rule is actually stricter and confers less discretion than the EPA's Tribal Minor NSR Rule. ADEQ must consider the source's emission rates, location of emission units within the facility and their proximity to ambient air, the terrain in which the source is or will be located, the source type, the location and emissions of nearby sources, and background concentration of regulated minor NSR pollutants. By comparison, the criteria in the EPA's Tribal Minor NSR Rule states that if the reviewing authority has reason to be concerned that the construction of your minor source or modification
Finally, ADEQ disagrees with the EPA's determination that R18-2-334(C)(1)(a)-(b) “appears to allow sources with lower levels of emissions to avoid both substantive NAAQS review and RACT requirements” and that the state's minor NSR Program therefore fails to ensure “that all sources subject to review under its NSR program will not interfere with attainment or maintenance of the NAAQS.” This objection is incorrect for two reasons. First, R18-2-334(C)(1)(a)-(c) represents ADEQ's reasonable judgment that the imposition of RACT on units with low emissions (20 percent of the source threshold) within a source otherwise subject to RACT is not a cost-effective means of protecting the NAAQS. Second, this provision does not, as the EPA contends, allow sources to avoid substantive NAAQS review. This provision clearly applies solely to sources that elect to comply with minor NSR through installation of RACT. These sources remain subject to the obligation to conduct an AQIA on the Director's request under R18-2-334(E), and there is nothing in the rule to suggest that emissions from units below the R18-2-334(C)(1)(a)-(b) thresholds would be excluded from the AQIA.
SRP also disagrees with the EPA's proposed disapproval based on the EPA's finding that the Director's discretion under R-18-2-334(E) was too great, and asserts that the EPA's proposed action conflicts with the EPA's policy on approving director discretion provisions. SRP argues that the Director's discretion in this regard is sufficiently specific in identifying when it applies and what criteria are to be applied and that therefore the relevant provisions are fully approvable into the Arizona SIP.
Upon review of ADEQ's comments, including clarifications regarding how the provisions of R18-2-334(E) apply, and in reliance on ADEQ's stated interpretation of its regulations, we no longer find that ADEQ's minor NSR program does not satisfy 40 CFR 51.160(a)(2) and (b)(2) based on the view that rule R18-2-334 does not require ADEQ to evaluate whether all sources subject to review under that rule may interfere with attainment or maintenance of the NAAQS.
We would also like to clarify that our proposed limited disapproval was not specifically related to ADEQ's choice to apply RACT for some sources subject to R18-2-334 while allowing certain smaller sources subject to the rule to avoid RACT. Rather, our proposed disapproval action related only to what we understood to be the potential for sources subject to R18-2-334 to apply RACT (or to proceed without applying RACT for certain sources with lower emissions)
Given our revised determination on this issue, it is not necessary to address all the arguments made by SRP concerning this issue, but we note that we agree with SRP (and ADEQ) that the
One commenter takes issue with the EPA's statements that finalizing its proposed limited disapproval would trigger an obligation for the EPA to promulgate a Federal Implementation Plan (FIP) and impose CAA sanctions if ADEQ does not correct the alleged deficiencies within 18 to 24 months. The commenter asserts that this contradicts the statutory limitations on the EPA's SIP-action authority under the CAA.
Section 110(c)(1) provides the EPA the authority to promulgate a FIP in only two circumstances: (1) The State failed to make a required SIP submission, or (2) the Administrator disapproves a SIP submission in whole or part. Section 179(a) contains similar conditions for imposing sanctions in nonattainment areas. The commenter claims that the EPA interprets its authority to impose a FIP or sanctions only when the disapproval relates to a mandatory SIP submission. In support of this assertion, the commenter cites to one action from Region 6 of the EPA that disapproved elements of the Texas Commission of Environmental Quality's (TCEQ's) major NSR rule to address the 2002 NSR changes (“[t]he provisions in these submittals . . . were not submitted to meet a mandatory requirement of the Act. Therefore, this final action to disapprove . . . the State submittals does not trigger a sanction or Federal Implementation Plan clock.”). The commenter concludes that such an interpretations of Section 110(c)(1) and Section 179(a) are reasonable because the EPA would otherwise, for example, be required to promulgate a FIP for disapproving a State's request to include odor provisions in its SIP that are unrelated to NAAQS compliance.
The commenter further states that ADEQ's current SIP contains fully-approved, minor NSR and major NSR permitting programs. As such, the State's requested SIP revisions addressed in the EPA's proposed action are not mandatory. The commenter further argues that the EPA referenced no information suggesting that it made a formal call for plan revision as required by Section 110(k)(5) of the CAA related to its proposed limited disapproval of ADEQ's NSR SIP submittal. As such, in general, Arizona is not under a mandatory duty to revise its existing SIP with regards to its NSR programs. The commenter argues that it is inappropriate for the EPA to replace a fully approved-SIP with a program that it alleges does not fully satisfy CAA requirements by using an approach that triggers the FIP clock and potentially imposes sanctions. ADEQ could withdraw the requested SIP submission and face no threat of a FIP or sanctions.
The EPA disagrees with the commenter's statement that the EPA's limited disapproval in this action does not trigger a FIP clock or potential sanctions, and disagrees that the EPA's action is inappropriate in light of this result.
The EPA continues to believe that limited disapproval of ADEQ's NSR SIP submittal triggers an obligation to promulgate a FIP unless ADEQ corrects the identified deficiencies and the EPA approves the related SIP revisions within 2 years, and that sanctions would be triggered by the EPA's limited disapproval of ADEQ's NA-NSR program revisions based on deficiencies related to CAA title I, Part D requirements for nonattainment areas if ADEQ fails to remedy the identified deficiencies so that the EPA can approve the revisions into the SIP before the sanctions apply. As stated in the notice for our proposal, we intend to work with ADEQ to remedy these deficiencies in a timely manner. Importantly, we note that the EPA's other option would have been a full disapproval of ADEQ's NSR SIP submittal, which would have required ADEQ to continue to implement the outdated rules in its SIP while also implementing its newer rules under State law. This would require ADEQ and permit applicants to continue to implement and comply with two redundant and sometimes inconsistent sets of NSR rules, contrary to ADEQ's request to update its SIP to incorporate its newer rules and remove its older, outdated rules.
Pursuant to section 110(c)(1) of the CAA, the EPA must promulgate a FIP within two years after our final limited disapproval of ADEQ's NSR SIP submittal, unless ADEQ adequately corrects the identified deficiencies and the EPA approves the corrected program into the Arizona SIP before that time. The commenter argues that the FIP clock applies only when a disapproval relates to a mandatory SIP submission, and asserts that the submitted revisions are not mandatory because ADEQ's existing SIP contains fully-approved minor and major NSR programs, and the revisions were not developed in response to a SIP call under CAA section 110(k)(5). The EPA disagrees with the commenter's argument.
Even if the EPA has not issued a SIP call under CAA section 110(k)(5),
In this case, the EPA cannot rely on provisions in the existing Arizona SIP to adequately address the deficiencies with the ADEQ NSR SIP submittal that we identified in our proposed rule and which form the basis for our final limited disapproval. ADEQ must address these deficiencies in a timely manner in order to avoid the requirement for the EPA to promulgate a FIP. As we made clear in the notice for our proposed action,
Similarly, for deficiencies related to CAA title I, Part D requirements for nonattainment areas, final limited disapproval of ADEQ's NSR SIP submission will result in the application of sanctions under CAA section 179 unless the deficiencies have been adequately corrected before the sanctions apply.
As with its arguments concerning the FIP clock, the commenter argues that CAA sanctions apply only when a disapproval relates to a mandatory SIP submission, and asserts that the submitted revisions are not mandatory because ADEQ's existing SIP contains fully-approved NSR permitting programs, and the revisions were not developed in response to a SIP call under CAA section 110(k)(5). The EPA again disagrees with the commenter's argument.
Even if the EPA has not issued a SIP call under CAA section 110(k)(5), sanctions generally will apply under CAA section 179 when the EPA disapproves a plan submission based on plan deficiencies that relate to title I, Part D requirements, unless ADEQ adequately corrects those deficiencies and the EPA takes action to approve a corrected plan submittal before the sanctions apply, or the EPA determines that the existing plan meets the applicable Part D requirements. See 40 CFR 52.31. A NA-NSR program that meets CAA requirements is a required element of a SIP. CAA §§ 110(a)(2)(C), 172(c)(5), 173; 40 CFR 51.165.
As discussed above, ADEQ's NSR SIP submittal included the removal of most of ADEQ's existing NSR program elements from the Arizona SIP, so upon the EPA's final action there will not be older NA-NSR SIP provisions that could potentially meet the CAA NA-NSR requirements that the EPA has determined are not satisfied in the NA-NSR program in ADEQ's NSR SIP submittal. The EPA's limited approval/limited disapproval action on ADEQ's NSR SIP submittal, including ADEQ's request to remove old and largely outdated NSR provisions from the Arizona SIP, allows us to approve into the SIP the State's choice to adopt and implement its updated and strengthened NA-NSR program while giving ADEQ time to remedy certain deficiencies that cause us not to grant full approval of the submittal. Furthermore, even if one assumed
We note that the EPA is also finalizing a partial disapproval—rather than limited approval/limited disapproval—for a separable ADEQ NSR program provision that is analogous to a previous federal NSR provision that a federal Court determined is not a permissible component of PSD programs—the PM
The EPA's limited disapproval action is based on program elements in ADEQ's NSR SIP submittal that do not meet CAA requirements and are not satisfied by the existing Arizona SIP provisions that remain in place following our final action.
Finally, our final limited disapproval also addresses some SIP elements or provisions that are not required (
SRP states that to proceed using the limited approval, limited disapproval mechanism, The EPA must make an on-the-record determination that the disapproved elements are not severable from the approved elements. The EPA has not made this finding or provided this explanation in its proposed notice.
The EPA disagrees with this comment. The commenter cites no authority for this unsupported proposition. Under CAA sections 110(k)(3) and 301(a) and the EPA's long-standing guidance, limited approval and partial approval are alternatives to full approval or full disapproval of a complete plan submission. Limited approval may be appropriate where a plan submittal contains some provisions that meet applicable CAA requirements and other provisions that do not, and the provisions are not separable. Partial approval may be used where a separable
Nevertheless, in general, we believe that, with the exception of the partial disapproval of the PM
One commenter states that the EPA's assertion that ADEQ may not exclude certain pollutant-emitting activities from PSD misinterprets the EPA's regulations. The commenter points to 40 CFR 51.160(e) and states that a State may exclude activities that it anticipates will have negligible or insignificant environmental impacts from either the major or minor NSR permit programs. This regulatory approach makes sense because it allows for a practical integration of the multiple preconstruction requirements. There is no basis for requiring a State to regulate activities with the more stringent requirements contained in the PSD or NA NSR program when those activities fall below the levels of concern established for the minor NSR program.
The regulations governing PSD and NA-NSR SIP programs contain the fundamental requirement that such programs adopt a specified definition for “stationary source.” 40 CFR 51.165(a)(1)(i), 51.166(b)(5). The regulations require the use of the prescribed definition, and state that deviations from the specified wording will be approved only if “the State specifically demonstrates that the submitted definition is “more stringent, or at least as stringent, in all respects” as the prescribed definition. 40 CFR 51.165(a)(1), 51.166(b). As explained in reference to the NA-NSR program in our March 18, 2015 proposal:
ADEQ must demonstrate that its definition of stationary source is at least as stringent as the federal definition at 51.165(a)(1)(i) in all respects.
We do not interpret 40 CFR 51.160(e) as allowing states to develop less stringent definitions for these programs without the necessary demonstration that the submitted definition is “more stringent, or at least as stringent, in all respects” as the prescribed definition as required by 40 CFR 51.165(a)(1) and 51.166(b). Section 51.160(e) does not contain any language giving states the discretion to exclude any type of source from the more specific major source permitting requirements in section 51.165 and 51.166. Section 51.160(e) does not say anything about sources that have “negligible or insignificant environmental impacts.” This section simply requires that a state plan identify the types and sizes of stationary sources that are covered by the “legally enforceable procedures” required under section 51.160(a) to review construction or modification of stationary sources. Sections 51.165 and 51.166 provide more detailed procedures that must apply to major stationary sources. These more specific provisions in sections 51.165 and 51.166 make clear that those procedures must cover the type and size of source covered by the definitions at 40 CFR 51.165(a)(1)(i) and 51.166(b)(5).
One commenter takes issue with our proposed limited disapproval of ADEQ's definition of projected actual emissions on the basis that it does not specifically require malfunction emissions to be included in the post-change projection. The EPA has not shown how ADEQ's exclusion of this term from ADEQ's definition makes the definition less stringent than the Federal rules. Malfunctions, by definition, are emissions associated with an unpredictable and not reasonably preventable event. In this respect, it is axiomatic that a source cannot reasonably project emissions that it cannot predict. By excluding malfunctions from its projected actual emissions procedure, ADEQ recognizes the EPA's own interpretation of “malfunctions” and is no less stringent than the federal definition. The EPA's proposed action also is inconsistent with other Regional Office SIP approvals that have approved definitions of “projected actual emissions” that do not require inclusion of malfunction emissions.
The commenter asserts that the EPA has not shown that ADEQ's exclusion of malfunction emissions from the definition of “projected actual emissions” makes the definition less stringent. However, ADEQ has the burden of demonstrating that its alternative definitions are not less stringent than the ones in the EPA's regulation. See 40 CFR 51.165(a)(1), 51.166(b). ADEQ's definitions under the PSD and NA-NSR programs warrant a limited disapproval because the EPA cannot reasonably conclude that ADEQ's definition is at least as stringent as the definitions in 40 CFR 51.165(a)(1) and/or 51.166(b). We note that ADEQ's definition for “baseline actual emissions” specifically includes startup, shutdown, and malfunction emissions, while ADEQ's definition for “projected actual emissions” includes startup and shutdown emissions but does not include malfunction emissions. Further, ADEQ's definition of “projected actual emissions” specifically excludes malfunction emissions associated with a shutdown. Based on the exclusion of malfunction emissions from the
With respect to the claim that the EPA has previously approved PSD or NA-NSR programs that do not include malfunctions emissions under the definition for projected actual emissions, we note that the examples provided by the commenter are not completely analogous. In those programs, the definition of baseline actual emissions also excluded malfunction emissions, whereas ADEQ has included those emissions in its definition of baseline actual emissions. Without further justification from ADEQ, this inconsistency across definitions makes it difficult for the EPA to determine the relative stringency of ADEQ's definitions as compared with those in 40 CFR 51.165 and 51.166. The commenter has not provided any information about the nature of the demonstrations that was supplied by the states that obtained the EPA approval for excluding malfunction emissions from both the definition of baseline actual emissions and projected actual emissions.
Notwithstanding prior action by the EPA in the context of SIPs in the distinct circumstances noted above, the EPA believes the proper interpretation of these definitions is that they require that all emissions, pre- and post-change, including malfunctions, be included in the definitions included in SIPs, consistent with the regulatory text, absent a demonstration that the State's regulation is at least as stringent as the federal definition as required by 40 CFR 51.165(a)(1) and 51.166(b).
We note that in reviewing this comment, we also reviewed our proposed limited disapproval related to the calculation of baseline actual emissions under ADEQ's PALs program at R18-2-412(B)(2). See 80 FR 14053. Upon review, we determined that our proposed limited disapproval related to the calculation of baseline actual emissions under ADEQ's PALs program at R18-2-412(B)(2) was in error because ADEQ's definition for baseline actual emissions at R18-2-401(2)(i) specifically includes startup, shutdown, and malfunction emissions. Therefore, this issue no longer provides a basis for our limited disapproval of ADEQ's NSR SIP submittal.
One commenter asserts that ADEQ's definition of regulated NSR pollutant is not deficient for not including the final two sentences in 40 CFR 51.166(b)(49)(i)(a). This language addresses issuance of permits before January 1, 2011. Since this SIP revision applies to changes after this date, it is not necessary for the definition to address circumstances that existed before SIP approval. Moreover, absence of the language, in any case, does not affect the stringency of the definition.
We agree with the commenter that while ADEQ may want to add to its definition these two sentences that provide additional clarification, this clarifying language is not necessary for SIP approval. As such, we no longer find this difference to be a deficiency with ADEQ's NSR program, and this issue is not a basis for our final limited disapproval.
The EPA proposes to disapprove ADEQ's major NSR programs because the SIP submittal does not include a definition for “subject to regulation.” Although the Federal regulations contain a definition for “subject to regulation,” the EPA made clear, at the time it adopted this definition, that states may adopt (or already have) alternative pathways for defining applicability of the major NSR program—the EPA did not intend for codification of “subject to regulation” to be a necessary element for SIP approval. See 75 FR 31514 at 31525. The EPA chose the “subject to regulation” pathway because it determined that this would allow other states to adopt the EPA's definition through interpretation without the need for a SIP revision.
ADEQ's major source definition refers to NSR regulated pollutants. ADEQ's definition of NSR regulated pollutant covers all pollutants ADEQ is currently required to regulate under its major NSR programs. ADEQ's program is not currently deficient for failing to include some unknown air pollutant that the EPA may regulate in the future. Should the EPA regulate such an air pollutant in the future, the EPA may follow the pathway it used for GHGs and issue a SIP call at that time. Similarly, ADEQ's definition of regulated NSR pollutant is not currently deficient for failing to include some unidentified air pollutant that the EPA might name in the future.
After further review and consideration of the comment, we are not including the absence of a definition of the term “subject to regulation” as a basis for our limited disapproval of the ADEQ NSR SIP submittal. Similarly, we are also not including the omission in ADEQ's PSD rules of language analogous to that in 40 CFR 51.166(b)(49)(iv) as a basis for our final limited disapproval of the ADEQ NSR SIP submittal. We note, however, that contrary to commenters' assertion, the ADEQ SIP is deficient because ADEQ's definition of regulated NSR pollutant does not cover all pollutants ADEQ is currently required to regulate under its major NSR programs, in that ADEQ's program does not regulate GHGs. However, the EPA has separately taken action to address this deficiency. The EPA previously established a FIP for GHGs for Arizona because ADEQ could not apply its PSD program to GHGs due to a State law prohibition.
One commenter states that we must approve ADEQ's definition of basic design parameter because the D.C. Circuit made no finding in
The EPA agrees with the commenter that our proposed partial disapproval of the definition for “basic design parameter” was erroneous. We note that ADEQ did not adopt any of the other provisions of the Equipment Replacement Provisions, which were the subject of the D.C. Circuit Court's decision in
Pursuant to section 110(k) of the CAA, the EPA is finalizing a limited approval and limited disapproval of the ADEQ rules listed in Table 1 above. We are also approving into the Arizona SIP the Arizona statutory provision relating to local delegation of state authority identified in Table 1 above. In addition, we are removing from the Arizona SIP certain rules and appendices, which are outdated and mostly being superseded by this action. See Table 2 above. We are also finalizing a partial disapproval of one provision of ADEQ's NSR SIP submittal concerning the PM
Our limited approval and limited disapproval action will approve the updated rules included in the ADEQ NSR SIP submittal into the ADEQ portion of the Arizona SIP.
Our limited disapproval action will trigger an obligation on the EPA to promulgate a FIP unless Arizona corrects the deficiencies that are the bases for the limited disapproval, and the EPA approves the related plan revisions, within two years of the final action. Additionally, for those deficiencies that are bases for our limited disapproval that relate to NA-NSR requirements under part D of title I of the Act, the offset sanction in CAA section 179(b)(2) would apply in the nonattainment areas under ADEQ's jurisdiction 18 months after the effective date of a final limited disapproval, and the highway funding sanctions in CAA section 179(b)(1) would apply in these areas six months after the offset sanction is imposed. Neither sanction will be imposed under the CAA if Arizona submits, and we approve, prior to the implementation of the sanctions, SIP revisions that correct the deficiencies that we identify in our final action.
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 ADEQ rules and the statutory provision 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
This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.
This rule will not have a significant impact on a substantial number of small entities because SIP approvals or disapprovals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve or disapprove requirements that the State is imposing. Therefore, because this action does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.
Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of State action. The Clean Air Act forbids the EPA to base its actions concerning SIPs on such grounds.
The EPA has determined that this action does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves or disapproves pre-existing requirements under State or local law, and imposes no new requirements.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or in the distribution of power and
Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires the EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. 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. Thus, Executive Order 13175 does not apply to this rule.
The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045, because it approves or disapproves State rules intended to implement a Federal standard.
This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.
Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, the EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.
The EPA believes application of VCS to this action would be inconsistent with the Clean Air Act.
Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
The EPA has determined that this rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not change the level of environmental protection for any affected populations.
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
Air pollution control, Carbon monoxide, Environmental protection, Greenhouse gases, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions and additions read as follows:
(c) * * *
(27) * * *
(i) * * *
(C) Previously approved in paragraphs (c)(27)(i)(A) and (B) of this section and now deleted without replacement: R9-3-101 (all paragraphs and nos. listed), paragraph B of R9-3-217, R9-3-301 (all paragraphs listed), R9-3-306 (all paragraphs listed), R9-3-307 (all paragraphs listed), R9-3-308, R9-3-310 (Paragraph C), R9-3-311 (Paragraph A), R9-3-312, R9-3-314, R9-3-315, R9-3-316, R9-3-317, R9-3-318, R9-3-518 (Paragraphs B and C), R9-3-319, R9-3-1101, and Appendix 10 (Sections
(43) * * *
(i) * * *
(C) Previously approved in paragraphs (c)(43)(i)(A) and (B) of this section and now deleted without replacement: R9-3-101 (all paragraphs and nos. listed), R9-3-301 (all paragraphs listed), R9-3-302 (all paragraphs listed), R9-3-303, R9-3-306 (all paragraphs listed), R9-3-307 (all paragraphs listed), and R9-3-518 (Paragraph A.1 to A.5).
(45) * * *
(i) * * *
(D) Previously approved in paragraphs (c)(45)(i)(A) and (B) of this section and now deleted without replacement: R9-3-101 (all paragraphs and nos. listed), R9-3-301 (all paragraphs listed), R9-3-306 (all paragraphs listed), R9-3-311 (all paragraphs listed), R9-3-509, and Appendix 10 (Sections A10.2 and A10.2.1).
(47) * * *
(i) * * *
(A) * * *
(
(50) * * *
(i) * * *
(C) Previously approved in paragraph (c)(50)(i)(A) of this section and now deleted without replacement: R9-3-310 (Paragraphs A and B) and Appendix 10 (Sections A10.1-A10.1.3.2).
(54) * * *
(i) * * *
(E) Previously approved in paragraphs (c)(54)(i)(B) and (c)(54)(i)(C) of this section and now deleted without replacement: R9-3-101 (all nos. listed except no. 20).
(H) Previously approved in paragraphs (c)(54)(i)(B), (C), and (D) of this section and now deleted without replacement: R9-3-301 (all paragraphs except paragraphs I and K), R9-3-302 (all paragraphs listed), R9-3-303 (all paragraphs listed), R9-3-304 (all paragraphs except paragraph H), R9-3-305, R9-3-306 (paragraph A only), and R9-3-1101 (all paragraphs listed).
(56) * * *
(i) * * *
(C) Previously approved in paragraphs (c)(56)(i)(A) and (B) of this section and now deleted without replacement: R9-3-101 (Nos. 135 and 157), R9-3-218, R9-3-310, R9-3-322, R9-3-1101 and Appendix 11.
(59) * * *
(i) * * *
(A) * * *
(
(161) * * *
(i) * * *
(A) * * *
(
(162) The following plan revision was submitted on October 29, 2012, and supplemented on September 6, 2013 and July 2, 2014, by the Governor's designee.
(i) * * *
(A) * * *
(
(
(ii) Additional materials.
(A) Arizona Department of Environmental Quality.
(
(
(
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve a State Implementation Plan (SIP) submission from the State of Iowa addressing the applicable requirements of Clean Air Act (CAA) section 110 for the 2008 National Ambient Air Quality Standards (NAAQS) for Lead (Pb), which requires that each state adopt and submit a SIP to support implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by EPA. These SIPs are commonly referred to as “infrastructure” SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.
EPA is also taking final action to approve a supplemental revision for the SIP to include article 1, section 2 of the Iowa Constitution, and portions of the Iowa Code and the Iowa Administrative Code to codify the relevant state laws as applied to conflict of interest requirements of section 128 of the CAA.
This final rule is effective December 2, 2015.
EPA has established a docket for this action under Docket ID No. EPA-R07-OAR-2015-0394. All documents in the electronic docket are listed in the
Heather Hamilton, Air Planning and Development Branch, U.S. Environmental Protection Agency, Region 7, 11201 Renner Boulevard, Lenexa, KS 66219;
Throughout this document, the terms “we,” “us,” or “our” refer to EPA. This section provides additional information by addressing the following:
On August 14, 2015, (80 FR 48791), EPA published a notice of proposed rulemaking (NPR) for the State of Iowa. The NPR proposed approval of Iowa's submission that provides the basic elements specified in section 110(a)(2) of the CAA necessary to implement, maintain, and enforce the 2008 Pb NAAQS. The NPR also proposed approval of a supplemental revision to include article 1, section 2 of the Iowa Constitution, and portions of the Iowa Code and the Iowa Administrative Code to codify the relevant state laws as applied to conflict of interest requirements of Sections 110(a)(2)(E) and 128 of the CAA.
On November 4, 2011, EPA received a SIP submission from the state of Iowa that addressed the infrastructure elements specified in section 110(a)(2) for the 2008 Pb NAAQS. The submission addressed the following infrastructure elements of section 110(a)(2): (A), (B), (C), (D), (E), (F), (G), (H), (J), (K), (L), and (M). On May 11, 2015, EPA received a supplemental SIP submission from the state of Iowa to include article 1, section 2 of the Iowa Constitution, and portions of the Iowa code and the Iowa Administrative Code to codify the relevant state laws as applied to conflict of interest requirements of Section 128 of the CAA. The rationale for EPA's proposed action to approve the SIP submissions for specific requirements of section 110(a)(2) of the CAA, and the submission for conflict of interest provisions are explained in the NPR and will not be restated here.
During the public comment period for the NPR one comment was received. The commenter stated that EPA cannot approve the Prevention of Significant Deterioration provisions unless the Particulate Matter (PM
EPA is approving Iowa's November 4, 2011, submission addressing the requirements of the CAA sections 110(a)(1) and (2) as applicable to the 2008 Pb NAAQS. Specifically, EPA approves the following infrastructure elements: 110(a)(2)(A), (B), (C), (D), (E), (F), (G), (H), (J), (K), (L), and (M) which are necessary to implement, maintain, and enforce the 2008 Pb NAAQS, as a revision to the Iowa SIP. EPA is also approving Iowa's May 11, 2015, submission to include article 1, section 2 of the Iowa Constitution, and portions of the Iowa code and the Iowa Administrative Code to codify the relevant state laws as applied to conflict of interest requirements of Sections 110(a)(2)(E) and 128 of the CAA.
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Iowa nonregulatory SIP provision described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available electronically through
Under the CAA the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 4, 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. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, EPA amends 40 CFR part 52 as set forth below:
Chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(e) * * *
Federal Communications Commission.
Final rule.
In this document, the Commission refines the rules it adopted in the Incentive Auction Report and Order and the preceding Channel Sharing Report and Order to provide greater flexibility and certainty regarding channel sharing agreements (“CSAs”). Among other things, we modify our rules to allow broadcasters that relinquish rights in the incentive auction in order to channel share to enter into CSAs after the auction and, whether they enter into CSAs before or after the auction, to determine the length of their agreements.
Effective December 2, 2015, except for §§ 1.2204(c)(4) and 73.3700(b)(1), which contain new or modified information collection requirements that require approval by OMB under the PRA and will become effective after the Commission publishes a notice in the
Kim Matthews, Media Bureau, Policy Division, 202-418-2154, or email at
This is a summary of the Commission's
The
In addition, the Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
1. Broadcasters will have the unique financial opportunity in the broadcast television spectrum incentive auction to voluntarily return some or all of their licensed spectrum usage rights in exchange for incentive payments. One of broadcasters' bid options will be to relinquish rights in order to share a channel with another licensee. The Commission established rules governing channel sharing agreements (“CSAs”) in the
2. Congress authorized the Commission to conduct the incentive auction to help meet the Nation's growing spectrum needs. Section 1452(a)(2) of the Spectrum Act provides for three bid options that will be available to eligible full power and Class A broadcast television licensees in the auction, including relinquishment of “usage rights in order to share a television channel with another licensee” (“channel sharing bid”). Section 1452(a)(4) provides that a licensee that voluntarily relinquishes usage rights in order to channel share and that possessed carriage rights on November 30, 2010 “shall have, at its shared location, the carriage rights . . . that would apply to such station at such location if it were not sharing a channel.” In the
3. The Commission addressed a variety of further issues related to channel sharing in the
4. The Expanding Opportunities for Broadcasters Coalition (“EOBC”) filed a Petition for Reconsideration of our channel sharing decisions in the
5. The National Cable & Telecommunications Association (“NCTA”) filed an opposition arguing that extending carriage rights to broadcasters that enter into post-auction CSAs would contravene the Spectrum Act. NCTA argues that this would cause uncertainty in the post-auction broadcaster transition process; confer greater cable carriage rights than Congress intended; lead to customer confusion; and might leave MVPDs unreimbursed. CTIA supports all of EOBC's requests, as do Fox, Ion Media, Tribune, and Univision.
6. We grant the EOBC Petition, with the exceptions noted below. In addition to addressing each of EOBC's above-stated requests for reconsideration below, we modify and clarify the pre- and post-auction CSA filing requirements that apply before and after the auction and address the scope of CSA review by Commission staff.
7. In the
8. EOBC asks the Commission to clarify that the act of entering into a CSA, in and of itself, does not trigger the reversionary interest rule and that parties to CSAs may bargain for common contractual rights consistent with existing Commission rules and policies. We received no opposition to EOBC's request. In its “Opposition and Reply,” CTIA joins and supports all of EOBC's reconsideration requests regarding channel sharing. Fox, Ion Media, Tribune, and Univision, who filed a reply comment in response to the
9. We grant EOBC's request. We clarify that parties to a CSA may grant each other options, puts, calls, rights of first refusal, and other common contingent interests, subject to all applicable Commission rules and policies, including the media ownership rules, without committing a
10. Under the rules adopted in the
11. EOBC requests that the Commission modify its rules to allow a winning license relinquishment bidder to execute a CSA after bidding in the auction is complete. Fox, Ion Media, Tribune, and Univision, who filed a reply comment in response to the
12. We grant EOBC's request, subject to the conditions set forth herein. Specifically, we modify our rules to allow winning bidders that relinquish their spectrum usage rights to enter into CSAs after the completion of the incentive auction, provided that they (1) indicate in their pre-auction applications that they have a present intent to find a channel sharing partner after the auction, and (2) execute and implement their CSAs by the date on which they would otherwise be required to relinquish their licenses. Parties to post-auction CSAs will be entitled to the same carriage rights as parties to pre-auction CSAs. We emphasize, however, that the exception to the rule prohibiting certain communications before and during the incentive auction will apply only to parties to pre-auction CSAs.
13. Subject to these conditions, we agree with EOBC that pre- and post-auction CSAs are the same for purposes of the Spectrum Act. We also agree with EOBC that providing this flexibility will encourage broadcasters to consider the channel sharing bid option by enabling them to participate in the auction even if they do not find a channel sharing partner before the auction begins. Indeed, as EOBC notes, parties may be able to negotiate CSAs more readily after the auction is complete, when fewer variables remain unknown. This action also may help to preserve independent voices by enabling licensees to continue broadcasting after they voluntarily relinquish rights in the incentive auction. As stated above, broadcasters that do not submit executed CSAs with their pre-auction applications will be ineligible for the exception to the prohibited communications rule. Accordingly, there will be no need for the staff to review a CSA prior to the auction to verify that the applicant qualifies for the exception.
14. In order to enter into a post-auction CSA, we will require that a license relinquishment bidder indicate
15. In addition, post-auction CSAs must be executed and implemented (
16. This requirement addresses NCTA's concern that allowing auction participants to enter into post-auction CSAs would introduce additional uncertainty into the post-auction transition process. As NCTA notes, “[u]nder the current rules, sharing stations must notify the Commission of their intent to share prior to the auction and must file their application for license for the shared channel within three months after receiving auction proceeds.” Under our ruling here, sharee stations likewise will have to execute and implement their post-auction CSAs by the time they have to relinquish their licenses, and thus they will be on the same notification timeline as those stations that entered into pre-auction CSAs. We believe that this timeframe also will provide adequate time for parties to post-auction CSAs to comply with the consumer and MVPD notice requirements laid out in the
17. Finally, we find that the reimbursement process set out in the
18. Under the rules adopted in the
19. We modify our rules to provide flexibility for broadcasters to determine the length of their CSAs. Specifically, we will permit broadcasters to choose the length of their channel sharing agreements. We agree that allowing term-limited CSAs will encourage channel sharing bids in the incentive auction by allowing parties to end the channel sharing relationship if they choose while still having the opportunity to continue operating. We also agree with EOBC that providing such flexibility is appropriate to meet broadcasters' individualized programming and economic needs. Consistent with our decision, as discussed below, we will not permanently designate channels as “shared” in the Table of Allotments. Instead, a channel's shared status will be indicated on a sharing station's license.
20. However, our decision to allow term-limited CSAs raises the question of whether to authorize CSAs by full power and Class A stations outside the incentive auction context. In the companion Notice of Proposed Rulemaking, we tentatively conclude that we should allow future CSAs outside the incentive auction context, and we invite comment on issues attendant to that proposal.
21. Under the rules adopted in the
22. EOBC argues that “[e]ven the possibility that the FCC could appoint a successor sharing partner will be troublesome to most broadcasters considering the channel sharing option.” Instead, EOBC argues that channel sharing parties should have “the option to reclaim the spectrum rights (but not the licenses) previously held by the departing party . . . Thus, if a sharee station relinquishes its spectrum, the host station could either find a new channel sharing partner . . . or resume use of the full six megahertz channel. If the host station relinquishes its spectrum, meanwhile, the sharee station(s) would have the option to assume the previously shared channel, subject to the technical parameters of the existing allotment.” CTIA agrees that, if a sharing station relinquishes its license, then the right to use the relinquished portion of the shared spectrum should return to the remaining sharing partner(s). Similarly, Fox, Ion Media, Tribute, and Univision agree that “upon expiration or termination of a CSA sharing stations should have the flexibility either to utilize the full capacity of their shared channel or to enter into a channel sharing arrangement with a new partner (or partners).” No parties opposed this request.
23. We grant EOBC's request, and modify our rules to allow parties to develop CSA terms that address what happens in the event that a sharing party's license is terminated for any reason, rather than providing that the terminated spectrum usage rights revert to the Commission for reassignment. Our decisions here do not affect the right of a channel sharing party to assign or transfer its license consistent with the
24. We agree with EOBC that, as business partners, channel sharers should “have the ability to choose partners that satisfy their own criteria.” The Commission will not select a sharing partner. To accommodate this flexibility, we will not permanently designate channels as “shared” in the Table of Allotments, and a channel's shared status will be indicated on the station license. In the event that a sharing partner relinquishes its license, its spectrum usage rights (but not its license) may revert to the remaining sharing partners if the partners so agree. Where only one sharing partner remains, it may apply to change its license to non-shared status using FCC Form 2100 Schedule B (formerly FCC Form 302) or F (formerly FCC Form 302-CA). If a full power station that is sharing with a Class A station relinquishes its license, then the Class A station would continue to operate under the rules governing Class A stations.
25. In order to provide additional certainty to broadcasters interested in the channel sharing bid option, and in light of our decision to allow post-auction CSAs, we modify and clarify our procedures for submission and review of both pre-auction and post-auction CSAs. At the outset, we emphasize that we will not question parties' business judgment in drafting CSAs.
26. If a licensee submits an executed CSA before the auction along with its auction application, we will accept for purposes of determining eligibility to participate the applicant's certification that the CSA complies with our channel sharing operating rules. We will not review the CSA itself at the pre-auction stage for compliance with our operating rules. We will review the CSA at the pre-auction stage solely to confirm that the parties qualify for the channel sharing exception to the rule prohibiting certain communication adopted in the
27. Post-auction, we will review CSAs submitted before or after the auction by successful bidders to determine whether the CSAs meet the requirements the Commission has adopted to ensure compliance with our CSA operating rules and policies. Although in the
28. Under the rules adopted in the
29. As required by the Regulatory Flexibility Act of 1980, as amended (“RFA”), an Initial Regulatory Flexibility Analysis (“IRFA”) was incorporated in the
30. This
31. Specifically, in the
32. No commenters directly responded to the IRFA in the
33. Pursuant to the Small Business Jobs Act of 2010, the Commission is required to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed rules as a result of those comments. The Chief Counsel did not file any comments in response to the rules adopted in this proceeding.
34. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the adopted rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” small organization,” and “small government jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
35. As noted, we incorporated a FRFA into the
36. In section D of the FRFA incorporated into the
37. The RFA requires an agency to describe any significant alternatives that it has considered in developing its approach, which may include the following four alternatives (among others): “(1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”
38. The reporting, recordkeeping, and other compliance requirements resulting from the First Order on Reconsideration will apply to all entities in the same manner. The Commission believes that applying the same rules equally to all entities in this context promotes fairness. The Commission does not believe that the costs and/or administrative burdens associated with the rules, including the payment of a construction permit filing fee by commercial broadcasters who are reverse auction winners and who will channel share, will unduly burden small entities. (Non-commercial broadcasters are exempt from such filing fees.) The construction permit itself will contain the same information included in the construction permit and license information of the channel sharer station and therefore can be copied without additional engineering work. The submission of the executed channel sharing agreement does not add cost as the rules already require execution of a channel sharing agreement between sharing parties.
39. While these new rules require additional filings for those reverse auction winning bidders that channel share, they give bidders, including broadcast television entities meeting the definition of small businesses, the increased flexibility to enter into post auction CSAs, to limit the term of their CSAs rather than make them permanent, and to request reversion of spectrum usage rights in the event of the termination of the license of a
40. None.
41. The Commission will send a copy of this
42. The Commission will send a copy of this First Order on Reconsideration, including this Supplemental FRFA, to the Chief Counsel for Advocacy of the Small Business Administration.
43. This document contains new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (“PRA”), Public Law 104-13. It will be submitted to the Office of Management and Budget (“OMB”) for review under section 3507(d) of the PRA. OMB, the general public, and other Federal agencies will be invited to comment on the new or modified information collection requirements contained in this proceeding in a separate published
44. We have assessed the effects of the policies adopted in this First Order on Reconsideration with regard to information collection burdens on small business concerns, and find that these policies will benefit many companies with fewer than 25 employees by providing them with options for voluntarily relinquishing broadcast spectrum usage rights and by streamlining the pre-auction application process. In addition, we have described impacts that might affect small businesses, which includes most businesses with fewer than 25 employees, in the Supplemental FRFA in Appendix B.
45. Accordingly, IT IS ORDERED that, pursuant to the authority contained in sections 1, 4, 301, 303, 307, 308, 309, 310, 316, 319, and 405 of the Communications Act of 1934, as amended, and sections 6402 and 6403 of Middle Class Tax Relief and Job Creation Act of 2012, Pub. L. 112-96, 126 Stat. 156, 47 U.S.C. 151, 154, 301, 303, 307, 308, 309, 310, 316, 319, 405, 1404, and 1452, this FIRST ORDER ON RECONSIDERATION is ADOPTED and parts 1 and 73 of Commission's rules are AMENDED as set forth in the Appendix A of the
46. IT IS FURTHER ORDERED that the rules adopted herein will become effective December 2, 2015, except for sections 1.2204(c)(4) and 73.3700(b)(1), which contain new or modified information collection requirements that require approval by the OMB under the PRA and WILL BECOME EFFECTIVE after the Commission publishes a notice in the
47. IT IS FURTHER ORDERED that, that pursuant to sections 4(i), and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i) and 405, and section 1.429 of the Commission's rules, 47 CFR 1.429, the Petition for Reconsideration filed by the Expanding Opportunities for Broadcasters Coalition IS HEREBY GRANTED IN PART AND IS OTHERWISE DISMISSED AS MOOT.
48. IT IS FURTHER ORDERED that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, SHALL SEND a copy of this First Order on Reconsideration, including the Supplemental Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.
49. IT IS FURTHER ORDERED that the Commission SHALL SEND a copy of this First Order on Reconsideration in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).
Administrative practice and procedure, Television.
Television, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Federal Communications Commission amends Parts 1 and 73 of Title 47 of the Code of Federal Regulations as follows:
15 U.S.C. 79,
(d)
(c) * * *
(4) * * *
(i) Whether it intends to enter into a channel sharing agreement if it becomes a winning bidder;
47 U.S.C. 154, 303, 334, 336, and 339.
(a) * * *
(3)
(b) * * *
(1) * * *
(i) Licensees of reassigned stations, UHF-to-VHF stations, and High-VHF-to-Low-VHF stations must file a minor change application for a construction permit for the channel specified in the Channel Reassignment Public Notice using FCC Form 2100 Schedule A (for a full power station) or E (for a Class A station) within three months of the release date of the Channel Reassignment Public Notice. Licensees that are unable to meet this filing deadline may request a waiver of the deadline no later than 30 days prior to the deadline.
(vii) Channel sharee stations must file a minor change application for a construction permit for the channel on which the channel sharer operates at least sixty (60) days prior to the date by which it must terminate operations on its pre-auction channel pursuant to paragraphs (b)(4)(i) and (ii) of this section. The application must include a copy of the executed channel sharing agreement.
(2) * * *
(i)
(ii)
(3)
(h) * * *
(2) Upon termination of the license of a party to a CSA, the spectrum usage rights covered by that license may revert to the remaining parties to the CSA. Such reversion shall be governed by the terms of the CSA in accordance with paragraph (h)(5)(i)(E) of this section. If upon termination of the license of a party to a CSA only one party to the CSA remains, the remaining licensee may file an application to change its license to non-shared status using FCC Form 2100, Schedule B (for a full power licensee) or F (for a Class A licensee).
(3)
(ii) A Class A channel sharee station licensee that is a party to a CSA with a full power channel sharer station licensee must comply with the rules of part 73 governing power levels and interference, and must comply in all other respects with the rules and policies applicable to Class A television stations, as set forth in §§ 73.6000
(iii) A full power channel sharee station licensee that is a party to a CSA with a Class A channel sharer station licensee must comply with the rules of part 74 of this chapter governing power levels and interference.
(iv) A Class A channel sharee station may qualify only for the cable carriage rights afforded to “qualified low power television stations” in § 76.56(b)(3) of this chapter.
(4)
(ii) The licensee of an NCE station operating on a reserved channel under § 73.621 that becomes a party to a CSA, either as a channel sharee station or as a channel sharer station, will retain its NCE status and must continue to comply with § 73.621.
(iii) If the licensee of an NCE station operating on a reserved channel under § 73.621 becomes a party to a CSA, either as a channel sharee station or as a channel sharer station, the portion of the shared television channel on which the NCE station operates shall be reserved for NCE-only use.
(iv) The licensee of an NCE station operating on a reserved channel under § 73.621 that becomes a party to a CSA may assign or transfer its shared license only to an entity qualified under § 73.621 as an NCE television licensee.
(5)
(A) Access to facilities, including whether each licensee will have unrestrained access to the shared transmission facilities;
(B) Allocation of bandwidth within the shared channel;
(C) Operation, maintenance, repair, and modification of facilities, including a list of all relevant equipment, a description of each party's financial obligations, and any relevant notice provisions;
(D) Transfer/assignment of a shared license, including the ability of a new licensee to assume the existing CSA; and
(E) Termination of the license of a party to the CSA, including reversion of spectrum usage rights to the remaining parties to the CSA.
(ii) CSAs must include provisions:
(A) Affirming compliance with the requirements in paragraph (h)(5) of this section and all relevant Commission rules and policies; and
(B) Requiring that each channel sharing licensee shall retain spectrum usage rights adequate to ensure a sufficient amount of the shared channel capacity to allow it to provide at least
Federal Communications Commission.
Final rule.
In this Second Order on Reconsideration, the Federal Communications Commission (Commission) provides more flexibility to broadcasters interested in the channel sharing option in the broadcast incentive auction by clarifying that back-up channel sharing agreements (“CSAs”) are permitted under its rules and providing more time for successful bidders to transition to shared facilities after the auction. The Commission also provides guidance regarding how the CSA exception to the prohibited communications rule applies with respect to back-up CSAs.
Effective December 2, 2015.
Shaun Maher,
This is a summary of the Commission's Second Order on Reconsideration, FCC 15-139, adopted October 21, 2015, in MB Docket No. 15-137. The full text of the Second Order on Reconsideration is available for inspection and copying during regular business hours in the FCC Reference Center, 445 12th Street SW., Room CY-A257, Portals II, Washington, DC 20554. This document is available in alternative formats (computer diskette, large print, audio record, and Braille). Persons with disabilities who need documents in these formats may contact the FCC by email:
The Commission is seeking separate OMB approval for FCC Form 2100, Schedule B (for a full power station) and F (for a Class A station) and FCC Form 177.
1. The Commission adopted rules for the broadcast incentive auction in the Incentive Auction R&O including rules for parties interested in entering into CSAs. The Commission recently modified those channel sharing rules to provide greater flexibility to stations considering that option. In this Second Order on Reconsideration, the Commission announces that the availability of back-up channel sharing arrangements would provide additional flexibility for stations considering channel sharing. In particular, it would enable both parties to a CSA to participate in the auction while mitigating the risk that the auction system could freeze both stations in the same round and thus deprive both stations of a post-auction host or “sharer” station. For some, the risk of being left without any spectrum on which to share may be too great and foreclose that kind of participation. The Commission concludes that a back-up CSA could mitigate that risk and encourage greater participation.
2. The Commission clarifies that, if both parties to a CSA participate in the auction, the rules allow either or both parties to also enter into a back-up CSA with one other station in the same DMA to act as the back-up host or sharer station. By allowing the parties to secure a fallback arrangement in the event that both parties relinquish their spectrum usage rights in the auction, this clarification will help promote wider participation in the auction by broadcasters that require assurance that they will remain on the air in the DMA. The Commission reminds parties that all of their auction-related activity and communications, including with respect to back-up CSAs, must adhere to the antitrust laws as well as the rules.
3. In the Second Order on Reconsideration, the Commission rejects the Broadcaster Representatives' request to allow “contingent multi-party CSAs across multiple markets.” The Commission concludes that multi-market back-up CSAs are not necessary to address the uncertainty created if multiple parties to a particular CSA participate in the auction. Such a result would undermine the general goal of the rules prohibiting certain communications, which are intended to reinforce existing antitrust laws, facilitate the detection of collusive conduct, and assure incentive auction participants that the auction process will be fair and objective. The Commission restated that it crafted the CSA exception to apply on an agreement-by-agreement basis in order to encourage channel sharing relationships without undermining these objectives.
4. The Commission also clarifies that, consistent with the foregoing, the CSA exception to the reverse auction rule prohibiting certain communications applies only to communications between parties to a single CSA at any given time. Further, the CSA exception only applies to a CSA, including back-up CSAs, if the CSA was entered into and filed with the Commission by the application deadline. If both stations pursuant to the primary CSA have a bidding status of “frozen—provisional winner,”
5. The Commission notes that under the reverse auction bidding procedures, the bidding status of a “frozen—provisional winner” may change to “bidding in the current round” if the auction enters a subsequent stage. Accordingly, if the host in the primary CSA, which was no longer operative because its bidding status became “frozen—provisional winner” in the
6. The Commission also finds that the attractiveness of the channel sharing option would be enhanced if sharees were given additional time to plan and execute their transition to the host's facilities. Currently, the rules require that all winning go off-air bidders in the reverse auction, including winning channel sharees, must terminate operations on their pre-auction channels within three months of when they receive auction proceeds. While three months for termination of operations is sufficient for go off-air winners who intend to relinquish their licenses and cease broadcasting altogether, the Commission recognizes that winning bidders that plan to share a channel will remain in operation and may therefore need more time to implement the move to the sharer's facility. For instance, a channel sharee may need time to deal with technical issues associated with transitioning to its shared location. If it is changing its community of license, it may also need to negotiate modifications to carriage agreements or finalize new must-carry arrangements with multichannel video programming distributors.
7. For these reasons, the Commission modifies section 73.3700(b)(4)(ii) of the rules to extend the amount of time a sharee in a pre- or post-auction CSA will have to relinquish its pre-auction channel to six months after receipt of its reverse auction proceeds. As the Commission decided in the Incentive Auction R&O, winning channel sharing bidders may request a waiver of up to an additional three months to cease operations on their pre-auction channel, pursuant to section 1.3 of the rules, and the Commission will view these requests most favorably. Further, winning channel sharing bidders may request an additional three-months, and the Commission will view the additional requests favorably as well so long as it determines that grant of the extension will not delay the post-auction transition. The Commission finds that this extension of the transition period to six months, and the availability of waivers of up to an additional six months, is unlikely to adversely affect the Commission's post-auction transition timeline.
The Regulatory Flexibility Act of 1980, as amended (RFA), requires that a regulatory flexibility analysis be prepared for notice-and-comment rule making proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the U.S. Small Business Administration (SBA).
In 2012, Congress mandated that the Commission conduct an incentive auction of broadcast television spectrum as set forth in the Middle Class Tax Relief and Job Creation Act of 2012 (“Spectrum Act”). The incentive auction will have three major pieces: (1) A “reverse auction” in which full power and Class A broadcast television licensees submit bids to voluntarily relinquish certain broadcast rights in exchange for payments; (2) a reorganization or “repacking” of the broadcast television bands in order to free up a portion of the ultra-high frequency (“UHF”) band for other uses; and (3) a “forward auction” of licenses for flexible use of the newly available spectrum. In the Incentive Auction R&O, the Commission adopted rules to implement the broadcast television spectrum incentive auction. Among other things, the Commission adopted rules for broadcast stations that choose to channel share. Pursuant to the RFA, a Final Regulatory Flexibility Analysis (“FRFA”) was incorporated into the Incentive Auction R&O.
This Second Order on Reconsideration reflects clarifications and modifications to the Commission's rules arising in response to comments filed by Fox, ION, Tribune, and Univision (the “Broadcaster Representatives”). The Commission generally responds favorably to the Broadcaster Representatives' requests, finding that providing these clarifications will increase broadcasters' flexibility to use the channel sharing bid option and will make the option more attractive. Specifically, this Second Order on Reconsideration clarifies the Commission's rules to permit broadcasters to enter into back-up channel sharing agreements (“CSAs”) with an additional partner to mitigate the risk that stations that intend to channel share could be left without spectrum after the auction, if both partners receive a status of “frozen-provisionally winning” in the same round of the reverse auction. The Commission also clarified that the CSA exception to the general prohibition on communications regarding bids and bidding strategy will apply to that back-up CSA, so long as the back-up CSA was filed before the application deadline, is the requirement for all CSAs. This Second Order on Reconsideration also permits back-up agreements based on price or other contingencies, but declines to extend the CSA exception to them as introducing unacceptable risk of becoming a vehicle for collusion. Finally, this Second Order on Reconsideration extends the transition period for channel sharing winning bidders from three months to six months, and extends the possibility for additional waivers from three months to six months, barring any delay this would cause other transitioning broadcasters.
Neither of these changes adopted in this Second Order on Reconsideration will impose additional costs. The changes provide greater flexibility for both stations that wish to pursue channel sharing agreements pre-auction and those that become channel sharing stations post-auction. Therefore, the Commission certifies that the changes adopted in this Second Order on Reconsideration will not have a significant economic impact on a substantial number of small entities.
The Commission will send a copy of the Second Order on Reconsideration, including a copy of this Final Regulatory Flexibility Certification, in a report to Congress pursuant to the Congressional Review Act. In addition, the Second Order on Reconsideration and this certification will be sent to the Chief Counsel for Advocacy of the Small Business Administration, and will be published in the
None.
Television and reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:
47 U.S.C. 154, 303, 334, 336 and 339.
(b) * * *
(3)
(4) * * *
(ii) The licensee of a channel sharee station and a licensee of a license relinquishment station that has indicated in its Form 177 an intent to enter into a post-auction channel sharing agreement must comply with the notification and cancellation procedures in § 73.1750 and terminate operations on its pre-auction channel within six months of the date that the licensee receives its incentive payment pursuant to section 6403(a)(1) of the Spectrum Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; inseason adjustment
NMFS is adjusting the 2015 seasonal apportionments of the total allowable catch (TAC) for pollock in the Gulf of Alaska (GOA) by re-apportioning unharvested pollock TAC in Statistical Areas 610, 620, and 630 of the GOA. This action is necessary to provide opportunity for harvest of the 2015 pollock TAC, consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska.
Effective 1200 hours, Alaska local time (A.l.t.), October 28, 2015, until 2400 hours A.l.t., December 31, 2015.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council (Council) under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The annual pollock TACs in Statistical Areas 610, 620, and 630 of the GOA are apportioned among four seasons, in accordance with § 679.23(d)(2). Regulations at § 679.20(a)(5)(iv)(B) allow the underharvest of a seasonal apportionment to be added to subsequent seasonal apportionments, provided that any revised seasonal apportionment does not exceed 20 percent of the seasonal apportionment for a given statistical area. Therefore, NMFS is increasing the D season apportionment of pollock in Statistical Areas 610, 620, and 630 of the GOA to reflect the underharvest of pollock in those areas during the C season. In addition, any underharvest remaining beyond 20 percent of the originally specified seasonal apportionment in a particular area may be further apportioned to other statistical areas. Therefore, NMFS also is increasing the D season apportionment of pollock to Statistical Areas 610 and 630 based on the underharvest of pollock in Statistical Areas 620 of the GOA. These adjustments are described below.
The D seasonal apportionment of the 2015 pollock TAC in Statistical Area 610 of the GOA is 12,185 metric tons (mt) as established by the final 2015 and 2016 harvest specifications for groundfish of the GOA (80 FR 10250, February 25, 2015). In accordance with § 679.20(a)(5)(iv)(B), the Administrator, Alaska Region, NMFS (Regional Administrator), hereby increases the D season apportionment for Statistical Area 610 by 2,437 mt to account for the underharvest of the TAC in Statistical Areas 610 and 620 in the C season. This increase is in proportion to the estimated pollock biomass and is not greater than 20 percent of the D seasonal apportionment of the TAC in Statistical Area 610. Therefore, the revised D seasonal apportionment of the pollock TAC in Statistical Area 610 is 14,622 mt (12,185 mt plus 2,437 mt).
The D seasonal apportionment of the pollock TAC in Statistical Area 620 of the GOA is 14,628 mt as established by the final 2015 and 2016 harvest specifications for groundfish of the GOA (80 FR 10250, February 25, 2015). In accordance with § 679.20(a)(5)(iv)(B), the Regional Administrator hereby increases the D seasonal apportionment for Statistical Area 620 by 2,926 mt to account for the underharvest of the TAC in Statistical Areas 620 in the C season. This increase is not greater than 20 percent of the D seasonal apportionment of the TAC in Statistical Area 620. Therefore, the revised D seasonal apportionment of the pollock TAC in Statistical Area 620 is 17,554 mt (14,628 mt plus 2,926 mt).
The D seasonal apportionment of pollock TAC in Statistical Area 630 of the GOA is 18,639 mt as established by the final 2015 and 2016 harvest specifications for groundfish of the GOA (80 FR 10250, February 25, 2015). In accordance with § 679.20(a)(5)(iv)(B), the Regional Administrator hereby increases the D seasonal apportionment for Statistical Area 630 by 3,728 mt to account for the underharvest of the TAC in Statistical Areas 620 and 630 in the C season. This increase is in proportion
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would provide opportunity to harvest increased pollock seasonal apportionments. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 27, 2015.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A330-200, -200 Freighter, and -300 series airplanes; and Model A340-200 and -300 series airplanes. This proposed AD was prompted by reports that cracks were found on an adjacent hole of certain frames of the center wing box (CWB). This proposed AD would require removing fasteners, a rototest inspection of fastener holes, installing new fasteners; and if necessary, oversizing the holes and doing rototest inspections for cracks, and repairing any cracking that is found. We are proposing this AD to detect and correct cracking on certain holes of certain frames of the CWB, which could affect the structural integrity of the airplane.
We must receive comments on this proposed AD by December 17, 2015.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0149, dated June 13, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200, -200 Freighter, and -300 series airplanes; and Model A340-200 and -300 series airplanes. The MCAI states:
During accomplishment of A330 Airworthiness Limitation Item (ALI) task 57-11-04 on the rear fitting of the Frame (FR) 40 between stringers 38 and 39 on both [left-hand] LH/[right-hand] RH sides, cracks were found on an adjacent hole. After reaming at second oversize of the subject hole, the crack was still present.
Other crack findings on this adjacent hole have been reported on A330 and A340-200/-300 aeroplanes as a result of sampling inspections.
This condition, if not detected and corrected, could affect the structural integrity of the aeroplane.
For the reasons described above, this [EASA] AD requires removal of the fasteners and repetitive rototest inspections of fastener holes at FR40 vertical web located above Center Wing Box (CWB) lower panel reference and/or below CWB lower panel reference on both sides and, depending on findings, accomplishment of the applicable corrective actions.
Note: These holes affected by this [EASA] AD are different from the ones affected by EASA AD 2009-0001 [
Required actions also include oversizing certain holes, installing new fasteners, and repairing any cracking that is found. The initial compliance times range from 13,500 to 30,900 flight cycles, or 57,000 to 162,000 flight hours, depending on operation and utilization. The repetitive compliance times are 7,400 flight cycles/24,300 flight hours or 5,950 flight cycles/40,400 flight hours from ALI embodiment. You may examine the MCAI in the AD docket on
Airbus has issued the following service information. The service information describes procedures for removing the fasteners and doing a repetitive rototest inspection of fastener holes at frame (FR) 40 vertical web on both sides, installing new fasteners in transition fit, and oversizing the holes.
• Airbus Service Bulletin A330-57-3114, dated March 12, 2013.
• Airbus Service Bulletin A330-57-3115, dated April 4, 2013.
• Airbus Service Bulletin A330-57-3116, dated March 12, 2013.
• Airbus Service Bulletin A340-57-4123, dated March 12, 2013.
• Airbus Service Bulletin A340-57-4124, Revision 01, dated August 22, 2013.
• Airbus Service Bulletin A340-57-4125, dated March 12, 2013.
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 product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We estimate that this proposed AD affects 35 airplanes of U.S. registry.
We also estimate that it would take about 78 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $0 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $232,050, or $6,630 per product, per inspection cycle.
In addition, we estimate that any necessary follow-on actions would take up to 98 work-hours and require parts costing $136,400, for a cost of up to $144,730 per product. We have no way of determining the number of aircraft that might need this action.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by December 17, 2015.
None.
This AD applies to the airplanes identified in paragraphs (c)(1) and (c)(2) of this AD, certificated in any category, all manufacturer serial numbers, except those on which Airbus Modification (Mod) 55792 or Mod 55306 has been embodied in production, and except those on which Airbus Repair Instruction R57115092 has been embodied in service on both right-hand (RH) and left-hand (LH) sides.
(1) Airbus Model A330-201, -202, -203, -223, -223F, -243 -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(2) Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by reports that cracks were found on an adjacent hole of certain frames of the center wing box (CWB). We are issuing this AD to detect and correct cracking on certain holes of the CWB, which could affect the structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Do a rototest inspection of the fastener holes at the frame (FR) 40 vertical web, on both sides, as specified in table 1 to paragraph (g) of this AD, except as required by paragraph (k) of this AD.
If no crack is found during any inspection required by paragraph (g) of this AD, do the actions specified in paragraphs (h)(1) and (h)(2) of this AD.
(1) Before further flight, install new fasteners in the transition fit, in accordance with the Accomplishment Instructions of the service information identified in table 1 to paragraph (g) of this AD; as applicable.
(2) Repeat the inspection required by paragraph (g) of this AD thereafter at the applicable time identified in paragraph 1.E., “COMPLIANCE,” of the service information identified in table 1 to paragraph (g) of this AD; as applicable.
If any crack is found during any inspection required by paragraph (g) of this AD: Before further flight, oversize the holes to the first oversize in comparison with the current hole diameter, and do a rototest inspection for cracks, in accordance with the Accomplishment Instructions of the service information identified in table 1 to paragraph (g) of this AD; as applicable.
(1) If no cracking is found during the rototest inspection required by paragraph (i) of this AD, do the actions specified in paragraphs (i)(1)(i) and (i)(1)(ii) of this AD.
(i) Before further flight: Install new fasteners in the transition fit, in accordance with the Accomplishment Instructions of the service information identified in table 1 to paragraph (g) of this AD; as applicable.
(ii) Repeat the inspection required by paragraph (g) of this AD thereafter at the applicable time identified in paragraph 1.E., “COMPLIANCE,” of the service information identified in table 1 to paragraph (g) of this AD; as applicable.
(2) If cracking is found during the rototest inspection required by paragraph (i) of this AD, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
Accomplishment of the initial and repetitive inspections required by this AD terminates accomplishment of Airworthiness Limitation Items Tasks 57-11-04 and 57-11-02 of the Airworthiness Limitation Section (ALS) Part 2, Damage Tolerant Airworthiness Limitation Items (DT ALI).
(1) Installation of new fasteners as specified in paragraph (h)(1) of this AD does not terminate the repetitive inspections required by paragraph (g) of this AD.
(2) Accomplishment of the corrective actions specified in paragraphs (i) and (i)(1) of this AD does not terminate the repetitive inspections required by paragraph (g) of this AD.
(3) Accomplishment of the repair specified in paragraph (i)(2) of this AD does not terminate repetitive inspections required by paragraph (g) of this AD, unless the approved repair method specified otherwise.
(1) If the service information identified in table 1 to paragraph (g) of this AD specifies contacting Airbus for appropriate action: Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Airbus's EASA DOA.
(2) Where paragraph 1.E., “Compliance,” of the service information specified in table 1 to paragraph (g) of this AD specifies a Compliance Time in terms of a “Threshold” and “Grace Period,” this AD requires compliance at the later of the applicable Threshold and Grace Period.
(3) Where paragraph 1.E., “Compliance,” of the service information specified in table 1 to paragraph (g) of this AD specifies a Threshold as “before next flight,” this AD requires compliance before the next flight after the applicable finding.
This paragraph provides credit for actions required by paragraphs (g) and (i) of this AD, if those actions were performed before the effective date of this AD using the service information specified in paragraph (l)(1), (l)(2), (l)(3), (l)(4), (l)(5), (l)(6), (l)(7), (l)(8), or (l)(9) of this AD. This service information is not incorporated by reference in this AD.
(1) Airbus Technical Disposition Reference LR57D11023270, Issue B, dated July 12, 2011.
(2) Airbus Technical Disposition Reference LR57D11029171, Issue B, dated September 6, 2011.
(3) Airbus Technical Disposition Reference LR57D11029173, Issue B, dated September 6, 2011.
(4) Airbus Technical Disposition Reference LR57D11030741, Issue B, dated September 22, 2011.
(5) Airbus Technical Disposition Reference LR57D11029170, Issue C, dated September 6, 2011.
(6) Airbus Technical Disposition Reference LR57D11023714, Issue B, dated July 12, 2011.
(7) Airbus Technical Disposition Reference LR57D11029172, Issue B, dated September 6, 2011.
(8) Airbus Technical Disposition Reference LR57D11030740, Issue C, dated September 22, 2011.
(9) Airbus Service Bulletin A340-57-4124, dated April 4, 2013.
The following provisions also apply to this AD:
(1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149. Information may be emailed to:
(2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Airbus's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0149, dated June 13, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
Federal Trade Commission (“FTC” or “Commission”).
Notice of proposed rulemaking.
The Commission proposes amendments to the Energy Labeling Rule to create requirements related to a new label database on the Department of Energy's (DOE's) Web site, redesign ceiling fan labels, improve and update the comparability ranges for refrigerator labels, revise central air conditioner labels in response to new DOE enforcement requirements, improve water heater labels, and update current plumbing disclosures.
Written comments must be received on or before January 11, 2016.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Hampton Newsome, Attorney, (202) 326-2889, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580.
The Commission issued the Energy Labeling Rule (“Rule”) in 1979,
The Rule requires manufacturers to attach yellow EnergyGuide labels for many of the covered products and prohibits retailers from removing the labels or rendering them illegible. In addition, it directs sellers, including retailers, to post label information on Web sites and in paper catalogs from which consumers can order products. EnergyGuide labels for most covered products contain three key disclosures: estimated annual energy cost; a product's energy consumption or energy efficiency rating as determined from Department of Energy (DOE) test procedures; and a comparability range displaying the highest and lowest energy costs or efficiency ratings for all similar models. For energy cost calculations, the Rule specifies national average costs for applicable energy sources (
This Notice seeks comment on several proposed changes to the Energy Labeling Rule, including requirements related to a new label database on DOE's Web site, revised ceiling fan labels, new refrigerator comparability range information, portable air conditioner labeling, labeling for dual-mode refrigerators, revised central air conditioner labels in response to proposed changes to DOE's enforcement rules, water heater labels, and plumbing disclosures. The Commission sought comment on a few of these issues during its regulatory review of the Energy Labeling Rule.
The Commission predicted that the proposal would not create undue burdens because the DOE and FTC rules already require manufacturers of most covered products to submit annual reports through CCMS.
In supporting the proposal, the Joint Commenters explained that a centralized database will likely reduce the time manufacturers spend fielding requests about label information and retailers spend complying with online label requirements. The California Utilities added that the central database will benefit many different market actors, including consumers, distributors, retailers, and organizations running energy efficiency incentive programs. According to the California Utilities, it would also help state agencies and efficiency organizations track compliance with various efficiency performance and labeling requirements. Amazon and the Direct Marketing Association (DMA) further explained that the proposal would increase overall industry efficiency by reducing the time retailers spend identifying and obtaining the correct EnergyGuide labels. This would allow retailers to make new products available to consumers and to complete internal compliance audits of their catalogues faster and at lower cost. Amazon and DMA also expect the database to encourage general compliance with the Rule, decrease instances of mislabeling, minimize retailer burdens, and increase label availability. DMA noted that manufacturers must already publish EnergyGuide labels on publicly accessible Web sites. Amazon agreed, explaining that the proposal would not place an undue burden on manufacturers who already publish EnergyGuide labels on publicly accessible Web sites and have open lines of electronic communication with CCMS.
The Air-Conditioning, Heating, and Refrigeration Institute (AHRI) and Goodman, from the heating and cooling equipment industry, also supported an online database. AHRI already includes label images on its own online directory for the heating and cooling equipment of its members. However, because its database displays labels in PDF format, it recommended that DOE or the FTC allow PDF files, in addition to URL links. Goodman recommended that the FTC rely on the EnergyGuide labels already generated by the AHRI database rather than requiring manufacturers to submit this information.
The Association of Home Appliance Manufacturers (AHAM) and the National Electrical Manufacturers Association (NEMA) opposed the proposal, identifying several concerns. First, according to AHAM, because manufacturers often certify new models to DOE before they design and post labels on their Web sites, a new submission requirement could complicate existing reporting. Specifically, AHAM suggested that posting labels to the DOE Web site prior to certification may run afoul of DOE and EPA restrictions on marketing prior to government certification. AHAM further argued that the proposal would yield little benefit because neither consumers nor retailers use CCMS to shop for products and existing FTC requirements already require the labels on manufacturer Web sites. According to AHAM, a URL link would also increase burdens by forcing some manufacturers to redesign their Web pages, which may not currently use separate links to display products. It may also require burdensome coordination with private labelers. Finally, AHAM argued that the frequent need to report information could lead to errors on the DOE Web site that could subject manufacturers to civil penalties. NEMA echoed AHAM's concerns, stating the database requirement would make it difficult for manufacturers to ensure they update the links over time. NEMA asserted that the average consumer will not view the CCMS database for label information but rather will look to a company Web site first. Likewise, manufacturers already maintain their own databases, so the CCMS database is not necessarily useful.
As discussed in the 2014 SNPRM and indicated by commenters, such a repository should benefit consumers and retailers by providing access to a single comprehensive database that contains all the covered labels. Retailers
The proposal is unlikely to create undue burdens on manufacturers. The Rule already requires manufacturers of most covered products to submit annual reports. DOE likewise requires manufacturers to make detailed electronic submissions through CCMS.
In addition, manufacturers will be able to incorporate the link submissions into their current reporting. The proposed rule requires that manufacturers submit the label links prior to distributing the products in commerce, consistent with current labeling requirements. Thus, the proposal is unlikely to require manufacturers to submit such information earlier. Although AHAM and NEMA suggested such an approach may run afoul of DOE and EPA certification requirements, it is not clear how this would occur. Nevertheless, the Commission seeks further comment on this issue. In addition, though some manufacturers may have to make modest changes to their Web sites to create links for their labels, any final rule would give them ample time to do so and thus minimize any burden associated with the change. Finally, it is not clear how the proposal would create submission errors beyond those that already occur with current submission requirements. The possibility of submission errors should be low because manufacturers will include their label links as part of the model certification reports they already submit to CCMS.
The Commission seeks comments on this proposal. Among other things, comments should address whether manufacturers should provide label links for specialty consumer lamps and LED (light-emitting diode) general service lamps, which are not currently subject to FTC or DOE reporting requirements.
The proposed label follows the EnergyGuide label format, consistent with other products displayed in showrooms, such as refrigerators and clothes washers. The proposed yellow label features the familiar “EnergyGuide” logo and includes a daily use assumption of six hours, an energy rate of 12 cents per kWh, and operation at high speed.
After the 2014 SNPRM, DOE proposed revisions to the ceiling fan test procedure (79 FR 62521 (Oct. 17, 2014)) and new efficiency standards (79 FR 58290 (Sept. 29, 2014)). As part of that proceeding, DOE is considering setting the hours of operation to be used on the label, a representative or average speed, and a revised scope of products covered by the test procedure. Such new DOE requirements would govern much of the label's content.
The American Lighting Association (ALA), an industry group representing many fan manufacturers, did not oppose label changes but offered several suggestions. First, it urged the FTC to coordinate labeling changes with DOE to avoid duplication of time, energy, and compliance costs. Second, to reduce the burden associated with relabeling thousands of models, ALA recommended a 12-month compliance period for new models and a five-year compliance period for current products, instead of the proposed blanket two-year period. ALA reasoned that, because the approximate life cycle of most models is five years or less, an extended compliance period will greatly reduce industry burden.
Finally, the ALA comments urged the Commission to reconsider the usage assumptions behind the proposed label (
In the 2014 SNPRM (79 FR 34642, June 18, 2014), the Commission proposed consolidating the ranges for various refrigerator model types, based on comments suggesting that a substantial number of consumers consider several different configurations when shopping. The consolidation of ranges would facilitate such comparison shopping, simplify the range categories, and alert consumers to the relative energy efficiency of various refrigerator types. 79 FR at 34651, June 18, 2014. To effectuate this goal, the Commission proposed to consolidate ranges for automatic defrost models purchased by the vast majority of residential consumers, while maintaining separate categories for less common models.
The Joint Commenters repeated their strong support for consolidating ranges. However, in contrast to the Commission's proposal, they recommended that the amendments consolidate all refrigerator-freezers into a single range, regardless of defrost features. They noted that some of the existing categories contain few, if any, models, and thus provide no meaningful comparison information at all.
Alternatively, both the Joint Commenters and the California Utilities recommended a hybrid approach, which would display two ranges on the label—one with comparative information for a specific model configuration (
AHAM opposed consolidation.
Additionally, AHAM took issue with the data presented by commenters to support range consolidation. First, AHAM discounted data from Consumer Reports demonstrating that 40 percent of visitors to Consumer Reports' online refrigerator/freezer ratings reviewed multiple configurations. AHAM argued that, because Consumer Reports focuses on informative editorial reviews, including features beyond energy, consumers likely visit their site to narrow their choices prior to shopping. Second, AHAM disagreed with the Joint Commenters' interpretation of AHAM data indicating that more than half of side-by-side refrigerator-freezer owners buy replacement units with a different configuration. AHAM argued that these results do not necessarily support the proposal to consolidate the ranges.
The comments also offered different views on whether the proposal meets the Congressional intent of EPCA. AHAM asserted that the proposal conflicts with DOE's designated specific refrigerator-freezer product categories, which represent significant specific consumer benefits, preferences, and utilities. In contrast, the Joint Commenters argued that nothing in EPCA suggests the Commission must adhere to DOE's feature‐protecting approach.
In addition to proposed Rule language to effect this change to the label, this Notice includes proposed updated ranges based on new model data from the DOE database, including a new range reflecting consolidated range data for all refrigerators. These consolidated ranges will appear on the labels along with those applicable to the particular product class. Before issuing final refrigerator ranges, the Commission will consider updating the numbers based on the most recent data.
The proposal also amends the range tables to cover bottom-mounted freezers with through-the-door ice, a popular product subcategory currently not covered by the various tables. To accomplish this, the proposed amendments redesignate Appendix A7, which currently covers an obsolete category (top-mounted freezer with through-the-door ice models). In addition, the proposal modifies the size categories in each table to ensure consistency in all the ranges across all sizes. Consistent with past range changes, the Commission plans to provide manufacturers with 90 days after final amendments to comply with the updated labels. The Commission seeks comment on the proposal.
The Commission proposes to add a new Rule provision addressing covered refrigerator models that can operate as a refrigerator or a freezer under the DOE rules, depending on user settings. In 2014, DOE announced that such convertible refrigerator-freezers must be tested and certified to meet efficiency standards applicable to both refrigerators and freezers.
AHAM, which did not oppose the proposal, emphasized that the FTC should not require EnergyGuide labels for these products until DOE finalizes a regulation designating them as covered products and completes a test procedure. In addition, AHAM indicated that the FTC should provide more information about the label's benefits to consumers and a more detailed proposal. AHAM also noted that, as with room air conditioners, retail display practices for portable air conditioners are mixed (
The California Utilities supported labels on portable air conditioners and recommended that the Commission immediately require such labels based on an existing test procedure (ANSI/AHAM PAC-1-2009). It argued that doing so would provide consumer benefits while DOE finalizes its own test procedure.
Portable air conditioners are common in the marketplace, use energy equivalent to already-covered room air conditioners, and vary in their energy use. Specifically, DOE has reported that the aggregate energy use of portable ACs has been increasing as these units have become popular in recent years.
The Commission proposes to require labels for portable air conditioners identical to the current room air conditioner label in content and format. The proposed amendments include the DOE's proposed definition of “portable air conditioner” at section 305.3.
At this time, DOE has not issued a final test procedure or language for the definition of “portable air conditioner.”
The Commission proposes several amendments to the heating and cooling equipment label requirements related to new issues not discussed in the 2014 SNPRM. As detailed below, these proposed changes involve revised central air conditioner labels to reflect upcoming changes to DOE rules, new labels for rooftop furnace-air conditioner systems, manufacturer name disclosures on the label, and a clarification for disclosures of multiple model numbers on the label.
During the fall of 2014, DOE conducted a negotiated rulemaking to establish enforcement rules for current regional standards applicable to central air conditioners.
The recommended change, if implemented by DOE, will require revisions to the EnergyGuide label for central air conditioners because the current label advises installers to ensure the rating for the system (
Specifically, the FTC proposes three types of labels for split systems. First, labels for models that may be installed anywhere (
In addition, consistent with the recommended approach, the proposed label would disclose only the efficiency rating for lowest rated coil-condenser combination (
In response, the Commission proposes amending section 305.12 to allow a single label for these products reflecting the ratings for furnace and air conditioner (or heat pump) combinations as long as the unit meets all applicable air conditioner regional standards. For models that do not meet the air conditioner standards,
The Commission seeks comment on whether it should modify water heater labels in response to a new DOE test procedure (79 FR 40541 (July 11, 2014)).
In anticipation of these changes, the Commission seeks comment on amendments to the water heater label ranges to provide both: (1) Tank capacity information; and (2) first hour rating information consistent with the four new DOE categories. Because water heaters are commonly marketed by tank size (
The Commission also plans to update the comparability range for water heaters to reflect the results of the new test procedure and significant efficiency increases driven by the new DOE standards (see Figures 3 and 4).
The Commission proposes to update the marking and labeling requirements in section 305.16 to reference the current ASME standards for showerheads and faucets (“A112.18.1”), as well as water closets and urinals (“A112.19.2”). The proposed change updates these references by removing the letter “M,” which appeared in obsolete versions of the standards' titles (
The Commission recently sought comments on labeling for several refrigeration products not covered by existing labeling requirements (79 FR 78736 (Dec. 31, 2014)) in response to recent DOE efforts to set standards and establish test procedures for such products, which include cooled cabinets, non-compressor refrigerators, hybrid refrigerators, compact hybrid refrigerators, hybrid freezers, and residential ice makers.
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before January 11, 2016. Write “Energy Labeling Amendments (16 CFR part 305) (Project No. R611004)” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, do not include any trade secret or any commercial or financial information which is privileged or confidential, as discussed in section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you prefer to file your comment on paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex E), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex E), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
Because written comments appear adequate to present the views of all interested parties, the Commission has not scheduled an oral hearing regarding these proposed amendments. Interested parties may request an opportunity to present views orally. If such a request is made, the Commission will publish a document in the
The current Rule contains recordkeeping, disclosure, testing, and reporting requirements that constitute information collection requirements as defined by 5 CFR 1320.3(c), the definitional provision within the Office of Management and Budget (OMB) regulations that implement the Paperwork Reduction Act (PRA). OMB has approved the Rule's existing information collection requirements through May 31, 2017 (OMB Control No. 3084-0069). The proposed amendments make changes in the Rule's labeling requirements that will increase the PRA burden as detailed below.
Total Estimate: Accordingly, the estimated total hour burden of the proposed amendments is 2,242 with associated labor costs of $53,177 and annualized capital or other non-labor costs totaling $30,000.
Pursuant to section 3506(c)(2)(A) of the PRA, the FTC invites comments on: (1) Whether the proposed information collection is necessary, including whether the information will be practically useful; (2) the accuracy of our burden estimates, including whether the methodology and assumptions used are valid; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information. All comments should be filed as prescribed in the
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 through 612, requires that the Commission provide an Initial Regulatory Flexibility Analysis (IRFA) with a proposed rule and a Final Regulatory Flexibility Analysis (FRFA), if any, with the final rule, unless the Commission certifies that the rule will not have a significant economic impact on a substantial number of small entities.
The Commission does not anticipate that the proposed rule will have a significant economic impact on a substantial number of small entities. The Commission recognizes that some
The Commission estimates that the amendments will apply to 150 online and paper catalog sellers of covered products and about 50 portable air conditioner manufacturers. The Commission expects that approximately 150 qualify as small businesses.
Accordingly, this document serves as notice to the Small Business Administration of the FTC's certification of no effect. To ensure the accuracy of this certification, however, the Commission requests comment on whether the proposed rule will have a significant impact on a substantial number of small entities, including specific information on the number of entities that would be covered by the proposed rule, the number of these companies that are small entities, and the average annual burden for each entity. Although the Commission certifies under the RFA that the rule proposed in this notice would not, if promulgated, have a significant impact on a substantial number of small entities, the Commission has determined, nonetheless, that it is appropriate to publish an IRFA in order to inquire into the impact of the proposed rule on small entities. Therefore, the Commission has prepared the following analysis:
The Commission is proposing expanded product coverage and additional improvements to the Rule to help consumers in their purchasing decisions for high efficiency products.
The objective of the rule is to improve the effectiveness of the current labeling program. The legal basis for the Rule is the Energy Policy and Conservation Act (42 U.S.C. 6292
Under the Small Business Size Standards issued by the Small Business Administration, appliance manufacturers qualify as small businesses if they have fewer than 1,000 employees (for other household appliances the figure is 500 employees). Catalog sellers qualify as small businesses if their sales are less than $8.0 million annually. The Commission estimates that there are approximately 150 entities subject to the proposed rule's requirements that qualify as small businesses.
The changes under consideration would slightly increase reporting or recordkeeping requirements associated with the Commission's labeling rules as discussed above. The amendments likely will increase compliance burdens by extending the labeling requirements to portable air conditioners and creating an online database. The Commission assumes that the label design change will be implemented by graphic designers.
The Commission has not identified any other federal statutes, rules, or policies that would duplicate, overlap, or conflict with the proposed rule. The Commission invites comment and information on this issue.
The Commission seeks comment and information on the need, if any, for alternative compliance methods that, consistent with the statutory requirements, would reduce the economic impact of the rule on small entities. For example, the Commission is currently unaware of the need to adopt any special provisions for small entities. In addition, the database requirement requires only electronic compliance methods, and does not impose any additional or more burdensome paper-based requirements. However, if such issues are identified, the Commission could consider alternative approaches such as extending the effective date of these amendments for catalog sellers to allow them additional time to comply beyond the labeling deadline set for manufacturers. Nonetheless, if the comments filed in response to this notice identify small entities that are affected by the proposed rule, as well as alternative methods of compliance that would reduce the economic impact of the rule on such entities, the Commission will consider the feasibility of such alternatives and determine whether they should be incorporated into the final rule.
Written communications and summaries or transcripts of oral communications respecting the merits of this proceeding, from any outside party to any Commissioner or Commissioner's advisor, will be placed on the public record.
Advertising, Energy conservation, Household appliances, Labeling, Reporting and recordkeeping requirements.
For the reasons discussed above, the Commission proposes to amend part 305 of title 16, Code of Federal Regulations, as follows:
42 U.S.C. 6294.
(z)
(a) For each covered product that a manufacturer distributes in commerce after July 15, 2013, which is required by this part to bear an EnergyGuide or Lighting Facts label, the manufacturer must make a copy of the label available on a publicly accessible Web site in a manner that allows catalog sellers to hyperlink to the label or download it for use in Web sites or paper catalogs. The label for each specific model must remain on the Web site for six months after production of that model ceases.
(b) Manufacturers must submit the Web site address for the online labels covered by paragraph (c) In lieu of submitting the required information to
(a)
(b)
(d)
(f)
(2) Name of manufacturer or private labeler shall, in the case of a corporation, be deemed to be satisfied only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. Inclusion of the name of the manufacturer or private labeler is optional at the discretion of the manufacturer or private labeler.
(3) Model number(s) will be the designation given by the manufacturer or private labeler.
(4) Capacity or size is that determined in accordance with § 305.7. For refrigerators, refrigerator-freezers, and freezers, the capacity provided on the label shall be the model's total refrigerated volume (VT) as determined in accordance with § 305.7.
(5) Unless otherwise indicated in this paragraph, estimated annual operating costs for refrigerators, refrigerator-freezers, freezers, clothes washers, dishwashers, room air conditioners, portable air conditioners, and water heaters are as determined in accordance with §§ 305.5 and 305.10. Thermal efficiencies for pool heaters are as determined in accordance with § 305.5. Labels for clothes washers and dishwashers must disclose estimated annual operating cost for both electricity and natural gas as illustrated in the sample labels in appendix L to this part. Labels for dual-mode refrigerator-freezers that can operate as either a refrigerator or a freezer must reflect the estimated energy cost of the model's most energy intensive configuration.
(6) Unless otherwise indicated in this paragraph, ranges of comparability for estimated annual operating costs or thermal efficiencies, as applicable, are found in the appropriate appendices accompanying this part.
(7) Placement of the labeled product on the scale shall be proportionate to the lowest and highest estimated annual operating costs or thermal efficiencies, as applicable.
(8) Labels for refrigerators, refrigerator-freezers, freezers, dishwashers, clothes washers, and water heaters must contain the model's estimated annual energy consumption as determined in accordance with § 305.5 and as indicated on the sample labels in appendix L to this part. Labels for room air conditioners, portable air conditioners, and pool heaters must contain the model's energy efficiency rating or thermal efficiency, as applicable, as determined in accordance with § 305.5 and as indicated on the sample labels in appendix L to this part. Labels for dual-mode refrigerator-freezers that can operate as either a refrigerator or a freezer must reflect the estimated energy cost of the model's most energy intensive configuration.
(9) Labels must contain a statement as illustrated in the prototype labels in appendix L to this part and specified as follows by product type:
(i) Labels for refrigerators and refrigerator-freezers must contain a statement as illustrated in the prototype labels in appendix L to this part and specified as follows (fill in the blanks with the appropriate year and energy cost figures):
Your cost will depend on your utility rates and use.
Both cost ranges based on models of similar size capacity.
[Insert statement required by § 305.11(f)(9)(iii)].
Estimated energy cost is based on a national average electricity cost of _cents per kWh. ftc.gov/energy.
(ii) For refrigerators, refrigerator-freezers, and freezers manufactured on or after September 15, 2014 and clothes washers manufactured after March 7, 2015, the label shall contain the text and graphics illustrated in sample labels 1 and 2 of appendix L to this part, including the statement:
Compare only to other labels with yellow numbers.
Labels with yellow numbers are based on the same test procedures.
(iii) For refrigerators and refrigerator-freezers, the following sentence shall be included as part of the statement required by § 305.11(f)(9)(i):
(A) For models covered under appendix A1 to this part, the sentence shall read:
Models with similar features have no freezer and automatic defrost.
(B) For models covered under appendix A2 to this part, the sentence shall read:
Models with similar features have manual defrost.
(C) For models covered under appendix A3 to this part, the sentence shall read:
Models with similar features have partial automatic defrost.
(D) For models covered under appendix A4 to this part, the sentence shall read:
Models with similar features have automatic defrost, top-mounted freezer, and no through-the-door ice.
(E) For models covered under appendix A5 to this part, the sentence shall read:
Models with similar features have automatic defrost, side-mounted freezer, and no through-the-door ice.
(F) For models covered under appendix A6 to this part, the sentence shall read:
Models with similar features have automatic defrost, bottom-mounted freezer, and no through-the-door ice.
(G) For models covered under appendix A7 to this part, the sentence shall read:
Models with similar features have automatic defrost, bottom-mounted freezer through-the-door ice.
(H) For models covered under appendix A8 to this part, the sentence shall read:
Models with similar features have automatic defrost, side-mounted freezer, and through-the-door ice.
(iv) Labels for freezers must contain a statement as illustrated in the prototype labels in appendix L to this part and specified as follows (fill in the blanks with the appropriate year and energy cost figures):
Your cost will depend on your utility rates and use.
[Insert statement required by § 305.11(f)(10)(v).]
Estimated energy cost is based on a national average electricity cost of _ cents per kWh.ftc.gov/energy.
(v) For freezers, the following sentence shall be included as part of the statement required by § 305.11(f)(9)(iv):
(A) For models covered under appendix B1 to this part, the sentence shall read:
Cost range based only on upright freezer models of similar capacity with manual defrost.
(B) For models covered under appendix B2 to this part, the sentence shall read:
Cost range based only on upright freezer models of similar capacity with automatic defrost.
(C) For models covered under appendix B3 to this part, the sentence shall read:
Cost range based only on chest and other freezer models of similar capacity.
(vi) For room air conditioners covered under appendix E to this part, the statement will read as follows (fill in the blanks with the appropriate model type, year, energy type, and energy cost figure):
Your costs will depend on your utility rates and use.
Cost range based only on models [of similar capacity without reverse cycle and with louvered sides; of similar capacity without reverse cycle and without louvered sides; with reverse cycle and with louvered sides; or with reverse cycle and without louvered sides]. Estimated annual energy cost is based on a national average electricity cost of _ cents per kWh and a seasonal use of 8 hours use per day over a 3 month period.
For more information, visit
(vii) For water heaters covered by appendices D1, D2, and D3 to this part, the statement will read as follows (fill in the blanks with the appropriate fuel type, year, and energy cost figures):
Your costs will depend on your utility rates and use.
Cost range based only on models of similar tank size ([40 gallons or less, between 40 and 55 gallons, or 55 gallons or more]), fueled by [natural gas, oil, propane, or electricity], and a [very small, low, medium, or large] hourly hot water output ([_-_] gallons).
Estimated energy cost is based on a national average [electricity, natural gas, propane, or oil] cost of [_ cents per kWh or $_ per therm or gallon].
Estimated yearly energy use: ___ [kWh or therms]
* Also known as First Hour Rating.
ftc.gov/energy.
(viii) For instantaneous water heaters (appendix D4 to this part), the statement will read as follows (fill in the blanks with the appropriate model type, the operating cost, the year, and the energy cost figures):
Your costs will depend on your utility rates and use.
Cost range based only on instantaneous gas water heater models with a [very small, low, medium, or large] gallons per minute ([_-_] gallons).
Estimated energy cost is based on a national average [electricity, natural gas, or propane] cost of [_ cents per kWh or $_ per therm or gallon].
For more information, visit
(ix) For dishwashers covered by appendices C1 and C2 to this part, the statement will read as follows (fill in the blanks with the appropriate appliance type, the energy cost, the number of loads per week, the year, and the energy cost figures):
Your costs will depend on your utility rates and use.
Cost range based only on [compact/standard] capacity models.
Estimated energy cost is based on 4 washloads a week, and a national average electricity cost of _ cents per kWh and natural gas cost of $_ per therm.
For more information, visit
(x) For clothes washers covered by appendices F1 and F2 to this part, the statement will read as follows (fill in the blanks with the appropriate appliance type, the energy cost, the number of loads per week, the year, and the energy cost figures):
Your costs will depend on your utility rates and use.
Cost range based only on [compact/standard] capacity models.
Estimated energy cost is based on 8 washloads a week and a national average electricity cost of _ cents per kWh and natural gas cost of $_ per therm.
For more information, visit
(xi) For pool heaters covered under appendices J1 and J2 to this part, the statement will read as follows:
Efficiency range based only on models fueled by [natural gas or oil].
For more information, visit
(f) * * *
(2) Name of manufacturer or private labeler shall, in the case of a corporation, be deemed to be satisfied only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. Inclusion of the name of the manufacturer or private labeler is optional at the discretion of the manufacturer or private labeler.
(3) The model's basic model number. The label may include multiple model numbers on a single label for models as long as the models share the same efficiency ratings and capacities.
(14) Manufacturers of models that qualify as both furnaces and central air conditioners or heat pumps under DOE requirements may combine the disclosures required by this section on one label for models that meet all applicable DOE regional efficiency standards.
(g)
(2) Name of manufacturer or private labeler shall, in the case of a corporation, be deemed to be satisfied only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. Inclusion of the name of the manufacturer or private labeler is optional at the discretion of the manufacturer or private labeler.
(3) The model's basic model number. The label may include multiple model numbers on a single label for models as long as the models share the same efficiency ratings and capacities.
(4) The model's capacity. Inclusion of capacity is optional at the discretion of the manufacturer or private labeler for all models except split-system labels, which may not disclose capacity.
(5) The seasonal energy efficiency ratio (SEER) for the cooling function of central air conditioners as determined in accordance with § 305.5. For the heating function, the heating seasonal performance factor (HSPF) shall be calculated for heating Region IV for the standardized design heating requirement nearest the capacity measured in the High Temperature Test in accordance with § 305.5. In addition,
(6)(i) Each cooling-only central air conditioner label shall contain a range of comparability consisting of the lowest and highest SEER for all cooling-only central air conditioners consistent with sample label 7A in appendix L to this part.
(ii) Each heat pump label, except as noted in paragraph (g)(6)(iii) of this section, shall contain two ranges of comparability. The first range shall consist of the lowest and highest seasonal energy efficiency ratios for the cooling side of all heat pumps consistent with sample label 8 in appendix L to this part. The second range shall consist of the lowest and highest heating seasonal performance factors for the heating side of all heat pumps consistent with sample label 8 in appendix L to this part.
(iii) Each heating-only heat pump label shall contain a range of comparability consisting of the lowest and highest heating seasonal performance factors for all heating-only heat pumps following the format of sample label 8 in appendix L to this part.
(7) Placement of the labeled product on the scale shall be proportionate to the lowest and highest efficiency ratings forming the scale.
(8) The following statement shall appear on the label in bold print as indicated in the sample labels in appendix L to this part.
For energy cost info, visit
(9) All labels on split-system condenser units must contain one of the following three statements:
(i) For labels disclosing only the seasonal energy efficiency ratio for cooling, the statement should read:
This system's efficiency rating depends on the coil your contractor installs with this unit. Ask for details.
(ii) For labels disclosing both the seasonal energy efficiency ratio for cooling and the heating seasonal performance factor for heating, the statement should read:
This system's efficiency ratings depend on the coil your contractor installs with this unit. The heating efficiency rating will vary slightly in different geographic regions. Ask your contractor for details.
(iii) For labels disclosing only the heating seasonal performance factor for heating, the statement should read:
This system's efficiency rating depends on the coil your contractor installs with this unit. The efficiency rating will vary slightly in different geographic regions. Ask your contractor for details.
(10) The following statement shall appear at the top of the label as illustrated in the sample labels in appendix L to this part:
Federal law prohibits removal of this label before consumer purchase.
(11) For any single-package air conditioner with a minimum Energy Efficiency Ratio (EER) of at least 11.0, any split system central air conditioner with a rated cooling capacity of at least 45,000 Btu/h and minimum efficiency ratings of at least 14 SEER and 11.7 EER, and any split-system central air conditioners with a rated cooling capacity less than 45,000 Btu/h and minimum efficiency ratings of at least 14 SEER and 12.2 EER, the label must contain the following regional standards information:
(i) A statement that reads: Notice Federal law allows this unit to be installed in all U.S. states and territories.
(ii) For split systems, a statement that reads:
Energy Efficiency Ratio (EER): The installed system's minimum EER is _.
(iii) For single-package air conditioners, a statement that reads:
Energy Efficiency Ratio (EER): This model's EER is [_].
(12) For any split system central air conditioner with a rated cooling capacity of at least 45,000 Btu/h and minimum efficiency ratings of at least 14 SEER but lower than 11.7 EER, and any split-system central air conditioners with a rated cooling capacity less than 45,000 Btu/h and minimum efficiency ratings of at least 14 SEER but lower than 12.2 EER.
(i) A statement that reads:
Notice Federal law allows this unit to be installed only in: AK, AL, AR, CO, CT, DC, DE, FL, GA, HI, ID, IL, IA, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE., NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, WY and U.S. territories. Federal law prohibits installation of this unit in other states.
(ii) A map and accompanying text as illustrated in the sample label 7A in appendix L.
(iii) For split-system air conditioner systems, a statement that reads Energy Efficiency Ratio (EER): The installed system's minimum EER is _.
(13) For any split system central air conditioner with a minimum rated efficiency rating less than 14 SEER:
(i) A statement that reads:
Notice Federal law allows this unit to be installed only in: AK, CO, CT, ID, IL, IA, IN, KS, MA, ME, MI, MN, MO, MT, ND, NE., NH, NJ, NY, OH, OR, PA, RI, SD, UT, VT, WA, WV, WI, WY, and U.S. Territories. Federal law prohibits installation of this unit in other states.
(ii) A map and accompanying text as illustrated in the sample label 8 in appendix L.
(iii) For split-system air conditioner systems, a statement that reads:
Energy Efficiency Ratio (EER): The installed system's minimum EER is _.
(14) For any single-package air conditioner with a minimum EER below 11.0, the label must contain the following regional standards information consistent with sample label 7A in appendix L to this part:
(i) A statement that reads:
Notice Federal law allows this unit to be installed only in: AK, AL, AR, CO, CT, DC, DE, FL, GA, HI, ID, IL, IA, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE., NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, WY and U.S. territories. Federal law prohibits installation of this unit in other states.
(ii) A map and accompanying text as illustrated in the sample label 7A in appendix L to this part.
(15) No marks or information other than that specified in this part shall appear on or directly adjoining this label except that:
(i) A part or publication number identification may be included on this label, as desired by the manufacturer. If a manufacturer elects to use a part or publication number, it must appear in the lower right-hand corner of the label and be set in 6-point type or smaller.
(ii) The energy use disclosure labels required by the governments of Canada or Mexico may appear directly adjoining this label, as desired by the manufacturer.
(iii) The manufacturer may include the ENERGY STAR logo on the label for certified products in a location consistent with the sample labels in appendix L to this part. The logo must be no larger than 1 inch by 3 inches in size. Only manufacturers that have signed a Memorandum of Understanding with the Department of Energy or the Environmental Protection Agency may add the ENERGY STAR logo to labels on qualifying covered products; such manufacturers may add the ENERGY STAR logo to labels only on those covered products that are
(a)
(i) Headlines, including the title “EnergyGuide,” and text as illustrated in the sample labels in appendix L to this part;
(ii) The product's estimated yearly energy cost based on 6 hours use per day and 12 cents per kWh;
(iii) The product's airflow at high speed expressed in cubic feet per minute and determined pursuant to § 305.5;
(iv) The product's energy use at high speed expressed in watts and determined pursuant to § 305.5 of this part as indicated in the sample label in appendix L of this part;
(v) The statement “Your cost depends on rates and use”;
(vi) The statement “All estimates at high speed, excluding lights”;
(vii) The statement “the higher the airflow, the more air the fan will move;”
(viii) The statement “Airflow Efficiency: __ Cubic Feet Per Minute Per Watt”;
(ix) The address
(x) For fans fewer than 49 inches in diameter, the label shall display a cost range for 36” to 48” ceiling fans of $2 to $53;
(xi) For fans 49 inches or more in diameter, the label shall display a cost range for 49” to 60” ceiling fans of $3 to $29; and
(xii) The ENERGY STAR logo as illustrated on the ceiling fan label illustration in Appendix L for qualified products, if desired by the manufacturer. Only manufacturers that have signed a Memorandum of Understanding with the Department of Energy or the Environmental Protection Agency may add the ENERGY STAR logo to labels on qualifying covered products; such manufacturers may add the ENERGY STAR logo to labels only on those products that are covered by the Memorandum of Understanding;
(2)
(3)
(4)
(a) The following provisions apply to any covered central air conditioner, heat pump, or furnace.
(1)
(2)
(ii) Retailers, including assemblers, who sell covered central air conditioners, heat pumps, and furnaces (including boilers) to consumers must show the labels for the products they offer to customers and let them read the labels before the customers agree to purchase the product. For example, the retailer may display labeled units in their store or direct consumers to the labels in a binder or computer at a counter or service desk.
(iii) Retailers, including installers and assemblers, who negotiate or make sales at a place other than their regular places of business, including sales over the telephone or through electronic communications, must show the labels for the products they offer to customers and let them read the labels before the customers agree to purchase the product. If the labels are on a Web site, retailers, including assemblers, who negotiate or make sales at a place other than their regular places of business, may choose to provide customers with instructions to access such labels in lieu of showing them a paper version of the information. Retailers who choose to use the Internet for the required label disclosures must provide customers the opportunity to read such information prior to sale of the product.
(3)
By direction of the Commission.
Centers for Medicare & Medicaid Services (CMS), HHS.
Request for information.
In this request for information (RFI), we seek public input to inform the potential development of standards with regard to Medicaid beneficiaries' access to covered services under the Medicaid program. Specifically, we are interested in obtaining information on core access to care measures and metrics that could be used to measure access to care for beneficiaries in the Medicaid program (including in fee-for-service and managed care delivery systems) and used to develop local, state and national thresholds and goals to inform and improve access in the program. We are also interested in feedback on approaches to using the metrics, which could include setting access goals and thresholds and formal processes for beneficiaries to raise access concerns.
In commenting, refer to file code CMS-2328-NC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Jeremy Silanskis, (410) 786-1592.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
CMS and states have the responsibility under section 1902(a)(30)(A) of the Social Security Act (the Act) to assure that Medicaid payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the state plan at least to the extent that such care and services are available to the general population in the geographic area. We interpret this provision to mean rates and payments for Medicaid services are set at levels that ensure value, quality and provider participation. In the past, our oversight of this provision has primarily focused on ensuring that payment methodologies are economic and efficient, as well as consistent with upper payment limits for certain services. During the recent economic downturn, and in light of state proposals to dramatically reduce provider payments, we began requesting that states provide information to document that services are available and access remains after payment reductions go into effect. We found that state processes for documenting access were generally inconsistent and in many cases did not adequately document access.
To address this, on May 6, 2011, we published the proposed rule entitled “Medicaid Program; Methods for Assuring Access to Covered Medicaid Services” (hereafter referred to as the “Access to Care” proposed rule) (76 FR 26342). In that rule, we proposed a specific process through which states would document that their payment rates provide access to care. The proposed rule, which applies to services that states cover through the Medicaid state plan, is being finalized with comment period concurrent with the issuance of this request for information (RFI). Among other new processes, the rule requires states describe access monitoring review plans that address: The extent to which enrollee needs are fully met, the availability of care and qualified service providers, changes in service utilization and comparisons between Medicaid payments and payments made by other health payers for equivalent services. At a minimum, the access monitoring review plans apply to the following service categories: Primary care (including pediatric care), physician specialists, behavioral health (including substance use disorder services), pre- and post-natal obstetric services, and home health. If states reduce or restructure payments, or receive complaints about access to care for other services, they must add those services to the review plans and monitor access to those services over the ensuing 3 years. States, with public input from stakeholders, would determine measures and thresholds used to monitor access as the final rule does not require a core set of measures or describe national thresholds for Medicaid access to care.
We also recently proposed changes that promote access to care for beneficiaries who receive services through Medicaid managed care. On June 1, 2015, we issued a proposed rule entitled “Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability (80 FR 31098), which proposed to modernize Medicaid and Children's Health Insurance Program (CHIP) managed care regulations to update the programs' rules and strengthen the delivery of quality care for beneficiaries. In that rule, we proposed: Minimum requirements for states when setting and monitoring network adequacy standards, certification of managed care plan networks at least on an annual basis, and annual reporting on the accessibility and availability of services. Similar to the “Access to Care” final rule with comment period that appears elsewhere in this issue of the
We believe that, to the extent there are similarities in the methods and measures used to review and analyze network adequacy for managed care networks and access to care in fee-for-service, aligning such methods and measures would ease the administrative burden on states and ensure that all Medicaid beneficiaries receive the care that they need regardless of whether they are in fee-for-service, are enrolled with a managed care organization, or receive services through a Medicaid waiver program. We are undertaking this effort to review access to care across the entire program for all individuals enrolled in Medicaid regardless of the delivery system mechanism.
Importantly, earlier this year, the Supreme Court decided in
We recognize that many factors affect access to Medicaid services, including: Level of payment, geographic location, time and distance to the closest provider, workforce, numbers of specialists and other types of providers within the state, lack of knowledge of
• Developing a core set of measures of access that all states would monitor and publicly report on;
• Measuring access to long term care and home and community based services;
• Setting national access to care thresholds; and
• Establishing a process for access to care that would allow beneficiaries experiencing access issues to raise and seek resolution of their concerns.
We also invite input on additional actions that we or states may take to further measure and promote access to care in the Medicaid program.
In seeking this input, we recognize that we have not yet identified a clear, defined set of access measures that demonstrates whether access to care is sufficient. We are seeking input to identify a feasible set of measures and metrics that meaningfully demonstrate whether access to care is sufficient. We requested comments on potential core metrics and thresholds through the “Access to Care” proposed rule and received many suggestions. Generally, the responses suggested set levels of payment or access to providers consistent with Medicare or private insurance, without corresponding metrics and data sources to conduct a comparative analysis. Other health payers, such as Medicare, may be further along in measuring access through data collection tools. As any new data collection requirements would impose administrative burden on states and providers, we are particularly interested in how existing efforts, like the Medicare Current Beneficiary Survey and the Consumer Assessment of Healthcare Providers and Systems (and approved supplemental data sets), may be modified to apply to the Medicaid program.
We note that through this RFI, we are seeking comments on areas of measurement and metrics that may indicate sufficient access in Medicaid programs regardless of delivery system. We are not attempting to develop areas of measurement that indicate causes of access deficiency, such as information on social determinants of health. While we appreciate the importance of understanding the reasons behind access problems and identifying those issues through data, our initial goal is to develop indicators of sufficient access that can be affected by Medicaid policy levers.
We are inviting states, beneficiaries, advocacy organizations, providers, managed care organizations, research and measurement communities, professional associations and other members of the public to share analyses and opinions related to the following topics: (1) Access to care data collection and methodology; (2) access to care thresholds and goals; (3) alternative processes for access concerns; and (4) access to care measures.
The terms: Measures, metrics, and thresholds, are used throughout this RFI. By measures, we mean concrete, quantifiable indicators that can be used to assess access to care in Medicaid. Measures have both a numerator and a denominator (for example, 500 Medicaid participating physicians in the state this year divided by the number of Medicaid enrollees this year, or the state received 50 beneficiary complaints this month divided by the number of beneficiaries enrolled). Metrics are used to examine measures relative to a baseline assessment (for example, there 10 percent more physicians participating in Medicaid this year than last year, or the state received 20 percent fewer complaints this month than last month). A threshold would be a minimum acceptable value for access to care that is based on the measures and metrics.
To better inform us on the nature and scope of access to care measures and metrics, we are requesting comments on how to focus our efforts to determine the best indicators of access in Medicaid across services and delivery systems. Consideration of the following questions may be helpful in providing us your ideas and suggestions.
• What do you perceive to be the advantages and disadvantages to requiring a national core set of access to care measures and metrics? Who do you believe should collect and analyze the national core set data?
• Do you believe there are specific access to care measures that could be universally applied across services? If so, please describe such measures.
• What information and methods do you believe large health care programs use to measure access to care that could be used by the Medicaid program? What role can health information technology lay in measuring access to care?
• What do you believe are the primary indicators of access to care in the Medicaid program? Is measured variance in these indicators based on differences in things such as: Provider participation and location, appointment times, waiting room times, call center times, prescription fill times, other?
• Do you believe a national core set of access measures or metrics should apply across all services, or is it more appropriate to target a core set of access measures by service?
• Do you believe questions in provider and beneficiary surveys should be consistent for Medicaid and Medicare beneficiaries? If not, what differences do you believe should be accommodated for the Medicaid program, including differences in covered services?
• What do you believe we should consider in undertaking access to care data collection in areas related to: Differences between fee-for-service (FFS) and managed care delivery, variations in services such as acute and long-term care, community and institutional settings for long-term care delivery, behavioral health, variations in access for pediatric and adult populations and individuals with disabilities, and variations in access for rural and urban areas? Consider also individuals with chronic conditions who may have limited functional support needs related to activities of daily living but nonetheless require more intensive care than other Medicaid beneficiaries, such as persons living with HIV/AIDS.
• Specific to long-term services and supports, including home and community based services, what factors do you believe we should consider in measuring access to care? Do you believe we should incorporate into reviews of access to care for these services economic factors and significant policy factors such as: Minimum wage and overtime requirements, direct service worker shortages, training and professional development costs, or other factors?
• Do you believe measuring access to Home and Community Based Services (HCBS) differs from measuring access to acute medical care? Please describe.
• Do you believe access to HCBS should be tracked in FFS and in managed care delivery systems? Do you perceive any differences between tracking HCBS in each system?
• Do you believe there are additional metrics that need to be tracked related to HCBS?
To better inform us on how to interpret and use access to care metrics, we are requesting comments on setting access thresholds and how we might use the thresholds to improve access in the Medicaid program. Consideration of the following questions may be helpful in providing us your ideas and suggestions.
• Do you believe we should set thresholds for Medicaid access to care? If so, do you believe such thresholds should be set at the national, state or local levels? Why?
• If we set Medicaid access thresholds, how do you believe they should be used? For instance: For issuing compliance actions to states that do not meet the thresholds, as benchmarks for state improvement, for use in appeals processes for beneficiaries that have trouble accessing services, or in other ways?
We are considering requiring standard access to care complaint driven processes to better ensure access and are interested in how data gathered and analyzed through a core set of measures might aid in resolving complaints, please consider the following questions:
• Do you believe there are existing and effective processes to resolve consumers' concerns regarding health care access issues that might be useful for all state Medicaid programs?
• What do you believe are the advantages and disadvantages of either a complaint resolution process or a formal appeals hearing for access to care concerns?
• Who do you believe should be the responsible party (for example, the state or federal government, an independent third party, a civil servant, an administrative law judge, etc.) to hear beneficiary access to care complaints and/or appeals?
• For an access to care appeal, what criteria do you believe should be used to help determine:
++Whether an appeal should be heard?
++Whether an appeal merits recommendations to the state Medicaid agency?
• Which access to care areas of measurement or specific metrics may be useful in setting thresholds that would help hearings officers assess appeals and determine access to care remedies?
• Lack of timeliness of an appeal could undermine the time sensitive efforts associated with remediating an individual's access to medical services. You may want to consider providing information on the following:
++How could appeals be expedited?
++What outcomes could an appeals officer offer if services are unavailable to Medicaid beneficiaries?
++Are there other non-appeal based processes that could be used instead?
In conjunction with this RFI, you may want to consider each of the topics listed below, and suggest what you believe we should prioritize. You are also welcome to provide additional metrics that are associated with measurement areas that are relevant indicators of access to care in the Medicaid program and feasible to collect and analyze.
For each suggested metric, you may consider describing the following:
• Suggested relevant data metrics,
• whether the metric is currently reported for Medicaid services,
• the feasibility of collecting the metric,
• the associated data sources/set(s) where the metrics are available,
• the financial cost (if any) of collecting the proposed metric,
• should including the metric in a more robust (or updated) Medicaid access policy be given priority;
• the party responsible/steward(s) of the metric data source,
• the metric validation process,
• whether the metric is relevant to all Medicaid populations or specific to particular groups, (for example, adults or pediatric populations, including children with special health care needs, or to people with disabilities or to dually eligible beneficiaries),
• whether the metric is applicable to FFS, managed care or both delivery systems,
• whether the metric is relevant for various subpopulations such as eligibility category, institutional status, or geographic region,
• whether the metric should be measured at the local, state or national level,
• as appropriate for Medicaid, thresholds associated with the metric,
• the challenges and advantages of the proposed metric, and how the metric is indicative to Medicaid access to care.
We are soliciting public comment on the following availability of care and providers measurement areas within geographic areas. In addition to feedback on the proposed metrics below, we are also interested in your thoughts on how “geographic areas” should be defined.
• Primary care physicians (including pediatricians) and clinicians accepting any/new patients.
• Physician specialists accepting any/new patients.
• Specialty care (for example, addiction and psychiatric services,, home and community based services, specialty pharmacy) accepting any/new patients.
• Availability of direct support workforce for home health and home and community-based services.
• Dentists accepting any/new patients.
• Psychiatric and substance abuse clinicians such as psychiatrists, child psychiatrists, psychologists, and psychiatric social workers and mental health counselors accepting any/new patients.
• Physicians and clinicians experiencing difficulties referring patients to specialty care.
• Psychiatrists experiencing difficulties referring patients with serious mental illness to primary care.
• Available primary care clinics, federally qualified health centers or rural health clinics.
• Available retail community pharmacies.
• Available behavioral health clinics or community mental health centers.
• Available inpatient care.
• Other.
We are soliciting public comment on the following beneficiary reported access measurement areas:
• Beneficiaries reporting a usual source of primary care.
• Beneficiaries reporting difficulty finding a specialist/general clinician, not taking any new patients and/or the beneficiary's insurance.
• Beneficiaries able to access specialists or behavioral health care if they have: Chronic conditions, heart disease, behavioral health issues, etc.
• Beneficiaries able to access long-term services and supports in institutional settings.
• Beneficiaries able to access home and community based services.
• Women able to access: Pap smears, mammograms.
• Children and adults able to access appropriate immunizations and/or seasonal vaccines.
• Beneficiaries reporting delayed care and reason for delay.
• Unmet need for specialty, primary, follow-up, dental, prescriptions, and mental health and substance abuse treatment due to cost concerns.
• Beneficiaries getting needed care quickly.
• Wait times for appointments (for example, to primary care, urgent care, physician specialists, pre-natal care, behavioral health providers, and long-term services and supports in community settings).
• Length of delays in accessing long term services and supports in community setting due to direct service worker shortages and/or lack of adequate training.
• Call-center capability standards to support providing beneficiaries with information that can improve their access, and produce useful metrics for monitoring.
• Call-center metrics that reveal issues with beneficiary access and their resolution.
• Other.
We are soliciting public comment on the following service utilization measurement areas:
• Trends in service utilization by geographic regions within the state.
• Trends in emergency room utilization relative to primary and mental health and substance abuse treatment care utilization.
• Rates of utilization (for example, At least one of the following visits in the prior six months/year: Physician (including nurse practitioners and physician assistants), dental, specialty, behavioral health, and primary care/well-child.)
• Other.
We are soliciting public comment on the following comparison of payment measurement areas:
• Payment rates for services set at a specific percentage of Medicare.
• Medicaid payment rates compared to surrounding states, Medicare, commercial payers.
• Acquisition costs compared to Medicaid payments for pharmaceuticals.
• Comparisons or measures that would inform managed care rate adequacy (the payment managed care plans make to providers).
• Other.
We will evaluate the responses to this RFI, in addition to the findings from research that we are currently conducting, to inform whether it is advisable to collect and analyze core national measures at this time and the methods to conduct the collection. We may also use this information to help determine which measures could best inform understanding of access to care and to support the design of national or state and local thresholds.
Because of the large number of public comments we normally receive on
Food Safety and Inspection Service, USDA.
Notice and request for comments.
The Food Safety and Inspection Service (FSIS) is announcing the establishment of an FSIS and Agricultural Marketing Service (AMS) Export Verification (EV) Program. The program is designed to verify establishments' control of closed-faced sandwiches destined for Canada. Among other things, Canada is requiring that closed-faced sandwiches be produced under a Hazard Analysis and Critical Control Point (HACCP) plan. Under the program, the sandwiches will be produced in establishments that are under FSIS' voluntary reimbursable inspection service and that are operating under conditions that are as consistent as practical with those under which other post-lethality exposed meat and poultry products are produced under 9 CFR part 430. Closed-faced sandwiches are under jurisdiction of the Food and Drug Administration (FDA), but FDA does not require that the sandwiches be produced under a HACCP plan. It also does not verify that the requirements of 9 CFR part 430 are met. Consequently, FSIS and AMS are establishing this voluntary program. Once the program is implemented, only establishments participating in this program will be able to export closed-faced sandwiches to Canada.
Submit comments on or before
FSIS invites interested persons to submit comments on the issues described below. Comments may be submitted by one of the following methods:
Daniel L. Engeljohn, Ph.D., Assistant Administrator, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250; Telephone: (202) 205-0495, or by Fax: (202) 720-2025.
Establishments seeking to participate in this program should contact FSIS by phone at (202) 720-0082, or by email at
In February 2013, the Canadian Food Inspection Agency (CFIA) audited the United States' food safety system for meat and poultry products intended for export to Canada.
Meat and poultry products prepared in official establishments are subject to mandatory inspection by FSIS under the Federal Meat Inspection Act (21 U.S.C. 601,
However, not all RTE products containing meat or poultry fall under FSIS's regulatory jurisdiction. Closed-faced sandwiches are not considered traditional products of the meat or poultry industries, and therefore they fall under the regulatory jurisdiction of FDA.
Establishments producing these RTE products may receive FSIS reimbursable voluntary inspection, but this inspection does not include microbiological testing for pathogen control or verification of HACCP plans or sanitation standard operating procedures (Sanitation SOP). FSIS conducts this reimbursable voluntary inspection to certify products for export under the Agricultural Marketing Act of 1946 (7 U.S.C. 1621,
AMS and FSIS have developed a collaborative testing program to verify pathogen control for closed-face sandwiches produced under FSIS voluntary inspection and intended for export to Canada. This program, which AMS will administer, may eventually include other RTE products. The program will include two types of testing, routine and intensified, to ensure that participating establishments are controlling
For routine testing, AMS will randomly select dates once per year when product samples will be collected. FSIS will collect the product samples and pack them for shipment to the USDA National Science Laboratories in Gastonia, North Carolina. FSIS will collect six samples regardless of plant size, production volume, or process design. If an establishment produces both post-lethality-exposed and non-post-lethality-exposed products, six product samples will be taken from the former and two from the latter. AMS will analyze the samples for
At least once per year, AMS also will select dates for intensified testing at a participating establishment. AMS will also conduct this testing if it finds a positive
For both types of testing, the establishment will pay all costs for sample collection, shipping, shipping materials, and analysis. See
In order for the establishments to meet Canada's requirements for import of closed-face sandwiches, FSIS will offer voluntary inspection services and will verify that the establishments are producing these products under HACCP and Sanitation SOPs. Therefore, to ship this product to Canada, establishments will need to comply with the requirements in 9 CFR part 417 and 9 CFR 416.11-.17.
By participating in the EV program and receiving voluntary inspection from FSIS (including verification of HACCP plans and Sanitation SOPs), establishments that produce closed-face sandwiches and that meet all FSIS and AMS EV program requirements will be able to meet Canada's stated import requirements for closed-faced sandwiches. To receive these services, establishments should contact FSIS at (202) 720-0082, or by email at
Comments are invited on: (a) The timetable for implementation of this program, including readiness to participate in the program's pathogen testing and HACCP verification, and business and trade interests affected by compliance or non-compliance with the program; (b) how the proposed programs can be implemented operationally to avoid disruption of trade or business activities; and (c) any other operational issues that commenters need clarified. FSIS will clarify any issues or make adjustments to the implementation date of the program in a Constituent Update.
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Public awareness of all aspects of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS also will make this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public hearings.
The New England Fishery Management Council (Council) will hold one public hearing and one webinar to solicit Public comments on Draft Amendment 19 to the Scallop Fishery Management Plan (FMP).
The webinar will be held on November 16, 2015 and the meeting will
The Public document can be obtained by contacting the New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950 at (978) 465-0492 or on their Web site at
Thomas Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The agendas for the following hearings are as follows: New England Fishery Management Council staff will brief the public on the scallop amendment and the contents of the Draft Environmental Assessment prior to opening the hearing for public comments. The schedule is as follows:
1.
2.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas Nies (see
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Recreational Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Tuesday, November 17, 2015 at 9:30 a.m.
The meeting will be held at the DoubleTree by Hilton, 50 Ferncroft Road, Danvers, MA 01923; phone: (978) 777-2500; fax: (978) 750-7959.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Advisory Panel will receive a presentation on the results of the Northeast Fisheries Science Center's (NEFSC) 2015 Groundfish Operational Assessments for Gulf of Maine cod, Gulf of Maine haddock, and other groundfish stocks of interest to the recreational fishery. The panel will also receive an overview of draft alternatives in Framework Adjustment 55 (FW 55) specifications and management measures of interest to the recreational fishery, and associated draft impact analysis. They will also review a presentation on the results from NEFSC's bioeconomic model for recreational fisheries for cod and haddock in the Gulf of Maine. Also on the agenda is to develop recommendations to the Groundfish Committee for FY 2016 Gulf of Maine cod and Gulf of Maine haddock recreational measures. The panel will also develop recommendations to the Groundfish Committee for 2016 Council priorities. Additionally, they will also discuss GARFO's Recreational Implementation Plan and develop recommendations to the Groundfish Committee. They will also discuss other business as necessary.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a correction to a public hearing on Amendments to the U.S. Caribbean Reef Fish, Spiny Lobster, and Corals and Reef Associated Plants and Invertebrates Fishery Management Plans: Timing of Accountability Measure-Based Closures.
The Caribbean Fishery Management Council (CFMC) is considering modifying the timing for the implementation of accountability measure (AM)-based closures in the Caribbean Exclusive Economic Zone
Following are the actions and management alternatives:
The Draft Amendment consists of two actions:
Action 1: Modify the timing for the implementation of AM-based closures in the EEZ;
Alternative 1: No action. Continue AM-based closures resulting from an annual catch limit (ACL) overage beginning on December 31st of the closure year and extending backward into the year for the number of days neccesary to achieve the required reduction in landings.
Preferred Alternative 2: Accountability measure-based closures resulting from an ACL overage will begin on September 30th of the closure year and would extend backward into the year for the number of days necessary to achieve the required reduction in landings. This closure start date would apply to all fishery management units (FMUs) for each of Puerto Rico commercial and recreational sectors, St. Thomas/St. John, St. Croix, and Caribbean-wide. If for any FMU in any year, the number of available days running from September 30th backward to the beginning of the year is not enough to achieve the required reduction in landings, then the additional days needed would be captured by extending the closure forward, beginning on October 1st and continuing for however many days are needed to fulfill the required reduction.
Alternative 3: Accountability measure-based closures resulting from an ACL overage will begin on January 1st of the closure year and extend forward into the year for the number of days necessary to achieve the required reduction in landing. This closure start date would apply to all FMUs for each of Puerto Rico commercial and recreational sectors, St. Thomas/St. John, St. Croix, and Caribbean-wide.
Alternative 4: Establish a fixed fishing closure start date for the implementation of AMs for each FMU by island/island group (A. Puerto Rico, B. St. Thomas/St. John, C. St. Croix, and D. Caribbean-wide). A different start date may be chosen for each FMU on each island/island group. The start date will begin on the last day of the identified month and go backward towards the beginning of the year. If for any FMU in any year, the number of days left in the year is not enough to achieve the required reduction in landings, then those additional days would be captured by extending the closure forward toward the end of the year.
Action 2: Specify a time period for revisiting the approach to establish AM-based closures selected in Action 1.
Alternative 1: No action. Do not specify how often the approach chosen should be revisited.
Preferred Alternative 2: Review the approach selected no longer than 2 years from implementation and every 2 years thereafter.
Alternative 3: Review the approach selected no longer than 5 years from implementation and every 5 years thereafter.
Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone (787) 766-5926.
This notice is a correction to a meeting notice
Copy of the draft document, “Amendments to the US Caribbean Reef Fish, Spiny Lobster, and Corals and Reef Associated Plants and Invertebrates Fishery Management Plans: Timing of Accountability Measure-Based Closures”, can be found at the CFMC Web page:
Written comments can be sent to the Council not later than December 10, 2015, by regular mail to the address below, or via email to
These meetings are physically accessible to people with disabilities. For more information or request for sign language interpretation and other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918-1903, telephone (787) 766-5926, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 41 Assessment Webinar 2 and 3.
The SEDAR 41 assessments of the South Atlantic stocks of red snapper and gray triggerfish will consist of a series of workshop and webinars: Data Workshops; an Assessment Workshop and webinars; and a Review Workshop. See
SEDAR 41 Assessment Webinar 2 will be held on Tuesday, November 17, 2015, from 9 a.m. until 1 p.m. and Assessment Webinar 3 will be held on Tuesday, December 1, 2015, from 9 a.m. until 1 p.m.
Julia Byrd, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: Data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.
The items of discussion in the Assessment webinar are as follows:
Participants will discuss any remaining data issues and provide modeling advice to prepare for the Assessment Workshop.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration, Commerce.
Notice of availability; request for comments.
We, NMFS, announce that the
We will consider and address, as appropriate, all substantive comments received during the comment period. Comments on the Proposed Plan must be received no later than 5 p.m. Pacific daylight time on January 4, 2016.
You may submit comments on the Public Draft Recovery Plan by the following methods:
•
•
•
Patricia Dornbusch, NMFS Snake River Fall Chinook Salmon Recovery Coordinator, at (503) 230-5430, or
We are responsible for developing and implementing recovery plans for Pacific salmon and steelhead listed under the ESA of 1973, as amended (16 U.S.C. 1531
We believe it is essential to have local support of recovery plans by those whose activities directly affect the listed species and whose continued commitment and leadership will be needed to implement the necessary recovery actions. We therefore support and participate in collaborative efforts to develop recovery plans that involve state, tribal, and federal entities, local communities, and other stakeholders. For this Proposed Plan for threatened Snake River Fall Chinook Salmon, we worked collaboratively with state, tribal, and federal partners to produce a recovery plan that satisfies the ESA requirements. We have determined that this
For the purpose of recovery planning for the ESA-listed species of Pacific salmon and steelhead in Idaho, Oregon, and Washington, NMFS designated five geographically based “recovery domains.” The Snake River Fall Chinook Salmon ESU spawning range is in the Interior Columbia domain. For each domain, NMFS appointed a team of scientists, nominated for their geographic and species expertise, to provide a solid scientific foundation for recovery plans. The Interior Columbia Technical Recovery Team included biologists from NMFS, other federal agencies, states, tribes, and academic institutions.
A primary task for the Interior Columbia Technical Recovery Team was to recommend criteria for determining when each component population within an ESU or distinct population segment (DPS) should be considered viable (
We also collaborated with state, tribal, and federal biologists and resource managers to provide technical information used to develop the Proposed Plan. In addition, NMFS established a multi-state (Idaho, Oregon, and Washington), tribal, and federal partners' regional forum called the Snake River Coordination Group that addresses the four ESA-listed Snake River salmon and steelhead species. They met twice a year to be briefed and provide technical and policy information to NMFS. We presented regular updates on the status of this Proposed Plan to the Snake River Coordination Group and posted draft chapters on NMFS' West Coast Region Snake River recovery planning Web page. We also made full drafts of the Proposed Plan available for review to the state, tribal, and Federal entities with whom we collaborated to develop the plan.
In addition to the Proposed Plan, we developed and incorporated the
The Proposed Plan, including the recovery plan modules, is now available for public review and comment.
The Proposed Plan contains biological background and contextual information that includes description of the ESU, the planning area, and the context of the plan's development. It presents relevant information on ESU structure, guidelines for assessing salmonid population and ESU status, and a brief summary of Interior Columbia Technical Recovery Team products on population structure and species status. It also presents NMFS' proposed biological viability criteria and threats criteria for delisting.
As described in Chapter 2 of the Proposed Plan, the historical Snake River fall Chinook salmon ESU consisted of two populations. The population above the Hells Canyon Dam Complex is extirpated, leaving only one extant population—the Lower Mainstem Snake River population. An ESU with a single population would be at greater extinction risk than an ESU with multiple populations. This is a key consideration in the proposed Snake River fall Chinook salmon biological viability criteria, since there is more than one possible scenario for achieving the criteria. The proposed viability criteria include two possible scenarios and a placeholder for developing additional scenarios that would be consistent with delisting. Scenario A focuses on achieving ESA delisting with two populations (
The Proposed Plan also describes specific information on the following: Current status of Snake River Fall Chinook Salmon; limiting factors and threats throughout the life cycle that have contributed to the species decline; recovery strategies and actions addressing these limiting factors and threats; and a proposed research, monitoring, and evaluation program for adaptive management. For recovery actions, the Proposed Plan includes a table summarizing each proposed action, life stage affected, estimated costs, timing, and potential implementing entities. It also describes how implementation, prioritization of actions, and adaptive management will proceed. The Proposed Plan also summarizes time and costs (Chapter 9) required to implement recovery actions. In some cases, costs of implementing actions could not be determined at this time and NMFS is interested in additional information regarding scale, scope, and costs of these actions. We are also particularly interested in comments on establishing appropriate forums to coordinate implementation of the recovery plan.
With approval of the final recovery plan, we will commit to implement the actions in the plan for which we have authority and funding; encourage other federal and state agencies and tribal governments to implement recovery actions for which they have responsibility, authority, and funding; and work cooperatively with the public and local stakeholders on implementation of other actions. We expect the recovery plan to guide us and other federal agencies in evaluating federal actions under ESA section 7, as well as in implementing other provisions of the ESA and other statutes. For example, the plan will provide greater biological context for evaluating the effects that a proposed action may have on a species by providing delisting criteria, information on priority areas for addressing specific limiting factors, and information on how the ESU can tolerate varying levels of risk.
When we are considering a species for delisting, the agency will examine whether the section 4(a)(1) listing factors have been addressed. To assist in this examination, we will use the delisting criteria described in Section 3.2 and Section 3.3 of the Proposed Plan, which include both biological criteria and criteria addressing each of the ESA section 4(a)(1) listing factors, as well as any other relevant data and policy considerations.
We will also work with the proposed implementation structure, as described in Chapter 8 of the Proposed Plan, to coordinate among existing forums, develop implementation priorities, and address science and adaptive management issues.
Section 4(f)(1)(B) of the ESA requires that recovery plans incorporate, to the extent practicable, (1) objective, measurable criteria which, when met, would result in a determination that the species is no longer threatened or endangered; (2) site-specific management actions necessary to achieve the plan's goals; and (3) estimates of the time required and costs to implement recovery actions. We conclude that the Proposed Plan meets the requirements of ESA section 4(f) and are proposing to adopt it as the
We are soliciting written comments on the Proposed Plan. All substantive comments received by the date specified above will be considered and incorporated, as appropriate, prior to our decision whether to approve the plan. While we invite comments on all aspects of the Proposed Plan, we are particularly interested in comments on developing specific scenarios to address the placeholder recovery scenario, comments on the cost of recovery actions for which we have not yet determined implementation costs, and comments on establishing an appropriate implementation forum for the plan. We will issue a news release announcing the adoption and availability of the final plan. We will post on the NMFS West Coast Region Web site (
16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The North Pacific Fishery Management Council (Council) Groundfish Plan Team will meet in Seattle, WA.
The meeting will be held on Monday, November 16, to Friday, November 20, 2015, from 8 a.m. to 5 p.m.
The meeting will be held at the Alaska Fishery Science Center, Traynor Room 2076 and NMML Room 2039, 7600 Sand Point Way NE., Building 4, Seattle, WA 98115.
Diana Stram, Council staff; telephone: (907) 271-2809.
The Plan Teams will compile and review the annual Groundfish Stock Assessment and Fishery Evaluation (SAFE) reports, (including the Economic Report, the Ecosystems Consideration Chapter, and the stock assessments for BSAI and GOA groundfishes), and recommend final groundfish harvest specifications for 2016/17.
The Agenda is subject to change, and the latest version will be posted at
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
Bureau of Consumer Financial Protection.
Policy Guidance.
On September 29, 2015, the Bureau of Consumer Financial Protection (Bureau) joined with the U.S. Department of the Treasury and the U.S. Department of Education to release a
This Policy Guidance is applicable November 2, 2015.
Michael Pierce, Program Manager, Office for Students and Young Americans, 1700 G Street NW., 20552, 202-435-7938.
The U.S. Department of Education, the U.S. Department of the Treasury, and the Consumer Financial Protection Bureau have developed a
Consistent with their respective authorities, responsibilities, and missions, the Departments and the Bureau are committed to working together so that all student loan borrowers have access to (1) the information they need to repay their loans responsibly and avoid default; (2) protections so that they will be treated fairly even if they are struggling to repay their loans; and (3) mechanisms so that errors are resolved expeditiously and assurances that student loan servicers, both in the marketplace and through federally-contracted companies, are held accountable for their conduct. The following principles have been developed to advance these goals.
There are four main types of postsecondary education loans under which borrowers have outstanding balances. Direct Loans are federal loans made directly to borrowers by the U.S. Department of Education through the William D. Ford Federal Direct Loan program. Federal Family Education Loan Program (FFELP) loans were originated by private lenders and guaranteed by the federal government. Federal Perkins Loans, which are co-funded by institutions of higher education and the federal government,
In addition, the respective loan types come with varying levels of consumer protections and special benefits. Direct Loans, in general, offer borrowers more protections than private or FFELP loans. Borrowers with FFELP loans continue to consolidate into the Direct Loan program to access certain protections and benefits including the Public Service Loan Forgiveness Program, the nonaccrual of interest for servicemembers serving in areas of hostilities, and certain income-driven repayment plans. For federal loans, pursuant to provisions in the HEA, institutions of higher education are required to provide certain disclosures to borrowers that provide them with clear and helpful information about their loans and repayment options as part of schools' statutorily required entrance and exit counseling duties.
The Departments and the Bureau intend to work closely with one another, consistent with their respective authorities, to strengthen servicing protections for student loan borrowers, and will seek to ensure that student loan servicing is, where appropriate:
•
•
•
•
This Policy Guidance is a non-binding general statement of policy. It does not establish any binding legal requirements. It is therefore exempt from notice and comment rulemaking requirements under the Administrative Procedure Act pursuant to 5 U.S.C. 553(b). Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis. 5 U.S.C. 603(a), 604(a). The Bureau has determined that this Policy Guidance does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501,
Department of Education (ED), Office of Career, Technical and Adult Education (OCTAE).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before January 4, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Laura Messenger, (202) 245-7840.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Elementary and Secondary Education (OESE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before January 4, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Inas El-Sabban, (202) 205-3810.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Because MSP is a formula grant program, the size of individual state awards is based on student population and poverty rates, with no state receiving less than one half of one percent of the total appropriation. Each state is then responsible for administering a competitive grant making process to determine the distribution of funds across proposed MSP projects.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following land acquisition reports:
Take notice that the Commission received the following PURPA 210(m)(3) filings:
Take notice that the Commission received the following electric reliability filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following land acquisition reports:
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:
In accordance with the National Environmental Policy Act of 1969, as amended, 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 an application to amend the El Dorado Project license filed by El Dorado Irrigation District (licensee). The licensee proposes constructing an earthen stability buttress, raising the crest of the dam, and upgrading appurtenant facilities. No Federal lands would be involved in the proposed action. The project is located on the South Fork American River adjacent to the unincorporated community of Pollock Pines in El Dorado, County, California.
An environmental assessment (EA) has been prepared for Commission staff's review of the proposed action, containing staff's analysis of the proposed action and concluding that approval of the proposal, with staff's recommended measures, would not constitute a major federal action significantly affecting the quality of the human environment. The EA is available for electronic review and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426. The EA may also be viewed on the Commission's Web site at
Any comments on the EA should be filed by
On August 14, 2015, Cave Run Energy, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project located at the U.S. Army Corps of Engineers' (Corps) Cave Run Dam, located on the Licking River in Rowan and Bath Counties, Kentucky. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following: (1) A bifurcation structure constructed at the end of the dam's outlet conduit; (2) a powerhouse containing three turbine/generating units with a total capacity of 4.95 megawatts; (3) a 70-foot-long, 150-inch-diameter steel penstock; (4) a 1,200-foot-long, 12.7-kilovolt transmission line. The proposed project would have an average annual generation of 20,000 megawatt-hours, and operate utilizing surplus water from the Cave Run Dam, as directed by the Corps.
Applicant Contact: Mr. Mark Boumansour, Cave Run Energy, LLC, 1401 Walnut St., Suite 220, Boulder, CO 80302. (303) 440-3378.
FERC Contact: Dustin Wilson, phone: (202) 502-6528.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and competing applications may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
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 47,897), the Office of Energy Projects has reviewed Baker County, Oregon's (Baker County) application for a license to construct its proposed Mason Dam Hydroelectric Project, and has prepared an Environmental Assessment (EA). The proposed 3.4-megawatt (MW) project would be located on the Powder River, at the existing U.S. Bureau of Reclamation's (Reclamation) Mason Dam, near Baker City, in Baker County, Oregon. The project would occupy federal land managed by Reclamation and the U.S. Forest Service.
The EA contains Commission staff's analysis of the potential environmental impacts of the proposed hydroelectric project. The EA 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 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
Any comments should be filed within 45 days from the date of this notice.
The Commission strongly encourages electronic filings. Please file comments using the Commission's eFiling system at
You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support. In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. Please affix “Project No. 12686-004” to all comments.
Please contact Kenneth Hogan (Commission Staff) by telephone at (202) 502-8434, or by email at
Take notice that on October 9, 2015, Tennessee Gas Pipeline Company, L.L.C. (Tennessee) filed an application with the Federal Energy Regulatory Commission, pursuant to section 7(c) of the Natural Gas Act (NGA), to construct, install, modify, operate, and maintain certain pipeline facilities located in Pennsylvania, as described in more detail below, all as more completely described in the Application. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site web at
Any questions regarding the application should be directed to Patrick Stewart, Senior Counsel, Tennessee Gas Pipeline Company, L.L.C., 1001 Louisiana Street, Houston, Texas 77002, phone: (713) 369-8765, facsimile: (713) 420-1601, email:
Specifically, Tennessee requests authorization for the construction and operation of the Orion Project, which include: (1) An approximately 8.23 mile long, 36-inch diameter pipeline loop along Tennessee's existing 300 Line right-of-way in Wayne and Pike Counties, Pennsylvania, ending at existing Compressor Station 323 (Loop 322); (2) an approximately 4.68 mile long, 36-inch diameter pipeline loop along Tennessee's existing 300 Line right-of-way in Pike County, Pennsylvania, beginning at Compressor Station 323 (Loop 323); and (3) certain appurtenant and auxiliary facilities. Tennessee has executed binding precedent agreements with shippers for 100 percent of the 135,000 Dth per day of incremental firm transportation capacity created by the Orion Project. The Orion Project is estimated to cost $143,549,615.
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
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
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Additional comments may be submitted on or before December 2, 2015.
Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2015-0533 to (1) EPA online using
Rebecca von dem Hagen, Environmental Protection Agency, Stratospheric Protection Division, Office of Atmospheric Programs, MC 6205J, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 343-9445; fax number: (202) 343-2362; email address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On August 13, 2015 (40 FR 48529), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received one (1) comment during the comment period, which is addressed in the ICR supporting statement. Any additional comments on this ICR should be submitted to EPA and OMB within 30 days of this notice.
EPA has established a public docket for this ICR, which is available for online viewing at
Use EPA's electronic docket and comment system at
Environmental Protection Agency (EPA).
Notice of a public meeting.
The U.S. Environmental Protection Agency (EPA) is announcing a meeting of the National Drinking Water Advisory Council (NDWAC), as authorized under the Safe Drinking Water Act. The meeting is scheduled for November 17, 18 and 19, 2015. The NDWAC typically considers issues associated with drinking water protection and public drinking water systems. During this meeting, the NDWAC will focus discussions on developing recommendations for the EPA Administrator on the Lead and Copper National Primary Drinking Water Regulation—Long Term Revisions.
The meeting on November 17, 2015, will be held from 8:30 a.m. to 4:15 p.m.; November 18, 2015, from 8 a.m. to 5 p.m.; and November 19, 2015, from 8 a.m. to noon, eastern time.
The public meeting will be held in Crystal City, Arlington, Virginia. The exact location of the meeting will be noticed in the
For more information about this meeting or to request written materials, contact Michelle Schutz of the Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, by phone at 202-564-7374 or by email at
To ensure adequate time for public involvement, individuals or organizations interested in presenting an oral statement should notify Michelle Schutz by November 9, 2015, by email at
Environmental Protection Agency (EPA).
Notice; request for public comment.
In accordance with Section 122(i) of the Comprehensive Environmental Response, Compensation and Liability Act, as amended (CERCLA), 42 U.S.C. 9622(i), notice is hereby given of a proposed administrative settlement for recovery of response costs incurred for the Ashue Road Site located at Section 17, Township 11, Range 19 in Wapato, Yakima County, Washington. Under this proposed settlement, the settling parties are Groat Bros., Inc., T.W. Clark Construction, LLC, and the Wapato School District No. 207. The proposed settlement requires the settling parties to pay $95,000 to the Environmental Protection Agency Hazardous Substance Superfund. Upon payment of this sum to Environmental Protection Agency (EPA), the settling parties will be released from their obligations for payments to EPA for costs EPA incurred at the Site prior to the effective date of the proposed settlement.
For 30 days following the date of publication of this notice, the EPA will receive written comments relating to the proposed settlement. The EPA will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The EPA's response to any comments received will be available for public inspection at the U.S. EPA Region 10 Office, located at 1200 Sixth Avenue, Seattle, Washington 98101.
Comments must be received on or before December 2, 2015.
Submit your comments, identified by Docket ID No. EPA-R10-CERCLA-10-2015-0134, to the Federal eRulemaking Portal:
Ted Yackulic, Assistant Regional Counsel, Office of Regional Counsel, Mail Stop ORC-113, Environmental Protection Agency, 1200 Sixth Avenue, Suite 900, Seattle, Washington 98101; telephone number: (206) 553-1218; fax number: (206) 553-1762; email address:
The ASHUE ROAD SITE is located at Section 17, Township 11, Range 19 in Wapato, Yakima County, WA, and is located on fee property within the reservation for the Yakama Nation. The Site covers approximately 2.46 acres. There is a residential home within the Site. The area surrounding the Site supports agricultural and residential uses. During 2012 a portion of the Wapato High School in Wapato, Washington was demolished. The Wapato School District No. 207 engaged T.W. Clark Construction, LLC as the general contractor for the demolition work. T.W. Clark Construction, LLC hired Groat Bros., Inc. as sub-contractor for performing demolition work and transporting demolition materials from the High School. The demolition work included the demolition of materials that contained asbestos. A portion of materials generated during the Wapato High School demolition project were transported to the Site for disposal. The Site is not licensed by the State of Washington, Yakima County, or the Yakama Nation to receive demolition materials or materials that contain hazardous substances for disposal. EPA conducted a field investigation of the Site on October 5, 2012. EPA's investigation revealed the presence of asbestos in the demolished materials disposed of at the Site. Asbestos is a hazardous substance. EPA oversaw the performance of a removal action at the Site by T.W. Clark Construction, LLC, and Groat Bros. Inc. The removal action involved the excavation and off-Site disposal of the high school demolition wastes. EPA incurred approximately $311,330.96 performing or overseeing the performance of response costs at the Site. Pursuant to the terms of the CERCLA Section 122(h)(1) Settlement Agreement for Recovery of Response Costs, the settling parties will pay EPA $95,000. In return for the payment of this amount, EPA covenants not to sue the settling parties for past response costs—response costs incurred by EPA prior to the effective date of the Settlement Agreement—at the Site. In the event that EPA continues to incur response costs at the Site, EPA's covenant not to sue does not include costs incurred by EPA after the effective date of the Settlement Agreement.
Environmental Protection Agency (EPA).
Notice of tentative approval.
Notice is hereby given that the State of Oklahoma is revising its approved Public Water System Supervision (PWSS) program. Oklahoma has adopted the Revised Total Coliform Rule (RTCR) by reference under Title 252 Chapter 631 Subchapters 1-3 of the
All interested parties may request a public hearing. A request for a public hearing must be submitted by December 2, 2015 to the Regional Administrator at the EPA Region 6 address shown below. Frivolous or insubstantial requests for a hearing may be denied by the Regional Administrator. However, if a substantial request for a public hearing is made by December 2, 2015, a public hearing will be held. If no timely and appropriate request for a hearing is received and the Regional Administrator does not elect to hold a hearing on his own motion, this determination shall become final and effective on December 2, 2015. Any request for a public hearing shall include the following information: The name, address, and telephone number of the individual, organization, or other entity requesting a hearing; a brief statement of the requesting person's interest in the Regional Administrator's determination and a brief statement of the information that the requesting person intends to submit at such hearing; and the signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.
All documents relating to this determination are available for inspection between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, at the following offices: Oklahoma Department of Environmental Quality, Public Water System Compliance, 707 North Robinson, Oklahoma City, Oklahoma 73102; and United States Environmental Protection Agency, Region 6, Drinking Water Section (6WQ-SD), 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202. Copies of the documents which explain the rule can also be obtained at EPA's Web site at
For further information contact Evelyn Rosborough, Environmental Protection Specialist, Water Quality Protection Division, U.S. Environmental Protection Agency Region 6, 1445 Ross Ave., Dallas, TX 75202-2733, telephone (214) 665-7515, facsimile (214) 665-6490, or email:
Authority: Section 1413 of the Safe Drinking Water Act, as amended (1996), and 40 CFR part 142 of the National Primary Drinking Water Regulations.
Environmental Protection Agency (EPA).
Notice of public meeting.
The Environmental Protection Agency (EPA) will host a meeting of the Interagency Steering Committee on Radiation Standards (ISCORS) on Monday, November 9, 2015 in Washington, DC. The purpose of ISCORS is to foster early resolution and coordination of regulatory issues associated with radiation standards. Member agencies include: EPA; the Nuclear Regulatory Commission; and Departments of Energy; Defense; Transportation; Homeland Security; Health and Human Services; and Labor's Occupational Safety and Health Administration. Observer agencies include: The Office of Science and Technology Policy, Office of Management and Budget, Defense Nuclear Facilities Safety Board, as well as state representatives from Arizona and Pennsylvania. ISCORS maintains several objectives: (1) Facilitate a consensus on allowable levels of radiation risk to the public and workers; (2) promote consistent and scientifically sound risk assessment and risk management approaches in setting and implementing standards for occupational and public protection from ionizing radiation; (3) promote completeness and coherence of Federal standards for radiation protection; and (4) identify interagency radiation protection issues and coordinate their resolution. ISCORS meetings include presentations by Subcommittee Chairs and discussions of current radiation protection issues. Committee meetings normally involve pre-decisional intra-governmental discussions and, as such, are normally not open for observation by members of the public or media. This particular ISCORS meeting is open to all interested members of the public. Time will be reserved on the agenda for members of the public to provide comments.
A discussion on the draft International Atomic Energy Agency (IAEA) Safety Requirements document, DS457, Preparedness and Response for a Nuclear or Radiological Emergency, is scheduled for this meeting and is intended to provide an overview and invite viewpoints on the draft document during the IAEA Member State review process. The U.S. government, as a member state of the IAEA, is afforded an opportunity to provide comments. The draft document is available at:
The meeting will be held on Monday, November 9, 2015, from 1:00 p.m. to 4:30 p.m.
The ISCORS meeting will be held in Room 1153 at the USEPA William Jefferson Clinton East Building (WJC East), 1201 Constitution Avenue NW., Washington, DC. Attendees are required to present a photo ID such as a government agency photo identification badge or valid driver's license. The Department of Homeland Security has begun implementing REAL ID Act requirements for visitors who present state-issued driver's licenses as IDs at restricted federal facilities. Driver's licenses from states and territories that do not comply with the REAL ID Act will not be accepted as identification. More details on these ID requirements can be found at
Marisa Thornton, Radiation Protection Division, Office of Radiation and Indoor Air, Mailcode 6608T, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone 202-343-9237; fax 202-343-2304; email
Pay parking is available for visitors at multiple garages around the Ronald Reagan building and Federal Triangle complex. Visitors can also ride metro to the Federal Triangle station (Blue and Orange Line). After exiting the turnstiles, go up both escalators to street level. Turn around and walk towards 12th Street NW. Turn right on 12th Street and continue walking until you get to Constitution Avenue. Then turn right onto Constitution Avenue and 1201 William Jefferson Clinton East is the first building on your right.
Visit the ISCORS Web site,
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency is planning to submit an information collection request (ICR), “Tips and Complaints Regarding Environmental Violations (Renewal)” (EPA ICR No. 2219.05, OMB Control No. 2020-0032) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before January 4, 2016.
Submit your comments, referencing Docket ID No. EPA-HQ-OECA-2009-0494, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Michael LeDesma, Legal Counsel Division, Office of Criminal Enforcement, Forensics, and Training; Environmental Protection Agency, Building 25, Box 25227, Denver Federal Center, Denver, CO 80025; telephone number: 303-462-9453 or fax number: 303-462-9075; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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,
As with complaints provided by phone, fax, or electronic mail, we expect that tippers or complainants are already in the possession of information that leads them to suspect a violation of environmental law when they contact EPA to report the matter. Accordingly, EPA believes that the burden associated with the reporting is merely that arising from the need to read the instructions and type or select information into the appropriate fields. In our estimate, this amounts to approximately
EPA does not maintain hardcopies of the information supplied through the webform. Tips or complaints not acted upon within 30 days are automatically purged from the database. Tips or complaints upon which some action is taken are preserved for a period of five years, pursuant to the record schedule for criminal investigations.
Equal Employment Opportunity Commission.
Notice.
Notice is hereby given of the appointment of members to the Performance Review Board of the Equal Employment Opportunity Commission.
Lisa M. Williams, Chief Human Capital Officer, U.S. Equal Employment Opportunity Commission, 131 M Street NE., Washington, DC 20507, (202) 663-4306.
Publication of the Performance Review Board (PRB) membership is required by 5 U.S.C. 4314(c)(4). The PRB reviews and evaluates the initial appraisal of a senior executive's performance by the supervisor, and makes recommendations to the Chair, EEOC, with respect to performance ratings, pay level adjustments and performance awards.
The following are the names and titles of executives appointed to serve as members of the SES PRB. Members will serve a 12-month term, which begins on November 18, 2015.
PRB Chair: Ms. Delner Franklin-Thomas, Director, Birmingham District Office, Equal Employment Opportunity Commission.
Members:
Alternate: Ms. Germaine Roseboro, Director, Office of the Chief Financial Officer, Equal Employment Opportunity Commission.
By the direction of the Commission.
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the renewal of existing information collections, as required by the Paperwork Reduction Act of 1995. The FDIC recently requested comment for 60 days on proposals to renew the information collections described below. Only one comment was received, as explained below. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these information collections, and again invites comment on these renewals.
Comments must be submitted on or before December 2, 2015.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Gary Kuiper or Manny Cabeza, at the FDIC address above.
Proposal to revise and renew the following currently-approved collections of information:
FDIC Form 3700/59, Fair Inclusion of Minorities and Women, is a contract clause implementing Section 342(c)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5452). The contract clause seeks a commitment from an FDIC Contractor to ensure, to the maximum extent possible consistent with applicable law, the fair inclusion of minorities and women in its workforce and the workforces of its applicable subcontractors. Further, the clause asserts the FDIC's right to request documentation from the Contractor that demonstrates the Contractor's good faith effort to include minorities and women in its workforce and subcontractors' workforces, and requires the Contractor to annually certify that it has made such good faith efforts.
FDIC Form 3700/04A, Contractor Representations and Certification, must be completed by any offeror that responds to a solicitation for an award over $100,000. The Form is being revised to add two certifications, “Certification Regarding Fair Inclusion of Minorities and Women” and “Representation by Corporations Regarding an Unpaid Delinquent Federal Tax Liability.” The “Certification Regarding Fair Inclusion of Minorities and Women” implements § 342 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5452) and requires an offeror to certify to its commitment to equal opportunity in employment and contracting and that it has made and will continue to make a good faith effort to ensure, to the maximum extent possible, the fair inclusion of minorities and women in its workforce and in the workforce of its applicable subcontractors. The “Representation by Corporations Regarding an Unpaid Delinquent Federal Tax Liability” implements Section 744 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235)), by requiring an offeror to represent whether it is or is not “a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability.”
One comment was received regarding this information collection that did not address the propriety of the collection of information, the practical utility of the information requested, or the accuracy of FDIC's estimate of the burden of the collection of information. The comment addressed policy considerations that FDIC believes are fully embodied in the implementing statutory provisions and the information and certifications requested in the forms included in the collection of information.
The information collections pursuant to section 114 require each financial institution and creditor to create an Identify Theft Prevention Program and report to the board of directors, a committee thereof, or senior management at least annually on compliance with the proposed regulations. In addition, staff must be trained to carry out the program. Each credit and debit card issuer is required to establish policies and procedures to assess the validity of a change of address request. The card issuer must notify the cardholder or use another means to assess the validity of the change of address.
The Agencies believe that the entities covered by the proposed regulation are already furnishing addresses that they have reasonably confirmed to be accurate to consumer reporting agencies from which they receive a notice of address discrepancy as a usual and customary business practice. Therefore, this requirement is not included in the burden estimates set out below.
Policies and Procedures:
Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the collections 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 collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10461 First East Side Savings Bank, Tamarac, Florida (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of First East Side Savings Bank (Receivership Estate); The Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective October 1, 2015 the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10466 Hometown Community Bank, Braselton, Georgia (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Hometown Community Bank (Receivership Estate); The Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-
Effective October 1, 2015 the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 16, 2015.
A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
1.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 16, 2015.
A. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
1.
B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 27, 2015.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
1.
2.
B. Federal Reserve Bank of St. Louis (Yvonne Sparks, Community Development Officer) P.O. Box 442, St. Louis, Missouri 63166-2034:
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors no later than November 27, 2015.
A. Federal Reserve Bank of Boston (Richard Walker, Community Affairs Officer) 600 Atlantic Avenue, Boston, Massachusetts 02210-2204:
1.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning subcontract consent. A notice was published in the
Submit comments on or before December 2, 2015.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
•
•
Ms. Mahruba Uddowla, Procurement Analyst, Office of Government-wide Policy, contact via telephone 703-605-2828 or email at
Federal Acquisition Regulation (FAR) clause 52.244-2, Subcontracts, requires prime contractors to provide contracting officers notification before the award of any cost-plus-fixed-fee subcontract, or certain fixed-price subcontracts. This requirement for advance notification is driven by statutory requirements in 10 U.S.C. 2306 and 41 U.S.C. 3905. FAR clause 52.244-2 also requires prime contractors to get consent to subcontract for cost-reimbursement, time-and-materials, labor-hour, or letter contracts, and also for unpriced actions under fixed-price contracts that exceed the simplified acquisition threshold.
The objective of requiring consent to subcontract, as discussed in FAR Part 44, is to evaluate the efficiency and effectiveness with which the contractor spends Government funds, and complies with Government policy when subcontracting. The Government requires a contractor to provide certain information (
Based on information from the Federal Procurement Data System (FPDS) regarding contracts that would be required to provide information pursuant to FAR clause 52.244-2, an upward adjustment is being made to the number of respondents. As a result, an upward adjustment is being made to the estimated annual reporting burden hours since the notice regarding the
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Please cite OMB Control No. 9000-0149, Subcontract Consent, in all correspondence.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by January 4, 2016.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
1.
The Cross-Center Evaluation is utilizing a longitudinal mixed methods approach to evaluate the Centers' services as they develop and mature over the course of the study period. Multiple data collection strategies will be used to efficiently capture quantitative and qualitative data to enable analyses that address each evaluation question. Proposed Cross-Center Evaluation data sources for this effort include (1) satisfaction surveys to assess recipients' satisfaction with services, such as the Learning Experiences Satisfaction Survey; (2) a leadership interview, administered to all State child welfare directors, Tribal child welfare directors, and CIP coordinators that are receiving services from the Centers; and (3) a collaboration survey, an annual Web-based survey administered to the directors and staff of the three Centers. Center-specific data sources for this effort include (1) assessment tools such as the Tribal Organizational Assessment Caseworker Interview; and (2) service-specific feedback forms, such as the Center for States Intensive Projects instrument and the Center for Courts CQI Workshops instrument.
In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address:
The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Food and Drug Administration, HHS.
Notice of availability; revised guidance document.
The Food and Drug Administration (FDA or we) is issuing a revised guidance document that extends the compliance policy described in the guidance for industry entitled “DSCSA Implementation: Product Tracing Requirements for Dispensers—Compliance Policy.” This revised guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of product without receiving transaction information, transaction history, and transaction statements (product tracing information), prior to or at the time of a transaction, or do not capture and maintain the product tracing information, as required by the FD&C Act.
Effective November 2, 2015. For information about enforcement dates, please see the
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
Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
On July 6, 2015, FDA published a Notice of Availability in the
On November 27, 2013, the DSCSA (Title II of Pub. L. 113-54) was signed into law. Section 202 of DSCSA adds sections 581 and 582 to the FD&C Act, which set forth new definitions and requirements for the tracing of products through the pharmaceutical distribution supply chain. Starting in 2015, trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) were required under sections 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to exchange product tracing information when engaging in transactions involving certain prescription drugs. For dispensers, requirements for the tracing of products through the pharmaceutical distribution supply chain under section 582(d)(1) of the FD&C Act took effect on July 1, 2015. FDA published a guidance document on July 6, 2015, stating that it does not intend to take action against dispensers who, prior to November 1, 2015, (1) accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act, or (2) do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.
Some dispensers—primarily smaller, independent pharmacies and health systems—have expressed concern that they will be unable to comply with these requirements by November 1, 2015. Thus, FDA recognizes that these dispensers continue to need additional time to work with trading partners to ensure that the product tracing information required by section 582 of the FD&C Act is captured and maintained by dispensers. In light of these concerns, FDA does not intend to take action against dispensers who, prior to March 1, 2016: (1) Accept ownership of product without receiving product tracing information, prior to or at the time of a transaction, as required by section 582(d)(1)(A)(i) of the FD&C Act or (2) do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act. This compliance policy does not extend to other requirements of the FD&C Act applicable to dispensers and other trading partners, including those in section 582 of the FD&C Act, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification, and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners. The guidance document explains the scope of the compliance policy in further detail.
The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the document at
Food and Drug Administration, HHS.
Notice of Availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on progesterone gel entitled “Draft Guidance on Progesterone.” The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for progesterone gel.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 4, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.
In the
FDA initially approved new drug application 020701 for Crinone gel in July 1997. There are no approved ANDAs for this product. We are now issuing a draft guidance for industry on BE recommendations for generic progesterone gel (“Draft Guidance on Progesterone”).
In June 2013, Watson Laboratories, manufacturer of the reference listed drug, Crinone, submitted a citizen petition requesting that FDA require ANDA applicants to demonstrate bioequivalence to Crinone with studies that include pharmacokinetic and clinical endpoint studies and to issue a draft BE guidance identifying these studies. (FDA notes that subsequent to submission of the petition, Watson Laboratories informed FDA that the company has changed its name to Actavis Labs UT Inc.) FDA has reviewed the issues raised in the petition and is responding to the petition (Docket No. FDA-2013-P-0664, available at
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115).
Persons with access to the Internet may obtain the document at either
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices.” This guidance describes the types of information that should be provided to support a claim of electromagnetic compatibility (EMC) in a premarket submission for an electrically powered medical device. Electromagnetic disturbance is electronic product radiation that may interfere with the performance of an electrically powered medical device in its intended environment (
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 December 17, 2015.
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.”
•
An electronic copy of the guidance document is available for download from the Internet. See the
Donald Witters, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 62, Rm. 1130, Silver Spring, MD 20993-0002, 301-796-2483.
FDA is announcing the availability of a draft guidance to provide FDA's current thinking on the types of information that should be provided in a premarket submission to support a claim of electromagnetic compatibility for an electrically powered medical device. EMI is a hazard with associated risk for electrically powered medical devices. EMC assessment can help to ensure that the risks associated with performance degradation of electrically powered medical devices due to EMI are adequately mitigated.
The draft guidance includes information consistent with specifications described in FDA-recognized consensus national or international standards for EMC such as in the International Electrotechnical Commission (IEC) 60601-1-2: Edition 3: 2007-03, Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests; IEC 60601-1-2: Edition 4.0: 2014-01, Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests; Association for the Advancement of Medical Instrumentation (AAMI)/American National Standards Institute (ANSI)/IEC 60601-1-2: 2007/(R) 2012 Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests; and AAMI/ANSI/IEC 60601-1-2: 2014, Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests Standards that sponsors and manufacturers of electrically powered medical devices often reference. This draft guidance is intended to help ensure that clear and consistent information is provided in premarket submissions regarding medical device EMC and to facilitate the review of submissions with EMC claims.
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 information that should be provided to support claims of electromagnetic compatibility of electrically powered medical devices. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statute and regulations.
Persons interested in obtaining a copy of the draft 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 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 814 have been approved under OMB control number 0910-0231. The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120. The collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078. The collections of information in 21 CFR part 814, subpart H have been approved under OMB control number 0910-0332. The collections of information in sections 520(m) and 515A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j and 21 U.S.C. 360e-1, respectively) and 613(b) of Food and Drug Administration Safety and Innovation Act have been approved under OMB control number 0910-0661.
Office of the Secretary, HHS.
Notice.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on the ICR must be received on or before January 4, 2016.
Submit your comments to
Information Collection Clearance staff,
When submitting comments or requesting information, please include the document identifier HHS-OS-4040-New-60D for reference.
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
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.
OS specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Indian Health Service, HHS.
Notice; extension of the comment period.
This document extends the comment period for the notice to propose Redesignation of the Service Delivery Area for the Wampanoag Tribe of Gay Head (Aquinnah), which was published in the
The comment period for the notice published in the
Because of staff and resource limitations, we cannot accept comments by facsimile transmission. You may submit comments in one of three ways (please choose only one of the ways listed):
1.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
2.
3.
Comments will be made available for public inspection at the Rockville address from 8:30 a.m. to 5:00 p.m., Monday-Friday, approximately three weeks after publication of this notice.
Carl Harper, Director, Office of Resource Access and Partnerships, Indian Health Service, 801 Thompson Avenue, Rockville, Maryland 20852. Telephone: (301) 443-1553.
The notice that was published in the
The Bureau of Indian Affairs recognized the Wampanoag Tribe of Gay Head on February 10, 1987. Martha's Vineyard, Dukes County was designated as the Aquinnah service delivery area in the Wampanoag Tribal Council of Gay Head, Inc., Indian Claims Settlement Act of 1987, Public Law 100-95.
This comment period is being extended to allow all interested parties the opportunity to comment on the proposed rule. Therefore, we are extending the comment period until November 22, 2015.
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 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.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
12 U.S.C. 1701z-1 Research and Demonstrations.
Office of the Deputy Secretary, HUD.
Notice of appointments.
The Department of Housing and Urban Development announces the establishment of two Performance Review Boards to make recommendations to the appointing authority on the performance of its
Laura H. Hogshead, Rafael C. Diaz, Tonya T. Robinson, and Lynn M. Ross will serve as members of the Departmental Performance Review Board to review noncareer SES performance. The address is: Department of Housing and Urban Development, Washington, DC 20410-0050.
Persons desiring any further information about the Performance Review Board and its members may contact Juliette Middleton, Director, Office of Executive Resources, Department of Housing and Urban Development, Washington, DC 20410. Telephone (202) 402-3058. (This is not a toll-free number)
Bureau of Ocean Energy Management (BOEM), Interior.
List of Restricted Joint Bidders.
Pursuant to the joint bidding provisions of 30 CFR 556.41-556.44, the Director of the Bureau of Ocean Energy Management is publishing a List of Restricted Joint Bidders. Each entity within one of the following groups is restricted from bidding with any entity in any of the other following groups at Outer Continental Shelf oil and gas lease sales to be held during the bidding period November 1, 2015, through April 30, 2016. This List of Restricted Joint Bidders will cover the period November 1, 2015, through April 30, 2016, and replace the prior list published on May 18, 2015, which covered the period of May 1, 2015, through October 31, 2015.
Bureau of Ocean Energy Management (BOEM), Interior.
Notice of Availability of a Research Lease of Submerged Lands for Renewable Energy Activities on the Outer Continental Shelf Offshore Virginia.
BOEM has issued a wind energy research lease to the Commonwealth of Virginia, Department of Mines, Minerals and Energy for an area situated on the Outer Continental Shelf offshore Virginia. The purpose of this notice is to inform the public of the availability of the executed lease, Renewable Energy Lease No. OCS-A-0497.
Proposed activities on the lease include the installation and operation of wind turbine generators and resource assessment devices, as well as associated offshore substation platforms, interarray cables, and subsea export cables. The total acreage of the lease area is approximately 2,135 acres. The lease area is comprised of six aliquots (
This Notice of the Availability of a wind energy research lease is published pursuant to 30 CFR 585.238(f), which implements subsection 8(p) of the Outer Continental Shelf Lands Act (43 U.S.C. 1337(p)).
Mr. Casey Reeves, BOEM Office of Renewable Energy Programs, 45600 Woodland Road, Sterling, Virginia 20166, (703) 787-1320 or
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has found no violation of section 337 of the Tariff Act of 1930, 19 U.S.C. 1337, in the above-captioned investigation, and has terminated the investigation.
Amanda P. Fisherow, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2737. The public version of the complaint can be accessed on the Commission's electronic docket (EDIS) at
The Commission instituted this investigation on January 28, 2014, based on a complaint filed by Magna Electronics Inc. of Auburn Hills, Michigan.
On April 27, 2015, the ALJ issued his final ID. The ID found that no violation of section 337 has occurred. Specifically, the ID found that the '659 and '840 patents were not indirectly infringed, that the '840 patent is invalid, and that the domestic industry requirement for the '840 patent has not been met. The ALJ also issued his recommendation on remedy and bonding.
On May 11, 2015, Magna and TRW each filed petitions for review. On May 19, 2015, the parties, including OUII, filed responses to the respective petitions for review. On May 28, 2015, Magna filed a corrected response. The Commission determined to review the ID's findings with respect to: (1) Importation; (2) whether the asserted claims of the '659 patent require a camera; (3) direct infringement of the '659 patent; (4) induced infringement of the '659 and '840 patents; (5) contributory infringement of the '659 and '840 patents; (6) whether the '659 patent satisfies the requirements of 35 U.S.C. 112; (7) anticipation of the '659 patent claims based on Rayner; (8) anticipation of the '659 patent claims based on Batavia; (9) anticipation of the '659 patent claims based on the SafeTrac Prototype; (10) obviousness of the '659 patent based on Rayner in combination with Blank; (11) obviousness of the '659 patent based on Batavia, the SafeTrac Prototype, and the Navlab 1997 Demo; (12) whether the claims are invalid under the America Invents Act § 33(a); and (13) the technical prong of domestic industry for the '659 and '840 patents.
On August 17, 2015, the parties briefed the issues on review, remedy, bonding, and the public interest. On August 27, 2015, the parties filed their reply submissions. After the conclusion of this briefing, TRW filed “Respondent's Short Submission Out Of Time Regarding Complainant Admission on Commission Topic 2” and Magna filed a response thereto.
After considering the final ID, written submissions, and the record in this investigation, the Commission has determined to affirm-in-part and reverse-in-part the final ID and to terminate the investigation with a finding of no violation of section 337. Specifically, the Commission finds that (1) the importation requirement has not been satisfied for the '659 patent; (2) the asserted claims of the '659 patent do not require a camera; (3) certain automobiles equipped with a mounting system configured to receive certain accused products directly infringe the '659 patent; (4) the accused products do not contributorily infringe the '659 patent; (5) the accused products do not induce infringement of the '659 patent; (6) claims 1 and 3 of the '659 patent are invalid under 35 U.S.C. 103 based on Rayner in view of Blank; (7) claims 1 and 3 of the '659 patent are not anticipated by Rayner; (8) the asserted claims are not invalid under the America Invents Act § 33(a); (9) the technical prong of the domestic industry requirement for the '840 patent has not been met; and (10) the technical prong of the domestic industry requirement for the '659 patent has not been met. The Commission also (11) takes no position on indirect infringement of the '840 patent; (12) takes no position on importation with respect to the '840 patent; (13) takes no position on whether claim 1 of the '659 patent is invalid based on Batavia, the SafeTrac Prototype, and the Navlab 1997 Demo, either alone or in combination; (14) takes no position on whether the asserted claims of the '659 patent satisfy the requirements of 35 U.S.C. 112; and (15) rejects TRW's filing titled “Respondent's Short Submission Out Of Time Regarding Complainant Admission on Commission Topic 2.”
A Commission Opinion will issue shortly.
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.
United States International Trade Commission.
Notice.
The Commission hereby gives notice that it has instituted a review pursuant to the Tariff Act of 1930 (“the Act”), as amended, to determine whether revocation of the antidumping duty order on wooden bedroom furniture from China would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the
Mary Messer (202-205-3193), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
(1)
(2) The
(3) The
(4) The
(5) An
Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Carol McCue Verratti, Deputy Agency Ethics Official, at 202-205-3088.
(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and Email address of the certifying official.
(2) A statement indicating whether your firm/entity is a U.S. producer of the
(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.
(4) A statement of the likely effects of the revocation of the antidumping duty order on the
(5) A list of all known and currently operating U.S. producers of the
(6) A list of all known and currently operating U.S. importers of the
(7) A list of 3-5 leading purchasers in the U.S. market for the
(8) A list of known sources of information on national or regional prices for the
(9) If you are a U.S. producer of the
(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the
(b) Capacity (quantity) of your firm to produce the
(c) the quantity and value of U.S. commercial shipments of the
(d) the quantity and value of U.S. internal consumption/company transfers of the
(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the
(10) If you are a U.S. importer or a trade/business association of U.S. importers of the
(a) The quantity and value (landed, duty-paid but not including antidumping or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of
(b) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of
(c) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of
(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the
(a) Production (quantity) and, if known, an estimate of the percentage of total production of
(b) Capacity (quantity) of your firm(s) to produce the
(c) the quantity and value of your firm's(s') exports to the United States of
(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the
(13) (OPTIONAL) A statement of whether you agree with the above definitions of the
This proceeding is being conducted under authority of Title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.61 of the Commission's rules.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 22) of the presiding administrative law judge (“ALJ”) granting-in-part complainant's motion for leave to amend the amended complaint and notice of investigation.
Michael Liberman, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-3115. 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 under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“Section 337”), on June 25, 2015, based on a complaint filed by Pacific Bioscience Laboratories, Inc. of Redmond, Washington (“PBL”) on April 30, 2015. An amended complaint was filed on May 20, 2015. 80 FR 36576-77 (Jun. 25, 2015). The amended complaint, as supplemented, alleges a violation of Section 337 by reason of infringement of certain claims of U.S. Patent Nos. 7,320,691 (“the '691 patent”) and 7,386,906, and U.S. Design Patent No. D523,809 by numerous respondents. The amended complaint further alleges violations of Section 337 based upon the importation into the United States, or in the sale of certain electric skin care devices, brushes and chargers therefor, and kits containing the same, by reason of trade dress infringement, the threat or effect of which is to destroy or substantially injure an industry in the United States.
On September 11, 2015, complainant PBL filed a motion pursuant to 19 CFR 210.14(b) seeking leave to amend its amended complaint and the Commission's notice of investigation to (1) change the name of respondent “Michael Todd True Organics LP” to “Michael Todd LP” in order to reflect the new name of that entity; (2) assert violation as to an additional accused product of respondents Michael Todd LP and MTTO LLC (collectively, “MT”); and (3) assert infringement of additional claims of the '691 patent by MT's accused products. On September 23, 2015, the Commission investigative attorney filed a response supporting the motion in part and opposing the motion in part. On September 28, 2015, PBL filed a reply brief.
On October 2, 2015, the ALJ issued Order No. 22, granting-in-part and denying-in-part complainant's motion. The ALJ granted PBL's motion with
Pursuant to Commission Rule 210.14(b), the name change of respondent “Michael Todd True Organics LP” to “Michael Todd LP” is an ID. No party petitioned for review of the subject ID, and the Commission has determined not to review it.
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.
United States International Trade Commission.
November 6, 2015 at 11:00 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 701-TA-525 and 731-TA-1260-1261 (Final)(Certain Welded Line Pipe from Korea and Turkey). The Commission is currently scheduled to complete and file its determinations and views of the Commission on November 18, 2015.
5. Outstanding action jackets: None.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission:
United States International Trade Commission.
November 9, 2015 at 11:00 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 731-TA-753, 754, and 756 (Third Review)(Cut-to-Length Carbon Steel Plate from China, Russia, and Ukraine). The Commission is currently scheduled to complete and file its determinations and views of the Commission on December 2, 2015.
5. Outstanding action jackets: none.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission:
On October 26, 2015, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Southern District of Iowa in the lawsuit entitled
Defendant Barton Solvents, Inc. (Barton) distributes chemicals, oils, surfactants, and plasticizers, and provides custom liquid blending, food grade packaging, and laboratory services. The Complaint alleges the following violations at five solvent blending, storage and distribution plants owned and operated by Barton in Iowa and Kansas: (1) Violations of Section 112(r)(1) of the Clean Air Act, known as the General Duty Clause (GDC), 42 U.S.C. 7412(r)(1); (2) violation of Section 304 of the Emergency Planning and Community Right-To-Know Act, 42 U.S.C. 10004; (3) violations of the Spill Prevention Control and Countermeasure (SPCC) regulations promulgated under Section 311(j) of the Clean Water Act, 40 CFR 1321(j); and (4) violations of multiple federal and state Resource Conservation and Recovery Act (RCRA) requirements, 42 U.S.C. 6901
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 $21.00 (25 cents per page
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 January 4, 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 John R. Scherbenske, 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): Not-for-profit institutions; Federal, State, local, and tribal governments.
Abstract: Title 21, United States Code (U.S.C.), Section 952, and Title 21, Code of Federal Regulations (CFR), § 1315.34 require that persons who desire to import the List I chemicals Ephedrine, Pseudoephedrine, or Phenylpropanolamine during the next calendar year shall apply to DEA on DEA Form 488 for an import quota for those List I chemicals.
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.
Coordinating Council on Juvenile Justice and Delinquency Prevention, Justice.
Notice of meeting.
The Coordinating Council on Juvenile Justice and Delinquency Prevention announces its next meeting.
Friday, November 13, 2015, from 3:00 p.m. to 4:45 p.m. (Eastern Time).
The meeting will take place in the third floor main conference room at the U.S. Department of Justice, Office of Justice Programs, 810 7th St. NW., Washington, DC 20531.
Visit the Web site for the Coordinating Council at
The Coordinating Council on Juvenile Justice and Delinquency Prevention (“Council”), established by statute in the Juvenile and Delinquency Prevention Act of 1974 section 206(a) (42 U.S.C. 5616(a)), will meet to carry out its advisory functions. Documents such as meeting announcements, agendas, minutes, and reports will be available on the Council's Web page,
Although designated agency representatives may attend, the Council membership consists of the Attorney General (Chair), the Administrator of the Office of Juvenile Justice and Delinquency Prevention (Vice Chair), the Secretary of Health and Human Services (HHS), the Secretary of Labor (DOL), the Secretary of Education (DOE), the Secretary of Housing and Urban Development (HUD), the Director
Photo identification will be required for admission to the meeting.
The Council expects that the public statements submitted will not repeat previously submitted statements. Written questions from the public are also invited at the meeting.
Bureau of International Labor Affairs, Labor.
Notice of charter renewal.
On September 30, 2015, President Obama continued the President's Committee on the International Labor Organization (ILO) for two years through September 30, 2017 (E.O. 13708, 80 FR 60271 (October 5, 2015)). In response, and pursuant to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App. 2), the Secretary of Labor renewed the committee's charter on October 13, 2015.
The committee is composed of seven members: The Secretary of Labor (chair), the Secretary of State, the Secretary of Commerce, the Assistant to the President for National Security Affairs, the Assistant to the President for Economic Policy, and one representative each from organized labor and the business community, designated by the Secretary. The labor and business members are the presidents of the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) and the United States Council for International Business (USCIB), respectively, as the most representative organizations of U.S. workers and employers engaged in ILO matters.
The authority for this notice is granted by the Federal Advisory Committee Act (5 U.S.C. App. 2) and Executive Order No. 13708 of September 30, 2015.
Robert B. Shepard, Director, Office of International Relations, Bureau of International Labor Affairs, U.S. Department of Labor, telephone (202) 693-4808.
Mine Safety and Health Administration, Labor.
Notice.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations Part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.
All comments on the petitions must be received by the MSHA's Office of Standards, Regulations, and Variances on or before December 2, 2015.
You may submit your comments, identified by “docket number” on the subject line, by any of the following methods:
1.
2.
3.
MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments.
Barbara Barron, Office of Standards,
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.
(1) The Eagle Mine is a trackless mining environment that utilizes rubber-tired, diesel- powered equipment.
(2) The majority of the work performed in this environment keeps the miners on or near mobile equipment.
(3) Mine Emergency Planning requires miners report to refuge chambers during emergencies.
(4) There are two 4-person and three 12-person MineARC refuge chambers strategically located underground.
(5) Only 48 persons are allowed underground at any given time, based on occupancy ratings of refuge chambers.
(6) Refuge chambers are strategically located and able to be reached within 10-minutes from the working locations.
(7) Secondary escape ways are located on each level are able to be reached within 10 minutes from anywhere on the working level.
(8) Miners currently carry Drager Oxy 6000 on their mine belt. The Drager Oxy 6000 is an MSHA approved SCSR that weighs 3.5 kg/7.7lbs.
(9) The Ocenco M-20 SCSR is an MSHA approved SCSR that weights 3.2 lbs.
(10) Miners will frequently catch the release latches of the Oxy 6000 SCSR on equipment handles, requiring replacement of the units.
The petitioner proposes to:
(1) Require all Cementation miners to wear Ocenco M-20 unit Self-Contained Self-Rescue Devices on their mine belts.
(2) Require all Cementation miners to inspect their issued Ocenco M-20 unit on a daily basis
(3) Have one Drager Oxy 6000 SCSR per occupant seat located on each piece of Cementation underground equipment or vehicle.
(4) Have the equipment operators inspect the Drager Oxy 6000 SCSR stored on Cementation equipment as part of the pre-op inspection.
(5) Provide cached six Drager Oxy 6000 SCSRs in each refuge chamber. The SCSRs will be inspected on a weekly basis as part of the weekly refuge chamber inspection.
(6) Provide cached five Drager Oxy 6000 SCSRs at the secondary escape way on each working level of the mine. These SCSRs will be inspected on a weekly basis.
(7) Store the MSHA Rated SCSRs in a sealed box that is clearly marked with highly visible reflective signage indicated on all escape and evacuation maps posted in the mine. These SCSRs will be inspected on a weekly basis.
(8) Provide training for all underground miners quarterly in the use, limitations, care, and inspection of the 10-minue and the 1-hour SCSR devices. This training will include:
(a) Hands-on training for all types of self-rescue devices used at the mine, which include:
(i) Instruction and demonstration in the use, care, and maintenance of self-rescue devices; and
(ii) The complete donning of the SCSR by assuming a donning position, opening the device, activating the device, inserting the mouthpiece, and putting on the nose clip.
(b) Hands on training in transferring from a 10-minute SCSR to a 1-hour SCSR.
(9) Provide instructor certified training annually for each Cementation miner that will include donning SCSRs in smoke, simulated smoke, or an equivalent environment, and breathing through a realistic SCSR training unit that provides the sensation of SCSR airflow resistance and heat.
(10) Have the operator certify by signature and date that the training was conducted according to the conditions in this petition, at the completion of training. This certification will include the names of the miners who participated in the training.
(11) The certifications will be made available to the Cementation miner's representative or an authorized Representative of the Secretary on request. This certificate will be kept at the mine for three years.
(12) Inspect all stored 1-hour SCSRs in the mine for defects in accordance with the manufacturer's instructions on a weekly basis and record the results for each device. Records of these inspections will be made available to the miner's representative and an Authorized Representative of the Secretary on request. Records of these inspections will be maintained for three years.
(13) Maintain all SCSRs in good condition. SCSRs that do not function properly will be removed from service and replaced with properly functioning SCSRs.
The petitioner asserts that the combination of self-contained self-rescue devices will at all times guarantee no less than the same measure of protection for miners as afforded by the standard.
(a) Westvaco is governed in part by 30 CFR 57.22214, which prohibits compliance with 30 CFR 57.4760(a), if controls doors are used.
As a Class III underground mine, “changes in ventilation which affect the
The actuation of control doors near intake shafts changes the ventilation of the main air current, could occur while the mine is not idle, and may adversely affect safety, even if only performed when fire, smoke, or toxic gases are detected. In contrast, controlled air reversal would only be instituted by management to improve safety by moving combustion gases out of the mine and away from miners. Accordingly, changes in a mine's ventilation via control doors has the potential to conflict with 30 CFR 57.22214. On the other hand, mechanical ventilation reversal of the airflow would not conflict, thereby providing further reasons for the approval of this petition.
b. Empirical testing of the underground airflow confirms that Tronox can accomplish ventilation reversal pursuant to 30 CFR 57.4760(a)(2).
Tronox and its predecessor have operated Westvaco since before the Mine Act was enacted. Throughout that time, Westvaco worked with knowledge that, if necessary, a reversal of airflow was always available to control the spread of fire, smoke, and toxic gases.
During an April 8, 2015, MSHA spot inspections, the Secretary's authorized representative issued the Citations to Tronox for alleged violation of the standard. In response to the Citations, Tronox upgraded its ventilation system. Westvaco has three intake shafts (Nos. 8, 5, and 7), each equipped with identical 1500 hp Jeffry 8HU Vane Axial ventilation fans, located on the surface. These fans provide the motive air forced into the mine to maintain a positive pressure, forcing air out of the mine through Shaft Nos. 1, 2, 3, 4, 6, and 9. Tronox engineering upgrades allow the mine's hoistman to turn off the ventilation fans, individually or in combination, from their workstation. The hoistman's station is manned during every shift at Westvaco.
After the upgrades were complete, Tronox performed engineering tests and analyses to confirm that the on-duty hoistman could mechanically reverse the ventilation airflow in the mine by turning off the main fans in various permutations. Specifically, by turning off one of the three main fans that force air into the mine, Tronox is able to maintain positive pressure while simultaneously directing the flow of air toward a different exhaust shaft.
Tronox tested the fans' effect on underground airflow with anemometers, smoke tubes, pressure transducers, and synchronized watches. During the test, Tronox turned off each ventilation fan and measured the airflow direction, velocity, and pressure fluctuations at the bottom of the shaft, before and after each fan was de-energized. The airflow direction was cross-checked at the top of the shaft to validate the findings underground. The pressure transducers at the top and bottom of the intake shaft were set to log pressure readings every five seconds. The testing showed a quantifiable change in the direction of the underground airflow near each of the shaft stations, which would control the spread of smoke and toxic gases underground in the event of a fire.
1. When the 8 Shaft fan is operating the airflow in the vicinity traveled away from the 8 Shaft, through the east and southern passageways, towards the longwall. The anemometer and smoke tube recorded the velocity of the airflow in the area.
When the 8 Shaft fan is turned off, the direction of the airflow reversed in less than two minutes, and the 8 Shaft transitioned from an intake shaft to an exhaust shaft. The velocity of the airflow, now traveling towards the 8 Shaft, was measured between 35 and 125 feet per minute.
Most important when the 8 Shaft fan was running the airflow in the three passageways—east, south, and southwest—emanating from the 8 Shaft had been towards the 5 Shaft and 7 Shaft. With the 8 Shaft turn off, the airflow in these three passages reversed, traveling towards the 8 Shaft and away from the 5 Shaft and 7 Shaft. In the event Westvaco experiences a fire in the southern section of the mine, by turning off the 8 Shaft fan, the change in air pressure would force the smoke and toxic gases to travel towards and exit the mine through the 8 Shaft. At the same time, fresh air from the 5 Shaft and 7 Shaft main fans would fill the passageways used by the miners to reach the two designated escape routes at the 5 Shaft and 7 Shaft, and would enhance the safety of the evacuation in a means comparable to, or exceeding the safety provided by the control doors.
2. When the 5 Shaft is operating, the airflow in the vicinity traveled away from the 5 Shaft through the north, west, and southern passageways. The anemometers recorded the velocity of the airflow in this area.
When the 5 Shaft was turned off, once again the direction of the airflow reversed in less than two minutes, and the 5 Shaft transitioned from an intake shaft to an exhaust shaft. The velocity of the airflow, now traveling towards the 5 Shaft, was measured between 140 and 195 feet per minute.
Similar to the 8 Shaft, when the 5 Shaft fan was running, the airflow in the three adjacent passageways—east, south, and southwest—emanating from the 5 Shaft had been towards the 8 Shaft and the 7 Shaft. With the 5 Shaft fan turned off, the airflow in these three passages reversed, traveling towards the 5 Shaft and away from the 8 Shaft and the 7 Shaft. In the event Westvaco experienced a fire in the central section of the mine, by turning off the 5 Shaft fan, the change in air pressure would force the smoke and toxic gases to travel towards and exit the mine through the 5 Shaft. At the same time, fresh air from the 8 Shaft and the 7 Shaft main fans would fill the northern and southern passageways, would provide the miners with good air as they progressed to the 8 Shaft primary hoist or the 7 Shaft northern escape route, and would enhance the safety of the evacuation in a means comparable to or exceeding the safety provided by control doors.
3. When the 7 Shaft fan is operating the airflow in the vicinity traveled away from the 7 Shaft, through west passageway. The anemometer recorded the velocity of the airflow in the area.
When the 7 Shaft fan was turned off, the direction of the airflow reversed in less than two minutes, and the 7 Shaft transitioned from an intake shaft to an exhaust shaft. The velocity of the airflow, now traveling towards the 7 Shaft, was measured at 195 feet per minute.
The 7 Shaft is on the northern side of the mine, and the intake air travels from the 7 Shaft down a westward passageway before joining the airstream supplied by the 5 Shaft in the center of the mine. With the 7 Shaft fan turned off, the airflow in the northern section of the mine is reversed, and the air supplied by the 5 Shaft flows into the northern section and exhausts through the 7 Shaft. In the event Westvaco experienced a fire in the norther section of the mine, by turning off the 7 Shaft fan, the change in air pressure would force the smoke and toxic gases to travel towards and exit the mine through the 7 Shaft. At the same time, fresh air from the 5 Shaft main fan would fill the northern section passageways, would provide the miners with good air as they progressed to the 8 Shaft primary hoist or the 5 Shaft escape route, and would enhance the safety of the evacuation in
4. Overall results of engineering upgrades and Westvaco conditions. Based on the empirical data gathered from Tronox' testing, the upgrades permit the reversal of the direction of the airflow underground in all sections of the mine within two minutes. This performance demonstration, when used in accordance with the Westvaco Emergency Control Plan, readily complies with subsection (a)(2) of the standard, and provides equivalent or improved protection as compared to subsection (a)(1) of the standard, while preventing a potential diminution of safety from other compliance methods.
Control doors in an underground mine are intended to constrain or restrict airflow and ventilation in an attempt to isolate fire, smoke, and toxic gases. By isolating these hazards, control doors (in theory) prevent airflow migrating from the hazardous area to sections of the mine that can expel any hazardous gases or smoke. By isolating various sections of a mine and restricting the ventilation, control doors potentially trap smoke and toxic gases in areas miners may need to travel in order to reach operational hoists and escapeways. However, the ability to mechanically reverse the ventilation airflow in designated sections of the mine, not only draws smoke and toxic gases away from egress points, it provide a source of fresh air into the areas where miners are located.
c. The installation of control doors at Westvaco could result in a diminution of safety by reducing or eliminating ventilation during an evacuation. The purpose of the standard is to “control the spread of fire, smoke and toxic gases.” The first alternative to comply with the Standard envisions the installation of control doors. The second alternative envisions mechanical ventilation reversal, 30 CFR 57.4760(a). The alternatives are mutually exclusive. If Tronox is forced to implement the first alternative, and the installed control doors were actuated in response to an emergency, Westvaco's main fans at the affected intake shafts would be isolated and rendered ineffective. The fans, if left running would be forcing air into closed shafts, and the motors would be forced out of their operating ranges and likely stalled, resulting in a loss of ventilation in passageways adjoining the closed control doors.
Conversely, Tronox' procedures were tested and proven to reverse the airflow in the mine with the shutdown of a main fan. Requiring Tronox to install control doors would restrict this airflow reversal, and would likely increase the accumulation of smoke and toxic gases in areas confined between any control doors that closed in an emergency. A better solution to protect the health and safety of the evacuating miners would affirm that an airflow reversal will draw smoke and toxic gases out of the shaft, rather than accumulating underground where miners are still evacuating.
Moreover, compliance with 30 CFR 57.4760(a)(2), which specifically authorizes airflow reversal, provides a greater or equal level to safety than the use of control doors. By continuing to operate fans at the unaffected intake shafts, Westvaco is maintaining positive pressure, impeding the geological formation from degassing, and reducing the amount of methane in the mine. The airflow reversal provides a superior measure of protection than the alternatives, which would not impede degassing of subsurface methane into the workplace.
1. The alternate solution contemplated by 30 CFR 57.4760(a)(1), control doors, will result in a diminution of safety to miners at Westvaco, as compared to Tronox' installed engineering upgrades that produce air reversal capability for use in a manner consistent with its escape and evacuation plan. If the control doors for all three shafts were actuated in response to an emergency, all three ventilation fans would have to be turned off. Turning off all three fans and having the control doors closed would put Westvaco in a more hazardous situation than utilizing intentional reverse airflow ventilation because: (a) Contaminated air near the fire may not be forced up the designated exhaust shaft needed to provide safety for the miners; and (b) there may be no ventilation source for the miners along the escape routes or in the shafts.
In addition, the standard requires that control doors be constructed so that they can be opened from either side by one person, or be provided with a personnel door that can be opened from either side, 30 CFR 57.4760(a)(1)(vi). Although this requirement for control doors to have a method that allows miners to pass through them to reach the intake shaft makes sense from an entrapment standpoint, the fact that the doors may be opened during an emergency creates the potential for toxic gases to migrate from one side of the door to the other. In addition, opening and closing control doors or personnel doors during an emergency creates the potential for the door to be accidentally opened or left open.
2. Tronox' implementation of mechanical ventilation reversal meets the criteria required by 30 CFR 44.4(a). As demonstrated by Tronox' testing, analysis, and Westvaco's layout, Tronox' ability to remotely reverse fan ventilation enables Tronox to direct, as opposed to simply restrict, the flow of air underground during a fire. Airflow reversal would be used only in emergencies, with the approval of the mine Manager/Disaster Director or his/her designee. In the event of an emergency, the Disaster Director will continually assess the location of the miners and the location of the fire and/or smoke source, and the 8, 5, and 7 Shafts will be maintained as air intake shafts to provide fresh air underground. In the event that the Disaster Director determines that air reversal via the shutdown of airflow from one of these intake shafts is necessary to control the spread of fire, smoke, or toxic gases, and will not adversely affect the evacuation, the Disaster Director will coordinate with the Ventilation Coordinator the shutdown of a main fan to reverse the airflow in the desired area. The Safety Coordinator, pursuant to Westvaco' Emergency Control Plan, will inform MSHA of the airflow reversal.
For example, the Disaster Director would order the fan at the 8 Shaft to be turned off in the event there is a fire or smoke in the southern section of the mine, and miners are to the north of the fire or smoke source. If the Disaster Director determines that the drop in air pressure would force smoke and toxic gases to travel toward Shaft No. 8, and allow fresh air to flow from the 7 Shaft and 5 Shaft, the Disaster Director would direct the Ventilation Coordinator to shut down the 8 Shaft's main fan. During this reversal of airflow, the air in the east, and south passageways emanating from the 8 Shaft would now exhaust through the 8 Shaft as the miners underground continued to execute their trained response—to evacuate in fresh air by a secondary escape route.
In contrast to control doors, which merely segregate the intake shafts and mine passageways into isolated or unventilated zones and can be accidently closed or left open. Tronox' use of mechanical ventilation reversal can provide beneficial affects to the entire mine. The ventilation reversal can draw air, smoke, and toxic gases near the fire away from the remainder of the mine on a continual basis as the miners egress.
Ventilation reversal allows miners to arrive at each shaft station without having to stop to open a control/personnel door and then close it behind them. Moreover, the positive effects of the ventilation reversal are preserved as the miners reach the shaft stations. In
Notwithstanding the fact that Tronox' use of mechanical ventilation reversal is entirely consistent with 30 CFR 57.4760(a), Tronox recognizes that the benefits of this engineering solution will be maximized with additional training for its miners. If this petition is approved, Tronox proposes to provide additional training, beyond its current Part 48 training, that will instruct miners and supervisors on the ventilation reversal capability upgrades and the condition and procedures for their use during emergencies.
Tronox continues to maintain that its engineering upgrades at Westvaco, along with its evacuation and escape plans, comply with the standard, 30 CFR 57.4760(a)(2), and the citations should be terminated. Nevertheless, in the alternative to the extent MSHA contends that control doors or other abatement means are required, Tronox respectfully requests MSHA grant this petition for modification of the standard. For the reasons discussed above, permitting Tronox to mechanically reverse the ventilation, in conjunction with the proposed additional training measures, provides equal or greater protection to the miners than installing control doors that will constrict airflow underground. In addition, the imposition of 30 CFR 57.4760(a)(1) at Westvaco, as applied by MSHA, as opposed to the application of 30 CFR 57.4760(a)(2) as described herein, will result in a diminution of safety to the miners at Westvaco.
The petitioner asserts that application of the existing standard will result in a diminution of safety to the miners and that the proposed alternative method will at all times guarantee no less than the same measure of protection afforded by the existing standard.
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A). This program helps to assure 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, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Fire Protection (Underground Coal Mines).
All comments must be received on or before January 4, 2016.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below.
•
•
•
Sheila McConnell, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Fire protection standards for underground coal mines are based on section 311(a) of the Federal Mine Safety and Health Act of 1977 (Mine Act).
30 CFR 75.1100 requires that each coal mine be provided with suitable firefighting equipment adapted for the size and conditions of the mine, and that the Secretary of Labor shall establish minimum requirements of the type, quality, and quantity of such equipment.
30 CFR 75.1100-3 requires that chemical fire extinguishers be examined every 6 months and that the date of the examination be recorded on a permanent tag attached to the extinguisher.
30 CFR 75.1103-5(a)(2)(ii) requires that a map or schematic be updated within 24 hours of any change in the locations of automatic fire warning sensors and the intended air flow direction at these locations. This map or schematic would be kept at a manned surface location where personnel have an assigned post of duty.
30 CFR 75.1103-8(a) requires that a qualified person examine the automatic fire sensor and warning device systems on a weekly basis and conduct a functional test of the complete system at least once every seven days.
Section 75.1103-8(b) requires that a record of the weekly automatic fire sensor functional tests be maintained by the mine operator and kept for a period of one year.
30 CFR 75.1103-8(c) requires that sensors be calibrated in accordance with the manufacturer's calibration instructions at intervals not to exceed 31 days. Records of the sensor calibrations must be maintained by the operator and kept for a period of one year.
30 CFR 75.1103-11 requires that each fire hydrant and hose be tested at least once a year and the records of those tests be maintained at an appropriate location.
30 CFR 75.1501(a)(3) requires the operator to certify that each responsible person is trained and that the certification is maintained at the mine for at least one year.
30 CFR 75.1502 requires each mine operator to adopt and follow a mine evacuation and firefighting program of instruction that addresses all mine emergencies created as a result of a fire, an explosion, or a gas or water inundation. In addition, this section requires mine operators to submit this program of instruction, and any revisions, to MSHA for its approval and to train miners regarding the use of the program of instruction, and any revisions to such program of instruction, after it is approved by MSHA.
MSHA is soliciting comments concerning the proposed information collection related to Fire Protection (Underground Coal Mines). MSHA is particularly interested in comments that:
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the
• Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to 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,
The information collection request will be available on
The public may also examine publicly available documents at USDOL-Mine Safety and Health Administration, 201 12th South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.
Questions about the information collection requirements may be directed to the person listed in the
This request for collection of information contains provisions for Fire Protection (Underground Coal Mines). MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Mine Safety and Health Administration, Labor.
Notice.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations Part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.
All comments on the petitions must be received by the MSHA's Office of Standards, Regulations, and Variances on or before December 2, 2015.
You may submit your comments, identified by “docket number” on the subject line, by any of the following methods:
1.
2.
3.
MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments.
Barbara Barron, Office of Standards, Regulations, and Variances at 202-693-9447 (Voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.
(1) Nonpermissible electronic surveying equipment will only be used until equivalent permissible electronic surveying equipment is available or if viable new mechanical surveying equipment is not commercially available.
(2) Lila Canyon will maintain a logbook for electronic surveying equipment. The logbook will be kept with each corresponding instrument. The logbook will contain the date of manufacture and/or purchase of each particular piece of electronic surveying equipment. The logbook will be made available to MSHA on request.
(3) All nonpermissible electronic surveying equipment to be used in or inby the last open crosscut will be examined by the person that will operate the equipment prior to taking
(i) Checking the instrument for any physical damage and the integrity of the case.
(ii) Removing the battery and inspecting for corrosion.
(iii) Inspecting the contact points to ensure a secure connection to the battery.
(iv) Reinserting the battery and powering up and shutting down to ensure proper connections.
(v) Checking the battery compartment cover or battery attachment to ensure that it is securely fastened.
(4) Recording the results of the inspection in the equipment logbook.
(5) The equipment will be examined at least weekly by a qualified person as defined in 30 CFR 75.153. The examination results will be recorded weekly in the equipment logbook. Inspection entries in the logbook may be expunged after one year.
(6) All nonpermissible electronic surveying equipment will be serviced according to the manufacturer's recommendations. Dates of service will be recorded in the equipment logbook and will include a description of the work performed.
(7) The nonpermissible surveying equipment that will be used in or inby the last open crosscut will not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance.
(8) Nonpermissible surveying equipment will not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more methane is detected while the nonpermissible surveying equipment is being used, the equipment will be deenergized immediately and withdrawn outby the last open crosscut. Prior to returning inby the last open crosscut, all requirements of 30 CFR 75.323 will be complied with.
(9) As an additional safety check, prior to setting up and energizing nonpermissible electronic surveying equipment in or inby the last open crosscut, the surveyor(s) will conduct a visual examination of the immediate area for evidence that the areas appear to be sufficiently rock dusted and for the presence of accumulated float coal dust. If the rock dusting appears insufficient or the presence of accumulated coal dust is observed, the equipment may not be energized until sufficient rock dust has been applied and/or the accumulations of coal dust have been cleaned up. If nonpermissible electronic surveying equipment is to be used in an area that is not rocked dusted within 40 feet of a working face where a continuous miner is used to extract coal, the area will be rock dusted prior to energizing the electronic surveying equipment.
(10) All hand-held methane detectors will be MSHA approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors must provide visual and audible warnings when methane is detected at or above 1.0 percent.
(11) Prior to energizing any of the nonpermissible surveying equipment in or inby the last open crosscut, methane tests must be made no more than eight inches from the roof or floor at the location of the equipment.
(12) All areas to be surveyed will be pre-shifted according to 30 CFR 75.360 prior to surveying. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 will be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, an additional examination is not required.
(13) A qualified person as defined in existing 30 CFR 75.151 will continuously monitor for methane immediately before and during the use of nonpermissible surveying equipment inby the last open crosscut. A second person in the surveying crew, if there are two people in the crew, will also continuously monitor for methane. That person will either be a qualified person as defined in 30 CFR 75.151 or will be in the process of being trained to be a qualified person but will not make such tests for a period of 6 months, as required by 30 CFR 75.151. On completion of the 6-month training period, the second person on the survey crew must become qualified in order to continue on the survey crew. If the surveying crew consists of one person, such person will monitor for methane with two separate devices. While the equipment is used in or inby the last open crosscut, one qualified person who is continuously monitoring for methane will remain with the electronic surveying equipment.
(14) Batteries contained in the surveying equipment must be “changed out” or “charged” in intake air outby the last open crosscut. Replacement batteries for the electronic surveying equipment will not be brought in or inby the last open crosscut. On each entry into the mine, all batteries for the electronic surveying equipment must be fully charged.
(15) When using nonpermissible electronic surveying equipment inby the last open crosscut the surveyor must confirm by measurement or by inquiry of the person in charge of the section that the air quantity on the section, on that shift, in the last open crosscut or coming to the longwall face is the quantity that is required by the mine's ventilation plan.
(16) Nonpermissible electronic surveying equipment will not be used when coal production is occurring in the section. All mining in the section will cease prior to use of the equipment in or inby the last open crosscut.
(17) Personnel engaged in the use of surveying equipment will be properly trained to recognize the hazards and limitations associated with the use of surveying equipment in areas where methane could be present.
(18) All persons who operate nonpermissible electronic surveying equipment will receive specific training on the terms and conditions of the proposed decision and order before using nonpermissible electronic surveying equipment in or inby the last open crosscut. A record of the training will be kept with the other training records.
(19) Within 60 days after the Proposed Decision and Order (PDO) becomes final, the petitioner will submit proposed revisions for their approved part 48 training plan to the District Manager. The revisions will specify initial and refresher training regarding the terms and conditions in the PDO. When training is conducted on the terms and conditions stated in the PDO, an MSHA Certificate of Training (Form 5000-23) will be completed. Comments on the certificate of training will indicate surveyor training.
(20) Lila Canyon will replace or retire from service any electronic surveying instrument that was acquired prior to December 31, 2001, within one year of the PDO becoming final. Lila Canyon will replace or retire from service any electronic surveying instrument that was acquired between January 1, 2002 and December 31, 2007; and within two years of the PDO becoming final. Within three years of the date that the PDO becomes final, Lila Canyon will replace or retire from service any electric theodolite that was acquired more than five years prior to the date that the PDO becomes final, or any total station acquired more than ten years prior to the day that the PDO becomes final. After five years, Lila Canyon will maintain a cycle of purchasing new electronic surveying equipment whereby theodolites will be no older than five years from date of manufacture and total stations will be no older than 10 years from date of manufacture.
(21) Lila Canyon is responsible for seeing that all surveying contractors hired by Lila Canyon are using relatively new electronic equipment,
The petitioner asserts that application of the existing standard will result in a diminution of safety to the miners and that the proposed alternative method will at all times guarantee no less than the same measure of protection afforded by the existing standard.
(1) Nonpermissible electronic surveying equipment will only be used until equivalent permissible electronic surveying equipment is available or if viable new mechanical surveying equipment is not commercially available.
(2) Lila Canyon will maintain a logbook for electronic surveying equipment. The logbook will be kept with each corresponding instrument. The logbook will contain the date of manufacture and/or purchase of each particular piece of electronic surveying equipment. The logbook will be made available to MSHA on request.
(3) All nonpermissible electronic surveying equipment to be used in the return will be examined by the person that will operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These checks will include:
(i) Checking the instrument for any physical damage and the integrity of the case.
(ii) Removing the battery and inspecting for corrosion.
(iii) Inspecting the contact points to ensure a secure connection to the battery.
(iv) Reinserting the battery and powering up and shutting down to ensure proper connections.
(v) Checking the battery compartment cover or battery attachment to ensure that it is securely fastened.
(4) Recording the results of the examination in the equipment logbook.
(5) The equipment will be examined at least weekly by a qualified person as defined in 30 CFR 75.153. The examination results will be recorded weekly in the equipment logbook. Inspection entries in the logbook may be expunged after one year.
(6) All nonpermissible electronic surveying equipment will be serviced according to the manufacturer's recommendations. Dates of service will be recorded in the equipment logbook and will include a description of the work performed.
(7) The nonpermissible surveying equipment that will be used in the return will not be put into service until MSHA has inspected the equipment and determined that it is in compliance.
(8) Non permissible surveying equipment will not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more methane is detected while the nonpermissible surveying equipment is being used, the equipment will be deenergized immediately and withdrawn out of the return. Prior to returning into the return, all requirements of 30 CFR 75.323 will be complied with.
(9) As an additional safety check, prior to setting up and energizing nonpermissible electronic surveying equipment in the return, the surveyor(s) will conduct a visual examination of the immediate area for evidence that the areas appear to be sufficiently rock dusted and for the presence of accumulated float coal dust. If the rock dusting appears insufficient or the presence of accumulated coal dust is observed, the equipment may not be energized until sufficient rock dust has been applied and/or the accumulations of coal dust have been cleaned up. If nonpermissible electronic surveying equipment is to be used in an area that is not rock dusted within 40 feet of a working face where a continuous miner is used to extract coal, the area will be rock dusted prior to energizing the electronic surveying equipment.
(10) All hand-held methane detectors will be MSHA approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors must provide visual and audible warnings when methane is detected at or above 1.0 percent.
(11) Prior to energizing any of the nonpermissible surveying equipment in the return, methane tests must be made no more than eight inches from the roof or floor at the location of the equipment.
(12) All areas to be surveyed will be pre-shifted according to 30 CFR 75.360 prior to surveying. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 will be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, an additional examination is not required.
(13) A qualified person as defined in existing 30 CFR 75.151 will continuously monitor for methane immediately before and during the use of nonpermissible surveying equipment in the return. A second person in the surveying crew, if there are two people in the crew, will also continuously monitor for methane. That person will either be a qualified person as defined in 30 CFR 75.151 or will be in the process of being trained to be a qualified person but will not make such tests for a period of 6 months, as required by 30 CFR 75.151. Upon completion of the 6 month training period the second person on the survey crew must become qualified to continue on the survey crew. If the surveying crew consists of one person, such person will monitor for methane with two separate devices. While the equipment is in the return, one qualified person who is continuously monitoring for methane will remain with the electronic surveying equipment.
(14) Batteries contained in the surveying equipment must be “changed out” or “charged” in intake air, out of the return. Replacement batteries for the electronic surveying equipment will not be brought into the return. On each entry into the mine, all batteries for the electronic surveying equipment must be fully charged.
(15) When using nonpermissible electronic surveying equipment in the return, the surveyor must confirm by measurement or by inquiry of the person in charge of the section that the air quantity on the section, on that shift, in the last open crosscut or coming to
(16) Nonpermissible electronic surveying equipment will not be used when coal production is occurring in the section. All mining in the section will cease prior to use of the equipment in the return.
(17) Personnel engaged in the use of surveying equipment will be properly trained to recognize the hazards and limitations associated with the use of surveying equipment in areas where methane could be present.
(18) All persons who operate nonpermissible electronic surveying equipment will receive specific training on the terms and conditions of the proposed decision and order before using nonpermissible electronic surveying equipment in the return. A record of the training will be kept with the other training records.
(19) Within 60 days after the Proposed Decision and Order (PDO) becomes final, the petitioner will submit proposed revisions for their approved part 48 training plan to the District Manager. The revisions will specify initial and refresher training regarding the terms and conditions in the PDO. When training is conducted on the terms and conditions stated in the PDO, an MSHA Certificate of Training (Form 5000-23) will be completed. Comments on the certificate of training will indicate surveyor training.
(20) Lila Canyon will replace or retire from service any electronic surveying instrument that was acquired prior to December 31, 2001; within one year of the PDO becoming final. Lila Canyon will replace or retire from service any electronic surveying instrument that was acquired between January 1, 2002 and December 31, 2007; and within two years of the PDO becoming final. Within three years of the date that the PDO becomes final, Lila Canyon will replace or retire from service any electric theodolite that was acquired more than five years prior to the date that the PDO becomes final, or any total station acquired more than ten years prior to the day that the PDO becomes final. After five years, Lila Canyon will maintain a cycle of purchasing new electronic surveying equipment whereby theodolites will be no older than five years from date of manufacture and total stations will be no older than 10 years from date of manufacture.
(21) Lila Canyon is responsible for seeing that all surveying contractors hired by Lila Canyon are using relatively new electronic equipment,
The petitioner asserts that application of the existing standard will result in a diminution of safety to the miners and that the proposed alternative method will at all times guarantee no less than the same measure of protection afforded by the existing standard.
(1) Nonpermissible electronic surveying equipment will only be used until equivalent permissible electronic surveying equipment is available or if viable new mechanical surveying equipment is not commercially available.
(2) Lila Canyon will maintain a logbook for electronic surveying equipment. The logbook will be kept with each corresponding instrument. The logbook will contain the date of manufacture and/or purchase of each particular piece of electronic surveying equipment. The logbook will be made available to MSHA on request.
(3) All nonpermissible electronic surveying equipment to be used within 150 feet of pillar workings or longwall face will be examined by the person that will operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These checks will include:
(i) Checking the instrument for any physical damage and the integrity of the case.
(ii) Removing the battery and inspecting for corrosion.
(iii) Inspecting the contact points to ensure a secure connection to the battery.
(iv) Reinserting the battery and powering up and shutting down to ensure proper connections.
(v) Checking the battery compartment cover or battery attachment to ensure that it is securely fastened.
(4) Recording the results of the inspection in the equipment logbook.
(5) The equipment will be examined at least weekly by a qualified person as defined in 30 CFR 75.153. The examination results will be recorded weekly in the equipment logbook. Inspection entries in the logbook may be expunged after one year.
(6) All nonpermissible electronic surveying equipment will be serviced according to the manufacturer's recommendations. Dates of service will be recorded in the equipment logbook and will include a description of the work performed.
(7) The nonpermissible surveying equipment that will be used within 150 feet of pillar workings or the longwall face will not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance.
(8) Nonpermissible surveying equipment will not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more methane is detected while the nonpermissible surveying equipment is being used, the equipment will be deenergized immediately and withdrawn further than 150 feet from pillar workings or longwall faces. Prior to returning within 150 feet from pillar workings or longwall faces, all requirements of 30 CFR 75.323 will be complied with.
(9) As an additional safety check, prior to setting up and energizing nonpermissible electronic surveying equipment within 150 feet of pillar workings, the surveyor(s) will conduct a visual examination of the immediate area for evidence that the areas appear to be sufficiently rock dusted and for the presence of accumulated float coal dust. If the rock dusting appears insufficient or the presence of accumulated coal dust is observed, the equipment may not be energized until sufficient rock dust has been applied and/or the accumulations of coal dust have been cleaned up. If nonpermissible electronic surveying equipment is to be used in an area that is not rock dusted within 40 feet of a working face where a continuous miner is used to extract coal, the area will be rock ducted prior to
(10) All hand-held methane detectors will be MSHA approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors must provide visual and audible warnings when methane is detected at or above 1.0 percent.
(11) Prior to energizing any of the nonpermissible surveying equipment within 150 feet of pillar workings or longwall faces, methane tests must be made no more than eight inches from the roof or floor at the location of the equipment.
(12) All areas to be surveyed will be pre-shifted according to 30 CFR 75.360 prior to surveying. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 will be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, an additional examination is not required.
(13) A qualified person as defined in existing 30 CFR 75.151 will continuously monitor for methane immediately before and during the use of nonpermissible surveying equipment within 150 feet of pillar workings or longwall faces. A second person in the surveying crew, if there are two people in the crew, will also continuously monitor for methane. That person will either be a qualified person as defined in 30 CFR 75.151 or will be in the process of being trained to be a qualified person but will not make such tests for a period of 6 months, as required by 30 CFR 75.151. On completion of the 6 month training period the second person on the survey crew must become qualified to continue on the survey crew. If the surveying crew consists of one person, such person will monitor for methane with two separate devices. While the equipment is used within 150 feet of pillar workings or longwall faces, one qualified person who is continuously monitoring for methane will remain with the electronic surveying equipment.
(14) Batteries contained in the surveying equipment must be “changed out” or “charged” more than 150 feet away from pillar workings or the longwall face. Replacement batteries for the electronic surveying equipment will not be brought in or inby the last open crosscut, into the return, or within 150 feet of pillar workings or longwall faces. On each entry into the mine, all batteries for the electronic surveying equipment must be fully charged.
(15) When using nonpermissible electronic surveying equipment within 150 feet of pillar workings or the longwall face, the surveyor must confirm by measurement or by inquiry of the person in charge of the section that the air quantity on the section, on that shift, in the last open crosscut or coming to the longwall face is the quantity that is required by the mine's ventilation plan.
(16) Nonpermissible electronic surveying equipment will not be used when coal production is occurring in the section. All mining in the section will cease prior to use of the equipment within 150 feet of pillar workings and longwall faces.
(17) Personnel engaged in the use of surveying equipment will be properly trained to recognize the hazards and limitations associated with the use of surveying equipment in areas where methane could be present.
(18) All persons who operate nonpermissible electronic surveying equipment will receive specific training on the terms and conditions of the proposed decision and order before using nonpermissible electronic surveying equipment within 150 feet of the longwall face or pillar workings. A record of the training will be kept with the other training records.
(19) Within 60 days after the Proposed Decision and Order (PDO) becomes final, the petitioner will submit proposed revisions for their approved part 48 training plan to the District Manager. The revisions will specify initial and refresher training regarding the terms and conditions in the PDO. When training is conducted on the terms and conditions stated in the PDO, an MSHA Certificate of Training (Form 5000-23) will be completed. Comments on the certificate of training will indicate surveyor training.
(20) Lila Canyon will replace or retire from service any electronic surveying instrument that was acquired prior to December 31, 2001; within one year of the PDO becoming final. Lila Canyon will replace or retire from service any electronic surveying instrument that was acquired between January 1, 2002 and December 31, 2007; and within two years of the PDO becoming final. Within three years of the date that the PDO becomes final, Lila Canyon will replace or retire from service any electric theodolite that was acquired more than five years prior to the date that the PDO becomes final, or any total station acquired more than ten years prior to the day that the PDO becomes final. After five years, Lila Canyon will maintain a cycle of purchasing new electronic surveying equipment whereby theodolites will be no older than five years from date of manufacture and total stations will be no older than 10 years from date of manufacture.
(21) Lila Canyon is responsible for seeing that all surveying contractors hired by Lila Canyon are using relatively new electronic equipment,
The petitioner asserts that application of the existing standard will result in a diminution of safety to the miners and that the proposed alternative method will at all times guarantee no less than the same measure of protection afforded by the existing standard.
Occupational Safety and Health Administration (OSHA), Department of Labor
Notice of public meeting.
This notice is to advise interested persons that on Thursday, November 12, 2015, OSHA will conduct a public meeting to discuss proposals in preparation for the 30th session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS) to be held December 9 to December 11, 2015 in Geneva, Switzerland. OSHA, along with the U.S. Interagency GHS (Globally Harmonized System of Classification and Labelling of Chemicals) Coordinating Group, plans to consider the comments and information gathered at this public meeting when developing the U.S. Government positions for the
Also, on Thursday, November 12, 2015, the Department of Transportation (DOT), Pipeline and Hazardous Materials Safety Administration (PHMSA) will conduct a public meeting (See Docket No. PHMSA-2015-0188, Notice No. 15-19) to discuss proposals in preparation for the 48th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCOE TDG) to be held November 30 to December 9, 2015, in Geneva, Switzerland. During this meeting, PHMSA is also requesting comments relative to potential new work items that may be considered for inclusion in its international agenda. PHMSA will also provide an update on recent actions to enhance transparency and stakeholder interaction through improvements to the international standards portion of its Web site.
Thursday November 12, 2015
Both meetings will be held at the DOT Headquarters Conference Center, West Building, 1200 New Jersey Avenue SE., Washington, DC 20590.
OSHA public meeting: 1:00 p.m. to 2:30p.m. EDT, Conference Rooms 8-10.
RCC public meeting: 3:00 p.m. to 4:30 p.m. EDT, Conference Rooms 8-10.
Attendees may use the same form to pre-register for both the PHMSA and the OSHA meetings. Failure to pre-register may delay your access into the DOT Headquarters building. Additionally, if you are attending in-person, arrive early to allow time for security checks necessary to access the building.
Conference call-in and “live meeting” capability will be provided for both meetings.
The number is reserved and the Live Meeting link is setup for all day.
Toll Free: 888-675-2535
Access code: 3614708
International Toll: 215-446-0145
Access: 3614708
Attendee URL:
For information about the PHMSA Meeting at 9:00 a.m.: Mr. Steven Webb or Mr. Aaron Wiener, Office of Hazardous Materials Safety, Department of Transportation, Washington, DC 20590: Telephone: (202) 366-8553.
For information about the OSHA Meeting at 1:00 p.m. and the RCC Meeting at 3:00 p.m.: Ms. Maureen Ruskin, Office of Chemical Hazards-Metals, OSHA Directorate of Standards and Guidance, Department of Labor, Washington, DC 20210: Telephone: (202) 693-1950, email:
General topics on the agenda include:
• Review of Working papers
• Correspondence Group updates
• Regulatory Cooperation Council (RCC) Update
Information on the work of the UNSCEGHS including meeting agendas, reports, and documents from previous sessions, can be found on the United Nations Economic Commission for Europe (UNECE) Transport Division Web site located at the following web address:
Informal Papers submitted to the UNSCEGHS provide information for the Sub-committee and are used either as a mechanism to provide information to the Sub-committee or as the basis for future Working Papers. Informal Papers for the 30th session of the UNSCEGHS are located at:
The primary purpose of PHMSA's meeting will be to prepare for the 47th session of the UNSCE TDG. The 48th session of the UNSCE TDG is the first of four meetings scheduled for the 2015-2016 biennium. The UNSCE will consider proposals for the 20th Revised Edition of the United Nations Recommendations on the Transport of Dangerous Goods Model Regulations, which may be implemented into relevant domestic, regional, and international regulations from January 1, 2019. Copies of working documents, informal documents, and the meeting agenda may be obtained from the United Nations Transport Division's Web site at
Copyright Royalty Board, Library of Congress.
Notice soliciting comments on motion for partial distribution.
The Copyright Royalty Judges solicit comments on a motion for partial distribution in connection with 2014 DART Sound Recordings Fund royalties.
Comments are due on or before December 2, 2015.
This Notice is also posted on the agency's Web site (
LaKeshia Keys, Program Specialist, by telephone at (202) 707-7658 or email at
On July 23, 2015, the Alliance of Artists and Recording Companies (AARC), on behalf of itself and claimants with which it has reached settlements (Settling Claimants) filed with the Copyright Royalty Judges (Judges) a Notice of Settlement and Request for Partial Distribution of the 2014 DART Sound Recordings Fund Featured Recording Artists and Copyright Owners Subfunds Royalties (Notice and Request). In the Notice and Request, AARC states that the Settling Claimants have agreed among themselves concerning distribution of the 2014 DART Sound Recordings Fund royalties from two subfunds: Copyright Owners and Featured Recording Artists.
With respect to the Featured Recording Artists Subfund, AARC represents that it has reached settlements with all but one claimant (Herman Kelly) for that subfund and that the nonsettling claimant has unit sales totaling 1,287 in a universe of over one billion claimants' sound recordings sold in 2014. Notice and Request at 2.
With respect to the Copyright Owners Subfund, AARC represents that it had reached settlements with all but four claimants (Dr. Dwight Sanders, Eric Burns, Tajai Music, Inc., and Afterschool Publishing Company (APC), which is affiliated with Herman Kelly). The Judges have since dismissed the claims of Dr. Sanders and Mr. Burns. Order Dismissing Claims of Burns and Sanders (Sept. 11, 2015). AARC represents that the nonsettling parties have combined record sales of 794,469 units in a universe of nearly one billion record sales for 2014. Notice and Request at 2.
AARC requests a partial distribution of 98% from the Copyright Owners Subfund and an equal percentage from the Featured Recording Artists Subfund pursuant to Section 801(b)(3)(C) of the Copyright Act. Under that section of the Copyright Act, before ruling on a partial distribution motion the Judges must publish a notice in the
Interested claimants must submit comments to only one of the following addresses. Unless responding by email or online, claimants must submit an original, five paper copies, and an electronic version on a CD.
National Endowment for the Arts, National Foundation on the Arts and Humanities.
Notice of meeting.
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, notice is hereby given that the 71st meeting of the President's Committee on the Arts and the Humanities (PCAH) will tentatively be held in the Monument Room, Occidental Grill & Seafood, 1475 Pennsylvania Avenue NW., Washington, DC 20004. Ending time is approximate.
November 17, 2015 from 10:00 a.m. to 12:30 p.m.
Lindsey Clark of the President's Committee at (202) 682-5409 or
The meeting, on Wednesday, November 17th, will begin with welcome, overview of the agenda, and acknowledgement of new members. This will be followed by reports on Committee Programs (Film Forward, National Student Poets Program, NEH/Spoken Word Ambassador program, Turnaround Arts, and Financial forecasting/program sustainability) and Plans for 2016—Member Survey and Proposals (Review of survey data and main points, plans for 2016 activities). Remarks from the Executive Director will follow. There also will be reports from the President's Committee partners—the Institute of Museum and Library Services (IMLS), National Endowment for the Arts (NEA), and National Endowment for the Humanities (NEH), as well as other Partner updates. The meeting will adjourn after closing remarks.
The President's Committee on the Arts and the Humanities was created by Executive Order in 1982, which currently states that the “Committee shall advise, provide recommendations to, and assist the President, the National Endowment for the Arts, the National Endowment for the Humanities, and the Institute of Museum and Library Services on matters relating to the arts and the humanities.”
Any interested persons may attend as observers, on a space available basis, but seating is limited. Therefore, for this meeting, individuals wishing to attend are advised to contact Lindsey Clark of
If you need special accommodations due to a disability, please contact the Office of AccessAbility, National Endowment for the Arts, Constitution Center, 400 7th St. SW., Washington, DC 20506, (202) 682-5532, TDY-TDD (202) 682-5496, at least seven (7) days prior to the meeting.
National Transportation Safety Board.
Notice.
Notice is hereby given of the appointment of members of the National Transportation Safety Board, Performance Review Board (PRB).
Emily T. Carroll, Chief, Human Resources Division, Office of Administration, National Transportation Safety Board, 490 L'Enfant Plaza SW., Washington, DC 20594-0001, (202)314-6233.
Section 4314(c)(1) through (5) of Title 5, United States Code requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more SES Performance Review Boards. The board reviews and evaluates the initial appraisal of a senior executive's performance by the supervisor and considers recommendations to the appointing authority regarding the performance of the senior executive.
The following have been designated as members of the Performance Review Board of the National Transportation Safety Board:
Nuclear Regulatory Commission.
Construction permit application; notice of hearing.
The U.S. Nuclear Regulatory Commission (NRC or the Commission) will convene an evidentiary session to receive testimony and exhibits in the uncontested proceeding regarding the application from SHINE Medical Technologies, Inc. (SHINE), for a construction permit (CP) to construct a medical radioisotope production facility in Janesville, Wisconsin. This mandatory hearing will consider safety and environmental matters relating to the requested CP.
The hearing will be held on December 15, 2015, beginning at 9:00 a.m. Eastern Time. For the schedule for submitting pre-filed documents and deadlines affecting Interested Government Participants, see Section VI of the
Please refer to Docket ID 50-608 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:
•
•
•
Denise McGovern, Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-0681; email:
The Commission hereby gives notice that, pursuant to Section 189a of the Atomic Energy Act (AEA) of 1954, as amended (the Act), it will convene an evidentiary session to receive testimony and exhibits in the proceeding regarding the SHINE application for a CP under part 50 of title 10 of the
Part one of the SHINE's CP application was submitted by letter dated March 26, 2013 (ADAMS Accession No. ML13088A192), and by letter dated May 31, 2013 (ADAMS Accession No. ML13172A361), SHINE submitted the second and final part of its two-part application for a CP. By letter dated September 25, 2013 (ADAMS Accession No. ML13269A378), SHINE supplemented this submission with a discussion of preliminary plans for coping with emergencies, as required by 10 CFR 50.34(a)(10), completing its application for a CP. The construction permit application, including the environmental report, may be viewed in its entirety at ADAMS Accession No. ML13172A324. This mandatory hearing will concern safety and environmental matters relating to the requested CP application, as more fully described below.
The Commission will conduct this hearing beginning at 9:00 a.m., Eastern Time on December 15, 2015, at the Commission's headquarters in Rockville, Maryland. The hearing will continue on subsequent days, if necessary.
The Commission is the presiding officer for this proceeding.
The matter at issue in this proceeding is whether the review of the SHINE CP application by the Commission's staff has been adequate to support the findings found in 10 CFR 50.35, 50.40, 50.50, and 10 CFR 51.105. Those findings are as follows:
With respect to the CP: (1) Whether the applicant has described the proposed design of the facility, including, but not limited to, the principal architectural and engineering criteria for the design, and has identified the major features or components incorporated therein for the protection of the health and safety of the public; (2) whether such further technical or design information as may be required to complete the safety analysis, and which can reasonably be left for later consideration, will be supplied in the final safety analysis report (3) whether safety features or components, if any, which require research and development have been described by the applicant and the applicant has identified, and there will be conducted, a research and development program reasonably designed to resolve any safety questions associated with such features or components; (4) whether on the basis of the foregoing, there is reasonable assurance that, (i) such safety questions will be satisfactorily resolved at or before the latest date stated in the application for completion of construction of the proposed facility and (ii) taking into consideration the site criteria contained in 10 CFR part 100, the proposed facility can be constructed and operated at the proposed location without undue risk to the health and safety of the public; (5) whether there is reasonable assurance (i) that the construction of the facility will not endanger the health and safety of the public, and (ii) that construction activities can be conducted in compliance with the Commission's regulations; (6) whether the applicant is technically and financially qualified to engage in the proposed activities in accordance with the Commission's regulations in chapter I of title 10 of the CFR; (7) whether the issuance of a permit for the construction of the facility to the applicant will not, in the opinion of the Commission, be inimical to the common defense and security or to the health and safety of the public; and (8) whether the application meets the standards and requirements of the AEA and the Commission's regulations, and that notifications, if any, to other agencies or bodies have been duly made.
With respect to the CP: (1) Determine whether the requirements of Sections 102(2)(A), (C), and (E) of NEPA and the applicable regulations in 10 CFR part 51 have been met; (2) independently consider the final balance among conflicting factors contained in the record of the proceeding with a view to determining the appropriate action to be taken; (3) determine, after weighing the environmental, economic, technical, and other benefits against environmental and other costs, and considering reasonable alternatives, whether the construction permit should be issued, denied, or appropriately conditioned to protect environmental values; and (4) determine whether the NEPA review conducted by the NRC staff has been adequate.
No later than November 24, 2015, unless the Commission directs otherwise, the NRC staff and the applicant shall submit a list of its anticipated witnesses for the hearing.
No later than November 24, 2015, unless the Commission directs otherwise, the applicant shall submit its pre-filed written testimony. The NRC staff submitted its pre-filed testimony on October 23, 2015.
The Commission may issue written questions to the applicant or the NRC staff before the hearing. If such questions are issued, an order containing such questions will be issued no later than November 10, 2015. Responses to such questions are due November 24, 2015, unless the Commission directs otherwise.
No later than November 9, 2015, any interested State, local government body, or Federally-recognized Indian tribe may file with the Commission a statement of any issues or questions that the State, local government body, or Indian tribe wishes the Commission to give particular attention as part of the uncontested hearing process. Such statement may be accompanied by any supporting documentation that the State, local government body, or Indian tribe sees fit to provide. Any statements and supporting documentation (if any) received by the Commission using the agency's E-filing system
Many of the procedures and rights applicable to the inherently adversarial nature of NRC's contested hearing process are not available in this uncontested hearing. Participation in the NRC's contested hearing process is governed by 10 CFR 2.309 (for persons or entities, including a State, local government, or Indian tribe seeking to file contentions of their own) and 10 CFR 2.315(c) (for an interested State, local government, or Federally-recognized Indian tribe seeking to participate with respect to contentions filed by others). Participation in this uncontested hearing does not affect the right of a State, a local government, or an Indian tribe to participate in the separate contested hearing process.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Draft interim staff guidance; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment its draft Interim Staff Guidance (ISG) DSS-ISG-2015-XX, “Clarification of Licensee Actions in Receipt of Enforcement Discretion per Enforcement Guidance Memorandum (EGM) 15-002, ‘Enforcement Discretion for Tornado-generated Missile Protection Noncompliance.’ ” This draft ISG will provide clarifying guidance for NRC staff understanding of expectations for consistent oversight associated with implementing enforcement discretion for tornado missile protection noncompliance per EGM 15-002. This guidance will allow consistent enforcement and regulation of licensees that implement corrective actions outlined in EGM 15-002.
Submit comments by December 2, 2015. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Todd Keene, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1994, email:
Please refer to Docket ID NRC-2015-0231 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2015-0231 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
Following the issuance of EGM 15-002 (ADAMS Accession No, ML15111A269), the NRC staff received internal and external stakeholder comments requesting clarification in complying with NRC expectations for implementing enforcement discretion in accordance with the EGM 15-002, specifically the implementation of compensatory measures and guidance on addressing operability status of equipment once the EGM is implemented. Therefore, the NRC staff has developed draft ISG DSS-ISG-2015-XX, “Clarification of Licensee Actions in Receipt of Enforcement Discretion per Enforcement Guidance Memorandum (EGM) 15-002, `Enforcement Discretion for Tornado-generated Missile Protection Noncompliance,' ” to provide clarification concerning the implementation of EGM 15-002.
The NRC is requesting public comments on the draft ISG to ensure that it provides sufficiently clear guidance to the NRC staff concerning expectations for implementation of EGM 15-002.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-13 and CP2016-15 to consider the Request pertaining to the proposed Priority Mail Contract 152 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than November 4, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Kenneth R. Moeller to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-13 and CP2016-15 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than November 4, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On October 26, 2015, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a redacted copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2016-13 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than November 3, 2015. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2016-13 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than November 3, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 151 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-12 and CP2016-14 to consider the Request pertaining to the proposed Priority Mail Contract 151 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than November 4, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints James F. Callow to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-12 and CP2016-14 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, James F. Callow is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than November 4, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 27, 2015, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service ® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 27, 2015, it filed with the Postal Regulatory Commission a
The RRB invites comments on the proposed collection of information to determine (1) the practical utility of the collection; (2) the accuracy of the estimated burden of the collection; (3) ways to enhance the quality, utility, and clarity of the information that is the subject of collection; and (4) ways to
Under Section 8 of the Railroad Unemployment Insurance Act (RUIA), as amended by the Railroad Unemployment Improvement Act of 1988 (Pub. L. 100-647), the RRB determines the amount of an employer's contribution, primarily on the basis of the RUIA benefits paid, both unemployment and sickness, to the employees of the railroad employer. These experienced-based contributions take into account the frequency, volume, and duration of the employees' unemployment and sickness benefits. Each employer's contribution rate includes a component for administrative expenses as well as a component to cover costs shared by all employers. The regulations prescribing the manner and conditions for remitting the contributions and for adjusting overpayments or underpayments of contributions are contained in 20 CFR 345.
RRB Form DC-1, Employer's Quarterly Report of Contributions under the Railroad Unemployment Insurance Act, is used by railroad employers to report and remit their quarterly contributions to the RRB. Employers can use either the manual version of the form or its Internet equivalent. One response is requested quarterly of each respondent and completion is mandatory.
Comments regarding the information collection should be addressed to Charles Mierzwa, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois, 60611-2092 or
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
CHX proposes to amend CHX Rules to unify procedures for the handling of resting orders in a security subject to a trading halt, pause or suspension on the Exchange. CHX has designated this proposed rule change as non-controversial pursuant to Section 19(b)(3)(A)
In its filing with the Commission, the CHX included statements concerning the purpose of and basis for the proposed rule changes and discussed any comments it received on the
The Exchange proposes to amend CHX Rules to unify procedures for the handling of resting orders in a security subject to a trading halt, pause or suspension on the Exchange.
Currently, upon initiation of
• Stop all trading in the security;
• Cancel all resting orders marked Cancel On Halt, as defined under Article 1, Rule 2(b)(1)(B); and
• Reject all incoming orders; provided valid incoming Sub-second Non-displayed Auction Process Auction Only Orders (“SNAP AOOs”), as defined under Article 1, Rule 2(h)(3),
However, the Exchange handles resting orders in a security subject to a trading halt, pause or suspension on the Exchange differently depending on whether trading is stopped due to a LULD trading pause. In the case of a LULD trading pause, the Exchange will cancel
Upon the initiation of any trading halt, pause or suspension in a security on the Exchange, the Exchange now proposes to cancel all resting orders in the security, while maintaining the current exception for SNAP AOOs not marked Cancel On Halt. To this end, the Exchange proposes various amendments to CHX Rules, as described below.
Initially, as a global amendment, the Exchange proposes to replace certain references throughout CHX Rules to trading halts, suspensions and/or pauses, or some combination thereof, with the more uniform “trading halts, suspensions or pauses.” The Exchange believes that this consistency will promote clarity of CHX Rules. Specifically, the Exchange proposes to make such amendments to Article 1, Rule 2(b)(1)(B); Article 18, Rule 1(b)(3); Article 20, Rule 1(b) and (d);
Current paragraph .02 of Article 20, Rule 1 provides as follows:
If trading in one or more issues is suspended or halted, which requires the Exchange to suspend trading in the issue, other than a LULD Trading Pause, all orders in those issues shall remain in the Matching System unless they are cancelled by the Participant that submitted the order. The Matching System shall not accept any orders, or any changes to orders (other than cancellations), in those issues during a trading suspension or halt, subject to Article 18, Rule 1(c). Immediately after the trading halt or suspension has ended, the Matching System shall begin accepting orders and shall match them as provided in Rule 8(d), below.
The Exchange now proposes to amend paragraph. 02 to contemplate the proposed unification. The Exchange also proposes to clarify that “resting” orders shall be cancelled and that the amended rule applies to trading halts, pauses and suspensions “on the Exchange,” which obviates current language providing that the rule applies to trading halts that require the Exchange to suspend trading in the issue. As such, amended paragraph .02 provides as follows:
If trading in one or more issues is halted, paused or suspended on the Exchange, all resting orders in those issues shall be cancelled from the Matching System, subject to Article 18, Rule 1(c). The Matching System shall not accept any orders in those issues during a trading halt, pause or suspension, subject to Article 18, Rule 1(c). Immediately after the trading halt, pause or suspension has ended, the Matching System shall begin accepting orders and shall match them as provided in Rule 8(d), below.
Current Article 1, Rule 2(b)(1)(B) defines “Cancel On Halt” as follows:
A limit order modifier that requires an order to be automatically cancelled by the Matching System if a trading halt or suspension is declared in that security.
The Exchange now proposes to amend the definition to clarify that orders marked Cancel On Halt will be cancelled if a trading halt, pause or suspension is declared in the security “on the Exchange,” as certain operational halts declared by away markets may not require the Exchange to suspend trading in the security. Moreover, since the Exchange proposes to cancel all resting orders, except for SNAP AOOs, during a trading halt, pause or suspension, the Exchange proposes to adopt additional language that provides that all limit orders, except for SNAP AOOs, as defined under Article 1, Rule 2(h)(3), shall be deemed to have been received Cancel On Halt, which cannot be overridden by an order sender. The Exchange submits that this is appropriate because the current rules require SNAP AOOs to be placed in, or remain on, the SNAP AOO Queue during a trading halt, pause or suspension and, thus, such queued SNAP AOOs would already be inactive and removed from the SNAP CHX book, without the need for cancellations.
“Cancel On Halt”: a limit order modifier that requires an order to be automatically cancelled by the Matching System if a trading halt, pause or suspension is declared in that security by the Exchange.
All limit orders, except for SNAP AOOs, as defined under paragraph (h)(3), shall be deemed to have been received Cancel On Halt, which cannot be overridden by an order sender.
Current Article 18, Rule 1(c)(1) details the actions that would be taken if a trading halt is initiated on the Exchange during a SNAP Cycle.
SNAP CHX book
(A) During stages one or two. If the market snapshot taken pursuant to paragraph (b)(2)(E) or (F) indicates that a material halt, pause or suspension is in effect, the SNAP Cycle shall be aborted and not proceed to stage three or stage five, as applicable. The Exchange shall then cancel all orders resting on the SNAP CHX book, subject to paragraph (c)(2) below.
(B) During stages three or four. If the market snapshot taken pursuant to paragraph (b)(3)(B) or (b)(4)(B) indicates that a material halt, pause or suspension is in effect for the subject security, the SNAP Cycle shall be aborted and not proceed to stage five. The Exchange shall then cancel the unexecuted remainders of all orders resting on the SNAP CHX book, subject to paragraph (c)(2) below.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act
Specifically, the Exchange believes that the proposed unification of the Exchange's procedures regarding resting orders in a security subject to a trading halt, pause or suspension on the Exchange will simplify the Exchange's operational procedures, which will remove impediments to, and perfect the mechanisms of, a free and open market, in furtherance of the objectives of Section 6(b)(5). Moreover, the Exchange believes that the proposed unification and other clarifying amendments, will simplify CHX Rules, which will further enable the Exchange to be so organized as to have the capacity to be able to carry out the purposes of the Act and to comply, and to enforce compliance by its Participants and persons associated with its Participants, with the provisions of the Act, the rules and regulations thereunder, and the rules of the Exchange, in furtherance of the objectives of Section 6(b)(1).
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes that the proposed rule change does not implicate any competitive issues as it is intended to simplify and clarify CHX operational procedures with respect to trading halts, pauses and suspensions.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has requested that the Commission waive the requirement that the rule change, by its terms, not become operative for 30 days after the date of the filing as set forth in Rule 19b-4(f)(6)(iii),
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to delete Rule 410B governing reporting requirements for off-Exchange transactions. The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to delete Rule 410B, which sets forth certain regulatory reporting requirements for member or member organizations effecting off-Exchange transactions in Exchange listed securities that are not reported to the Consolidated Tape, and to make conforming amendments to Rule 9217 to delete a reference to Rule 410B.
Currently, Rule 410B requires members or member organizations to report to the Exchange transactions in NYSE-listed securities effected for the account of a member or member organization, or for the account of a customer of a member or member organization, that are not reported to the Consolidated Tape. Reports prepared pursuant to the Rule must contain the following information:
• Time and date of the transaction;
• stock symbol of the listed security;
• number of shares;
• price;
• marketplace where the transaction was executed;
• an indication whether the transaction was a buy (B), sell (S) or cross (C);
• an indication whether the transaction was executed as principal or agent; and
• the name of the contra-side broker-dealer to the trade.
Rule 410B was adopted in 1992. At the time, transactions in NYSE-listed stocks effected outside of business hours or in foreign markets were not reported to the Consolidated Tape and, with the exception of program trading information, were not reported to the Exchange. The Exchange (then the New York Stock Exchange, Inc.) believed that “all transactions in NYSE-listed stocks that are not reported to the Consolidated Tape should be reported to the Exchange in order to provide an accurate record of overall trading activity in NYSE-listed stocks.”
Despite the significant changes to the marketplace and the regulatory landscape in the ensuing decades, Rule 410B has not been substantively amended since it was adopted.
On July 30, 2007, the NASD, NYSE, and NYSE Regulation, Inc. (“NYSE Regulation”) consolidated their member firm regulation operations to create the Financial Industry Regulatory Authority, Inc. (“FINRA”), and entered into a plan to allocate to FINRA regulatory responsibility for common rules and common members (“17d-2
In 1998, FINRA (then the NASD) established the Order Audit Trail System (OATS), as an integrated audit trail of order, quote, and trade information for OTC equity securities and equity securities listed and traded on The Nasdaq Stock Market, Inc. (“Nasdaq”).
Rule 410B also predates the establishment of a FINRA Trade Reporting Facility (“TRF”). FINRA Rule 6110 requires FINRA members to report transactions in NMS stocks
The Exchange proposes to delete Rule 410B in its entirety. Rule 410B is a regulatory rule intended to enhance audit trail quality and improve surveillance and investigation of violative activities such as market manipulation and insider trading. As noted above, since 2010, surveillance and enforcement responsibilities across markets have been consolidated at FINRA, which conducts cross-market surveillances on the Exchange's behalf utilizing various data sources, including extensive trade and other information that FINRA collects pursuant to its rules. This trade information includes reports of off-exchange transactions. All of the Exchange's member organizations, with only nine exceptions, are members of FINRA and, as such, must report all off-exchange transactions to FINRA, including transactions away from the NYSE that are not reported to the Consolidated Tape. This information is essentially duplicative of the Rule 410B reports the Exchange currently supplies to FINRA. The one exception would be transactions in dually listed securities executed on and reported to a foreign securities exchange, which is not required to be reported because such trades are executed “on or through an exchange.”
The Exchange does not believe that eliminating the Rule 410B reporting requirement for the small number of NYSE-only members
For the foregoing reasons, the Exchange believes that Rule 410B should be deleted in its entirety.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
In particular, the Exchange believes that eliminating Rule 410B would remove impediments to and perfect the mechanism of a free and open market and a national market system by eliminating duplicative reporting by Dual Members of information those firms already provide to FINRA. The Exchange believes that eliminating Rule 410B reporting would not be inconsistent with the public interest and the protection of investors because FINRA would continue to receive information from Dual Members about off-Exchange transactions for incorporation in its cross-market surveillances. Further, the Exchange believes that eliminating Rule 410B reporting would not be inconsistent with the public interest and the protection of investors because the small number of NYSE-only firms that would no longer be subject to the reporting requirement have never submitted a report under the Rule.
The Exchange further believes that deleting corresponding references to Rule 410B in another rule would remove impediments to and perfects the mechanism of a free and open market by reducing potential confusion and adding transparency and clarity to the Exchange's rules, thereby ensuring that members, regulators and the public can more easily navigate and understand the Exchange's rulebook.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is not intended to address competitive issues, but rather it is designed to eliminate obsolete and duplicative regulatory reporting.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposed to amend Rule 6.13. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Rule 6.13 regarding complex orders. The proposed rule change (1) amends the rule provisions regarding the initiation of a complex order auction (“COA”), (2) adds rule provisions regarding the impact of certain incoming orders and changes in the leg markets on an ongoing COA, and (3) amends the rule provision related to the size of COA responses. The proposed rule change also makes technical and other nonsubstantive changes.
First, the Exchange proposes to amend Rule 6.13 and Interpretation and Policy .02 regarding the initiation of a COA. Currently, C2 Rule 6.13(c)(2) provides that on receipt of a COA-eligible order
The Exchange believes Participants should still maintain flexibility to have their COA-eligible orders not COA. In order to provide Participants with this flexibility, the proposed rule change adds that, notwithstanding the foregoing, Participants may request on an order-by-order basis that a COA-eligible order not COA (referred to as a “do-not-COA” request). Because of this proposed rule change, the Exchange deletes the language in Interpretation and Policy .02(a) that indicates Participants may request that complex orders be processed by COA on a class-by-class basis, as it is no longer necessary.
While the proposed rule change provides that Participants may include a do-not-COA request on complex orders, the proposed rule change indicates that an order with a do-not-COA request may still COA after it has rested on the COB pursuant to Interpretation and Policy .02.
The Exchange notes that an order with a do-not-COA request will still have execution opportunities. For example, such an order may execute automatically upon entry into the System against the leg markets or complex orders on the COB to the extent marketable (in accordance with allocation rules set forth in Rule 6.13). Additionally, pursuant to Rule 6.13(c)(8)(A), such an order on the opposite side of and marketable against a COA-eligible order may trade against the COA-eligible order if the System receives the order while a COA is ongoing. A do-not-COA request merely provides the order with the opportunity to execute upon entry into the System rather than after going through an auction; the order will be subject to the same priority and allocation rules.
Second, the proposed rule change adds subparagraphs Rule 6.13(c)(8)(D) and (E) to describe additional circumstances that will cause a COA to end early.
For example, assume that a COA-eligible order to buy with a net limit price of $1.20 is received when the book or COB price (and thus the starting price) is a net price bid of $1.10. The System will initiate a COA at a net price of $1.10. An incoming order with a do-not-COA request to buy at a net price of $1.10 or higher causes the original COA to end. To the extent possible, the original COA-eligible order will be filled first, and then the order with the do-not-COA request will be filled (subject to the COA allocation provisions describe above).
Proposed subparagraph (8)(E) provides that if the leg markets were not marketable against a COA-eligible order when the order entered the System (and thus prior to the initiation of a COA) but
For example, assume that the derived net leg market is $1.00 to $1.05. A COA-eligible order to buy at a net price of $1.02 is entered and initiates a COA. During the COA (prior to the end of the Response Time Interval), the derived net leg market offer changes to $1.01. Because this is marketable against the COA-eligible order, this change in the derived net leg markets will cause the COA to end. Assuming the derived net leg market offer price of $1.01 is the best net price at the end of the COA,
In the example above, if a complex order to buy at a net price of $1.01 was resting in the COB at the time the COA-eligible order to buy at a net price of $1.02 entered the System and initiated the COA, and the same change in the derived net leg markets occurs, assuming the derived net leg market offer price of $1.01 is the best net price at the end of the COA, the COA-eligible order will trade against the derived net leg offer at $1.01 first, because it was entered at (and thus willing to pay) a better net price than the resting complex order (to the extent there was insufficient size in the leg markets to fill the COA-eligible order, the remainder would then execute against complex orders in the COB and auction responses). If there is sufficient size left in the leg markets to trade against the resting complex order, then the resting order will also trade (in full or in a permissible ratio).
Third, the proposed rule amends Rule 6.13(c)(3)(A) to delete the language that RFR responses are limited to the size of the COA-eligible order for allocation purposes. If the allocation algorithm for complex orders in a class is pro-rata, the System is unable to block RFR responses that are larger than the size of the COA-eligible order. This proposed rule change will result in the rule regarding RFR responses more accurately reflecting current System functionality. The Exchange notes that RFR responses must continue to be on the opposite side of the market of the COA-eligible order and be expressed in the applicable minimum increment. RFR responses will be subject to the same allocation and priority rules. Pursuant to Rule 6.13(c)(7), RFR responses are firm with respect to the COA-eligible order for which the responses are submitted, provided that responses that exceed the size of a COA-eligible order are also eligible to trade with other incoming COA-eligible orders that are received during the Response Time Interval.
Finally, the proposed rule change makes technical and other nonsubstantive changes. Currently, Interpretation and Policy .05 provides that the Exchange may determine on a class-by-class basis (and announce via Regulatory Circular) which electronic allocation algorithm from Rule 6.12 will apply to complex orders in lieu of Rule 6.13(b)(1)(B) for COB executions and/or (Rule 6.13(c)(5)(B) through (D) for COA. The proposed rule change moves that language from Interpretation and Policy .05 to those paragraphs.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the proposed rule change removes impediments to a free and open market and protects investors by providing Participants with more flexibility regarding when complex orders will not COA. The proposed rule change removes the affirmative obligation currently imposed on Participants to request that their COA-eligible orders COA on a class-by-class basis, as Participants currently request that all of their COA-eligible orders COA upon entry into the System. Therefore, the proposed rule change to have COA as the default setting for COA-eligible orders will have no impact on COA-eligible orders submitted to the Exchange. The proposed rule change will allow Participants to evaluate then-current market conditions and determine if they do not want to COA orders based on those conditions and instead want those orders to route to the COB for potential immediate execution. These orders with do-not COA requests will continue to have execution opportunities and be subject to the same priority and allocation rules. In addition, the proposed rule change promotes just and equitable principles of trade and promotes competition because another options exchange has a substantially similar rule, as further described below, which similarly allows members to designate that orders not initiate a complex order auction on that exchange.
The current rules describe how COA-eligible orders received while a COA is ongoing would impact the COA. The proposed rule change also adds detail regarding how incoming orders with do-not-COA requests or that are not COA-eligible, as well as how changes in the leg markets, may impact ongoing COAs, which protects investors by enhancing the description in C2 Rules of current COA functionality and circumstances that may cause a COA to end early. Because the proposed rule change adds a provision regarding no-COA orders to the C2 Rules, the Exchange believes it is appropriate to add the provision regarding how no-COA orders would impact a COA to the C2 Rules as well to ensure investors understand how these orders may impact a COA. The Exchange believes the proposed rule change promotes just and equitable principles of trade because, if these orders cause a COA to end, any executions that occur following the COA occur in accordance with allocation principles in place, subject to an exception that the original COA-eligible order receive time priority. This exception prevents an order that was entered after the initiation of a COA from trading ahead of an order with the same price that may have executed or entered the COB if it did not COA. Similarly, the Exchange believe it is fair for a COA-eligible order that was entered at a better price than an order that was resting in the COB prior to initiation of the COA to execute against leg markets that become marketable against the COA-eligible order and resting order during the COA, because the Participant who entered the COA-eligible order was willing to pay a better price than that of the resting order. Incoming orders that do not COA and leg market changes impact a COA in a substantially similar manner as incoming COA-eligible orders; the proposed rule change just applies to different order types not covered by the current Rules. This proposed change does not substantively change the COA or allocation process.
The proposed rule change to delete the provision limiting the size of RFR responses to the size of the COA-eligible order further perfects the mechanism of a free and open market and protects investors because it more accurately describes current System functionality. RFR responses will be subject to the same allocation and priority rules, and COA will continue to function in the same manner. The Exchange notes that the rule related to the complex order auctions of another exchange does not limit responses size to the size of the auctioned order.
C2 does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change, including the ability to designate orders to not COA, is available to all Participants. The Exchange believes the proposed rule change provides Participants with more flexibility with respect to the submission of their complex orders. The proposed rule change also eliminates the affirmative obligation imposed on Participants to request that COA-eligible orders COA, which they all do for all classes. While Participants may need to undertake system work to allow them to include a do-not-COA request on orders, use of this designation is voluntary. C2 believes this flexibility may promote competition by encouraging submission of complex orders to the Exchange. To the extent that proposed rule change makes C2 a more attractive marketplace to market participants on other exchanges, such market participants may elect to send orders to C2 to take advantage of the additional functionality. Additionally, other exchanges may determine to provide similar functionality and further enhance competition. The Exchange also notes that another options exchange has substantially similar provisions as the proposed rule change, as described above.
The proposed rule change to add detail to the rules regarding the impact of changes in the leg markets on a COA describes current functionality and is merely intended to enhance the description of this functionality in the Rules, and thus has no impact on competition. The nonsubstantive and technical changes have no impact on competition.
The Exchange neither solicited nor received comments on the proposed rule change.
Within 45 days of the date of publication of this notice in the
A. By order approve or disapprove such proposed rule change, or
B. institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The proposed rule change consists of a change to Rule 3 of the Clearing Rules of the Mortgage-Backed Securities Division (“MBSD,” and its Clearing Rules, “MBSD Rules”) of FICC and Rule 3 of the Rulebook of the Government Securities Division (“GSD,” and its Rulebook, “GSD Rules”) of FICC to provide additional details regarding the requirement that MBSD and GSD Members participate in annual testing of FICC's business continuity and disaster recovery plans (“BCP Testing”).
In its filing with the Commission, FICC 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. FICC has prepared summaries, set forth in sections A, B and C below, of the most significant aspects of such statements.
The proposed rule change would amend Rule 3 (Ongoing Membership Requirements) of the MBSD Rules and Rule 3 (Ongoing Membership Requirements) of the GSD Rules to provide additional details regarding the requirement that MBSD and GSD Members participate in FICC's annual BCP Testing. Currently, pursuant to Rule 2A (Initial Membership Requirements) of the MBSD Rules and Rule 2A (Initial Membership Requirements) of the GSD Rules, each applicant for membership of either MBSD or GSD must fulfill operational testing requirements, as established by FICC, that may be imposed to ensure the operational capability of the applicant.”
Recently, the Commission promulgated Regulation Systems Compliance and Integrity (“Reg. SCI”), which requires FICC to establish standards to designate members
The proposed amendments to Rule 3 of the MBSD Rules and Rule 3 of the GSD Rules would increase transparency regarding BCP Testing, and ensure FICC's practice with respect to such testing is consistent with Reg. SCI by setting forth FICC's rights to: (i) Designate MBSD and GSD Members required to participate in BCP Testing using established standards; (ii) determine the scope and reporting of such BCP Testing; and (iii) require MBSD and GSD Members to comply with such BCP Testing within specified timeframes. In connection with these proposed amendments, FICC would refine the factors that it currently uses to designate MBSD and GSD Members for BCP Testing. For example, while FICC would continue to rely on activity-based thresholds to mandate participation with annual BCP Testing, FICC would also take into account additional factors when designating firms for BCP Testing, including, but not limited to: (i) Significant operational issues of the MBSD or GSD Member during the past twelve months; and (ii) past performance of the MBSD or GSD Member with respect to BCP Testing. MBSD and GSD Members would be informed of the specific standards that would be used by FICC, along with any updates or changes to these standards, which would be applied on a prospective basis, through established methods of communication between FICC and the Members of MBSD and GSD. Likewise, MBSD and GSD Members would be notified in advance that they have been designated to participate in BCP Testing for the upcoming year, and would be provided details concerning the nature of such testing as the particular test plans are determined.
FICC believes the proposed rule change would have no impact on MBSD and GSD Members relative to what those Members are currently required to do. As described above, FICC already requires certain MBSD and GSD Members to participate in BCP Testing on an annual basis. The proposed rule change provides further clarity with respect to these requirements for consistency with Reg. SCI.
Section 17A(b)(3)(F) of the Act requires, in part, that the MBSD Rules and GSD Rules be designed to promote the prompt and accurate clearance and settlement of securities transactions and to protect investors and the public interest.
Rule 17Ad-22(d)(2), promulgated under the Act, requires FICC to require that MBSD and GSD Members have robust operational capacity to meet obligations arising from participation in the clearing agency, to monitory that its participation requirements are met on an ongoing basis, and to have participation requirements that are objective and publicly disclosed.
Rule 1004(a) and (b) of Reg. SCI requires FICC to establish standards for the designation of those MBSD and GSD Members that FICC reasonably determines are, taken as a whole, the minimum necessary for the maintenance of fair and orderly markets in the event of the activation of its business continuity and disaster recovery plans, and to designate MBSD and GSD Members pursuant to those standards and require participation by such designated firms in scheduled BCP Testing annually.
By facilitating the testing of how business continuity and disaster recovery plans function between FICC and the MBSD and GSD Members during an emergency, the proposed rule change would facilitate the prompt and accurate clearance and settlement of securities transactions and protect investors and the public interest consistent with of the Act. The proposed rule change would provide additional details to the MBSD Rules and GSD Rules regarding the requirement for MBSD and GSD Members to take part in its BCP Testing annually, strengthening its compliance with Rule 17Ad-22(d)(2) and (4).
As such, FICC believes that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Act, Rule 17Ad-22(d)(2) and (d)(4), promulgated under the Act, and Rule 1004(a) and (b) of Reg. SCI, cited above.
FICC does not believe that the proposed rule change would impose any burden on competition because the proposed rule change would apply to all MBSD and GSD Members and only provides additional details regarding an existing requirement.
Written comments were not and are not intended to be solicited with respect to the proposed rule change, and none have been received.
Because the foregoing proposed rule change does not:
(i) Significantly affect the protection of investors or the public interest;
(ii) impose any significant burden on competition; and
(iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)
A proposed rule change filed under Rule 19b-4(f)(6)
FICC has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. According to FICC, the proposed rule change does not present any novel or controversial issues. Rather, FICC is merely providing additional details regarding BCP Testing requirements or adding provisions that are consistent with or required by Reg. SCI. Accordingly, the Commission believes that waiving the 30-day operative delay is consistent with the
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 Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-FICC-2015-004 and should be submitted on or before November 23, 2015.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (the “Commission”) has submitted to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below.
Conflicts of interest between investment company personnel (such as portfolio managers) and their funds can arise when these persons buy and sell securities for their own accounts (“personal investment activities”). These conflicts arise because fund personnel have the opportunity to profit from information about fund transactions, often to the detriment of fund investors. Beginning in the early 1960s, Congress and the Securities and Exchange Commission (“Commission”) sought to devise a regulatory scheme to effectively address these potential conflicts. These efforts culminated in the addition of section 17(j) to the Investment Company Act of 1940 (the “Investment Company Act”) (15 U.S.C. 80a-17(j)) in 1970 and the adoption by the Commission of rule 17j-1 (17 CFR 270.17j-1) in 1980.
Section 17(j) makes it unlawful for persons affiliated with a registered investment company (“fund”) or with the fund's investment adviser or principal underwriter (each a “17j-1 organization”), in connection with the purchase or sale of securities held or to be acquired by the investment company, to engage in any fraudulent, deceptive, or manipulative act or practice in contravention of the Commission's rules and regulations. Section 17(j) also authorizes the Commission to promulgate rules requiring 17j-1 organizations to adopt codes of ethics.
In order to implement section 17(j), rule 17j-1 imposes certain requirements on 17j-1 organizations and “Access Persons”
The rule requires each Access Person of a fund (other than a money market fund or a fund that does not invest in Covered Securities) and of an investment adviser or principal underwriter of the fund, who is not subject to an exception,
The requirements that the management of a rule 17j-1 organization provide the fund's board with new and amended codes of ethics and an annual issues and certification report are intended to enhance board oversight of personal investment policies applicable to the fund and the personal investment activities of Access Persons. The requirements that Access Persons provide initial holdings reports, quarterly transaction reports, and annual holdings reports and request approval for purchases of securities through IPOs and private placements are intended to help fund compliance personnel and the Commission's examinations staff monitor potential conflicts of interest and detect potentially abusive activities. The requirement that each rule 17j-1 organization maintain certain records is intended to assist the organization and the Commission's examinations staff in determining if there have been violations of rule 17j-1.
We estimate that annually there are approximately 75,497 respondents under rule 17j-1, of which 5,497 are rule 17j-1 organizations and 70,000 are Access Persons. In the aggregate, these respondents make approximately 108,305 responses annually. We estimate that the total annual burden of complying with the information collection requirements in rule 17j-1 is approximately 401,407 hours. This hour burden represents time spent by Access Persons that must file initial and annual holdings reports and quarterly transaction reports, investment personnel that must obtain approval before acquiring beneficial ownership in any securities through an IPO or private placement, and the responsibilities of Rule 17j-1 organizations arising from information collection requirements under rule 17j-1. These include notifying Access Persons of their reporting obligations, preparing an annual rule 17j-1 report and certification for the board, documenting their approval or rejection of IPO and private placement requests, maintaining annual rule 17j-1 records, maintaining electronic reporting and recordkeeping systems, amending their codes of ethics as necessary, and, for new fund complexes, adopting a code of ethics.
We estimate that there is an annual cost burden of approximately $5,000 per fund complex, for a total of $4,335,000, associated with complying with the information collection requirements in rule 17j-1. This represents the costs of purchasing and maintaining computers and software to assist funds in carrying out rule 17j-1 recordkeeping.
These burden hour and cost estimates are based upon the Commission staff's experience and discussions with the fund industry. The estimates of average burden hours and costs are made solely for the purposes of the Paperwork Reduction Act. These estimates are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules.
Compliance with the collection of information requirements of the rule is mandatory and is necessary to comply with the requirements of the rule in general. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number. Rule 17j-1 requires that records be maintained for at least five years in an easily accessible place.
The public may view the background documentation for this information collection at the following Web site,
Pursuant to Section 19(b)(1)
The Exchange proposes to delete Rule 410B—Equities governing reporting requirements for off-Exchange transactions. The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to delete Rule 410B—Equities (“Rule 410B”), which sets forth certain regulatory reporting requirements for member or member organizations effecting off-Exchange transactions in Exchange listed securities that are not reported to the Consolidated Tape, and to make conforming amendments to Rule 476A to delete a reference to Rule 410B.
Currently, Rule 410B requires members or member organizations to report to the Exchange transactions in NYSE-listed securities effected for the account of a member or member organization, or for the account of a customer of a member or member organization, that are not reported to the Consolidated Tape. Reports prepared pursuant to the Rule must contain the following information:
• Time and date of the transaction;
• stock symbol of the listed security;
• number of shares;
• price;
• marketplace where the transaction was executed;
• an indication whether the transaction was a buy (B), sell (S) or cross (C);
• an indication whether the transaction was executed as principal or agent; and
• the name of the contra-side broker-dealer to the trade.
Rule 410B was adopted by the Exchange's affiliate the New York Stock Exchange LLC (“NYSE”) in 1992. At the time, transactions in NYSE-listed stocks effected outside of business hours or in foreign markets were not reported to the Consolidated Tape and, with the exception of program trading information, were not reported to the Exchange. The Exchange (then the New York Stock Exchange, Inc.) believed that “all transactions in NYSE-listed stocks that are not reported to the Consolidated Tape should be reported to the Exchange in order to provide an accurate record of overall trading activity in NYSE-listed stocks.”
Despite the significant changes to the marketplace and the regulatory landscape in the ensuing decades, the Exchange adopted Rule 410B without amendment in 2008.
On July 30, 2007, the NASD, NYSE, and NYSE Regulation, Inc. (“NYSE Regulation”) consolidated their member firm regulation operations to create the Financial Industry Regulatory Authority, Inc. (“FINRA”), and entered into a plan to allocate to FINRA regulatory responsibility for common rules and common members (“17d-2 Agreement”).
In 1998, FINRA (then the NASD) established the Order Audit Trail System (OATS), as an integrated audit trail of order, quote, and trade information for OTC equity securities and equity securities listed and traded on The Nasdaq Stock Market, Inc. (“Nasdaq”).
Rule 410B also predates the establishment of a FINRA Trade Reporting Facility (“TRF”). FINRA Rule 6110 requires FINRA members to report transactions in NMS stocks
The Exchange proposes to delete Rule 410B in its entirety. Rule 410B is a regulatory rule intended to enhance audit trail quality and improve surveillance and investigation of violative activities such as market manipulation and insider trading. As noted above, since 2010, surveillance and enforcement responsibilities across markets have been consolidated at FINRA, which conducts cross-market surveillances on the Exchange's behalf utilizing various data sources, including extensive trade and other information that FINRA collects pursuant to its rules. This trade information includes reports of off-exchange transactions. All of the Exchange's member organizations, with only nine exceptions, are members of FINRA and, as such, must report all off-exchange transactions to FINRA, including transactions away from the Exchange that are not reported to the Consolidated Tape. This information is essentially duplicative of the Rule 410B reports the Exchange currently supplies to FINRA. The one exception would be transactions in dually listed securities executed on and reported to a foreign securities exchange, which is not required to be reported because such trades are executed “on or through an exchange.”
The Exchange does not believe that eliminating the Rule 410B reporting requirement for the small number of NYSE MKT-only members
For the foregoing reasons, the Exchange believes that Rule 410B should be deleted in its entirety.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
In particular, the Exchange believes that eliminating Rule 410B would remove impediments to and perfect the mechanism of a free and open market and a national market system by eliminating duplicative reporting by Dual Members of information those firms already provide to FINRA. The Exchange believes that eliminating Rule 410B reporting would not be inconsistent with the public interest and the protection of investors because FINRA would continue to receive information from Dual Members about off-Exchange transactions for incorporation in its cross-market surveillances. Further, the Exchange believes that eliminating Rule 410B reporting would not be inconsistent with the public interest and the protection of investors because the small number of NYSE [sic]-only firms that would no longer be subject to the reporting requirement have never submitted a report under the Rule.
The Exchange further believes that deleting corresponding references to Rule 410B in another rule would remove impediments to and perfects the mechanism of a free and open market by reducing potential confusion and adding transparency and clarity to the Exchange's rules, thereby ensuring that members, regulators and the public can more easily navigate and understand the Exchange's rulebook.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is not intended to address competitive issues, but rather it is designed to eliminate obsolete and duplicative regulatory reporting.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend Rule 6.53C. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Rule 6.53C regarding complex orders. The proposed rule change (1) amends the rule provisions regarding the initiation of a complex order auction (“COA”), (2) adds rule provisions regarding the impact of certain incoming orders and changes in the leg markets on an ongoing COA, and (3) updates the rule text regarding who can submit complex orders. The proposed rule change also makes technical and other nonsubstantive changes.
First, the Exchange proposes to amend Rule 6.53C and Interpretation and Policy .04 regarding the initiation of a COA. Currently, CBOE Rule 6.53C(d)(ii) provides that on receipt of (1) a COA-eligible order
The Exchange believes Trading Permit Holders should still maintain flexibility to have these two-legged orders not COA. In order to provide Trading Permit Holders with this flexibility, the proposed rule change adds that, notwithstanding the foregoing, Trading Permit Holders may request on an order-by-order basis that a COA-eligible order with two legs not COA (referred to as a “do-not-COA” request). The proposed rule change adds that if a two-legged order with a do-not-COA requests rests on PAR, the PAR operator may not request that the order COA (in other words, if the PAR operator submits that order for electronic processing, the PAR operator cannot override the Trading Permit Holder's do-not-COA order request, and the order will enter the COB). Because of this proposed rule change, the Exchange deletes the language in Interpretation and Policy .04(a) that indicates Trading Permit Holders may request that complex orders be COA'd on a class-by-class basis, as it is no longer necessary.
While the proposed rule change provides that Trading Permit Holders may include a do-not-COA request on complex orders with two legs, the proposed rule change indicates that an order with a do-not-COA request may still COA after it has rested on the COB pursuant to Interpretation and Policy .04.
The Exchange notes that an order with a do-not-COA request will still have execution opportunities. For example, such an order may execute automatically upon entry into the System against the leg markets or complex orders on the COB to the extent marketable (in accordance with allocation rules set forth in Rule 6.53C). Additionally, pursuant to Rule 6.53C(d)(viii)(1), such an order on the opposite side of and marketable against a COA-eligible order may trade against the COA-eligible order if the System receives the order while a COA is ongoing. A do-not-COA request merely provides the order with the opportunity to execute upon entry into the System rather than after going through an auction; the order will be subject to the same priority and allocation rules.
Second, the proposed rule change adds subparagraphs Rule 6.53C(d)(viii)(4) and (5) to describe additional circumstances that will cause a COA to end early.
For example, assume that a COA-eligible order to buy with a net limit price of $1.20 is received when the book or COB price (and thus the starting price) is a net price bid of $1.10. The System will initiate a COA at a net price of $1.10. An incoming order with a do-not-COA request to buy at a net price of $1.10 or higher causes the original COA to end. To the extent possible, the original COA-eligible order will be filled first, and then the order with the do-not-COA request will be filled (subject to the COA allocation provisions describe above).
Proposed subparagraph (viii)(5) provides that if the leg markets were not marketable against a COA-eligible order when the order entered the System (and thus prior to the initiation of a COA) but became marketable with the COA-eligible order prior to the expiration of the Response Time Interval, it will cause the COA to end.
For example, assume that the derived net leg market is $1.00 to $1.05. A COA-eligible order to buy at a net price of $1.02 is entered and initiates a COA. During the COA (prior to the end of the Response Time Interval), the derived net leg market offer changes to $1.01. Because this is marketable against the COA-eligible order, this change in the derived net leg markets will cause the COA to end. Assuming the derived net leg market offer price of $1.01 is the best net price at the end of the COA,
In the example above, if a complex order to buy at a net price of $1.01 was resting in the COB at the time the COA-eligible order to buy at a net price of $1.02 entered the System and initiated the COA, and the same change in the derived net leg markets occurs, assuming the derived net leg market offer price of $1.01 is the best net price at the end of the COA, the COA-eligible order will trade against the derived net leg offer at $1.01 first, because it was entered at (and thus willing to pay) a better net price than the resting complex order (to the extent there was insufficient size in the leg markets to fill the COA-eligible order, the remainder would then execute against complex orders in the COB and auction responses). If there is sufficient size left in the leg markets to trade against the resting complex order, then the resting order will also trade (in full or in a permissible ratio).
Third, the proposed rule change amends Rule 6.53C(c)(ii)(3) and Interpretation and Policy .06(c) to provide that all Trading Permit Holders and PAR Officials may submit orders or quotes to trade against orders in the COB. Currently, the rule provides that market participants
Finally, the proposed rule change makes technical and other nonsubstantive changes. Currently, Interpretation and Policy .09 provides that the Exchange may determine on a class-by-class basis which electronic matching algorithm from Rule 6.45A or 6.45B, as applicable, will apply to COB executions in lieu of the algorithm specified in Rule 6.53C(c)(ii)(2) and (3). The proposed rule change moves that language from Interpretation and Policy .09 to both of those paragraphs.
In addition, the proposed rule change amends Rule 6.53C(c)(ii)(3) to provide that order and quote types (not just quote types) not eligible to rest or trade against the COB will be automatically cancelled. The first several sentences in that subparagraph reference orders and quotes eligible to rest on the COB. The Exchange intended for both non-eligible orders and quotes to be cancelled; this proposed change merely makes the language in this paragraph consistent throughout. Additional nonsubstantive changes to Rule 6.53C are discussed above.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the proposed rule change removes impediments to a free and open market and protects investors by providing Trading Permit Holders with more flexibility regarding when complex orders will not COA. The proposed rule change removes the affirmative obligation currently imposed on Trading Permit Holders to request that their COA-eligible orders with two legs COA on a class-by-class basis, as Trading Permit Holders currently request that all of their COA-eligible orders COA upon entry into the System. Therefore, the proposed rule change to have COA as the default setting for COA-eligible orders will have no impact on COA-eligible orders submitted to the Exchange. The proposed rule change will allow Trading Permit Holders to evaluate then-current market conditions and determine if they do not want to COA orders with two legs based on those conditions and instead want those orders to route to the COB for potential immediate execution. These orders with do-not COA requests will continue to have execution opportunities and be subject to the same priority and allocation rules. In addition, the proposed rule change promotes just and equitable principles of trade and promotes competition because another options exchange has a substantially similar rule, as further described below, which similarly allows members to designate that orders not initiate a complex order auction on that exchange.
The current rules describe how COA-eligible orders received while a COA is ongoing would impact the COA. The proposed rule change also adds detail regarding how incoming orders with do-not-COA requests or that are not COA-eligible, as well as how changes in the leg markets, may impact ongoing COAs, which protects investors by enhancing the description in CBOE Rules of current COA functionality and circumstances that may cause a COA to end early. Because the proposed rule change adds a provision regarding no-COA orders to the CBOE Rules, the Exchange believes it is appropriate to add the provision regarding how no-COA orders would impact a COA to the CBOE Rules as well to ensure investors understand how these orders may impact a COA. The Exchange believes the proposed rule change promotes just and equitable principles of trade because, if these orders cause a COA to end, any executions that occur following the COA occur in accordance with allocation principles in place, subject to an exception that the original COA-eligible order receive time priority. This exception prevents an order that was entered after the initiation of a COA from trading ahead of an order with the same price that may have executed or entered the COB if it did not COA. Similarly, the Exchange believe it is fair for a COA-eligible order that was entered at a better price than an order that was resting in the COB prior to initiation of the COA to execute against leg markets that become marketable against the COA-eligible order and resting order during the COA, because the Trading Permit Holder who entered the COA-eligible order was willing to pay a better price than that of the resting order. Incoming orders that do not COA and leg market changes impact a COA in a substantially similar manner as incoming COA-eligible orders; the proposed rule change just applies to different order types not covered by the current Rules. This proposed change does not substantively change the COA or allocation process.
The proposed rule change to update the term market participants to Trading Permit Holders and PAR Officials and to reorganize certain provisions eliminates potential confusion regarding the processing of complex orders. This additional information further perfects the mechanism of a free and open market and a national market system and protects investors. Additionally, updating the term market participants to Trading Permit Holders and PAR Officials further benefits investors because it more accurately describes who may enter complex orders into the System. The Exchange notes that the Trading Permit Holders and PAR Officials includes all participants included in the current market participant definition (as well as additional participants).
CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change, including the ability to designate orders to not COA, is available to all Trading Permit Holders. The Exchange believes the proposed rule change provides Trading Permit Holders with more flexibility with respect to the submission of their complex orders. The proposed rule change also eliminates the affirmative obligation imposed on Trading Permit Holders to request that COA-eligible orders COA, which they all do for all classes. While Trading Permit Holders may need to undertake system work to allow them to include a do-not-COA request on orders, use of this designation is voluntary. CBOE believes this flexibility may promote competition by encouraging submission of complex orders to the Exchange. To the extent that proposed rule change makes CBOE a more attractive marketplace to market participants on other exchanges, such market participants may elect to send orders to CBOE to take advantage of the additional functionality. Additionally, other exchanges may determine to provide similar functionality and further enhance competition. The Exchange also notes that other options exchanges have substantially similar
The proposed rule change to add detail to the rules regarding the impact of changes in the leg markets on a COA describes current functionality and is merely intended to enhance the description of this functionality in the Rules, and thus has no impact on competition. The nonsubstantive and technical changes have no impact on competition.
The Exchange neither solicited nor received comments on the proposed rule change.
Within 45 days of the date of publication of this notice in the
A. By order approve or disapprove such proposed rule change, or
B. institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the certificate of incorporation and bylaws of its parent Company, CBOE Holdings, Inc. (“CBOE Holdings”). The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
CBOE Holdings is proposing to make certain amendments to its Certificate and Bylaws.
CBOE Holdings proposes to make various amendments to its Certificate. First, CBOE Holdings proposes to eliminate references that are applicable only in connection with the CBOE demutualization and CBOE Holdings initial public offering (“IPO”) in 2010. Currently, the Certificate provides for the designation, preferences and rights related to Class A-1 and Class A-2 common stock that had been authorized by the Board and CBOE Holdings' stockholders prior to the IPO. No shares of Class A-1 or Class A-2 common stock are currently outstanding, nor would CBOE Holdings be able to issue such shares at any time in the future as the current Certificate limits their use to the conversion of Class A and Class B common stock, which was issued in connection with the IPO and has been retired. Accordingly, CBOE Holdings proposes to delete obsolete provisions
CBOE Holdings also proposes to make various amendments to its Bylaws. First, CBOE Holdings proposes to adopt an Exclusive Forum Provision. Specifically, CBOE Holdings seeks to adopt Article 11—Forum for Adjudication of Disputes. Proposed Article 11 provides that Delaware would be the exclusive forum for any shareholder litigation against the Company. CBOE Holdings notes that the proposed adoption of Article 11 alleviates the risk of multi-forum shareholder litigation in which the same claims are litigated in different courts, which can potentially drain corporate resources, increase the distraction and hassle of litigation, and risk inconsistent rulings and judgments. CBOE Holdings also notes that exclusive forum provisions have been upheld by the Delaware Court of Chancery and that legislative amendments to the General Corporation Law of the State of Delaware (“DGCL”) related to exclusive forum provisions were recently signed into law by the Delaware governor and became effective August 1, 2015.
Next, CBOE Holdings proposes to amend various sections in Article 2 to delete obsolete and/or unnecessary language, as well as reflect current best practices among Delaware corporations in the drafting of their governing documents, including changes with respect to the scheduling, notice and action at meetings and the nomination of directors. For example, Section 2.2 of the Bylaws is proposed to be amended to delete language requiring the annual meeting of stockholders to be held on the third Tuesday in May of each year, as the Exchange does not believe such requirement is necessary. Additionally, Section 2.2 is proposed to be amended to eliminate now outdated language which provides that such requirement starts the year immediately following the year in which the restructuring of CBOE is consummated. Section 2.4 of the Bylaws is proposed to be amended to add language providing that certain notice requirements of each meeting of stockholders apply except as otherwise provided by the Certificate of Incorporation or CBOE Holdings Bylaws. CBOE Holdings also proposes to add language to Section 2.4 to explicitly provide that notices of all meetings shall state the means of remote communications, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at such meeting. CBOE Holdings notes that Section 2.1 already contemplates remote communications.
CBOE Holdings also proposes to amend the Bylaws to make other non-substantive changes. For example, CBOE Holdings proposes to amend Section 3.4 of the Bylaws to provide that a director may resign by giving either written or electronic notice as well as
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, CBOE Holdings believes that eliminating references in the Certificate that are applicable only in connection with the 2010 IPO removes obsolete language and alleviates potential confusion. Additionally, CBOE Holdings believes the remaining changes to the Certificate are non-substantive and clarifying in nature, which makes the Certificate easier to read and also alleviates potential confusion. The alleviation of potential confusion removes impediments to and perfects the mechanism of a free and open market and a national market system, and, in general, protect investors and the public interest.
The Exchange believes adopting Article 11 governing the forum for adjudication of disputes alleviates the risk of multi-forum shareholder litigation in which the same claims are litigated in different courts, which can potentially drain corporate resources, increase the distraction and hassle of litigation, and risk inconsistent rulings and judgments. The Exchange believes alleviating potential drain on corporate resources allows the Exchange to direct such resources in administration of the Exchange, enhancing investor protection.
CBOE Holdings believes the remaining changes are either clarifying in nature or reflect current best practices among Delaware corporations in the drafting of their governing documents and thus enhance investor protection by making CBOE Holdings governance documents clearer and easier to understand and in line with current governance best practices.
Because the proposed rule change relates to the governance of CBOE Holdings and not to the operations of the Exchange, the Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not:
A. significantly affect the protection of investors or the public interest;
B. impose any significant burden on competition; and
C. become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Regulation R, Rule 701 requires a broker or dealer (as part of a written agreement between the bank and the broker or dealer) to notify the bank if the broker or dealer makes certain determinations regarding the financial status of the customer, a bank employee's statutory disqualification status, and compliance with suitability or sophistication standards.
The Commission estimates that brokers or dealers would, on average, notify 1,000 banks approximately two times annually about a determination regarding a customer's high net worth or institutional status or suitability or sophistication standing as well as a bank employee's statutory disqualification status. Based on these estimates, the Commission anticipates that Regulation R, Rule 701 would result in brokers or dealers making approximately 2,000 notifications to banks per year. The Commission further estimates (based on the level of difficulty and complexity of the applicable activities) that a broker or dealer would spend approximately 15 minutes per notice to a bank. Therefore, the estimated total annual third party disclosure burden for the requirements in Regulation R, Rule 701 is 500
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following Web site:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the certificate of incorporation and bylaws of its parent Company, CBOE Holdings, Inc. (“CBOE Holdings”). The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed
CBOE Holdings is proposing to make certain amendments to its Certificate and Bylaws.
CBOE Holdings proposes to make various amendments to its Certificate. First, CBOE Holdings proposes to eliminate references that are applicable only in connection with the CBOE demutualization and CBOE Holdings initial public offering (“IPO”) in 2010. Currently, the Certificate provides for the designation, preferences and rights related to Class A-1 and Class A-2 common stock that had been authorized by the Board and CBOE Holdings' stockholders prior to the IPO. No shares of Class A-1 or Class A-2 common stock are currently outstanding, nor would CBOE Holdings be able to issue such shares at any time in the future as the current Certificate limits their use to the conversion of Class A and Class B common stock, which was issued in connection with the IPO and has been retired. Accordingly, CBOE Holdings proposes to delete obsolete provisions related to the designation, rights and preferences of these series of common stock. The Exchange also proposes to remove references to the 10% ownership concentration limitation applicable before the IPO. This change would not change the current ownership concentration limitation, which is 20%. CBOE Holdings also proposes other non-substantive changes to the Certificate include referring to the “Second” Amended and Restated Certificate of Incorporation, clarifying that any stockholder votes on the Bylaws would be in addition to any votes required by law, and updating references to the Common Stock, as only one class of common stock will be outstanding. The Exchange notes that the proposed changes will not have any effect on the rights of a stockholder.
CBOE Holdings also proposes to make various amendments to its Bylaws. First, CBOE Holdings proposes to adopt an Exclusive Forum Provision. Specifically, CBOE Holdings seeks to adopt Article 11—Forum for Adjudication of Disputes. Proposed Article 11 provides that Delaware would be the exclusive forum for any shareholder litigation against the Company. CBOE Holdings notes that the proposed adoption of Article 11 alleviates the risk of multi-forum shareholder litigation in which the same claims are litigated in different courts, which can potentially drain corporate resources, increase the distraction and hassle of litigation, and risk inconsistent rulings and judgments. CBOE Holdings also notes that exclusive forum provisions have been upheld by the Delaware Court of Chancery and that legislative amendments to the General Corporation Law of the State of Delaware (“DGCL”) related to exclusive forum provisions were recently signed into law by the Delaware governor and became effective August 1, 2015.
Next, CBOE Holdings proposes to amend various sections in Article 2 to delete obsolete and/or unnecessary language, as well as reflect current best practices among Delaware corporations in the drafting of their governing documents, including changes with respect to the scheduling, notice and action at meetings and the nomination of directors. For example, Section 2.2 of the Bylaws is proposed to be amended to delete language requiring the annual meeting of stockholders to be held on the third Tuesday in May of each year, as the Exchange does not believe such requirement is necessary. Additionally, Section 2.2 is proposed to be amended to eliminate now outdated language which provides that such requirement starts the year immediately following the year in which the restructuring of CBOE is consummated. Section 2.4 of the Bylaws is proposed to be amended to add language providing that certain notice requirements of each meeting of stockholders apply except as otherwise provided by the Certificate of Incorporation or CBOE Holdings Bylaws. CBOE Holdings also proposes to add language to Section 2.4 to explicitly provide that notices of all meetings shall state the means of remote communications, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at such meeting. CBOE Holdings notes that Section 2.1 already contemplates remote communications.
CBOE Holdings also proposes to amend the Bylaws to make other non-substantive changes. For example, CBOE Holdings proposes to amend Section 3.4 of the Bylaws to provide that a director may resign by giving either written or electronic notice as well as proposes to delete an unnecessary sentence related to the term of the Executive Committee members in Article 4, Section 4.2.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, CBOE Holdings believes that eliminating references in the Certificate that are applicable only in connection with the 2010 IPO removes obsolete language and alleviates potential confusion. Additionally, CBOE Holdings believes the remaining changes to the Certificate are non-substantive and clarifying in nature, which makes the Certificate easier to read and also alleviates potential confusion. The alleviation of potential confusion removes impediments to and perfects the mechanism of a free and open market and a national market system, and, in general, protect investors and the public interest.
The Exchange believes adopting Article 11 governing the forum for adjudication of disputes alleviates the risk of multi-forum shareholder litigation in which the same claims are litigated in different courts, which can potentially drain corporate resources, increase the distraction and hassle of litigation, and risk inconsistent rulings and judgments. The Exchange believes alleviating potential drain on corporate resources allows the Exchange to direct such resources in administration of the Exchange, enhancing investor protection.
CBOE Holdings believes the remaining changes are either clarifying in nature or reflect current best practices among Delaware corporations in the drafting of their governing documents and thus enhance investor protection by making CBOE Holdings governance documents clearer and easier to understand and in line with current governance best practices.
Because the proposed rule change relates to the governance of CBOE Holdings and not to the operations of the Exchange, the Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not:
A. Significantly affect the protection of investors or the public interest;
B. impose any significant burden on competition; and
C. 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
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:
• Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The proposed rule change consists of a change to DTC's Rule 2 to provide additional details regarding the requirement that Participants participate in annual testing of DTC's business continuity and disaster recovery plans (“BCP Testing”), 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.
The proposed rule change would amend DTC's Rule 2 (Participants and Pledgees) to provide additional details regarding the requirement that DTC Participants participate in DTC's annual BCP Testing. Currently, pursuant to DTC's Rule 2, an applicant for membership with DTC must demonstrate that it has “adequate personnel capable of handling transactions with the Corporation and adequate physical facilities, books and records and procedures to fulfill its anticipated commitments to, and to meet the operational requirements of, the Corporation, other Participants and Pledgees with necessary promptness and accuracy and to conform to any condition and requirement which the Corporation reasonably deems necessary for its protection.”
Recently, the Commission promulgated Regulation Systems Compliance and Integrity (“Reg. SCI”), which requires DTC to establish standards to designate members
The proposed amendments to Rule 2 would increase transparency regarding BCP Testing, and ensure DTC's practice with respect to such testing is consistent with Reg. SCI by setting forth DTC's rights to: (i) Designate Participants required to participate in BCP Testing using established standards; (ii) determine the scope and reporting of such BCP Testing; and (iii) require Participants to comply with such BCP Testing within specified timeframes. In connection with these proposed amendments, DTC would refine the factors that it currently uses to designate Participants for BCP Testing. For example, while DTC would continue to rely on activity-based thresholds to mandate participation with annual BCP Testing, DTC would also take into account additional factors when designating firms for BCP Testing, including, but not limited to: (i) Significant operational issues of the Participant during the past twelve months; and (ii) past performance of the Participant with respect to BCP Testing. Participants would be informed of the specific standards that would be used by DTC, along with any updates or changes to these standards, which would be applied on a prospective basis, through established methods of communication between DTC and its Participants. Likewise, Participants would be notified in advance that they have been designated to participate in BCP Testing for the upcoming year, and would be provided details concerning the nature of such testing as the particular test plans are determined.
DTC believes the proposed rule change would have no impact on DTC Participants relative to what Participants are currently required to do. As described above, DTC already requires certain Participants to participate in BCP Testing on an annual basis. The proposed rule change would provide further clarity with respect to these requirements for consistency with Reg. SCI.
Section 17A(b)(3)(F) of the Act requires, in part, that DTC's rules be designed to promote the prompt and accurate clearance and settlement of securities transactions and to protect investors and the public interest.
Rule 17Ad-22(d)(2), promulgated under the Act, requires DTC to require that its Participants have robust operational capacity to meet obligations arising from participation in the clearing agency, to monitory that its participation requirements are met on an ongoing basis, and to have participation requirements that are objective and publicly disclosed.
Rule 1004(a) and (b) of Reg. SCI requires DTC to establish standards for the designation of those Participants that DTC reasonably determines are, taken as a whole, the minimum necessary for the maintenance of fair and orderly markets in the event of the activation of its business continuity and disaster recovery plans, and to designate Participants pursuant to those standards and require participation by such designated Participants in scheduled BCP Testing annually.
By facilitating the testing of how business continuity and disaster recovery plans function between DTC and its Participants during an emergency, the proposed rule change would facilitate the prompt and accurate clearance and settlement of securities transactions and protect investors and the public interest consistent with of the Act. The proposed rule change would provide additional details to DTC's rules regarding the requirement for Participants to take part in its BCP Testing annually, strengthening its compliance with Rule 17Ad-22(d)(2) and (4).
As such, DTC believes that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Act, Rule 17Ad-22(d)(2) and (d)(4), promulgated under the Act, and Rule 1004(a) and (b) of Reg. SCI, cited above.
DTC does not believe that the proposed rule change would impose any burden on competition because the proposed rule change would apply to all Participants and only provides additional details regarding an existing requirement.
Written comments were not and are not intended to be solicited with respect to the proposed rule change, and none have been received.
Because the foregoing proposed rule change does not:
(i) Significantly affect the protection of investors or the public interest;
(ii) impose any significant burden on competition; and
(iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)
A proposed rule change filed under Rule 19b-4(f)(6)
NSCC has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. According to NSCC, the proposed rule change does not present any novel or controversial issues. Rather, NSCC is merely providing additional details regarding BCP Testing requirements or adding provisions that are consistent with or required by Reg. SCI. Accordingly, the
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 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 4.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of South Carolina (FEMA-4241-DR), dated 10/15/2015.
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 South Carolina, dated 10/15/2015, 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.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of South Carolina (FEMA-4241-DR), dated 10/15/2015.
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 South Carolina, dated 10/15/2015, is hereby amended to establish the incident period for this disaster as beginning 10/01/2015 and continuing through 10/23/2015.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 6.
This is an amendment of the Presidential declaration of a major disaster for the State of South Carolina (FEMA-4241-DR), dated 10/05/2015.
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 the State of SOUTH CAROLINA, dated 10/05/2015 is hereby amended to establish the incident period for this disaster as beginning 10/01/2015 and continuing through 10/23/2015.
All other information in the original declaration remains unchanged.
Department of State.
Notice.
Pursuant to section 11 of Annex V of the Joint Comprehensive Plan of Action (JCPOA), the Secretary of State has issued waivers and made findings with respect to relevant statutory sanctions. The contingent waivers exercised and findings made by the Secretary pertain to certain sanctions provided for in relevant sections of the Iran Freedom and Counter-Proliferation Act of 2012, the Iran Threat Reduction and Syria Human Rights Act of 2012, the National Defense Authorization Act for Fiscal Year 2012, and the Iran Sanctions Act of 1996. These waivers and findings would apply to certain transactions by non-U.S. persons involving Iran that take place after Implementation Day, as set forth in Annex V and the corresponding provisions of Annex II of the JCPOA. The transactions subject to the waivers and findings that the Secretary has issued include: Transactions with Iran's financial and banking sectors, including the Central Bank of Iran; transactions for the provision of underwriting services, insurance, or reinsurance in connection with activities consistent with the JCPOA; transactions with Iran's energy and petrochemical sectors, including the purchase or sale of petroleum, petroleum products, or petrochemicals or investment in or support to those sectors; transactions with Iran's shipping sector; trade with Iran in precious metals and other metals and software for activities consistent with the JCPOA; and trade with and support for Iran's automotive sector.
The waivers and findings included herein shall take effect upon confirmation by the Secretary of State that Iran has implemented the nuclear-related measures specified in Sections 15.1-15.11 of Annex V of the JCPOA as verified by the International Atomic Energy Agency.
Stu Huffman, Office of Economic Sanctions Policy and Implementation, Department of State, Telephone: (202) 647-8848.
The Secretary of State has hereby made the following determinations and certifications:
Pursuant to Sections 1244(i), 1245(g), 1246(e), and 1247(f) of the Iran Freedom and Counter-Proliferation Act of 2012 (subtitle D of title XII of Pub. L. 112-239, 22 U.S.C. 8801
1. Section 1244(c)(1) of IFCA
a. Transactions by non-U.S. persons;
b. transactions by U.S. persons for the sale of commercial passenger aircraft and spare parts and components for such aircraft, and associated services to Iran as described in Section 5.1.1 of Annex II to the JCPOA, provided that OFAC has issued any required licenses;
2. Section 1244(d) of IFCA for transactions by non-U.S. persons, excluding any transactions involving persons on the SDN List;
3. Section 1244(h)(2) of IFCA for transactions by foreign financial institutions, excluding any transactions involving persons on the SDN List;
4. Sections 1245(a)(1)(A) of IFCA for transactions by non-U.S. persons, excluding any transactions involving persons on the SDN List;
5. Sections 1245(a)(1)(B) of IFCA for transactions by non-U.S. persons, excluding any transactions involving persons on the SDN List;
6. Section 1245(a)(1)(C) of IFCA for transactions by non-U.S. persons for the sale, supply, or transfer directly or indirectly to or from Iran of materials described in Section 1245(d), and for associated services, with respect to materials that are:
(a) To be used in connection with the energy, shipping, or shipbuilding sector of Iran, or resold, retransferred, or otherwise supplied to an end user in one or more such sectors;
(b) sold, supplied, or transferred to any individual or entity blocked solely pursuant to E.O. 13599, or resold, retransferred, or otherwise supplied to such an individual or entity; and
(c) determined pursuant to Section 1245(e)(3) to be used as described in that section, or resold, retransferred, or otherwise supplied for use in the nuclear program of Iran;
7. Section 1245(c) of IFCA for transactions by non-U.S. persons that are within the scope of the waivers under Section 1245(a)(1) of IFCA as described in paragraphs 4-6 above, excluding any transactions involving persons on the SDN List;
8. Section 1246(a)(1)(A) of IFCA
9. Section 1246(a)(1)(B)(i) of IFCA for the provision of underwriting services or insurance or reinsurance by non-U.S. persons, excluding any transactions involving persons on the SDN List;
10. Section 1246(a)(1)(B)(ii) of IFCA for the provision of underwriting services or insurance or reinsurance by non-U.S. persons for transactions that are within the scope of the waivers under section 1245(a)(1)(B) and (C) of IFCA as described in paragraphs 5-6 above, excluding any transactions involving persons on the SDN List;
11. Section 1246(a)(1)(C) of IFCA for the provision of underwriting services or insurance or reinsurance by non-U.S. persons to or for any individual or entity blocked solely pursuant to E.O. 13599, excluding any transactions involving persons on the SDN List;
12. Section 1246(a) of IFCA for the provision of underwriting services or insurance or reinsurance by U.S. persons for the sale of commercial passenger aircraft and related parts and services to Iran as described in Section 5.1.1 of Annex II of the JCPOA, provided that OFAC has issued any required licenses, excluding any transactions involving persons on the SDN List; and
13. Section 1247(a) of IFCA
Pursuant to section 1245(d)(5) of the National Defense Authorization Act for FY 2012 (Pub. L. 112-81), as amended, I determine that it is in the national security interest of the United States to waive the imposition of sanctions under Section 1245(d)(1) to the extent necessary to implement the JCPOA, including the U.S. commitments with respect to sanctions described in Sections 17.1-17.2 and 17.5 of Annex V of the JCPOA, for transactions by foreign financial institutions with the Central Bank of Iran, excluding any transactions involving persons on the SDN List, effective as provided in the last paragraph below.
Pursuant to sections 212(d)(1) and 213(b)(1) of the Iran Threat Reduction and Syria Human Rights Act of 2012 (Pub. L. 112-158) (TRA) and section 4(c)(1)(A) of the Iran Sanctions Act of 1996 (Pub. L. 104-172, 50 U.S.C. 1701 note) (ISA), I find that it is vital to the national security interests of the United States to issue waivers regarding the application of sanctions under the following provisions for individuals and entities that engage in or propose to engage in the activities described in (1)-(3) below, effective as provided in the last paragraph below:
1. Section 212(a) of the TRA for transactions by non-U.S. nationals in cases where the transactions are for activities described in Sections 4.2.1, 4.3, and 4.4 of Annex II of the JCPOA and do not involve persons on the SDN List.
2. Section 213(a) of the TRA for transactions by non-U.S. nationals in cases where the transactions are for activities described in Section 4.1.5 and 4.1.7 of Annex II of the JCPOA and do not involve persons on the SDN List.
3. Section 5(a) of ISA for transactions by non-U.S. nationals in cases where the transactions are for activities described in Sections 4.2.1, 4.3.1, 4.3.2, 4.3.4, and 4.3.6 of Annex II of the JCPOA and do not involve persons on the SDN List.
The waivers and findings set forth above shall take effect upon confirmation by the Secretary of State that Iran has implemented the nuclear-related measures specified in Sections 15.1-15.11 of Annex V of the JCPOA as verified by the International Atomic Energy Agency.
End of the determinations by the Secretary of State.
The Fine Arts Committee of the Department of State will meet on November 6, 2015 at 9:00 a.m. in the Thomas Jefferson Room of the Harry S. Truman Building, 2201 C Street NW., Washington, DC. The meeting will last until approximately 3:00 p.m. and is open to the public.
The agenda for the committee meeting will include a summary of the work of the Fine Arts Office since its last meeting on June 2, 2015 and the announcement of gifts and loans of furnishings as well as financial contributions from January 1, 2015 through October 31, 2015.
Public access to the Department of State is strictly controlled and space is limited. Members of the public wishing to take part in the meeting should telephone the Fine Arts Office at (202) 647-1990 or send an email to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FMCSA 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. The FMCSA requests approval to extend an ICR titled,
Please send your comments to this notice by December 2, 2015. OMB must receive your comments by this date to act quickly on the ICR.
All comments should reference Federal Docket Management System (FDMS) Docket Number FMCSA-2015-0233. 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. Comments should be addressed to the attention of the Desk Officer, Department of Transportation/Federal Motor Carrier Safety Administration, and sent via electronic mail to
Mr. Jeff Secrist, Office of Registration and Safety Information, Department of Transportation, Federal Motor Carrier Safety Administration, West Building 6th Floor, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Telephone: 202-385-2367; email
Under the Financial and Operating Statistics (F&OS) program, FMCSA collects from Class I and Class II property carriers balance sheet and income statement data along with information on safety needs, tonnage, mileage, employees, transportation equipment, and other related data. FMCSA may also ask carriers to respond to surveys concerning their operations. The data and information collected would be made publicly available and used by FMCSA to determine a motor carrier's compliance with the F&OS program requirements prescribed at chapter III of title of 49 CFR part 369.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of applications for exemptions; request for comments.
FMCSA announces receipt of applications from 28 individuals for exemption from the vision requirement in the Federal Motor Carrier Safety Regulations. They are unable to meet the vision requirement in one eye for
Comments must be received on or before December 2, 2015. All comments will be investigated by FMCSA. The exemptions will be issued the day after the comment period closes.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2015-0071 using any of the following methods:
•
•
•
•
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” FMCSA can renew exemptions at the end of each 2-year period. The 28 individuals listed in this notice have each requested such an exemption from the vision requirement in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting an exemption will achieve the required level of safety mandated by statute.
Mr. Amundson, 59, has had amblyopia in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, 20/400. Following an examination in 2015, his optometrist stated, “Bruce Amundson definitely has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Amundson reported that he has driven straight trucks for 43 years, accumulating 215,000 miles, and tractor-trailer combinations for 15 years, accumulating 450,000 miles. He holds a Class A CDL from Iowa. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Baldwin, 51, has had optic nerve coloboma and retinal dysplasia in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, light perception. Following an examination in 2015, his optometrist stated, “Since Mr. Baldwin has been living his entire life with this left eye vision deficit, he has obviously made compensatory adaptations to it and has sufficient vision to perform driving tasks required to operate a commercial vehicle.” Mr. Baldwin reported that he has driven straight trucks for 12 years, accumulating 124,800 miles. He holds a Class C CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Clyde, 52, has had amblyopia in his right eye since birth. The visual acuity in his right eye is 20/400, and in his left eye, 20/20. Following an examination in 2015, his ophthalmologist stated, “In my medical opinion, this patient has been driving for over 30 years and has not had any accidents and therefore would seem his vision is sufficient for commercial driving.” Mr. Clyde reported that he has driven straight trucks for 27 years, accumulating 675,000 miles, and tractor-trailer combinations for 8 years, accumulating 200,000 miles. He holds a Class AM CDL from New York. His driving record for the last 3 years shows no crashes and 1 conviction for a moving violation in a CMV; he failed to obey a traffic control.
Mr. Coelho, 55, has had amblyopia in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, 20/200. Following an examination in 2015, his ophthalmologist stated, “He has had amblyopia of the left eye throughout his life. In my medical opinion, Mr. Coelho is qualified to operate a commercial motor vehicle.” Mr. Coelho reported that he has driven straight trucks for 38 years, accumulating 380,000 miles, and tractor-trailer combinations for 2 years, accumulating 30,000 miles. He holds a Class A CDL from Rhode Island. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Coutcher, 60, has had optic nerve atrophy in his left eye since 1995. The visual acuity in his right eye is 20/20, and in his left eye, 20/150. Following an examination in 2015, his optometrist stated, “In my opinion Levi Coutcher has sufficient vision to perform the tasks required to operate a commercial vehicle safely.” Mr. Coutcher reported that he has driven straight trucks for 14 years, accumulating 210,000 miles, and tractor-trailer combinations for 14 years,
Mr. Culbertson, 58, has optic neuropathy in his left eye due to a traumatic incident in 1995. The visual acuity in his right eye is 20/20, and in his left eye, counting fingers. Following an examination in 2015, his ophthalmologist stated, “In my medical opinion he has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Culbertson reported that he has driven straight trucks for 41 years, accumulating 410,000 miles, and tractor-trailer combinations for 9 years, accumulating 1.13 million miles. He holds a Class B CDL from Georgia. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Dawson, 50, has had central scotoma in his left eye since 2008. The visual acuity in his right eye is 20/20, and in his left eye, 20/100. Following an examination in 2015, his ophthalmologist stated, “In my medical opinion, Mr. Dawson does have sufficient vision to operate a commercial vehicle.” Mr. Dawson reported that he has driven straight trucks for 25 years, accumulating 500,000 miles, and tractor-trailer combinations for 25 years, accumulating 3 million miles. He holds a Class A CDL from Ohio. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Gast, 36, has a detached retina with subsequent repair in his right eye due to a traumatic incident in 2000. The visual acuity in his right eye is 20/50, and in his left eye, 20/20. Following an examination in 2015, his ophthalmologist stated, “Therefore it is my medical opinion that he has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Gast reported that he has driven straight trucks for 14 years, accumulating 26,000 miles, and tractor-trailer combinations for 2 years, accumulating 4,000 miles. He holds a Class A CDL from Missouri. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Gill, 50, has had esotropia and strabismic amblyopia in his right eye since birth. The visual acuity in his right eye is 20/400, and in his left eye, 20/20. Following an examination in 2015, his ophthalmologist stated, “Patient has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Gill reported that he has driven tractor-trailer combinations for 15 years, accumulating 1.2 million miles. He holds a Class A CDL from California. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Green, 58, has a prosthetic left eye due to a traumatic incident in 1960. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “He has sufficient vision to perform all driving tasks required to operate a commercial vehicle.” Mr. Green reported that he has driven straight trucks for 28 years, accumulating 21,840 miles. He holds a Class AM CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Grubb, 62, has had refractive amblyopia in his left eye since 2002. The visual acuity in his right eye is 20/25, and in his left eye, 20/800. Following an examination in 2015, his optometrist stated, “Patient has sufficient vision to drive a commercial vehicle.” Mr. Grubb reported that he has driven straight trucks for 43 years, accumulating 774,000 miles, and tractor-trailer combinations for 43 years, accumulating 1.29 million miles. He holds a Class DA CDL from Kentucky. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Hankins, 53, has had a prosthetic left eye due to a traumatic incident in 2001. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his ophthalmologist stated, “I understand he has been driving on a CDL . . . He has 110+ degrees of visual field on his right side. With side mirrors he should be able to continue to drive without difficulty.” Mr. Hankins reported that he has driven tractor-trailer combinations for 31 years, accumulating 2.64 million miles. He holds a Class AM CDL from Illinois. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Jacobs, 60, has had esotropia in his right eye since childhood. The visual acuity in his right eye is 20/60, and in his left eye, 20/20. Following an examination in 2014, his optometrist stated, “I certify that in my medical opinion does have sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Jacobs reported that he has driven tractor-trailer combinations for 34 years, accumulating 51,000 miles. He holds an operator's license from New Mexico. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Keplinger, 55, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/60, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “In my professional opinion, Mr. Keplinger has sufficient vision to operate a commercial vehicle.” Mr. Keplinger reported that he has driven tractor-trailer combinations for 14 years, accumulating 728,000 miles. He holds a Class AM CDL from Virginia. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Krushinski, 58, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/100, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “US Dept. Transportation . . . Horizontal visual field is satisfactory for driving.” Mr. Krushinski reported that he has driven straight trucks for 20 years, accumulating 680,000 miles. He holds an operator's license from New York. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Lana, 63, has had myopic degeneration and amblyopia in his left eye since birth. The visual acuity in his right eye is 20/25, and in his left eye, counting fingers. Following an examination in 2015, his ophthalmologist stated, “Myopic Degeneration Left and—congenital/stable [
Mr. Lang, 42, has a prosthetic left eye due to a traumatic incident in 1997. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “With best corrected vision of 20/20 -1 in the right eye and appropriate spectacle correction, pt. [
Mr. Langham, 56, has a chorioretinal scar in his right eye due to a traumatic incident in 1990. The visual acuity in his right eye is 20/60, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “I certify that Nate Langham has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Langham reported that he has driven straight trucks for 10 years, accumulating 15,000 miles, and tractor-trailer combinations for 15 years, accumulating 142,500 miles. He holds a Class AM CDL from Illinois. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Lewis, 49, has had refractive amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/100, and in his left eye, 20/15. Following an examination in 2015, his optometrist stated, “It is my medical opinion that Mr [
Mr. Lopez, 60, has had macular degeneration in his left eye since 1995. The visual acuity in his right eye is 20/25, and in his left eye, 20/400. Following an examination in 2015, his optometrist stated, “In my medical opinion, he has sufficient vision to perform the driving tasks required to operate a commercial vehicle at this time.” Mr. Lopez reported that he has driven tractor-trailer combinations for 23 years, accumulating 2.4 million miles. He holds an operator's license from North Carolina. His driving record for the last 3 years shows no crashes and 1 conviction for a moving violation in a CMV; he failed to obey a traffic sign.
Mr. Narretto, 65, has had a retinal detachment in his left eye since 2005. The visual acuity in his right eye is 20/20, and in his left eye, counting fingers. Following an examination in 2015, his ophthalmologist stated, “I, Dr. David Fargason, certify in my medical opinion that Mr. Narretto has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Narretto reported that he has driven straight trucks for 32 years, accumulating 384,000 miles. He holds a Class A CDL from Louisiana. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Ramos, 32, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/100, and in his left eye, 20/30. Following an examination in 2015, his optometrist stated, “In my medical opinion, I feel Mr. Ramos has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Ramos reported that he has driven tractor-trailer combinations for 3 years, accumulating 904,000 miles. He holds a Class A CDL from California. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Scott, 46, has had an ocular aneurysm in his right eye since 1990. The visual acuity in his right eye is no light perception, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “It is my medical opinion that Mr. Scott has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Scott reported that he has driven straight trucks for 18 years, accumulating 337,500 miles. He holds an operator's license from Ohio. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Seirer, 31, has complete loss of vision in his left eye due to a traumatic incident in 2009. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “In my medical opinion, Mr. Jarrod Seirer has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Seirer reported that he has driven straight trucks for 1 year, accumulating 75,000 miles, and tractor-trailer combinations for 11 years, accumulating 1.71 million miles. He holds a Class A CDL from Kansas. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Thompson, 28, has had refractive amblyopia in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, hand motion. Following an examination in 2015, his optometrist stated, “Due to his refractive amblyopia the best corrected acuity in the left eye is reduced, but this does not pose a problem at this time. I would recommend yearly eye exams and see no restrictions concerning his ability to safely operate a commercial motor vehicle.” Mr. Thompson reported that he has driven straight trucks for 4 years, accumulating 120,000 miles, and tractor-trailer combinations for 4 years, accumulating 120,000 miles. He holds a Class A CDL from Oregon. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Viscaya, 53, has had a retinal detachment in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “This patient can distinguish between red and green signals and also has sufficient vision in order to operate a commercial vehicle.” Mr. Viscaya reported that he has driven straight trucks for 18 years, accumulating 2.16 million miles, and tractor-trailer combinations for 18 years, accumulating 2.16 million miles. He holds a Class A CDL from North Carolina. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Vives, 32, has had a cataract in his right eye since childhood. The visual acuity in his right eye is 20/150,
Mr. Wright, 58, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/60, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “I do not foresee any visual problems with Mr. Wright that would make him unable to operate a commercial vehicle: Also, he has stated to never have had any problems in the past when operating a commercial vehicle.” Mr. Wright reported that he has driven straight trucks for 7 years, accumulating 84,000 miles. He holds an operator's license from Maryland. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA will consider all comments and material received during the comment period and may change this notice based on your comments.
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of applications for exemptions; request for comments.
FMCSA announces receipt of applications from 36 individuals for exemption from the vision requirement in the Federal Motor Carrier Safety Regulations. They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. If granted, the exemptions would enable these individuals to qualify as drivers of commercial motor vehicles (CMVs) in interstate commerce.
Comments must be received on or before December 2, 2015. All comments will be investigated by FMCSA. The exemptions will be issued the day after the comment period closes.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2015-0070 using any of the following methods:
•
•
•
•
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” FMCSA can renew exemptions at the end of each 2-year period. The 36 individuals listed in this notice have each requested such an exemption from the vision requirement in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting an exemption will achieve the required level of safety mandated by statute.
Mr. Annis, 72, has had pseudophakia and macular degeneration in his right eye since 2013. The visual acuity in his right eye is 20/70, and in his left eye, 20/40. Following an examination in 2015, his ophthalmologist stated, “The above mentioned are the results of his testing, Given these results, it is my medical opinion that he has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Annis reported that he has driven straight trucks for 2 years, accumulating 30,000 miles, and tractor-trailer combinations for 29 years, accumulating 3.48 million miles. He holds a Class A CDL from California. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Basista, 51, has had amblyopia in his right eye since birth. The visual acuity in his right eye is 20/50, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “In my opinion, Mr. Basista has sufficient vision to perform driving tasks required to operate a commercial vehicle.” Mr. Basista reported that he has driven straight trucks for 26 years, accumulating 130,000 miles. He holds an operator's license from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Bauer, 76, has had a retinal vein occlusion in his left eye since 1994. The visual acuity in his right eye is 20/20, and in his left eye, 20/100. Following an examination in 2015, his optometrist stated, “In my medical opinion, Mr. Bauer has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Bauer reported that he has driven straight trucks for 37 years, accumulating 444,000 miles. He holds a Class BM CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Brzuchalski, 55, has had a chronic retinal detachment in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “It is my medical opinion that Duane Brzuchalski has sufficient vision and visual ability to safely operate a commercial vehicle.” Mr. Brzuchalski reported that he has driven straight trucks for 10 years, accumulating 450,000 miles, and tractor-trailer combinations for 24 years, accumulating 1.68 million miles. He holds a Class A CDL from Arizona. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Burns, 51, has had amblyopia in his left eye since birth. The visual acuity in his right eye is 20/30, and in his left eye, counting fingers. Following an examination in 2015, his ophthalmologist stated, “He has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Burns reported that he has driven straight trucks for 30 years, accumulating 660,000 miles. He holds an operator's license from New York. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Calandrino, 59, has had strabismic amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/100, and in his left eye, 20/25. Following an examination in 2015, his optometrist stated, “He undoubtedly has sufficient vision to perform the driving tasks needed to operate a commercial vehicle.” Mr. Calandrino reported that he has driven straight trucks for 20 years, accumulating 300,000 miles. He holds an operator's license from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Canedy, 63, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/50, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “In my opinion when wearing his glasses Mr. Canedy has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Canedy reported that he has driven tractor-trailer combinations for 31 years, accumulating 1.4 million miles. He holds a Class A CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Dennis, 68, has complete loss of vision in his left eye due to a traumatic incident at birth. The visual acuity in his right eye is 20/25, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “External examination of Mr. Dennis' left eye revealed that the cornea in his left eye is opacified, his pupil is irregular, miotic, and displaced infero-nasally . . . Mr. Dennis stated that he has had a commercial drivers [sic] license for at least 30-35 years with this condition. I see no reason why he shouldn't be granted his health card at the present time.” Mr. Dennis reported that he has driven straight trucks for 15 years, accumulating 480,000 miles. He holds a Class A CDL from Tennessee. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Diamond, 44, has had refractive amblyopia in his right eye since birth. The visual acuity in his right eye is 20/150, and in his left eye, 20/20. Following an examination in 2014, his optometrist stated, “In my opinion, David has sufficient vision to perform driving tasks required to operate a commercial vehicle.”
Mr. Diamond reported that he has driven straight trucks for 22 years, accumulating 77,000 miles. He holds a Class B CDL from Illinois. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Frey, 71, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/50,
Mr. Glaude, 41, has had a partial coloboma of optic nerve in his left eye since birth. The visual acuity in his right eye is 20/15, and in his left eye, 20/50. Following an examination in 2015, his optometrist stated, “Jason certainly satisfies the requirements to legally drive and operate a commercial vehicle and his reduced acuity in the left eye is stable and poses no risks.” Mr. Glaude reported that he has driven straight trucks for 15 years, accumulating 750,000 miles. He holds a Class B CDL from Maine. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Griffin, 39, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is hand motion, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “In my opinion he does have good enough vision, visual fields, and visual sensory functioning to safely operate a commercial vehicle.” Mr. Griffin reported that he has driven straight trucks for 18 years, accumulating 1.7 million miles. He holds an operator's license from Oklahoma. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Hansen, 60, has had a branch retinal artery occlusion in his left eye since 2005. The visual acuity in his right eye is 20/25, and in his left eye, 20/150. Following an examination in 2015, his ophthalmologist stated, “In the doctor's medical opinion, Mr. Hansen has perfect vision and visual function in his right eye to drive safely and he has been driving safely in the past 10 years with some deficit in his left eye . . . If he has been granted to operate commercial vehicles in the past, I do not see a reason to not grant him to do so now.” Mr. Hansen reported that he has driven straight trucks for 14 years, accumulating 1.19 million miles. He holds an operator's license from Wisconsin. His driving record for the last 3 years shows one crash, to which he did not contribute and for which he was not cited, and one conviction for a moving violation in a CMV; he exceeded the speed limit by 11 mph.
Mr. Hursh, 71, has had a prosthetic right eye since 1995. The visual acuity in his right eye is no light perception, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “In my opinion, Mr. Hursh has the acuity, visual field, and color vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Hursh reported that he has driven straight trucks for 9 years, accumulating 27,000 miles. He holds a Class B CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Jefferies, 48, has had refractive amblyopia in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, 20/200. Following an examination in 2015, his optometrist stated, “In my medical opinion, Mr. Jefferies has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Jefferies reported that he has driven straight trucks for 19 years, accumulating 741,000 miles. He holds a Class E CDL from Florida. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Keefer, 53, has a corneal scar in his right eye due to a traumatic incident in childhood. The visual acuity in his right eye is counting fingers, and in his left eye, 20/15. Following an examination in 2015, his optometrist stated, “In my medical opinion, Mr. Keefer has sufficient vision to perform the driving tasks associated with driving a commercial vehicle.” Mr. Keefer reported that he has driven straight trucks for 36 years, accumulating 162,000 miles, and tractor-trailer combinations for 30 years, accumulating 99,000 miles. He holds a Class D CDL from Ohio. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Knuppel, 60, has had macular edema in his right eye since 2004. The visual acuity in his right eye is 20/150, and in his left eye, 20/30. Following an examination in 2015, his optometrist stated, “I hereby certify that in my medical opinion, the applicant has sufficient vision to perform the driving tasks required to safely operate a commercial motor vehicle (CMV).” Mr. Knuppel reported that he has driven tractor-trailer combinations for 39 years, accumulating 1.76 million miles. He holds a Class A CDL from Colorado. His driving record for the last 3 years shows no crashes and one conviction for a moving violation in a CMV; he exceeded the speed limit by 14 mph.
Mr. Kopesky, 58, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “I certify that in my professional opinion, Mr. James Kopesky has sufficient vision to perfom [sic] the driving tasks required to operate a commercial vehicle.” Mr. Kopesky reported that he has driven straight trucks for 25 years, accumulating 1.875 million miles. He holds an operator's license from Wisconsin. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Korthanke, 61, has had a retinal detachment in his right eye since 2013. The visual acuity in his right eye is 20/200, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “Richard has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Korthanke reported that he has driven straight trucks for 14 years, accumulating 42,000 miles, and tractor-trailer combinations for 14 years, accumulating 70,000 miles. He holds a Class A CDL from Kansas. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Leimkuehler, 63, has had refractive amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/1250. Following an examination in 2015, his optometrist stated, “His vision is clear and sufficient to perform the driving tasks required to operate a commercial vehicle.” Mr. Leimkuehler reported that he has driven straight trucks for 28 years, accumulating 1.4 million miles, and tractor-trailer combinations for 14 years, accumulating 980,000 miles. He holds a Class AM1
Mr. Letson, 54, has had complete loss of vision in his right eye since birth. The visual acuity in his right eye is no light perception, and in his left eye, 20/15. Following an examination in 2015, his ophthalmologist stated, “He has 130 degrees of vision in the left eye, and it is my opinion that Mr. Letson has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Letson reported that he has driven straight trucks for 4 years, accumulating 96,000 miles. He holds an operator's license from Michigan. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Marco, 50, has had amblyopia secondary to a mild corneal leukoma in his right eye since childhood. The visual acuity in his right eye is 20/60, and in his left eye, 20/20. Following an examination in 2015, his ophthalmologist stated, “He does have amblyopia in his right eye which accounts for the visual loss secondary to a mild corneal leukoma . . . This suggests he should not be denied a commercial driver's license with the appropriate considerations listed above.” Mr. Marco reported that he has driven straight trucks for 29 years, accumulating 1.51 million miles, tractor-trailer combinations for 29 years, accumulating 1.51 million miles, and buses for 15 years, accumulating 150,000 miles. He holds a Class A CDL from Texas. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. McLaughlin, 27, has complications due to fibrovascular ingrowth in his left eye due to a traumatic incident in 2011. The visual acuity in his right eye is 20/20, and in his left eye, light perception. Following an examination in 2015, his ophthalmologist stated, “In my opinion, I do believe he has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. McLaughlin reported that he has driven straight trucks for 5 years, accumulating 1,250 miles, tractor-trailer combinations for 5 years, accumulating 40,000 miles, and buses for 5 years, accumulating 500 miles. He holds a Class A CDL from South Dakota. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Morales, 48, has had a macular scar in his right eye since 2000. The visual acuity in his right eye is 20/100, and in his left eye, 20/20. Following an examination in 2015, his ophthalmologist stated, “In my opinion he has sufficient vision to preform driving tasks required to operate a commercial vehicle.” Mr. Morales reported that he has driven straight trucks for 23 years, accumulating 460,000 miles. He holds a Class B CDL from California. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Ogle, 63, has had refractive amblyopia in his right eye since birth. The visual acuity in his right eye is 20/300, and in his left eye, 20/25. Following an examination in 2015, his optometrist stated, “It is my opinion that refractive amblyopia for Mr. Ogle does not affect his ability to drive. I think he can perform the task of operating a commercial vehicle without restriction.” Mr. Ogle reported that he has driven straight trucks for 45 years, accumulating 562,500 miles, and tractor-trailer combinations for 18 years, accumulating 1.26 million miles. He holds a Class A CDL from South Dakota. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Quesada, 43, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/400, and in his left eye, 20/20. Following an examination in 2015, his ophthalmologist stated, “Based on these findings and in my experience as a physician, he has sufficient vision to operate a commercial vehicle.” Mr. Quesada reported that he has driven straight trucks for 21 years, accumulating 210,000 miles, and tractor-trailer combinations for 21 years, accumulating 210,000 miles. He holds a Class A CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Quintero, 51, has had complete loss of vision in his right eye due to a traumatic incident in childhood. The visual acuity in his right eye is no light perception, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “He does perceive light and balance through the eye and is capable of a binocular field and should perform adequately as a truck driver.” Mr. Quintero reported that he has driven straight trucks for 3 years, accumulating 15,000 miles, and tractor-trailer combinations for 18 years, accumulating 2.25 million miles. He holds a Class A CDL from Texas. His driving record for the last 3 years shows no crashes and one conviction for a moving violation in a CMV; he exceeded the speed limit by 10 percent or more.
Mr. Robinson, 63, has had macular degeneration in his left eye since 2010. The visual acuity in his right eye is 20/25, and in his left eye, hand motion. Following an examination in 2015, his optometrist stated, “It is my opinion at this time, that Mr. Robinson has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Robinson reported that he has driven straight trucks for 40 years, accumulating 1.2 million miles, and tractor-trailer combinations for 40 years, accumulating 2 million miles. He holds an operator's license from South Carolina. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Schoendienst, 61, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/70, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated that Mr. Schoendienst does have sufficient vision to perform the driving tasks required to operate a CMV. Mr. Schoendienst reported that he has driven straight trucks for 6 years, accumulating 165,000 miles. He holds a Class B CDL from Missouri. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Slattery, 49, has had anisotropic amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/100. Following an examination in 2015, his optometrist stated, “I feel he does have sufficient vision to perform all driving tasks required to operate a commercial vehicle.” Mr. Slattery reported that he has driven straight trucks for 37 years, accumulating 259,000 miles, and tractor-trailer combinations for 22 years,
Mr. Slemmer, 73, has a prosthetic right eye due to a traumatic incident in childhood. The visual acuity in his right eye is no light perception, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “I, Lou Mastrian OD, certify that James Slemmer has sufficient vision to perform the driving tasks required to operate a commercial vehicle based on the findings from his examination on May 7, 2015.” Mr. Slemmer reported that he has driven straight trucks for 54 years, accumulating 350,000 miles. He holds a Class A CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Smith, 68, has had Best disease in the macula of his right eye since 2002. The visual acuity in his right eye is 20/100, and in his left eye, 20/25. Following an examination in 2015, his optometrist stated, “It appears to be stable in both eyes at this time. It appears he is doing fine at this time and would be able to drive a commercial vehicle.” Mr. Smith reported that he has driven buses for 5 years, accumulating 12,500 miles. He holds a Class C CDL from North Carolina. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Stevens, 56, has aniridia, bullous keratopathy, aphakia, and exotropia in his right eye due to a traumatic incident in childhood. The visual acuity in his right eye is counting fingers, and in his left eye, 20/15. Following an examination in 2015, his ophthalmologist stated, “In my opinion, Mr. Stevens has sufficient visual function to perform the driving tasks required to operate a commercial vehicle.” Mr. Stevens reported that he has driven tractor-trailer combinations for 30 years, accumulating 1.5 million miles. He holds a Class A CDL from Iowa. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Szafranski, 33, has a retinal detachment in his right eye due to a traumatic incident in childhood. The visual acuity in his right eye is 20/80, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “In my medical opinion, Kevin has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Szafranski reported that he has driven straight trucks for 3 years, accumulating 31,200 miles. He holds a Class B CDL from North Dakota. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Talbott, 53, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/200. Following an examination in 2015, his ophthalmologist stated, “In my medical opinion, Mr. Talbott has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Talbott reported that he has driven straight trucks for 35 years, accumulating 3.5 million miles, and tractor-trailer combinations for 10 years, accumulating 1.25 million miles. He holds a Class AM CDL from Virginia. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Teemer, 31, has hypertropia and exotropia in his left eye due to a traumatic incident in childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/400. Following an examination in 2015, his ophthalmologist stated, “In summary, this patient is a monocular status patient, and has been operating a commercial vehicle for five years without incident.” Mr. Teemer reported that he has driven straight trucks for 4.5 years, accumulating 42,750 miles. He holds an operator's license from New Jersey. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA will consider all comments and material received during the comment period and may change this notice based on your comments.
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 99 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
Each group of renewed exemptions are effective from the dates stated in the discussions below. Comments must be received on or before December 2, 2015.
You may submit comments bearing the Federal Docket Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-1999-5578; FMCSA-2001-9258; FMCSA-2001-10578; FMCSA-2002-11426; FMCSA-2003-14223; FMCSA-2003-15892; FMCSA-2003-16241; FMCSA-2005-21711; FMCSA-2005-22194; FMCSA-2007-27897; FMCSA-2007-29019; FMCSA-2009-0121; FMCSA-2009-0154; FMCSA-2009-0206; FMCSA-2011-0092; FMCSA-2011-0142; FMCSA-2011-0275; FMCSA-2011-0276; FMCSA-2011-26690; FMCSA-2013-0022; FMCSA-2013-0166; FMCSA-2013-0169], using any of the following methods:
•
•
•
•
Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption from the vision requirements in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce, for a two-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The procedures for requesting an exemption (including renewals) are set out in 49 CFR part 381.
This notice addresses 99 individuals who have requested renewal of their exemptions in accordance with FMCSA procedures. FMCSA has evaluated these 99 applications for renewal on their merits and decided to extend each exemption for a renewable two-year period. Each individual is identified according to the renewal date.
The exemptions are extended subject to the following conditions: (1) That each individual has a physical examination every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the requirements in 49 CFR 391.41(b)(10), and (b) by a medical examiner who attests that the individual is otherwise physically qualified under 49 CFR 391.41; (2) that each individual provides a copy of the ophthalmologist's or optometrist's report to the medical examiner at the time of the annual medical examination; and (3) that each individual provide a copy of the annual medical certification to the employer for retention in the driver's qualification file and retains a copy of the certification on his/her person while driving for presentation to a duly authorized Federal, State, or local enforcement official. Each exemption will be valid for two years unless rescinded earlier by FMCSA. The exemption will be rescinded if: (1) The person fails 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.
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application for additional two year periods. The following group(s) of drivers will receive renewed exemptions effective in the month of December and are discussed below.
As of December 5, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 17 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (66 FR 17743; 66
The drivers were included in one of the following dockets: Docket Nos. FMCSA-2001-9258; FMCSA-2003-14223; FMCSA-2003-15892; FMCSA-2007-27897; FMCSA-2007-29019; FMCSA-2009-0121; FMCSA-2009-0206; FMCSA-2011-0092; FMCSA-2011-26690; FMCSA-2013-0022; FMCSA-2013-0166. Their exemptions are effective as of December 5, 2015 and will expire on December 5, 2017.
As of December 6, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 7 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (70 FR 57353; 70 FR 72689; 72 FR 62897; 74 FR 43217; 74 FR 57551; 74 FR 60021; 76 FR 70210; 78 FR 66099):
The drivers were included in one of the following dockets: Docket No. FMSCA-2005-22194; FMCSA-2009-0206. Their exemptions are effective as of December 6, 2015 and will expire on December 6, 2017.
As of December 13, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following individual, Bernard T. Gillette (PA), has satisfied the conditions for obtaining a renewed exemption from the vision requirements (78 FR 62935; 78 FR 76395).
The driver was included in the following docket: Docket No. FMCSA-2013-0166. The exemption is effective as of December 13, 2015 and will expire on December 13, 2017.
As of December 17, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 8 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (78 FR 62935; 78 FR 76395):
The drivers were included in one of the following dockets: Docket No. FMCSA-2013-0166. Their exemptions are effective as of December 17, 2015 and will expire on December 17, 2017.
As of December 22, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 5 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (72 FR 58362; 72 FR 67344; 74 FR 57553; 76 FR 49528; 76 FR 61143; 76 FR 64164; 76 FR 67248; 76 FR 70212; 76 FR 75940; 76 FR 79761; 78 FR 67460):
The drivers were included in one of the following dockets: Docket No. FMCSA-2007-29019; FMCSA-2011-0142; FMCSA-2011-0275; FMCSA-2011-0276. Their exemptions are effective as of December 22, 2015 and will expire on December 22, 2017.
As of December 24, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 38 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (78 FR 64274; 78 FR 77778):
The drivers were included in one of the following dockets: Docket No. FMCSA-2013-0169. Their exemptions are effective as of December 24, 2015 and will expire on December 24, 2017.
As of December 27, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 17 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (64 FR 27027; 64 FR 51568; 66 FR 53826; 66 FR 63289; 66 FR 66966; 67 FR 10471; 67 FR 19798; 68 FR 64944; 68 FR 69434; 69 FR 19611; 70 FR 48797; 70 FR 53412; 70 FR 57353; 70 FR 61493; 70 FR 67776; 70 FR 72689; 70 FR 74102; 72 FR 39879; 72 FR 52422; 74 FR 37295; 74 FR 48343; 74 FR 49069; 74 FR 60021; 76 FR 75942; 78 FR 67452):
The drivers were included in one of the following dockets: Docket No. FMCSA-1999-5578; FMCSA-2001-10578; FMCSA-2002-11426; FMCSA-
As of December 31, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 6 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (66 FR 53826; 66 FR 66966; 68 FR 61857; 68 FR 69434; 68 FR 75715; 70 FR 74102; 71 FR 646; 72 FR 71993; 72 FR 71998; 74 FR 65846; 76 FR 78729; 78 FR 67454; 78 FR 67462; 79 FR 4803):
The drivers were included in one of the following dockets: Docket No. FMCSA-2001-10578; FMCSA-2003-16241. Their exemptions are effective as of December 31, 2015 and will expire on December 31, 2017.
Each of the 99 applicants listed in the groups above has requested renewal of the exemption and has submitted evidence showing that the vision in the better eye continues to meet the requirement specified at 49 CFR 391.41(b)(10) and that the vision impairment is stable. In addition, a review of each record of safety while driving with the respective vision deficiencies over the past two years indicates each applicant continues to meet the vision exemption requirements.
These factors provide an adequate basis for predicting each driver's ability to continue to drive safely in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of two years is likely to achieve a level of safety equal to that existing without the exemption.
FMCSA will review comments received at any time concerning a particular driver's safety record and determine if the continuation of the exemption is consistent with the requirements at 49 U.S.C. 31136(e) and 31315. However, FMCSA requests that interested parties with specific data concerning the safety records of these drivers submit comments by December 2, 2015.
FMCSA believes that the requirements for a renewal of an exemption under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially granting the renewal and then requesting and evaluating, if needed, subsequent comments submitted by interested parties. As indicated above, the Agency previously published notices of final disposition announcing its decision to exempt these 99 individuals from the vision requirement in 49 CFR 391.41(b)(10). The final decision to grant an exemption to each of these individuals was made on the merits of each case and made only after careful consideration of the comments received to its notices of applications. The notices of applications stated in detail the qualifications, experience, and medical condition of each applicant for an exemption from the vision requirements. That information is available by consulting the above cited
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take immediate steps to revoke the exemption of a driver.
You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
We will consider all comments and material received during the comment period and may change this proposed rule based on your comments. FMCSA may issue a final rule at any time after the close of the comment period.
To view comments, as well as any documents mentioned in this preamble, To submit your comment online, go to
National Highway Traffic Safety Administration, DOT.
Receipt of petition.
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that
The closing date for comments on the petition is December 2, 2015.
Comments should refer to the docket and notice numbers above and be submitted by any of the following methods:
•
•
•
•
George Stevens, Office of Vehicle Safety Compliance, NHTSA (202-366-5308).
Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable FMVSS shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable FMVSS.
Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice in the
J.K. Technologies, LLC of Baltimore (JK), Maryland (Registered Importer 90-006) has petitioned NHTSA to decide whether nonconforming 2006 Mercedes-Benz SL passenger cars (manufactured before September 1, 2006) are eligible for importation into the United States. The vehicles which JK believes are substantially similar are 2006 Mercedes-Benz SL passenger cars (manufactured before September 1, 2006) that were manufactured for sale in the United States and certified by their manufacturer as conforming to all applicable FMVSS.
The petitioner claims that it compared non-U.S. certified 2006 Mercedes-Benz SL passenger cars (manufactured before September 1, 2006) to their U.S.-certified counterparts, and found the vehicles to be substantially similar with respect to compliance with most FMVSS.
JK submitted information with its petition intended to demonstrate that non-U.S. certified 2006 Mercedes-Benz SL passenger cars (manufactured before September 1, 2006), as originally manufactured, conform to many FMVSS in the same manner as their U.S. certified counterparts, or are capable of being readily altered to conform to those standards. Specifically, the petitioner claims that non-U.S. certified 2006 Mercedes-Benz SL passenger cars (manufactured before September 1, 2006) are identical to their U.S. certified counterparts with respect to compliance with Standard Nos. 102
The petitioner also contends that the vehicles are capable of being readily altered to meet the following standards, in the manner indicated:
Standard No. 101
Standard No. 108
Standard No. 110
Standard No. 111
Standard No. 114
Standard No. 118
Standard No. 138
Standard No. 208
Standard No. 209
Standard No. 301
Standard No. 401
The petitioner additionally states that a vehicle identification plate must be affixed to the vehicles near the left windshield post to meet the requirements of 49 CFR part 565.
All comments received before the close of business on the closing date indicated above will be considered, and will be available for examination in the docket at the above addresses both before and after that date. To the extent possible, comments filed after the closing date will also be considered. Notice of final action on the petition will be published in the
49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49 CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Proposed termination of explosive approvals.
PHMSA proposes to terminate the explosive approvals listed herein. PHMSA, via certified mail, attempted to contact all of the below listed approval holders during the month of October 2014. The certified letters were titled “Hazardous Materials Safety Law Division, Letter of Warning: Test Series 6(d) requirements for Division 1.4S Explosive Approvals.” The certified letters requested that the approval holders notify PHMSA within 30 days with their intent with respect to the approvals. They were given the options to provide evidence of UN 6(d) testing, request a reassignment of the EX number to a higher compatibility group than “S”, or request termination. To date, no correspondence has been received by PHMSA concerning the below listed explosive approval numbers.
Mr. Ryan Paquet, Director, Approvals and Permits Division, Office of Hazardous Materials Safety, (202) 366-4512, PHMSA, 1200 New Jersey Avenue SE., Washington, DC 20590. Correspondence with respect to the below listed explosive approval numbers should be sent to
In this notice, PHMSA's Office of Hazardous Materials Safety (OHMS) is proposing to terminate the approvals listed below for the approval holders' failure to provide PHMSA with evidence that UN 6(d) testing has been performed in accordance with 49 CFR 172.102(c)(1) (Special Provision 347) or requesting a reassignment of the EX number to a higher compatibility group other than “S”.
On January 19, 2011, PHMSA published a final rule (76 FR 3308; HM-215K) titled
PHMSA will terminate the below listed approvals 30 days after this notice is published in the
CSX Transportation, Inc. (CSXT) has filed a verified notice of exemption under 49 CFR part 1152 subpart F—
CSXT has certified that: (1) No freight traffic has moved over the Line for at least two years; (2) no formal complaint filed by a user of rail service on the Line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the Line is either pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of complainant within the two-year period; and (3) the requirements at 49 CFR 1105.7(c) (environmental report), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, this exemption will be effective on December 2, 2015, unless stayed pending reconsideration.
A copy of any petition filed with the Board should be sent to CSXT's representative: Louis E. Gitomer, Law Offices of Louis E. Gitomer, LLC, 600 Baltimore Avenue, Suite 301, Towson, MD 21204.
If the verified notice contains false or misleading information, the exemption is void ab initio.
CSXT has filed environmental and historic reports that address the effects, if any, of the abandonment on the environment and historic resources. OEA will issue an environmental assessment (EA) by November 6, 2015. Interested persons may obtain a copy of the EA by writing to OEA (Room 1100, Surface Transportation Board, Washington, DC 20423-0001) or by calling OEA at (202) 245-0305. Assistance for the hearing impaired is available through the Federal Information Relay Service at (800) 877-8339. Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), CSXT shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the Line. If consummation has not been effected by CSXT's filing of a notice of consummation by November 2, 2016, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
On October 13, 2015, the Long Island Rail Road Company (LIRR) filed with the Surface Transportation Board (Board) a petition under 49 U.S.C. 10502 for exemption from the prior approval requirements of 49 U.S.C. 10903 to abandon the following two segments of rail line: (1) An approximately 0.69-mile segment located between milepost 0.0 and milepost 0.69, in Long Island City, NY, and traversing United States Postal Service Zip Code 11101 and (2) an approximately 0.38-mile segment located between milepost 0.82 and milepost 1.2, in Long Island City, NY, and traversing United States Postal Service Zip Code 11101.
LIRR states that the two lines segments do not contain federally granted rights-of-way. Any documentation in LIRR's possession will be made available promptly to those requesting it.
The interest of railroad employees will be protected by the conditions set forth in
By issuance of this notice, the Board is instituting an exemption proceeding pursuant to 49 U.S.C. 10502(b). A final decision will be issued by January 29, 2016.
Any offer of financial assistance (OFA) under 49 CFR 1152.27(b)(2) will be due no later than February 8, 2016, or 10 days after service of a decision granting the petition for exemption, whichever occurs first. Each OFA must be accompanied by a $1,600 filing fee.
All interested persons should be aware that, following abandonment, the Line may be suitable for other public use, including interim trail use. Any request for a public use condition under 49 CFR 1152.28 or for interim trail use/rail banking under 49 CFR 1152.29 will be due no later than November 23, 2015. Each interim trail use request must be accompanied by a $300 filing fee.
All filings in response to this notice must refer to Docket No. AB 837X and must be sent to: (1) Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001; and (2) Brian K. Saltz, Assistant Deputy General Counsel, The Long Island Rail Road Company, Law Dept.—1143, Jamaica Station, Jamaica, New York 11435. Replies to the petition are due on or before November 23, 2015.
Persons seeking further information concerning abandonment procedures may contact the Board's Office of Public Assistance, Governmental Affairs, and Compliance at (202) 245-0238 or refer to the full abandonment or discontinuance regulations at 49 CFR part 1152. Questions concerning
An environmental assessment (EA) (or environmental impact statement (EIS), if necessary) prepared by OEA will be served upon all parties of record and upon any agencies or other persons who commented during its preparation. Other interested persons may contact OEA to obtain a copy of the EA (or EIS). EAs in these abandonment proceedings normally will be made available within 60 days of the filing of the petition. The deadline for submission of comments on the EA typically will be within 30 days of its service.
Board decisions and notices are available on our Web site at
Internal Revenue Service (IRS), Treasury.
Notice.
The Internal Revenue Service Advisory Council (IRSAC) will hold a public meeting on Wednesday, November 18, 2015.
Ms. Lorenza Wilds, IRSAC Program Manager, National Public Liaison, CL: NPL, 7559, 1111 Constitution Avenue NW., Washington, DC 20224. Telephone: 202-317-6851 (not a toll-free number). Email address:
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988), a public meeting of the IRSAC will be held on Wednesday, November 18, 2015, from 9:20 a.m. to 1:15 p.m. at the Marriott Wardman Park Hotel, 2660 Woodley Road NW., Virginia Ballroom, Washington, DC 20008. Issues to be discussed include, but not limited to:
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 4506-A, Request for Public Inspection or Copy of Exempt or Political Organization IRS Form.
Written comments should be received on or before January 4, 2016 to be assured of consideration.
Direct all written comments to Michael A. Joplin, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Martha R. Brinson, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning the consumer tipping survey study.
Written comments should be received on or before January 4, 2016 to be assured of consideration.
Direct all written comments to Christie Preston, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to R. Joseph Durbala, (202) 622-3634, at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet at
In support of this mission, IRS is seeking a standard clearance to conduct a minimum, one-year fielding of a nation-wide consumer tipping survey. The sample that would be used for this study, Ipsos' non-probability online panel, was only selected after a pilot study was conducted which compared the results from this vendor to another panel source (GfK KnowledgePanel, a probability-based online panel) and an independent source of tipping data in order to determine which method yielded the most accurate results while reducing respondent burden and cost to the IRS. The findings from the pilot study demonstrated that there were no consistent differences in the results gathered from the panels when compared against each other or when compared against the 3rd party source of data. As such, the decision was made to use the non-probability panel due to the reduced cost per completed survey, which will allow for a larger data collection and more precise estimates of tipping behavior for certain, low-incidence services.
This initiative flows from Goal 1 of the IRS Strategic Plan for FY 2014-2017: Deliver high quality and timely service to reduce taxpayer burden and encourage voluntary compliance.
The burden hour estimates breakdown as follows:
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.
Environmental Protection Agency (EPA).
Final rule.
EPA is finalizing updates and revisions to the existing worker protection regulation for pesticides. This final rule will enhance the protections provided to agricultural workers, pesticide handlers, and other persons under the Worker Protection Standard (WPS) by strengthening elements of the existing regulation, such as training, notification, pesticide safety and hazard communication information, use of personal protective equipment, and the providing of supplies for routine washing and emergency decontamination. EPA expects this final rule to prevent unreasonable adverse effects from exposure to pesticides among agricultural workers and pesticide handlers, vulnerable groups (such as minority and low-income populations, child farmworkers, and farmworker families) and other persons who may be on or near agricultural establishments, and to mitigate exposures that do occur. In order to reduce compliance burdens for family-owned farms, in the final rule EPA has expanded the existing definition of “immediate family” and continued the existing exemption from many provisions of the WPS for owners and members of their immediate families.
This final rule is effective January 1, 2016. Agricultural employers and handler employers will be required to comply with most of the new requirements on January 2, 2017, as provided in 40 CFR 170.2. Agricultural employers and handler employers will be required to comply with certain new requirements on January 1, 2018 or later, as provided in 40 CFR 170.311(a)(3), 170.401(c)(3), 170.501(c)(3) and 170.505(b).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2011-0184, is available at
Jeanne Kasai, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-3240; email address:
This action is issued under the authority of sections 2 through 35 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136-136y, and particularly section 25(a), 7 U.S.C. 136w(a).
EPA is revising the existing Worker Protection Standard (WPS), 40 CFR part 170, to reduce occupational pesticide exposure and incidents of related illness among agricultural workers (workers) and pesticide handlers (handlers) covered by the rule, and to protect bystanders and others from exposure to agricultural pesticide use. This regulation, in combination with other components of EPA's pesticide regulatory program, is intended to prevent unreasonable adverse effects of pesticides among workers, handlers and other persons who may be on or near agricultural establishments, including vulnerable groups, such as minority and low-income populations.
This final rule revises the existing WPS. Some significant changes are described in this Unit. Units V. through XIX. discuss in more detail the proposed rule, public comments submitted, EPA's responses to the public comments, and final regulatory requirements.
In regard to training, the final rule retains the proposed content expansions (including how to protect family members and reduce take-home exposure) and the requirement for employers to ensure that workers and handlers receive pesticide safety training every year. Employers are required to retain records of the training provided to workers and handlers for two years from the date of training. The final rule eliminates the training “grace period,” which allowed employers to delay providing full pesticide safety training to workers (for up to 5 days under the existing rule and for up to two days under the proposal) from the time worker activities began, if the workers received an abbreviated training prior to entering any treated area.
In regard to notification, the final rule retains the proposed requirements for employers to post warning signs around treated areas in outdoor production when the product used has a restricted-entry interval (REI) greater than 48 hours and to provide to workers performing early-entry tasks,
In regard to hazard communication, the final rule requires employers to post pesticide application information and a safety data sheet (SDS) for each pesticide used on the establishment (known together as pesticide application and hazard information) at a central location on the establishment (the “central display”), a departure from the proposal to eliminate the existing requirement for a central display of pesticide application-specific information. The final rule also requires the employer to maintain and make available to workers and handlers, their designated representatives, and treating medical personnel upon request, the pesticide application-specific information and the SDSs for pesticides used on the establishment for two years. The final rule does not include the proposed requirement for the employer to maintain copies of the labeling for each product used on the establishment for two years.
In regard to protections during pesticide applications, the final rule designates the area immediately surrounding the application equipment as the area from which workers and other persons must be excluded. This “application exclusion zone” differs
In regard to establishing a minimum age for handlers and workers performing early-entry tasks, the final rule requires that handlers and workers performing early-entry tasks be at least 18 years old, rather than the proposed minimum age of 16 years old. This minimum age does not apply to an adolescent working on an establishment owned by an immediate family member. The final rule does not require the employer to record workers' or handlers' birthdates as part of the training record, but does require the employer to verify they meet the minimum age requirements.
In regard to PPE, the final rule cross-references certain Occupational Safety and Health Administration's (OSHA) requirements for respirator use that employers will be required to comply with,
EPA has prepared an economic analysis (EA) of the potential impacts associated with this rulemaking (Ref. 1). This analysis, which is available in the docket, is summarized in greater detail in Unit II.C., and the following chart provides a brief outline of the costs and impacts.
You may be potentially affected by this action if you work in or employ persons working in crop production agriculture where pesticides are applied. 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:
EPA is finalizing changes to the WPS. The WPS is a regulation primarily intended to reduce the risks of injury or illness resulting from agricultural workers' and handlers' use and contact with pesticides on farms, forests, nurseries and greenhouses. The rule primarily seeks to protect workers (those who perform hand-labor tasks in pesticide-treated crops, such as harvesting, thinning, pruning) and handlers (those who mix, load and apply pesticides). The rule does not cover persons working with livestock. The existing regulation has provisions requiring employers to provide workers and handlers with pesticide safety training, posting and notification of treated areas, and information on entry restrictions, as well as PPE for workers who enter treated areas after pesticide application to perform crop-related tasks and handlers who mix, load, and apply pesticides.
The final rule takes into consideration comments received from the public in response to the proposed rule (Ref. 2), as well as additional information such as reported incidents of pesticide-related illness or injury.
EPA believes that the changes to the WPS offer targeted improvements that will reduce risk through protective requirements and improve operational efficiencies. Among other things, EPA expects the changes to:
EPA estimates the incremental cost of the revisions to the WPS to be between $60.2 and $66.9 million per year, given a three percent discount rate. Using a seven percent discount rate, the rule is estimated to cost between $56.2 and $66.9 million per year. The majority of the costs, $53.0 to $62.2 million per year, are borne by farms, nurseries, and greenhouses that hire labor and use pesticides, which account for about 20 percent of all farms producing crops in the United States. The approximately 2,000 commercial pesticide handling establishments, which are contracted to apply pesticides on farms, may collectively see an incremental cost of about $1.9 million per year. Family-owned farms that use pesticides and do not hire labor may collectively bear costs of about $1.4 million per year. Total costs amount to an average expenditure of about $30 per year per farm worker. Benefits, in terms of reduced illness from exposure to pesticides, are likely to exceed $64 million per year in terms of avoided costs associated with occupational pesticide incidents and with reductions in chronic diseases associated with occupational pesticide exposure, although the amount EPA can quantify is much less. The estimated quantified benefits from reducing acute worker and handler exposure to pesticides total between $0.6 million and $2.6 million annually.
The changes to the current WPS requirements are expected to lead to an overall reduction in incidents of unsafe pesticide exposure and to improve the occupational health of the nation's agricultural workers and pesticide handlers. This section provides an overview of the qualitative benefits of the proposal and the estimated benefits that would accrue from avoiding acute pesticide exposure in the population protected by the WPS. It also provides an estimate of the number of chronic illnesses with a plausible association with pesticide exposure that would have to be prevented by the rule changes in order for the total estimated benefits to meet the estimated cost of the proposal.
A sizeable portion of the agricultural workforce may be exposed occupationally to pesticides and pesticide residues. These exposures can pose significant long- and short-term health risks. It is difficult to quantify a specific level of risk and project the risk reduction that would result from this rule, because workers and handlers are potentially exposed to a wide range of pesticides with varying toxicities and risks. However, there is strong evidence that workers and handlers may be exposed to pesticides at levels that can cause adverse effects and that both the exposures and the risks can be substantially reduced. EPA believes the provisions in the final rule will reduce pesticide exposures and the associated risks.
The estimated quantified benefits from reducing acute worker and handler exposure to pesticides total between $0.6 million and $2.6 million annually (Ref. 1). This conservative estimate includes only the avoided costs in medical care and lost productivity to workers and handlers and assumes that just 10% of acute pesticide incidents are reported. It does not include quantification of the reduction in chronic effects of pesticide exposure to workers and handlers, reduced effects of exposure, including developmental impacts, to children and pregnant
Even if the lack of quantitative data impairs the reliability of estimates of the total number of chronic illnesses avoided, it is reasonable to expect that the proposed changes to the WPS will reduce pesticide exposure, and thereby reduce the incidence of chronic disease associated with pesticide exposure. Therefore, EPA conducted a “break even” analysis to consider the plausibility of the changes to the WPS reducing the incidence of chronic disease enough to cause the net benefits of the proposed rule to exceed its anticipated costs. Under this analysis, EPA looked at the costs associated with non-Hodgkin's lymphoma, prostate cancer, Parkinson's disease, lung cancer, bronchitis, and asthma and their frequency among agricultural workers, and found that reducing the incidence of lung cancer by 0.078% and the incidence of the other chronic diseases by 0.78% per year (about 44 total cases per year among the population of workers and handlers protected under the WPS) would produce quantified benefits sufficient to bridge the gap between the quantified benefits from reducing acute incidents and the final rule's estimated high-end cost of $66.9 million. Overall, the weight of evidence suggests that the requirements will result in long-term health benefits to agricultural workers and pesticide handlers in excess of the less than 1% reduction in just six diseases that corresponds with the break-even point for the final rule, not only by reducing their daily risk of pesticide exposures, but also by improving quality of life throughout their lives, resulting in a lower cost of health care and a healthier society.
The changes to the current WPS requirements, specifically improved training on reducing pesticide residues brought from the treated area to the home on workers' and handlers' clothing and bodies and establishing a minimum age for handlers and early entry workers, other than those covered by the immediate family exemption, mitigate the potential for children to be exposed to pesticides directly and indirectly. The unquantified benefit to adolescent workers and handlers, as well as children of workers and handlers is great; reducing exposure to pesticides could translate into fewer sick days, fewer days missed of school, improved capacity to learn, and better long-term health. Parents and caregivers reap benefits by having healthier families, fewer missed workdays, and better quality of life.
By finalizing several interrelated exposure-reduction measures, the rule is expected to avoid or mitigate approximately 44 to 73% of annual reported acute WPS-related pesticide incidents. EPA believes the final rule will substantially reduce for these workers and handlers the potential for adverse health effects (acute and chronic) from occupational exposures to such pesticides and their residues. These measures include requirements intended to reduce exposure by:
Further detail on the benefits of this proposal is provided in the document titled “Economic Analysis of the Agricultural Worker Protection Standard Revisions” which is available in the docket for this rulemaking (Ref. 1).
The existing WPS was published in 1992 and implemented fully in 1995. Since implementation, EPA has sought to ensure that the rule provides the intended protections effectively and to identify necessary improvements. To accomplish this, EPA engaged diverse stakeholders, individually and collectively through organized outreach efforts, to discuss the rule and get feedback from affected and interested parties. Groups with which EPA engaged included, but were not limited to, farmworker organizations, health care providers, state regulators, educators and trainers, pesticide manufacturers, farmers, organizations representing agricultural commodity producers and crop advisors. EPA engaged these groups formally through the National Assessment of the Pesticide Worker Safety Program (
Using feedback from stakeholders, along with other information, EPA developed proposed changes to the WPS and published them for public comment (Ref. 2). EPA received substantial feedback on the proposal, including about 2,400 written comments with over 393,000 signatures. Commenters included farmworker advocacy organizations, state pesticide regulatory agencies (states) and organizations, public health organizations, public health agencies, growers and grower organizations, agricultural producer organizations, applicators and applicator organizations, pesticide manufacturers and organizations, PPE manufacturers, farm bureaus, crop consultants and organizations, and others. The comments received covered a wide range of issues and took diverse positions. Overall, the comments were thoughtful and demonstrated a high level of interest in ensuring the protection of workers and handlers, while minimizing burden on employers and regulatory agencies. This document discusses some of the significant comments received and EPA's responses. A full summary of comments received and EPA's responses are available in the docket for this rulemaking (Ref. 4).
While considering stakeholder feedback and suggestions in developing the final rule, EPA also gathered additional information, such as updated demographic information for farmworkers, new data from the U.S. Department of Agriculture's (USDA) National Agricultural Statistics Service, information on other federal rules (
Under FIFRA's authority, EPA has implemented measures to protect workers, handlers, other persons, and the environment from pesticide exposure in two primary ways. First, EPA includes specific use instructions and restrictions on individual pesticide product labeling. These instructions and restrictions are the result of EPA's stringent registration and reevaluation processes and are based on the risks of the particular product. Since users must comply with directions for use and restrictions on a product's labeling, EPA uses the labeling to convey mandatory requirements for how the pesticide must be used to protect people and the environment from unreasonable adverse effects of pesticide exposure. Second, EPA enacted the WPS to expand protections against the risks of agricultural pesticides without making individual product labeling longer and much more complex. The WPS is a uniform set of requirements for workers, handlers and their employers that are generally applicable to all agricultural pesticides and are incorporated onto agricultural pesticide labels by reference. Its requirements complement the product-specific labeling restrictions and are intended to minimize occupational exposures generally.
Once an application for a new pesticide product is received, EPA conducts an evaluation, which includes a detailed review of scientific data to determine the potential impact on human health and the environment. EPA considers the risk assessments and results of any peer review, and evaluates potential risk management measures that could mitigate risks that exceed EPA's level of concern. In the registration process, EPA evaluates the proposed use(s) of the pesticide to determine whether it would cause adverse effects on human health, non-target species, and the environment. In evaluating the impact of a pesticide on occupational health and safety, EPA considers the risks associated with use of the pesticide (occupational, environmental) and the benefits associated with use of the pesticide (economic, public health, environmental). However, FIFRA does not require EPA to balance the risks and benefits for each audience. For example, a product may pose risks to workers, but risk may nevertheless be reasonable in comparison to the economic benefit of continued use of the product to society at large.
If the application for registration does not contain evidence sufficient for EPA to determine that the pesticide meets the FIFRA registration criteria, EPA communicates to the applicant the need for more or better refined data, labeling modifications, or additional use restrictions. Once the applicant has demonstrated that a proposed product meets the FIFRA registration criteria and any applicable requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 321
When EPA approves a pesticide, the labeling generally reflects all risk mitigation measures required by EPA. The risk mitigation measures may include requiring certain engineering controls, such as the use of closed systems for mixing pesticides and loading them into application equipment to reduce potential exposure to those who handle pesticides; establishing conditions on the use of the pesticide by specifying certain use sites, maximum application rate or maximum number of applications; or establishing REIs during which entry into an area treated with the pesticide is generally prohibited until residue levels have declined to levels unlikely to cause unreasonable adverse effects. Because users must comply with the directions for use and use restrictions on a product's labeling, EPA uses the labeling to establish and convey mandatory requirements for how the pesticide must be used to protect the applicator, the public, and the environment from pesticide exposure.
Under FIFRA, EPA is required to review periodically the registration of pesticides currently registered in the United States. The 1988 FIFRA amendments required EPA to establish a pesticide reregistration program. Reregistration was a one-time comprehensive review of the human health and environmental effects of pesticides first registered before November 1, 1984 to make decisions about these pesticides' future use. The 1996 amendments to FIFRA require that EPA establish, through rule making, an ongoing “registration review” process of all pesticides at least every 15 years. The final rule establishing the registration review program was signed in August 2006 (Ref. 16). The purpose of both re-evaluation programs is to review all pesticides registered in the United States to ensure that they continue to meet current safety standards based on up-to-date scientific approaches and relevant data.
Pesticides reviewed under the reregistration program that met current scientific and safety standards were declared “eligible” for reregistration. The results of EPA's reviews are summarized in Reregistration Eligibility Decision (RED) documents. The last RED was completed in 2008. Often before a pesticide could be determined “eligible,” additional risk reduction measures had to be put in place. For a number of pesticides, measures intended to reduce exposure to handlers and workers were needed and are reflected on pesticide labeling. To
EPA's registration review program is a recurring assessment of products against current standards. EPA will review each registered pesticide at least every 15 years to determine whether it continues to meet the FIFRA standard for registration. Pesticides registered before 1984 were reevaluated initially under the reregistration program. These and pesticides initially registered in 1984 or later are all subject to registration review.
In summary, EPA's pesticide reregistration and registration reviews assess the specific risks associated with particular chemicals and ensure that the public and environment do not suffer unreasonable adverse effects from those risks. EPA implements the risk reduction and mitigation measures identified in the pesticide reregistration and registration review programs through amendments to individual pesticide product labeling.
The risk reduction measures of the WPS may be characterized as being one of three types: Information, protection and mitigation. To ensure that employees will be informed about exposure to pesticides, the WPS requires that workers and handlers receive training on general pesticide safety, and that employers provide access to information about the pesticides with which workers and handlers may have contact. To protect workers and handlers from pesticide exposure, the WPS prohibits the application of pesticides in a manner that exposes workers or other persons, generally prohibits workers and other persons from being in areas being treated with pesticides, and generally prohibits workers from entering a treated area while an REI is in effect (with limited exceptions that require additional protections). In addition, the rule protects workers by requiring employers to notify them about areas on the establishment treated with pesticides, through posted and/or oral warnings. The rule protects handlers by ensuring that they understand proper use of and have access to required PPE. Finally, the WPS has provisions to mitigate exposures if they do occur by requiring the employer to provide to workers and handlers with an ample supply of water, soap and towels for routine washing and emergency decontamination. The employer must also make transportation available to a medical care facility if a worker or handler may have been poisoned or injured by a pesticide and provide information about the pesticide(s) to which the person may have been exposed.
EPA manages the risks and benefits of each pesticide product primarily through the labeling requirements specific to each pesticide product. If pesticide products are used according to the labeling, EPA does not expect use to cause unreasonable adverse effects. However, data on incidents of adverse effects to human health and the environment from the use of agricultural pesticides show that users do not always comply with labeling requirements. Rigorous ongoing training, compliance assistance and enforcement are needed to ensure that risk mitigation measures are appropriately implemented in the field. The framework provided by the WPS is critical for ensuring that the improvements brought about by reregistration and registration review are realized in the field. For example, the requirement for handlers to receive instruction on how to use the pesticide and the application equipment for each application is one way to educate handlers about updated requirements on product labeling to ensure they use pesticides in a manner that will not harm themselves, workers, the public or the environment. In addition, the REIs are established through individual product labeling, but action needs to be taken at the use site to ensure that workers are aware of areas on the establishment where REIs are in effect and given directions to be kept out of the treated area while the REI is in effect. The changes to the WPS are designed to enhance the effectiveness of the existing structure of protections and to better realize labeling-based risk mitigation measures at the field level.
Discussions with stakeholders over many years, together with EPA's review of incident data, led EPA to identify several shortcomings in the current regulation that will be addressed by this final rule. As discussed in Unit IV.A., EPA uses both product-specific labeling and the WPS to effectuate occupational protections for workers and handlers. EPA engages in ongoing reviews and reassessments of pesticide products to ensure they continue to meet the standard of not causing unreasonable adverse effects to human health and the environment. The WPS must be updated to ensure that the rule continues to complement the labeling-based protections and to address issues identified through experience with the WPS, and review of incident data and stakeholder engagement.
As noted in Unit IV.A., the components of the WPS generally can be grouped into three categories: Information, protection, and mitigation. Employers must provide workers and handlers with information needed to protect themselves, others, and the environment from pesticides and pesticide residues through pesticide safety training, pesticide application and hazard information, and access to labeling. Employers must provide protections to workers and handlers during and after applications in order to minimize potential for exposure. Finally, employers must be prepared to mitigate exposures that do occur by providing supplies for washing and emergency decontamination, and emergency transportation to a medical facility if necessary. These elements are
In summary, the WPS works in conjunction with product labeling to protect workers and handlers from occupational pesticide exposure. The rule imposes on the employer the responsibility for providing protections to workers and handlers and to ensure they have access to information necessary to protect themselves and others during and after pesticide application.
Current occupational health incident surveillance data show, however, that avoidable incidents continue to occur. For example, some of the occupational pesticide illnesses reported to state health agencies have occurred when workers entered a treated area before the REI expired. Although employers are obligated to warn workers to keep out of treated areas and to ensure that workers receive training on and information about treated areas, incidents continue to occur. Another example of potentially avoidable exposure is spray drift. Labeling instructs handlers to apply pesticides in a manner that does not contact other persons, but pesticide drift continues to cause exposure incidents. In addition to surveillance data, studies also show that pesticide residues are brought home by workers and handlers on their bodies and clothing (known as “take-home exposure”), creating an exposure pathway for family members.
This rulemaking is intended to reduce avoidable incidents by improving information, protections, and mitigations for workers and handlers without imposing unreasonable burdens on employers. Although EPA cannot quantify the specific reduction in incidents from any single change to the regulation, taken together, EPA estimates that the final rule will result in an annual reduction of between 540 and 1,620 acute, health-related incidents. In addition, EPA expects that the final rule will help reduce chronic health problems among workers and handlers by reducing daily pesticide exposures, and thereby improving quality of life throughout their lives, resulting in a lower cost of health care and a healthier society. (See Unit II.C.) Units V. through XIX. describe the final regulatory requirements and their potential to reduce avoidable incidents. The Economic Analysis for this rulemaking provides an estimate of the costs of the requirements and a quantitative and qualitative discussion of the potential benefits, including avoiding acute pesticide-related illnesses in workers and handlers (Ref. 1).
According to the most recent public data set available from the Department of Labor's (DOL) National Agricultural Worker Survey (NAWS) for 2011-2012, 64% of agricultural workers in the United States were born in Mexico and 6% in Central and South America (Ref. 6). A majority (69%) of all survey respondents speak Spanish as their primary language (Ref. 6). Approximately 65% of this population speaks a little or no English; 38% cannot read English at all and another 30% can only read English “a little” (Ref. 6). Many have received only some formal education; on average, the highest grade completed by foreign-born workers was seventh grade (Ref. 6).
Approximately 17% of the survey respondents were classified as migrant, having traveled at least 75 miles in the previous year to find a job in agriculture (Ref. 6). Only 17% of respondents lived in housing provided by their employer and 55% rented housing from someone other than their employer (Ref. 6). In general, agricultural workers surveyed by NAWS do not have access to employer-provided health insurance—in 2011-2012, only 21% of farmworkers reported having the option for employer-provided health insurance (Ref. 6). USDA research, based on NAWS data, also reports that workers have difficulty entering the health care system to receive treatment (Ref. 7). Cost was a significant barrier for two-thirds of farmworkers, while about a third listed language barriers as an impediment to receiving care. Most workers fear that seeking treatment will result in losing their job because someone will replace them while they are getting treatment or the employer will label them as troublemakers and dismiss them. The problem is more severe among undocumented workers because they fear seeking treatment will lead to deportation or other adverse legal action (Ref. 7). A USDA report indicates that the factors mentioned previously contribute to the disadvantaged status of hired workers in agriculture (Ref. 7).
The NAWS found that 19% of workers and handlers surveyed earned less than $10,000 annually from agricultural work, and another 39% earn between $10,000 and $20,000 annually. Over 55% of respondents reported a total family income below $22,500 (Ref. 6).
Both the existing WPS and the changes included in the final rule seek to eliminate some of the potential barriers to achieving effective protection of these persons by requiring training in a manner that workers and handlers can understand, requiring the employer to ensure that handlers understand relevant portions of the labeling before handling a pesticide, and expanding training to provide information on seeking medical care in the event of a pesticide exposure and highlighting the anti-retaliation provisions of the WPS.
Units V. through XVIII. discuss the final rule requirements and elements considered in the proposal but not included in the final rule. Unit XIX. discusses implementation of the final regulatory requirements. Each of these Units generally describes the existing rule, proposal and final regulatory requirements (where appropriate), and summarizes the major comments received and EPA's responses. A separate document summarizing the comments received that were relevant to the proposal and EPA's responses has also been prepared and is available in the docket for this rulemaking (Ref. 4).
EPA has grouped the discussion of the final rule and elements considered in the proposal but not included in the final rule as follows:
3.
The suggestions for biennial or triennial training and allowing the states to base the frequency of training for workers and handlers on their pesticide applicator recertification requirements would present similar administrative problems with tracking trainings and introduce the possibility that workers or handlers would miss information needed to protect themselves. Finally, the alternative to establish the frequency of training based on the calendar year presents similar issues with tracking training and needed frequency of repetition.
The recommendation for training to be tailored to the individual workers' tasks, experience, and prior training was rejected based on the difficulty in tracking the specific training needs with a mobile workforce, the need for multiple forms of training materials, and the potential burden on employers to determine specific needs for each employee. In addition, the training gives practical information that is useful to everyone who works with or around agricultural pesticides.
3.
EPA proposed to limit eligible trainers of workers to those who complete an EPA-approved train-the-trainer program or are designated by EPA or an appropriate state or tribal agency as trainers of certified applicators; being a certified applicator or trained as a handler under the WPS would not automatically qualify a person to train workers under the proposal. EPA did not propose to change the qualifications for trainers of handlers.
The final rule does not make any changes from the existing rule and proposal related to who is qualified to provide training to handlers.
The final regulatory text for worker and handler trainer qualifications is available at 40 CFR 170.401(c)(4) and 170.501(c)(4), respectively.
3.
There were few comments in support of retaining handlers as trainers for workers. One comment suggested that handlers could be required to take an
EPA agrees with the comment that handlers who have gone through a train-the-trainer course should be eligible to train workers. Under the final regulation, any person, including a handler, is qualified to train workers after successfully completing an approved train-the-trainer course.
Under the existing rule, pesticide handler safety training must include the following 13 basic safety training points:
• Format and meaning of information contained on pesticide labels and in labeling, including safety information such as precautionary statements about human health hazards.
EPA proposed additional content in worker pesticide safety training including, among other things, information on the requirements for early-entry notification and emergency assistance, how to reduce pesticide take-home exposure, the availability of hazard communication materials for workers, the minimum age requirements for handling and early entry, and the obligations of agricultural employers to provide protections to workers.
EPA proposed additional content in handler pesticide safety training, including the requirement for handlers to cease application if they observe a person, other than another trained and properly equipped handler, in the area being treated or the entry-restricted area, and information about the requirement for OSHA-equivalent training on respirator use, fit-testing of respirators, and medical evaluation in the event a handler must wear a respirator.
The final rule requires employers to ensure that workers are trained on the following topics after EPA has announced the availability of training materials (see Unit XIX. for information on the timing of implementation):
The responsibility of agricultural employers to do all of the following: Display safety data sheets for all pesticides used on the establishment, provide workers and handlers information about the location of the safety data sheets on the establishment, and provide workers and handlers unimpeded access to safety data sheets during normal work hours.
The final rule requires employers to ensure that handlers are trained on the following topics after EPA has announced the availability of training materials (see Unit XIX. for information on the timing of implementation):
• All content for worker training.
• Information on proper application and use of pesticides.
• Handlers must follow the portions of the labeling applicable to the safe use of the pesticide.
• Format and meaning of information contained on pesticide labels and in labeling applicable to the safe use of the pesticide.
• Need for and appropriate use and removal of all PPE.
• How to recognize, prevent, and provide first aid treatment for heat-related illness.
• Safety requirements for handling, transporting, storing, and disposing of pesticides, including general procedures for spill cleanup.
• Environmental concerns, such as drift, runoff, and wildlife hazards.
• Handlers must not apply pesticides in a manner that results in contact with workers or other persons.
• The responsibility of handler employers to provide handlers with information and protections designed to reduce work-related pesticide exposures and illnesses. This includes providing, cleaning, maintaining, storing, and ensuring proper use of all required personal protective equipment; providing decontamination supplies; and providing specific information about pesticide use and labeling information.
• The responsibility of handler employers to ensure handlers have received respirator fit-testing, training and medical evaluation if they are required to wear a respirator by the product labeling.
• The responsibility of agricultural employers to post treated areas as required by this rule.
EPA intends to develop the training materials that meet the final training requirements and to publish in the
The final requirements for the content of worker and handler pesticide safety training are available at 40 CFR 170.401(c)(2)-(3) and 170.501(c)(2)-(3), respectively.
Agricultural producer organizations expressed concern for the additional burden of the lengthier training. Some states asserted that several of the handler training points are beyond the scope of the WPS and should be addressed in applicator certification only. Specifically, they requested that EPA eliminate training on environmental concerns from pesticide use; proper application and use of pesticides; and requirements for handlers to understand the format and meaning of all information contained on pesticide labels and labeling, and to follow all pesticide label directions. These commenters stated that these training points are appropriate for persons who work under the supervision of certified applicators, but they do not relate directly to worker or handler safety. Two states recommended a revision to language in the handler training topics requiring that “all” information on the pesticide label would be required to be covered, stating that all labeling information may not be relevant to a given application.
In addition, this is not the first time that requirements included in the WPS have served purposes beyond the protection of agricultural workers and handlers. Section 170.210(a) of the existing rule requires that “The handler employer and the handler shall assure that no pesticide is applied so as to contact, either directly or through drift, any worker
One comment questioned the relevancy of environmental information in worker protection training. The Agency believes such training is relevant to worker protection. Many environmental concerns are applicable not only to the organisms in the environment, but also to workers and other persons who may be in that environment. Ground and surface water warnings, for example, are designed not to protect only aquatic organisms, but to protect workers and other persons who may be using the water for drinking, cooking, bathing, etc. The Agency notes that FIFRA defines “environment” as including “water, air, land, and all plants and man and other animals living therein, and the interrelationships which exist among these (Ref. 8).”
The final rule retains the requirement for handler training on environmental concerns related to pesticide use from the current WPS.
EPA does not agree that the training topic requiring handlers to receive instruction on proper application and use of pesticides is only appropriate for noncertified applicators making application under the direct supervision of a certified applicator. First, handlers routinely apply pesticides, and misapplication of pesticides can result in injury to persons covered by the WPS, including workers and handlers. Training on proper use can help prevent such misapplication and consequent exposure to people. Second, relying solely on the training of noncertified applicators under direct supervision would cover only applicators using Restricted Use Products (RUPs), and many agricultural use products covered by the WPS are not RUPs. To ensure that handlers under the WPS have the training to apply pesticides properly, it is necessary for them to be trained on proper use. The final rule includes the handler training topic requiring information on proper application and use of pesticides.
EPA does not agree with the commenters that requirements for handlers to understand the format and meaning of information on labels and to follow labeling directions are only appropriate for noncertified applicators applying under the supervision of certified applicators. To properly handle agricultural pesticides covered by the WPS rule, handlers need to understand the information on the labeling related to safe use of the pesticide and follow the use instructions. Use of a product in a manner inconsistent with the labeling may cause injury or illness to the handler and to others. For a more detailed discussion of the comments and EPA's responses on issues related to labeling, see Unit XVIII.A.
EPA acknowledges concerns raised by agricultural producer organizations and states that eliminating the “grace period” combined with the proposal to limit who is qualified to conduct worker training could result in an inadequate number of people available to provide worker training. The final rule continues to allow certified applicators to be trainers of workers (see Unit V.D.).
The final regulatory text for these requirements is available at 40 CFR 170.401(c)(1) and 170.501(c)(1).
The expansion of information provided in the training will enable workers and handlers to better protect themselves and their families, by increasing their knowledge of how to reduce take-home residues from treated areas. The training gives practical information that is useful to everyone who works with or around agricultural pesticides.
The requirement for recordkeeping is an important element of the training requirement. Although in itself not a protective factor, it will support the determination of compliance when partnered with worker and employer interviews and therefore promote adherence to the requirements. In the final rule the employer must provide the record to the worker or handler upon request. The burden of providing copies of training records will be offset by the reduction in the number of trainings that would otherwise have to be provided to workers and handlers who have already been trained at another establishment.
For outdoor production, EPA proposed requiring agricultural employers to post warning signs where the pesticide to be applied has an REI greater than 48 hours, and to allow the option of oral warning or posted notification for products with an REI of 48 hours or less. For enclosed space production, EPA proposed requiring posting of warning signs only when the product applied has an REI greater than four hours, and to allow the option of oral warning or posted notification for products with an REI of four hours or less.
3.
Several grower associations and farm bureaus supported the proposed change in notification requirements for indoor production but opposed the proposal for additional posting for outdoor production. They noted that signs can be destroyed, removed, or relocated and that agricultural producers may not return to some fields more than once per week. One grower association specifically requested that EPA clarify how enforcement would address these challenges without inappropriately penalizing agricultural employers. This group stated that workers are fully capable of understanding oral notification and suggest focusing instead on reinforcing the existing oral notification. Several grower organizations also did not agree that EPA justified the cost of the proposal with the benefits.
Farmworker advocacy organizations suggested a number of alternatives, including requiring both posting signs and providing oral warnings for all pesticide applications, or at a minimum for those pesticides with an REI of 12 hours or more. Some farmworker advocacy organizations suggested mandatory posting of any treated area subject to an REI greater than 24 hours, and others requested that EPA require mandatory posting of any treated area subject to an REI. They reiterated EPA's rationale that oral notification of pesticide application information is difficult to recall over multiple days, that oral notification may not be clearly communicated due to multiple language barriers and that it is difficult to verify whether oral notification was in fact given.
EPA disagrees with comments that suggest oral notification alone would provide sufficient notification to workers and agrees with comments that support increased posting requirements. As noted in the proposal for this rule, research has shown that oral instruction alone may not be an effective method of safety instruction. EPA is aware that compliance with the posting requirement for outdoor production could require some establishments to change their business practices or monitor posted fields more often.
EPA considered additional posting requirements presented by farmworker advocacy organizations and was not convinced that the increased cost to employers to post all treated areas, or to post areas treated with products with REIs of 12 hours or greater, or 24 hours or greater would result in significantly more increased protections than the requirement to post areas treated with products with an REI longer than 48 hours. EPA concluded that it is reasonable to expect workers to remember oral warnings regarding REIs for two work days, or about 48 hours total, and reasonable to require visual reminders for longer periods.
3.
A number of states commented that the existing sign is sufficient. They noted that although “Entry Restricted” is more accurate, it would be a costly change for growers that may lead to confusion and not be more protective than the language on the existing warning sign. States also commented that 20 years of training and experience with the current sign is what makes it effective for keeping workers out of fields under an REI. The states and farmworker advocacy organizations agreed that for the predominantly low-literacy population of farmworkers, a simpler message, along with training on the message, is more protective than the proposed wording for the warning sign.
3.
Some pesticide manufacturers opposed the proposal on the grounds that it is an overly prescriptive, costly, and unnecessary provision which would not provide additional protection above that already provided by the label and existing WPS.
A public health organization proposed adding pesticide application information and REIs to the posting requirement near worker housing areas. One state suggested revising the language by stating “Each border with any worker housing area provided by this establishment/employer within 100 feet of the treated area.”
EPA proposed to replace the existing requirement for the application information to be located at the central display with a requirement for employers to make the application information and additional hazard information accessible upon request by workers, handlers or their authorized representatives.
The designated representative must provide written evidence of such designation, including the name of the worker or handler being represented, a description of the specific information being requested, including dates of employment of the employee, the dates for which the records are requested, the type of work conducted by the worker or handler during that period, a statement indicating that the representative is designated by the worker or handler, the specific application and/or hazard information requested, a statement designating the representative to request the information on the worker's or handler's behalf, the date of the designation, and the printed name and contact information for the designated representative. If the information is to be sent to the requester, direction for where that information must be sent is to be included. When the employer is presented a request that contains all of the necessary information specified in the regulations, the employer must provide a copy of, or access to, all of the requested information that is applicable within 15 working days from the receipt of the request. Failure to respond to the request would be a violation of the rule. The final regulatory text for this requirement is available at 40 CFR 170.311(b)(9).
Workers and handlers who worked on the establishment may request, orally or in writing, the pesticide-specific information retained by the employer. The information must have been displayed while the worker or handler worked on the establishment. The employer must provide access to, or a copy of, the information within 15 days of the request. The regulatory text for this requirement is available at 40 CFR 170.311(b)(7).
Under the requirements to provide records to workers, handlers, and designated representatives, EPA also added language similar to that found in OSHA regulations (see 29 CFR 1910.1020(e)(1)(v)) to ensure that whenever a record has been previously provided without cost to a worker, handler, or their designated representative, the agricultural employer may charge reasonable, non-discriminatory administrative costs (
Medical personnel or persons acting under their supervision may also request the pesticide-specific
Lastly, the final rule makes some changes to the content of the required pesticide application information and when it must be posted, as explained in Units VII.C. and VII.D. The final regulatory text for this requirement is available at 40 CFR 170.311(b).
Most of these commenters supported the inclusion of a designated representative who could request the hazard information on behalf of a worker or handler, including farmworker advocacy organizations citing OSHA's requirements at 29 CFR 1910.1020(e)(1) that establish access to exposure records for workers in other industries. Comments in support of including access to hazard information by workers' or handlers' designated representatives note that workers and handlers may be reluctant to request the information for themselves due to their inability to communicate effectively with, or fear of, their employer, or because they may not be able to understand the information without help. One comment described a situation where a farmworker advocacy organization requested such information from an employer on behalf of two ill workers, but their request was denied because the workers themselves did not make the request.
In contrast, there was significant opposition from the agricultural industry to the proposal for the authorized representative, including growers, pesticide manufacturers, and their organizations, some states, and the Small Business Administration's Office of Advocacy. Comments from these groups centered on the additional burden on employers to provide the records. Commenters also expressed concerns that allowing access to pesticide application information by designated representatives could be abused by anti-pesticide organizations, who could send people onto the establishment requesting information purportedly on behalf of a worker or handler. In addition, some farm bureau comments stated that the requirement for providing the information to a representative is a violation of farmer's legal and privacy rights, stating that the representative could demand all information related to pesticides on that establishment.
Some commenters provided recommendations to improve the proposed requirement for a designated representative. Suggested improvements included limiting the designated representative requirement to current workers and handlers or to employees who worked on the establishment within two years of the request, limiting access to medical personnel only, or limiting the request to a specific incident. Many commenters recommended that the request be in written form, and include designation of the representative by the worker or handler. One state recommended defining a time frame for provision of the information to the requester. Another state suggested that the request clearly identify the information required to be provided to the authorized representative, and the purpose of the request or intended use of the information.
Many of the commenters in favor of keeping the existing central display requirement explained that a central display requirement that provides information about general pesticide safety, including symptoms of pesticide illness, and the specific pesticides used on the establishment, is necessary to protect the health of workers and handlers. First, having information available in non-emergency situations could help workers and handlers be aware of symptoms before they occur, help them avoid exposure, and possibly enhance the reporting of illnesses. Secondly, they stated that emergency medical personnel would not have to lose critical time tracking down information instead of treating the ill or injured person if they could rely on accessing the information quickly from the central display.
EPA also received comments from one pesticide manufacturer organization, a couple of states and some farm bureaus in favor of the proposal to eliminate the existing requirement for a central display of pesticide application information. These commenters agreed with EPA's observations in the preamble to the proposal that this requirement imposes a paperwork burden and that states often cite employers for technical violations of the display requirement. The commenters stated it is difficult to keep the displayed information current when application plans change, especially on large establishments. They also noted the difficulty keeping information legible when it is displayed at a central location subject to weather conditions. These commenters encouraged EPA to eliminate the existing central display requirement, not to finalize the proposed requirement to provide hazard communication information to workers, handlers, or their designated representative, and to require employers to only keep records of pesticide applications on their establishment.
EPA recognizes, however, that there can be difficulties in complying with the central display requirement. In response to comments about the difficulty of keeping accurate information posted, EPA has attempted to simplify the central display requirement by changing the required time frame for posting the application-specific information (see Unit VII.D.). EPA expects this modification to the requirement for the timing to post the application information will reduce the burden on employers, while providing employees with ready access to accurate information. In response to the comments about the difficulty of maintaining a legible central display when it is subject to weather conditions, EPA notes that the central display requirement does not mandate that employers post the information outdoors. The information must be displayed “where workers and handlers are likely to pass by and congregate and where it can be readily seen and read” and workers and handlers must be able to access the information at all times during work hours. This does not preclude the central display from being maintained in a location sheltered from weather conditions, such as a bathroom, break area, or changing area, as long as the requirements of this section are met.
EPA has been convinced by comments in support to retain the option for a designated representative to access hazard information (application information and SDS) on behalf of a worker or handler. EPA agrees that including in the rule a requirement, based on OSHA's rule at 29 CFR 1910.1020, for employers to provide the information to a representative who has been designated to act on the behalf of the worker or handler would give workers and handlers more access to information related to pesticides used in their workplace. Also, EPA is aware that California and Texas regulations include requirements for employee representatives' to be given access to hazard information for farmworkers, and comments from the Texas Department of Agriculture encouraged EPA to require the designation in writing and to limit access to records to the retention timeframe of two years. EPA is unaware of issues related to worker representatives in those states.
In response to the many comments opposing the establishment of the authorized or designated representative based on concerns for the potential for anti-chemical activists fraudulently acquiring records, the final rule includes a requirement for the representative to provide to the employer documentation (written authorization) signed by the worker or handler that clearly designates that person to act as his or her designated representative. The information that can be obtained is limited to the application and hazard information that is required by § 170.311(b) of the final rule that was required to be displayed while the worker or handler was on the establishment, and for the dates applicable to the worker's or handler's dates of employment on the establishment. The employer must provide the information regardless of the worker's or handler's employment status on that establishment at the time of the request.
EPA was convinced by comments about the need for the pesticide specific information by medical personnel treating workers or handlers who may have been exposed to pesticides on the establishment, and has added a requirement that employers promptly provide the information to the requesting medical personnel or persons they supervise. The information would help ensure that the medical considerations would include the possibility that a pesticide exposure was involved in the worker's or handler's illness.
EPA proposed to require employers to provide workers and handlers with access to the SDSs and pesticide labeling for products that have been applied on the establishment and to which workers and handlers may be exposed, in addition to the pesticide application information already required to be made available.
Some farmworker advocacy organizations, public health organizations, a grower organization, a farm bureau and others thought it would not be much of a burden on agricultural employers to acquire the SDSs of pesticide products because they are easily available online or can be requested from the pesticide manufacturer or distributor. One farmworker advocacy organization gave the Washington State Employer Hazard Communication rule (EHC rule) as an example of a requirement for employers to make SDSs available to employees that is feasible.
EPA received some comments both for and against providing pesticide product labeling. Many farmworker advocacy groups supported a requirement for the employer to provide the labeling. These commenters maintained that workers and handlers want more information on chemicals to which they may be exposed. On the other hand, farm bureaus, growers and grower organizations and states opposed a requirement to provide the labeling. These commenters expressed concern that EPA is expanding its mandate by requiring agricultural employers to provide the product “labeling” when it should be limited only to the WPS portions of the “label.” These commenters argued that an agricultural employer could easily violate this requirement by not having the most current or correct version of the labeling, such as a specimen or technical label.
EPA is persuaded that access to SDSs is not a significant obstacle to requiring agricultural employers to keep and display SDSs for pesticide products used on the establishment. Agricultural employers can obtain SDSs from the distributor of the pesticide, online, or upon request from the product manufacturer. For example, employers in industries other than agriculture—including retailers and wholesalers of agricultural chemicals—are required by the OSHA Hazard Communication Standard to make available SDSs to their employees.
Upon consideration of the comments, EPA has decided not to require agricultural employers include the pesticide product label or labeling as part of the central display requirement. EPA recognizes the burden on employers to provide both the SDS and label or labeling in addition to the pesticide application information. As noted previously, the SDS contains the health-related information requested in comments by worker advocates, and that would be most useful to persons providing treatment to those who may have been exposed to pesticides. EPA agrees that if necessary, the labeling for a product used for a specific application can be located using the application-specific information that employers are also required to post. See Unit XVIII.A. for a complete discussion of comments related to labels and labeling.
Many farmworker advocacy organizations suggested that EPA require SDSs to be available in multiple languages and provided two examples of similar requirements. First, one farmworker advocacy organization cited the Migrant and Seasonal Agricultural Worker Protection Act (29 U.S.C. 1801,
EPA has decided not to reduce the amount of time the SDS must be available. The cost of retaining the SDS, once obtained, is negligible. Employees and medical personnel could benefit from access to the health effects information in the SDS in case of symptoms that develop sometime after the application has been completed.
EPA disagrees with commenters' request to adopt a full hazard communication proposal as required by the Washington State ECHC for all hazardous chemicals. The full set of the WPS requirements in the final rule provide protections similar to those provided to workers in other industries under OSHA's Hazard Communication Standard program, while recognizing differences between agriculture and other industries. As discussed in the Agency's 1992 proposed rule on the Worker Protection Standard; Hazard Information (Ref. 18), in response to numerous concerns about potential overlap or conflict between EPA's July 1988 proposed WPS (Ref. 18) and OSHA's August 1988 proposed Hazard Communications Standard (Ref. 19), EPA committed to work with OSHA to minimize confusion and avoid duplication between the two agencies' requirements. Rather than require agricultural establishments that may not routinely use the same pesticides to develop and maintain a written Hazard Communication Standard plan listing all chemicals that will be used in the workplace, EPA's approach, in both the 1992 proposed rule on Hazard Information (Ref. 20) and this final rule, has been to identify specific requirements, tailored to fit the context of pesticide use in agricultural production that serve a purpose similar to the Hazard Communication Standard requirements in other industries. These requirements include pesticide safety training, display of basic pesticide safety information, notification or posting of treated areas, and access to information about pesticides used in the workplace at a central location. EPA notes that the WPS does not exempt employers with 10 or fewer employees, unlike OSHA's Hazard Communication Standard. EPA also notes that the cost of a developing and implementing a full hazard communication program specific to each establishment could be burdensome to small agricultural establishments.
Lastly, although EPA is not requiring that SDSs be translated at this time, EPA encourages and supports employers to display this information in such a way that workers and handlers can understand, including translation. EPA is open to conferring with stakeholders on the need for translation and identifying content to be translated, if necessary. EPA notes that some pesticide manufacturers already make pesticide product SDSs available in Spanish and EPA encourages employers to display Spanish SDSs where available and appropriate.
EPA proposed to require the agricultural employer to record and make available, in addition to the information required in the existing regulation: The specific crop or site treated, the start and end dates and times of the application, and the end date and duration of the REI.
The agricultural employer must record and display the information about the crop or site treated and the location of the treated area. EPA encourages employers to display the information in such a way that workers and handlers can understand and distinguish each treated area from all other areas on the establishment; in some cases, a map or diagram may be appropriate.
EPA encourages and supports the provision and display of the application information so it is most useful to workers and handlers on the establishment. One such option is to separate the information about treated areas, so those areas where an REI is in effect are distinct from those where the REI has expired, allowing the viewer to more quickly identify areas where entry is restricted. Similarly, maps highlighting areas where an REI is in effect and those where the REI has expired could also present the information in a user friendly, pictorial manner. EPA also sees an opportunity for employers to provide information of this nature through texting and other electronic means to their employees, and encourages such communication, in addition to the requirement for maintaining this information as part of the central display.
Several farm bureaus, one grower organization and several states opposed any changes. These commenters asserted that the content required by the existing regulation is already too burdensome. Several farm bureaus opposed EPA's proposed expansion of the content of records stating that EPA had not justified it with quantifiable benefits. A few states, two farmworker advocacy organizations and other commenters suggested various combinations of records limited to three or fewer pieces of information. One grower organization argued that only a record of the active ingredient is needed for medical treatment, while another questioned how a record of the REI benefits the health and safety of workers. Lastly, these commenters maintained that recordkeeping of general use pesticide applications is not required by law, the proposed requirement is duplicative of state and federal requirements, and commercial applicators already keep records.
The WPS requires agricultural employers to maintain records because those records provide information that is important for the protection of their employees. While a significant number of agricultural employers may also be certified as private pesticide applicators, their status as private applicators does not exempt them from the WPS recordkeeping required of agricultural employers. The WPS does not require private applicators to maintain records on account of their status as private applicators.
The risks of concern under the WPS include both RUPs and non-RUPs, while certification requirements at the federal level, including recordkeeping, only apply to those using RUPs. Neither the USDA application record requirements for private applicators of RUPs, nor state application record requirements for commercial applicators fully cover the information needed under the WPS for the protection of workers and handlers. The USDA required information does not include the active ingredients, duration of the REI or the start and end dates and times of applications, nor does it apply to applications of non-RUP pesticides. Commercial applicators would have to record the information required by the state pesticide regulatory agency, which must at a minimum include the kinds, amounts, uses, dates and places of RUP applications. 40 CFR 171.7(b)(1)(iii)(E). Also, state pesticide regulatory agencies may or may not require records of non-RUP applications. Therefore, it is unlikely that all states' commercial applicator RUP application records will match exactly the record requirements of the WPS. Because the records required to be maintained by USDA and the states do not include all of the information needed for protection of workers and handlers, it is appropriate to require such recordkeeping through the WPS.
EPA proposed to require the agricultural employer to provide the pesticide application information, the SDS and labeling upon request during normal work hours, no later than the end of the day.
EPA proposed to require employers to retain, for each application of a WPS-covered pesticide, the pesticide application information, labeling and SDS, for two years from the date of the end of the REI for each product applied.
Commenters from some farm bureaus, grower associations, and Small Business Administration's Office of Advocacy opposed a two-year recordkeeping requirement, in part because they asserted that EPA could not show quantifiable benefits. These commenters argued it would be a paperwork exercise without health and safety benefits driven based on the needs of enforcement, and instead should be replaced with a minimal, non-intrusive requirement. One commenter suggested requiring employers to keep records only during the harvest season.
EPA notes that this recordkeeping requirement does not necessarily impose a duplicative burden on agricultural employers to obtain pesticide application information and SDSs twice—once to satisfy the central display requirement and once to satisfy the recordkeeping requirement. Agricultural employers may satisfy this recordkeeping requirement by the removal of the pesticide application information and SDS from the central display 31 days from the expiration of the REI (or from the end of the pesticide application if there is no REI) and retaining those records for two years from the date of application. EPA recognizes that some employers may choose to maintain electronic copies of pesticide application records and the product SDS. The WPS does not specify that records must be kept on paper, so an employer can maintain records electronically as long as the employer satisfies all related requirements of the WPS, such as being able to quickly access and provide the required materials in the event of a pesticide emergency.
The agricultural employer must display this information for workers and handlers employed by the establishment at the central location. The current WPS requires handler employers to inform agricultural employers before the application takes place when there will be changes to scheduled pesticide applications, such as changes to scheduled pesticide application times, locations, and subsequent REIs.
In addition to maintaining the current requirements, EPA proposed to require the agricultural employer to also provide to the handler employer information about the location of “entry-restricted areas” on the establishment. EPA also proposed to require the handler employer to communicate to the agricultural employer the start and end times of pesticide applications and the end date of the REI. EPA also proposed to relax existing WPS requirements by requiring handler employers to provide information about any changes to pesticide application plans to the agricultural employer within two hours of the end of the application rather than before the application. Changes to the estimated application end time of less than one hour would not require notification.
Finally, in the proposal, EPA unintentionally omitted the provision in the existing WPS that the agricultural employer need not provide information to the handler employer about treated areas if the handler will not be in or walk within one-quarter mile of those treated areas.
EPA's proposal on the timing to provide notice of a change in application plans elicited many comments. EPA proposed that this
To prevent confusion about scheduled and actual start and end times and to avoid miscommunication, one state suggested that EPA require the handler employer to inform the agricultural employer of changes at any time on the application day. Two aerial applicators explained that a two-hour window for notification of change sounds reasonable on paper, but not in practice. During long workdays of the busy season, applicators would have to make phone calls in the middle of the night and send text messages, usually from the airplane during or in between applications. Also, it can take more than one day to complete an application because of factors such as the weather, a change in wind direction, or verifying the presence of bystanders. These situations could require the handler to give several updates to multiple parties, resulting in a greater chance for errors and noncompliance.
One commenter requested that EPA require notification of a change within 24 hours from the end of the actual application, while another advised EPA to require notification if the actual application completion time is two or more hours later than the scheduled application time. Several farm bureaus, a pesticide applicator and a crop consultant organization advised EPA to require that changes in application plans be communicated: Before the scheduled date and times, if the application is going to be made earlier than expected, or before the end of the REI as scheduled, if the application is made later than expected. One aerial applicator stated that if an REI is greater than 24 hours, EPA should require an information update before the scheduled REI expires or within 24 hours of the scheduled application time. Another aerial applicator recommended the handler employer and handler give the agricultural employer a window of estimated start and completion date(s) and time(s). In this situation, the handler would not make the application outside of that window without the approval of the agricultural employer, who in turn must keep workers out of the area during that time, unless notified of a change in the application start and completion date(s) and time(s).
Many commenters noted the absence of the existing provision that the agricultural employer need not provide information to the commercial handler employer if the handler will not be in or walk within one-quarter mile of an area that may be treated with a pesticide or under an REI, and noted this could result in the need to provide excessive, unnecessary information.
EPA has been convinced not to adopt the proposed change to expand the information required to be communicated by the agricultural employer to the handler employer to include information about the location of “entry-restricted areas” on the establishment. Requiring employers to exchange this information would not be practical given other changes in the rule related to the “entry-restricted areas” (replaced by “application exclusion zones” in the final rule) that make the tracking of such areas infeasible. EPA also agrees that it is not necessary for the handler employer to calculate the end time of the REI for each application and include it in the information conveyed to the agricultural employer. The requirement to provide this piece of information has been deleted from the final rule.
Most of the other information required to be exchanged by the final rule is already required to be exchanged by the existing rule, and therefore EPA does not agree that this requirement presents a substantially increased or unreasonable burden. Agricultural and handler employers are currently required to exchange information so agricultural employers may provide notification of application and treated areas under an REI to workers and handlers. Without this information transfer, accurate and timely notification would be difficult to achieve, exposing workers and handlers to potential exposure to pesticides. It is critical that the agricultural employer know the start times of applications in order to be able to notify workers and handlers (when they are on the establishment) so they may avoid treated areas. EPA recognizes that exchange of the expanded information may already occur on some establishments and expects those entities to experience less burden than in situations where such coordination has not already developed.
EPA recognizes that much of the information required may be available on sales agreements and purchase orders between commercial pesticide handlers and agricultural employers, which will reduce the burden for employers to gather it; however, without inclusion of the information exchange requirements in the WPS there is no assurance of timely exchange of all of the necessary information.
EPA considered the range of options suggested for the timing of the information exchange. Several of the recommendations for notification of application changes from the commercial pesticide handler employer to the agricultural employer can be accommodated under the final rule. For example, the applicator and agricultural employer can agree on a window of the estimated start and end times, with the understanding that the application would be made during that period, unless the two communicate and agree to a different timeframe. This would allow the agricultural employer to notify workers of the treatment, keep them from the area, and create and post the application information, satisfying the requirement.
EPA did not identify any suggestions from commenters, apart from those that would be covered by the final rule that would meet the needs for agricultural employers to provide employees notification of the application and inform them of treated areas under an REI, and to record and display the pesticide application information. Agricultural employers must have information about the start time of the application before it begins to ensure they have the ability to notify workers of the application before it commences. Agricultural employers must have the end time of the application to notify workers that although the application has ended, entry to the treated area remains prohibited because an REI is in effect. Without these details being provided prior to the application, agricultural employers are not able to fulfill their responsibilities to protect workers.
EPA notes that the method for notification of changes to application information should be agreed upon between the handler employer and the agricultural employer to ensure receipt, and can be accomplished through electronic media, telephone, or other means. The agricultural employer must receive the information in sufficient time to record and display the information for workers and handlers.
EPA expects these changes will ensure that the agricultural employer provides workers and handlers with accurate application information, which was problematic under the existing rule, and maintains accurate application records. The information exchanged and the timing of notification of changes of actual applications from scheduled applications remains essentially unchanged. Although notification can be given after the fact if a different pesticide product is applied or the application is completed after it was scheduled, this change does not make the WPS any less protective of workers, handlers and others. The agricultural employer will still have the essential information needed to know when and where to keep workers, handlers and others out of areas to be treated during and after treatment, and the revised information will be available in time for proper medical treatment if needed. The cost of including additional details is reasonable compared to the improved ability of workers and handlers to identify areas where pesticides are being applied or have recently been applied.
The requirements discussed in this section are intended to decrease the number of incidents in which workers and other persons are exposed to pesticides through unintentional contact during application. Drift is the off-site movement through the air of pesticide droplets or particles originating from pesticides applied as liquids or dry materials. Workers errantly in the area being treated may be directly exposed to pesticides during application. In addition, bystanders (both workers and non-workers) located outside a treated area may be exposed when pesticide droplets or particles move outside the area being treated through the air during and/or immediately after the pesticide application. As used here, the term “drift” includes both of these modes of exposure, but does not include off-site movement of pesticide-imbedded soil-borne particles by wind or vapor drift through volatilization of applied pesticide, although these are often categorized as “drift” in other contexts. EPA has developed methodologies for assessing the risks to bystanders from exposure to pesticides from drift and also from volatilization, and addresses risks of concern and other issues via the registration review process. The purpose of the requirements discussed in this section is to prevent workers and other persons from being exposed to pesticides by unintentional contact during application. The term “drift” is used as shorthand in this section to refer to unintentional exposure from both direct exposures to workers in the area being treated and drift exposures to workers and bystanders.
EPA did not propose any changes to the label statement. EPA proposed several minor wording changes to the WPS requirement for the handler employer and the handler, but the impact of the proposed requirement would be the same as under the existing WPS.
Many respondents from states and their organizations, grower associations, farm bureaus and pesticide manufacturer associations commented that EPA's risk assessments and pesticide labels include conservative protections for applicators, handlers, workers and bystanders. Some of these commenters argued that the existing restrictions on the labels, including REIs and pesticide-specific buffers, provide sufficient protection to workers and bystanders.
Many respondents from all commenter types commented on incidents where workers or bystanders reported being contacted by pesticides that were being applied. Some of these incidents involve workers in the areas where pesticides were applied and other incidents involve workers or bystanders being exposed to pesticides that drifted off the target site. Many of the commenters cited three broad studies that looked at data from SENSOR-
There is no one solution that can prevent all drift incidents and it will take a comprehensive approach, including additional regulatory requirements, education, outreach, and some common-sense voluntary measures to further reduce the number of people who are directly exposed to pesticide spray/applications. The additional regulatory requirements include revised requirements for entry restrictions during pesticide applications and for handlers to suspend applications in certain circumstances. Common-sense voluntary measures include a grower talking to his/her neighbors to let them know when pesticides are being applied so the neighbors can keep workers and others away from the boundary of adjacent establishments during that time, and participating in voluntary communication programs such as Spray Safe (
EPA proposed to establish entry-restricted areas during pesticide applications on farms and in forests, while slightly modifying the requirement for entry-restricted areas for nurseries and greenhouses. EPA proposed two types of entry restrictions: One for enclosed space production, which would apply to greenhouses and other types of indoor production operations (
In regard to outdoor production (
Many farmworker advocacy organizations and several public health organizations argued that EPA should revise the approach for entry restrictions to protect workers on neighboring property and to increase the length of the entry-restricted area. The recommended distances ranged from 60 to 200 feet for ground application and 300 feet to a mile or more for aerial application. EPA responded to some of these suggestions in its response to “Pesticides in the Air—Kids at Risk: Petition to Protect Children from Pesticide Drift (2009)” (Ref. 13).
Most of these commenters asserted that the proposed requirement to apply entry-restricted areas to farms and forests would present some logistical issues that could effectively shut down parts of the establishment. For example, many ground and aerial pesticide applications occur along rural roads or near access points to the agricultural establishment. These roads and access points would be within the proposed entry-restricted areas. On larger fields, pesticide applications could take several hours to complete. Commenters claimed that prohibiting workers from using these roads or gaining access to farm buildings for long periods of time would be impractical and could have an adverse economic impact. Many of the commenters stated that EPA did not account for the cost of stopping business during some pesticide applications. As an example, one grower organization opposed the “worker buffers” because they could take a lot of area out of cultivation on smaller farms, farms with widely varied crop maturities and farms that are not laid out in large blocks. Instead of arbitrary buffers, this commenter argued to keep the standard as it is—do not apply where workers are present and do not allow spray (or drift) to contact workers.
EPA has changed the final rule in several ways to address some of the concerns expressed in the comments about the logistical problems with the proposal. First, in the final rule EPA replaced the term “entry-restricted area” with “application exclusion zone,” which more clearly associates this restriction with the period during the pesticide application. This new term is also less likely to be confused with the term “restricted-entry interval.” Second, EPA revised the requirements for the application exclusion zone so that it is not based on the “treated area,” but instead a specified distance from the application equipment. The application exclusion zone is essentially a horizontal circle surrounding the application equipment that moves with the application equipment. For example, if a pesticide is applied aerially, the border of the application exclusion zone is a horizontal circle that extends 100 feet from the place on the ground directly below the aircraft, and moves with the aircraft as the application proceeds.
Because the application exclusion zone is based on the location of the application equipment, rather than the location of the treated area, the application exclusion zone could extend
The comments reflected a general lack of understanding that the proposed entry-restricted areas would exist only during application, and many comments anticipated conflicts between no-spray buffers on some pesticide labels and the proposed entry-restricted area. However, these are two different types of requirements. If a label specifies a “no-spray” buffer, pesticide cannot be applied in that area at any time. Under the final rule, a pesticide can be applied in an application exclusion zone, and the requirement for agricultural employers is to keep workers and other people out of this zone during the pesticide application. These two types of requirements are distinct, and as a result should not be problematic to implement.
EPA reassessed the application methods and distances in the proposed requirements for entry-restricted areas for outdoor production and made some changes in the description of application exclusion zones in the final rule in § 170.405(a)(1). The final rule maintains the proposed distances of 100 feet and 25 feet but revises the application methods associated with each distance.
The application methods that have an application exclusion zone of 100 feet are the ones where pesticide is expected to move a longer distance from where they are applied. The changes include:
The application methods that have an application exclusion zone of 25 feet are the ones where pesticide is expected to move a shorter distance from where they are applied. The changes include:
The corresponding changes to application methods were made to the Table—Entry Restrictions During Enclosed Space Production Pesticide Applications at 40 CFR 170.405(b)(4) for consistency.
EPA acknowledges that some pesticide labels will have restrictions that apply during applications that are different than the application exclusion zones. For example, the restrictions on soil fumigant labels are more restrictive than the application exclusion zone of 100 feet specified in § 170.405(a)(1)(i)(D). In situations like this, pesticide users must follow the product-specific instructions on the labeling. As stated in §§ 170.303(c) and 170.317(a), when 40 CFR Part 170 is referenced on a pesticide label, pesticide users must comply with all of the requirements in 40 CFR Part 170, except those that are inconsistent with product-specific instructions on the pesticide product labeling.
The final rule requires the handler performing the application to suspend application if people who should not be present are in the application exclusion zone (which ranges up to 100 feet from the application equipment for outdoor production) or in the area identified for exclusion for enclosed space production (which ranges from 25 feet to the entire enclosed space plus any adjacent structure that cannot be sealed off.) The final regulatory text for this requirement is available at 40 CFR 170.505(b).
Many states and their organizations, grower organizations, farm bureaus, applicator organizations, agricultural producer organizations and pesticide manufacturer organizations opposed the proposed requirement for handlers to stop or suspend pesticide applications in certain circumstances. Most of these commenters argued that the provision is unnecessary because it would not offer any protections or prevent contact from pesticide applications beyond the existing “do not contact” requirement. Some commenters raised logistical concerns: Applicators may not be aware that a person has entered a treated area or entry-restricted area in many situations, such as in a forest or an orchard in full leaf, in a very large field, or if there are restricted sight lines or rolling hills; the proposed requirement would impose unwarranted expectations for pilots, who would have to be fully aware of boundaries 100 feet on all sides of the target area while traveling at 150 mph; as proposed, an applicator would have to stop if a person is in an entry-restricted area even if it is not possible for that person to encounter pesticides because of wind conditions.
A few grower organizations and farm bureaus commented that there is a difference between stopping and suspending an application and asked whether this would require applicators to cease application altogether or suspend the application until a person is no longer in the area.
However, EPA revised the final rule in response to several points made by commenters. First, the final rule requires a handler to “immediately suspend a pesticide application” rather than to “immediately
EPA was persuaded by the commenters who raised logistical concerns about the proposed requirement, which were related to the handler not being able to see the person or a person entering an edge of a large area that is not near the application equipment. EPA revised the requirement in the final rule to decrease the size of the area that the handler must monitor for workers or persons other than handlers by removing the treated area from the area covered by this requirement and by changing the “application exclusion zone” so it is measured from the application equipment rather than from the edge of the treated area. In the final rule, the handler performing the application must suspend application if any of the identified people are in the application exclusion zone (which ranges up to 100 feet from the application equipment) rather than if any of the people are in the entire treated area plus that distance (up to 100 feet) from the edge of the treated area.
EPA was also persuaded by the comments and incident information about workers at neighboring establishments being directly contacted by drift. The incidents cited by commenters show that workers are directly exposed to pesticide applications from neighboring establishments as well as from the establishment where they are working. To reduce the number of incidents where workers are exposed to drift from neighboring establishments, the final rule extends the application exclusion zone beyond the boundaries of the agricultural establishment for this requirement, thus requiring applicators to immediately suspend applications if people other than a properly trained and equipped handler are in the application exclusion zone.
EPA has decided to extend the application exclusion zone beyond the boundaries of the agricultural establishment for the requirement to suspend applications for several reasons. First, this addresses more of the worker drift cases, where workers are within 100 feet of the agricultural establishment to protect more workers. Out of 17 incidents identified in the comments, only one would have been prevented if the application exclusion zone was limited to the boundaries of the agricultural establishment as provided in the proposed rule. The requirement in the final rule would have prevented at least four of the incidents reported in the comments, and possibly as many as 12, depending on the actual distances between the workers and application equipment, which were not specified in the comments. Second, the existing requirement that the handler must assure the pesticide is applied in a way that does not contact workers or other persons already extends beyond the boundary of the agricultural establishment. The new, explicit requirement to suspend application if people other than handlers are in the application exclusion zone is intended to supplement the existing “do not contact” requirement by giving the applicator specific criteria for suspending application. These specific criteria should be equally useful to applicators attempting to comply with the existing “do not contact” requirement beyond the boundaries of the agricultural establishment. Third, the application exclusion zone would extend a maximum of 100 feet beyond the boundary of an agricultural establishment only for the length of time it takes for the equipment applying the pesticide to pass by, so this should not shut down roads or access points to the establishment for long periods of time.
The existing regulation does not establish any age restriction for handlers or early-entry work. EPA proposed to prohibit persons younger than 16 years of age from handling pesticides, with an exception for handlers working on an establishment owned by an immediate family member. EPA requested comment on an alternative option of prohibiting any person under 18 years old from handling pesticides.
The existing WPS establishes conditions for when a worker may enter into a treated area under an REI. The conditions are related to the type of work performed (often referred to as “early-entry” tasks) and the length of time the worker may be in the treated area. However, the existing WPS establishes no minimum age for workers entering a treated area under an REI to perform early-entry tasks. EPA proposed to prohibit any worker under 16 years old from entering a treated area under an REI to perform early-entry tasks, with an exemption from this prohibition for persons covered by the immediate family exemption. EPA requested comment on an alternative option of prohibiting any person under 18 years old from entering treated areas during the REI to perform early-entry tasks.
The final rule prohibits persons younger than 18 years old from handling pesticides. EPA has retained the proposed exemption for handlers working on an establishment owned by an immediate family member. The final regulatory text for the prohibition is available at 40 CFR 170.309(c) and 170.313(c). The final regulatory text for the exemption is available at 40 CFR 170.601(a)(1)(i).
The final rule prohibits persons younger than 18 years old from entering treated areas during the REI to perform early-entry tasks, and retains the proposed exemption for persons working on an establishment owned by an immediate family member. The final regulatory text for this prohibition is available at 40 CFR 170.309(c) and 170.605(a). The final regulatory text for the exemption is available at 40 CFR 170.601(a)(1)(xii).
Some commenters expressed support for a minimum age of 16. States primarily supported EPA's proposal to establish a minimum age of 16, noting that establishing a minimum age of 18 would require them to change their state laws. Other commenters supporting the proposed minimum age of 16 noted that this requirement would align with DOL's restriction on handling pesticides in toxicity categories I and II in agriculture.
A few commenters opposed establishing any minimum age. These commenters asserted that EPA should not take any action because the DOL's hazardous occupations orders under the Fair Labor Standards Act (FLSA) already prohibit adolescents under 16 years old from handling pesticides in toxicity categories I and II in agriculture with limited exceptions. Some commenters also assert that establishing any minimum age for pesticide handlers is a matter that should be handled by the states, not EPA.
Some commenters requested that EPA eliminate the exception from any minimum age requirement for members of the owner's immediate family. Commenters assert that adolescents' developmental status does not differ if they are an employee on a farm owned by an immediate family member or by someone unrelated to them. Other commenters supported EPA's proposal or requested that EPA establish a higher minimum age only if EPA also retains the exception for members of the owner's immediate family.
EPA notes commenters' assertions that avoiding pesticide exposure in adolescents could result in higher potential economic benefit because of adolescents' longer potential lifespans. EPA agrees that it is appropriate to take reasonable precautions to protect adolescents from pesticide exposures, both because of the potential impact of pesticides on further development and because adolescents may not properly appreciate (and take appropriate steps to avoid) the risks of potential pesticide exposure. While statistical associations have been observed in studies that estimate the relation between pesticide exposure and chronic health outcomes such as cancer, the causal nature of these associations has not yet been determined; thus quantifying the magnitude of the chronic health risk reduction expected as a result of pesticide exposure reduction is not possible. However, based on what is known about the potential for biologically active chemicals generally to disrupt developmental processes, it is reasonable to have heightened concern for adolescents under the age of 18 in situations where they face particularly high pesticide exposures. Prohibiting adolescents under the age of 18 from handling agricultural pesticides will protect them from any potential risks of pesticide use through handling activities, ensuring that adolescents do not suffer unreasonable adverse effects from handling agricultural pesticides. Prohibiting adolescents under 18 years old from entering a treated area while an REI is in effect will protect them by delaying their entry into treated areas until residues are at a level that should not cause unreasonable adverse effects.
EPA recognizes that DOL prohibits persons under 18 years old from engaging in hazardous tasks in other industries, and that some states have taken action to prohibit certain adolescents from handling pesticides in agriculture (state minimum ages for pesticide handlers, where established, range from 16 years old to 18 years old). These examples of protections for adolescents in other industries or by states indicate a recognition that different standards for certain adolescents and adults are appropriate.
EPA disagrees with commenters' assertions that EPA should defer to the states or the FLSA and not establish any age-related restrictions on pesticide handling or early-entry activities. EPA has the responsibility under FIFRA to regulate the use of pesticides to avoid unreasonable adverse effects, apart from any requirements established by other federal or state laws. The DOL's actions under the FLSA limiting the use of certain pesticides to persons at least 16 years old do not preclude EPA from taking actions to ensure that human health and the environment are protected from unreasonable adverse effects. While DOL's hazardous occupations order prohibiting those under 16 years old from handling certain pesticides satisfies the purposes of the FLSA, those purposes are distinct from those of FIFRA. EPA has concluded that because, as discussed previously, adolescents' bodies, maturity, and judgment are still developing, the handling of agricultural pesticides and entry into a treated area while an REI is in effect by persons under 18 years old presents an unreasonable likelihood of adverse effects. Therefore, the final rule generally limits pesticide handling and early-entry activities to persons who are at least 18 years old.
EPA agrees that adolescents' developmental status does not differ if they are employees on a farm owned by an immediate family or by someone unrelated to them. However, EPA recognizes that imposing a minimum age for handling agricultural pesticides or performing early-entry tasks on owners or members of their immediate families could significantly disrupt some immediate family-owned farms. Given the high social cost of imposing a minimum age requirement on owners and members of their immediate families on farms owned by members of the same immediate family, EPA has finalized the proposed exemption to this requirement.
EPA cannot quantify the benefits associated with this specific proposal. However, this requirement would improve the health of adolescent handlers, as well as other workers and handlers on the establishment and the environment. It would also improve the health of adolescent workers by reducing their potential for exposure to pesticides in a treated area when an REI is in effect. As discussed in the preamble to the proposed rule, adolescents' judgment is not fully developed. Restricting adolescents' ability to handle pesticides will lead to less exposure potential for the handlers themselves, and less potential for misapplication that could cause negative impacts on other handlers or workers on the establishment, as well as the environment.
In addition to these existing requirements, EPA proposed to require
Several agricultural producer organizations and pesticide manufacturer organizations supported the proposal, but expressed concern for the requirement for employers to manage heat stress.
EPA agrees with commenters that heat stress can be a problem for workers in warm, humid climes and when employees must wear PPE. EPA notes that requirements related to heat stress for early entry workers are already included in the existing rule at 40 CFR170.112(c)(6)(x) and 170.112(c)(7).
In addition, EPA proposed to limit the time a worker may be in the treated area under the agricultural emergency exception when the label of the product used to treat the area requires both oral and written notification (“double notification”). Under the existing rule, there is no time limit; EPA proposed to establish allowing workers to be in a treated area under this exception for a maximum of 4 hours in any 24 hour period.
Commenters also suggested that there is a need for entities other than EPA, state departments of agriculture and the state pesticide regulatory agencies to declare agricultural emergencies. In the examples provided by commenters, fires and broken irrigation or chemigation pipes could pose risks to the public and the crop.
The need for pre-approval for conditions that may result in an agricultural emergency is a requirement in the existing rule. EPA has responded to the concern of the grower organization through its Interpretive Guidance Workgroup on the existing WPS, which clarified that state pesticide regulatory agencies may establish guidance or regulations describing the circumstances that could constitute an agricultural emergency and for which entry into areas under an REI is permitted. If a grower determines that such conditions exist at a site, then workers may enter the area while the REI is in effect under the agricultural emergency exception, consistent with applicable restrictions.
EPA has decided not to expand the declaring agencies to include municipal agencies such as local fire departments, but will work with state pesticide regulatory agencies and departments of agriculture to support identification of circumstances that could constitute an agricultural emergency in their jurisdictions. EPA recommends that these entities identify, in their states, local conditions that could constitute such emergencies. Through state regulation or by policy, these agencies may pre-approve entry when such conditions occur.
EPA proposed to incorporate the terms and conditions for these exceptions into the final rule, and to eliminate the requirement for the need for irrigation to be unforeseen.
The existing rule also requires the employer to provide contact information for the nearest emergency medical care facility and to promptly update the safety information poster when any of the required contact information changes.
EPA proposed changing the term for what employers must display from “pesticide safety poster” to “pesticide safety information.” EPA proposed retaining the existing content requirements of the existing rule, with one exception. EPA proposed removing the item regarding federal rules to allow the other information to be more prominent. EPA proposed retaining the requirement to display the contact information for the medical facility and amending the language from “nearest emergency medical care facility” to “a nearby operating medical facility.” Finally, EPA proposed requiring the employer to provide on the display the name, address, and telephone number of the state or tribal pesticide regulatory agency.
The final rule delays implementation of the changes to the required pesticide safety information until two years after the rule is made final, in order to allow time for model pesticide safety information display materials to be developed and distributed.
In general, agricultural producer organizations did not object to the proposed changes for providing emergency medical information but two commenters were concerned about spurious reporting of alleged violations resulting from inclusion of the state or tribal regulatory agency in the pesticide safety information. Two commenters interpreted the proposal as requiring injured workers to contact state or tribal agencies responsible for enforcement for emergency medical attention. A grower organization pointed out that the nearest operating medical facility might change depending on the time of day and wondered if they needed to list hours of operation and addresses of all emergency medical care facilities in the area where the employer operates.
One commenter suggested the safety poster should always be in a standardized format and requested that EPA not allow the information to be displayed in several different formats.
In response to concerns about the placement of the medical facility information and the inclusion of regulatory agency information in the display, EPA has revised the regulatory text to clarify that the contact information about the medical facility must be clearly identified as the emergency medical contact information on the display. Displaying the regulatory agency information is important for the ability of workers and handlers to report possible violations, and in those states where it is already required, it does not appear to have generated spurious reporting of alleged violations. EPA appreciates that some states may already require employers to make such medical and regulatory information available and where state requirements meet or exceed the federal requirement, they do not need to be duplicated. However, EPA has added this requirement to the WPS to ensure the information is available to workers and handlers in all states.
EPA is finalizing the proposed requirement to identify a
EPA disagrees with the comment requesting that the information be displayed in a standardized format. As long as the information is provided in a way that workers and handlers can understand, EPA sees no need to mandate a specific format.
The remaining grower organizations believed that the proposed requirement would pose a significant burden. One commenter stated that duplicating the pesticide safety information at multiple sites throughout an agricultural organization did not equate to a better training program and believed this requirement would likely result in additional fines for noncompliance without raising safety awareness. Some pointed out that workers are bused in for a day in the field and irrigators are sent to different areas by phone; none of these congregate at a central location.
Many states opposed displaying the pesticide safety information at decontamination sites. Because of the mobile nature of many decontamination sites, such as the back of a pickup truck, some noted the proposed requirement would be burdensome. One indicated that it would be difficult for a grower owning fields across multiple counties to keep the pesticide safety information accurate. They generally supported displaying the pesticide safety information at permanent decontamination sites and base of operation mix/load sites. Several states asked for clarification about what types of decontamination sites would be required to display the pesticide safety information and suggested that portable toilet facilities and plumbed wash sites would be more appropriate locations.
Others mentioned the lack of protection from the weather of the pesticide safety information at OSHA-required restroom facilities and the lack of access to this information when the vehicles carrying decontamination supplies are locked up at night. Two states recommended different sizes for the pesticides safety information. One state suggested that pesticide safety information displays be no larger than 11 x 17 inches and laminated to withstand at least one year's worth of weather conditions for use at decontamination sites; this state also recommended resizing the existing pesticide safety information to 8.5 x 11 inches or less and made of durable card stock or plastic for the agricultural workers to take home.
EPA does not agree with the contention that requiring the pesticide safety information display at multiple locations would result in fines for noncompliance, without greatly benefiting the employee. The pesticide safety information display reinforces the
EPA appreciates the comments regarding display size and options for lamination. The final rule does not establish a specific size for the information or require it to be laminated. However, the final rule requires the information to be legible at all times while it is displayed, and EPA expects that employers will opt for the optimal size and protection from the elements for their specific needs. Because the final rule limits the type of decontamination sites covered by this requirement and includes flexibility for identifying the regulatory agency and a nearby operating emergency medical care facility, it is possible but unlikely that some growers with larger establishments may need to provide different specific contact information about the regulatory agency and/or the medical facility, depending on the area where workers or handlers are working.
Commenters suggested the information be available in English and Spanish. EPA notes that the requirement is for the information to be provided in a manner that the workers and handlers can understand, which may include making it available in English and Spanish, or in other languages as appropriate.
EPA plans to develop and make available to agricultural and handler employers posters bearing the pesticide safety information, in a bilingual and pictorial format and with space for employers to add the required regulatory agency and medical facility information. As discussed in the proposed rule, the information does not have to be displayed as a poster as long as the display includes the required information and meets the requirements of the section.
EPA requested comment on the proposed quantities of water and the use of waterless cleansing agents in place of soap, water, and single-use towels. EPA also requested information on the efficacy of waterless cleansing agents for removing pesticide residues.
Finally, one farm bureau commenter stated that large scale planting activities can place workers more than one-quarter mile from vehicular access, and retaining the existing requirement is more reasonable than expecting workers to carry washing water with them.
To ensure that workers and handlers needing emergency decontamination can use water that is more accessible than the decontamination water provided by the employer, the employer no longer must predetermine that the quality of the water meets the criteria or permit their employees access. The rule permits the use of natural waters for emergency decontamination, but does not require it. Workers and handlers seeking to mitigate an emergency exposure will be informed in their training to use the nearest clean water to immediately rinse off if such water is more readily available than the employer-provided decontamination supplies, and then go to where the employer-provided supplies are to fully decontaminate. EPA believes the benefits of using natural clean waters to decontaminate immediately in an emergency pesticide exposure situation outweighs the potential risks of making workers or handlers wait until they can use supplied decontamination water that has been evaluated for quality but may be less available to immediately address the exposure. EPA thinks that washing in natural waters in any agricultural area is unlikely to pose risks comparable to a significant direct pesticide exposure.
The term “potable” in the preamble and regulatory text for the proposed rule was a typographical error and has been corrected to “portable” in the final rule.
EPA does not believe there will be any cost associated with deleting the provision allowing employers to direct workers and handlers to use natural waters in addition to the decontamination supplies required by the rule. The final rule still allows workers and handlers to use clean, natural waters, but removes employers' obligation to ensure that the water is of a temperature and quality that will not cause harm.
Because EPA is not imposing a requirement for employers to provide shower facilities for handlers, there is no estimated cost. Refer to the Economic Analysis of the proposed rule for details regarding the estimated cost of requiring showers for handlers (Ref. 14).
The existing WPS requires employers of workers or handlers, including those handlers employed by the agricultural establishment or those working for a pesticide handling establishment, to provide prompt transportation to an emergency medical facility to employees who have been poisoned or injured by exposure to pesticides used on the establishment. Emergency medical assistance under the existing rule consists of the prompt provision of transportation to an emergency medical facility for the worker or handler and the provision of obtainable information about the exposure, including information about the product(s) that may have been used, to emergency
EPA proposed to require agricultural and handler employers to provide emergency medical assistance within 30 minutes after learning that an employee may have been poisoned or injured by exposure to pesticides as a result of his or her employment, replacing the current standard of “prompt.” The proposed change was intended to ensure that the potentially injured party would be on route to a medical facility within 30 minutes.
EPA also proposed that the employer provide a copy of the pesticide label, or specific information from the label, along with the SDS and circumstances of the pesticide use and potential exposure, to employees potentially injured by exposure to pesticides and to treating medical personnel.
EPA has retained the existing requirement for providing transportation and information promptly. The final rule clarifies that these requirements apply only to current or recently employed workers, and that emergency assistance must be provided if there is reason to believe that a worker or handler has been potentially exposed to pesticides or shows symptoms of pesticide exposure.
EPA has amended the requirement for the information that the employer must provide related to emergency assistance. The final rule requires the employer to provide to treating medical personnel a copy of the SDS, product name, EPA registration number and active ingredient for each pesticide product to which the person may have been exposed, as well as the circumstances of application or use of the pesticide on the agricultural establishment and the circumstances that could have resulted in exposure to the pesticide. This is a slight change to the existing rule which makes the information available to the worker or handler. In this final rule, the worker or handler has access to the information through the hazard communications requirement. This provision deals specifically with meeting the needs for medical assistance, and requires that the information be provided to the medical personnel.
EPA has clarified in the final rule that the provision of the emergency assistance requirement for transportation and information applies only to currently employed workers seeking emergency medical assistance or recently employed workers within 72 hours after their employment for acute exposures occurring on the agricultural establishment.
The final regulatory text for these requirements is available at 40 CFR 170.309(f) and 170.313(k).
Readiness is among the most important factors in an employer's ability to promptly carry out the emergency assistance requirements. EPA strongly encourages employers to develop an emergency response plan and to address in such a plan details related to the emergency medical assistance requirements of the WPS. EPA also encourages employers to periodically test, evaluate and, if necessary, update the plan. EPA will develop a sample plan to help employers prepare for possible pesticide-related emergencies. Employers can also find additional information concerning the development and implementation of an emergency preparedness program at the U.S. Department of Homeland Security's Web site,
Although EPA believes that it is important for employers to develop emergency response plans, EPA has not made this a requirement of the final rule. EPA recognizes that pesticide exposure is just one of many hazards that should be addressed in an emergency response plan, and that EPA has very little information about the extent of emergency planning in the agricultural community. Accordingly, EPA has decided that it would be unwise to address this issue in the WPS without the benefit of a more robust dialogue with all stakeholders.
The Progressive Congressional Caucus, many farmworker advocacy organizations and public health organizations expressed concern that the proposed emergency response time of 30 minutes is too long and recommended that it should be further reduced. Commenters reasoned that pesticide poisoning can be fatal or result in long-term effects if not quickly treated.
On the other hand, many commenters, mostly growers and farm bureaus, and some states and agricultural producer organizations expressed opposition to the proposal and favored retaining “prompt ” to allow more flexibility due to geographical constraints. The Small Business Administration's Office of Advocacy stated that small farms that are farther away from medical facilities would not be able to obtain emergency transportation within the timeframe. Those with few employees and limited transportation options would be overburdened in attempting to comply with a 30 minute timeframe.
Commenters representing many states, several agricultural industries, many growers and farm bureaus, and the Small Business Administration's Office of Advocacy recommended that emergency response requirements should apply only to current employees seeking emergency medical assistance for acute incidents.
Additional comments from states and their organizations recommended that the agriculture emergency requirement address only acute exposures to current employees of the establishment. They raised concerns for the potential for former employees or those with exposures in the past to request emergency assistance. One commenter stated that allowing any person who was ever employed by the establishment the ability to demand emergency assistance could cause problems with compliance and enforcement. Some of these organizations requested clarification of the term “emergency medical facility.”
Commenters also recommended that the requirement allow, similar to OSHA, trained first aid providers on the establishment to provide care, which could enable more timely treatment.
Commenters noted that requiring the employer to provide the label to employees potentially injured by exposure to pesticides and to treating medical personnel could lead to further exposure, if the employee takes an open container of pesticides bearing the label. Further, commenters suggested that the information outlined in the proposal could be obtained from sources other than the label.
The final rule requires employers to comply with the emergency assistance requirements by promptly making transportation available to an emergency medical facility for potentially injured employees and providing the SDS, specific product information, and information about the exposure to the treating medical personnel. Because the information about the pesticide may be critical to effectively manage the illness, EPA decided to focus the requirement to ensure that treating medical personnel receive the information. The agricultural employer must provide that information in a way that is reasonably expected to be accessible to the treating medical personnel. The requirement does not preclude the employer providing the information to injured employees and does not prevent injured employees from requesting this information. This requirement will allow continued flexibility for employers and encourage timely medical treatment for potentially injured employees.
In deciding to retain the requirement for prompt provision of transportation, EPA also took into consideration OSHA's standard for the provision of transportation to persons in construction, which requires “Proper equipment for prompt transportation of the injured person to a physician or hospital.” 29 CFR 1926.50(e).
EPA agrees with the recommendation to clarify that the requirement applies only to current or recently employed workers seeking emergency medical assistance for acute exposures occurred at the agricultural establishment, and has revised the final rule accordingly.
EPA notes that for some cases of suspected pesticide injury, the attention of a trained first aid provider can mitigate the injury. Such treatment would not negate the obligations of the employer to provide transportation promptly to an injured employee, or to provide information about the pesticide and exposure to medical personnel, but is encouraged. Allowing a competent first aid provider to administer timely treatment to an injured employee could offset complications from longer exposures.
EPA agrees with comments that a requirement to provide the label in the event of an emergency could be burdensome and place employees at risk for additional exposure if the label is attached to an open container of pesticides. EPA has not included the proposed requirement to provide the label or information from the label; rather, the final rule requires the employer to provide the necessary information, but does not specify the source of the information. EPA has removed from the list of specific pieces of information the employer must provide information about antidote, first aid, and recommended treatment because the SDS contains this information. EPA notes that the information about the product and the SDS will be available as part of the pesticide application and hazard information.
In response to the requests for clarification of what qualifies as an emergency medical facility, EPA notes that a hospital, clinic, or infirmary offering emergency health services qualifies.
Finally, the employer must provide information about the pesticide and the exposure to the treating medical personnel.
There are no incremental costs associated with the decision to retain the requirement of prompt provision of transportation in the existing rule. The cost associated with the SDS were included in the costs for the pesticide application and hazard information. There are significant benefits to reducing damage from pesticide exposure by prompt medical attention.
EPA proposed to require handler employers to comply with the respirator fit testing, training, and medical evaluation requirements set by OSHA at 29 CFR 1910.134 whenever a respirator other than a dust or mist filtering mask is required by the labeling. EPA did not propose any new requirements for filtering facepiece respirators (OSHA's term for dust or mist filtering masks). The OSHA standard includes a specific standard for fitting a user for respirator use, training on recognizing when the respirator seal may be broken, and what steps to take to properly use and maintain respirators. OSHA also requires respirator users to be medically evaluated to ensure the respirator use does not cause undue stress on their bodies. EPA proposed to require that employers comply with the OSHA requirements for fit testing, training, and medical evaluation by cross-referencing 29 CFR 1910.134, in order to avoid creating a duplicative regulation and to ensure that if technology advances lead OSHA to amend its standard, the change would automatically apply to pesticide uses subject to the WPS as well. EPA also proposed to require handler employers to maintain records of the fit test, training, and medical evaluation for two years.
In the final rule, EPA has retained the proposed requirement for handler employers to maintain records of the fit testing, medical evaluation, and training. The final rule clarifies that the required training is limited to the care and use of respirators, 29 CFR 1910.134(k)(1)(i)-(vi), and does not include the training on the general requirements (
The final regulatory text for these requirements is available at 40 CFR 170.507(b)(10) and 170.507(d)(7).
Furthermore, many farmworker advocacy organizations stated that EPA should require compliance with all elements of 29 CFR 1910.134, rather than the proposal to just include fit testing, training, and medical evaluation. Specifically, they urged EPA to adopt OSHA's requirements for employers to develop a respiratory protection program (29 CFR 1910.134(c)) and conduct a workplace hazard evaluation (29 CFR 1910.134(d)(1)(iii)).
Nearly all commenters expressed support for a general requirement related to proper respirator care and use, such as appears in the existing rule. However, many pesticide manufacturers and their associations, state farm bureaus and agricultural producer organizations questioned the feasibility of the proposed requirement for medical evaluations because locating qualified physicians practicing in rural areas would be difficult. Other farm bureaus noted that the OSHA standard applies to general industries, shipyards, marine terminals, longshoring and construction, and it would not likely be easily adopted in agricultural settings. Some commenters, including the Small Business Administration's Office of Advocacy, also asserted that EPA's cost estimates associated with the medical evaluations and fit testing were too low.
Some commenters, including a state farm bureau, raised concerns that EPA's reference to OSHA's regulations could give OSHA legal grounds to pursue oversight of certain small farming operations, contrary to provisions of existing law.
EPA acknowledges that, if the final rule were to require handler employers to comply with the OSHA requirement to adopt a worksite-specific respiratory protection program, such a requirement would address in detail the selection, cleaning, storing, repair and replacement of respirators, as well as worksite-specific procedures when respirator use is required. EPA has decided not to expand the final rule to include the OSHA requirement to adopt a worksite-specific respiratory protection program because specific respirator requirements are described on EPA-approved, product-specific pesticide labeling. These product-specific respirator requirements are based on the acute inhalation toxicity of the end-use product or a comprehensive risk assessment informed by incident data, or on extensive pesticide active ingredient toxicology data, exposure science and epidemiology data (if available), or on both. Therefore, requiring a general worksite-specific respiratory protection program would duplicate the analysis underlying product-specific respirator requirements included on pesticide labeling.
EPA acknowledges that implementing respirator fit testing, training, and medical evaluation in agriculture will place additional burden on agricultural employers. However, the proper fit and use of respirators is essential in order to realize the protections respirators are intended to provide. EPA's pesticide risk assessment process relies on National Institute for Occupational Safety and Health (NIOSH) protection factors (
EPA is aware of several states, including California, Oregon and Washington, that have successfully incorporated all aspects of the OSHA standard for respirators in agriculture, demonstrating the feasibility of applying OSHA's requirements in agriculture. North Carolina has incorporated many innovative ways to facilitate the medical evaluation and fit testing process, and helped farmers (including handler employers) locate reputable sources for online services for fit testing and medical evaluation, and sources for NIOSH-approved respirators, filters, and cartridges. EPA plans to work with stakeholders such as state regulatory agencies, universities, and others to provide outreach assistance such as training programs and written materials and to encourage the dissemination of information about fit testing and medical evaluation resources.
EPA has reviewed and revised its cost estimates for fit testing, training and medical evaluation. The cost estimate assumes that farms would designate one handler to be fit tested so the incremental costs for the filtering facepiece respirators reflects the need to fit test and train on multiple types of respirators. The increased costs also reflects the cost of the on-line medical evaluation, which replaces the estimated time of a medical technician reviewing the evaluation, and the cost of the employer's time to arrange (if off-site) or oversee (if on-farm) the evaluation and fit test, which was previously omitted. EPA has also updated wages, price of materials and services such as the cost of the medical evaluation and the fit test materials. Details of the revised estimate are available in the Economic Analysis for this final rule (Ref. 1).
EPA recognizes that some handlers may not be able to use a tight-fitting respirator. EPA notes that the purpose of the medical evaluation is to ensure handlers are able to tolerate the physical burden caused by the use of respirators. Many medical conditions, such as cardiovascular diseases and the reduced pulmonary function caused by smoking, could impede the ability of the handler to wear a respirator without adverse health impacts. The medical evaluation should identify these potential issues and disqualify the handler from using a tight-fitting respirator. Tight fitting respirators include filtering facepiece respirators, full and half face elastomeric respirators and tight fitting powered air purifying respirators (PAPR). However, for these handlers, loose-fitting PAPRs are an option for respiratory protection because they do not require medical evaluations or fit testing. EPA notes that many handler employers may be able to rely on online services where medical evaluations can be performed by relying on medical questionnaires. The employee would complete the medical questionnaire, which would be provided to the licensed medical professional for review. If the employee is cleared by the review, he or she is approved to wear a respirator. If the employee is not cleared through the review of the questionnaire, the employer may send the employee for further medical review
EPA does not believe that including in the WPS a requirement that employers must perform respirator fit testing, training, and medical evaluation in accordance with OSHA's requirements by cross-reference to 29 CFR 1910.134 affects the scope of OSHA's jurisdiction. This final rule changes only the FIFRA WPS, which is implemented and enforced by EPA, the States and Tribes, and not by OSHA.
However, in consideration of the commenters who asked that EPA require compliance with all elements of OSHA requirements at 29 CFR 1910.134, the Agency re-evaluated other elements of that regulation. As part of that re-evaluation, EPA identified an inconsistency between the Agency's proposal and OSHA's requirements concerning a change schedule for the replacement of the gas- or vapor-removing canisters or cartridges. Specifically, OSHA requirements address change schedules that utilize NIOSH end-of-service-life indicator designations (29 CFR 1910.134(d)(3)(iii)(B)(2)). To ensure respirator protections are of greater consistency across industries, EPA has added the OSHA requirement that triggers the replacement of the gas- or vapor-removing canisters or cartridges to the list of conditions in the final rule at § 170.507(d)(7) through an incorporation by reference.
EPA cannot quantify the benefits associated with this specific requirement. However, ensuring that handlers can safely use respirators and that those respirators fit properly will increase the protections offered by respirators to the levels presumed in EPA's pesticide registration decisions. This should lead to a reduction in occupational pesticide-related illnesses. In comparison to these expected benefits of proper respirator use and reduced illnesses, the costs associated with the final rule requirements appear to be reasonable.
In contrast, some grower organizations stated that the current requirement is adequate and EPA should not adopt the proposal. Some farm bureaus opposed the proposal and thought the concern for individuals gaining access to contaminated PPE was well meaning yet hypothetical. Some of these commenters suggested it could lead to confusing violation scenarios, specifically from the interpretation of “render unusable.”
EPA disagrees with comments from farm bureaus suggesting that there is little likelihood of persons accessing contaminated PPE. As mentioned in the preamble to the proposed rulemaking, state pesticide regulatory agencies have raised concerns for the potential reuse of contaminated PPE to EPA. EPA relies on state pesticide regulatory agencies to raise issues with implementation of the existing WPS that arise when they conduct inspections of WPS establishments. EPA has chosen to amend the existing rule in response to the input provided by the States.
The existing WPS does not have a requirement to monitor cholinesterase (ChE) levels in workers or handlers. In the proposal, EPA invited comment on whether to require routine ChE monitoring of handlers. However, because EPA's initial judgement was that the benefits of routine ChE monitoring would not justify the cost, EPA did not propose to add a requirement for routine monitoring of ChE inhibition in handlers.
The final rule does not include a requirement for routine ChE monitoring for handlers.
In addition, some of the commenters objected that ChE monitoring is an invasive process, and that routine ChE monitoring would be extremely time-consuming and costly and would provide information of questionable value. One commenter stated that a proper ChE monitoring program would require that a baseline be established for employees, and that it would be highly unlikely that a baseline could be obtained for many workers because of previous exposure to organophosphate insecticides, while another commenter suggested that exposure to other common materials can change the levels of ChE, especially in serum level measurements, making it difficult to establish a baseline. Another commenter added that the timing of meals, stress, physical activity, and changes in body mass can cause ChE levels to fluctuate within an individual, and that the baseline value should be taken on the day of handling a ChE-inhibiting pesticide prior to exposure due to this intra-individual variability. The commenter suggested that baselines established every 1 to 2 years, as currently recommended by Washington State and California, respectively, would not provide meaningful information concerning the degree of exposure due to these daily fluctuations.
Conversely, several commenters, including some members of Congress, the California Department of Public Health, Washington State's Department of Health and Department of Labor and Industries, several public health organizations, academics, and farmworker advocacy organizations supported the idea of adopting a routine ChE monitoring program as part of this rulemaking, particularly for handlers who use ChE-inhibiting pesticides like organophosphates and N-methyl-carbamate pesticides. Many of these commenters cited the existing ChE monitoring programs in California and Washington State in their arguments for why ChE monitoring should be expanded nationally.
Some commenters stated that California and Washington have longstanding medical monitoring programs with proven track records in reducing exposure to, and illnesses from, highly neurotoxic chemicals. These commenters stated that the successful implementation of these monitoring programs has helped health professionals understand the effects of these classes of pesticides and prevent poisoning by identifying overexposure. Two commenters stated that Washington's program is effective and protects workers as reflected by worksite field evaluations of action level ChE depressions, which have identified multiple pesticide WPS violations that are believed to contribute to worker exposure. A couple of commenters stated that the benefits realized by the state programs, which would expand nationally if monitoring were to be required, include:
• Greater certainty about the frequency of pesticide overexposure.
• Avoidance of serious pesticide illness.
• Improved compliance with the WPS.
Some commenters cited Washington State's data that shows that the percentage of overexposed participating handlers who required remedial action fell from 20% when the program started in 2004 to 6% in 2013, for a reduction of 70%. These commenters stated that Washington's Department of Labor and Industries found that ChE monitoring helped identify the causes of overexposure, which allowed for those causes to be corrected by alerting employers and handlers to unsafe work practices, conditions, or equipment. Additionally, a couple of commenters stated that the percentages of handlers who actually reached the removal level from handling ChE-inhibiting pesticides remained consistently low after the implementation of the ChE monitoring program, with the percentages being 3.8% in 2004, 0% in 2010 and 2011, 2.3% in 2012, and 4% in 2013. These commenters believed that the sharp decline in the number of handlers needing remedial action, along with the consistently low percentage of handlers who exceeded 20% below their baseline (
Some commenters in support of requiring ChE monitoring also discussed the costs associated with ChE monitoring. They stated that the cost of implementation should not deter EPA from requiring medical monitoring on a national level. A few commenters stated that EPA's estimate that the cost of ChE monitoring would average $53 per year per agricultural establishment was a small cost when contrasted with the 70% reduction in overexposure according to Washington State's data. A couple of commenters also stated that monitoring in California and Washington has led to substantially fewer pesticide poisonings and reduced use of these highly toxic pesticides, and can, in turn, reduce long-term medical costs to farmworkers and the agricultural economy. Some commenters stated that EPA's analysis did not include an estimation of the medical expenses that were saved, the lost wages prevented, and the pesticide-related illnesses avoided as a result of early detection and intervention. As a result, the commenters believed that the benefits of a national ChE monitoring program would more than justify the costs given the severe effects of overexposure to ChE-inhibiting pesticides.
Other commenters supporting ChE monitoring stated that employees who handle ChE-inhibiting chemicals in non-agricultural sectors routinely receive the protection of medical monitoring. For example, some commenters stated that OSHA requires medical monitoring for workers who handle a wide range of toxic substances. They also stated that USDA requires monitoring of its employees who may be exposed to organophosphate or carbamate pesticides. These commenters stated that these safeguards should be provided for all workers who handle these pesticides, and therefore should be included in the final rule.
The revised labeling with increased protections and new mitigation measures resulting from the reregistration of organophosphates and carbamates will also result in lowered handler exposure. Reregistration has resulted in some uses of the most acutely toxic organophosphates being phased out. For the remaining uses, EPA has imposed additional PPE requirements, requirements for closed-system mixing and loading, and reductions to rates of application and number of annual applications permitted. As labels with updated PPE requirements for handlers are seen and followed in the field, EPA expects to see reduced numbers of overexposures. Additionally, the organophosphates and carbamates that are still registered are being used less frequently and being replaced by pesticides with lower risks, also reducing the potential for overexposure.
While EPA estimated the costs of a national, routine ChE monitoring program to be at least $15.2 million annually, or about $53 per agricultural establishment per year and $120 per commercial pesticide handling establishment per year, this estimate does not include the full costs that would be expected of a national ChE monitoring program. As stated in the proposed rule, a national, routine ChE monitoring program would likely include program components such as training, recordkeeping, clinical testing, and field investigations, which were not included in the estimated costs because the initial $15.2 million estimate appeared by itself to be disproportionately high in comparison to the expected benefits. Additionally, the estimated costs do not include the states' costs to build infrastructure to support ChE monitoring or to cover continued laboratory costs such as equipment maintenance and administrative support. If EPA were to calculate these additional costs, the estimated costs would be much higher than $15.2 million annually. Therefore, EPA stands by its assessment in the proposed rule that the cost of implementing a national, routine ChE monitoring program is not justified by its limited benefits.
EPA believes that the increased handler protections being finalized in this rulemaking, combined with the product-specific risk mitigation measures, will appropriately address the elevated potential for ChE inhibition in handlers. Moreover, the training and PPE elements of the final rule will have the combined effect of providing important protective benefits to all pesticide handlers through increased knowledge of exposure risks and prevention strategies. This approach will lead to a reduction of pesticide exposures because it prevents handler exposure before it occurs.
Since EPA is not requiring routine ChE monitoring, there are no costs associated with this decision.
Note, too, that the existing WPS definitions of workers and handlers depend upon them being employed for compensation. Therefore, any person performing worker or handler tasks who does not receive a wage, salary or other compensation is not a worker or handler protected by the WPS, regardless of familial relationship to the owner.
EPA requested comment on but did not propose changes narrowing the immediate family exemption in two ways: (1) Limiting it only to those immediate family members of an owner of an agricultural establishment who are at least 16 years old, and (2) eliminating the exemptions from requirements regarding emergency assistance for workers and handlers and regarding handler monitoring during fumigant application.
As part of the proposal to establish a minimum age for pesticide handlers and early-entry workers, EPA proposed to add an exemption from the minimum age requirements to the immediate family exemption.
EPA has amended the exemption from certain provisions of the WPS for owners and members of their immediate families to include exemptions from the minimum age requirements for handlers and early-entry workers. The final regulatory text for this exemption is available at 40 CFR 170.601(a)(1)(i) and 170.601(a)(1)(xii).
EPA has clarified the final regulatory text related to the exemption from certain provisions of the WPS for owners and members of their immediate families. The exemption in the final rule will apply to owners and members of their immediate family on any agricultural establishment where a majority of the establishment is owned by one or more members of the same immediate family. The final regulatory text for this exemption is available at 40 CFR 170.601(a)(1).
EPA has not included in the final rule any of the other changes to the owner and immediate family exemption considered in the proposal.
A few commenters requested that EPA expand the definition to include cousins. Many commenters, including the Small Business Administration's Office of Advocacy, requested that EPA expand the definition further to include aunts, uncles, nieces, nephews, and cousins. Commenters requesting further expansion of the definition noted that an expansion of the family members considered immediate family under the WPS would better reflect the reality of the family farm in America. Commenters also requested that EPA further expand the definition and exemption to recognize varying ownership patterns used to assure the continued operation of the farm and the involvement of siblings and their heirs. One commenter suggested that EPA align the exemption with USDA's interpretation of farm ownership by family members, which considers a “family farm” to be one where a majority of the farm is owned by family members, rather than retaining EPA's interpretation of the exemption as applying only on establishments that are wholly owned by one or more members of the same immediate family.
A few commenters requested that EPA delete the definition of immediate family and eliminate the exemption. These commenters noted that risks from pesticide exposure are the same for family and non-family members, so all persons need the same level of protection regardless of their familial relationship to the owner.
EPA considered commenters' requests to expand the definition of “immediate family.” Commenters suggested that a definition that includes cousins, or cousins, aunts, uncles, nieces and nephews would better reflect the actual patterns of family-based farm ownership in the United States. EPA agrees with commenters' suggestions that family-based farm ownership may extend beyond relationships covered by EPA's existing or proposed definition. EPA agrees with commenters' requests to expand the definition to include aunts, uncles, nieces, nephews, and first cousins. For clarity, EPA has chosen to define “first cousin” as the child of a parent's sibling,
EPA has clarified the applicability of the exemption in the final rule in response to comments. The exemption in the final rule applies to the owners and their immediate family members on any agricultural establishment where a majority of the establishment is owned by one or more members of the same immediate family. A “majority of the establishment” means that more than 50 percent of the equity in the establishment is owned by one or more members of the same immediate family as defined in the WPS.
EPA agrees that the risks associated with pesticide exposure do not vary based on a person's relationship to the owner of the establishment. However, EPA recognizes that family-owned farms need flexibility and expects that those family members working on an establishment covered by the immediate family exception would be adequately prepared and supervised by family members. Although owners and their immediate family members are exempted from certain provisions of the WPS (
Although owners of establishments and members of their immediate family are exempt from some of the provisions of the rule, EPA expects that they will voluntarily follow the provisions from which they are exempt, or achieve equivalent risk mitigations through other means. EPA encourages owners and family members to carefully study the WPS requirements and assure themselves that they are not placing each other at risk of unreasonable adverse effects.
EPA proposed to eliminate the exemptions for employees directly supervised by certified or licensed crop advisors. EPA also proposed to eliminate the exemption from the worker decontamination and emergency assistance provisions for certified or licensed crop advisors employed as workers on agricultural establishments.
The crop advisor associations also expressed concern that EPA underestimated the economic impact to crop advisors, and in turn to farmers, of eliminating this exemption, citing specifically the increased costs of additional PPE, the cost of work done by certified or licensed crop advisors instead of by their employees, and the cost of increased management time. Crop consultant associations and other commenters contended that these increased costs could discourage investment in integrated pest management (IPM) and result in increased pesticide use that might put workers at increased risk of pesticide exposure. Several states supported EPA's proposal to eliminate the crop advisor exemption.
Incident monitoring programs do not capture illness data specifically associated with crop advising tasks because cases are categorized under a general “field worker” label. However, EPA's risk assessments indicate that people doing crop advising tasks during an REI are at risk of chronic, low-level pesticide exposure over time. PPE requirements and availability of decontamination supplies during and after an REI are fundamental to mitigating risks of concern for workers. Allowing workers who are supervised by certified or licensed crop advisors to conduct crop advising tasks without the same basic protections provided for other workers would establish a lesser standard of protection for similar types of work. EPA understands that IPM programs require post-application entry and the timing is critical to efficacy. By retaining the exemption for certified or licensed crop advisors to conduct crop advising tasks during an REI and allowing flexibility for employers to substitute the label required PPE for handlers with either PPE for early-entry workers or a standard set of PPE, the
The final rule retains the existing requirements for PPE when a closed system is used: Labeling-mandated PPE must be immediately available for use in an emergency and handlers must use protective eyewear for closed systems that operate under pressure.
The final regulatory text for the definition of closed systems is available at 40 CFR 170.305. The final regulatory text for the closed system exception is available at 40 CFR 170.607(d)(3).
In response to comments advocating that EPA require closed systems for all Toxicity Category I pesticides under the rulemaking, EPA reminds the commenters that worker risk assessments and the risk management processes establish the required protections that appear on product labels. EPA identifies the basic protections, often PPE, to protect handlers from risks of concern. If handler exposure during mixing and loading is above the established level of concern, and if PPE does not reduce exposure to below the level of concern, the pesticide label may require a closed system for mixing and loading. EPA has required the use of closed systems on some product labeling.
EPA recognizes that the reduction in handler PPE alone is not likely to be enough incentive for an employer to use closed systems. However, EPA is convinced that on larger establishments, the efficiency and comparative protection value of a closed system, combined with the reduction in PPE that must be worn by the handler, may induce users to adopt closed systems. Establishing requirements for such closed systems—whether required or used voluntarily—is necessary to protect handlers, who could be exposed to concentrated pesticides if they use poorly designed or constructed closed systems.
EPA agrees with the comments that a broad definition of “closed system” will encourage industry innovation better than the proposed prescriptive rule and will allow flexibility for employers to design systems specific to their needs. A broad performance standard, along with requirements concerning operating instructions, training and maintenance, will enable employers, handlers and regulatory personnel to determine whether a closed system qualifies for the exemption. The operating standards will ensure that the closed systems are used as intended and are adequately maintained.
EPA notes that the California Department of Pesticide Regulation (CDPR) no longer supports use of the prescriptive-based criteria upon which EPA modeled the proposal outlined in the NRPM. In December 2014, CDPR published proposed regulations outlining a simplified, performance-based criteria for closed system design. California is the only state with specific closed system standards, and has required their use with certain chemicals since the 1970s. CDPR developed their revised closed systems standard and discussed the proposal with representatives from groups that will be directly affected including agricultural producer organizations, manufacturers, applicators, and growers, as well as at CDPR's Pesticide Registration and Evaluation Committee and the Agricultural Pest Control Advisory Committee and Pest Management Advisory Committee meetings. EPA considered CDPR's proposed rule in the development of the final closed systems standard. EPA's final closed system requirements were developed using CDPR's proposal as a model and do not conflict with CDPR's proposed closed system requirements.
Section 170.607(d)(2)(i) establishes a performance standard for closed systems. Specifically, a closed system must remove the pesticide from its original container and transfer the pesticide product through connecting hoses, pipes and couplings that are sufficiently tight to prevent exposure of handlers to the pesticide product, except for the negligible escape associated with normal operation of the
EPA also adjusted the final regulatory text for closed systems to address the comments about water soluble packaging. The regulatory text in the final rule was revised to state clearly that the closed system exception from PPE applies when intact, sealed water soluble packaging is loaded into a mixing tank or system. The regulation also clarifies that water soluble packaging is no longer a closed system if the integrity of the packaging is compromised. This language in the final rule incorporates EPA's current position about water soluble packaging and closed systems, as established in the Interpretive Guidance on the WPS:
While the final rule includes only a performance standard, EPA recognizes that it may be helpful to have guidance on how to construct a system to meet that standard. As part of California's proposed rulemaking, CDPR and the University of California, Davis (UC Davis) developed plans for building a closed system to release along with the proposal. The “Overview of Closed Systems Components and User Designs” document includes lists of component parts (and costs) for three levels of systems (basic, medium and high). The design plans developed by CDPR and UC Davis will provide users with examples of representative closed systems components so they can identify or develop acceptable closed systems.
EPA adjusted the closed system cost estimates from the proposed rule in several ways to reflect changes in the final rule. The cost estimate in the proposed rule assumed that some users of closed systems would purchase new systems while others would revert to using PPE. In light of the revised definition, the final cost estimate assumes that most users would simply purchase an adapter to connect their existing closed system to the pesticide container, which is the part that most likely needs to be added to convert existing mechanical transfer systems to be closed systems that meet EPA's criteria. These changes and costs are based on the CDPR and UC Davis document “Overview of Closed Systems Components and User Designs,” which includes lists of component parts and their costs for three levels of systems. In addition, the cost of developing operating instructions was added, assuming that most closed systems are custom-made systems that would require the employer to develop operating instructions, while the costs of keeping records of maintenance was deleted. EPA reduced the estimated number of farms using closed systems based on information from the Agricultural Handler Exposure Task Force, which showed that the limited number of pesticide users who use closed systems are primarily larger establishments and commercial pesticide handling establishments. Therefore, the estimated costs of the closed system criteria decreased from the proposed rule to the final rule.
Using closed systems is preferred to wearing PPE as an approach for managing chemical exposure in the “hierarchy of controls” established under standard industrial hygiene principles. Enclosing the chemical and substantially reducing the potential for exposure at the source reduces the potential for subsequent exposure to handlers, other people, and the environment.
An aerial applicators association asserted that aerial applications of pesticides using open cockpit aircraft
EPA proposed to eliminate the requirement for any labeling-specified respiratory protection PPE when applying pesticides from inside an enclosed cab. This would have allowed handlers to substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified PPE in all cases no matter what type of respiratory protection PPE was required by the labeling.
EPA has retained other exceptions to PPE requirements for handlers using enclosed cabs. Specifically, all of the PPE required by the pesticide product labeling for applicators must be immediately available to handlers in an enclosed cab and be stored in a sealed container to prevent contamination. Handlers must wear the applicator PPE if they exit the cab within a treated area during application or when a REI is in effect. Once PPE has been worn in a treated area, handlers must remove it before reentering the cab to prevent contamination of the cab.
The final regulatory text for the enclosed cab exception is available at 40 CFR 170.607(e).
Labeling may include booklets distributed with the product when such documentation is too long to be included on the label that is securely attached to the container. For example, some products have labeling that is 60 or more pages long. FIFRA and EPA regulations require certain information to appear on the label—on or attached to the pesticide container. Other information necessary to use the product safely, such as directions for use, may be included in a booklet distributed with, but not securely attached to, the container (40 CFR 156.10(i)(1)(ii)); this information could also be available on the Internet if the producer has decided to provide web-distributed labeling for the product (Ref. 21). In either format, the information would be considered labeling. Labeling sometimes includes enforceable references to other documents that do not physically accompany the container, such as the WPS.
The existing rule discusses employers' responsibilities related to pesticide labels and labeling in several places. The existing rule requires agricultural and handler employers to ensure that pesticides are used in a manner consistent with the labeling. When the emergency assistance provisions of the WPS are triggered, the existing rule requires employers to provide information from the product labeling to affected workers, handlers, and/or treating medical personnel. Handlers must receive training on the format and meaning of information contained on pesticide labels and in labeling. Finally, employers must ensure that handlers have either read or have been informed in a manner they understand of all labeling requirements related to safe use of the pesticide, and that the handler has access to the product labeling during handling activities.
Although the proposal reorganized the rule, some of the requirements for the existing rule outlined in the previous paragraph remained essentially unchanged in the proposed rule,
For handler training requirements, EPA has amended the language in the final rule to delete the word “all” related to labeling. The final rule requires handlers to receive training on following
For labeling and application-specific information the employer must provide to the handler, EPA has amended the final rule to require the employer to provide the handler with information on all
Some commenters generally disagreed with EPA's use of “labeling” and requested that EPA use “label” instead throughout the rule. They asserted that labeling is too broad and that labeling includes materials not attached to the container, such as advertisements, brochures and pamphlets. Commenters assert that the broadness of “labeling” applied to requirements to provide or retain this information could result in a requirement on employers to track down many ancillary pieces of information for a complete record, or to face a technical violation for failure to retain all elements of the labeling.
Under the agricultural and commercial pesticide handler employer duties, at 40 CFR 170.9(a) and 170.13(a) of the proposal, commenters said that EPA's use of labeling was too broad. They asserted that employers' liability should be only to comply with the WPS rather than with the label or all relevant labeling because making the employer responsible for complying with all labeling exceeds the scope and intent of the WPS. They also noted that certified applicators, those competent to use pesticides according to the labeling instructions and who make the actual applications, should be required to comply with the labeling, but that the agricultural employer should not.
In regard to emergency assistance, commenters requested that EPA delete the reference to labeling and replace it with a requirement to provide the label and EPA registration number of the product. Commenters note that this requirement would be sufficient to provide appropriate information for emergencies.
Commenters also requested that in the section on pesticide application and hazard information, EPA delete the requirement for the employer to maintain copies of the labeling for all WPS-labeled pesticides used on the establishment, and instead to require the employer to maintain a copy of the label and EPA-registration number. Again, commenters noted that such a requirement would likely result in technical violations without providing benefit to workers or handlers.
In the sections on handler training and establishment-specific information, commenters took issue with requirements to train handlers on all labeling and to ensure that for specific applications handlers have read the labeling or have been informed of all labeling requirements. Commenters noted that a requirement for handlers to be trained on all labeling requirements, rather than those pertinent to their specific tasks, would be overly broad and unnecessary. Commenters requested that EPA replace “labeling” with “label” in these sections.
Labeling does not include advertisements, pamphlets or brochures unless they accompany the product when sold or are referenced on the labeling. For instance, EPA has indicated that documents such as marketing brochures used to sell the product and to provide information to customers and is not labeling as defined by FIFRA section 2(p). (
Because mandatory use directions often appear in the labeling of agricultural pesticides, rather than the label, some provisions of the WPS appropriately use the word “labeling.” Where the word “labeling” appears in the WPS, employers are responsible for following or providing labeling as defined in FIFRA. This does not require employers to find, retain, or provide advertisements, pamphlets or marketing brochures that do not meet the definition of “labeling.”
For example, it is appropriate that agricultural and handler employers' duties under the final rule include ensuring compliance with “labeling” rather than just the label. The existing regulation has the same requirement under general duties and prohibited actions. 40 CFR 170.7(a)(2). The labeling may include directions for use or other information essential to the safe and effective application of the pesticide, or specific information related to WPS protections, such as the REI. For these reasons, EPA has decided not to replace “labeling” with “label” throughout the final rule as suggested by the commenters.
Furthermore, the obligation of certified applicators (or any other person legally applying a pesticide) to follow the labeling does not negate the obligation of agricultural and handler employers to comply with the labeling. Requirements related to the WPS are found both in the regulation (
However, EPA agrees that certain WPS requirements could be limited to the information on the label or specific information from the label, and has specified “label” instead of “labeling” or specific information from the label where appropriate. For example, EPA agrees with commenters that employers need not provide all labeling in the event of the emergency. In the current rule, EPA lists specific information that must be provided to a potentially injured worker or handler, or to treating medical personnel: Product name, EPA registration number, active ingredients, antidote, and first aid and medical treatment information. Since all of this information is required on the label (40 CFR 156.10(a)(1)), the final rule allows the employer to provide a copy of the label or this specific information from the label, in addition to providing a copy of the SDS, when emergency assistance is required.
EPA also agrees with commenters' request to eliminate the requirement for employers to maintain copies of the labeling for all pesticides with a WPS reference statement used on the establishment. EPA agrees that if workers, handlers, or other persons need information on a specific product that was used on the establishment, such information can be obtained using the EPA registration number and product name. In response to comments received, EPA has replaced the proposal with a requirement for the employer to retain only the EPA registration number, active ingredient(s), product name, and other application-specific information for such products, in addition to the SDS.
Similarly, EPA agrees that requiring handler employers to ensure that handlers have been trained generally on, and for specific applications have read or been informed of all labeling requirements may be unnecessary if they are only using a product for a single type of application. The labeling could include directions for use covering multiple application methods and multiple crop sites, which may be of no relevance to a particular handler. Although the final rule continues to refer to “labeling” in this context, it now requires employers to ensure that for specific applications, handlers have read the portions of the labeling applicable to the safe use of the pesticide or have been informed in a manner they understand of all portions of the labeling applicable to the safe use of the pesticide. Further, EPA has amended handler training to require that handlers are instructed on their duty to follow the portions of the labeling applicable to the safe use of the pesticide, and on the format and meaning of information contained on pesticide labels and in labeling.
The proposed rule included these same protections for persons other than workers and handlers and added several additional provisions that would affect “other persons.” The proposed requirement for a handler to cease or suspend application if a worker or other person is in the treated area or entry-restricted area was intended to supplement the existing “do not contact” requirements, which already protect persons other than workers or handlers. In addition, EPA proposed to include “other persons involved in the use of a pesticide to which this part applies” in the proposed anti-retaliation provision in § 170.15.
During USDA's FIFRA section 25 review of the final rule, USDA commented that the definition for “agricultural plant” depends on the definition for “commercial production,” and the definition for “commercial production” depends on the definition for “agricultural plant” (Ref. 15). USDA said similar issues exist in the definitions of “agricultural establishment” and “farm,” “forest operation,” and “nursery.” USDA recommended resolving these circular dependencies. USDA also commented that the proposed definitions of “employ,” “labor contractor,” and “commercial pesticide handler employer” contained problematic language that could confusion as to who is ultimately responsible for providing the handler protections in Subpart F of the proposed rule.
In response to comments from USDA made during their FIFRA section 25 review of the final WPS rule, EPA agrees that the definitions for “agricultural plant” and “commercial production,” and the definitions for “agricultural establishment” and “farm,” “forest operation,” and “nursery” are circular (Ref. 15). While EPA is not convinced that serious confusion would result, EPA has eliminated some definitions and revised others to address USDA's concern. The terms “commercial production,” “farm,” “nursery,” and “forest operation” appear only in the definition section and are not used elsewhere in the regulation. Accordingly, EPA has deleted these definitions and merged their substantive content into the definitions of “agricultural establishment” and “agricultural plant.” EPA also agrees that the current definitions of labor contractor and commercial pesticide handler employer contain some problematic language that could result in potential confusion and/or conflict regarding agricultural employer and commercial pesticide handler employer duties under the rule. In the final rule, EPA has adopted revised definitions for “employ,” “labor contractor,” and “commercial pesticide handler employer” to address the potential confusion that could result from conflicting language in the existing proposed definitions. EPA believes the revised regulatory text clarifies that CPHEs are responsible for the handlers they employ and agricultural employers would no longer be considered employers of CPHE handlers for the purposes of the WPS, without overlooking the fact that some handlers are hired by agricultural employers through labor contractors and not CPHEs. A copy of USDA's comments and EPA's responses is available in the docket for this rulemaking. (Ref. 15).
EPA disagrees with the recommendation to limit the definition to certain persons that could be asked to request the information on behalf of the worker or handler. EPA believes that specifying classes of persons permitted to serve as designated representative would unnecessarily limit worker and handler access to needed information. The final rule requires employers to respond to such requests within 15 days. However, to ensure that medical personnel treating a worker or handler have timely access to information necessary for purposes of diagnosis or treatment, EPA has included a separate requirement for employers to promptly provide the information to treating medical personnel or those working under their direction, at 170.311(b)(8).
During USDA's FIFRA section 25 review of the final rule, USDA commented that the inclusion of the term “natural forest” in the definition of “outdoor production” creates confusion since there is no explanation of what the term “natural forest” means and therefore the term is not needed (Ref. 15).
EPA does not agree with the request to add the phrase “where the production of agricultural plants for research or commercial purposes occurs” to the definitions of enclosed space production and outdoor
Some commenters requested clarification of whether structures such as “hoop houses,” and “high tunnels” are considered a type of enclosed space production. The term “greenhouse” in the WPS has resulted in enforcement problems, because of the extreme variability in the types of structures that might be considered greenhouses. This problem is compounded when considering the many greenhouse-type structures (
EPA agrees with USDA that the inclusion of the term “natural forest” in the definition of “outdoor production” creates confusion and is not needed. In response, EPA has revised the final definition of outdoor production accordingly (Ref. 15).
EPA interprets “arranging for application of the pesticide” as used in § 170.9(a) and § 170.305 as a means of assuring that the entities (generally the agricultural employer or handler employer) with the most authority and control over WPS compliance would be legally responsible for WPS compliance. EPA does not interpret “arranging for application of the pesticide” as making subordinate persons who merely perform the clerical functions of arranging for application of the pesticide liable for WPS compliance. Therefore, since EPA has not been made aware of any instances where the existing interpretation of the term use has resulted in any problems for growers, states or the agricultural industry, EPA has moved the definition for the term “use” into the definitions section of the rule without any change from the proposal.
EPA discussed renaming the regulation “Requirements for Protection of Agricultural Workers and Pesticide Handlers” in the preamble of the proposal and proposed reorganizing the rule into four subparts: “General Provisions,” “Requirements for Protection of Agricultural Workers,” “Requirements for Protection of Pesticide Handlers,” and “Exemptions and Exceptions.” EPA proposed creating the “General Provisions” subpart to describe certain obligations for agricultural employers, handler employers, and those requirements that apply to both. The proposal included subparts “Requirements for Protection of Agricultural Workers” and “Requirements for Protection of Pesticide Handlers” to provide information that supplements the general duties and obligations for employers and to outline the content of the training and decontamination supplies that the employer must provide for workers and handlers respectively. EPA proposed to consolidate most of the exceptions and exemptions into a separate subpart titled “Exemptions and Exceptions” to make them easier to find and reference.
EPA has determined that it is appropriate to allow one year for employers, trainers, and state and tribal regulators to prepare for the changes to the WPS. See Unit XIX. In order to allow the existing WPS to remain in effect for one year and to make available the revised regulatory language in advance of the implementation date, both the existing WPS and the revised WPS must appear in the Code of Federal Regulations. Thus the final rule provides that Subparts A, B and C of part 170 will remain in effect until one year after the effective date of this final rule. Subparts D, E, F and G of part 170 contain the full text of the revised WPS; however, these subparts will not be implemented until one year after the effective date of this final rule. Some provisions of subparts D, E, F and G, such as pesticide safety training and the pesticide information display, will not be implemented until two years after the effective date of this final rule. One year after the effective date of this final rule, subparts A, B and C will no longer be effective. At that time, EPA intends to
In addition to finalizing the proposed structuring of the rule, EPA has added a new section providing a process for allowing states and tribes to request equivalency determinations from EPA for existing state or tribal laws or regulations that may provide protections equivalent to the WPS. EPA has added this to a retitled subpart: “Exemptions, Exceptions and Equivalency.”
EPA also agrees with the commenter that the proposed restructuring of the rule increases the clarity of the rule and the relationship among the components. EPA is adopting the proposed restructuring of the WPS in the final rule with the minor modifications noted. EPA expects the revised part 170 will be easier to read and understand, thereby improving compliance by worker and handler employers.
EPA proposed to make the final rule effective 60 days after the date of publication in the
EPA has included in the final rule a one-year delay from the effective date of the final rule before employers must comply with any of the new WPS requirements. Thus, on January 2, 2017, employers will be required to comply with almost all of the new and revised WPS requirements. However, employers will not be required to comply with certain new WPS provisions until two years after the effective date of the final rule. This two year delay applies to the new requirements for pesticide safety training for workers and handlers, pesticide safety information and handlers to suspend applications when workers or other persons are in the application exclusion zone. As proposed, the final rule provides that compliance with certain new training requirements will not be required until the later of two years after the effective date of the final rule, or 180 days after EPA publishes in the
The final regulatory text for these provisions is available at 40 CFR 170.2, 170.311(a)(3), 170.401(c)(3), 170.501(c)(3) and 170.505(b).
Many comments from states, pesticide safety educators, trainers, grower associations and pesticide manufacturer associations pointed out a need for appropriate training and compliance assistance materials to support effective implementation. Commenters indicated that it was essential for EPA to have updated communications and compliance assistance materials, such as fact sheets and the “WPS How to Comply” manual, developed and available to all affected parties in order for the regulated community to be able to learn and understand new requirements. Several states, grower associations and pesticide manufacturer associations commented that EPA should provide more time before the new rule requirements become effective so that regulators and the regulated community can more adequately prepare for compliance with new requirements. However, several farmworker advocacy organizations urged EPA to implement the proposed training requirements for workers and handlers sooner than the proposal of 2 years from the effective date of the final rule.
EPA disagrees with comments that the compliance dates for the new worker and handler training requirements should be implemented sooner than 2 years from the effective date of the final rule as outlined in the proposal. EPA believes that up to 18 months could be needed in order to develop and disseminate new, high quality, multi-lingual worker and handler training materials in multimedia formats that comply with the new requirements. Additionally trainers will have to obtain the new training materials, become familiar with the new training content and ensure that they continue to meet any eligibility requirements to train. Therefore, EPA has decided to retain the proposed requirement to delay the new training requirements for 2 years from the effective date of the final rule (or 180 days after the announcement that training materials are available, whichever is later) to allow adequate time for development and widespread distribution of the materials to trainers and employers. While EPA agrees that it is important for workers and handlers to have the new safety training information as soon as possible, time will be needed to create and distribute new training materials and to allow existing trainers to familiarize themselves with those new materials. In order to maximize compliance with the final rule, and in the interests of consistency and efficiency, EPA intends to develop and make available suitable training materials. EPA intends to have new training materials developed and disseminated as soon as practical and will encourage employers to begin using the new materials as soon as they become available so that many workers and handlers will begin receiving the benefits of the new training before the required date.
EPA is committed to a robust outreach, communications and training effort to communicate the new rule requirements to affected WPS stakeholders. To facilitate implementation, EPA plans to issue plain language “how to comply” fact sheets and guidance materials once the
The discussion of the overall expected costs and benefits for implementation are discussed in Unit II.C. EPA believes that delaying the dates for compliance with the final rule for one year after the effective date will allow regulators and the regulated community to better prepare for compliance with the rule while delaying immediate costs and allowing time for employers to explore ways to minimize implementation costs.
The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the person listed under
This action is a significant regulatory action because it may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866 (58 FR 51735, October 4, 1993). Accordingly, EPA submitted the action to the Office of Management and Budget (OMB) for review under Executive Order 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB recommendations have been documented in the docket. EPA prepared an economic analysis of the potential costs and benefits associated with this action, which is available in the docket and summarized in Unit II.C. (Ref. 1).
The information collection activities in this final rule have been submitted to OMB for approval under the PRA, 44 U.S.C. 3501
The information collection activities related to the existing Worker Protection Standard are already approved by OMB in an ICR titled “Worker Protection Standard Training and Notification” (EPA ICR No. 1759; OMB Control No. 2070-0148). The final rule ICR addresses adjustments to the estimated number of respondents, time for activities, and wage rates related to the current regulatory requirements as approved under OMB Control No. 2070-0148. In addition, the final rule ICR addresses program changes related to the amendments, including modifications to restrictions in field entry activities during REIs; increased hazard communications; increased training (for both workers and handlers); provisions for information during emergency assistance; and recordkeeping for respirator and training requirements.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9, and on applicable collection instruments. When OMB approves this ICR, the Agency will announce that approval in the
I certify that this action will not have a significant economic impact on a substantial number of small entities under RFA, 5 U.S.C. 601
Although EPA was not required by the RFA to convene a Small Business Advocacy Review (SBAR) Panel because this rule would not have a significant economic impact on a substantial number of small entities, EPA nevertheless convened a panel to obtain advice and recommendations from small entity representatives potentially subject to this rule's requirements. A copy of the SBAR Panel Report is included in the docket for this rulemaking (Ref. 3).
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The rule requirements would primarily affect agricultural employers and handler employers. The total estimated annualized cost of the final rule is $60.2—66.9 million.
This action does not have federalism implications, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). 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. However, this action may be of significant interest to state governments, because states provide enforcement for pesticide laws. EPA solicited and received comments from state partners on the proposed revisions, which are addressed in this final rule preamble and the response to comments document.
This action does not have Tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). The proposed rule would not regulate tribal governments directly; agricultural employers and pesticide handler employers are the directly affected entities. Thus, Executive Order 13175 does not apply to this action.
This final rule is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not an economically significant regulatory action as defined by Executive Order 12866. However, it is reasonable to expect that the environmental health or safety risks addressed in this rule may have a disproportionate effect on children. As such, EPA considered the best available science in order to protect children against environmental health risks and this final rule is consistent with EPA's 1995 Policy on Evaluating Health Risks to Children (
Protections include improved training on reducing pesticide residues brought from treated areas to the home on workers and handlers' clothing and bodies and establishing a minimum age of 18 for handlers and early entry workers. With regard to establishing an age restriction, while studies have not demonstrated a clear cut off point at which adolescents are fully developed, literature indicates that their development may continue until they reach their early to mid-20s. Additionally, research has shown that adolescents may take more risks, be less aware of the potential consequences of their actions on themselves and others, and be less likely to protect themselves from known risks. All of this information supports establishing a minimum age to allow those handling pesticides to develop more fully before putting themselves, others, and the environment at risk, and to allow those performing early-entry activities to develop more fully in order to adequately protect themselves from the risks of entering a treated area while an REI is in effect. The final rule will reduce the potential for misuse by
Children face the risk of pesticide exposure from work in pesticide-treated areas, from the use of pesticides near their homes, and from residues of pesticides brought home by family members after a day of working with pesticides or in pesticide-treated areas. The final rule is expected to reduce these exposures and risks. By establishing a minimum age for certain pesticide-related activities in agriculture, children would receive less exposure to pesticides that may lead to chronic or acute pesticide-related illness. Another requirement to reduce risk to children is training for workers and handlers on the risks presented by take-home pesticide exposure and how best to reduce it.
Like DOL's regulations that implement the FLSA, the rule regulates the ages at which children can work in certain agricultural activities. The rule establishes a minimum age of 18 for pesticide handlers and for early-entry workers, except those working on an establishment owned by an immediate family member. Since children in agriculture may face elevated risks of pesticide exposure due to their immaturity, failure to exercise good judgment, and developing bodies, EPA feels that they warrant special consideration in light of the Executive Order on children's health. EPA expects that the final rule will mitigate or eliminate many agricultural pesticide risks faced by youths.
Additional information on EPA's consideration of the risks to children in development of this action can be found in the Economic Analysis for this action (Ref. 1).
This action is not a “significant energy action” under Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy.
This rulemaking does not involve technical standards that would require Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
EPA believes that this rule would not have disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994), because it increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. In fact, the population of agricultural workers and handlers that the rule seeks to protect is comprised primarily of minority and low-income individuals. As reviewed in Unit IV.B.3., the farmworker community, due to occupation, economic status, health, language and other sociodemographic characteristics, faces an increased risk of pesticide exposure which this rulemaking seeks to reduce through improving communication and protections.
EPA engaged with stakeholders from affected communities extensively in the development of this rulemaking, in order to obtain meaningful involvement of all parties. EPA believes that the rule would improve the health of agricultural workers and handlers by, among other things, increasing the frequency of training, enhancing training content to include ways to minimize pesticide exposure to children and in the home, adding posting of treated areas near worker and handler housing to prevent accidental entry, and establishing a minimum age for pesticide handlers and early-entry workers.
This action is subject to the CRA, 5 U.S.C. 801
Environmental protection, Agricultural worker, Employer, Farms, Forests, Greenhouses, Nurseries, Pesticide handler, Pesticides, Worker protection standard.
Therefore, 40 CFR Chapter I is amended as follows:
7 U.S.C. 136w.
(a)
(b)
(b)
(c) * * *
(1) The name, address, and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. Displays conforming to § 170.311(a)(3)(ix) meet the requirements of this paragraph.
(b)
(c) * * *
(1) The name, address, and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the
This regulation is primarily intended to reduce the risks of illness or injury to workers and handlers resulting from occupational exposures to pesticides used in the production of agricultural plants on agricultural establishments. It requires agricultural employers and commercial pesticide handler employers to provide specific information and protections to workers, handlers and other persons when pesticides are used on agricultural establishments in the production of agricultural plants. It also requires handlers to wear the labeling-specified clothing and personal protective equipment when performing handler activities, and to take measures to protect workers and other persons during pesticide applications.
(a) This regulation applies whenever a pesticide product bearing a label requiring compliance with this part is used in the production of agricultural plants on an agricultural establishment, except as provided in paragraphs (b) and (c) of this section.
(b) This regulation does not apply when a pesticide product bearing a label requiring compliance with this part is used on an agricultural establishment in any of the following circumstances:
(1) As part of government-sponsored public pest control programs over which the owner, agricultural employer and handler employer have no control, such as mosquito abatement and Mediterranean fruit fly eradication programs.
(2) On plants other than agricultural plants, which may include plants in home fruit and vegetable gardens and home greenhouses, and permanent plantings for ornamental purposes, such as plants that are in ornamental gardens, parks, public or private landscaping, lawns or other grounds that are intended only for aesthetic purposes or climatic modification.
(3) For control of vertebrate pests, unless directly related to the production of an agricultural plant.
(4) As attractants or repellents in traps.
(5) On the harvested portions of agricultural plants or on harvested timber.
(6) For research uses of unregistered pesticides.
(7) On pasture and rangeland where the forage will not be harvested for hay.
(8) In a manner not directly related to the production of agricultural plants, including, but not limited to structural pest control and control of vegetation in non-crop areas.
(c) Where a pesticide product's labeling-specific directions for use or other labeling requirements are inconsistent with requirements of this part, users must comply with the pesticide product labeling, except as provided for in §§ 170.601, 170.603 and 170.607.
Terms used in this part have the same meanings they have in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In addition, the following terms, when used in this part, shall have the following meanings:
(1) Mixing, loading, or applying pesticides.
(2) Disposing of pesticides.
(3) Handling opened containers of pesticides, emptying, triple-rinsing, or cleaning pesticide containers according to pesticide product labeling instructions, or disposing of pesticide containers that have not been cleaned. The term does not include any person who is only handling unopened pesticide containers or pesticide containers that have been emptied or cleaned according to pesticide product labeling instructions.
(4) Acting as a flagger.
(5) Cleaning, adjusting, handling, or repairing the parts of mixing, loading, or application equipment that may contain pesticide residues.
(6) Assisting with the application of pesticides.
(7) Entering an enclosed space after the application of a pesticide and before the inhalation exposure level listed in the labeling has been reached or one of the ventilation criteria established by § 170.405(b)(3) or the labeling has been met to operate ventilation equipment, monitor air levels, or adjust or remove coverings used in fumigation.
(8) Entering a treated area outdoors after application of any soil fumigant during the labeling-specified entry-restricted period to adjust or remove coverings used in fumigation.
(9) Performing tasks as a crop advisor during any pesticide application or restricted-entry interval, or before the inhalation exposure level listed in the pesticide product labeling has been reached or one of the ventilation criteria established by § 170.405(b)(3) or the pesticide product labeling has been met.
(1) Pre-application activities, including, but not limited to:
(i) Arranging for the application of the pesticide.
(ii) Mixing and loading the pesticide.
(iii) Making necessary preparations for the application of the pesticide, including responsibilities related to worker notification, training of workers or handlers, providing decontamination supplies, providing pesticide safety information and pesticide application and hazard information, use and care of personal protective equipment, providing emergency assistance, and heat stress management.
(2) Application of the pesticide.
(3) Post-application activities intended to reduce the risks of illness and injury resulting from handlers' and workers' occupational exposures to pesticide residues during and after the restricted-entry interval, including responsibilities related to worker notification, training of workers or early-entry workers, providing decontamination supplies, providing pesticide safety information and pesticide application and hazard information, use and care of personal protective equipment, providing emergency assistance, and heat stress management.
(4) Other pesticide-related activities, including, but not limited to, transporting or storing pesticides that have been opened, cleaning equipment, and disposing of excess pesticides, spray mix, equipment wash waters, pesticide containers, and other pesticide-containing materials.
Agricultural employers must:
(a) Ensure that any pesticide is used in a manner consistent with the pesticide product labeling, including the requirements of this part, when applied on the agricultural establishment.
(b) Ensure that each worker and handler subject to this part receives the protections required by this part.
(c) Ensure that any handler and any early entry worker is at least 18 years old.
(d) Provide to each person, including labor contractors, who supervises any workers or handlers information and directions sufficient to ensure that each
(e) Require each person, including labor contractors, who supervises any workers or handlers to provide sufficient information and directions to each worker and handler to ensure that they can comply with the provisions of this part.
(f) Provide emergency assistance in accordance with this paragraph. If there is reason to believe that a worker or handler has experienced a potential pesticide exposure during his or her employment on the agricultural establishment or shows symptoms similar to those associated with acute exposure to pesticides during or within 72 hours after his or her employment on the agricultural establishment, and needs emergency medical treatment, the agricultural employer must do all of the following promptly after learning of the possible poisoning or injury:
(1) Make available to that person transportation from the agricultural establishment, including any worker housing area on the establishment, to an operating medical care facility capable of providing emergency medical treatment to a person exposed to pesticides.
(2) Provide all of the following information to the treating medical personnel:
(i) Copies of the applicable safety data sheet(s) and the product name(s), EPA registration number(s) and active ingredient(s) for each pesticide product to which the person may have been exposed.
(ii) The circumstances of application or use of the pesticide on the agricultural establishment.
(iii) The circumstances that could have resulted in exposure to the pesticide.
(g) Ensure that workers or other persons employed by the agricultural establishment do not clean, repair, or adjust pesticide application equipment, unless trained as a handler under § 170.501. Before allowing any person not directly employed by the agricultural establishment to clean, repair, or adjust equipment that has been used to mix, load, transfer, or apply pesticides, the agricultural employer must provide all of the following information to such person:
(1) Pesticide application equipment may be contaminated with pesticides.
(2) The potentially harmful effects of exposure to pesticides.
(3) Procedures for handling pesticide application equipment and for limiting exposure to pesticide residues.
(4) Personal hygiene practices and decontamination procedures for preventing pesticide exposures and removing pesticide residues.
(h) Display, maintain, and provide access to pesticide safety information and pesticide application and hazard information in accordance with § 170.311 if workers or handlers are on the establishment and within the last 30 days a pesticide product has been used or a restricted-entry interval for such pesticide has been in effect on the establishment.
(i) Ensure that before a handler uses any equipment for mixing, loading, transferring, or applying pesticides, the handler is instructed in the safe operation of such equipment.
(j) Ensure that before each day of use, equipment used for mixing, loading, transferring, or applying pesticides is inspected for leaks, clogging, and worn or damaged parts, and any damaged equipment is repaired or replaced.
(k) Ensure that whenever handlers employed by a commercial pesticide handling establishment will be on an agricultural establishment, the handler employer is provided information about, or is aware of, the specific location and description of any treated areas on the agricultural establishment where a restricted-entry interval is in effect that the handler may be in (or may walk within
(l) Ensure that workers do not enter any area on the agricultural establishment where a pesticide has been applied until the applicable pesticide application and hazard information for each pesticide product applied to that area is displayed in accordance with § 170.311(b), and until after the restricted-entry interval has expired and all treated area warning signs have been removed or covered, except for entry permitted by § 170.603 of this part.
(m) Provide any records or other information required by this part for inspection and copying upon request by an employee of EPA or any duly authorized representative of a Federal, State or Tribal government agency responsible for pesticide enforcement.
(a)
(1)
(2)
(i) Help keep pesticides from entering your body. Avoid getting on your skin or into your body any pesticides that may be on plants and soil, in irrigation water, or drifting from nearby applications.
(ii) Wash before eating, drinking, using chewing gum or tobacco, or using the toilet.
(iii) Wear work clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and socks, and a hat or scarf).
(iv) Wash or shower with soap and water, shampoo hair, and put on clean clothes after work.
(v) Wash work clothes separately from other clothes before wearing them again.
(vi) Wash immediately in the nearest clean water if pesticides are spilled or sprayed on the body. As soon as possible, shower, shampoo, and change into clean clothes.
(vii) Follow directions about keeping out of treated or restricted areas.
(viii) The name, address, and telephone number of a nearby operating medical care facility capable of providing emergency medical treatment. This information must be clearly identified as emergency medical contact information on the display.
(ix) There are Federal rules to protect workers and handlers, including a requirement for safety training.
(3)
(i) Avoid getting on the skin or into the body any pesticides that may be on or in plants, soil, irrigation water, tractors, and other equipment, on used personal protective equipment, or drifting from nearby applications.
(ii) Wash before eating, drinking, using chewing gum or tobacco, or using the toilet.
(iii) Wear work clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and socks, and a hat or scarf).
(iv) Wash or shower with soap and water, shampoo hair, and put on clean clothes after work.
(v) Wash work clothes separately from other clothes before wearing them again.
(vi) If pesticides are spilled or sprayed on the body use decontamination supplies to wash immediately, or rinse off in the nearest clean water, including springs, streams, lakes or other sources if more readily available than decontamination supplies, and as soon as possible, wash or shower with soap and water, shampoo hair, and change into clean clothes.
(vii) Follow directions about keeping out of treated areas and application exclusion zones.
(viii) Instructions to employees to seek medical attention as soon as possible if they believe they have been poisoned, injured or made ill by pesticides.
(ix) The name, address, and telephone number of a nearby operating medical care facility capable of providing emergency medical treatment. This information must be clearly identified as emergency medical contact information on the display.
(x) The name, address and telephone number of the State or Tribal pesticide regulatory agency.
(4)
(5)
(i) The site selected pursuant to § 170.311(b)(2) for display of pesticide application and hazard information.
(ii) Anywhere that decontamination supplies must be provided on the agricultural establishment pursuant to §§ 170.411, 170.509 or 170.605, but only when the decontamination supplies are located at permanent sites or being provided at locations and in quantities to meet the requirements for 11 or more workers or handlers.
(6)
(7)
(b)
(1)
(i) A copy of the safety data sheet.
(ii) The name, EPA registration number, and active ingredient(s) of the pesticide product.
(iii) The crop or site treated and the location and description of the treated area.
(iv) The date(s) and times the application started and ended.
(v) The duration of the applicable labeling-specified restricted-entry interval for that application.
(2)
(3)
(4)
(5)
(6)
(7)
(i) If a person is or was employed as a worker or handler by an establishment during the period that particular pesticide application and hazard information was required to be displayed and retained for two years in accordance with §§ 170.311(b)(5) and 170.311(b)(6), and the person requests a copy of such application and/or hazard information, or requests access to such application and/or hazard information after it is no longer required to be displayed, the agricultural employer must provide the worker or handler with a copy of or access to all of the requested information within 15 days of the receipt of any such request. The worker or handler may make the request orally or in writing.
(ii) Whenever a record has been previously provided without cost to a worker or handler or their designated representative, the agricultural employer may charge reasonable, non-discriminatory administrative costs (
(9)
(i) Any worker's or handler's designated representative may request access to or a copy of any information required to be retained for two years by § 170.311(b)(6) on behalf of a worker or handler employed on the establishment during the period that the information was required to be displayed. The agricultural employer must provide access to or a copy of the requested information applicable to the worker's or handler's time of employment on the establishment within 15 days after receiving any such request, provided the request meets the requirements specified in § 170.311(b)(9)(ii).
(ii) A request by a designated representative for access to or a copy of any pesticide application and/or hazard
(A) The name of the worker or handler being represented.
(B) A description of the specific information being requested. The description should include the dates of employment of the worker or handler, the date or dates for which the records are requested, type of work conducted by the worker or handler (
(C) A written statement clearly designating the representative to request pesticide application and hazard information on the worker's or handler's behalf, bearing the worker's or handler's printed name and signature, the date of the designation, and the printed name and contact information for the designated representative.
(D) If the worker or handler requests that the pesticide application and/or the hazard information be sent, direction for where to send the information (
(iii) If the written request from a designated representative contains all of the necessary information specified in § 170.313(b)(9)(ii), the employer must provide a copy of or access to all of the requested information applicable to the worker's or handler's time of employment on the establishment to the designated representative within 15 days of receiving the request.
(iv) Whenever a record has been previously provided without cost to a worker or handler or their designated representative, the agricultural employer may charge reasonable, non-discriminatory administrative costs (
Commercial pesticide handler employers must:
(a) Ensure that any pesticide is used in a manner consistent with the pesticide product labeling, including the requirements of this part, when applied on an agricultural establishment by a handler employed by the commercial pesticide handling establishment.
(b) Ensure each handler employed by the commercial pesticide handling establishment and subject to this part receives the protections required by this part.
(c) Ensure that any handler employed by the commercial pesticide handling establishment is at least 18 years old.
(d) Provide to each person, including labor contractors, who supervises any handlers employed by the commercial pesticide handling establishment, information and directions sufficient to ensure that each handler receives the protections required by this part. Such information and directions must specify the tasks for which the supervisor is responsible in order to comply with the provisions of this part.
(e) Require each person, including labor contractors, who supervises any handlers employed by the commercial pesticide handling establishment, to provide sufficient information and directions to each handler to ensure that the handler can comply with the provisions of this part.
(f) Ensure that before any handler employed by the commercial pesticide handling establishment uses any equipment for mixing, loading, transferring, or applying pesticides, the handler is instructed in the safe operation of such equipment.
(g) Ensure that, before each day of use, equipment used by their employees for mixing, loading, transferring, or applying pesticides is inspected for leaks, obstructions, and worn or damaged parts, and any damaged equipment is repaired or is replaced.
(h) Ensure that whenever a handler who is employed by a commercial pesticide handling establishment will be on an agricultural establishment, the handler is provided information about, or is aware of, the specific location and description of any treated areas where a restricted-entry interval is in effect, and the restrictions on entering those areas.
(i) Provide the agricultural employer all of the following information before the application of any pesticide on an agricultural establishment:
(1) Specific location(s) and description of the area(s) to be treated.
(2) The date(s) and start and estimated end times of application.
(3) Product name, EPA registration number, and active ingredient(s).
(4) The labeling-specified restricted-entry interval applicable for the application.
(5) Whether posting, oral notification or both are required under § 170.409.
(6) Any restrictions or use directions on the pesticide product labeling that must be followed for protection of workers, handlers, or other persons during or after application.
(j) If there are any changes to the information provided in § 170.313(i)(1), § 170.313(i)(4), § 170.313(i)(5), § 170.313(i)(6) or if the start time for the application will be earlier than originally forecasted or scheduled, ensure that the agricultural employer is provided updated information prior to the application. If there are any changes to any other information provided pursuant to § 170.313(i), the commercial pesticide handler employer must provide updated information to the agricultural employer within two hours after completing the application. Changes to the estimated application end time of less than one hour need not be reported to the agricultural employer.
(k) Provide emergency assistance in accordance with this paragraph. If there is reason to believe that a handler employed by the commercial pesticide handling establishment has experienced a potential pesticide exposure during his or her employment by the commercial pesticide handling establishment or shows symptoms similar to those associated with acute exposure to pesticides during or within 72 hours after his or her employment by the commercial pesticide handling establishment, and needs emergency medical treatment, the commercial pesticide handler employer must do all of the following promptly after learning of the possible poisoning or injury:
(1) Make available to that person transportation from the commercial pesticide handling establishment, or any agricultural establishment on which that handler may be working on behalf of the commercial pesticide handling establishment, to an operating medical care facility capable of providing emergency medical treatment to a person exposed to pesticides.
(2) Provide all of the following information to the treating medical personnel:
(i) Copies of the applicable safety data sheet(s) and the product name(s), EPA registration number(s) and active ingredient(s) for each pesticide product to which the person may have been exposed.
(ii) The circumstances of application or use of the pesticide.
(iii) The circumstances that could have resulted in exposure to the pesticide.
(l) Ensure that persons directly employed by the commercial pesticide handling establishment do not clean, repair, or adjust pesticide application equipment, unless trained as a handler under § 170.501. Before allowing any person not directly employed by the commercial pesticide handling establishment to clean, repair, or adjust equipment that has been used to mix, load, transfer, or apply pesticides, the commercial pesticide handler employer
(1) Notice that the pesticide application equipment may be contaminated with pesticides.
(2) The potentially harmful effects of exposure to pesticides.
(3) Procedures for handling pesticide application equipment and for limiting exposure to pesticide residues.
(4) Personal hygiene practices and decontamination procedures for preventing pesticide exposures and removing pesticide residues.
(m) Provide any records or other information required by this part for inspection and copying upon request by an employee of EPA or any duly authorized representative of a Federal, State or Tribal government agency responsible for pesticide enforcement.
No agricultural employer, commercial pesticide handler employer, or other person involved in the use of a pesticide to which this part applies, shall intimidate, threaten, coerce, or discriminate against any worker or handler for complying with or attempting to comply with this part, or because the worker or handler provided, caused to be provided or is about to provide information to the employer or the EPA or any duly authorized representative of a Federal, State or Tribal government regarding conduct that the worker or handler reasonably believes violates this part, has made a complaint, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing concerning compliance with this part, or has objected to, or refused to participate in, any activity, policy, practice, or assigned task that the worker or handler reasonably believed to be in violation of this part. Any such intimidation, threat, coercion, or discrimination violates FIFRA section 12(a)(2)(G), 7 U.S.C. 136j(a)(2)(G).
(a) Under FIFRA section 12(a)(2)(G), it is unlawful for any person “to use any registered pesticide in a manner inconsistent with its labeling.” When this part is referenced on a label, users must comply with all of its requirements, except those that are inconsistent with product-specific instructions on the pesticide product labeling, except as provided for in §§ 170.601, 170.603 and 170.607.
(b) A person who has a duty under this part, as referenced on the pesticide product labeling, and who fails to perform that duty, violates FIFRA section 12(a)(2)(G) and is subject to a civil penalty under section 14. A person who knowingly violates section 12(a)(2)(G) is subject to section 14 criminal sanctions.
(c) FIFRA section 14(b)(4) provides that a person is liable for a penalty under FIFRA if another person employed by or acting for that person violates any provision of FIFRA. The term “acting for” includes both employment and contractual relationships, including, but not limited to, labor contractors.
(d) The requirements of this part, including the decontamination requirements, must not, for the purposes of section 653(b)(1) of Title 29 of the U.S. Code, be deemed to be the exercise of statutory authority to prescribe or enforce standards or regulations affecting the general sanitary hazards addressed by the OSHA Field Sanitation Standard, 29 CFR 1928.110, or other agricultural non-pesticide hazards.
(a)
(b)
(1) A worker who is currently certified as an applicator of restricted use pesticides under part 171 of this chapter.
(2) A worker who has satisfied the handler training requirements in § 170.501.
(3) A worker who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or the State or Tribal agency responsible for pesticide enforcement, provided that such certification or licensing requires pesticide safety training that includes all the topics in § 170.501(c)(2) or § 170.501(c)(3) as applicable depending on the date of training.
(c)
(2) The training must include, at a minimum, all of the following topics:
(i) Where and in what form pesticides may be encountered during work activities.
(ii) Hazards of pesticides resulting from toxicity and exposure, including acute and chronic effects, delayed effects, and sensitization.
(iii) Routes through which pesticides can enter the body.
(iv) Signs and symptoms of common types of pesticide poisoning.
(v) Emergency first aid for pesticide injuries or poisonings.
(vi) How to obtain emergency medical care.
(vii) Routine and emergency decontamination procedures, including emergency eye flushing techniques.
(viii) Hazards from chemigation and drift.
(ix) Hazards from pesticide residues on clothing.
(x) Warnings about taking pesticides or pesticide containers home.
(xi) Requirements of this subpart designed to reduce the risks of illness or injury resulting from workers' occupational exposure to pesticides, including application and entry restrictions, the design of the warning sign, posting of warning signs, oral warnings, the availability of specific information about applications, and the protection against retaliatory acts.
(3) EPA intends to make available to the public training materials that may be used to conduct training conforming to the requirements of this section. Within 180 days after a notice of availability of such training materials appears in the
(i) The responsibility of agricultural employers to provide workers and handlers with information and protections designed to reduce work-related pesticide exposures and illnesses. This includes ensuring workers and handlers have been trained on pesticide safety, providing pesticide safety and application and hazard information, decontamination supplies and emergency medical assistance, and notifying workers of restrictions during applications and on entering pesticide treated areas. A worker or handler may designate in writing a representative to request access to pesticide application and hazard information.
(ii) How to recognize and understand the meaning of the posted warning signs used for notifying workers of restrictions on entering pesticide treated areas on the establishment.
(iii) How to follow directions and/or signs about keeping out of pesticide treated areas subject to a restricted-entry interval and application exclusion zones.
(iv) Where and in what forms pesticides may be encountered during work activities, and potential sources of pesticide exposure on the agricultural establishment. This includes exposure to pesticide residues that may be on or in plants, soil, tractors, application and chemigation equipment, or used personal protective equipment, and that pesticides may drift through the air from nearby applications or be in irrigation water.
(v) Potential hazards from toxicity and exposure that pesticides present to workers and their families, including acute and chronic effects, delayed effects, and sensitization.
(vi) Routes through which pesticides can enter the body.
(vii) Signs and symptoms of common types of pesticide poisoning.
(viii) Emergency first aid for pesticide injuries or poisonings.
(ix) Routine and emergency decontamination procedures, including emergency eye flushing techniques, and if pesticides are spilled or sprayed on the body to use decontamination supplies to wash immediately or rinse off in the nearest clean water, including springs, streams, lakes or other sources if more readily available than decontamination supplies, and as soon as possible, wash or shower with soap and water, shampoo hair, and change into clean clothes.
(x) How and when to obtain emergency medical care.
(xi) When working in pesticide treated areas, wear work clothing that protects the body from pesticide residues and wash hands before eating, drinking, using chewing gum or tobacco, or using the toilet.
(xii) Wash or shower with soap and water, shampoo hair, and change into clean clothes as soon as possible after working in pesticide treated areas.
(xiii) Potential hazards from pesticide residues on clothing.
(xiv) Wash work clothes before wearing them again and wash them separately from other clothes.
(xv) Do not take pesticides or pesticide containers used at work to your home.
(xvi) Safety data sheets provide hazard, emergency medical treatment and other information about the pesticides used on the establishment they may come in contact with. The responsibility of agricultural employers to do all of the following:
(A) Display safety data sheets for all pesticides used on the establishment.
(B) Provide workers and handlers information about the location of the safety data sheets on the establishment.
(C) Provide workers and handlers unimpeded access to safety data sheets during normal work hours.
(xvii) The rule prohibits agricultural employers from allowing or directing any worker to mix, load or apply pesticides or assist in the application of pesticides unless the worker has been trained as a handler.
(xviii) The responsibility of agricultural employers to provide specific information to workers before directing them to perform early-entry activities. Workers must be 18 years old to perform early-entry activities.
(xix) Potential hazards to children and pregnant women from pesticide exposure.
(xx) Keep children and nonworking family members away from pesticide treated areas.
(xxi) After working in pesticide treated areas, remove work boots or shoes before entering your home, and remove work clothes and wash or shower before physical contact with children or family members.
(xxii) How to report suspected pesticide use violations to the State or Tribal agency responsible for pesticide enforcement.
(xxiii) The rule prohibits agricultural employers from intimidating, threatening, coercing, or discriminating against any worker or handler for complying with or attempting to comply with the requirements of this rule, or because the worker or handler provided, caused to be provided or is about to provide information to the employer or the EPA or its agents regarding conduct that the employee reasonably believes violates this part, and/or made a complaint, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing concerning compliance with this rule.
(4) The person who conducts the training must meet one of the following criteria:
(i) Be designated as a trainer of certified applicators, handlers or workers by EPA or the State or Tribal agency responsible for pesticide enforcement.
(ii) Have completed an EPA-approved pesticide safety train-the-trainer program for trainers of workers.
(iii) Be currently certified as an applicator of restricted use pesticides under part 171 of this chapter.
(d)
(i) The trained worker's printed name and signature.
(ii) The date of the training.
(iii) Information identifying which EPA-approved training materials were used.
(iv) The trainer's name and documentation showing that the trainer met the requirements of § 170.401(c)(4) at the time of training.
(v) The agricultural employer's name.
(2) An agricultural employer who provides, directly or indirectly, training required under paragraph (a) must provide to the worker upon request a copy of the record of the training that contains the information required under § 170.401(d)(1).
Before any worker performs any activity in a treated area on an agricultural establishment where within the last 30 days a pesticide product has been used, or a restricted-entry interval for such pesticide has been in effect, the agricultural employer must ensure that the worker has been informed of, in a manner the worker can understand, all of the following establishment-specific information:
(a) The location of pesticide safety information required by § 170.311(a).
(b) The location of pesticide application and hazard information required by § 170.311(b).
(c) The location of decontamination supplies required by § 170.411.
(a)
(i) The application exclusion zone is the area that extends 100 feet horizontally from the application equipment in all directions during application when the pesticide is applied by any of the following methods:
(A) Aerially.
(B) Air blast application.
(C) As a spray using a spray quality (droplet spectrum) of smaller than medium (volume median diameter of less than 294 microns).
(D) As a fumigant, smoke, mist, or fog.
(ii) The application exclusion zone is the area that extends 25 feet horizontally from the application equipment in all directions during application when the pesticide is applied not as in § 170.405(a)(1)(i)(A)-(D) and is sprayed from a height of greater than 12 inches from the planting medium using a spray quality (droplet spectrum) of medium or larger (volume median diameter of 294 microns or greater).
(iii) There is no application exclusion zone when the pesticide is applied in a manner other than those covered in paragraphs (a)(1)(i) and (a)(1)(ii) of this section.
(2) During any outdoor production pesticide application, the agricultural employer must not allow or direct any worker or other person, other than an appropriately trained and equipped handler involved in the application, to enter or to remain in the treated area or an application exclusion zone that is within the boundaries of the establishment until the application is complete.
(3) After the application is complete, the area subject to the labeling-specified restricted-entry interval and the post-application entry restrictions specified in § 170.407 is the treated area.
(b)
(2) After the time specified in column C of the Table under paragraph (b)(4) of this section has expired, the area subject to the labeling-specified restricted-entry interval and the post-application entry restrictions specified in § 170.407 is the area specified in column D of the Table under paragraph (b)(4) of this section.
(3) When column C of the Table under paragraph (b)(4) of this section specifies that ventilation criteria must be met, ventilation must continue until the air concentration is measured to be equal to or less than the inhalation exposure level required by the labeling. If no inhalation exposure level is listed on the labeling, ventilation must continue until after one of the following conditions is met:
(i) Ten air exchanges are completed.
(ii) Two hours of ventilation using fans or other mechanical ventilating systems.
(iii) Four hours of ventilation using vents, windows, or other passive ventilation.
(iv) Eleven hours with no ventilation followed by one hour of mechanical ventilation.
(v) Eleven hours with no ventilation followed by two hours of passive ventilation.
(vi) Twenty-four hours with no ventilation.
(4) The following Table applies to paragraphs (b)(1), (2), and (3) of this section.
(a) After the application of any pesticide to an area of outdoor production, the agricultural employer must not allow or direct any worker to enter or to remain in the treated area before the restricted-entry interval specified on the pesticide product labeling has expired and all treated area warning signs have been removed or covered, except for early-entry activities permitted by § 170.603.
(b) After the application of any pesticide to an area of enclosed space production, the agricultural employer must not allow or direct any worker to enter or to remain in the areas specified in column D of the Table in § 170.405(b)(4), before the restricted-entry interval specified on the pesticide product labeling has expired and all treated area warning signs have been removed or covered, except for early-entry activities permitted by § 170.603.
(c) When two or more pesticides are applied to a treated area at the same time, the applicable restricted-entry interval is the longest of all applicable restricted-entry intervals.
(a)
(1
(ii)
(iii)
(iv)
(v)
(2)
(i) From the start of the application in an enclosed space production area until the end of any restricted-entry interval, the worker will not enter any part of the entire enclosed structure or space.
(ii) From the start of the application to an outdoor production area until the end of any restricted-entry interval, the worker will not enter, work in, remain in, or pass on foot through the treated area or any area within
(iii) The worker was involved in the application of the pesticide as a handler, and is aware of all information required by paragraph (c)(1) of this section.
(b)
(1)
(i) Be one of the three sizes specified in paragraph (b)(3) of this section and comply with the posting placement and spacing requirements applicable to that sign size.
(ii) Be posted prior to but no earlier than 24 hours before the scheduled application of the pesticide.
(iii) Remain posted throughout the application and any restricted-entry interval.
(iv) Be removed or covered within three days after the end of the application or any restricted-entry interval, whichever is later, except that signs may remain posted after the restricted-entry interval has expired as long as all of the following conditions are met:
(A) The agricultural employer instructs any workers on the establishment that may come within
(B) The agricultural employer ensures that workers do not enter the treated area while the signs remain posted, other than entry permitted by § 170.603 of this part.
(v) Remain visible and legible during the time they are required to be posted.
(2)
(ii) The agricultural employer may replace the Spanish language portion of the warning sign with equivalent terms in an alternative non-English language if that alternative language is the language read by the largest group of workers at that agricultural establishment who do not read English. The alternative language sign must be in the same format as the original sign and conform to all other requirements of paragraph (b)(2)(i) of this section.
(3)
(ii) When posting an outdoor production area using the standard sign, the signs must be visible from all reasonably expected points of worker entry to the treated area, including at least each access road, each border with any worker housing area within 100 feet of the treated area and each footpath and other walking route that enters the treated area. Where there are no reasonably expected points of worker entry, signs must be posted in the corners of the treated area or in any other location affording maximum visibility.
(iii) When posting an enclosed space production area using the standard sign and the entire structure or space is subject to the labeling-specified restricted-entry interval and the post-application entry restrictions specified in § 170.407, the signs must be posted so they are visible from all reasonably expected points of worker entry to the structure or space. When posting treated areas in enclosed space production using the standard sign and the treated area only comprises a subsection of the structure or space, the signs must be posted so they are visible from all reasonably expected points of worker entry to the treated area including each aisle or other walking route that enters the treated area. Where there are no reasonably expected points of worker entry to the treated area, signs must be posted in the corners of the treated area or in any other location affording maximum visibility.
(iv) If a smaller warning sign is used with “DANGER” and “PELIGRO” in letters at least 7/8 inch in height and the remaining letters at least 1/2 inch in height and a red circle at least three inches in diameter containing an upraised hand and a stern face, the signs must be posted no farther than 50 feet apart around the perimeter of the treated area in addition to the locations specified in paragraphs (b)(3)(ii) or (b)(3)(iii) of this section.
(v) If a smaller sign is used with “DANGER” and “PELIGRO” in letters at least 7/16 inch in height and the remaining letters at least 1/4 inch in height and a red circle at least one and a half inches in diameter containing an upraised hand and a stern face, the signs must be posted no farther than 25 feet apart around the perimeter of the treated area in addition to the locations specified in paragraphs (b)(3)(ii) or (b)(3)(iii) of this section.
(vi) A sign with “DANGER” and “PELIGRO” in letters less than 7/16 inch in height or with any words in letters less than 1/4 inch in height or a red circle smaller than one and a half inches in diameter containing an upraised hand and a stern face will not satisfy the requirements of the rule.
(c)
(1) The location(s) and description of any treated area(s) subject to the entry restrictions during and after application specified in §§ 170.405 and 170.407.
(2) The dates and times during which entry is restricted in any treated area(s) subject to the entry restrictions during and after application specified in §§ 170.405 and 170.407.
(3) Instructions not to enter the treated area or an application exclusion zone during application, and that entry to the treated area is not allowed until the restricted-entry interval has expired and all treated area warning signs have been removed or covered, except for entry permitted by § 170.603 of this part.
(a)
(b)
(1)
(2)
(c)
(2) If the only pesticides applied in the treated area are products with restricted-entry intervals of four hours or less, the decontamination supplies must be provided from the time workers first enter the treated area until at least seven days after the restricted-entry interval expires.
(d)
(a)
(b)
(1) A handler who is currently certified as an applicator of restricted use pesticides under part 171 of this chapter.
(2) A handler who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or the State or Tribal agency responsible for pesticide enforcement, provided that a requirement for such certification or licensing is pesticide safety training that includes all the topics set out in § 170.501(c)(2) or § 170.501(c)(3) as applicable depending on the date of training.
(c)
(2) The pesticide safety training materials must include, at a minimum, all of the following topics:
(i) Format and meaning of information contained on pesticide labels and in labeling, including safety information such as precautionary statements about human health hazards.
(ii) Hazards of pesticides resulting from toxicity and exposure, including acute and chronic effects, delayed effects, and sensitization.
(iii) Routes by which pesticides can enter the body.
(iv) Signs and symptoms of common types of pesticide poisoning.
(v) Emergency first aid for pesticide injuries or poisonings.
(vi) How to obtain emergency medical care.
(vii) Routine and emergency decontamination procedures.
(viii) Need for and appropriate use of personal protective equipment.
(ix) Prevention, recognition, and first aid treatment of heat-related illness.
(x) Safety requirements for handling, transporting, storing, and disposing of pesticides, including general procedures for spill cleanup.
(xi) Environmental concerns such as drift, runoff, and wildlife hazards.
(xii) Warnings about taking pesticides or pesticide containers home.
(xiii) Requirements of this subpart that must be followed by handler employers for the protection of handlers and other persons, including the prohibition against applying pesticides in a manner that will cause contact with workers or other persons, the requirement to use personal protective equipment, the provisions for training and decontamination, and the protection against retaliatory acts.
(3) EPA intends to make available to the public training materials that may be used to conduct training conforming to the requirements of this section. Within 180 days after a notice of availability of such training materials appears in the
(i) All the topics required by § 170.401(c)(3).
(ii) Information on proper application and use of pesticides.
(iii) Handlers must follow the portions of the labeling applicable to the safe use of the pesticide.
(iv) Format and meaning of information contained on pesticide labels and in labeling applicable to the safe use of the pesticide.
(v) Need for and appropriate use and removal of all personal protective equipment.
(vi) How to recognize, prevent, and provide first aid treatment for heat-related illness.
(vii) Safety requirements for handling, transporting, storing, and disposing of pesticides, including general procedures for spill cleanup.
(viii) Environmental concerns, such as drift, runoff, and wildlife hazards.
(ix) Handlers must not apply pesticides in a manner that results in contact with workers or other persons.
(x) The responsibility of handler employers to provide handlers with information and protections designed to reduce work-related pesticide exposures and illnesses. This includes providing, cleaning, maintaining, storing, and ensuring proper use of all required personal protective equipment; providing decontamination supplies; and providing specific information about pesticide use and labeling information.
(xi) Handlers must suspend a pesticide application if workers or other persons are in the application exclusion zone.
(xii) Handlers must be at least 18 years old.
(xiii) The responsibility of handler employers to ensure handlers have received respirator fit-testing, training and medical evaluation if they are required to wear a respirator by the product labeling.
(xiv) The responsibility of agricultural employers to post treated areas as required by this rule.
(4) The person who conducts the training must have one of the following qualifications:
(i) Be designated as a trainer of certified applicators or pesticide handlers by EPA or the State or Tribal agency responsible for pesticide enforcement.
(ii) Have completed an EPA-approved pesticide safety train-the-trainer program for trainers of handlers.
(iii) Be currently certified as an applicator of restricted use pesticides under part 171 of this chapter.
(d)
(i) The trained handler's printed name and signature.
(ii) The date of the training.
(iii) Information identifying which EPA-approved training materials were used.
(iv) The trainer's name and documentation showing that the trainer met the requirements of § 170.501(c)(4) at the time of training.
(v) The handler employer's name.
(2) The handler employer must, upon request by a handler trained on the establishment, provide to the handler a copy of the record of the training that contains the information required under § 170.501(d)(1).
(a)
(2) The handler employer must ensure that the handler has access to the applicable product labeling at all times during handler activities.
(3) The handler employer must ensure that the handler is aware of requirements for any entry restrictions, application exclusion zones and restricted-entry intervals as described in §§ 170.405 and 170.407 that may apply based on the handler's activity.
(b)
(1) The location of pesticide safety information required by § 170.311(a).
(2) The location of pesticide application and hazard information required by § 170.311(b).
(3) The location of decontamination supplies required by § 170.509.
(a)
(b)
(c)
(d)
(1) Any handler in an enclosed space production area during a fumigant application maintains continuous visual or voice contact with another handler stationed immediately outside of the enclosed space.
(2) The handler stationed outside the enclosed space has immediate access to and uses the personal protective equipment required by the fumigant labeling for applicators in the event that entry becomes necessary for rescue.
(a)
(b)
(1) If the pesticide product labeling requires that “chemical-resistant” personal protective equipment be worn, it must be made of material that allows no measurable movement of the
(2) If the pesticide product labeling requires that “waterproof” personal protective equipment be worn, it must be made of material that allows no measurable movement of water or aqueous solutions through the material during use.
(3) If the pesticide product labeling requires that a “chemical-resistant suit” be worn, it must be a loose-fitting, one- or two-piece chemical-resistant garment that covers, at a minimum, the entire body except head, hands, and feet.
(4) If the pesticide product labeling requires that “coveralls” be worn, they must be loose-fitting, one- or two-piece garments that cover, at a minimum, the entire body except head, hands, and feet.
(5) Gloves must be the type specified on the pesticide product labeling.
(i) Gloves made of leather, cotton, or other absorbent materials may not be worn while performing handler activities unless gloves made of these materials are listed as acceptable for such use on the pesticide product labeling.
(ii) Separable glove liners may be worn beneath chemical-resistant gloves, unless the pesticide product labeling specifically prohibits their use. Separable glove liners are defined as separate glove-like hand coverings, made of lightweight material, with or without fingers. Work gloves made from lightweight cotton or poly-type material are considered to be glove liners if worn beneath chemical-resistant gloves. Separable glove liners may not extend outside the chemical-resistant gloves under which they are worn. Chemical-resistant gloves with non-separable absorbent lining materials are prohibited.
(iii) If used, separable glove liners must be discarded immediately after a total of no more than 10 hours of use or within 24 hours of when first put on, whichever comes first. The liners must be replaced immediately if directly contacted by pesticide. Used glove liners must not be reused. Contaminated liners must be disposed of in accordance with any Federal, State, or local regulations.
(6) If the pesticide product labeling requires that “chemical-resistant footwear” be worn, one of the following types of footwear must be worn:
(i) Chemical-resistant shoes.
(ii) Chemical-resistant boots.
(iii) Chemical-resistant shoe coverings worn over shoes or boots.
(7) If the pesticide product labeling requires that “protective eyewear” be worn, one of the following types of eyewear must be worn:
(i) Goggles.
(ii) Face shield.
(iii) Safety glasses with front, brow, and temple protection.
(iv) Full-face respirator.
(8) If the pesticide product labeling requires that a “chemical-resistant apron” be worn, a chemical-resistant apron that covers the front of the body from mid-chest to the knees must be worn.
(9) If the pesticide product labeling requires that “chemical-resistant headgear” be worn, it must be either a chemical-resistant hood or a chemical-resistant hat with a wide brim.
(10) The respirator specified by the pesticide product labeling must be used. Whenever a respirator is required by the pesticide product labeling, the handler employer must ensure that the requirements of paragraphs (b)(10)(i) through (iii) of this section are met before the handler performs any handler activity where the respirator is required to be worn. The handler employer must maintain for two years, on the establishment, records documenting the completion of the requirements of paragraphs (b)(10)(i) through (iii) of this section.
(i) Handler employers must provide handlers with fit testing using the respirator specified on the pesticide product labeling in a manner that conforms to the provisions of 29 CFR 1910.134.
(ii) Handler employers must provide handlers with training in the use of the respirator specified on the pesticide product labeling in a manner that conforms to the provisions of 29 CFR 1910.134(k)(1)(i) through(vi).
(iii) Handler employers must provide handlers with a medical evaluation by a physician or other licensed health care professional that conforms to the provisions of 29 CFR 1910.134 to ensure the handler's physical ability to safely wear the respirator specified on the pesticide product labeling.
(c)
(2) The handler employer must ensure that, before each day of use, all personal protective equipment is inspected for leaks, holes, tears, or worn places, and any damaged equipment is repaired or discarded.
(d)
(2) If any personal protective equipment cannot or will not be cleaned properly, the handler employer must ensure the contaminated personal protective equipment is made unusable as apparel or is made unavailable for further use by employees or third parties. The contaminated personal protective equipment must be disposed of in accordance with any applicable laws or regulations. Coveralls or other absorbent materials that have been drenched or heavily contaminated with a pesticide that has the signal word “DANGER” or “WARNING” on the label must not be reused and must be disposed of as specified in this paragraph. Handler employers must ensure that any person who handles contaminated personal protective equipment described in this paragraph wears the gloves specified on the pesticide product labeling for mixing and loading the product(s) comprising the contaminant(s) on the equipment. If two or more pesticides are included in the contaminants, the gloves worn must meet the requirements for mixing and loading all of the pesticide products.
(3) The handler employer must ensure that contaminated personal protective equipment is kept separate from non-contaminated personal protective equipment, other clothing or laundry and washed separately from any other clothing or laundry.
(4) The handler employer must ensure that all washed personal protective equipment is dried thoroughly before being stored or reused.
(5) The handler employer must ensure that all clean personal protective equipment is stored separately from personal clothing and apart from pesticide-contaminated areas.
(6) The handler employer must ensure that when filtering facepiece respirators are used, they are replaced when one of the following conditions is met:
(i) When breathing resistance becomes excessive.
(ii) When the filter element has physical damage or tears.
(iii) According to manufacturer's recommendations or pesticide product labeling, whichever is more frequent.
(iv) In the absence of any other instructions or indications of service life, at the end of eight hours of cumulative use.
(7) The handler employer must ensure that when gas- or vapor-removing respirators are used, the gas- or vapor-removing canisters or cartridges are
(i) At the first indication of odor, taste, or irritation.
(ii) When the maximum use time is reached as determined by a change schedule conforming to the provisions of 29 CFR 1910.134(d)(3)(iii)(B)(2).
(iii) When breathing resistance becomes excessive.
(iv) When required according to manufacturer's recommendations or pesticide product labeling instructions, whichever is more frequent.
(v) In the absence of any other instructions or indications of service life, at the end of eight hours of cumulative use.
(8) The handler employer must inform any person who cleans or launders personal protective equipment of all the following:
(i) That such equipment may be contaminated with pesticides and there are potentially harmful effects from exposure to pesticides.
(ii) The correct way(s) to clean personal protective equipment and how to protect themselves when handling such equipment.
(iii) Proper decontamination procedures that should be followed after handling contaminated personal protective equipment.
(9) The handler employer must ensure that handlers have a place(s) away from pesticide storage and pesticide use areas where they may do all of the following:
(i) Store personal clothing not worn during handling activities.
(ii) Put on personal protective equipment at the start of any exposure period.
(iii) Remove personal protective equipment at the end of any exposure period.
(10) The handler employer must not allow or direct any handler to wear home or to take home employer-provided personal protective equipment contaminated with pesticides.
(e)
(a)
(b)
(1)
(2)
(3)
(c)
(1)
(2)
(3)
(d)
(2) Whenever a handler is applying a pesticide product whose labeling requires protective eyewear for handlers, the handler employer must provide at least one pint of water per handler in portable containers that are immediately available to each handler.
(a)
(i) Section 170.309(c).
(ii) Section 170.309(f) through (j).
(iii) Section 170.311.
(iv) Section 170.401.
(v) Section 170.403.
(vi) Section 170.409.
(vii) Sections 170.411 and 170.509.
(viii) Section 170.501.
(ix) Section 170.503.
(x) Section 170.505(c) and (d).
(xi) Section 170.507(c) through (e).
(xii) Section 170.605(a) through (c) and (e) through (j).
(2) The owners of agricultural establishments must provide all of the applicable protections required by this part for any employees or other persons on the establishment that are not members of their immediate family.
(1) The crop advisor is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal agency responsible for pesticide enforcement.
(2) The certification or licensing program requires pesticide safety training that includes all the information in § 170.501(c)(2) or § 170.501(c)(3) as applicable depending on the date of training.
(3) The crop advisor who enters a treated area during a restricted-entry interval only performs crop advising tasks while in the treated area.
An agricultural employer may direct workers to enter treated areas where a restricted-entry interval is in effect to perform certain activities as provided in this section, provided that the agricultural employer ensures all of the applicable conditions of this section and § 170.605 of this part are met.
(a)
(1) The worker will have no contact with anything that has been treated with the pesticide to which the restricted-entry interval applies, including, but not limited to, soil, water, air, or surfaces of plants. This exception does not allow workers to perform any activities that involve contact with treated surfaces even if workers are wearing personal protective equipment.
(2) No such entry is allowed until any inhalation exposure level listed in the pesticide product labeling has been reached or any ventilation criteria required by § 170.405(b)(3) or the pesticide product labeling have been met.
(b)
(1) No hand labor activity is performed.
(2) The time in treated areas where a restricted-entry interval is in effect does not exceed one hour in any 24-hour period for any worker.
(3) No such entry is allowed during the first 4 hours after the application ends.
(4) No such entry is allowed until any inhalation exposure level listed in the pesticide product labeling has been reached or any ventilation criteria required by § 170.405(b)(3) or the pesticide product labeling have been met.
(c)
(2) A worker may enter a treated area where a restricted-entry interval is in effect in an agricultural emergency to perform tasks necessary to mitigate the effects of the agricultural emergency, including hand labor tasks, if the agricultural employer ensures that all the following criteria are met:
(i) The State department of agriculture, or the State or Tribal agency responsible for pesticide enforcement declares an agricultural emergency that applies to the treated area, or agricultural employer has determined that the circumstances within the treated area are the same as circumstances the State department of agriculture, or the State or Tribal agency responsible for pesticide enforcement has previously determined would constitute an agricultural emergency.
(ii) The agricultural employer determines that the agricultural establishment is subject to the circumstances that result in an agricultural emergency meeting the criteria of paragraph (c)(1) of this section.
(iii) If the labeling of any pesticide product applied to the treated area requires workers to be notified of the location of treated areas by both posting and oral notification, then the agricultural employer must ensure that no individual worker spends more than four hours out of any 24-hour period in treated areas where such a restricted-entry interval is in effect.
(iv) No such entry is allowed during the first 4 hours after the application ends.
(v) No such entry is allowed until any inhalation exposure level listed in the pesticide product labeling has been reached or any ventilation criteria required by § 170.405(b)(3) or the pesticide product labeling have been met.
(d)
(1) No hand labor activity is performed.
(2) No worker is allowed in the treated area for more than eight hours in a 24-hour period.
(3) No such entry is allowed during the first 4 hours after the application ends.
(4) No such entry is allowed until any inhalation exposure level listed in the pesticide product labeling has been reached or any ventilation criteria required by § 170.405(b)(3) or the pesticide product labeling have been met.
(5) The task is one that, if not performed before the restricted-entry interval expires, would cause substantial economic loss, and there are no alternative tasks that would prevent substantial loss.
(6) With the exception of irrigation tasks, the need for the task could not have been foreseen.
(7) The worker has no contact with pesticide-treated surfaces other than
(8) The labeling of the pesticide product that was applied does not require that workers be notified of the location of treated areas by both posting and oral notification.
If an agricultural employer directs a worker to perform activities in a treated area where a restricted-entry interval is in effect, all of the following requirements must be met:
(a) The agricultural employer must ensure that the worker is at least 18 years old.
(b) Prior to early entry, the agricultural employer must provide to each early-entry worker the information described in paragraphs (b)(1) through (8) of this section. The information must be provided orally in a manner that the worker can understand.
(1) Location of early-entry area where work activities are to be performed.
(2) Pesticide(s) applied.
(3) Dates and times that the restricted-entry interval begins and ends.
(4) Which exception in § 170.603 is the basis for the early entry, and a description of tasks that may be performed under the exception.
(5) Whether contact with treated surfaces is permitted under the exception.
(6) Amount of time the worker is allowed to remain in the treated area.
(7) Personal protective equipment required by the pesticide product labeling for early entry.
(8) Location of the pesticide safety information required by § 170.311(a) and the location of the decontamination supplies required by § 170.605(h).
(c) Prior to early entry, the agricultural employer must ensure that each worker either has read the applicable pesticide product labeling or has been informed, in a manner that the worker can understand, of all labeling requirements and statements related to human hazards or precautions, first aid, and user safety.
(d) The agricultural employer must ensure that each worker who enters a treated area during a restricted-entry interval is provided the personal protective equipment specified in the pesticide product labeling for early entry. The agricultural employer must ensure that the worker uses the personal protective equipment as intended according to manufacturer's instructions and follows any other applicable requirements on the pesticide product labeling. Personal protective equipment must conform to the standards in § 170.507(b)(1) through (9).
(e) The agricultural employer must maintain the personal protective equipment in accordance with § 170.507(c) and (d).
(f) The agricultural employer must ensure that no worker is allowed or directed to wear personal protective equipment without implementing measures sufficient to prevent heat-related illness and that each worker is instructed in the prevention, recognition, and first aid treatment of heat-related illness.
(g) The agricultural employer must instruct each worker on the proper use and removal of the personal protective equipment, and as appropriate, on its cleaning, maintenance and disposal. The agricultural employer must not allow or direct any worker to wear home or to take home employer-provided personal protective equipment contaminated with pesticides.
(h) During any early-entry activity, the agricultural employer must provide decontamination supplies in accordance with § 170.509, except the decontamination supplies must be outside any area being treated with pesticides or subject to a restricted-entry interval, unless the decontamination supplies would otherwise not be reasonably accessible to workers performing early-entry tasks.
(i) If the pesticide product labeling of the product applied requires protective eyewear, the agricultural employer must provide at least one pint of water per worker in portable containers for eyeflushing that is immediately available to each worker who is performing early-entry activities.
(j) At the end of any early-entry activities the agricultural employer must provide, at the site where the workers remove personal protective equipment, soap, single-use towels and at least three gallons of water per worker so that the workers may wash thoroughly.
(a)
(2) A chemical-resistant suit may be substituted for coveralls and a chemical-resistant apron.
(b)
(c)
(d)
(i) Handlers using a closed system to mix or load pesticides with a signal word of “DANGER” or “WARNING” may substitute a long-sleeved shirt, long pants, shoes and socks, chemical-resistant apron, protective eyewear, and any protective gloves specified on the labeling for handlers for the labeling-specified personal protective equipment.
(ii) Handlers using a closed system to mix or load pesticides other than those specified in paragraph (d)(1)(i) of this section may substitute protective eyewear, long-sleeved shirt, long pants, and shoes and socks for the labeling-specified personal protective equipment.
(2) The exceptions of paragraph (d)(1) of this section apply only in the following situations:
(i) Where the closed system removes the pesticide from its original container and transfers the pesticide product through connecting hoses, pipes and couplings that are sufficiently tight to prevent exposure of handlers to the pesticide product, except for the negligible escape associated with normal operation of the system.
(ii) When loading intact, sealed, water soluble packaging into a mixing tank or system. If the integrity of a water soluble packaging is compromised (for example, if the packaging is dissolved, broken, punctured, torn, or in any way allows its contents to escape), it is no longer a closed system and the labeling-specified personal protective equipment must be worn.
(3) The exceptions of paragraph (d)(1) of this section apply only where the handler employer has satisfied the requirements of § 170.313 and all of the following conditions:
(i) Each closed system must have written operating instructions that are clearly legible and include: Operating procedures for use, including the safe removal of a probe; maintenance, cleaning and repair; known restrictions or limitations relating to the system, such as incompatible pesticides, sizes (or types) of containers or closures that cannot be handled by the system; any limits on the ability to measure a pesticide; and special procedures or limitations regarding partially-filled containers.
(ii) The written operating instructions for the closed system must be available at the mixing or loading site and must be made available to any handlers who use the system.
(iii) Any handler operating the closed system must be trained in its use and operate the closed system in accordance with its written operating instructions.
(iv) The closed system must be cleaned and maintained as specified in the written operating instructions and as needed to make sure the system functions properly.
(v) All personal protective equipment specified in the pesticide product labeling is immediately available to the handler for use in an emergency.
(vi) Protective eyewear must be worn when using closed systems operating under pressure.
(e)
(2) All of the personal protective equipment required by the pesticide product labeling for applicators must be immediately available and stored in a sealed container to prevent contamination. Handlers must wear the applicator personal protective equipment required by the pesticide product labeling if they exit the cab within a treated area during application or when a restricted-entry interval is in effect. Once personal protective equipment is worn in a treated area, it must be removed before reentering the cab to prevent contamination of the cab.
(3) Handlers may substitute a long-sleeved shirt, long pants, shoes and socks for the labeling-specified personal protective equipment for skin and eye protection. If a filtering facepiece respirator (NIOSH approval number prefix TC-84A) or dust/mist filtering respirator is required by the pesticide product labeling for applicators, then that respirator need not be worn inside the enclosed cab if the enclosed cab has a properly functioning air ventilation system which is used and maintained in accordance with the manufacture's written operating instructions. If any other type of respirator is required by the pesticide labeling for applicators, then that respirator must be worn.
(f)
(2)
(3)
(g)
(i) The personal protective equipment specified on the pesticide product labeling for early entry.
(ii) Coveralls, shoes plus socks and chemical-resistant gloves made of any waterproof material, and eye protection if the pesticide product labeling applied requires protective eyewear for handlers.
(2) The application has been complete for at least four hours.
(3) No such entry is allowed until any inhalation exposure level listed in the pesticide product labeling has been reached or any ventilation criteria required by § 170.405(b)(3) or the pesticide product labeling have been met.
(4) The crop advisor or crop advisor employee who enters a treated area during a restricted-entry interval only performs crop advising tasks while in the treated area.
(a) States and Tribes that have promulgated worker protection regulations to protect agricultural workers and pesticide handlers from occupational pesticide exposure effective prior to January 1, 2016, have the option of requesting authority to continue implementing any provision(s) of the State's or Tribe's existing regulations that provides equivalent or greater protection in lieu of implementing any similar provision(s) in this part.
(b) States or Tribes must submit requests for the authority to continue implementing State or Tribal regulation provision(s) in lieu of any similar provision(s) in this part by
(1) Identification of the provision(s) of this part for which the State or Tribe is requesting regulatory equivalency.
(2) Appropriate documentation establishing that the pertinent State or Tribal worker protection provision(s) provides environmental and human health protection that meets or exceeds the protections provided by the identified provision(s) in this part.
(3) Identification of any additional modifications to existing State or Tribal regulations that would be necessary in order to provide environmental and human health protection that meets or exceeds the similar provisions of this part, and an estimated timetable for the State or Tribe to effect these changes.
(4) The expected economic impact of requiring compliance with the requirement(s) of this part in comparison with compliance with the State or Tribal requirement(s), and an explanation of why it is important that employers subject to the State or Tribal authority comply with the State or Tribal requirement(s) in lieu of similar provision(s) in this part.
(5) The signature of the designated representative of the State or Tribal agency responsible for pesticide enforcement.
(c) EPA's Office of Pesticide Programs will review the State's or Tribe's letter and supporting materials and determine whether the State or Tribal provision(s) provide environmental and human health protection that meets or exceeds the comparable provision(s) of this part.
(d) EPA's Office of Pesticide Programs will inform the State or Tribe of its determination through a letter. The letter will either:
(1) Authorize the State or Tribe to continue implementing its worker protection regulatory provision(s) in lieu of the comparable provision(s) of this part; or
(2) Deny the State or Tribe authorization to continue implementing its worker protection regulatory provision(s) in lieu of the comparable provision(s) of this part and detail any reasons for declining authorization.
(e)
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule with comment period.
This final rule with comment period provides for a transparent data-driven process for states to document whether Medicaid payments are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with section 1902(a)(30)(A) of the Social Security Act (the Act) and to address issues raised by that process. The final rule with comment period also recognizes electronic publication as an optional means of providing public notice of proposed changes in rates or ratesetting methodologies that the state intends to include in a Medicaid state plan amendment (SPA). We are providing an opportunity for comment on whether future adjustments would be warranted to the provisions setting forth requirements for ongoing state reviews of beneficiary access.
In commenting, please refer to file code CMS-2328-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD— Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Jeremy Silanskis, (410) 786-1592.
Comments received timely will be also available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
In the May 6, 2011
In this final rule with comment period, we are providing increased state flexibility within a framework to document measures supporting beneficiary access to services. This final rule with comment period implements methods for states to use in complying with section 1902(a)(30)(A) of the Act by requiring that states review data and trends to evaluate access to care for covered services and conduct public processes to obtain public input on the adequacy of access to covered services in the Medicaid program. This information will be updated and monitored regularly. Should the data reveal short-comings in Medicaid beneficiaries' access to care, states must take corrective actions. The final rule with comment period also recognizes electronic publication as an optional means of providing public notice of proposed changes in rates or ratesetting methodologies that the state intends to include in a Medicaid state plan amendment (SPA). This final rule with comment period will meet the expectations of the May 6, 2011 proposed rule to establish a transparent data-driven process that ensures that rates are consistent with section 1902(a)(30)(A) of the Act.
The Medicaid statute requires that states provide coverage to certain groups of individuals, and also requires that such coverage include certain minimum benefits. States may elect to cover other populations and benefits. To give meaning to coverage requirements and options, beneficiaries must have meaningful access to the health care items and services that are within the scope of the covered benefits. This is consistent with the requirements of section 1902(a)(30)(A) of the Act, which provides that states must have methods and procedures to assure that payments to providers are “sufficient to enlist enough providers so that care and services are available under the plan at least to the same extent that such care and services are available to the general population in the geographic area,” which we refer to as the “access requirement.” Many factors affect whether beneficiaries have access to Medicaid services, including but not limited to: The beneficiaries' health care needs and characteristics; state or local service delivery models; procedures for enrolling and reimbursing qualified providers; the availability of providers in the community; the capacity of Medicaid participating providers; and Medicaid service payment rates to providers. To align with the statutory requirements, states may employ any number of strategies to ensure or improve access to care that are targeted toward one or more of these factors.
We have not previously defined through federal regulation an approach to guide states in meeting the statutory access requirement at section 1902(a)(30)(A) of the Act. In the absence of federal guidance and a clear process for monitoring and ensuring access, at times budget-driven payment changes in state Medicaid programs led to confusion and litigation for states and to possible access problems for beneficiaries. CMS's review of state payment rate methodologies for compliance with this requirement was on a case-by-case basis and was hampered by the lack of consistent information related to beneficiary access. We historically relied on state certifications and available supporting information to conclude that Medicaid payment rates met the statutory standards.
In the May 6, 2011 proposed rule, we proposed to adopt an approach for states to analyze access to care for Medicaid services through data and information from beneficiaries and providers. The approach specifically focused on: (1) The extent to which enrollee needs are met; (2) the availability of care and providers; and (3) changes in beneficiary utilization. The purpose of the proposed regulation was not to create an access standard or rate thresholds that each state must meet, but to develop a standard process for each state to follow in documenting access to care. The regulation proposed to require that states conduct regular reviews of Medicaid access to care that rely upon: Payment data, trends in utilization, provider enrollment, feedback from providers and beneficiaries, and other pertinent information that describes access to Medicaid services. The access data reviews would be used to inform state payment changes as well as our approval decisions when states proposed provider payment reductions. In addition, the proposed rule specified that states must conduct a public process when reducing Medicaid payment rates and monitor changes in access to care after payment reductions are approved by us and go into effect.
Earlier this year, the Supreme Court decided in
While states will continue to have the discretion to set program rates and improve access to care through a variety of strategies, this final rule, and any additional measures we adopt, will increase the information available to CMS, to ensure that rates meet the requirements of section 1902(a)(30)(A) of the Act and that access improvement strategies work to improve care delivery when there are deficiencies. We are also developing internal standard operating procedures to bolster the administrative record that is used to document compliance with the final rule for individual SPAs and ensure that there is consistent national application of these policies.
States have broad flexibility under the Act to establish service delivery systems for covered health care items and services, to design the procedures for enrolling providers of such care, and to set the methods for establishing provider payment rates. For instance, many states provide medical assistance primarily through capitated managed care arrangements, while others use FFS payment arrangements (with or without primary care case management). Increasingly, states are developing service delivery models that emphasize medical homes, health homes, or broader integrated care models to provide and coordinate medical services. The delivery system design and accompanying payment methodologies can significantly shape beneficiaries' abilities to access needed care by facilitating the availability of such care. In addition, the delivery system model and payment methodologies can improve access to care by making available care management teams, physician assistants, community care coordinators, telemedicine and telehealth, nurse help lines, health information technology and other methods for providing coordinated care and services and support in a setting and timeframe that meet beneficiary needs.
We have issued a series of State Medicaid Directors (SMD) letters to promote and provide guidance on pathways to implementing integrated care models which can provide higher quality care at lower cost. We have also worked with states to explore innovative approaches to improving care and lowering cost through the Innovation Accelerator Program, the Medicaid Value-Based Learning Collaborative series, group workshop sessions, and one-to-one technical assistance discussions. All of these efforts seek to drive systemic changes in the Medicaid program that manage program costs consistent with the economy and efficiency provisions of section 1902(a)(30)(A) of the Act while also promoting the quality of care.
As state delivery system models have evolved, so have their provider payment systems. For most services, states develop rates based on the costs of providing the service, a review of the amount paid by commercial payers in the private market, or as a percentage of rates paid under the Medicare program for equivalent services. Often, rates are updated based on specific trending factors such as the Medicare Economic Index or a Medicaid trend factor that incorporates a state-determined inflation adjustment rate. Rates may include incentive payments that encourage providers to serve Medicaid populations and improve care. For instance, some states have authorized Medicaid providers to receive separate payments for treatment services and for care coordination and care management. Some states have increased provider payments based on achievement of certain specified quality or health outcome measures.
We have worked with states to design payment and service delivery systems to ensure program savings are aligned with better care quality and promote rather than reduce access to services. Although states may experience reductions in service utilization or overall provider payments for high cost services as a result of program innovations that emphasize preventive care and divert individuals into more appropriate treatment modalities, including serving them in the most integrated setting appropriate to the needs of the individual consistent with
The flexibility in designing service delivery systems and provider payment methodologies, as described above, is consistent with the requirement in section 1902(a)(30)(A) of the Act that state Medicaid plans must provide: Such methods and procedures relating to the utilization of, and the payment for, care and services available under the plan as may be necessary to safeguard against unnecessary utilization of such care and services. As well, states must assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the same extent that such care and services are available to the general population in the geographic area.
Consistent with the requirement in section 1902(a)(30)(A) of the Act to provide payment for quality care in an effective and efficient manner, states can use their ratesetting policies to seek the best value. Achieving best value has been a key strategy for some states that have attempted to reduce costs in the Medicaid program in these difficult fiscal times. We do not intend to impair states' abilities to pursue that goal, or to impair states' abilities to explore innovative approaches to providing services and lowering costs for other reasons. In this final rule with comment period, we hope to clarify that, although states must demonstrate that beneficiaries have access to covered services at least comparable to others in the geographic area, this access can be through service delivery networks, using payment methodologies different from other individuals in the geographic area. Comparable access does not
Payment rates should be neither too low nor too high to ensure access to care for Medicaid beneficiaries and to ensure the economy and efficiency of Medicaid services and spending. Setting total payments too high does not necessarily improve beneficiary access. This is particularly true when higher payments are targeted to select providers and do not necessarily translate into improved access to services. Payment reductions or other adjustments to payment rates can help to manage Medicaid program costs and ensure efficiency of service provision, without necessarily violating requirements to ensure access to care. For example, a state may amend its program to use a selective contract to provide incontinence supplies which results in lower payment rates for those supplies while maintaining statewide access to those supplies. Or a state may reduce payments for hospital readmissions to encourage the hospital to collaborate with a primary care case management provider in the community. A state may also rebalance its long term services and supports spending consistent with
However, payment reductions or other adjustments can, in some circumstances, compromise beneficiary access to services. Consequently, we affirm in this final rule with comment period that such payment rate changes be made only with consideration of the potential impact on access to care for Medicaid beneficiaries and with effective processes for assuring access. Payment rate changes do not comply with the Medicaid access requirements if they result in a denial of sufficient access to covered care and services. Non-compliant changes could adversely affect beneficiaries' abilities to obtain needed, cost-effective preventive care, create stress on safety-net providers, and counteract state delivery reform efforts that seek to reduce cost and increase quality.
At times, budget-driven payment changes have led to confusion among states and providers about the analysis required to demonstrate compliance with Medicaid access requirements at section 1902(a)(30)(A) of the Act. States attempting to reduce Medicaid costs through payment rate changes have increasingly been faced with litigation challenging payment rate reductions as inconsistent with the statutory access provision. Further, resulting court decisions have not offered consistent approaches to compliance. These decisions have at times left states, providers, and beneficiaries without clear and consistent guidelines and resulted in uncertainty in moving forward in designing service delivery systems and payment methodologies. For instance, several federal Courts of Appeals have addressed access and payment issues, but there has been no consensus concerning the data or standards that would be relevant in determining compliance with the Medicaid statute. More recently, in March 2015, the Supreme Court ruled in
In the May 6, 2011 proposed rule, we intended to establish consistent procedures that all states would follow in reviewing and understanding Medicaid access to care on an ongoing basis and monitoring access after reducing or restructuring rates. Specifically, we proposed that states conduct ongoing access reviews for all Medicaid services over 5-year periods that evaluate: The extent to which enrollee needs are met; the availability of care and providers; and changes in beneficiary utilization of covered services. We proposed that within the reviews, states would need to include information about access gathered through ongoing beneficiary feedback mechanisms and comparisons of Medicaid payments to Medicare, commercials rates, or Medicaid service costs. We proposed that when states reduce or restructure rates in ways that could harm access to care, they consider concerns raised by beneficiaries and stakeholders and develop and monitor indices to ensure sustained access after implementing the rate changes. States would have the discretion to choose the data used to measure and analyze access to care and mechanisms to receive information from beneficiaries and other stakeholders.
This final rule with comment period recognizes the importance of stronger processes and data to ensure access to care while supporting state flexibility to design the appropriate measures to demonstrate and monitor access to care, which reflect the unique and evolving state service delivery models and service rate structures. A uniform approach to meeting the statutory requirement under section 1902(a)(30)(A) of the Act could prove challenging at this time, given local variations in service delivery, beneficiary needs, provider practice roles, and limitations on data. At this time, we are issuing this final rule with comment period to establish approaches for states to demonstrate consistency with the access requirement using a consistent, transparent process, rather than setting nationwide standards. These approaches will also strengthen our ability to make sound and data-driven decisions about the adequacy of state payment rates.
This final rule with comment period will not directly require states to adjust payment rates; nor will it require states to adopt policies that are inconsistent with efficiency, economy, and quality of care. Even if access issues are discovered as a result of the analysis that is required under this rule, states may be able to resolve those issues through means other than increasing payment rates. This rule requires that beneficiary access must be considered in setting and adjusting payment methodologies for Medicaid services. If a problem is identified, any number of steps, including payment increases, might be appropriate to address the problem, such as: Redesigning service delivery strategies or improving provider enrollment and retention efforts. This final rule with comment period provides that we will review these access issues in making SPA approval decisions, and describes a more consistent and transparent way for states to collect and analyze the necessary information to support such reviews.
We consider the requirements of this final rule with comment period as a component of a broader strategy to ensure access in the Medicaid program. However, the 2011 proposed rule did not anticipate the Supreme Court decision:
Specifically, as we issue this final rule with comment period, we are concurrently issuing a request for information (RFI) that solicits feedback from stakeholders on whether and which core access measures, thresholds, and appeals processes would provide additional information or approaches that would be useful to us and states in ensuring access to care for Medicaid beneficiaries. We are interested in access measures that would apply regardless of the service delivery approach adopted by the state, and would include access measures applicable for populations enrolled in managed care. Ultimately, our RFI-related goals are to better measure, monitor, and ensure Medicaid access across state program and delivery systems and understand the economic and policy factors that affect access to care. The RFI is published elsewhere in this
In addition to issuing this final rule with comment period and the RFI, we also will improve our administrative processes associated with documenting the basis for approval and disapprovals when states propose SPAs that reduce rates or restructure payments in ways that may affect access to care. The information that is gathered by states through the processes described in this final rule with comment, as well as through additional state and CMS processes for ensuring Medicaid access to care, will be the basis for our approval decisions and we will build our administrative SPA records with this information.
We proposed to address state processes for setting payment rates by amending existing regulations at § 447.203, § 447.204, and § 447.205. The following is a summary of our proposals.
We proposed to revise § 447.203(b) to require state Medicaid agencies to demonstrate access to care by documenting in an access monitoring review plan their consideration of: Enrollee needs; the availability of care and providers; and the utilization of services. The experiences of beneficiaries should be a primary determinant of whether access is sufficient. We solicited comments that would serve to help states narrow the focus of the data review to core elements that would demonstrate sufficient access to care. We received, through public comments, many suggested elements that states could incorporate into access reviews, but there was no consensus among commenters as to measures that could be universally applied across all services. We will continue to study whether a core set of measures and thresholds should be applied to Medicaid access to care and are soliciting more information from stakeholders on this question through the RFI process.
Proposed § 447.203(b)(1)(i) through (iii) would have required states to review and make publically available data trends and factors that measure: Enrollee needs; availability of care and providers; and utilization of services. Consistent with the statutory requirement, we proposed that states review this data by state designated geographic location.
We proposed revisions to § 447.203(b)(1)(iii)(B) to require that the review must include: (1) An estimate of the percentile which Medicaid payment represents of the estimated average customary provider charges; (2) an estimate of the percentile which Medicaid payment represents of one, or more, of the following: Medicare payment rates, the average commercial payment rates, or the applicable Medicaid allowable cost of the services; and (3) an estimate of the composite average percentage increase or decrease resulting from any proposed revision in payment rates.
We proposed in § 447.203(b)(1)(iii)(B)(3) that the Medicaid payment rates must include both base and supplemental payments for Medicaid services. Since states often reimburse service providers according to different payment schedules based on governmental status, we proposed at § 447.203(b)(1)(iii)(C) that states stratify the access review data by state government owned or operated, non-state government owned or operated and private providers.
In § 447.203(b)(1)(iii)(D), we proposed to describe the minimum content that must be in included in the rate review. Specifically, we proposed to require that states describe the measures that were used to conduct the review and their relationship to enrollee needs, the availability of care and providers, service utilization and Medicaid payment rates as compared to other payment structures.
Proposed § 447.203(b)(2) described the timeframe for states to conduct the data review and make the information available to the public through accessible public records or Web sites on an on-going basis for all covered services. We proposed that the annual reviews begin no later than 2013, so states would have the discretion to determine a timeframe to review each covered Medicaid service, as long as the state reviewed a subset of services each year and each covered service is reviewed at least once every 5 years. We provided states this 5-year cycle to reduce the burden while accommodating the need for review to assure compliance with section 1902(a)(30)(A) of the Act.
Because of the need to demonstrate service access in the context of a payment rate reduction, we proposed in § 447.203(b)(3)(i) that states would need to conduct the review relevant to the affected service prior to submission of a SPA implementing a reduction. If the state had already reviewed access relating to the types of services that are subject to the rate reduction within 12 months prior to the proposed rate reduction, and maintained an ongoing monitoring mechanism for beneficiary complaints, its review relative to the rate reduction could be referenced in the previous review. To ensure sustained access to care, we included provisions at § 447.203(b)(3)(ii) that would require states to develop ongoing monitoring procedures through which they periodically review indices to measure sustained access to care. We also proposed at § 447.203(b)(4) to require states to have a mechanism for beneficiary input on access to care, such as hotlines, surveys, ombudsman or other equivalent mechanisms. Additionally, we proposed at § 447.203(b)(5) a corrective action procedure requiring states to submit a remediation plan should access issues be discovered through the access review or monitoring processes. These requirements were proposed to ensure that states would oversee and address future access concerns.
In § 447.204, we proposed to implement the statutory requirement that Medicaid payment rates must be consistent with efficiency, economy,
We proposed to clarify and modernize changes to the public notice requirement at § 447.205. We also solicited comments on whether it is advisable to delete the term “significant” from § 447.205(a) and explicitly state that notice is required for any change in rates. Alternatively, we solicited comments on whether to adopt a threshold for significance and what that threshold might be.
Further, we proposed to recognize electronic publication as an optional means of publishing payment notice. To do so, we proposed adding § 447.205(d)(iv), which would allow notice to be published on a Web site developed and maintained by the single state Medicaid agency or other responsible state agency that is accessible to the general public on the Internet.
We received at total of 181 comments from states, advocacy groups, providers, provider organizations and individuals on the May 6, 2011 proposed rule. The comments ranged from support for the proposal to specific questions or comments regarding the proposed changes. We received some comments that were outside of the scope of the proposed rule, and therefore, not addressed in this final rule with comment period.
The following are brief summaries of the public comments received, and our responses to those public comments:
We received many comments that were general in nature and were not specific to any of the provisions of the May 6, 2011 proposed rule. We have summarized and responded to those comments below.
This final rule with comment period requires states to review access information on an ongoing basis for primary care services, including physician, federally qualified health centers (FQHC), clinic, dental care, etc.; physician specialist services (for example, cardiology, urology, radiology); behavioral health services, including mental health and substance abuse disorder treatment; pre- and post-natal obstetric services including labor and delivery; and home health services (as defined in § 440.70), whether or not the payment methodologies change. States may also choose to select additional services to review through the access monitoring review plan. In addition, when changes to payment methodologies are made through the SPA process, the state must be able to support that change with documentation that access to care will not be adversely affected, and must monitor access after the change is made. If, for example, a state removes an annual inflation adjustment and therefore freezes rates from 1 year to the next when an increase in inflation was anticipated, a current access review will be required to support approval of a SPA, and the state will also need to continue to monitor access. In addition, whether or not the state changes payment methodologies (including for services outside of the ongoing monitoring and review requirements), required ongoing mechanisms to receive beneficiary and provider feedback would indicate to states and CMS access issues that arise for any Medicaid service.
We will work with states to identify, based on feedback from beneficiaries and providers and other available information and data, additional services that may require more regular review based on data analysis or known concerns. We are soliciting comments in this final rule with comment period on whether additional categories of service should be added to the list of required ongoing reviews included in the rule.
Therefore, while we continue to study this issue, in this final rule with comment period we are adopting the proposed multi-faceted approach to reviewing access to care that includes data analysis and feedback from beneficiaries, providers and stakeholders rather than national thresholds. The analysis of this information must also weigh relevant state-specific circumstances. As a result, we are requiring states to have a public review timeframe for the access monitoring review plan which will allow interested parties to review and comment on the state's monitoring plans for a period of no less than 30 days before the monitoring plan is finalized and submitted to CMS.
States are expected to solicit feedback during the development of the access monitoring review plan and corrective action plans and could also use the existing Medical Care Advisory Committees for input into the process.
Based on feedback from states that ongoing 5-year access reviews for all services would overly burden state agencies, we determined a process similar to the commenters' to be the appropriate regulatory framework. Such a process will include a review of primary care services, physician specialist services, behavioral health
We received several comments that discussed concerns over the proposed changes to the public process requirements.
This final rule with comment period incorporates many of the provisions of the May 6, 2011 proposed rule but also makes substantial modifications based on responses to the public comments. Those provisions of this final rule with comment period that differ from the proposed rule are as follows:
• The term “access review” is replaced throughout by the term “access monitoring review plan” to emphasize that the regulation is intended to establish a process by which states monitor and measure access, rather than just the requirement that data is due to CMS.
• Section 447.203(b) is revised to clarify that the states' access monitoring review plans must be developed in consultation with the state's medical care advisory committee and submitted to CMS, and will be reviewed by CMS. This section has been revised to also indicate that the plans must be made available for public review and comment for a period of no less than 30 days prior to the finalization of the plan and submission to CMS. This allows stakeholders time to comment on the appropriateness of the specific measures the state will use to determine that there is adequate access to Medicaid services.
• Section 447.203(b)(1) is revised to state that the access monitoring review plan must include the items specified under the access review procedures, as well as data sources, methodologies, assumptions, trends and factors, and thresholds so that it is clear that measurable data and analysis are essential components of the access monitoring review plans.
• Section 447.203(b)(1) is revised by replacing the term “access review” with “access monitoring review plan” for the reasons described above. We made clarifying changes to the monitoring plan framework, specifying that reviews must measure whether beneficiary needs are fully met, that the providers analyzed as part of the review are enrolled in the program, and that the access analysis must demonstrate access to care within state specified geographic areas. This is consistent with the statutory requirements. We also added a requirement that the analysis describe the characteristics of the beneficiary population (including considerations for care, service, and payment variations for pediatric and adult populations and for individuals with disabilities). This is important to understand specific access needs within geographic areas.
• Section 447.203(b)(2) is revised to specify that beneficiary and provider input must be considered within the access monitoring review plans. We have also indicated potential sources of this information, such as the public rate-setting process, medical care advisory committees, and letters to state and federal officials. In addition to the data the state will review, ongoing input from beneficiaries and providers will help states understand access issues (and suggestions to improve access) on a real-time basis and potentially target access improvements and remediation strategies.
• Section 447.203(b)(3) changes the analysis of payments to compare Medicaid payments as a percentage of other public and private health payment rates within geographic areas of the state. We proposed that states compare Medicaid rates to provider charges and Medicare payments rates, the average commercial payment rates or the applicable allowable cost of Medicaid services. We also proposed that states stratify this information based on provider ownership status. The final rule with comment period modified the requirement to streamline the information and allow states flexibility in demonstrating the comparative analysis of the Medicaid payment rates as now defined in § 447.203(b)(1)(C). The analysis required in the final rule with comment reduces administrative burden associated with the proposed requirements while continuing to provide a basis to understand how Medicaid service payments compared to other health payer payments. The statute discusses the sufficiency of rates in ensuring access to services; however, as we have stated, rates may not be the only or most important determinant of access in the Medicaid program.
• Section 447.203(b)(4) provides details on the review plan standards and methodologies. To provide additional clarity on types of information that states can use for these reviews, we have described suggested data elements for state consideration including, but not limited to: time and distance standards, providers participating in the Medicaid program, providers with open panels, providers accepting new Medicaid beneficiaries, service utilization patterns, identified beneficiary needs, logs of beneficiary and provider feedback and suggestions for improvement, etc. While not specifically required, these data elements may be used by states to address the framework described in the final rule with comment and represents the scope of the analysis that states should conduct when reviewing access to care. This responds to state and provider concerns that the data reviews in the May 6, 2011 proposed rule lacked clear direction and standards for how CMS will evaluate the sufficiency of a state's access analysis.
• Section 447.203(b)(5) regarding the “Access Review Timeline” has been modified to clarify that states will need to comply with the provision of this final rule with comment period. We received many comments on the timing associated with the access data reviews. In the final rule with comment, states will be required to conduct the first review for the specified subset of
• Section 447.203(b)(5)(ii) was revised to change the requirement that states review all covered services within a 5-year period to require that states review a subset of service categories at least once every 3 years. Language has also been added to this section to clarify that the states are required to “complete a full review of the data collected through the monitoring plan methodology.” Paragraphs (b)(5)(ii)A, (ii)(B), (ii)(C), (ii)(D), and (ii)(E) were added to define the specific categories of services that must be included in the access monitoring review plan. Paragraph (b)(5)(ii)(A) adds primary care services which includes physician, FQHC, clinic, dental care, etc. Paragraph (b)(5)(ii)(B) adds physician specialist services which includes services which are provided via a referral from a primary care provider, for example, cardiology, urology and radiology. Paragraph (b)(5)(ii)(C) adds behavioral health services which includes mental health, substance use disorder, etc. Paragraphs (b)(5)(ii)(D) adds pre- and post-natal obstetric services including labor and delivery. Paragraph (b)(5)(ii)(E) adds home health services. These categories were added because they are frequently used services in Medicaid, and access to these services indicates that an individual has primary sources of care, which may increase the likelihood of having their care needs met. Paragraph (b)(5)(ii)(F) has been added clarify that additional services are to be added to the access monitoring review plan when states reduce or restructure rates. Paragraph (b)(5)(ii)(G) was added to require states to review access for additional services based on a significantly higher than usual level of beneficiary, provider, or stakeholder access complaints. Paragraph (b)(5)(ii)(H) was added to allow additional types of services selected by the state. These modifications remove some burden from the states, particularly those that have continuously monitored Medicaid access to care and do not have widespread access issues. We are requesting comment on the revisions to paragraphs (b)(5)(ii)(A) through (ii)(E).
• Section 447.203(b)(6)(i) was revised to clarify that access monitoring review plans shall be updated to incorporate an access review as described under paragraph (b)(1) of this section when a state submits a SPA to reduce payment or restructure payment in circumstances when the changes could result in diminished access for the service or services affected by the SPA. We have further clarified in this paragraph that a state must update the access monitoring review plan within 12 months of the effective date of the submitted SPA.
• Section 447.203(b)(6)(ii) which describes monitoring procedures, has been retitled “Monitoring procedures.” The monitoring process has been modified to require incorporation of access monitoring review plans and procedures, including period review protocols and clearly defined measures and thresholds, into the Medicaid state plan reimbursement methodology and to require the first monitoring review to occur within a year after the effective date of a SPA rate change and continue periodically for a period of at least 3 years after the effective date of the SPA authorizing the payment reduction or restructuring.
• Section 447.203(b)(7) describes that states must have mechanisms for ongoing beneficiary input on access to care (through hotlines, surveys, ombudsman, or another equivalent mechanism). In response to concerns over individual access issues, we revised the provision to require states to promptly respond to public input with an appropriate investigation, analysis, and response. The state is also required to maintain records of the input and the nature of the state's responses. While CMS recognizes that services provided through home and community-based waivers or 1115 demonstrations are not bound by the procedural requirements of this rule, states may understand through these feedback mechanisms access issues that may also arise for individuals receiving services through those delivery systems.
• Section 447.203(b)(8) is revised to clarify that states have a number of options to address access to care issues that are identified through the access monitoring review plans. These remediation efforts can include but are not limited to: modifying payment rates; improving outreach to providers; reducing barriers to provider enrollment; providing additional transportation to services; improving care coordination; or changing provider licensing or scope of practice polices. This is an acknowledgement that access to care is not determined by payment rates alone but rather that when enough providers are enlisted in the program states may need to find ways to connect beneficiaries with the care and services that they need.
• In § 447.204(a), the term “recipients” is changed to “beneficiaries.”
• Section 447.204(a)(1) is revised to incorporate the baseline data review requirement and as part of the information that states consider prior to the submission of a SPA that proposes to reduce or restructure Medicaid service payment rates. The results of the baseline data should inform states on compliance with section 1902(a)(30)(A) of the Act and project the potential impact of rate policies on access to care.
• Section 447.204(a)(2) is revised to indicate that prior to the submission of a SPA that proposes to reduce or restructure Medicaid service payment rates, states must consider input from providers, as well as input from beneficiaries and other affected stakeholders. This change was added based on public comments that requested that feedback from providers be considered in addition to beneficiaries as part of the public process.
• Section 447.204(b) is modified to more clearly state that with any proposed SPA affecting payment rates, states must provide the most recent access monitoring review plan, if any, together with an analysis of the effect of the change in payment rates on access, and a specific analysis of the information and concerns expressed in input from affected stakeholders. With this change, is more clearly delineated that states must furnish the information gathered under the procedures of the final rule with comment to CMS as part of the SPA submission process. We will use this information to inform our SPA approval decisions.
• Section 447.204(c) and (d) were edited to more clearly describe CMS's enforcement process if a state does not submit the supporting documentation described in the final rule with comment period along with SPAs. If a state does not submit the supporting documentation, then the SPA would be disapproved. Likewise, if a state submits a SPA and the access analysis does not demonstrate adequate access, the SPA would be disapproved. To address access deficiencies, CMS may also take a compliance action using the procedures described at § 430.35 of this chapter which is specified at 447.204(d). These edits were made for clarity and did not alter the agency's proposed approach to enforcing the provisions of the final rule with comment period.
• Section 447.205(iv) was proposed to allow states to issue public notice on Web sites maintained by the single state agency. We revised this section to provide some additional parameters
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
In the May 6, 2011, proposed rule (76 FR 26352-26359), we solicited public comments on each of the section 3506(c)(2)(A) required issues for the following information collection requirements (ICRs). PRA-related comments were received as indicated below in section C under “Comments Associated with the Collection of Information Requirements.”
To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2014 National Occupational Employment and Wage Estimates for all salary estimates (
As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
Section 447.203(b) requires that states develop and make public an access monitoring review plan that considers, at a minimum: Beneficiary needs, the availability of care and providers, utilization of services, characteristics of the beneficiary population, and provider payment rates. States are also required under this provision to monitor data and beneficiary and provider input on an ongoing basis and address known access issues through corrective action.
This final rule with comment period provides states with the discretion to determine appropriate data sources that will be used to conduct the review. We believe most of the data that will be used to inform access is available to states and may already be collected by states as part of Medicaid program reviews and payment rate-setting procedures. We also note that states have flexibility to compare Medicaid rates to one or more of Medicare rates, commercial rates, or Medicaid cost, as may be appropriate to the service under review. The burden associated with these requirements is the time and effort associated with analyzing this information, making it available to the public, and periodically updating the information relative to activities states are already undertaking. We have attempted to mitigate any new burden by identifying data that states are likely to currently possess, identifying other data sources that might be informative to state access reviews, and limiting the categories of services states will be required to review.
Section 1902(a)(30)(A) of the Act requires states to ensure that Medicaid beneficiaries have access to care and services that is equivalent to care provided to the general population within a geographic area. Based on public comments received we are revising the requirements of § 447.203(b) to limit the scope of Medicaid services that states must review on an ongoing basis. This final rule with comment period stipulates that states must develop an access monitoring review plan for the specified service categories and update the plan every 3 years. States will also be required to develop an access monitoring review plan when a state submits a SPA to reduce or restructure payment rates in circumstances where the changes could result in access issues for the service or services affected by the SPA. In this way, states would consider the impact that such proposals may have on access to care and demonstrate compliance with section 1902(a)(30)(A) of the Act. States may complete this review within the prior 12 months of the SPA submission.
The data analysis activities described in this final rule with comment period are claimable as administrative claiming activities and are reimbursable at the general 50 percent FFP rate for
The provisions at § 447.203(b)(1) through (3) require that states develop and make publically available an access monitoring review plan using data trends and factors that considers: Beneficiary needs, availability of care and providers, and changes in beneficiary utilization of covered services. Consistent with the statutory requirement, we have clarified that states demonstrate access to care within specific geographic regions. After careful consideration of the comments received, we are finalizing the review framework with some modifications in an effort to minimize the administrative burden associated with the requirement. Though we recognize that no methodology to gauge access to care is flawless, we believe that the framework, as supported by state data sources, is appropriate to inform whether the Medicaid access requirements are met.
Section 447.203(b)(1) and (2) describes the minimum factors that states must considered when developing an access monitoring review plan. Specifically, we require the review to include feedback from both Medicaid beneficiaries and Medicaid providers, an analysis of Medicaid payment data, and a description of the specific measures the state will use to analyze access to care. We recommend that states use existing provider feedback mechanism such as medical care advisory committees described in § 431.12 to ease burden on states rather than create new requirements.
Section 447.203(b)(3) requires that states include percentage comparisons of Medicaid payment rates to other public (including, as practical, Medicaid managed care rates) or private health coverage rates within geographic areas of the state. This requirement was modified based on comments received to allow states maximum flexibility in comparing Medicaid payment rates to the rates of other payers.
Section 447.203(b)(4) describes the minimum content that must be in included in the monitoring plan. States are required to describe: The measures the state uses to analyze access to care issues, how the measures relate to the overarching framework, access issues that are discovered as a result of the review, and the state Medicaid agency's recommendations on the sufficiency of access to care based on the review.
Section 447.203(b)(5) describes the timeframe for states to develop and complete its access monitoring review plan the data review and make the information available to the public through accessible public records or Web sites on an on-going basis for the following categories of services: Primary care, physician specialist services, behavioral health, pre- and post-natal obstetric services including labor and delivery, home health services and additional services as determined necessary by the state or CMS. The initial access monitoring review plans are to be completed by July 1 after the effective date of this final rule with comment period. The plan must be updated at least every 3 years, but no later than July 1 of the update year. We estimate that the requirements to develop and make the access monitoring review plans publically available under § 447.203(b)(1) through (4) will affect all states. We have defined specific categories of services that states must develop access monitoring review plans for, while allowing states to include additional service categories as necessary. We assume states will conduct reviews in the context of rate reductions or restructuring payment rates and we consider the burden associated with rate reduction or restructuring reviews as part of the ongoing estimated burden.
The one-time burden associated with the requirements under § 447.203(b)(1) through (5) is the time and effort it would take, on average, each of the 50 state Medicaid programs and the District of Columbia (51 total respondents) to develop and make publically available an access monitoring review plan for the specific categories of Medicaid services. The uniform nature of the initial menu of services required for the access monitoring review plans are the reason we present average impacts.
We estimate that it will take 5,100 hr to develop the access monitoring review plan, 8,160 hr to collect and analyze the data, and 2,040 to publish the plan and 510 hr for a manager to review and approve the plan (15,810 total hours). We also estimate a cost of $22,631,80 per state and a total of $1,154,221.80.
In deriving these figures we used the following hourly labor rates and time to complete each task: 80 hr at $41.42/hr for a research assistant staff to gather data, 80 hr at $84.50/hr for an information analyst staff to analyze the data, 100 hr at $87.36/hr for management analyst staff to develop the content of the access monitoring review plan, 40 hr at $67.38/hr for business operations specialist staff to publish the access monitoring review plan, and 10 hr at $112.70/hr for managerial staff to review and approve the access monitoring review plan.
The ongoing burden associated with the requirements under § 447.203(b)(1) through (5) is the time and effort it would take each of the 50 state Medicaid programs and the District of Columbia (51 total respondents) to develop and make publically available an access monitoring review plan for the specific categories of Medicaid services. The access monitoring review plans must be updated at least every 3 years.
We anticipate that the average initial and ongoing burden is likely to be the same since states will need to re-run the data, determine whether to add or drop measures, consider public feedback, and write-up new conclusions based on the information they review. In this regard, we estimate it will take 5,100 hr to develop the access monitoring review plan, 8,160 hr to collect and analyze the data, and 2,040 to publish the plan, and 510 hr for a manager to review and approve the plan (15,810 total hours). We also estimate a cost of $22,631,80 per state and a total of $1,154,221.80.
In deriving these figures we used the following hourly labor rates and time to complete each task: 80 hr at $41.42/hr for a research assistant staff to gather data, 80 hr at $84.50/hr for an information analyst staff to analyze the data, 100 hr at $87.36/hr for management analyst staff to update the content of the access monitoring review plan, 40 hr at $67.38/hr for business operations specialist staff to publish the access monitoring review plan, and 10 hr at $112.70/hr for managerial staff to review and approve the access monitoring review plan.
The requirements and burden will be submitted to OMB under control number 0938-1134 (CMS-10391). Annualized over the three-year reporting period, we estimate 17 responses, 5,270 hr, $7,543.93 (per state), and $384,740.60 (aggregate).
Section 447.203(b)(6)(ii) requires states to have procedures within the access monitoring review plan to monitor continued access after implementation of a SPA that reduces or restructures payment rates. The monitoring procedures must be in place for at least 3 years following the effective date of a SPA that reduces or restructures payment rates.
The ongoing burden associated with the requirements under § 447.203(b)(6)(ii) is the time and effort it would take each of the 50 state Medicaid programs and the District of Columbia to monitor continued access following the implementation of a SPA that reduces or restructures payment rates. The requirements will affect all states that implement a rate reduction or restructure payment rates. We estimate that in each SPA submission cycle, 22 states will implement these rate changes based on the number of states that proposed such reductions in FY 2010. Please note that we are using FY 2010 as the basis for our estimate because of the unusual high volume of rate reduction SPAs that states submitted during this period. By basing our estimate on FY 2010 data, we anticipate the highest potential for burden associated with this final rule with comment period.
We estimate that it will take, on average, 880 hr to develop the monitoring procedures, 528 hr to periodically review the monitoring results, and 66 hr for review and approval of the monitoring procedures (1,474 total hours). We also estimate an average cost of $5,929.14 per state and a total of $130,441.08.
In deriving these figures we used the following hourly labor rates and time to complete each task: 40 hr at $87.36/hr for management analyst staff to develop the monitoring procedures, 24 hr at $87.36/hr for management analyst staff to periodically review the monitoring results, and 3 hr at $112.70/hr for management staff to review and approve the monitoring procedures.
The requirements and burden will be submitted to OMB under control number 0938-1134 (CMS-10391).
Section 447.203(b)(7) requires that states have a mechanism for obtaining ongoing beneficiary, provider and stakeholder input on access to care issues, such as hotlines, surveys, ombudsman, or other equivalent mechanisms. States must promptly respond to public input with an appropriate investigation, analysis, and response. They must also maintain records of the beneficiary input and the nature of the state response.
We estimate that the requirement will affect all states that do not currently have a means of beneficiary feedback. Since we currently do not know which states have implemented these mechanisms, we are assuming in our estimate that all states will need to develop new mechanisms. The one-time burden associated with the requirements under § 447.203(b)(7) is the time and effort it would take, on average, for each of the 50 state Medicaid programs and the District of Columbia (51 total respondents) to develop and implement beneficiary feedback mechanisms.
We estimate that it will take an average 5,100 hr to develop the feedback effort and 255 hr to approve the feedback effort (5,355 total hours). We also estimate an average cost of $9,299.50 per state and a total of $474,274.50.
In deriving these figures we used the following hourly labor rates and time to complete each task: 100 hr at $87.36/hr for management analyst staff to develop the feedback effort and 5 hr at $112.70/hr for managerial staff to review and approve the feedback effort.
The ongoing burden associated with the requirements under § 447.203(b)(7) is the time and effort it would take each of the 50 state Medicaid programs and the District of Columbia (51 total respondents) to monitor beneficiary feedback mechanisms.
The overall effort associated with monitoring the feedback will primarily be incurred by analysts who will gather, review and make recommendations for and conduct follow-up on the feedback. We do not estimate that the approval of the recommendations will not require as significant effort from managers. We estimate that it will take an average of 3,825 hr to monitor the feedback results, and 255 hr to approve the feedback effort (4,080 total hours). We also estimate an average cost of $7,115.50 per state and a total of $362,890.50.
In deriving these figures we used the following hourly labor rates and time to complete each task: 75 hr at $87.36/hr for management analyst staff to monitor feedback results and 5 hr at $112.70/hr for managerial staff to review and approve the feedback effort.
The requirements and burden will be submitted to OMB under control number 0938-1134 (CMS-10391).
Section 447.203(b)(8) institutes a corrective action procedure that requires states to submit to CMS a corrective action plan should access issues be discovered through the access monitoring processes. The requirement is intended to ensure that states will oversee and address any future access concerns.
This is a new requirement and thus we have no past data to use to determine how many states will identify access issues as they conduct their data reviews and monitoring activities. We assume that many states currently have mechanisms in place to monitor access to care and identify issues. While we are careful not to under-estimate the burden associated with this provision, we believe that a maximum of 10 states may identify access issues per year. The on-time burden associated with the requirements under § 447.203(b)(7) is the time and effort it would take 10 state Medicaid programs to develop and implement corrective action plans.
We estimate that it will take an average of 200 hr to identify issues requiring corrective action, 400 hr to develop the corrective action plans, and 30 hr to review and approve the corrective action plans (630 total hours). We also estimate an average cost of $5,579.70 per state and a total of $55,797.00.
In deriving these figures we used the following hourly labor rates and time to complete each task: 20 hr at $87.36/hr for management analyst staff to identify issues requiring corrective action, 40 hr at $87.36/hr for management analyst staff to develop the corrective action plans, and 3 hr at $112.70/hr for managerial staff to review and approve the corrective action plans.
The requirements and burden will be submitted to OMB under control number 0938-1134 (CMS-10391).
Sections 447.204(a)(1) and (a)(2) require that states consider (when proposing to reduce or restructure Medicaid payment rates) the data collected through § 447.203 and undertake a public process that solicits input on the potential impact of the proposed reduction or restructuring of Medicaid service payment rates on beneficiary access to care. In § 447.204(b), we have also clarified that we may disapprove a proposed rate reduction or restructuring if the SPA does not include or consider the data review and a public process. As an alternative, or additionally, we may take a compliance action in accordance with § 430.35.
We are estimating, annually, that for each SPA revision approximately 22 states will develop and implement these rate changes that would require a public process based on the number of states that proposed such reductions in FY 2010. Again, we are using FY 2010 as the estimate due to the high number of rate reduction proposals submitted by states in that year.
We estimate that it will take an average of 440 hr to develop the public process and 66 hr for review and approval of the public process (506 total hours). We also estimate an average cost
In deriving these figures we used the following hourly labor rates and time to complete each task: 20 hr at $87.36/hr for management analyst staff to develop the public process and 3 hr at $112.70/hr for managerial staff to review and approve the public process.
The ongoing burden associated with the requirements under § 447.204 is the time and effort it would take 22 state Medicaid programs to oversee a public process.
The overall effort associated with developing the public process will primarily be incurred by analysts who develop and initiate public process activities. We do not estimate that efforts associated with review and approval of the activities will increase for overseeing managers. We estimate it will take an average of 880 hr to oversee the public process and 66 hr for review and approval of the public process (946 total hours). We also estimate an average cost of $3,832.50 per state and a total of $84,315.00
In deriving these figures we used the following hourly labor rates and time to complete each task: 40 hr at $87.36/hr for management analyst staff to oversee the public process and 3 hr at $112.70/hr for managerial staff to review and approve the public process.
The requirements and burden will be submitted to OMB under control number 0938-1134 (CMS-10391).
The provisions at § 447.205 clarify when states must issue public notice to providers and allow for the electronic publication of those notices. Section 447.205(d)(2)(iv)(A) through (D) allow those notices to be published on the single state Medicaid agency or other state-developed and maintained Web site that is accessible to the general public via the Internet. The burden associated with developing and issuing public notice at § 447.205 is not affected by this requirement since the revision would simply address an additional (in this case, electronic) means of notification. Consequently, we do not include the electronic notice activity in our burden analysis.
We submitted a copy of this final rule to OMB for its review of the rule's information collection and recordkeeping requirements. The requirements are not effective until they have been approved by the OMB.
To obtain copies of the supporting statement and any related forms for the proposed collections discussed above, please visit CMS' Web site at
We invite public comments on these potential information collection requirements. If you wish to comment, please identify the rule (CMS-2328-FC) and submit your comments to the OMB desk officer via one of the following transmissions:
ICR-related comments are due December 2, 2015.
Because of the large number of public comments we normally receive on
This final rule with comment period revises regulatory provisions in § 447.203 and § 447.204 to create a standardized, transparent process for states to follow as part of their broader efforts to assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available to the general population in the geographic area, as required by section 1902(a)(30)(A) of the Act. This rule also clarifies and amends § 447.205, which require states to issue public notice to their providers when changing Medicaid payment methods and standards. The changes to the public notice requirement will alleviate confusion on when states must issue notice to providers and recognize electronic media as a means to issue the notices.
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 Order 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). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We do not believe that there is potential for this provision to surpass the threshold for economic significance because the proposed data analysis effort is generally consistent with current state oversight and review activities and states have flexibility within the reviews to use their existing data or build upon that data when reviewing access to care.
In fact, the guidance provided under this rule intends to focus disparate state efforts in monitoring and overseeing data and beneficiary concerns, which offers a clear framework to comply with section 1902(a)(30)(A) of the Act. In the absence of federal guidance, states have likely misspent resources in efforts to interpret and comply with section 1902(a)(30)(A) of the Act. We will also make every effort, in collaboration with state and federal partners, to identify resources and tools that states may use to review and monitor access to care within their state Medicaid programs. In this final rule with comment period, we are soliciting public comments to begin identifying data sources and will continue to provide assistance as states develop their reviews and monitoring procedures.
Based on our analysis above, we estimate that even if these data collection efforts were totally new to a state and each state were to either bid a contract to gather and publish the data collection effort and public process required under this rule or conduct the collection and public process with state agency resources, the economic effects would not surpass $100 million or more in any 1 year.
Further, we are not requiring states to directly adjust payment rates as a result of the provisions of this final rule with comment period, nor to take any steps that would not be consistent with efficiency, economy, and quality of care. Rather, these rules propose to clarify that beneficiary access must be considered in setting and adjusting payment methodology for Medicaid services. If a problem is identified, any number of steps might be appropriate, such as redesigning service delivery strategies, or improving provider enrollment and retention efforts. It has historically been within our regulatory authority to make SPA approval decisions based on sufficiency of beneficiary service access and this rule merely provides a more consistent and transparent way to gather and analyze the necessary information to support such reviews.
The RFA requires agencies to analyze options for regulatory relief for small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small government jurisdictions. For details, see the Small Business Administration's Web site at
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 604 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 and the Secretary have determined that this final rule with comment period will 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 (UMRA) 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 2015, that threshold is approximately $144 million. This final rule with comment period will not impose a mandate that will result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of more than $144 million in any one year.
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 the estimated total cost associated with the provisions in this final rule with comment period is around $2.3 million annually, it will not impose significant costs on state or local governments, the requirements of E.O. 13132 are not applicable. We also note that the costs associated with this final rule with comment are allocated across 51 state governments. To the extent that costs are for the proper and efficient administration of the Medicaid state plan, many of the activities required under this final rule are likely available at the Medicaid matching rate for administrative expenditures.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
This section provides an overview of regulatory alternatives that CMS considered for this final rule with comment period. In determining the appropriate approach to guide states in their efforts to meet the requirements of section 1902(a)(30)(A) of the Act and demonstrate sufficient access to Medicaid services, we consulted with SMDs, federal agency policy officials and the MACPAC. Based, in part, on these discussions we arrived at the provisions discussed in this rule, which seek to balance state obligations to meet the statutory requirement of section 1902(a)(30)(A) of the Act and potential new burden associated with the proposal. To achieve this balance, we have set forth a process that provides a framework for states to demonstrate access to Medicaid services using available data resources and in consideration of unique and evolving health care delivery systems. We have also emphasized the importance of considering beneficiary input in determining and monitoring access to Medicaid services throughout the process as discussed in this final rule with comment period.
The process for documenting access to care and service payment rates described at § 447.203 will require states to develop and make publically available access monitoring review plans that address the extent to which beneficiary needs are met, the availability of care and providers, and changes in beneficiary utilization of covered services and other factors. The access monitoring review plan would also include percentage comparisons of Medicaid payment rates to other public or private health coverage rates within geographic areas of the state. The access monitoring review plans are to be developed for a subset of Medicaid service categories and updated at least every 3 years or, in the context of a SPA proposal to reduce provider rates or restructure provider rates in circumstance that may negatively impact access to care, within 12 months of implementing the SPA.
As an alternative to the proposed framework for reviewing access to care, we considered requiring states to report standard data measures to demonstrate sufficient access to care and section 1902(a)(30)(A) of the Act. We also considered setting national access thresholds or requiring states to establish and demonstrate access thresholds. As we have highlighted throughout this final rule with comment period, there are no standardized, transparent methodologies for demonstrating access to care that would be appropriate to adopt at this time.
Rather than prescribe data measures that may not align with all services or set threshold standards, we have adopted a general framework, which sets forth a three-part review that applies across services and delivery systems and will allow states the flexibility to determine, through current or new data sources, appropriate measures of access to care. As states analyze their existing data sources and those that we identify through work with MACPAC and our federal partners, we believe that states may arrive at best practices for determining sufficient Medicaid access to care which could be replicated across state delivery systems and will evolve with new approaches to delivering health care to Medicaid beneficiaries. In addition, we are issuing an RFI to solicit feedback from stakeholders on whether data exists to develop core access measures and thresholds would provide additional information or approaches that would be useful to us and states in ensuring access to care to Medicaid beneficiaries.
States will be required to develop access monitoring review plans for the following service categories: Primary care; physician specialist services; behavioral health; pre- and post-natal obstetric services, including labor and delivery; home health services and other service categories as determined necessary based on beneficiary, provider or stakeholder complaints; the access monitoring review plans must be reviewed and updated at least every 3 years. States must also submit an access review, completed within the 12 months prior, with any SPA that proposes to reduce or restructure provider payments for each of the impacted services. We have arrived at this subset of service categories because they are frequently used services in Medicaid and they are considered gateway services, meaning if a beneficiary has access to these services, it is likely that the majority of the beneficiary's needs are being met.
We considered requiring the review for all services on an annual basis or a review period that is more frequent than 5 years. After careful consideration of the burden associated with annual reviews, which were a foremost concern for some commenters, we determined 3 year ongoing reviews as an appropriate frequency period. The final rule with comment period provides for more frequent reviews for fewer high demand services and requires additional review and monitoring over three years for services subject to rate reductions or restructuring of payments or when the Medicaid agency receives a significantly higher than usual level of complaints about access to care from beneficiaries, providers, or other stakeholders. In this way, the final rule with comment period ensures that access to care reviews for most services will be conducted as potential issues arise or circumstances change. We believe that, absent rate reductions or restructuring of payments, the 3-year review and monitoring periods combined with ongoing solicitation of information about access from beneficiaries are sufficient to identify access issues that may occur over time.
This final rule with comment period will require states to develop monitoring procedures after implementing provider rate reductions or restructuring rates in ways that may negatively impact access to care. We require these monitoring procedures because the impact of rate changes on access to care may not be apparent at the time the changes are adopted. We considered not requiring states to monitor access after implementing the changes and to continue to rely on the 5-year reviews to ensure that access is maintained. However, we believe that it is important for states to identify and address access issues that arise from specific SPA actions, such as reimbursement rate reductions or restructuring.
The requirements of § 447.203 and § 447.204 emphasize the importance of involving beneficiaries in determining access issues and the impact that state rate changes will have on access to care. Specifically, we require that states implement an ongoing mechanism for beneficiary input on access to care (through hotlines, surveys, ombudsman, or another equivalent mechanism) and receive input from beneficiaries (and affected stakeholders) on the impact that proposed rates changes will have through a public process. We believe that beneficiaries' experiences in accessing Medicaid services is the most important indicator of whether access is sufficient and beneficiary input will be particularly informative in identifying access issues.
We also considered a requirement that states consult with beneficiaries when developing their corrective action plans in instances when the access data reviews or monitoring procedures identify access issues. While we encourage states to solicit beneficiary
Accounting, Administrative practice and procedure, Drugs, Grant programs-health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, and Rural areas.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
(b) In consultation with the medical care advisory committee under § 431.12 of this chapter, the agency must develop a medical assistance access monitoring review plan and update it, in accordance with the timeline established in paragraph (b)(5) of this section. The plan must be published and made available to the public for review and comment for a period of no less than 30 days, prior to being finalized and submitted to CMS for review.
(1)
(i) The extent to which beneficiary needs are fully met;
(ii) The availability of care through enrolled providers to beneficiaries in each geographic area, by provider type and site of service;
(iii) Changes in beneficiary utilization of covered services in each geographic area.
(iv) The characteristics of the beneficiary population (including considerations for care, service and payment variations for pediatric and adult populations and for individuals with disabilities); and
(v) Actual or estimated levels of provider payment available from other payers, including other public and private payers, by provider type and site of service.
(2)
(3)
(4)
(5)
(i) Develop its access monitoring review plan by July 1 of the first review year, and update this plan by July 1 of each subsequent review period;
(ii) For all of the following, complete an analysis of the data collected using the methodology specified in the access monitoring review plan in paragraphs (b)(1) through (4) of this section, with a separate analysis for each provider type and site of service furnishing the type of service at least once every 3 years:
(A) Primary care services (including those provided by a physician, FQHC, clinic, or dental care).
(B) Physician specialist services (for example, cardiology, urology, radiology).
(C) Behavioral health services (including mental health and substance use disorder).
(D) Pre- and post-natal obstetric services including labor and delivery.
(E) Home health services.
(F) Any additional types of services for which a review is required under paragraph (b)(6) of this section;
(G) Additional types of services for which the state or CMS has received a significantly higher than usual volume of beneficiary, provider or other stakeholder access complaints for a geographic area, including complaints received through the mechanisms for beneficiary input consistent with paragraph (b)(7) of this section; and
(H) Additional types of services selected by the state.
(6)
(ii)
(A) The procedures must provide for a periodic review of state determined and clearly defined measures, baseline data, and thresholds that will serve to demonstrate continued sustained service access, consistent with efficiency, economy, and quality of care.
(B) The monitoring procedures must be in place for a period of at least 3 years after the effective date of the state plan amendment that authorizes the payment reductions or restructuring.
(7)
(ii) States should promptly respond to public input through these mechanisms citing specific access problems, with an appropriate investigation, analysis, and response.
(iii) States must maintain a record of data on public input and how the state responded to this input. This record will be made available to CMS upon request.
(8)
(i) The state's corrective actions may address the access deficiencies through a variety of approaches, including, but not limited to: Increasing payment rates, improving outreach to providers, reducing barriers to provider enrollment, proving additional transportation to services, providing for telemedicine delivery and telehealth, or improving care coordination.
(ii) The resulting improvements in access must be measured and sustainable.
(a) The agency's payments must be consistent with efficiency, economy, and quality of care and sufficient to enlist enough providers so that services under the plan are available to beneficiaries at least to the extent that those services are available to the general population. In reviewing payment sufficiency, states are required to consider, prior to the submission of any state plan amendment that proposes to reduce or restructure Medicaid service payment rates:
(1) The data collected, and the analysis performed, under § 447.203.
(2) Input from beneficiaries, providers and other affected stakeholders on beneficiary access to the affected services and the impact that the proposed rate change will have, if any, on continued service access. The state should maintain a record of the public input and how it responded to such input.
(b) The state must submit to CMS with any such proposed state plan amendment affecting payment rates:
(1) Its most recent access monitoring review plan performed under § 447.203(b)(6) for the services at issue;
(2) An analysis of the effect of the change in payment rates on access; and
(3) A specific analysis of the information and concerns expressed in input from affected stakeholders.
(c) CMS may disapprove a proposed state plan amendment affecting payment rates if the state does not include in its submission the supporting documentation described in paragraph (b) of this section, for failure to document compliance with statutory access requirements. Any such disapproval would follow the procedures described at part 430 Subpart B of this title.
(d) To remedy an access deficiency, CMS may take a compliance action using the procedures described at § 430.35 of this chapter.
(d) * * *
(2) * * *
(iv) A Web site developed and maintained by the single State agency or other responsible State agency that is accessible to the general public, provided that the Web site:
(A) Is clearly titled and can be easily reached from a hyperlink included on Web sites that provide general information to beneficiaries and providers, and included on the State-specific page on the Federal Medicaid Web site.
(B) Is updated for bulletins on a regular and known basis (for example, the first day of each month), and the public notice is issued as part of the regular update;
(C) Includes the actual date it was released to the public on the Web site; or
(D) Complies with national standards to ensure access to individuals with disabilities; and
(E) Includes protections to ensure that the content of the issued notice is not modified after the initial publication and is maintained on the Web site for no less than a 3-year period.
| 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 |