83_FR_237
Page Range | 63559-63774 | |
FR Document |
Page and Subject | |
---|---|
83 FR 63561 - Airworthiness Directives; The Boeing Company Airplanes | |
83 FR 63773 - National Pearl Harbor Remembrance Day, 2018 | |
83 FR 63674 - Sunshine Act Meetings | |
83 FR 63642 - Sunshine Act Meeting | |
83 FR 63697 - Savage, Bingham & Garfield Railroad Company-Discontinuance of Trackage Rights Exemption-in Whiting, Ind. | |
83 FR 63631 - Endangered and Threatened Species; Take of Anadromous Fish | |
83 FR 63695 - Eagle Fund IV-A, L.P.; Notice Seeking Exemption Under the Small Business Investment Act, Conflicts of Interest | |
83 FR 63696 - Eagle Fund IV, L.P.; Notice Seeking Exemption Under the Small Business Investment Act, Conflicts of Interest | |
83 FR 63647 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
83 FR 63642 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
83 FR 63640 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
83 FR 63633 - Manual for Courts-Martial; Publication of Supplementary Materials | |
83 FR 63632 - Science Advisory Board | |
83 FR 63698 - Roster of Arbitrators-Annual Update | |
83 FR 63633 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; State Charter School Facilities Incentive Grants Program (1894-0001) | |
83 FR 63671 - Land Acquisitions; the Dry Creek Rancheria Band of Pomo Indians, California | |
83 FR 63607 - Air Plan Approval; Ohio; Revisions to Particulate Matter Rules | |
83 FR 63656 - Su-Chiao Kuo: Debarment Order | |
83 FR 63625 - Polyethylene Terephthalate Film, Sheet, and Strip From Taiwan: Final Results of Antidumping Duty Administrative Review; 2016-2017 | |
83 FR 63634 - Proposed Agency Information Collection | |
83 FR 63621 - Circular Welded Carbon-Quality Steel Pipe From the Sultanate of Oman: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017 | |
83 FR 63619 - Circular Welded Non-Alloy Steel Pipe From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017 | |
83 FR 63615 - Initiation of Antidumping and Countervailing Duty Administrative Reviews | |
83 FR 63626 - Monosodium Glutamate From the Republic of Indonesia: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017 | |
83 FR 63627 - Certain Pasta From Italy: Final Results of Antidumping Duty Administrative Review; 2016-2017 | |
83 FR 63622 - Steel Concrete Reinforcing Bar From Mexico: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017 | |
83 FR 63613 - Foreign-Trade Zone 24-Pittston, Pennsylvania; Application for Subzone; adidas America, Inc.; Wilkes-Barre, Pennsylvania | |
83 FR 63613 - Foreign-Trade Zone (FTZ) 41-Milwaukee, Wisconsin; Authorization of Production Activity; Generac Power Systems, Inc. (Outdoor Power Equipment, Pumps, and Lawn and Garden Equipment); Jefferson and Whitewater, Wisconsin | |
83 FR 63664 - Submission for OMB Review; 30-Day Comment Request National Cancer Institute (NCI) Future Fellows Resume Databank | |
83 FR 63664 - National Institute of Mental Health; Notice of Closed Meeting | |
83 FR 63635 - Notice of Change in Control; Pieridae Energy (USA) Ltd. | |
83 FR 63633 - Notice of Intent To Grant Exclusive Patent License to H2 Power, LLC; Chicago, IL | |
83 FR 63659 - National Vaccine Injury Compensation Program; List of Petitions Received | |
83 FR 63699 - Notice of Final Federal Agency Actions on Proposed Highway in California | |
83 FR 63700 - Notice of Final Federal Agency Actions on Proposed Highway in California | |
83 FR 63668 - Foreign Endangered Species; Marine Mammals; Receipt of Permit Applications | |
83 FR 63661 - Nominations to the Advisory Committee on Blood and Tissue Safety and Availability | |
83 FR 63674 - United States et al. v. The Charlotte-Mecklenburg Hospital Authority, d/b/a Carolinas Healthcare System; Proposed Final Judgment and Competitive Impact Statement | |
83 FR 63685 - Request for Information on National Strategic Overview for Quantum Information Science | |
83 FR 63630 - Submission for OMB Review; Comment Request | |
83 FR 63629 - Submission for OMB Review; Comment Request | |
83 FR 63701 - Pipeline Safety: Random Drug Testing Rate; Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information | |
83 FR 63631 - Marine Mammals; File No. 20532 | |
83 FR 63672 - Notice of Public Meeting for the Utah Resource Advisory Council/Recreation Resource Advisory Council, Utah | |
83 FR 63686 - Information Collection: NRC Form 748, National Source Tracking Transaction Report | |
83 FR 63687 - Information Collection: Request for Information Pursuant to 10 CFR 50.54(f) Regarding Recommendations 2.1, 2.3 and 9.3, of the Near Term Task Force Review of Insights From the Fukushima Dai-ichi Event | |
83 FR 63662 - Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin; Availability of Document; Request for Comments; Notice of Peer-Review Meeting | |
83 FR 63688 - Sacramento Municipal Utility District; Rancho Seco Nuclear Generating Station; Correction | |
83 FR 63612 - Notice of Public Meeting of the Tennessee Advisory Committee | |
83 FR 63672 - Certain Microfluidic Devices; Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Schedule for Filing Written Submissions on the Issues Under Review and on Remedy, the Public Interest, and Bonding; Extension of Target Date | |
83 FR 63692 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delay a New Protocol “Ouch to Trade Options” or “OTTO” on The Nasdaq Options Market LLC (“NOM”) | |
83 FR 63689 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment Nos. 1 and 2, To List and Trade Shares of the FormulaFolios Sector Rotation ETF, a Series of the Northern Lights Fund Trust IV, Under Rule 14.11(i), Managed Fund Shares | |
83 FR 63613 - Impact of the Implementation of the Chemical Weapons Convention (CWC) on Legitimate Commercial Chemical, Biotechnology, and Pharmaceutical Activities Involving “Schedule 1” Chemicals (Including Schedule 1 Chemicals Produced as Intermediates) During Calendar Year 2018 | |
83 FR 63638 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese (Renewal) | |
83 FR 63639 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Pesticide Active Ingredient Production (Renewal) | |
83 FR 63636 - Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Kansas | |
83 FR 63636 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Metallic Mineral Processing Plants (Renewal) | |
83 FR 63637 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Kraft Pulp Mills (Renewal) | |
83 FR 63666 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Petition for Nonimmigrant Worker | |
83 FR 63667 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Monthly Report on Naturalization Papers | |
83 FR 63665 - Agency Information Collection Activities; Revision of a Currently Approved Collection: Freedom of Information/Privacy Act Request | |
83 FR 63648 - The Food and Drug Administration's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for Comments | |
83 FR 63651 - Current Good Manufacturing Practice-Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Draft Guidance for Industry; Availability | |
83 FR 63700 - Request for Comments on the Renewal of a Previously Approved Information Collection: Application for Conveyance of Port Facility Property | |
83 FR 63657 - David J. Fishman: Debarment Order | |
83 FR 63658 - The Tobacco Products Scientific Advisory Committee; Notice of Meeting | |
83 FR 63587 - Fisheries Off West Coast States; Modifications of the West Coast Recreational and Commercial Salmon Fisheries; Inseason Actions #12 through #37 | |
83 FR 63578 - Safety Zone; Menominee River, Marinette, WI | |
83 FR 63695 - Presidential Declaration of a Major Disaster for the State of California | |
83 FR 63695 - Presidential Declaration Amendment of a Major Disaster for the Commonwealth of the Northern Mariana Islands | |
83 FR 63694 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Florida | |
83 FR 63702 - National Research Advisory Council; Notice of Meeting; Cancellation | |
83 FR 63569 - List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | |
83 FR 63694 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of North Carolina | |
83 FR 63694 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the Commonwealth of Virginia | |
83 FR 63668 - Rental Assistance Demonstration: Amendment to Final Notice | |
83 FR 63645 - Advancing Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Smoke, and Identify and Eliminate Tobacco-Related Disparities; Request for Information | |
83 FR 63696 - Presidential Declaration of a Major Disaster for Public Assistance Only for the Commonwealth of Pennsylvania | |
83 FR 63697 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Georgia | |
83 FR 63696 - Presidential Declaration of a Major Disaster for Public Assistance Only for the Tohono O'Odham Nation | |
83 FR 63643 - Privacy Act of 1974; System of Records | |
83 FR 63697 - 60-Day Notice of Proposed Information Collection: Special Immigrant Visa Form | |
83 FR 63579 - Air Plan Approval; Oregon; Removal of Obsolete Regulations | |
83 FR 63638 - Clean Air Act Prevention of Significant Deterioration Permit Issued to Palmdale Energy LLC for the Palmdale Energy Project | |
83 FR 63603 - Proposed Amendment of Multiple Air Traffic Service (ATS) Routes; Western United States | |
83 FR 63567 - Amendment of VOR Federal Airways V-318 and V-352; Northeastern United States | |
83 FR 63601 - Proposed Amendment of VOR Federal Airways V-128 and V-144 in the Vicinity of Kankakee, IL | |
83 FR 63578 - Change Address Quality Threshold for Intelligent Mail Package Barcode | |
83 FR 63594 - Airworthiness Directives; Bombardier, Inc., Airplanes | |
83 FR 63598 - Airworthiness Directives; Airbus SAS Airplanes | |
83 FR 63596 - Airworthiness Directives; Gulfstream Aerospace LP (Type Certificate Previously Held by Israel Aircraft Industries, Ltd.) Airplanes | |
83 FR 63559 - Airworthiness Directives; CFM International S.A. Turbofan Engines | |
83 FR 63604 - Identity Theft Rules | |
83 FR 63612 - First Responder Network Authority Combined Committee and Board Meeting | |
83 FR 63704 - Renewable Fuel Standard Program: Standards for 2019 and Biomass-Based Diesel Volume for 2020 | |
83 FR 63574 - TRICARE Pharmacy Benefits Program Reforms | |
83 FR 63565 - Airworthiness Directives; Bombardier, Inc., Airplanes | |
83 FR 63746 - Revising the Beryllium Standard for General Industry | |
83 FR 63581 - Comprehensive Review of the Uniform System of Accounts; Jurisdictional Separations and Referral to the Federal-State Joint Board |
First Responder Network Authority
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Army Department
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Citizenship and Immigration Services
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
Antitrust Division
Occupational Safety and Health Administration
Federal Aviation Administration
Federal Highway Administration
Maritime Administration
Pipeline and Hazardous Materials Safety Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for all CFM International S.A. (CFM) LEAP-1B21, -1B23, -1B25, -1B27, -1B28, -1B28B1, -1B28B2, -1B28B2C, -1B28B3, -1B28BBJ1, and -1B28BBJ2 turbofan engines. This AD requires removing certain electronic engine control (EEC) system operation (OPS) and engine health monitoring (EHM) software and installing versions eligible for installation. This AD was prompted by six aborted takeoffs on the similarly designed CFM LEAP-1A model turbofan engine after those engines did not advance to the desired takeoff fan speed due to icing in the pressure sensor line. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 26, 2018.
We must receive comments on this AD by January 25, 2019.
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 final rule, contact CFM International Inc., Aviation Operations Center, 1 Neumann Way, M/D Room 285, Cincinnati, OH 45125; phone: 877-432-3272; fax: 877-432-3329; email:
You may examine the AD docket on the internet at
Christopher McGuire, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7120; fax: 781-238-7199; email:
We received reports of six aborted takeoffs on the similarly designed CFM LEAP-1A model turbofan engine that occurred after those engines did not advance to the desired takeoff fan speed. While we have not received any reports of aborted takeoffs with the CFM LEAP-1B model turbofan engine, the unsafe condition is likely to exist because of similarities in design and instances of ice and moisture found in the pressure sense subsystem lines. The aborted takeoffs happened on the first takeoff of the day after the airplane was exposed to sub-freezing temperatures for more than six hours. After further investigation, the operator found water and ice in the pressure sensor lines, which prevented the pressure sensor from accurately measuring the pressure. As a result, CFM improved the EEC OPS and EHM software to detect and accommodate pressure sensor line freezing. This condition, if not addressed, could result in icing in the pressure sensor lines, inaccurate pressure sensor readings, failure of one or more engines, loss of thrust control, and loss of the airplane. We are issuing this AD to address the unsafe condition on these products.
We reviewed CFM Service Bulletin (SB) LEAP-1B-73-00-0016-01A-930A-D, Issue 002, dated October 30, 2018. The SB introduces new EEC OPS and EHM software and describes procedures for replacing the software.
We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This AD requires removing certain EEC OPS and EHM software and installing software that is eligible for installation.
CFM SB LEAP-1B-73-00-0016-01A-930A-D, Issue 002, dated October 30, 2018, recommends that you install the new EEC OPS and EHM software. This AD requires that you install the new EEC OPS and EHM software, and prohibits the use of earlier EEC OPS and EHM software versions.
We consider this AD interim action. CFM is developing a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved,
An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the compliance time for the required action is shorter than the time necessary for the public to comment and for us to publish the final rule. The software must be removed and replaced within 60 days to ensure that icing does not develop in the pressure sensor lines on the affected engines. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons stated above, we find that good cause exists for making this amendment effective in less than 30 days.
This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We estimate that this AD affects 100 engines installed on airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
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.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 26, 2018.
None.
This AD applies to all CFM International S.A. (CFM) LEAP-1B21, -1B23, -1B25, -1B27, -1B28, -1B28B1, -1B28B2, -1B28B2C, -1B28B3, -1B28BBJ1, and -1B28BBJ2 turbofan engines.
Joint Aircraft System Component (JASC) Code 7600, Engine Controls.
This AD was prompted by aborted takeoffs on the similarly designed CFM LEAP-1A model turbofan engine after those engines did not advance to the desired takeoff fan speed due to icing in the pressure sensor line. While we have not received any reports of aborted takeoffs with the CFM LEAP-1B model engine, the unsafe condition is likely to exist because of similarities in design and instances of ice and moisture found in the pressure sense subsystem lines. We are issuing this AD to prevent icing in the pressure sensor lines and inaccurate pressure sensor readings. The unsafe condition, if not addressed, could result in failure of one or
Comply with this AD within the compliance times specified, unless already done.
(1) Within 60 days after the effective date of this AD, remove electronic engine control (EEC) system operation (OPS) software, P/N 2628M86P10 or earlier; and engine health monitoring (EHM) software, P/N 2628M87P10 or earlier, from the engine and from service.
(2) Before further flight after the removal of the EEC OPS and EHM software required by paragraph (g)(1) of this AD, install EEC OPS and EHM software that is eligible for installation.
After 60 days from the effective date of this AD, do not operate any engine identified in paragraph (c) of this AD with EEC OPS software, P/N 2628M86P10 or earlier, installed; or EHM software, P/N 2628M87P10 or earlier, installed.
(1) The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j) of this AD. You may email your request to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Christopher McGuire, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7120; fax: 781-238-7199; email:
None.
Rule document 2018-26365 was originally published on pages 62697 through 62700 in the issue of Thursday, December 6, 2018. In that publication, on page 62700, in Figure 2 to paragraph (h), the last sentence in the table was inadvertently truncated. The corrected document is published here in its entirety.
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 737-8 and -9 airplanes. This emergency AD was sent previously to all known U.S. owners and operators of these airplanes. This AD requires revising certificate limitations and operating procedures of the airplane flight manual (AFM) to provide the flight crew with runaway horizontal stabilizer trim procedures to follow under certain conditions. This AD was prompted by analysis performed by the manufacturer showing that if an erroneously high single angle of attack (AOA) sensor input is received by the flight control system, there is a potential for repeated nose-down trim commands of the horizontal stabilizer. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 21, 2018 to all persons except those persons to whom it was made immediately effective by Emergency AD 2018-23-51, issued on November 7, 2018, which contained the requirements of this amendment.
We must receive comments on this AD by January 22, 2019.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
You may examine the AD docket on the internet at
The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (phone: 800-647-5527) is in the
Douglas Tsuji, Senior Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3548; email:
On November 7, 2018, we issued Emergency AD 2018-23-51, which requires revising certificate limitations and operating procedures of the AFM to provide the flight crew with runaway horizontal stabilizer trim procedures to follow under certain conditions. This emergency AD was sent previously to all known U.S. owners and operators of these airplanes. This action was prompted by analysis performed by the manufacturer showing that if an erroneously high single AOA sensor input is received by the flight control system, there is a potential for repeated nose-down trim commands of the horizontal stabilizer. This condition, if not addressed, could cause the flight crew to have difficulty controlling the airplane, and lead to excessive nose-down attitude, significant altitude loss, and possible impact with terrain.
We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This AD requires revising certificate limitations and operating procedures of the AFM to provide the flight crew with runaway horizontal stabilizer trim procedures to follow under certain conditions.
We consider this AD interim action. If final action is later identified, we might consider further rulemaking then.
An unsafe condition exists that requires the immediate adoption of Emergency AD 2018-23-51, issued on November 7, 2018, to all known U.S. owners and operators of these airplanes. The FAA found that the risk to the flying public justified waiving notice and comment prior to adoption of this rule because an erroneously high single AOA sensor input received by the flight control system can result in a potential for repeated nose-down trim commands of the horizontal stabilizer, which could cause the flight crew to have difficulty controlling the airplane, and lead to excessive nose-down attitude, significant altitude loss, and possible impact with terrain. These conditions still exist and the AD is hereby published in the
Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.
This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We estimate that this AD affects 45 airplanes of U.S. registry. We estimate the following costs to comply with this AD:
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.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 21, 2018 to all persons except those persons to whom it was made immediately effective by Emergency AD 2018-23-51, issued on November 7, 2018, which contained the requirements of this amendment.
None.
This AD applies to all The Boeing Company Model 737-8 and -9 airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 27, Flight controls.
This AD was prompted by analysis performed by the manufacturer showing that if an erroneously high single angle of attack (AOA) sensor input is received by the flight control system, there is a potential for repeated nose-down trim commands of the horizontal stabilizer. We are issuing this AD to address this potential resulting nose-down trim, which could cause the flight crew to have difficulty controlling the airplane, and lead to excessive nose-down attitude, significant altitude loss, and possible impact with terrain.
Comply with this AD within the compliance times specified, unless already done.
Within 3 days after the effective date of this AD, revise the Certificate Limitations chapter of the applicable AFM to include the information in figure 1 to paragraph (g) of this AD.
Within 3 days after the effective date of this AD, revise the Operating Procedures chapter of the applicable AFM to include the information in figure 2 to paragraph (h) of this AD.
(1) The Manager, Seattle ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Douglas Tsuji, Senior Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3548; email:
None.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. This AD was prompted by reports of drainage holes on the belly fairing forward and middle access panels being obstructed with sealant. This AD requires inspecting for and removing all sealant blocking the drainage holes on the belly fairing forward and middle access panels. We are issuing this AD to address the unsafe condition on these products.
This AD is effective January 15, 2019.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of January 15, 2019.
For service information identified in this final rule, contact Bombardier, Inc., 400 Côte Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
You may examine the AD docket on the internet at
Darren Gassetto, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7323; fax 516-794-5531; email
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. The NPRM published in the
We are issuing this AD to address fluid leakage that could lead to the accumulation of flammable fluids/vapors, beyond the design capacity of the belly fairing venting provisions, which could ignite if an ignition source (
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2018-14, dated May 1, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. The MCAI states:
Bombardier Aerospace (BA) has informed Transport Canada that the drainage holes on the belly fairing forward and middle access panels may be obstructed with sealant. The purpose of the drainage holes is to allow for drainage of a limited quantity of fluids due to any leaks, should they occur. This condition, if not corrected, may prevent the timely detection of fluid leakage that could lead to the accumulation of flammable fluids/vapors, beyond the design capacity of the belly fairing venting provisions [which could ignite if an ignition source (
This [Canadian] AD is issued to mandate the removal of all sealant blocking the drainage holes on the belly fairing forward and middle access panels.
You may examine the MCAI in the AD docket on the internet at
We gave the public the opportunity to participate in developing this final rule. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the relevant data and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
Bombardier has issued the following service information for Bombardier Model BD-700-1A10 airplanes.
• Service Bulletin 700-53-051, dated May 17, 2017.
• Service Bulletin 700-53-6009, dated May 17, 2017.
Bombardier has issued the following service information for Bombardier Model BD-700-1A11 airplanes.
• Service Bulletin 700-1A11-53-026, dated May 17, 2017.
• Service Bulletin 700-53-5010, dated May 17, 2017.
This service information describes procedures for inspecting for and removing sealant blocking the drainage holes on the belly fairing forward and middle access panels. These documents are distinct since they apply to different airplane models and configurations. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 376 airplanes of U.S. registry. We estimate
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under 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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective January 15, 2019.
None.
This AD applies to Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes, certificated in any category, serial numbers 9001 through 9707 inclusive, 9709 through 9717 inclusive, 9719 through 9726 inclusive, 9728, 9730, 9732 through 9734 inclusive, 9736 through 9740 inclusive, 9742 through 9745 inclusive, 9749, 9751, 9757, and 9998.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by reports of drainage holes on the belly fairing forward and middle access panels being obstructed with sealant. We are issuing this AD to address fluid leakage that could lead to the accumulation of flammable fluids/vapors, beyond the design capacity of the belly fairing venting provisions, which could ignite if an ignition source (
Comply with this AD within the compliance times specified, unless already done.
Within 375 flight hours or 12 months, whichever occurs first, after the effective date of this AD, do a general visual inspection for and remove all sealant blocking the drainage holes on the belly fairing forward and middle access panels, in accordance with the Accomplishment Instructions of the applicable service information listed in figure 1 to paragraph (g) of this AD.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2018-14, dated May 1, 2018, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Darren Gassetto, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7323; fax 516-794-5531; email
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Bombardier Service Bulletin 700-1A11-53-026, dated May 17, 2017.
(ii) Bombardier Service Bulletin 700-53-051, dated May 17, 2017.
(iii) Bombardier Service Bulletin 700-53-5010, dated May 17, 2017.
(iv) Bombardier Service Bulletin 700-53-6009, dated May 17, 2017.
(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
(4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies the descriptions of VHF Omnidirectional Range (VOR) Federal airways V-318 and V-352 to reflect the removal of certain route segments within Canadian airspace that were deleted by NAV CANADA. This rule modifies the above airway descriptions to match the current configuration of the routes.
Effective date 0901 UTC, February 28, 2019. The Director of the Federal Register approves this incorporation by reference action under Title 1 Code of Federal Regulations part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11 Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Paul Gallant, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the descriptions of VOR Federal airwaysV-318 and V-352 to maintain the accuracy of navigation publications.
NAV CANADA is the company that operates Canada's civil air navigation service. As part of Canada's efforts to expand the availability of area navigation (RNAV) routing, NAV CANADA has amended certain routes that traverse both Canadian and United States airspace. In this case, the descriptions of VOR Federal airwaysV-318 and V-352, as published in FAA Order 7400.11C, originate in Canadian airspace, then traverse through United States airspace (in the State of Maine) then reenter Canadian airspace.
The current route description ofV-318 extends between the Quebec, PQ, Canada, VORTAC and the St John, NB, Canada, VOR/DME. NAV CANADA has deleted that segment at the western end of V-318 that runs between the Quebec VORTAC and the United States/Canadian border, at the PINTE, Canada, navigation fix. Therefore, the FAA is removing that segment from the V-318 description. The remainder of the route from the PINTE fix to the Houlton, ME, VOR/DME, and on to the St John, Canada VOR/DME remains in effect as currently charted.
The current route description ofV-352 extends between the Beauce, PQ, Canada VORTAC and the Fredericton, NB, Canada, VOR/DME. NAV CANADA has deleted the segment on the western end of the route between the Beauce VORTAC and the DEPRI, ME, waypoint (WP) at the United States/Canadian border. Additionally, NAV CANADA has deleted the route segment on the eastern end of the route between the Houlton, ME, VOR/DME and the Fredericton, NB, VOR/DME. FAA is amending the description of V-352 to remove the segments deleted by NAV CANADA. The amended V-352 lies totally within United States airspace and extends between PATTA, ME, navigation fix (defined by the intersection of the Beauce, PQ, Canada VOR/DME 085°(T)/100°(M) and the Bangor, ME, VORTAC 336°(T)/355°(M) radials) and the Houlton, ME, VOR/DME.
VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11C dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document will be subsequently amended in the Order.
This document amends FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the
This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying the descriptions of VOR Federal airways V-318 and V-352 to remove certain route segments in Canadian airspace.
The amended V-318 description reads:
“From INT Beauce, PQ, Canada 103° and Quebec, PQ, Canada 047° radials; Houlton, ME; INT Houlton 128° and St John, NB, Canada 267° radials; to St John. The airspace in Canada is excluded.”
The FAA is amending the description of V-352 by removing the words “From Beauce, Quebec, Canada, via” and replacing them with the words “From INT Beauce, PQ, Canada 085°(T)/100°(M) and Bangor, ME 336°(T)/355°(M) radials; to” and removing the words “to Fredericton, NB, Canada, excluding the airspace in Canada.” The amended route is entirely within United States airspace.
The amended V-352 description reads:
“From INT Beauce, PQ, Canada 085° and Bangor, ME, 336° radials; to Houlton, ME.”
Because this amendment is necessary to update the descriptions of V-318 and V-352 by removing airway segments in Canadian airspace that have been deleted by NAV CANADA, I find that notice and public procedure under 5 U.S.C. 553(b) are impractical and contrary to the public interest. This action is necessary to ensure agreement between navigation databases and accurate depiction of the routes on aeronautical charts.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is
The FAA has determined that this action, of modifying the descriptions of VOR Federal airways V-318 and V-352 to reflect the removal of certain route segments within Canadian airspace deleted by NAV CANADA, qualifies for categorical exclusion under the National Environmental Policy Act and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F—Environmental Impacts: Policies and Procedures, Paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points). This action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this action has been reviewed for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis, and it is determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
From INT Beauce, PQ, Canada 103° and Quebec, PQ, Canada, 047° radials; Houlton, ME; INT Houlton 128° and St John, NB, Canada, 267° radials; to St John. The airspace within Canada is excluded.
From INT Beauce, PQ, Canada 085° and Bangor, ME 336° radials; to Houlton, ME.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Drug products appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the final rule adds two entries to this list of drug products.
This rule is effective January 10, 2019.
For access to the docket to read background documents or comments received, go to
Alexandria Fujisaki, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5169, Silver Spring, MD 20993-0002, 301-796-3110.
FDA is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (referred to as “the withdrawn or removed list” or “the list”) (§ 216.24 (21 CFR 216.24)). Drug products appearing on the withdrawn or removed list may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b). In this final rule, the Agency is finalizing in part the proposed amendments to § 216.24 set forth in the proposed rule published in the
After soliciting public comments and consulting with the FDA Pharmacy Compounding Advisory Committee (the Committee), we are adding the following entries to the list in § 216.24 of drug products that have been withdrawn or removed from the market because such drug products or
Sections 503A, 503B, and 701(a) of the FD&C Act (21 U.S.C. 353a, 353b, and 371(a)) provide the principal legal authority for this final rule.
The Agency is not aware of routine compounding of the drug products that are the subject of this final rule. Therefore, we do not estimate any compliance costs or loss of sales as a result of the prohibition against compounding these drug products for human use. The Agency has determined that this rulemaking is not a significant regulatory action as defined by Executive Order 12866.
Section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from the following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of new drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)).
In addition, section 503B of the FD&C Act describes the conditions that must be satisfied for a drug compounded for human use by or under the direct supervision of a licensed pharmacist in an outsourcing facility to be exempt from three sections of the FD&C Act: (1) Section 502(f)(1), (2) section 505, and (3) section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security).
One of the conditions that must be satisfied for a drug product to qualify for the exemptions under sections 503A or 503B of the FD&C Act is that the compounder does not compound a drug product that appears on a list published by the Secretary of Health and Human Services (the Secretary) (delegated to FDA) of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (the withdrawn or removed list) (see sections 503A(b)(1)(C), 503B(a)(4), and 503B(a)(11) of the FD&C Act).
The drug products listed in the withdrawn or removed list codified at § 216.24 have been withdrawn or removed from the market because they have been found to be unsafe or not effective. A drug product that is included in the withdrawn or removed list is not eligible for the exemptions provided in section 503A(a) from sections 501(a)(2)(B), 502(f)(1), and 505 of the FD&C Act. In addition, a drug that is included in the withdrawn or removed list is not eligible for the exemptions provided in section 503B(a) from sections 502(f)(1), 505, and 582 of the FD&C Act.
The Food and Drug Modernization Act of 1997 (Pub. L. 105-115) added section 503A to the FD&C Act. On October 8, 1998, FDA proposed a rule in the
Following the addition of section 503B to the FD&C Act on November 27, 2013, through the enactment of the Drug Quality and Security Act (Pub. L. 113-54), FDA published a proposed rule to revise and update the list in § 216.24 on July 2, 2014 (79 FR 37687); FDA published the final rule to amend § 216.24 in the
At a meeting held on June 17 and 18, 2015 (see the
In the
The Agency has considered the public discussion and the advice provided by the Committee regarding these matters at the June 2015 meeting, as well as the October 2016 proposed rule, including the comments submitted on the proposed rule (see section IV). Based on the information before FDA and its own knowledge and expertise, FDA is adding two entries from the proposed rule to the withdrawn or removed list in § 216.24.
The two entries FDA is adding to § 216.24 are as follows:
At this time, FDA is not finalizing the entry in the proposed rule for all drug products containing aprotinin. The addition of an entry to the withdrawn or removed list for drug products containing aprotinin remains under consideration by FDA.
Four comments, all from individuals, were submitted on the October 2016 proposed rule. FDA has summarized and responded to the relevant comments in the following paragraphs. A comment about “hernia repair with mesh and plug” has not been answered because it was not relevant to this rulemaking. Comments regarding the proposed addition of an entry to the withdrawn or removed list for aprotinin will not be answered at this time because the entry remains under consideration by FDA.
To make it easier to identify the comments and FDA's responses, the word “Comment,” in parentheses, appears before the comment's description, and the word “Response,” in parentheses, appears before the Agency's response. We have numbered each comment to help distinguish between different comments. Similar comments are grouped together under the same number, and, in some cases, different subjects discussed in the same comment are separated and designated as distinct comments for purposes of FDA's response. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which the comments were received.
(Comment 1) One comment supported the proposal to include all drug products containing bromocriptine mesylate for prevention of physiological lactation on the withdrawn or removed list.
(Response 1) FDA agrees with the comment.
(Comment 2) FDA received one comment opposing the proposal to include all drug products containing bromocriptine mesylate for prevention of physiological lactation on the withdrawn or removed list. The comment asserts that bromocriptine mesylate offers “significant improvements in the quantity and quality of life,” and, although it has “serious adverse effects,” the benefits of bromocriptine mesylate compared to its risks “should warrant continuous approvability.”
(Response 2) FDA disagrees with the comment. For the reasons that follow, FDA will add all drug products containing bromocriptine mesylate for prevention of physiological lactation to the list in § 216.24.
As a preliminary matter, the issue in this rulemaking is whether all drug products containing bromocriptine mesylate for the indication of prevention of physiological lactation were withdrawn or removed from the market because they were found to be unsafe or not effective for this indication. The criteria that must be met to place a drug product on the withdrawn or removed list are laid out in the FD&C Act. Under sections 503A and 503B of the FD&C Act, to be placed on the withdrawn or removed list, drug products must have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.
As FDA previously explained in the October 2016 proposed rule, FDA withdrew approval of PARLODEL (bromocriptine mesylate, NDA 17962) for the indication of prevention of physiological lactation in a document published in the
FDA's 2015 review, which included a discussion of the withdrawal of PARLODEL's indication for the prevention of physiological lactation, was presented to the Committee at the meeting held on June 17 and 18, 2015, and the Committee voted in favor of the Agency's proposal to include all drug products containing bromocriptine mesylate for the prevention of physiological lactation on the list. For these reasons, FDA proposed in the October 2016 proposed rule to include all drug products containing bromocriptine mesylate for the prevention of physiological lactation on the withdrawn or removed list.
The comment offered no scientific rationale or support for its position that this drug product should not be on the list; therefore, FDA is including bromocriptine mesylate for prevention of physiological lactation on the withdrawn or removed list.
(Comment 3) One comment supported the proposal to include all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride on the withdrawn or removed list.
(Response 3) FDA agrees with the comment.
(Comment 4) FDA received one comment on the proposal to include all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride suggesting “perhaps there is more to investigate and stricter regulation of the administration of IV ondansetron hydrochloride is warranted in the future.”
(Response 4) FDA intends to monitor future approvals, withdrawals, or removals of drugs, to consider other relevant information that may suggest the need to revise the withdrawn or removed list, and to propose modifications as appropriate. In addition, members of the public can submit a citizen petition at any time under 21 CFR 10.25 and 10.30 requesting that FDA add, modify, or remove an entry on the list (with data to support their request), and FDA will consider and respond to the petition.
(Comment 5) FDA received one comment opposing the proposal to include all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride on
(Response 5) FDA disagrees with the comment. For the reasons that follow, FDA will add all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride to the list in § 216.24.
As noted earlier, the issue in this rulemaking is whether drug products containing greater than a 16 mg single dose of ondansetron hydrochloride were withdrawn or removed from the market because they were found to be unsafe or not effective.
As FDA previously explained in the October 2016 proposed rule, in the
FDA's review of intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride was presented to the Committee at the meeting held on June 17 and 18, 2015, and the Committee voted in favor of the Agency's proposal to include all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride on the list. For these reasons, FDA proposed in the October 2016 proposed rule to include all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride on the withdrawn or removed list.
(Comment 6) FDA received one comment asserting that ondansetron hydrochloride should not be recommended for use by pregnant women because it was not approved by FDA for pregnant women.
(Response 6) This comment is outside the scope of this rulemaking. Compounded drugs are not FDA approved and this rulemaking addresses the placement of certain drug products on the withdrawn or removed list, including all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride. As previously noted, drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act. Therefore, to the extent the commenter believes that intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride should not be compounded for pregnant women under the exemptions provided by sections 503A and 503B of the FD&C Act, we agree. The addition of the entry FDA is finalizing regarding ondansetron hydrochloride through this rulemaking for the list in § 216.24 will prohibit compounding of intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride under the exemptions provided by sections 503A and 503B of the FD&C Act for all patients, including pregnant women.
Sections 503A and 503B of the FD&C Act provide the principal legal authority for this final rule. As described previously in section II, section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from three sections of the FD&C Act (sections 501(a)(2)(B), 502(f)(1), and 505). One of the conditions that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that the licensed pharmacist or licensed physician does not compound a drug product that appears on a list published by FDA in the
Section 503B of the FD&C Act describes the conditions that must be satisfied for a drug compounded for human use by or under the direct supervision of a licensed pharmacist in an outsourcing facility to be exempt from three sections of the FD&C Act (sections 502(f)(1), 505, and 582). One of the conditions in section 503B of the FD&C Act that must be satisfied to qualify for the exemptions is that the drug does not appear on a list published by FDA of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective (see section 503B(a)(4)). To be eligible for the exemptions in section 503B, a drug must be compounded in an outsourcing facility in which the compounding of drugs occurs only in accordance with section 503B, including as provided in section 503B(a)(4) of the FD&C Act.
Thus, sections 503A and 503B of the FD&C Act, in conjunction with our general rulemaking authority in section 701(a) of the FD&C Act (21 U.S.C. 371(a)), serve as our principal legal authority for this final rule revising FDA's regulation on the list of drug products withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective in § 216.24.
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because small businesses are not expected to incur any compliance costs or loss of sales due to this regulation, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $150 million, using the most current (2017) Implicit Price Deflator for the Gross Domestic Product. This final rule is not expected to result in an expenditure in any year that would meet or exceed this amount.
This final rule amends § 216.24 concerning human drug compounding. Specifically, the final rule adds to the list of drug products that may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (see section II). We are adding two entries to the list: Drug products containing bromocriptine mesylate for prevention of physiological lactation and intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride. The Agency is not aware of routine compounding of these drug products; therefore, we do not estimate any compliance costs or loss of sales as a result of the prohibition against compounding these drugs for human use.
Unless we certify that a rule will not have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires us to analyze regulatory options to minimize any significant economic impact of a regulation on small entities. Most pharmacies meet the Small Business Administration definition of a small entity, which is defined as having annual sales less than $27.5 million for this industry. We are not aware of any routine compounding of the drug products that are the subject of this final rule and do not estimate any compliance costs or loss of sales to small businesses as a result of the prohibition against compounding these drug products. Therefore, we certify that this final rule will not have a significant economic impact on a substantial number of small entities.
This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required.
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency concludes that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
The following references are on display in the Dockets Management Staff (see
1. Transcript for the June 17-18, 2015, Meeting of the Pharmacy Compounding Advisory Committee, available at
2. Briefing Information for the June 17-18, 2015, Meeting of the Pharmacy Compounding Advisory Committee, available at
Drugs, Prescription drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 216 is amended as follows:
21 U.S.C. 351, 352, 353a, 353b, 355, and 371.
Office of the Secretary, Department of Defense (DoD).
Interim final rule.
This interim final rule implements Section 702 of the National Defense Authorization Act for Fiscal Year 2018 (NDAA FY18). The law makes significant changes to the TRICARE Pharmacy Benefits Program, specifically it: Updates co-payment requirements; authorizes a new process for encouraging use of pharmaceutical agents that provide the best clinical effectiveness by excluding coverage for particular pharmaceutical agents that provide very little or no clinical effectiveness relative to similar agents and for giving preferential status to agents that provide enhanced clinical effectiveness; and authorizes special reimbursement methods, amounts, and procedures to encourage use or high-value products and discourage use of low-value products with respect to pharmaceutical agents provided as part of medical services from authorized providers.
This interim final rule is effective December 11, 2018. Comments must be received by February 11, 2019.
David W. Bobb, RPh, JD, Chief, Pharmacy Operations, Defense Health Agency (DHA), telephone (703) 681-2890.
This interim final rule implements Section 702 of the National Defense Authorization Act for Fiscal Year 2018 (NDAA FY18), which does three things: (1) It updates cost-sharing requirements for outpatient pharmaceutical prescriptions filled by retail pharmacies and the TRICARE mail order pharmacy program. (2) It authorizes a new Uniform Formulary process for encouraging use of pharmaceutical agents in the TRICARE Pharmacy Benefits Program that provide the best clinical effectiveness by excluding coverage for particular pharmaceutical agents that provide very little or no clinical effectiveness relative to similar agents and giving preferential status to agents that provide enhanced clinical effectiveness. (3) It authorizes special reimbursement methods, amounts, and procedures to encourage use of high-value products and discourage use of low-value products with respect to pharmaceutical agents provided as part of medical services from authorized providers. This interim final rule implements each of these three statutory changes. This is being issued as an interim final rule in order to implement expeditiously the reforms authorized by Section 702, as specifically authorized by subsection (b)(3) of that section. Based on that clear Congressional authority and intent, the Department finds that obtaining public comment in advance of issuing this rule is impracticable, unnecessary, and contrary to the public interest. Delaying expeditious implementation by waiting for public comments to this interim rule not only delays the significant cost savings to the government that will be realized through implementation but also continues to allow coverage of pharmaceutical agents that do not provide the best clinical effectiveness for beneficiaries. In addition, subsection (b)(3) of Section 702 states that “in order to implement expeditiously the reforms authorized . . . (A) the Secretary of Defense may prescribe an interim final rule, (B) not later than one year after prescribing the interim final rule and considering public comments with respect to such interim final rule, by prescribing a final rule.” Clearly Congressional intent is to implement the authorized reforms quickly. Nonetheless, DoD invites public comments on this rule and is committed to considering all comments and issuing a final rule as soon as practicable (but not later than one year after issuance of this interim final rule).
This interim final rule is under the primary authority of 10 U.S.C. 1074g, 1079 and 1086, and Section 702 of NDAA-18. Specifically, section 702(b)(3) of NDAA-18 authorizes DoD to “prescribe such changes to the regulations implementing the TRICARE program . . . by prescribing an interim final rule.” TRICARE program regulations (32 CFR part 199) are issued under statutory authorities including 10 U.S.C. 1074g (the Pharmacy Benefits Program) and 10 U.S.C. 1079 and 1086 (TRICARE medical benefits). Section 702 of NDAA-18 amends both section 1074g and section 1079 (the section 1079 amendment being automatically applicable to section 1086).
The major provisions of the interim final rule are the following.
1.
2.
3.
The interim final rule amends 32 CFR 199.21(i)(2), which is the paragraph of the TRICARE regulation that governs cost-sharing amounts under the Pharmacy Benefits Program. The amended language simply cross references the statutory specifications on cost-sharing, including the table set forth in 10 U.S.C. 1074g(a)(6)(A). This table lists cost sharing amounts for the years 2018 through 2027 for generic, formulary, and non-formulary pharmaceutical agents dispensed by retail network pharmacies and the mail order pharmacy program. Two exceptions are that there is a $0 cost-share for vaccines/immunizations authorized as preventive care for eligible beneficiaries and provided by
The interim final rule amends 32 CFR 199.21(e)(3) to provide that the Pharmacy and Therapeutics Committee may recommend and the Director may, after considering the comments and recommendations of the Beneficiary Advisory Panel, approve special uniform formulary actions to encourage use of pharmaceutical agents that provide the best clinical effectiveness to covered beneficiaries and DoD, including consideration of better care, healthier people, and smarter spending. Such special actions may operate as exceptions to the normal rules and procedures. Specifically, the Pharmacy and Therapeutics Committee may recommend complete or partial exclusion from the pharmacy benefits program of any pharmaceutical agent the Director determines provides very little or no clinical effectiveness relative to similar agents—
The interim final rule amends 32 CFR 199.14(a)(6) and (j)(1) to provide that TRICARE may adopt special reimbursement methods, amounts, and procedures to encourage the use of high-value pharmaceutical agents as part of medical services furnished in a hospital outpatient setting or as part of any other medical services provided to TRICARE beneficiaries. Although TRICARE generally follows Medicare's reimbursement methodology when practicable for such medical services which include medically necessary administration of drugs, Section 702(b)(2) of NDAA FY18 authorizes the adoption of special reimbursement methods when determined appropriate to encourage the use of high-value pharmaceutical agents and discourage the use of low-value agents. For example, Medicare's reimbursement formula for physician-administered drugs paid under Part B is Average Sales Price (ASP) + 6%. Medicare and TRICARE reimburse providers ASP + 6 percent for the drug regardless of the price a provider pays for the drug.
Both Medicare and TRICARE acknowledge that such payment for physician-administered drugs does not incentivize high-value clinically driven, low cost drugs. To the contrary, the payment methods for physician-administered drugs using the ASP plus 6 percent raises many concerns including that it may encourage the use of more expensive drugs because the 6% add-on generates more revenue for more expensive drugs without regard to the relative clinical value of the product compared to other products in the same drug class. In order to remove the incentive for using higher priced products that have no higher clinical value, TRICARE may utilize the authority provided by the NDAA-18 to restructure—at least for certain selected drug classes, or categories of pharmaceuticals (identified in coordination with the Pharmacy and Therapeutics Committee, or other entities as described in the implementing instructions)—the reimbursement amount. For example, TRICARE is evaluating established the ASP add-on as a percentage (likely 6 percent) of the median value of all drugs in a particular class, rather than attaching the 6% add-on to the ASP of a particular drug. The specific modifications to drug pricing for physician-administered drugs authorized by this IFR and NDAA FY18 shall be published in TRICARE's implementing instructions (manuals) as approved by the Director, DHA, and shall be published on the health.mil website. The amendment to § 199.14(j)(1) will authorize this.
This is being issued as an interim final rule in order to implement expeditiously the reforms authorized by Section 702, as specifically authorized by subsection (b)(3) of that section. Based on that clear Congressional authority and intent, the Department finds that obtaining public comment in advance of issuing this rule is impracticable, unnecessary, and contrary to the public interest.
E.O. 13771 seeks to control costs associated with the government imposition of private expenditures required to comply with Federal regulations and to reduce regulations that impose such costs. Consistent with the analysis of transfer payments under OMB Circular A-4, this interim final rule does not involve regulatory costs subject to E.O. 13771. Rather, this interim final rule affects only health care reimbursement payments under the TRICARE program. Aside from the “housekeeping” change to the regulation to incorporate the updated copayment amounts enacted by Congress, the interim final rule makes two changes to the program: a new authority under the Uniform Formulary process and revised payment authority for pharmaceutical agents as part of medical services.
Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This interim final rule has been designated a “significant regulatory action,” although not economically significant, under section
The economic effect of these changes is limited to government reimbursements to health care providers/suppliers that under Circular A-4 are not considered as costs imposed on the economy. The expected reduction in government payments to pharmaceutical companies is based on some predicted increase in use of higher value medications and a corresponding decrease in the use of lower value medications in drug classes where different drugs have comparable clinical effect. The expected value of this shift in use of some medications—
An initial analysis identified a sample group of candidate drugs that do not offer additional therapeutic benefit over other formulary items. By comparing the current costs to those of a lower-priced comparator and assuming similar utilization rates, the average cost avoidance was $1.5M/drug/year, with a more conservative cost avoidance of $1M/drug/year. When fully implemented, this new process could average 30 drugs per year at a conservative cost avoidance of $1M/drug/year.
Under the Congressional Review Act, a major rule may not take effect until at least 60 days after submission to Congress of a report regarding the rule. A major rule is one that would have an annual effect on the economy of $100M or more or have certain other impacts. This final rule is not a major rule under the Congressional Review Act.
The Regulatory Flexibility Act requires that each Federal agency analyze options for regulatory relief of small businesses 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 governmental jurisdictions. This interim final rule is not an economically significant regulatory action, and it will not have a significant impact on a substantial number of small entities. Therefore, this rule is not subject to the requirements of the RFA.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100M in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $140M. This interim final rule will not mandate any requirements for state, local, or tribal governments or the private sector.
This rulemaking does not contain a “collection of information” requirement, and will not impose additional information collection requirements on the public under Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. chapter 35).
This interim final rule has been examined for its impact under E.O. 13132, and it does not contain policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the national Government and the States, or on the distribution of powers and responsibilities among the various levels of Government. Therefore, consultation with State and local officials is not required.
Claims, Dental health, Health care, Health insurance, Individuals with disabilities, Mental health, Mental health parity, Military personnel.
For the reasons stated in the preamble, the DoD amends 32 CFR part 199 as set forth below:
5 U.S.C. 301; 10 U.S.C. chapter 55.
(a) * * *
(6) * * *
(i) * * *
(I)
(ii)
(B) Under the above governing provisions, TRICARE will recognize to the extent practicable, in accordance with 10 U.S.C. 1089(j)(2), Medicare's OPPS reimbursement methodology to include specific coding requirements, ambulatory payment classifications (APCs), nationally established APC amounts and associated adjustments (
(C) While TRICARE intends to remain as true as possible to Medicare's basic OPPS methodology, there will be some deviations required to accommodate TRICARE's unique benefit structure and beneficiary population as authorized under the provisions of 10 U.S.C. 1079(j)(2).
(D) TRICARE is also authorized to deviate from Medicare's basic OPPS methodology to establish special reimbursement methods, amounts, and procedures to encourage use of high-value products and discourage use of low-value products with respect to pharmaceutical agents provided as part of medical services from authorized providers. Therefore, drugs administered other than oral method provided on an outpatient basis by hospitals are paid on the same basis as drugs administered other than oral method covered by the allowable charge method under paragraph (j)(1) of this section.
(E)
(
(
(
(j) * * *
(1) * * *
(xi)
(e) * * *
(3)
(ii) Actions under paragraph (e)(3)(i) of this section may include a complete or partial exclusion from the pharmacy benefits program of any pharmaceutical agent the Director determines provides very little or no clinical effectiveness relative to similar agents to covered beneficiaries and DoD. A partial exclusion under this paragraph may take the form (as one example) of a limitation on the clinical conditions, diagnoses, or indications for which the pharmaceutical agent may be prescribed. A partial exclusion may be implemented through any means recommended by the Pharmacy and Therapeutics Committee, including but not limited to preauthorization under paragraph (k) of this section. In the case of a partial exclusion, a pharmaceutical agent may be available on the non-formulary tier of the uniform formulary for limited purposes and for other purposes be excluded.
(iii) Actions under paragraph (e)(3)(i) of this section may also include giving preferential status to any non-generic pharmaceutical agent of the uniform formulary by treating it for purposes of cost-sharing as a generic product.
(i) * * *
(2) * * *
(ii) For pharmaceutical agents obtained from a retail network pharmacy, the cost share will be as provided in 10 U.S.C. 1074g(a)(6), except that there is a $0 cost-share for vaccines/immunizations authorized as preventive care for eligible beneficiaries.
(iv) For pharmaceutical agents obtained under the TRICARE mail order program, the cost share will be as provided in 10 U.S.C. 1074g(a)(6), except that there is a $0 cost-share for smoking cessation pharmaceutical agents covered under the smoking cessation program.
(x) For any year after 2027, the cost-sharing amounts under this paragraph shall be equal to the cost-sharing amounts for the previous year adjusted by an amount, if any, determined by the Director to reflect changes in the costs of pharmaceutical agents and prescription dispensing, rounded to the nearest dollar. These cost changes, if any, will consider costs under the
(A) Generic drugs in the retail point of service;
(B) Formulary drugs in the retail point of service;
(C) Generic drugs in the mail order point of service;
(D) Formulary drugs in the mail order point of service;
(E) Non-formulary drugs.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone on the Menominee River in Marinette WI on December 15, 2018 from 10 a.m. to 12 p.m. This action is necessary and intended to protect the safety of life and property on navigable waterways before, during and after the launch of a naval vessel from Marinette Marine on the Menominee River in Marinette, WI. During the enforcement period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in the safety zone. No person or vessel may enter into, transit, or anchor within the safety zone while it is being enforced unless authorized by the Captain of the Port Lake Michigan or a designated representative.
The regulations in 33 CFR 165.929 will be enforced for safety zone (f)(13), Table 165.929, from 10 a.m. through 12 p.m. on December 15, 2018.
If you have questions about this notice of enforcement, call or email marine event coordinator MSTC Kaleena Carpino, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI; telephone (414) 747-7148, email
The Coast Guard will enforce the Operations at Marinette Marine Safety Zone listed as item (f)(13) in Table 165.929 of 33 CFR 165.929 on December 15, 2018 from 10 a.m. to 12 p.m. This action is being taken to protect the safety of life and property on navigable waterways of the Menominee River, WI.
The safety zone will encompass all waters of the Menominee river in the vicinity of Marinette Marine Corporation, from the Bridge Street Bridge located in position 45°06.188′ n, 087°37.583′ w, then approximately .95 nm south east to a line crossing the river perpendicularly passing through positions 45°05.881′ n, 087°36.281′ w and 45°05.725′ n, 087°36.385′ w (NAD 83). As specified in 33 CFR 165.929, all vessels must obtain permission from the Captain of the Port Lake Michigan or a designated representative to enter, move within or exit the safety zone while it is enforced. Vessels or persons granted permission to enter the safety zone must obey all lawful orders or directions of the Captain of the Port Lake Michigan or a designated representative.
This notice of enforcement is issued under authority of 33 CFR 165.929; Safety Zones; Annual events requiring safety zones in the Captain of the Port Lake Michigan zone, and 5 U.S.C. 552(a). In addition to this publication in the
The Captain of the Port Lake Michigan or a designated representative will inform the public through a Broadcast Notice to Mariners of any changes in the planned schedule. The Captain of the Port Lake Michigan or a representative may be contacted via Channel 16, VHF-FM or at (414) 747-7182
Postal Service
Interim final rule with request for comments.
The Postal Service is revising
Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service®, 475 L'Enfant Plaza SW, Room 4446, Washington, DC 20260-5015. If sending comments by email, include the name and address of the commenter and send to
Malaki Gravely at (202) 268-7553 or
The Postal Service will increase the IMpb® Address Quality (AQ) threshold from 89 percent to 90 percent. The effective date of the new IMpb Address Quality threshold will coincide with the effective date for the previously determined threshold increases for Manifest Quality (MQ) and Barcode Quality (BQ).
On February 27, 2018, the Postal Service published a proposed rule,
On September 21, 2018, the Postal Service published a final rule,
Additional time was needed to discuss the validation requirements for Address Quality before increasing the AQ threshold. The Postal Service and mailing industry have agreed on 90% as the new AQ threshold. The new AQ threshold is effective January 31, 2019, and the assessment of the IMpb Noncompliance Fee pursuant to this new AQ threshold will begin on February 1, 2019. Additionally, the Address Quality (AQ) validation
The Postal Service adopts the following changes to
Administrative practice and procedure, Postal Service.
Accordingly, 39 CFR part 111 is amended as follows:
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
* * * Failure to meet any compliance quality threshold in Exhibit 2.1.8 will result in the assessment of the IMpb Noncompliance Fee. For details, see Publication 199:
We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving the removal of outdated rules in the Code of Federal Regulations (CFR) for the State of Oregon because they are duplicative or obsolete. Removal of such material from the air program subparts is designed to improve cost effectiveness and usability of the CFR. The EPA is also approving non-substantive revisions to reflect updated citations and correcting a typographical error. This final action makes no substantive changes to the Oregon State Implementation Plan and imposes no new requirements.
This action is effective on January 10, 2019.
The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2018-0022. All documents in the docket are listed on the
Christi Duboiski, EPA Region 10, at (360) 753-9081, or
Throughout this document, wherever “we”, “us” or “our” is used, it is intended to refer to the EPA.
This action is being taken pursuant to Executive Order 13563—
This final action is a “housekeeping” exercise that removes duplicative or obsolete CFR provisions and corrects a non-substantive typographical error. The EPA is approving the removal of 40 CFR 52.1973, 40 CFR 52.1974 paragraphs (b) and (c), 40 CFR 52.1977, and 40 CFR 52.1982; and approving the amendment to 40 CFR 52.1974(a). The EPA is removing the duplicative or obsolete rules because they have been revised or superseded by subsequently approved SIP revisions. These actions make no substantive changes to the SIP. The changes will be accurately reflected in 40 CFR part 52, subpart MM for the State of Oregon.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and it will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 11, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(a) This section identified the original “State of Oregon Clean Air Act Implementation Plan” and all revisions submitted by Oregon that were federally approved prior to July 1, 2013. The information in this section is available in the 40 CFR, part 52, Volume 4 (§ 52.1970 to End) edition revised as of July 1, 2013.
(b)-(c) [Reserved]
(a) Except for compliance schedules under OAR 340-200-0050, emission limitations and other provisions contained in Air Contaminant Discharge Permits issued by the State in accordance with the provisions of the Federally-approved rules for Air Contaminant Discharge Permits (OAR chapter 340, Division 216), Plant Site Emission Limit (OAR chapter 340, Division 222), Alternative Emission Controls (OAR 340-226-0400) and Public Participation (OAR chapter 340, Division 209), shall be applicable requirements of the Federally-approved Oregon SIP (in addition to any other provisions) for the purposes of section 113 of the Clean Air Act and shall be enforceable by EPA and by any person in the same manner as other requirements of the SIP. Plant site emission limits and alternative emission limits (bubbles) established in Federal Operating Permits issued by the State in accordance with the Federally-approved rules for Plant Site Emission Limit (OAR chapter 340, Division 222) and Alternative Emission Controls (OAR 340-226-0400), shall be applicable requirements of the Federally-approved Oregon SIP (in addition to any other
Federal Communications Commission.
Final rule.
In this document, the Commission simplifies its jurisdictional separations rules, applying the separations processes previously reserved for smaller carriers to all carriers subject to those rules, and harmonizing the jurisdictional separations rules with the accounting rules. With this action, the Commission continues to modernize existing rules and eliminate outdated compliance requirements.
Christopher Koves, Pricing Policy Division, Wireline Competition Bureau at 202-418-8209 or by email at
This is a summary of the Commission's Report and Order, WC Docket No. 14-130, CC Docket No. 80-286; FCC 18-141, adopted on October 16, 2018, and released on October 17, 2018. A full-text version of this document can be obtained at the following internet address:
1. In this Report and Order (Order), the Commission simplifies its part 36 jurisdictional separations rules to allow all carriers to use the simpler jurisdictional separations processes previously reserved for smaller carriers. In so doing, the Commission harmonizes its part 36 rules with the Commission's previous amendments to its part 32 accounting rules. The amendments the Commission adopts today to its part 36 rules further its goal of updating and modernizing its rules to eliminate outdated compliance burdens on carriers so that they can focus their resources on building modern networks that bring economic opportunity, job creation, and civic engagement to all Americans.
2. Jurisdictional separations is the third step in a four-step regulatory process. First, a rate-of-return carrier records its costs and revenues in various accounts using the Uniform System of Accounts (USOA) prescribed by the Commission's part 32 rules. Second, the carrier divides the costs and revenues in these accounts between regulated and nonregulated activities in accordance with part 64 of the Commission's rules, a step that helps ensure that the costs of nonregulated activities will not be recovered through regulated interstate rates. Third, the carrier separates the regulated costs and revenues between the intrastate and interstate jurisdictions using the part 36 rules. Finally, the carrier apportions the interstate regulated costs among the interexchange services and rate elements that form the cost basis for its exchange access tariff. Carriers subject to rate-of-return regulation perform this apportionment in accordance with the Commission's part 69 rules.
3. Historically, the part 32 rules divided incumbent local exchange carriers (LECs) into two classes for accounting purposes based on the amounts of their annual regulated revenues. Class A incumbent LECs were the larger carriers, and Class B incumbent LECs were the smaller carriers (most recently those with less than $157 million in annual regulated revenues). The Commission's former part 32 rules required Class A carriers to create and maintain a more granular set of accounts than it required of the smaller Class B carriers. In all but one case, Class A carrier accounts could be grouped into sets that were represented by single Class B carrier accounts—that is, such Class A accounts consolidated into, or “rolled up” into, Class B accounts.
4. In the
5. In October 2017, after seeking public comment on how best to harmonize the part 32 and part 36 rules, the Joint Board released a
6. In February 2018, the Commission released the
7. In this Order, the Commission harmonizes its part 36 jurisdictional separations rules with the changes to the part 32 accounting rules that the Commission adopted in the
8. First, the Commission removes from its part 36 rules references to Class A accounts because carriers are no longer required to keep such accounts. As the Commission proposed, it: (a) Deletes references to Class A accounts and the phrase “Class B accounts” in part 36 rules that contain parallel references to Class A accounts and the Class B accounts into which they roll up; (b) deletes references to current-year account balances and modify references to Class A carriers in other part 36 rules; and (c) deletes references to Class A accounts in §§ 36.501 and 36.505 of the rules. As USTelecom explains, these revisions are “necessary clean-up to ensure that both rule parts [
9. Second, the Commission amends § 36.112 to allow former Class A carriers (carriers with revenue equal to or greater than $157 million for calendar year 2016) to select between the legacy Class A and Class B procedures in apportioning their general support facilities costs. As the Commission observed in the
10. Third, consistent with the Joint Board's recommendation and the Commission's proposals, the Commission corrects certain stylistic and typographical errors in part 36. As USTelecom explains, these ministerial corrections make the separations rules clearer.
11. The Commission agrees with the Joint Board that its proposed revisions to part 36 should “become effective as soon as practicable” and with USTelecom's argument that adopting the Commission's proposed harmonizing changes to part 36 “as soon as possible” avoids potentially “confusing” and “contradictory” rules. The Commission also agrees with USTelecom that January 1, 2019 is the earliest practicable effective date for these changes, because it corresponds with the carriers' practices of keeping their USOA accounts on a calendar year basis and using their USOA accounting results for regulatory purposes. The Commission therefore selects January 1, 2019 as the effective date of the rule changes it is adopting.
12.
13.
14.
15. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Final Regulatory Flexibility Analysis (FRFA) on the possible significant economic impact on small entities by this Report and Order (Order). An Initial Regulatory Flexibility Analysis (IRFA) was incorporated into the Notice of Proposed Rulemaking, 83 FR 10817 (
16. In this Report and Order (Order), the Commission amends its part 36 jurisdictional separations rules to harmonize them with the Commission's reforms to reduce and eliminate unnecessary or outdated part 32 accounting rules. Jurisdictional separations are the third step in a four-step regulatory process used to establish tariffed rates for interstate and intrastate regulated services for incumbent local exchange carriers (LECs). Carriers first record costs into various part 32 accounts, which they then apportion into regulated and nonregulated costs pursuant to part 64, and further separate the regulated costs between intrastate and interstate jurisdictions pursuant to part 36.
17. In the
18. The purpose of the part 36 amendments adopted in this Order are to ensure that part 36 is consistent with the part 32 reforms adopted in the
19. There were no comments that specifically addressed the proposed rules and policies presented in the
20. Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comments filed by the Chief Counsel 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 proposed rules in this proceeding.
21. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). Nationwide, there are a total of approximately 27.9 million small businesses, according to the SBA.
22.
23. The Commission has included small incumbent LECs in this RFA analysis. As noted above, a “small business” under the RFA is one that,
24. None.
25. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include (among others) the following four alternatives: (1) The establishment of differing compliance and reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or part thereof, for small entities.
26. As discussed above, the purpose of this Order is to ensure that the part 36 rules are consistent with the amendments to the part 32 rules adopted in the
27. The rules adopted in this Order will ease the administrative burden of regulatory compliance for incumbent LECs, including any small incumbent LECs those rules affect. The
28. None.
29. The Commission will send a copy of the Order, including this FRFA, in a report to be sent to Congress and the Government Accountability Office pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996. In addition, the Commission will send a copy of the Order, including the FRFA, to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the Order and FRFA (or summaries thereof) will also be published in the
30. Accordingly,
31.
32.
33.
Communications common carriers, Reporting and recordkeeping requirements, Telephone, Uniform System of Accounts.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 36 as follows:
47 U.S.C. 151, 152, 154(i) and (j), 201, 205, 220, 221(c), 254, 303(r), 403, 410, and 1302 unless otherwise noted.
(a) The costs of the general support facilities of local exchange carriers that had annual revenues from regulated telecommunications operations equal to or greater than $157 million for calendar year 2016 are apportioned among the operations on the basis of either the method in paragraph (a)(1) of this section or the method in paragraph (a)(2) of this section, at the election of the local exchange carrier:
(1) The separation of the costs of the combined Big Three Expenses which include the following accounts:
(2) The separation of the costs of Central Office Equipment, Information Origination/Termination Equipment, and Cable and Wire Facilities, combined.
(b) The costs of the general support facilities of local exchange carriers that had annual revenues from regulated telecommunications operations less than $157 million for calendar year 2016 are apportioned among the operations on the basis of the separation of the costs of Central Office Equipment, Information Origination/Termination Equipment, and Cable and Wire Facilities, combined.
(a) * * *
(c) * * *
(1) * * *
(i) The cost of power equipment used by one category is assigned directly to that category,
(a) Tandem switching equipment is contained in Account 2210. * * *
(c) Effective July 1, 2001, through December 31, 2018, study areas subject
The additions read as follows:
(c) * * *
(1) Subsidiary Record Categories (SRCs) for Salaries and Wages, Benefits and Other Expenses are applicable to all of the expense accounts except for:
(i) SRCs for access expenses are maintained to identify interstate and state access expense and billing and collection expense for carrier's carrier.
(a) * * *
(a) * * *
(b) The expenses in these accounts are apportioned among the operations on the basis of the separation of the investments in central office equipment—Accounts 2210, 2220 and 2230, combined.
Plant nonspecific operations expenses include the following accounts:
(c) The expenses in this account are apportioned among the operations on the basis of the separation of the cost of the combined Big Three Expenses which include the following accounts:
This account includes the taxes arising from the operations of the company,
(a) Operating Investment Tax Credits.
(b) Operating Federal Income Taxes.
(c) Operating State and Local Income Taxes.
(d) Operating Other Taxes.
(e) Provision for Deferred Operating Income Taxes.
The revision reads as follows:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Modification of fishing seasons.
NMFS announces 26 inseason actions in the ocean salmon fisheries. These inseason actions modified the commercial and recreational salmon fisheries in the area from the U.S./Canada border to the U.S./Mexico border.
The effective dates for the inseason actions are set out in this document under the heading Inseason Actions.
Peggy Mundy at 206-526-4323.
In the 2018 annual management measures for ocean salmon fisheries (83 FR 19005, May 1, 2018), NMFS announced management measures for the commercial and recreational fisheries in the area from the U.S./Canada border to the U.S./Mexico border, beginning May 1, 2018, through April 30, 2019. NMFS is authorized to implement inseason management actions to modify fishing seasons and quotas as necessary to provide fishing opportunity while meeting management objectives for the affected species (50 CFR 660.409). Inseason actions in the salmon fishery may be taken directly by NMFS (50 CFR 660.409(a)—Fixed inseason management provisions) or upon consultation with the Pacific Fishery Management Council (Council) and the appropriate State Directors (50 CFR 660.409(b)—Flexible inseason management provisions). The state management agencies that participated in the consultations described in this document were: California Department of Fish and Wildlife (CDFW), Oregon Department of Fish and Wildlife (ODFW), and Washington Department of Fish and Wildlife (WDFW).
Management of the salmon fisheries is generally divided into two geographic areas: north of Cape Falcon (U.S./Canada border to Cape Falcon, OR) and south of Cape Falcon (Cape Falcon, OR, to the U.S./Mexico border). Within the north and south of Cape Falcon areas, there are further subarea divisions used to manage impacts on salmon stocks or stock groups as well as economic impacts to communities. The management areas affected by the inseason actions in this document are described here.
All other restrictions and regulations remain in effect as announced for the 2018 ocean salmon fisheries and 2019 salmon fisheries opening prior to May 1, 2019 (83 FR 19005, May 1, 2018), and as modified by prior inseason actions.
The RA determined that the best available information indicated that coho, Chinook salmon, and Pacific halibut abundance forecasts and expected fishery effort in 2018 supported the above inseason actions recommended by the states of Washington, Oregon, and California. The states manage the fisheries in state waters adjacent to the areas of the U.S. exclusive economic zone consistent with these federal actions. As provided by the inseason notice procedures of 50 CFR 660.411, actual notice of the described regulatory action was given, prior to the time the action was effective, by telephone hotline numbers 206-526-6667 and 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts on Channel 16 VHF-FM and 2182 kHz.
NOAA's Assistant Administrator (AA) for NMFS finds that good cause exists for this notification to be issued without affording prior notice and opportunity for public comment under 5 U.S.C. 553(b)(B) because such notification would be impracticable. As previously noted, actual notice of the regulatory action was provided to fishers through telephone hotline and radio notification. This action complies with the requirements of the annual management measures for ocean salmon fisheries (83 FR 19005, May 1, 2018), the Pacific Coast Salmon Fishery Management Plan (FMP), and regulations implementing the FMP under 50 CFR 660.409 and 660.411. Prior notice and opportunity for public comment was impracticable because NMFS and the state agencies had insufficient time to provide for prior notice and the opportunity for public comment between the time coho, Chinook salmon, and Pacific halibut catch and effort projections and abundance forecasts were developed and fisheries impacts were calculated, and the time the fishery modifications had to be implemented in order to ensure that fisheries are managed based on the best available scientific information, ensuring that conservation objectives and limits for impacts to salmon species listed under the Endangered Species Act are not exceeded. The AA also finds good cause to waive the 30-day delay in effectiveness required under 5 U.S.C. 553(d)(3), as a delay in effectiveness of this action would allow fishing at levels inconsistent with the goals of the FMP and the current management measures.
This action is authorized by 50 CFR 660.409 and 660.411 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 Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This proposed AD was prompted by reports indicating there is a possibility of excessive error in the signal generated by the angle of attack (AOA) transducer. This proposed AD would require replacing certain AOA transducers. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by January 25, 2019.
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 NPRM, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email
You may examine the AD docket on the internet at
John DeLuca, Aerospace Engineer, Avionics and Electrical Systems Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7369; fax 516-794-5531; email
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2018-17, dated June 29, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The MCAI states:
Bombardier has received reports from the manufacturer of its Angle of Attack (AOA) transducers indicating that there is a possibility of excessive error in the signal generated by the AOA Transducer. It is possible that this error may not be detected by the stall protection computer, which could lead to late stall protection system activation and potentially result in the loss of control of the aeroplane. The error could be a result of incorrect assembly or/and internal wear in the AOA Transducer.
This [Canadian] AD mandates the modification or replacement of the AOA transducers in order to prevent late activation of the stick pusher in the stall protection system.
You may examine the MCAI in the AD docket on the internet at
Bombardier has issued Service Bulletin 601R-27-165, dated December 20, 2016. This service information describes procedures for replacing certain AOA transducers with new or modified AOA transducers. 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 the relevant information and determined the unsafe condition described previously is likely to exist or develop
This proposed AD would require accomplishing the actions specified in the service information described previously.
The applicability of the MCAI is limited to Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes having serial number 7003 through 7067 inclusive and 7069 through 7891 inclusive, and equipped with AOA transducers having part number (P/N) 45-150-340, C16258AA, or C16258AB. However, the applicability of this proposed AD specifies Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes having serial number 7003 through 7067 inclusive and 7069 through 7891 inclusive. Airplanes having serial number 7003 through 7067 inclusive and 7069 through 7891 inclusive that are not equipped with the affected parts must comply with the parts installation prohibition specified in paragraph (h) of this proposed AD.
We estimate that this proposed AD affects 525 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all known costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
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 January 25, 2019.
None.
This AD applies to Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes, certificated in any category, having serial number 7003 through 7067 inclusive and 7069 through 7891 inclusive.
Air Transport Association (ATA) of America Code 27, Flight Controls.
This AD was prompted by reports indicating there is a possibility of excessive error in the signal generated by the angle of attack (AOA) transducer. We are issuing this AD to address this potential error, which, if not detected by the stall protection computer, could lead to late activation of the stall protection system and possible loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 9,000 flight hours or 46 months, whichever occurs first, after the effective date of this AD, replace the AOA transducers having part number (P/N) 45-150-340, C16258AA, or C16258AB, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 601R-27-165, dated December 20, 2016.
As of the effective date of this AD, no person may install any AOA transducer having P/N 45-150-340, C16258AA, or C16258AB, on any airplane.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2018-17, dated June 29, 2018, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact John DeLuca, Aerospace Engineer, Avionics and Electrical Systems Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7369; fax 516-794-5531; email
(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Gulfstream Aerospace LP Model Gulfstream G150 airplanes. This proposed AD was prompted by reports of corrosion in the solder joints of the upper and lower front relay box connectors to the printed circuit board. This proposed AD would require replacement of the existing relay boxes with modified boxes. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by January 25, 2019.
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 NPRM, contact Gulfstream Aerospace Corporation, P.O. Box 2206, Mail Station D-25, Savannah, GA 31402-2206; telephone 800-810-4853; fax 912-965-3520; email
You may examine the AD docket on the internet at
Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The Civil Aviation Authority of Israel (CAAI), which is the aviation authority for Israel, has issued Israeli Airworthiness Directive ISR-I-24-2018-09-7, dated October 1, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Gulfstream Aerospace LP Model Gulfstream G150 airplanes. The MCAI states:
The existing Upper and Lower Front Relay Box might be prone to corrosion in the relay box connector's solder joint to the printed circuit board. As a result various CAS [crew alerting system] messages such as slats unbalance and auto slats fail, Mach trim fail, etc. . . . might be reported [and could interfere with continued safe operation of the airplane]. To prevent this condition replacement of existing relay boxes with modified boxes featuring an added acrylic conformal coating should be performed.
Five occurrences on G150 model in last 3 years had been reported.
You may examine the MCAI in the AD docket on the internet at
Gulfstream has issued Service Bulletin 150-24-193, dated March 30, 2018. This service information describes procedures for removing and replacing the upper and lower front relay boxes.
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 the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously.
We estimate that this proposed AD affects 81 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all known costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
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 January 25, 2019.
None.
This AD applies to Gulfstream Aerospace LP (Type Certificate previously held by Israel Aircraft Industries, Ltd.) Model Gulfstream G150 airplanes, certificated in any category, serial numbers 201 through 326 inclusive.
Air Transport Association (ATA) of America Code 24, Electrical power.
This AD was prompted by reports of corrosion in the solder joints of the upper and lower front relay box connectors to the printed circuit board. We are issuing this AD to address corrosion in the front relay box connector solder joints. If not addressed, this condition could cause false crew alerting system (CAS) messages, such as slats unbalance, auto slats fail, and Mach trim fail, which could interfere with continued safe operation of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 36 months after the effective date of this AD, remove the upper front relay box, Israel Aerospace Industries (IAI) part number (P/N) 25G8130301-510/-512/-514/-516, and replace with IAI P/N 25G8130301-516, upgraded to MOD A, and remove the lower front relay box, IAI P/N 25G8130300-512/-516/-518/-520, and replace with an improved lower front relay box, IAI P/N 25G8130300-520, upgraded to MOD A, in accordance with the Accomplishment Instructions of Gulfstream Service Bulletin 150-24-193, dated March 30, 2018.
As of the applicable compliance time specified in paragraph (h)(1) or (h)(2) of this AD, do not install relay box IAI P/N 25G8130301-510/-512/-514/-516 or IAI P/N 25G8130300-512/-516/-518/-520 on any airplane, except relay box IAI P/N 25G8130301-516 or IAI P/N 25G8130300-520 that has been upgraded to MOD A as specified in paragraph (g) of this AD may be installed.
(1) For airplanes that have IAI P/N 25G8130301-510/-512/-514/-516 or IAI P/N 25G8130300-512/-516/-518/-520 installed as of the effective date of this AD: After modification of the airplane as required by this AD.
(2) For airplanes that do not have IAI P/N 25G8130301-510/-512/-514/-516 or IAI P/N 25G8130300-512/-516/-518/-520 installed as of the effective date of this AD: As of the effective date of this AD.
(1) Although Gulfstream Service Bulletin 150-24-193, dated March 30, 2018, specifies returning parts to the manufacturer, this AD does not include that requirement.
(2) Although Gulfstream Service Bulletin 150-24-193, dated March 30, 2018, specifies to submit certain information to the manufacturer, this AD does not include that requirement.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Israeli Airworthiness Directive ISR-I-24-2018-09-7, dated October 1, 2018, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
(3) For service information identified in this AD, contact Gulfstream Aerospace Corporation, P.O. Box 2206, Mail Station D-25, Savannah, GA 31402-2206; telephone 800-810-4853; fax 912-965-3520; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Airbus SAS Model A318 and A319 series airplanes, Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. This proposed AD was prompted by a report that taperloks used in a certain wing-to-fuselage junction were found to be non-compliant with the applicable specification, resulting in a loss of pre-tension in the fasteners. This proposed AD would require repetitive special detailed inspections of the center and outer wing box lower stiffeners and panels at a certain junction on the left- and right-hand sides for any cracking, and repair if necessary. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by January 25, 2019.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For the incorporation by reference (IBR) material described in the “Related IBR material under 1 CFR part 51” section in
You may examine the AD docket on the internet at
Sanjay Ralhan, Aerospace Engineer,
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0218, dated October 11, 2018; corrected October 26, 2018 (“EASA AD 2018-0218”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A318 and A319 series airplanes, Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The MCAI states:
Taperloks used in the wing-to-fuselage junction at Rib 1 were found to be non-compliant with the applicable specification, resulting in a loss of pre-tension in the fasteners.
This condition, if not detected and corrected, could affect the structural integrity of the aeroplane. To address this potential unsafe condition, Airbus issued SB A320-57-1129 and SB A320-57-1130, later revised twice, providing instructions for repetitive internal inspections of the lower stiffeners and for repetitive external inspections of the lower panels of the center and outer wing box at the level of Rib 1 junction. Consequently, EASA issued AD 2007-0067, later revised [which corresponds to FAA AD 2008-02-15, Amendment 39-15345 (73 FR 4063, January 24, 2008) (“AD 2008-02-15”)], to require accomplishment of these inspections.
Since EASA AD 2007-0067R1 was issued, new events and the results of studies identified an aging effect on these parts. Prompted by these findings, Airbus revised SB A320-57-1129 (now at Revision 05) and A320-57-1130 (now at Revision 04), expanding the applicability, modifying the area to be inspected and updating the inspection intervals.
For the reasons stated above, this [EASA] AD retains the requirements of EASA AD 2007-0067R1, which is superseded, expands the Applicability, modifies the areas to be inspected and revises the inspection thresholds and intervals.
This [EASA] AD is republished to correct typographical errors in paragraph (2) and in Tables 1 and 3.
This NPRM would not supersede AD 2008-02-15. Rather, we have determined that a stand-alone AD would be more appropriate to address the changes in the MCAI. This NPRM would require repetitive special detailed inspections of the center and outer wing box lower stiffeners and panels at the level of rib 1 junction on the left- and right-hand sides for any cracking, and repair if necessary. Accomplishment of the proposed actions would then terminate all of the requirements of AD 2008-02-15.
EASA AD 2018-0218 describes procedures for repetitive special detailed inspections of the center and outer wing box lower stiffeners and panels at the level of rib 1 junction on the left- and right-hand sides for any cracking, and repair if necessary. EASA AD 2018-0218 also provides procedures for an optional modification, which would terminate the repetitive inspections. This material 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 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 the same type design.
In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA worked with Airbus and the EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. As a result, EASA AD 2018-0218 will be incorporated by reference in the FAA final rule. This proposed AD would, therefore, require compliance with the provisions specified in EASA AD 2018-0218, except for any differences identified as exceptions in the regulatory text of this proposed AD. Service information specified in EASA AD 2018-0218 that is required for compliance with EASA AD 2018-0218 will be available at
EASA AD 2018-0218, dated October 11, 2018; corrected October 26, 2018; might refer to service information that contains procedures or tests that are identified as RC. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an alternative method of compliance (AMOC), provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition.
We estimate that this proposed AD affects 516 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
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.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
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 January 25, 2019.
This AD affects AD 2008-02-15, Amendment 39-15345 (73 FR 4063, January 24, 2008) (“AD 2008-02-15”).
This AD applies to Airbus SAS Model A318-111, -112, -121, and -122 airplanes, Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes, Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes, certificated in any category, as identified in the European Aviation Safety Agency (EASA) AD 2018-0218, dated October 11, 2018; corrected October 26, 2018 (“EASA AD 2018-0218”).
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by a report that taperloks used in the wing-to-fuselage junction at rib 1 were found to be non-compliant with the applicable specification, resulting in a loss of pre-tension in the fasteners. We are issuing this AD to address the loss of pre-tension in the fasteners, which could affect the structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2018-0218.
(1) For purposes of determining compliance with the requirements of this AD: Where EASA AD 2018-0218 refers to its effective date, this AD requires using the effective date of this AD.
(2) The “Remarks” section of EASA AD 2018-0218 does not apply.
(3) Where EASA AD 2018-0218 refers to instructions provided by Airbus, for this AD, the instructions must be approved using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
Accomplishing the actions required by this AD terminates all requirements of AD 2008-02-15.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) For information about EASA AD 2018-0218, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 89990 6017; email
(2) For more information about this AD, contact Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend VHF Omnidirectional Range (VOR) Federal airways V-128 and V-144 in the vicinity of Kankakee, IL. The modifications are necessary due to the planned decommissioning of the Kankakee, IL (IKK), VOR navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) routes. The Kankakee VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.
Comments must be received on or before January 25, 2019.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1(800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2018-0990; Airspace Docket No. 18-AGL-13 at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Colby Abbott, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the National Airspace System as necessary to preserve the safe and efficient flow of air traffic.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-2018-0990; Airspace Docket No. 18-AGL-13) and be submitted in triplicate to the Docket Management Facility (see
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2018-0990; Airspace Docket No. 18-AGL-13.” The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the
The FAA is planning decommissioning activities for the Kankakee, IL (IKK), VOR in 2019 as one of the candidate VORs identified for discontinuance by the FAA's VOR MON program and listed in the final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum Operational Network),” published in the
With the planned decommissioning of the Kankakee VOR, the remaining ground-based NAVAID coverage in the area is insufficient to enable the continuity of the affected airways. As such, proposed modifications to V-128 and V-144 would result in the airways starting at the next NAVAID beyond the Kankakee VOR to avoid establishing gaps in the route structures. To overcome the loss of the airway segments proposed to be removed, instrument flight rules (IFR) traffic could use adjacent VOR Federal airways V-9, V-24, and V-227 between the Janesville, WI, VOR/DME and the Brickyard, IN, VOR/Tactical Air Navigation (VORTAC) or VOR Federal airways V-38 and V-156 between the Bradford, IL, VORTAC and the Fort Wayne, IN, VORTAC to circumnavigate the affected area. Additionally, IFR traffic could file point to point through the affected area using fixes that will remain in place, or receive air traffic control (ATC) radar vectors through the area. Visual flight rules pilots who elect to navigate via the airways through the affected area could also take advantage of the adjacent VOR Federal airways or ATC services listed previously.
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 to modify VOR Federal airways V-128 and V-144. The planned decommissioning of the Kankakee, IL, VOR has made these actions necessary. The proposed VOR Federal airway changes are outlined below.
All radials in the route descriptions below are unchanged and stated in True degrees.
VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11C dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document would be subsequently published in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
From Brickyard, IN; INT Brickyard 137° and Cincinnati, OH, 290° radials; Cincinnati; York, KY; Charleston, WV; to Casanova, VA.
From Fort Wayne, IN; Appleton, OH; Zanesville, OH; Morgantown, WV; Kessel, WV; to Linden, VA.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend three domestic Very High Frequency Omnidirectional Range (VOR) Federal Airways (V-113, V-137, and V-485) in the western United States. The modifications are necessary due to the planned decommissioning of Priest, CA, VOR navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) routes. The Priest, CA, VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.
Comments must be received on or before January 25, 2019.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2018-0850; Airspace Docket No. 18-AWP-17 at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Kenneth Ready, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the National Airspace System as necessary to preserve the safe and efficient flow of air traffic.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-2018-0850; Airspace Docket No. 18-AWP-17) and be submitted in triplicate to the Docket Management Facility (see
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2018-0850; Airspace Docket No. 18-AWP-17.” The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the
The FAA is planning decommissioning activities for the Priest, CA, VOR in 2019 as one of the candidate VORs identified for discontinuance by the FAA's VOR MON program and listed in the final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum Operational Network),” published in the
With the planned decommissioning of the Priest VOR, the remaining ground-based NAVAID coverage in the area is insufficient to enable the continuity of the affected airways. As such, proposed modifications to V-113, V-137, and V-485 would result in gaps in the route structures.
To overcome the gap in V-113, instrument flight rules (IFR) traffic could use adjacent VOR Federal airways V-248 and V-107 between the Paso Robles, CA, VORTAC and the Panoche, CA, VORTAC.
V-137 is proposed to terminate at the Avenal, CA, VOR/DME instead of the Salinas, CA, VORTAC (current route termination point). Alternate course to reach the Salinas, CA, VORTAC is to file V-248.
V- 485 is proposed to terminate at the Fellows, CA, VOR/DME instead of the San Jose, CA, VOR/DME (current route termination point). Alternate course to reach San Jose, CA, VOR/DME is to file V-25. Additionally, ATS route T-333 is proposed to be extended as part of another rulemaking action that will mitigate the loss of V-485.
Lastly, IFR traffic could file point to point through the affected area using fixes that will remain in place, or receive air traffic control (ATC) radar vectors through the area. Visual flight rules pilots who elect to navigate via the airways through the affected area could also take advantage of the adjacent VOR Federal airways or ATC services listed previously.
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 to modify Domestic VOR Federal Airways (V-113, V-137 and V-485). The proposed route changes are outlined below.
Domestic VOR Federal Airways in paragraph 6010 of FAA Order 7400.11C dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Domestic VOR Federal Airways listed in this document will be subsequently published in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
From Morro Bay, CA; to Paso Robles, CA. From Panoche, CA; to Linden, CA; INT Linden 046°(T) 029°(M) and Mustang, NV, 208°(T) 192°(M) radials; Mustang; 42 miles, 24 miles, 115 MSL, 95 MSL, Sod House, NV; 67 miles, 95 MSL, 85 MSL, Rome, OR; 61 miles, 85 MSL, Boise, ID; Salmon, ID; Coppertown, MT; Helena, MT; to Lewistown, MT.
From Mexicali, Mexico; via Imperial, CA; INT Imperial 350°(T) 336°(M) and Thermal, CA 144°(T) 131°(M) radials; Palm Springs, CA; Palmdale, CA; Gorman, CA; Avenal, CA. The airspace within Mexico is excluded.
From Ventura, CA; to Fellows, CA. The airspace within W-289 and R-2519 more than three (3) statute miles west of the airway centerline and the airspace within R-2519 below 5,000 feet MSL is excluded.
Federal Trade Commission.
Request for public comment.
The Federal Trade Commission (“FTC” or “Commission”) requests public comment on its Identity Theft Rules. The Commission is soliciting comment as part of the FTC's systematic review of all current Commission regulations and guides.
Comments must be received on or before February 11, 2019.
Interested parties may file a comment online or on paper by:
•
•
See the Instructions for Submitting Comments part of the
Stacy Procter, Western Region—Los Angeles Office, Bureau of Consumer Protection, Federal Trade Commission, 10990 Wilshire Blvd., Suite 400, Los Angeles, CA 90024, (310) 824-4300, or Amanda Koulousias, Division of Privacy and Identity Protection, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580, (202) 326-3334.
The Fair and Accurate Credit Transactions Act (“FACTA”) was enacted in December 2003.
In November 2007, the Commission and banking agencies published final rules and guidelines implementing the red flags provisions of section 615 of the FCRA.
The Red Flags Rule requires each “financial institution” and “creditor” subject to the Commission's enforcement authority to periodically determine whether it maintains “covered accounts,” and to develop and maintain a written Identity Theft Prevention Program (“Program”) to detect, prevent and mitigate identity theft in connection with the opening or existence of any “covered account.”
The Commission periodically reviews all of its rules and guides. These reviews seek information about the costs and benefits of the agency's rules and guides, and their regulatory and economic impact. The information obtained assists the Commission in identifying those rules and guides that warrant modification or rescission. Therefore, the Commission solicits comments on, among other things, the economic impact and benefits of the Identity Theft Rules; possible conflict between the Identity Theft Rules and state, local, or other federal laws or regulations; and the effect on the Identity Theft Rules of any technological, economic, or other industry changes.
The Commission requests written comment on any or all of the following questions. These questions are designed to assist the public and should not be construed as a limitation on the issues about which public comments may be submitted. The Commission requests that responses to its questions be as specific as possible, including a reference to the question being answered, and refer to empirical data or other evidence upon which the comment is based whenever available and appropriate.
1. Is there a continuing need for specific provisions of the Rules? Why or why not?
2. What benefits have the Rules provided to consumers? What evidence supports the asserted benefits?
3. What modifications, if any, should be made to the Rules to increase the benefits to consumers?
a. What evidence supports the proposed modifications?
b. How would these modifications affect the costs the Rules impose on businesses, including small businesses?
4. What significant costs, if any, have the Rules imposed on consumers? What evidence supports the asserted costs?
5. What modifications, if any, should be made to the Rules to reduce any costs imposed on consumers?
a. What evidence supports the proposed modifications?
b. How would these modifications affect the benefits provided by the Rules?
6. What benefits, if any, have the Rules provided to businesses, including small businesses? What evidence supports the asserted benefits?
7. What modifications, if any, should be made to the Rules to increase their benefits to businesses, including small businesses?
a. What evidence supports the proposed modifications?
b. How would these modifications affect the costs the Rules impose on businesses, including small businesses?
c. How would these modifications affect the benefits to consumers?
8. What significant costs, if any, including costs of compliance, have the Rules imposed on businesses, including small businesses? What evidence supports the asserted costs?
9. What modifications, if any, should be made to the Rules to reduce the costs imposed on businesses, including small businesses?
a. What evidence supports the proposed modifications?
b. How would these modifications affect the benefits provided by the Rules?
10. What evidence is available concerning the degree of industry compliance with the Rules?
11. What modifications, if any, should be made to the Rules to account for changes in relevant technology or economic conditions? What evidence supports the proposed modifications?
12. Do the Rules overlap or conflict with other federal, state, or local laws or regulations? If so, how?
a. What evidence supports the asserted conflicts?
b. With reference to the asserted conflicts, should the Rules be modified? If so, why, and how? If not, why not?
1. Do the guidelines in appendix A of the Red Flags Rule need updating? If so, what updates should be made?
a. What evidence supports the proposed modification?
b. [Reserved]
2. The Red Flags Rule covers creditors that regularly and in the ordinary course of business: (1) Obtain or use consumer reports in connection with a credit transaction; (2) furnish information to consumer reporting agencies in connection with a credit transaction; or (3) advance funds to or on behalf of a person, based on an obligation of the person to repay the funds or repayable from specific property pledged by or on behalf of the person, unless the expenses for which the funds are advanced are incidental to a service the creditor provides to that person. Is there any other type of creditor that is not subject to the Red Flags Rule that offers or maintains accounts that are subject to a reasonably foreseeable risk of identity theft?
a. If so, what type of creditor and what evidence supports that conclusion?
b. [Reserved]
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before February 11, 2019. Write “Identity Theft Rules, 16 CFR part 681, Project No. 188402” on the 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 website, at
In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you must follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comments to be withheld from the public record. Your comment will be kept confidential only if the FTC General Counsel 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 comment online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Identity Theft Rules, 16 CFR part 681, Project No. 188402” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B), 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 B), Washington, DC 20024.
Visit the Commission website at
By direction of the Commission.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve assorted revisions to Ohio's particulate matter rules that the state requested EPA approve into the Ohio State Implementation Plan (SIP) under the Clean Air Act. One set of revisions address sources subject to a requirement for continuous opacity monitoring for which such monitoring is unreliable. The revisions add two alternatives; one alternative requires the source to conduct continuous emission monitoring, and the other alternative subjects the source to an alternative monitoring plan assessing compliance with limits specified for alternative parameters. Other revisions in the rule remove provisions for facilities that have shut down and make nonsubstantive revisions to the language of the rules.
Comments must be received on or before January 10, 2019.
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2018-0384 at
John Summerhays, Environmental Scientist, Attainment Planning and Maintenance, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6067,
This supplementary information section is arranged as follows:
The Ohio Environmental Protection Agency (Ohio
As a result of its review, Ohio concluded that rule revisions were needed to address facilities subject to requirements for continuous opacity monitoring for which such monitoring does not provide reliable determinations of opacity. This concern especially applies to power plants that have installed wet flue gas desulfurization equipment. While power plants are generally required under OAC 3745-17-03(C) to implement continuous opacity monitoring, in accordance with requirements in Title 40 Code of Federal Regulations part 51, appendix P (40 CFR part 51, appendix P), plants with wet flue gas desulfurization equipment in some cases have water vapor in the flue gas that can render continuous opacity measurements unreliable.
To address this concern, Ohio revised its rules to offer two alternatives for plants subject to requirements for continuous opacity monitoring for which such monitoring is unreliable. The first alternative is to conduct continuous emissions monitoring. The second alternative is to conduct monitoring of operational parameters that are identified as suitable for determining compliance with particulate emission limitations. Further description of these alternatives and the requirements that Ohio adopted in association with these requirements are described in the following section.
Ohio's June 1, 2018 submittal only requested approval of the second of these alternatives. However, on August 9, 2018, Ohio revised its request to ask that EPA approve both alternatives. Accordingly, this rulemaking addresses both alternatives.
A second set of revisions Ohio made to its rules was to clarify that appliances for residential wood combustion are not subject to the limitations in Ohio's particulate matter regulations. A third set of revisions removed provisions that are no longer necessary because the affected facility has shut down. A final set of revisions modified the wording of selected text to reflect new semantic preferences.
Previous revisions to the rules in OAC Chapter 3745-17 provided a category of power plants operating continuous opacity monitoring systems the option to demonstrate compliance with an alternate set of opacity limits. Ohio requested approval of those revisions on June 4, 2003, but EPA proposed to disapprove those revisions on June 27, 2005, at 70 FR 36901. Subsequently, on September 5, 2014, Ohio withdrew its submittal of these revisions. While these provisions remain part of OAC 3745-17-03, Ohio's June 1, 2018 submittal clarifies that the state is not requesting EPA action on these provisions.
As noted above, the existing Ohio SIP includes provisions that, in accordance with 40 CFR part 51, appendix P, facilities meeting the criteria of appendix P, notably including most power plants, must operate continuous opacity monitoring systems. However, the installation of wet flue gas desulfurization control equipment on power plants commonly increases the quantity of water vapor within the stack, which in some cases has rendered the continuous opacity monitoring unreliable. This problem has led to consideration of alternative approaches for providing continuous monitoring of whether particulate matter emission controls are operating properly.
Limits on opacity complement limits on particulate mass emissions in assuring that the particulate matter emission controls that are part of the plan for attaining particulate matter air quality standards are operating properly. Stack tests provide a more direct measure of the quantitative efficiency of the control of particulate matter mass, at least with respect to filterable particulate matter (since most limits and therefore most stack tests do not measure condensable particulate matter). On the other hand, opacity observations generally provide a more convenient and less costly measure of particulate matter control, which when done by human observers (in accordance with Method 9) are designed to address condensable as well as filterable particulate matter. Opacity monitoring can also readily be conducted continuously using in-stack monitoring equipment. Therefore, EPA promulgated appendix P to provide for continuous opacity monitoring, most notably for power plants, to provide more continuous evidence as to whether the affected sources are controlling their particulate matter emissions appropriately. The primary criterion of this rulemaking, then, is whether any alternative monitoring that becomes authorized under this rule for any facility provides an appropriate continuous assessment of the effectiveness of particulate matter emission control that is comparable to the continuous assessment that EPA sought to achieve by promulgating appendix P.
The first alternative that Ohio incorporated into OAC 3745-17-03 was continuous monitoring of the mass of particulate emissions. As specified in OAC 3745-17-03(D), such monitoring is to be conducted in accordance with EPA's Performance Specification 11, as given in 40 CFR part 60, appendix B. Facilities seeking to use this alternative in lieu of continuous opacity monitoring must request permission from Ohio and from EPA. Facilities authorized to use this alternative must comply with a limit of 0.03 pounds of particulate matter per million British Thermal Units (lbs/MMBTU) on a 24-hour average basis (based on an average of all hourly average emission rates over a calendar day period) as well as any other limit in OAC Chapter 3745-17 to which the facility is subject. OAC 3745-17-03(D) authorizes changes in routine monitoring of pertinent sources but does not relax any limits to which an affected source is subject. Notably, opacity in excess of the 20 percent limit in the SIP that is observed through Method 9 remains a violation of the SIP, in a manner that is unaffected by OAC 3745-17-03(D) or its prospective usage in specific cases. Thus, for example, cases involving substantial emissions of condensable particulate matter sufficient to cause violation of the 20 percent opacity limit would still be grounds for enforcement action, independent of whether any filterable particulate matter emission measurements have been made.
Continuous emissions monitoring by its nature provides continuous information on how well the source is controlling particulate matter emissions as continuous opacity monitoring. Given the mass and opacity limits that apply, EPA believes that the two approaches provide comparable measures of how well the source is controlling particulate matter emissions. OAC 3745-17-03(D) provides that Ohio and EPA will review the situation for each facility on a case-by-case basis to assure that use of continuous emission monitoring in lieu of continuous opacity monitoring is warranted. For these reasons, EPA believes that OAC 3745-17-03(D) provides a suitable alternative means for facilities in appropriate cases to assess the adequacy of particulate matter emission control in lieu of continuous opacity monitoring.
The second alternative to continuous opacity monitoring provided in OAC 3745-17-03 is the continuous monitoring of operational parameters. For example, in selected cases, EPA accepts baghouse leak detection systems as a suitable alternative to continuous opacity monitoring. Under OAC 3745-17-03(E), facilities seeking to conduct parameter monitoring in lieu of continuous opacity monitoring must submit a request that includes a proposed monitoring plan. This plan must specify the parameters to be monitored, the parameters must be indicative of whether the facility is complying with the applicable mass and opacity limitations to which the facility is subject, and the plan must specify the acceptable range of values of the parameters that are to be required to be met. OAC 3745-17-03(E) states that parameter values outside the range specified as indicative of compliance shall constitute a federally enforceable violation of facility control requirements. Upon approval by Ohio and EPA, the facility is then subject to this monitoring plan in lieu of being required to conduct continuous opacity monitoring.
As with OAC 3745-17-03(D), OAC 3745-17-03(E) does not relax any limits to which the source is subject. For example, observations using Method 9 indicating a violation of the 20 percent opacity limit in the SIP would remain grounds by which a source with excessive particulate matter emissions (whether filterable particulate matter or condensable particulate matter or both) could be identified and subject to enforcement action as violating opacity limits. In a limited number of cases, the monitoring of the operations of a facility and its control equipment (
As summarized above, Ohio's revisions to OAC Chapter 3745-17, besides the addition of alternatives to continuous opacity monitoring discussed in the previous section, include clarification that OAC Chapter 3745-17 rules do not regulate residential wood combustion, removal of provisions that pertain to facilities that have shut down, and modification of wording for phrases that Ohio wishes to rephrase.
Chapter 3745-17 includes 11 rules, extending from 3745-17-01 to 3745-17-14 but not including adopted but now rescinded rules numbered 3745-17-02, 3745-17-05, or 3745-17-06.
Rule 3745-17-02, entitled “Air Quality Standards,” was previously moved to OAC Chapter 3745-25 for consolidation with air quality standards for other pollutants. EPA approved the moved rule, in OAC 3745-25-02, in an action published on October 26, 2010, at 75 FR 65572, but EPA did not approve the rescission of OAC 3745-17-02. Therefore, EPA is proposing to approve the rescission of OAC 3745-17-02 as part of this action. OAC 3745-17-05 and 3745-17-06 have already been rescinded from the SIP.
The following discussion reviews each rule's revisions individually.
While Ohio requested approval of most of OAC 3745-17-03, Ohio expressly excluded two elements of OAC 3745-17-03 from this request. One of these elements, in OAC 3745-17-03(B)(1)(b), offers an alternate opacity limit (in brief, authorizing 1.1 percent of nonexempt 6-minute opacity values to exceed 20 percent opacity) for power plants operating continuous opacity monitoring systems. The second, associated element is the phrase in OAC 3745-17-03(B)(1)(a) stating “Except as provided in paragraph (B)(1)(b) of this rule”. These are provisions that Ohio submitted on June 4, 2003, that EPA proposed to disapprove on June 27, 2005, and that Ohio withdrew from consideration on September 5, 2014. Accordingly, EPA is proposing to act on most of OAC 3745-17-03, notably including paragraphs 3745-17-03(D) and (E), but EPA is proposing not to act on subparagraph 3745-17-03(B)(1)(b) and the specified phrase in 3745-17-03(B)(1)(a).
Revised OAC 3745-17-03 modifies the reference method for measuring opacity, which previously only identified Method 9 (in 40 CFR 60 appendix A), to include “USEPA method 9 or continuous opacity monitoring as specified in paragraph (C) of this rule.” These two methods make different measurements, notably insofar as Method 9 involves human observations which consider the effect of condensable particulate matter (
Revised OAC 3745-17-03 also contains a small number of editorial revisions, for example converting singular/plural constructions to the plural (
Ohio also removed source-specific opacity limits for sources that have shut down, and Ohio made editorial revisions similar to those discussed above. These revisions are approvable.
EPA is proposing to approve the rules in OAC 3745-17 that Ohio requested be approved. A full listing of the rules that EPA is proposing to approve is provided in Table 1. EPA is proposing to approve the entirety of all of these rules except for OAC 3745-17-03, for which Ohio's request excluded specified sections. In addition, EPA is proposing to remove OAC 3745-17-02, which Ohio has rescinded and the substance of which has been recodified (and approved into the SIP) within OAC 3745-25-02.
In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference the Ohio particulate matter rules discussed in section IV. “What Action is EPA Taking?” of this preamble. EPA has made, and will continue to make, these documents generally available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.
U.S. Commission on Civil Rights.
Notice of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Tennessee Advisory Committee will hold a public hearing to hear testimony on the civil rights issues related to legal financial obligations in Tennessee.
Tuesday, January 8, 2019 from 09:45 a.m.-4:30 p.m.
Nashville Public Library, 615 Church Street, Nashville, Tennessee 37219
Jeff Hinton, GFO, at
Members of the public are invited to come in and listen to the discussion. Written comments will be accepted until February 8, 2019 and may be mailed to the Regional Program Unit Office, U.S. Commission on Civil Rights, 230 S Dearborn, Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324 or may be emailed to Jeff Hinton at
First Responder Network Authority (FirstNet), National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice of public meeting of the First Responder Network Authority Board.
The Board of the First Responder Network Authority (Board) will convene an open public meeting of the Board and the Board Committees on December 13, 2018.
A joint meeting of the four FirstNet Board Committees and the FirstNet Board will be held on December 13, 2018, between 11:00 a.m. and 2:30 p.m. (ET). The meeting of the FirstNet Board and the Governance and Personnel, Technology, Consultation and Outreach, and Finance Committees will be open to the public from 11:00 a.m. to 2:30 p.m. (ET).
The meeting on December 13, 2018 will be held at the Hyatt Regency Tysons Corner Center, 7901 Tysons One Place, McLean, VA 22102. Members of the public may listen to the meeting by dialing toll free 1-888-469-2980 and entering participant code 4810197#.
Karen Miller-Kuwana, Board Secretary, FirstNet, 12201 Sunrise Valley Drive, M/S 243, Reston, VA 20192; telephone: (571) 665-6177; email:
This notice informs the public that the FirstNet Board and the Board Committees will convene an open public meeting on December 13, 2018.
The Combined Committee and Board Meetings are accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Ms. Miller-Kuwana by telephone (571) 665-6177 or email at
The meeting will also be webcast. Please refer to FirstNet's website at
An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Eastern Distribution Center, Inc., grantee of FTZ 24, requesting subzone status for the facility of adidas America, Inc., located in Wilkes-Barre, Pennsylvania. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on December 4, 2018.
The proposed subzone (89.39 acres) is located at 550 New Commerce Blvd., Wilkes-Barre. No authorization for production activity has been requested at this time. The proposed subzone would be subject to the existing activation limit of FTZ 24.
In accordance with the Board's regulations, Elizabeth Whiteman of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is January 22, 2019. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to February 4, 2019.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Elizabeth Whiteman at
On August 6, 2018, Generac Power Systems, Inc. (Generac) submitted a notification of proposed production activity to the FTZ Board for its facilities within Subzone 41J, in Jefferson and Whitewater, Wisconsin.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
Bureau of Industry and Security, Commerce.
Notice of inquiry.
The Bureau of Industry and Security (BIS) is seeking public comments on the impact that implementation of the Chemical
Comments must be received by January 10, 2019.
You may submit comments by any of the following methods (please refer to RIN 0694-XC051 in all comments and in the subject line of email comments):
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• By mail or delivery to Regulatory Policy Division, Bureau of Industry and Security, U.S. Department of Commerce, Room 2099B, 14th Street and Pennsylvania Avenue NW, Washington, DC 20230.
For questions on the Chemical Weapons Convention requirements for “Schedule 1” chemicals, contact Douglas Brown, Treaty Compliance Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, U.S. Department of Commerce, Phone: (202) 482-2163. For questions on the submission of comments, contact Willard Fisher, Regulatory Policy Division, Office of Exporter Services, Bureau of Industry and Security, U.S. Department of Commerce, Phone: (202) 482-2440.
In providing its advice and consent to the ratification of the Convention on the Prohibition of the Development, Production, Stockpiling, and Use of Chemical Weapons and Their Destruction, commonly called the Chemical Weapons Convention (CWC or “the Convention”), the Senate included, in Senate Resolution 75 (S. Res. 75, April 24, 1997), several conditions to its ratification. Condition 9, titled “Protection of Advanced Biotechnology,” calls for the President to certify to Congress on an annual basis that “the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms in the United States are not being significantly harmed by the limitations of the Convention on access to, and production of, those chemicals and toxins listed in Schedule 1.” On July 8, 2004, President Bush, by Executive Order 13346, delegated his authority to make the annual certification to the Secretary of Commerce.
The CWC is an international arms control treaty that contains certain verification provisions. In order to implement these verification provisions, the CWC established the Organization for the Prohibition of Chemical Weapons (OPCW). The CWC imposes certain obligations on countries that have ratified the Convention (
“Schedule 1” chemicals consist of those toxic chemicals and precursors set forth in the CWC “Annex on Chemicals” and in “Supplement No. 1 to part 712—SCHEDULE 1 CHEMICALS” of the Chemical Weapons Convention Regulations (CWCR) (15 CFR parts 710-722). The CWC identified these toxic chemicals and precursors as posing a high risk to the object and purpose of the Convention.
The CWC (Part VI of the “Verification Annex”) restricts the production of “Schedule 1” chemicals for protective purposes to two facilities per State Party: A single small-scale facility (SSSF) and a facility for production in quantities not exceeding 10 kg per year. The CWC Article-by-Article Analysis submitted to the Senate in Treaty Doc. 103-21 defined the term “protective purposes” to mean “used for determining the adequacy of defense equipment and measures.” Consistent with this definition and as authorized by Presidential Decision Directive (PDD) 70 (December 17, 1999), which specifies agency and departmental responsibilities as part of the U.S. implementation of the CWC, the Department of Defense (DOD) was assigned the responsibility to operate these two facilities. Although this assignment of responsibility to DOD under PDD-70 effectively precluded commercial production of “Schedule 1” chemicals for protective purposes in the United States, it did not establish any limitations on “Schedule 1” chemical activities that are not prohibited by the CWC. However, DOD does maintain strict controls on “Schedule 1” chemicals produced at its facilities in order to ensure accountability for such chemicals, as well as their proper use, consistent with the object and purpose of the Convention.
The provisions of the CWC that affect commercial activities involving “Schedule 1” chemicals are implemented in the CWCR (see 15 CFR 712) and in the Export Administration Regulations (EAR) (see 15 CFR 742.18 and 15 CFR 745), both of which are administered by the Bureau of Industry and Security (BIS). Pursuant to CWC requirements, the CWCR restrict commercial production of “Schedule 1” chemicals to research, medical, or pharmaceutical purposes. The CWCR prohibit commercial production of “Schedule 1” chemicals for “protective purposes” because such production is effectively precluded per PDD-70, as described above—see 15 CFR 712.2(a). The CWCR also contain other requirements and prohibitions that apply to “Schedule 1” chemicals and/or “Schedule 1” facilities. Specifically, the CWCR:
(1) Prohibit the import of “Schedule 1” chemicals from States not Party to the Convention (15 CFR 712.2(b));
(2) Require annual declarations by certain facilities engaged in the production of “Schedule 1” chemicals in excess of 100 grams aggregate per calendar year (
(3) Provide for government approval of “declared Schedule 1” facilities (15 CFR 712.5(f));
(4) Provide that “declared Schedule 1” facilities are subject to initial and routine inspection by the OPCW (15 CFR 712.5(e) and 716.1(b)(1));
(5) Require 200 days advance notification of establishment of new “Schedule 1” production facilities producing greater than 100 grams aggregate of “Schedule 1” chemicals per calendar year (15 CFR 712.4);
(6) Require advance notification and annual reporting of all imports and exports of “Schedule 1” chemicals to, or from, other States Parties to the Convention (15 CFR 712.6, 742.18(a)(1) and 745.1); and
(7) Prohibit the export of “Schedule 1” chemicals to States not Party to the Convention (15 CFR 742.18(a)(1) and (b)(1)(ii)).
For purposes of the CWCR (see 15 CFR 710.1), “production of a Schedule 1 chemical” means the formation of “Schedule 1” chemicals through chemical synthesis, as well as processing to extract and isolate “Schedule 1” chemicals produced by a biochemical or biologically mediated reaction. Such production is understood, for CWCR declaration purposes, to include intermediates, by-products, or waste products that are produced and consumed within a defined chemical manufacturing sequence, where such intermediates, by-products, or waste products are chemically stable and therefore exist for a sufficient time to make isolation from the manufacturing stream possible, but where, under normal or design operating conditions, isolation does not occur.
In order to assist in determining whether the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms in the United States are significantly harmed by the limitations of the Convention on access to, and production of, “Schedule 1” chemicals as described in this notice, BIS is seeking public comments on any effects that implementation of the CWC, through the Chemical Weapons Convention Implementation Act and the CWCR, has had on commercial activities involving “Schedule 1” chemicals during calendar year 2018. To allow BIS to properly evaluate the significance of any harm to commercial activities involving “Schedule 1” chemicals, public comments submitted in response to this notice of inquiry should include both a quantitative and qualitative assessment of the impact of the CWC on such activities.
All comments must be submitted to one of the addresses indicated in this notice. The Department requires that all comments be submitted in written form. BIS will consider all comments received on or before January 10, 2019. All comments (including any personally identifying information or information for which a claim of confidentially is asserted either in those comments or their transmittal emails) will be made available for public inspection and copying. Parties who wish to comment anonymously may do so by submitting their comments via
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with October anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.
Applicable December 11, 2018.
Brenda E. Brown, Office of AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-4735.
Commerce has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping and countervailing duty orders and findings with October anniversary dates.
All deadlines for the submission of various types of information, certifications, or comments or actions by Commerce discussed below refer to the number of calendar days from the applicable starting time.
If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (POR), it must notify Commerce within 30 days of publication of this notice in the
In the event Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review. We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 30 days of publication of the initiation
In the event Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:
In general, Commerce has found that determinations concerning whether particular companies should be “collapsed” (
Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.
Section 504 of the Trade Preferences Extension Act of 2015 amended the Act by adding the concept of particular market situation (PMS) for purposes of constructed value under section 773(e) of the Act.
Neither section 773(e) of the Act nor 19 CFR 351.301(c)(v) set a deadline for the submission of PMS allegations and supporting factual information. However, in order to administer section 773(e) of the Act, Commerce must receive PMS allegations and supporting factual information with enough time to consider the submission. Thus, should an interested party wish to submit a PMS allegation and supporting new factual information pursuant to section 773(e) of the Act, it must do so no later than 20 days after submission of initial responses to section D of the questionnaire.
In proceedings involving non-market economy (NME) countries, Commerce begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is Commerce's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.
To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, Commerce analyzes each entity exporting the subject merchandise. In accordance with the separate rates criteria, Commerce assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both
All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification, as described below. For these administrative reviews, in order to demonstrate separate rate eligibility, Commerce requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on Commerce's website at
Entities that currently do not have a separate rate from a completed segment of the proceeding
For exporters and producers who submit a separate-rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.
In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than October 31, 2019.
During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.
For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period, of the order, if such a gap period is applicable to the POR.
Interested parties must submit applications for disclosure under administrative protective orders in accordance with the procedures outlined in Commerce's regulations at 19 CFR 351.305. Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures (
Commerce's regulations identify five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). These regulations require any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being
Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness of that information.
Parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by the Secretary.
These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that the producers/exporters subject to this review made sales of circular welded non-alloy steel pipe (CWP) from the Republic of Korea (Korea) at less than normal value during the period of review (POR) November 1, 2016, through October 31, 2017. Interested parties are invited to comment on these preliminary results.
Applicable December 11, 2018.
Mark Kennedy or Peter Zukowski, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-7883 or (202) 482-0189, respectively.
The merchandise subject to the order is circular welded non-alloy steel pipe and tube. Imports of the product are currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 7306.30.1000, 7306.30.5025, 7306.30.5032, 7306.30.5040, 7306.30.5055, 7306.30.5085, and 7306.30.5090. While the HTSUS subheadings are provided for convenience and customs purposes, the written description is dispositive. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.
Commerce conducted this review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act). Constructed export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.
For a full description of the methodology underlying our conclusions,
We preliminarily determine that the following weighted-average dumping
We intend to disclose the calculations performed for these preliminary results to the parties within five days after public announcement of the preliminary results in accordance with 19 CFR 351.224(b). Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically
If a respondent's weighted-average dumping margin is above
For entries of subject merchandise during the POR produced by Husteel Co., Ltd. or Hyundai Steel Company for which they did not know their merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.
For the 23 companies which were not selected for individual examination, we will instruct CBP to apply the rates listed above to all entries of subject merchandise produced and/or exported by these firms.
We intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review.
The following deposit requirements will be effective upon publication of the notice of final results of this review for all shipments of CWP from Korea entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for companies subject to this review will be the rates established in the final results of the review; (2) for merchandise exported by producers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation but the producer is, the cash deposit rate will be the rate established for the most recent period for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 4.80 percent,
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
Commerce is issuing and publishing these results in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily finds that circular welded carbon-quality steel pipe (CWP) from the Sultanate of Oman (Oman) has been sold in the United States at prices below normal value (NV) during the period of review (POR), June 8, 2016, through November 30, 2017. We invite interested parties to comment on these preliminary results.
Applicable December 11, 2018.
Dennis McClure or Robert Palmer, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-5973 or (202) 482-9068, respectively.
On February 23, 2018, Commerce initiated the antidumping duty administrative review on circular welded carbon-quality steel pipe from the Sultanate of Oman.
The merchandise subject to the Order
Commerce is conducting this review in accordance with section 751(a)(1)(B) and (a)(2) of the Tariff Act of 1930, as amended (the Act). Export price was calculated in accordance with section 772 of the Act. NV was calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions,
We preliminarily determine that, for the period of June 8, 2016, through November 30, 2017, the following weighted-average dumping margin exists:
We intend to disclose the calculations performed for these preliminary results of review to interested parties within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs to Commerce no later than 30 days after the date of publication of this notice.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically-filed document must be received successfully in its entirety by ACCESS by 5 p.m. Eastern Standard Time within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; (3) whether any participant is a foreign national; and (4) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of
We intend to issue the final results of this administrative review, including the results of its analysis of issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless the deadline is extended.
Upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
Pursuant to 19 CFR 351.212(b)(1), as Al Jazeera reported the entered value for its U.S. sales, we calculated importer-specific
The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable.
In accordance with our “automatic assessment” practice, for entries of subject merchandise during the POR produced by Al Jazeera for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate.
We intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review.
The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Al Jazeera will be the rate established in the final results of this review; (2) for previously reviewed or investigated companies not participating in this review, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment of this proceeding in which the company was reviewed; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair value (LTFV) investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently-completed segment of this proceeding for the manufacturer of subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 7.36 percent, the all-others rate established in the LTFV investigation.
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
Notification To Interested Parties
The preliminary results of review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that Grupo Simec made sales of subject merchandise at less than normal value during the November 1, 2016, through October 31, 2017, period of review (POR), and Deacero S.A.P.I de C.V. (Deacero) did not. We invite interested parties to comment on these preliminary results.
Applicable December 11, 2018.
Stephanie Moore (Deacero) or Patricia Tran (Grupo Simec), AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington DC 20230; telephone (202) 482-3692 or (202) 482-1503, respectively.
On January 11, 2018, pursuant to section 751(a)(1) of the Tariff Act of 1930, as amended (the Act), Commerce initiated an administrative review of the antidumping duty order on steel concrete reinforcing bar (rebar) from Mexico.
On March 13, 2018, we selected Deacero and Grupo Simec as mandatory respondents.
Imports covered by the order are shipments of steel concrete reinforcing bar imported in either straight length or coil form (rebar) regardless of metallurgy, length, diameter, or grade. The merchandise subject to review is currently classifiable under items 7213.10.0000, 7214.20.0000, and 7228.30.8010. The subject merchandise may also enter under other Harmonized Tariff Schedule of the United States (HTSUS) numbers including 7215.90.1000, 7215.90.5000, 7221.00.0017, 7221.00.0018, 7221.00.0030, 7221.00.0045, 7222.11.0001, 7222.11.0057, 7222.11.0059, 7222.30.0001, 7227.20.0080, 7227.90.6085, 7228.20.1000, and 7228.60.6000. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.
Commerce is conducting this review in accordance with section 751(a)(2) of the Act. Export and constructed export price were calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our preliminary results,
As a result of this review, we calculated a weighted-average dumping margin of 3.70 percent for Grupo Simec and a de minimis margin for Deacero for the period November 1, 2016 through October 31, 2017. Therefore, in accordance with section 735(c)(5)(A) of the Act, we assigned the weighted-average dumping margin of 3.70 percent calculated for Grupo Simec to the nine non-selected companies in these preliminary results, as referenced below.
Upon issuance of the final results, Commerce shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review. If the weighted-average dumping margin for Deacero or Grupo Simec is not zero or
In accordance with Commerce's assessment practice, for entries of subject merchandise during the POR produced by each respondent for which it did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.
We intend to issue instructions to CBP 15 days after publication of the final results of this review.
The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for respondents noted above will be the rate established in the final results of this administrative review, except if the rate is less than 0.50 percent and, therefore,
We intend to disclose the calculations performed in these preliminary results to parties in this proceeding within five days of the date of publication of this notice.
Pursuant to 19 CFR 351.309(c)(ii), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than five days after the date for filing case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
We intend to issue the final results of this administrative review, including the results of our analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act.
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and increase the subsequent assessment of the antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that Nan Ya Plastics Corporation (Nan Ya) did not sell subject merchandise at less than normal value during the POR, July 1, 2016 through June 30, 2017.
Applicable December 11, 2018.
Jacqueline Arrowsmith, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5255.
On August 10, 2018, Commerce published the preliminary results for this administrative review.
The products covered by the antidumping duty order are all gauges of raw, pretreated, or primed polyethylene terephthalate film, sheet, and strip (PET film), whether extruded or coextruded. Excluded are metalized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer of more than 0.00001 inches thick. Imports of PET film are currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under item number 3920.62.00.90. HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of the antidumping duty order is dispositive.
Based on our analysis of U.S. Customs and Border Protection (CBP) information and information provided by Shinkong Materials Technology Corporation (SMTC) and its affiliate Shinkong Synthetic Fibers Corporation (SSFC), we determine that SMTC had no shipments of the subject merchandise during the POR.
As there are no changes from, or comments upon, the
Commerce determines that the weighted-average dumping margin exists for the period July 1, 2016, through June 30, 2017:
Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries in this review, in accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1). Commerce intends to issue assessment instructions directly to CBP 15 days after publication of these final results of review. Because we calculated a zero margin in the final results of this review for Nan Ya, in accordance with 19 CFR 351.212, we will instruct CBP to liquidate the appropriate entries without regard to dumping duties.
In accordance with Commerce's practice, for entries of subject merchandise during the POR that SMTC or its affiliate, SSFC, did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate such entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Nan Ya will be 0.00 percent, the rate established in the final results of this review; (2) for previously reviewed or investigated companies not covered in this review, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this or any previous review or in the original less-than-fair-value (LTFV) investigation but the manufacturer is, the cash-deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) if neither the exporter nor the manufacturer is a firm covered in this or any previous review or the investigation, the cash-deposit rate will continue to be the all-others rate of 2.40 percent, which is the all-others rate established by Commerce in the LTFV investigation.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that PT. Cheil Jedang Indonesia (CJ Indonesia), the sole respondent in this administrative review, made sales of subject merchandise in the United States at prices below normal value during the period of review covering November 1, 2016, through October 31, 2017 (POR). Commerce is also rescinding the administrative review with respect to PT. Miwon Indonesia (Miwon). We invite interested parties to comment on these preliminary results.
Applicable December 11, 2018.
Gene H. Calvert, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3586.
On January 11, 2018, based on requests from interested parties, Commerce initiated the administrative review on monosodium glutamate (MSG) from the Republic of Indonesia (Indonesia) covering Miwon and CJ Indonesia.
The product covered by this review is MSG from Indonesia. A complete description of the scope of the order can be found in the Preliminary Decision Memorandum.
Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review. The notice initiating the instant administrative review was published on January 11, 2018. On April 4, 2018, Daesang America, Inc. (Daesang), a U.S. importer of MSG from Indonesia, timely withdrew its request for an administrative review with respect to Miwon.
Commerce is conducting this administrative review in accordance with sections 751(a)(1)(B) and (2) of the Act. Export price and constructed export price are calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. A full description of the methodology underlying these preliminary results can be found in the Preliminary Determination Memorandum. A list of the topics included in the Preliminary Decision Memorandum is included as an appendix to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically
Commerce preliminarily determines that a weighted-average margin of 24.68 percent exists for CJ Indonesia for the period November 1, 2016, through October 31, 2017.
Upon issuance of the final results of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
If the weighted-average dumping margin for CJ Indonesia is not zero or
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by CJ Indonesia for which the producer did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate entries not reviewed at the all-others rate if there is no rate for the
For the company for which this review is rescinded (
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for CJ Indonesia will be the rate established in the final results of this review, except if the rate is less than 0.5 percent and, therefore,
Commerce intends to disclose to interested parties the calculations performed in reaching these preliminary results within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit written comments (case briefs) at a date to be determined by Commerce and rebuttal comments (rebuttal briefs) within five days after the time limit for filing case briefs.
Interested parties who wish to request a hearing must do so within 30 days of publication of these preliminary results by submitting a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, using Enforcement and Compliance's ACCESS system.
Commerce intends to issue the final results of this administrative review, including the results of its analysis of issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless otherwise extended.
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these preliminary results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that Ghigi 1870 S.p.A. and Pasta Zara S.p.A. (collectively, Ghigi/Zara) sold pasta
Applicable December 11, 2018.
Joy Zhang (Ghigi/Zara) or George McMahon (Indalco), AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1168 or (202) 482-1167, respectively.
Commerce published the
Imports covered by the order are shipments of certain non-egg dry pasta. The merchandise subject to review is currently classifiable under items 1901.90.90.95 and 1902.19.20 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive.
In the Issues and Decision Memorandum, we addressed all issues raised in parties' case and rebuttal briefs. In the Appendix to this notice, we provide a list of the issues raised by parties. The Issues and Decision Memorandum is a public document and is on-file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on our review of the record and comments received from interested parties, these final results do not differ from the
As a result of this review, Commerce calculated a weighted-average dumping margin that is above
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce shall determine and Customs and Border Protection (CBP) shall assess antidumping duties on all appropriate entries.
In accordance with Commerce's “automatic assessment” practice,
We intend to issue assessment instructions directly to CBP 15 days after publication of the final results of this review.
The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication of the final results of this administrative review, as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for respondents noted above will be the rate established in the final results of this administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most
We intend to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5).
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
The recordkeeping and reporting requirements at §§ 648.74, 648.75, and 648.76 form the basis for this collection of information. We request information from surfclam and ocean quahog individual transferable quota (ITQ) permit holders to issue ITQ permits and to process and track requests from permit holders to transfer quota share or cage tags. We also request information from surfclam and ocean quahog ITQ permit holders to track and properly account for surfclam and ocean quahog harvest shucked at sea. Because there is not a standard conversion factor for estimating unshucked product from shucked product, NMFS requires vessels that shuck product at sea to carry on board the vessel a NMFS-approved observer to certify the amount of these clams harvested. This information, upon receipt, results in an efficient and accurate database for management and monitoring of fisheries of the Northeastern U.S. EEZ.
Georges Bank has been closed to the harvest of surfclams and ocean quahogs since 1990 due to red tide blooms that cause paralytic shellfish poisoning (PSP). We reopened a portion of the Georges Bank Closed Area starting in 2012 under certain conditions. We request information from surfclam and ocean quahog ITQ permit holders who fish in the reopened area to ensure compliance with the Protocol for Onboard Screening and Dockside Testing in Molluscan Shellfish. The U.S. Food and Drug Administration, the commercial fishing industry, and NMFS developed the PSP protocol to test and verify that clams harvested from Georges Bank continue to be safe for human consumption. The National Shellfish Sanitation Program adopted the PSP protocol at the October 2011 Interstate Shellfish Sanitation Conference.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
The Magnuson-Stevens Fishery Conservation and Management Act authorizes the Gulf of Mexico Fishery Management Council (Gulf Council) and South Atlantic Fishery Management Council (South Atlantic Council) to prepare and amend fishery management plans for any fishery in Federal waters under their respective jurisdictions. NMFS and the Gulf Council manage the reef fish fishery in the Gulf of Mexico (Gulf) under the Fishery Management Plan (FMP) for Reef Fish Resources of the Gulf of Mexico. NMFS and the South Atlantic Council manage the fishery for rock shrimp in the South Atlantic under the FMP for the Shrimp Fishery in the South Atlantic Region. The vessel monitoring system (VMS) regulations for the Gulf reef fish fishery and the South Atlantic rock shrimp fishery may be found at 50 CFR 622.28 and 622.205, respectively.
The FMPs and the implementing regulations contain several specific management areas where fishing is restricted or prohibited to protect habitat or spawning aggregations, or to control fishing pressure. Unlike size, bag, and trip limits, where the catch can be monitored on shore when a vessel returns to port, area restrictions require at-sea enforcement. However, at-sea enforcement of offshore areas is difficult due to the distance from shore and the limited number of patrol vessels, resulting in a need to improve enforceability of area fishing restrictions through remote sensing methods. In addition, all fishing gears are subject to some area fishing restrictions. Because of the sizes of these areas and the distances from shore, the effectiveness of enforcement through over flights and at-sea interception is limited. An electronic VMS allows a more effective means to monitor vessels for intrusions into restricted areas.
The VMS provides effort data and significantly aids in enforcement of areas closed to fishing. All position reports are treated in accordance with NMFS existing guidelines for confidential data. As a condition of authorized fishing for or possession of Gulf reef fish or South Atlantic rock shrimp in or from Federal waters, vessel owners or operators subject to VMS requirements must allow NMFS, the United States Coast Guard, and their authorized officers and designees, access to the vessel's position data obtained from the VMS.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
National Marine Fisheries Service (NMFS) has issued regulations under authority of the Western and Central Pacific Fisheries Convention Implementation Act (WCPFCIA; 16 U.S.C. 6901
The information collected from these requirements is used by NOAA and the WCPFC to help ensure compliance with domestic laws and the Commission's conservation and management measures, and are necessary in order for the United States to satisfy its obligations under the Convention.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; re-opening of public comment period.
The National Marine Fisheries Service (NMFS) is announcing the re-opening of a public comment period regarding recreational fisheries in the State of Idaho. The FMEP, provided by the Idaho Department of Fish and Game (IDFG), specifies the implementation of fisheries targeting adipose-fin-clipped, hatchery-origin Snake River steelhead within the State of Idaho and in boundary waters with Oregon and Washington. On November 6, 2018, NMFS opened a 30-day public comment period on a Fishery Management and Evaluation Plan (FMEP) pursuant to the protective regulations promulgated for Pacific salmon and steelhead under the Endangered Species Act (ESA). That comment period ended on December 6, 2018. In response to a request received from the public, NMFS intends to obtain additional information.
Comments must be received at the appropriate address or fax number (see
Written comments on the application should be addressed to the NMFS Sustainable Fisheries Division, 1201 NE Lloyd Boulevard, Suite 1100, Portland, OR 97232. Comments may be submitted by email. The mailbox address for providing email comments is:
Allyson Purcell, at phone number: (503) 736-4736, or via email:
Chinook salmon (
Steelhead (
Sockeye salmon (
IDFG submitted the FMEP to NMFS describing fisheries targeting adult adipose-fin-clipped, hatchery-origin steelhead within the State of Idaho and in boundary waters with Oregon and Washington. The plan was submitted under ESA limit 4 of the 4(d) Rule. These fisheries were designed to support fishing opportunities while minimizing potential risks to ESA-listed species. The FMEP describes timing, location, harvest impact limits, licensing, and gear requirements, and requires that all fish caught with an intact adipose fin be released unharmed. A variety of monitoring and evaluation is included in the FMEP.
This reopening is in place of a planned extension of the comment period. NMFS had previously considered extending the comment period by seven days, until December 13. However, extensions may only occur while the comment period is ongoing, and NMFS could not be certain that a public notice of an extension would be published before December 6. Therefore, to avoid potential confusion, we are executing a reopening of the comment period to accept comments until December 13, so that the result is identical to the planned extension. This additional period for public comment will not affect NMFS's overall schedule for completing our ESA review.
As specified in the July 10, 2000, ESA 4(d) rule for salmon and steelhead (65 FR 42422) and updated June 28, 2005 (70 FR 37160), NMFS may approve an FMEP if it meets criteria set forth in 50 CFR 223.203(b)(4)(i)(A) through (I). Prior to final approval of an FMEP, NMFS must publish notification announcing the FMEP's availability for public review and comment.
Under section 4 of the ESA, the Secretary of Commerce is required to adopt such regulations as he deems necessary and advisable for the conservation of species listed as threatened. The ESA salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005) specifies categories of activities that contribute to the conservation of listed salmonids and sets out the criteria for such activities. Limit 4 of the updated 4(d) rule (50 CFR 223.203(b)(4)) further provides that the prohibitions of paragraph (a) of the updated 4(d) rule (50 CFR 223.203(a)) do not apply to fisheries provided that an FMEP has been approved by NMFS to be in accordance with the salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application for permit amendment.
Notice is hereby given that Stephen John Trumble, Ph.D., Baylor University, 101 Bagby Ave, Waco, TX 76706, has applied in due form for an amendment to Scientific Research Permit No. 20532 for the import, export,
Written, telefaxed, or email comments must be received on or before January 10, 2019.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Shasta McClenahan or Jennifer Skidmore, (301) 427-8401.
The subject amendment to Permit No. 20532 is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
Permit No. 20532, issued on October 26, 2016 (81 FR 70100), authorizes the permit holder to receive, import, and export biological samples from seven species of cetaceans from museum holdings, stranded animals, or legally subsistence hunted animals worldwide for scientific research to chronologically profile anthropogenic and physiological data including hormones and pesticides to record exposure and stress. The permit holder is requesting the permit be amended to include authorization to import earwax and baleen samples from additional cetacean species including: 50 each of Bryde's (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of public meeting.
This notice sets forth the schedule and proposed agenda of a meeting of the NOAA Science Advisory Board (SAB). The members will discuss issues outlined in the section on Matters to be considered.
The meeting will be held Wednesday, February 27, 2019 from 1:00 p.m. EST to 4:00 p.m. EST. These times and agenda topics described below are subject to change. For the latest agenda please refer to the SAB website:
The meeting will be held at the Hugh Gregg Coastal Conservation Center, 93 Depot Road, Greenland, NH 03840. Members of the public may participate virtually by registering at:
Dr. Cynthia Decker, Executive Director, SSMC3, Room 11230, 1315 East-West Hwy., Silver Spring, MD 20910; Phone Number: 301-734-1156; Email:
The NOAA Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.
Department of the Army, DoD.
Notice of intent.
The Department of the Army hereby gives notice of its intent to grant to H2 Power, LLC; a corporation having its principle place of business at 333 North Michigan Avenue, Suite 1117, Chicago, IL 60601, an exclusive license.
Written objections must be filed not later than 15 days following publication of this announcement.
Send written objections to U.S. Army Research Laboratory, Technology Transfer and Outreach Office, RDRL-DPT/Annmarie Martin, Building 321, Room 126, 6375 Johnson Rd., Aberdeen Proving Ground, MD 21005-5425.
Annmarie Martin, (410) 278-9106, email:
The Department of the Army plans to grant an exclusive license to H2 Power, LLC related to “Aluminum based nanogalvanic compositions useful for generating hydrogen gas and low temperature processing thereof”, U.S. Patent Application No.: 16/042632, Filing Date July, 2018 in the fields of use related to;
The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the U.S. Army Research Laboratory receives written objections including evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). Competing applications completed and received by the U.S. Army Research Laboratory within fifteen (15) days from the date of this published notice will also be treated as objections to the grant of the contemplated exclusive license.
Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Joint Service Committee on Military Justice (JSC), Department of Defense.
Publication of discussion and analysis (supplementary materials) accompanying the Manual for Courts-Martial, United States (2019 ed.) (MCM).
The JSC hereby publishes Supplementary Materials accompanying the MCM as amended by Executive Order 13825. These changes have not been coordinated within the Department of Defense under DoD Directive 5500.1, “Preparation, Processing and Coordinating Legislation, Executive Orders, Proclamations, Views Letters and Testimony,” June 15, 2007, and do not constitute the official position of the Department of Defense, the Military Departments, or any other Government agency. These Supplementary Materials have been approved by the JSC and the General Counsel of the Department of Defense, and shall be applied in conjunction with the rule with which they are associated. The Discussions are effective insofar as the Rules they supplement are effective, but may not be applied earlier than the date of publication in the
These Supplementary Materials are effective as of January 1, 2019.
Lieutenant Commander Jennifer Luce, JAGC, USN (202) 685-7058 or
Public Comments: The JSC solicited public comments for these supplementary materials via the
Due to the length of the changes, they are being made available on the internet rather than being printed in the
Office of Innovation and Improvement (OII), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a reinstatement of a previously approved information collection.
Interested persons are invited to submit comments on or before January 10, 2019.
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 Clifton Jones, 202-205-2204.
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 Energy Efficiency and Renewable Energy, U.S. Department of Energy.
Notice and request for comments.
The Department of Energy (DOE) invites public comment on a proposed collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995.
Comments regarding this proposed information collection must be received on or before January 10, 2019. If you anticipate difficulty in submitting comments within that period, contact the person listed in
Jay Wrobel, EE-5A/Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, by fax at (202) 586-9234, or by email at
Requests for additional information should be directed to Jay Wrobel, EE-5A/Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, by fax at (202) 586-9234, or by email at
This information collection request contains:
(1) 1910-NEW;
(2)
(3) T
(4)
There are four types of information to be collected from primary participants: (1) Background data, including contact information and basic information about the CHP packager's experience with CHP design, durability and performance testing—collected in the CHP Packager Enrollment Form; (2) Background data, including contact information and basic information about the CHP solutions provider's experience with CHP design, durability and performance testing, installation, operation and maintenance—collected in the CHP Solutions Provider Enrolment Form; (3) contact information and program description of market engagement programs that support Packaged CHP systems—collected in the Market Engagement Registration Form; and (4) Information, including packaged system component descriptions, design data, full-load and part-load performance data at three ambient conditions—collected in Packaged CHP System Application Form; Background data will primarily be used as a means to recognize CHP packers and solution providers, and establish the e-Catalog.
(5)
(6)
(7)
(8)
Energy Policy Act of 2005 sec 911—Energy Efficiency and sec 106 Voluntary Commitments to Reduce Industrial Energy Intensity.
Office of Fossil Energy, DOE.
Notice of change in control.
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of a Notice of Change in Control (Notice) filed by Pieridae Energy (USA) Ltd. (Pieridae US) in the above-referenced docket on August 31, 2018. The Notice describes a change in control of Pieridae Energy Limited, the parent company of Pieridae US.
Protests, motions to intervene or notices of intervention, as applicable, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, December 26, 2018.
Larine Moore or Amy Sweeney, U.S. Department of Energy (FE-34), Office of Regulation, Analysis, and Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9478; (202) 586-2627.
Cassandra Bernstein, U.S. Department of Energy (GC-76), Office of the Assistant General Counsel for Electricity and Fossil Energy, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9793.
The Notice was filed under section 3 of the Natural Gas Act (NGA), 15 U.S.C. 717b. Pieridae US filed a Notice of Change in Control in the above-referenced docket on August 31, 2018.
Additional details can be found in the Notice, posted on the DOE/FE website at:
DOE/FE will review Pieridae US's Notice in accordance with its Procedures for Changes in Control Affecting Applications and Authorizations to Import or Export Natural Gas (CIC Procedures).
Interested persons will be provided 15 days from the date of publication of this notice in the
Filings may be submitted using one of the following methods: (1) Preferred method: emailing the filing to
The Notice and any filed protests, motions to intervene or notice of interventions, and comments are available for inspection and copying in the Office of Regulation, Analysis, and Engagement docket room, Room 3E-042, 1000 Independence Avenue SW, Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.
The Notice and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address:
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's approval of the State of Kansas' request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.
EPA approves the authorized program revisions/modifications as of December 11, 2018.
Devon Martin, U.S. Environmental Protection Agency, Office of Environmental Information, Mail Stop 2824T, 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-2603,
On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the
On September 11, 2018, the Kansas Department of Health and Environment (KDHE) submitted an application titled “Kansas Environmental Information Management System” for revisions/modifications to its EPA-approved programs under title 40 CFR to allow new electronic reporting. EPA reviewed KDHE's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Kansas' request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 50-52, 60-65, and 70, is being published in the
Part 52—Approval and Promulgation of Implementation Plans;
Part 60—Standards of Performance For New Stationary Sources;
Part 62—Approval and Promulgation of State Plans for Designated Facilities and Pollutants;
Part 63—National Emission Standards for Hazardous Air Pollutants for Source Categories; and
Part 70—State Operating Permit Programs.
KDHE was notified of EPA's determination to approve its application with respect to the authorized programs listed above.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Metallic Mineral Processing Plants (EPA ICR Number 0982.12, OMB Control Number 2060-0016), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2018. Public comments were previously requested, via the
Additional comments may be submitted on or before January 10, 2019.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0030, to: (1) EPA 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,
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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
In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 60, subpart LL.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Kraft Pulp Mills (EPA ICR No. 1055.12, OMB Control No. 2060-0021), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2018. Public comments were previously requested, via the
Additional comments may be submitted on or before January 10, 2019.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0034, to: (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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
In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 60, subpart BB.
Environmental Protection Agency.
Notice of final action.
This notice announces that the Environmental Protection Agency, Region IX (EPA Region IX) issued a final permit decision to Palmdale Energy, LLC for a Clean Air Act Prevention of Significant Deterioration (PSD) permit for the construction of the Palmdale Energy Project (PEP).
The final PSD permit decision for the PEP was issued and became effective on October 25, 2018. Pursuant to section 307(b)(1) of the Clean Air Act, judicial review of this final permit decision, to the extent it is available, may be sought by filing a petition for review in the United States Court of Appeals for the Ninth Circuit within 60 days of December 11, 2018.
The EPA established a docket for this action under Docket ID No. EPA-R09-OAR-2017-0473. All documents in the docket are listed on the
Lisa Beckham, Permits Office (Air-3), U.S. Environmental Protection Agency, Region IX, (415) 972-3811,
On April 25, 2018, EPA Region IX initially issued PSD Permit No. SE 17-01 to Palmdale Energy, LLC under 40 CFR 124.15, authorizing the construction and operation of the PEP. By its own terms, and consistent with 40 CFR 124.15(b), the effective date of the permit was delayed as the result of the filing of a petition for review of the Region's permit decision with the EAB.
On October 23, 2018, the EAB denied review of the permit decision.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese (EPA ICR No. 1831.07, OMB Control No. 2060-0391), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2018. Public comments were previously requested, via the
Additional comments may be submitted on or before January 10, 2019.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0066, to: (1) EPA online using
EPA's policy is that all comments received will be included in the public
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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
In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 63, subpart XXX.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Pesticide Active Ingredient Production (EPA ICR No. 1807.09, OMB Control No. 2060-0370), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2018. Public comments were previously requested, via the
Additional comments may be submitted on or before January 10, 2019.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0062 to: (1) EPA 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.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; 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 either online at
In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before February 11, 2019. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The Commission first adopted a public inspection file requirement for broadcasters more than 40 years ago. The public file requirement grew out of Congress' 1960 amendment of Sections 309 and 311 of the Communications Act of 1934. Finding that Congress, in enacting these provisions, was guarding
The information collection requirements contained in 47 CFR 25.701(d) require each DBS provider to keep and permit public inspection of a complete and orderly record (political file) of all requests for DBS origination time made by or on behalf of candidates for public office, together with an appropriate notation showing the disposition made by the provider of such requests, and the charges made, if any, if the request is granted. The disposition includes the schedule of time purchased, when the spots actually aired, the rates charged, and the classes of time purchased. Also, when free time is provided for use by or on behalf of candidates, a record of the free time provided is to be placed in the political file. All records required to be retained by this section must be placed in the political file as soon as possible and retained for a period of two years. DBS providers must make available, by fax, email, or by mail upon telephone request, copies of documents in their political files and assist callers by answering questions about the contents of their political files. If a requester prefers access by mail, the DBS provider must pay for postage but may require individuals requesting documents to pay for photocopying. If a DBS provider places its political file on its website, it may refer the public to the website in lieu of mailing copies.
Any material required to be maintained in the political file must be made available to the public by either mailing or website access or both.
The information collection requirements contained in 47 CFR 25.701(d) require DBS providers to place all new political file material required to be retained by this section in the online file hosted by the Commission.
47 CFR 25.701(f)(6) information collection requirements require each DBS provider to maintain a public file containing a complete and orderly record of quarterly measurements of: Channel capacity and yearly average calculations on which it bases its four percent reservation, as well as its responses to any capacity changes; a record of entities to whom noncommercial capacity is being provided, the amount of capacity being provided to each entity, the conditions under which it is being provided and the rates, if any, being paid by the entity; and a record of entities that have requested capacity, disposition of those requests and reasons for the disposition. All records required by this provision must be placed in a file available to the public as soon as possible and be retained for a period of two years.
47 CFR 25.701(f)(6) to require DBS providers to place all public file material required to be retained by this section in the online file hosted by the Commission. Each DBS provider must place in the online file the records required to be placed in the public inspection file by 47 CFR 25.701(e)(commercial limits in children's programs) and by 47 CFR 25.601 and Part 76, Subpart E (equal employment opportunity requirements) and retain those records for the period required by those rules. In addition, each DBS provider is required to provide a link to the public inspection file hosted on the Commission's website from the home page of its own website, if the provider has a website, and provide on its website contact information for a representative who can assist any person with disabilities with issues related to the content of the public files. Each DBS provider is also required to include in the online public file the name, phone number, and email address of the licensee's designated contact for questions about the public file. In addition, each DBS provider must place the address of the provider's local public file in the Commission's online file unless the provider has fully transitioned to the FCC's online public file (
47 CFR 25.702(b) requires each SDARS licensee to maintain a complete and orderly record (political file) of all requests for SDARS origination time made by or on behalf of candidates for public office, together with the disposition made by the provider of such requests, and the charges made, if any, if the request is granted. The disposition must include the schedule of time purchased, when the spots actually aired, the rates charged, and the classes of time purchased. Also, when free time is provided for use by or on behalf of candidates, a record of the free time provided is to be placed in the political file. SDARS licensees are required to place all records required by this section in the political file as soon as possible and retain the record for a period of two years.
The information collection requirements contained in 47 CFR 25.702(c) require each SDARS applicant or licensee to place in the online file hosted by the Commission the records required to be placed in the public inspection file by 47 CFR 25.601 and 73.2080 (equal employment opportunities) and to retain those records for the period required by those rules. Each SDARS licensee must provide a link to the public inspection file hosted on the Commission's website from the home page of its own website, if the licensee has a website, and provide on its website contact information for a representative who can assist any person with disabilities with issues related to the content of the public files. Each SDARS licensee is also required to include in the online public file the name, phone number, and email address of the licensee's designated contact for questions about the public file. In addition, each SDARS licensee must place the address of the provider's local public file in the Commission's online file unless the provider has fully transitioned to the FCC's online public file (
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before February 11, 2019. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The information is used by a vessel radio operator during an emergency situation, and is designed to assist the radio operator to utilize proper distress procedures during a time when he or she may be subject to considerable stress or confusion.
Thursday, December 13, 2018 at 10:00 a.m.
1050 First Street NE, Washington, DC (12th floor).
This meeting will be open to the public.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna C. Brown, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.
Thursday, December 13, 2018 following the open meeting.
1050 First Street NE, Washington, DC.
This meeting will be closed to the public.
Compliance matters pursuant to 52 U.S.C. 30109.
Matters relating to internal personnel decisions, or internal rules and practices.
Information the premature disclosure of which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Federal Retirement Thrift Investment Board (FRTIB).
Notice of a new system of records.
Pursuant to the Privacy Act of 1974, 5 U.S.C. 552a, the Federal Retirement Thrift Investment Board (FRTIB) is proposing to establish a new system of records. Records contained in this system will be used to educate participants about various aspects of the TSP.
This system will become effective upon its publication in today's
You may submit written comments to FRTIB by any one of the following methods:
•
•
•
Marla Greenberg, Chief Privacy Officer, Federal Retirement Thrift Investment Board, Office of General Counsel, 77 K Street NE, Suite 1000, Washington, DC 20002, (202) 942-1600. For access to any of the FRTIB's systems of records, contact Amanda Haas, FOIA Officer, Office of General Counsel, at the above address and phone number.
FRTIB is proposing to establish a new system of records entitled, “FRTIB-20, Communications, Education, and Outreach Materials.” The proposed system of records is necessary to assist FRTIB's Office of Communications and Education in effectively educating and communicating with Thrift Savings Plan (TSP) participants and other individuals.
Files maintained as part of FRTIB-20 include: Information about TSP participants and other individuals who receive educational messages from FRTIB or who have otherwise corresponded with FRTIB, including names, personal and business phone numbers, mailing addresses, email addresses, and social media handles; aggregated data and FRTIB analysis of participant behavior; incoming feedback and other correspondence; FRTIB's response; the FRTIB responder's name and business information; additional unsolicited personal information provided by individuals; video recordings of volunteer participants; and related materials. FRTIB is proposing to add sixteen routine uses to apply to FRTIB-20.
FRTIB-20, Communications, Education, and Outreach Materials.
Unclassified.
Records are located at the Federal Retirement Thrift Investment Board, 77 K Street NE, Suite 1000, Washington, DC 20002. Records may also be maintained at additional locations for Business Continuity purposes.
Director, Office of Communications and Education, Federal Retirement Thrift Investment Board, 77 K Street NE, Suite 1000, Washington, DC 20002, or by phone by calling (202) 942-1600.
5 U.S.C. 8474.
The purpose of the system is to educate TSP participants and other individuals about the TSP; to track and analyze aggregated activity to determine the effectiveness of targeted outreach campaigns; and to solicit feedback regarding FRTIB education and outreach efforts.
TSP participants; individuals interested in TSP updates or educational events; and individuals who wish to provide feedback on TSP outreach efforts, including targeted mailings, email campaigns, educational events, social media accounts, and focus groups.
Records in this system include, but are not limited to records received, created, or compiled through FRTIB social media accounts, educational outreach efforts, educational events, requests for feedback, and other communications. The type of information in the records may include the names and contact information of the data subject, including mailing addresses, email addresses, phone numbers, and social media handles, of TSP participants or other individuals interested in the TSP; aggregated participant activity data, and FRTIB analysis of participant behavior following targeted communications from FRTIB; feedback on FRTIB communications; FRTIB's response; the name and business information of FRTIB employees; additional unsolicited personal information provided by individuals; and video or audio recordings of participants and others who voluntarily participate in FRTIB's educational campaigns or events.
Information in this system is obtained from TSP participant accounts; individuals who sign up to receive email or SMS/text message updates and educational materials from FRTIB; and individuals who interact with the FRTIB through various social media sites or as a result of other educational outreach efforts.
Information about covered individuals may be disclosed without consent as permitted by the Privacy Act of 1974, as amended, 5 U.S.C. 552a(b); and:
1. Routine Use—Audit: A record from this system of records may be disclosed to an agency, organization, or individual for the purpose of performing an audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to FRTIB officers and employees.
2. Breach Mitigation and Notification: Response to Breach of FRTIB Records: A record from this system of records may
3. Routine Use—Response to Breach of Other Records: A record from this system of records may be disclosed to another Federal agency or Federal entity, when FRTIB determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
4. Routine Use—Congressional Inquiries: A record from this system of records may be disclosed to a Congressional office from the record of an individual in response to an inquiry from that Congressional office made at the request of the individual to whom the record pertains.
5. Routine Use—Contractors, et al.: A record from this system of records may be disclosed to contractors, grantees, experts, consultants, the agents thereof, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for FRTIB, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to FRTIB officers and employees.
6. Routine Use—Former Employees: A record from this system of records may be disclosed to a former employee of the FRTIB, in accordance with applicable regulations, for purposes of responding to an official inquiry by a federal, state, or local government entity or professional licensing authority; or facilitating communications with a former employee that may be necessary for personnel-related or other official purposes where the FRTIB requires information or consultation assistance from the former employee regarding a matter within that person's former area of responsibility.
7. Routine Use—Investigations, Third Parties: A record from this system of records may be disclosed to third parties during the course of a law enforcement investigation to the extent necessary to obtain information pertinent to the investigation, provided disclosure is appropriate to the proper performance of the official duties of the third party officer making the disclosure.
8. Routine Use—Investigations, Other Agencies: A record from this system of records may be disclosed to appropriate federal, state, local, tribal, or foreign government agencies or multilateral governmental organizations for the purpose of investigating or prosecuting the violations of, or for enforcing or implementing, a statute, rule, regulation, order, license, or treaty where FRTIB determines that the information would assist in the enforcement of civil or criminal laws.
9. Routine Use—Law Enforcement Intelligence: A record from this system of records may be disclosed to a federal, state, tribal, local, or foreign government agency or organization, or international organization, lawfully engaged in collecting law enforcement intelligence information, whether civil or criminal, or charged with investigating, prosecuting, enforcing or implementing civil or criminal laws, related rules, regulations or orders, to enable these entities to carry out their law enforcement responsibilities, including the collection of law enforcement intelligence.
10. Routine Use—Law Enforcement Referrals: A record from this system of records may be disclosed to an appropriate federal, state, tribal, local, international, or foreign agency or other appropriate authority charged with investigating or prosecuting a violation or enforcing or implementing a law, rule, regulation, or order, where a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.
11. Routine Use—Litigation, DOJ or Outside Counsel: A record from this system of records may be disclosed to the Department of Justice, FRTIB's outside counsel, other federal agency conducting litigation or in proceedings before any court, adjudicative or administrative body, when: (1) FRTIB, or (2) any employee of FRTIB in his or her official capacity, or (3) any employee of FRTIB in his or her individual capacity where DOJ or FRTIB has agreed to represent the employee, or (4) the United States or any agency thereof, is a party to the litigation or has an interest in such litigation, and FRTIB determines that the records are both relevant and necessary to the litigation and the use of such records is compatible with the purpose for which FRTIB collected the records.
12. Routine Use—Litigation, Opposing Counsel: A record from this system of records may be disclosed to a court, magistrate, or administrative tribunal in the course of presenting evidence, including disclosures to opposing counsel or witnesses in the course of civil discovery, litigation, or settlement negotiations or in connection with criminal law proceedings or in response to a subpoena.
13. Routine Use—NARA/Records Management: A record from this system of records may be disclosed to the National Archives and Records Administration (NARA) or other federal government agencies pursuant to the Federal Records Act.
14. Routine Use—Redress: A record from this system of records may be disclosed to a federal, state, tribal, local, international, or foreign government agency or entity for the purpose of consulting with that agency or entity: (1) To assist in making a determination regarding redress for an individual in connection with the operations of a FRTIB program; (2) for the purpose of verifying the identity of an individual seeking redress in connection with the operations of a FRTIB program; or (3) for the purpose of verifying the accuracy of information submitted by an individual who has requested such redress on behalf of another individual.
15. Routine Use—Security Threat: A record from this system of records may be disclosed to federal and foreign government intelligence or counterterrorism agencies when FRTIB reasonably believes there to be a threat or potential threat to national or international security for which the information may be useful in countering the threat or potential threat, when FRTIB reasonably believes such use is to assist in anti-terrorism efforts, and disclosure is appropriate to the proper performance of the official duties of the person making the disclosure.
16. A record from this system may be shared with other Federal agencies to register and notify individuals regarding TSP-related educational events.
Records are maintained in paper and electronic form, including on computer databases and cloud-based services, all of which are securely stored.
Records are retrieved by name, account number, email address, phone number, social media handle, demographics, or other unique identifier of the individual about whom they are maintained.
These records are maintained in accordance with General Records Schedules 6.4 (Public Affairs Records) and 6.5 (Public Customer Service Records) issued by the National Archives and Records Administration (NARA).
FRTIB has adopted appropriate administrative, technical, and physical controls in accordance with FRTIB's security program to protect the security, confidentiality, availability, and integrity of the information, and to ensure that records are not disclosed to or accessed by unauthorized individuals.
Individuals seeking to access records within this system must submit a request pursuant to 5 CFR part 1630. Attorneys or other persons acting on behalf of an individual must provide written authorization from that individual, such as a Power of Attorney, in order for the representative to act on their behalf.
See Record Access Procedures above.
See Record Access Procedures above.
None.
None.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Request for information.
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) leads comprehensive efforts to prevent the initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; help current smokers quit; and identify and eliminate tobacco-related disparities. In late 2017, CDC solicited input from the public in the
Written comments must be received on or before February 11, 2019.
Submit comments by any one of the following methods:
•
Randi Frank, Office on Smoking and Health, Centers for Disease Control and Prevention, 4770 Buford Hwy, Mail Stop S107-7, Atlanta, GA 30341; Telephone (770) 488-5114; Email:
Tobacco use is the leading cause of preventable disease, disability, and death in the United States.
Cigarette smoking alone causes more than 480,000 deaths each year, including more than 41,000 secondhand smoke related deaths, and costs the country over $300 billion annually in health care spending and lost productivity.
Any form of tobacco product use is unsafe for youth, irrespective of whether it is smoked, smokeless, or electronic. Since brain development continues through the early to mid-20s, the use of products containing nicotine, including e-cigarettes, can be harmful to youth and young adults. Specifically, the use of these products can disrupt the growth of brain circuits that control attention, learning, and susceptibility to addiction.
The U.S. Surgeon General has concluded that there is no risk-free level of secondhand smoke exposure; even brief exposure can be harmful to health.
Although progress has been made in reducing tobacco use in the general population, disparities persist across population groups.
Addressing the social and environmental factors that influence tobacco use can advance equity in tobacco prevention and control, and reduce tobacco-related disparities among populations disproportionately impacted by tobacco use.
CDC is specifically interested in receiving information on the following issues:
(1) What innovative strategies are working in communities to prevent tobacco use among youth, especially in terms of flavored tobacco products and e-cigarettes?
(2) How can CDC best educate all community members about the harmful effects of secondhand smoke exposure?
(3) How can CDC support state and local health departments and their partners to improve community engagement with populations most at risk for tobacco use?
(4) What innovative strategies are effective in communities to decrease tobacco use in population groups that have the greatest burden of tobacco use and secondhand smoke exposure?
(5) What science, tools, or resources does the public health sector need CDC to develop in order to enhance and sustain tobacco prevention and control efforts?
1. U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014.
2. Xu X, Bishop EE, Kennedy SM, Simpson SA, Pechacek TF. Annual Healthcare Spending Attributable to Cigarette Smoking: An Update. American Journal of Preventive Medicine 2014;48(3):326-33.
3. U.S. Department of Health and Human Services. E-cigarette use among youth and young adults: a report of the Surgeon General. Atlanta, GA: US Department of Health and Human Services, CDC; 2016 [accessed 2018 Oct 18].
4. Cullen KA, Ambrose BK, Gentzke AS, Apelberg BJ, Jamal A, King BA.
5. Ambrose BK, Day HR, Rostron B, et al. Flavored Tobacco Product Use Among US Youth Aged 12-17 Years, 2013-2014.
6. National Academies of Sciences, Engineering, and Medicine. 2018. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press. doi:
7. Department of Health and Human Services.
8. U.S. Department of Health and Human Services.
9. Centers for Disease Control and Prevention. Vital signs: Disparities in nonsmokers' exposure to secondhand smoke—United States, 1999-2012. Morbidity and Mortality Weekly Report. 2015;64:103-108.[accessed 2018 Oct 22].
10. Centers for Disease Control and Prevention. Cigarette smoking—United States, 1965-2008. Morbidity and Mortality Weekly Report. 2011;60(01):109-3. [accessed 2018 Oct 22].
11. King BA, Dube SR, Tynan MA. Current tobacco use among adults in the United States: findings from the National Adult Tobacco Survey.
12. Centers for Disease Control and Prevention. Best Practices User Guide: Health Equity in Tobacco Prevention and Control. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2015.
13. Centers for Disease Control and Prevention. Best Practices for Comprehensive Tobacco Control Programs—2014. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014 [accessed 2018 Oct 18].
14. Centers for Disease Control and Prevention.
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 February 11, 2019.
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' at website 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) 786-4669.
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 cond uct 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.
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38328 through 38342), out of an abundance of caution, in the face of a nationwide epidemic of opioid over prescription, we finalized a refinement to the HCAHPS Survey measure as used in the Hospital Inpatient Quality Reporting Program by removing the previously adopted Pain Management questions and incorporating new Communication About Pain questions beginning with patients discharged in January 2018. As discussed in the CY 2019 OPPS/ASC proposed rule (83 FR 37218), since finalization of the Communication About Pain questions, we have received feedback that some stakeholders are concerned that, although the revised questions focus on communications with patients about their pain and treatment of that pain, rather than how well their pain was controlled, the questions still could potentially impose pressure on hospital staff to prescribe more opioids in order to achieve higher scores on the HCAHPS Survey.
In response to stakeholder feedback, recommendations from the
2.
Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled “FDA's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock.” Stakeholders, including healthcare providers (HCPs) and medical specialty groups, have expressed concerns regarding the availability of certain compounded drug products from outsourcing facilities that they would like to have on-hand as in-office supplies of non-patient-specific compounded drugs (“office stock”). The purpose of the public meeting is to provide HCPs, outsourcing facilities, entities considering becoming outsourcing facilities, and other interested parties with an opportunity to present to FDA their perspectives concerning access to office stock from outsourcing facilities in light of FDA's enforcement policies as proposed in the revised draft guidance on current good manufacturing practice (CGMP) for human drug compounding outsourcing facilities.
The public meeting will be held on May 21, 2019, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public meeting by June 21, 2019. See the
The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 21, 2019. The
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 Dockets Management Staff, 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
Bronwen Blass, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-5092.
Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounded drug products serve an important role for patients whose clinical needs cannot be met by an FDA-approved drug product, such as for a patient who has an allergy to a certain dye contained in an FDA-approved drug product and needs a medication compounded without that dye, or an elderly patient or a child who cannot swallow a pill and needs a medicine in a liquid form that is not available in an approved product. Drug products can be compounded consistent with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) by licensed pharmacists in State-licensed pharmacies and Federal facilities, or by licensed physicians, or consistent with section 503B of the FD&C Act (21 U.S.C. 353b) by compounders known as outsourcing facilities.
Sometimes, it is necessary for HCPs in hospitals, clinics, offices, or other settings to have a certain compounded drug product on hand, so they can administer it to a patient who presents with an immediate need for the compounded drug product. Such drug products are often known as “office stock,” and outsourcing facilities are uniquely permitted to supply these compounded products in accordance with the law.
For example, if a patient presents at an ophthalmologist's office with a fungal eye infection, timely administration of a compounded antifungal medication may be critical to preventing vision loss. In such a case, the ophthalmologist may need to inject the patient with a compounded drug product immediately, rather than writing a prescription and waiting for the drug product to be compounded and shipped to the prescriber. In other cases, compounded drug products may need to be administered by a healthcare practitioner in his or her office because it would not be safe for the patient to take the drug home for self-administration, and it would be preferable for the physician to have the drug in his or her office to administer immediately upon diagnosis, rather than asking the physician to order the drug and have the patient return to the healthcare practitioner for administration.
Although compounded drugs can serve an important role for certain patients in cases such as these, they also can pose a higher risk to patients than FDA-approved drugs. Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. Because compounded drug products are subject to a lower regulatory standard than FDA-approved drug products, they present a greater risk to patients and should not be administered to patients unless their medical needs cannot be met by FDA-approved drug products.
Sections 503A and 503B of the FD&C Act address human drug compounding. Section 503A, added to the FD&C Act by the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act:
• Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning CGMP requirements);
• section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and
• section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications).
A compounded drug product may be eligible for the exemptions under section 503A of the FD&C Act only if it is, among other things, compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient. Among other conditions, to qualify for the exemptions under section 503A, the drug product must be compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician (section 503A(a)).
New section 503B, added to the FD&C Act by the Drug Quality and Security Act in 2013, created a new category of compounders called
Section 503B of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from three sections of the FD&C Act:
• Section 502(f)(1);
• section 505; and
• section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements).
In contrast to compounders compounding in accordance with section 503A of the FD&C Act, outsourcing facilities may, but need not, obtain prescriptions for identified individual patients for their
Elsewhere in this issue of the
In the revised draft guidance, FDA made a number of revisions to address comments submitted on the 2014 draft. For example, the revised draft guidance differentiates between CGMP requirements applicable to sterile drug products and nonsterile drug products where appropriate. Among other changes, FDA made revisions to address comments on (1) stability testing, including the assignment of a beyond use date (BUD) as an expiration date; (2) a clear definition of “in-use time,” distinguishing it from “BUD” and “expiration date”; (3) testing batches before release for distribution; and (4) collection and use of samples retained from distributed batches, known as reserve samples. For a more comprehensive discussion of the policies proposed in the revised draft guidance, please see the revised draft guidance (available at:
FDA is seeking public input regarding outsourcing facilities supplying compounded drugs for office stock in light of the CGMP policies described in the revised draft guidance, if finalized as written. FDA has developed a list of topics to facilitate a productive discussion at the public meeting. This list is not intended to be exhaustive, and FDA encourages comments on the potential implications of the policies pertaining to compliance with CGMP requirements described in the revised draft CGMP guidance, if finalized as written, for outsourcing facilities supplying drugs compounded for office stock. Policies include, but are not limited to, those related to stability studies, beyond use dating, and release testing. Issues that are of specific interest to the Agency include the following:
• Perspectives related to demand and supply of office stock, including:
○ Ways in which HCPs seek to identify outsourcing facilities that compound the drugs they want for office stock, as well as issues, if any, with this process.
○ Communications between HCPs and outsourcing facilities to address potential issues related to requested formulations, timing, and order size.
○ Coordination or consolidation of orders among providers for same or similar compounded drug products.
○ HCPs' experiences with the availability of office stock products from outsourcing facilities.
• Perspectives related to orders for drug products that an outsourcing facility has not made or does not routinely make.
○ Factors outsourcing facilities consider before deciding whether to fill an order for a requested compounded drug product that it has not previously made or does not routinely make.
○ The impact that FDA's policies proposed in the revised draft guidance would have on outsourcing facilities filling orders for requested products not previously or routinely made.
• Perspectives related to small volume orders of office stock products, including:
○ HCPs' experiences seeking small volume orders from outsourcing facilities.
○ Factors outsourcing facilities consider before determining whether to produce small batches of compounded drug products for office stock.
○ The impact that FDA's policies proposed in the revised draft guidance would have on outsourcing facilities' decisions regarding filling small volume orders and/or producing small batches of compounded drug products for office stock.
○ Whether/how the revisions proposed in the revised draft guidance would affect registration of compounders engaged in smaller-scale production as outsourcing facilities.
• Perspectives related to beyond use dating for office stock products, including:
○ How long HCPs seek to keep office stock drug products before use.
○ The impact that FDA's policies proposed in the revised draft guidance would have on outsourcing facilities' production of compounded drug products for office stock with beyond use dating desired by HCPs.
FDA will post the agenda and other meeting materials at least 5 days before the meeting on the public meeting website. More information regarding the meeting, including the public meeting website address, will be posted at:
Registration is free and in-person attendance is based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each
If you need special accommodations due to a disability, please contact
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” This revised draft guidance describes FDA's policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility's operations.
Submit either electronic or written comments on the revised draft guidance by February 11, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit either electronic or written comments concerning the collection of information under the Paperwork Reduction Act of 1995 (PRA) proposed in the revised draft guidance by February 11, 2019.
You may submit comments on any guidance at any time 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 Dockets Management Staff, 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
Submit comments on information collection issues under the PRA to the Office of Management and Budget (OMB) in the following ways:
• Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or email to
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
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
Marci Kiester, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2258, Silver Spring, MD 20993-0002, 301-796-0600.
FDA is announcing the availability of a revised draft guidance for industry entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” Under section 503B(b) of the FD&C Act (21 U.S.C. 353b(b)), a compounder can register as an outsourcing facility with FDA. Drug products compounded in an outsourcing facility can qualify for exemptions from FDA approval requirements in section 505 of the FD&C Act (21 U.S.C. 355), the requirement to label products with adequate directions for use under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), and the drug supply chain security requirements in section 582 of the FD&C Act (21 U.S.C. 360eee-1), if the requirements in section 503B are met. Outsourcing facilities are inspected by FDA according to a risk-based schedule and must comply with other provisions of the FD&C Act, including CGMP requirements under section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)). FDA intends to issue CGMP regulations specific to outsourcing facilities. Until final regulations are issued, this draft guidance describes FDA's policies regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211.
This draft guidance revises the draft guidance for industry entitled “Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act,” which published in July 2014 (79 FR 37743). This revised draft guidance applies to drugs compounded in accordance with section 503B. In addition, this guidance generally applies to drugs that outsourcing facilities repackage and biological products that outsourcing facilities mix, dilute, or repackage in accordance with relevant guidance for outsourcing facilities. This revised draft guidance reflects FDA's intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.
The comment period on the initial draft guidance ended on September 2, 2014. FDA received 26 comments on the draft guidance. In response to received comments or on its own initiative, FDA made changes and updates in the revised draft guidance as follows.
FDA received a number of comments regarding the requirements in FDA regulations applicable to nonsterile drug products because the draft guidance focused primarily on sterile compounding. To address these comments, the revised draft guidance differentiates between requirements applicable to sterile drug products and nonsterile drug products where appropriate. The revised draft guidance also distinguishes the risks presented by using sterile and nonsterile components in producing sterile drug products and offers recommendations and policies on quality control commensurate with the risk. Further, the revised draft guidance addresses concerns raised regarding FDA's policies in several other areas. FDA made significant revisions to address comments on (1) stability testing, including the assignment of a beyond use date (BUD) as an expiration date; (2) release testing; (3) the potential use of a drug master file to address contract laboratory testing arrangements and testing of component quality before use in compounding; (4) the use of accredited third-party laboratories to perform testing; (5) a clear definition of “in-use time,” distinguishing it from “BUD” and “expiration date”; and (6) reserve samples.
We note that the default BUDs and storage conditions associated with nonsterile drug products described in this revised draft guidance differ from those described for nonsterile repackaged drug products in FDA's guidance for industry entitled “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities” (Repackaging guidance). FDA believes that the BUDs described in this revised draft CGMP guidance are also relevant to nonsterile drug products repackaged by outsourcing facilities. When this guidance is finalized, we intend to make conforming revisions to the BUDs for repackaged nonsterile drug products in the Repackaging guidance, as appropriate.
Finally, this revised draft contains revisions to the conditions under which the Agency generally would not intend to take regulatory action regarding the requirement to test the finished product before release (see § 211.165 (21 CFR 211.165)). These revisions make a broader range of production volumes eligible for the relevant enforcement policy, which we believe would encourage additional compounders to register as outsourcing facilities. Compared to compounders that are not registered under section 503B of the
This revised 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 “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” 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. This guidance is not subject to Executive Order 12866.
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from OMB for each collection of information that they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the collection of information associated with this document, FDA invites comments on these topics: (1) Whether the proposed information collected is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
A quality control unit must be established by outsourcing facilities to oversee various aspects of drug production and to monitor quality assurance (see,
FDA estimates that annually approximately 74 outsourcing facilities
The revised draft guidance describes those elements of facility design of outsourcing facilities that are considered critical to assuring the quality of sterile drug products at those facilities. For example, the draft guidance states that sterile drugs should be produced only in ISO 5 (International Organization for Standardization) or better air quality and that the ISO 5 zone or critical area must be qualified (
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 2) will individually document approximately 20 studies and tests (“No. of Records per Recordkeeper” in table 1, row 2) that are critical to assuring the quality of sterile drug products. FDA also estimates that preparing and maintaining each record as described in the guidance will take on average approximately 1.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 2).
The revised draft guidance describes procedures that should be established and followed that assign responsibility for sanitation and describe the cleaning schedules, methods, equipment, and materials to be used in cleaning buildings and facilities. For multiuse facilities and nondedicated equipment, changeover and cleaning procedures for equipment and utensils must be established and followed to prevent contamination (see §§ 211.42 and 211.67). Procedures for cleaning and disinfecting must also be established (see §§ 211.42, 211.56, and 211.67). If powder drugs are handled, procedures must be established and followed to appropriately manage cross-contamination risk (§ 211.100 (21 CFR 211.100)). Processes and procedures should minimize contamination risks posed by the number and complexity of manipulations, number of simultaneous operations and workstations, and staging of materials used in the process. Temperature and humidity must be maintained in cleanrooms; such controls are critical to reduce microbial growth (see 21 CFR 211.46). In addition, the guidance describes that procedures should ensure recording of instances when there is a loss of positive pressure in the cleanroom during production.
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 3) will individually establish and maintain approximately 6 records (procedures and documentation) for
The revised draft guidance states that operations and appropriate written procedures designed to prevent microbial contamination include a well-defined and documented program for environmental monitoring that evaluates the potential routes of microbial contamination of the human drug that could arise from the air, surfaces, process, operation, and personnel practices (see §§ 211.42(c)(10)(iv), 211.100, and 211.113(b)). Personnel monitoring should include a routine program for daily/shift monitoring of operators' gloves and an appropriate schedule for monitoring other critical sites of the gown (
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 4) will individually establish approximately 1,200 environmental and personnel monitoring procedures and records to document test results (“No. of Records per Recordkeeper” in table 1, row 4) for aseptic processing areas. FDA also estimates that preparing and maintaining the environmental and personnel monitoring procedures as described in the guidance will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 4).
Scientifically sound and appropriate criteria for containers and closures must be established to ensure that containers and closures used for drug products are suitable for each drug product for which they will be used (see § 211.160(b) (21 CFR 211.160(b))). Appropriate procedures must be established for testing the containers and closures to determine whether they meet the criteria for use, and the tests and results must be documented (see 21 CFR 211.84(d)(3) and 211.184). Procedures for storage, if appropriate, of sterilized containers or closures must be established in a manner to prevent contamination and to maintain sterility (see 21 CFR 211.80(a) and (b)).
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 5) will individually establish and maintain approximately 300 procedures and pieces of documentation for testing containers and closures (“No. of Records per Recordkeeper” in table 1, row 5) in the aseptic processing areas. FDA also estimates that preparing and maintaining these procedures and documentation as described in the guidance will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 5).
Procedures should be established and records maintained for routine calibration and maintenance of equipment (mechanical, electronic, or automated).
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 6) will individually establish and maintain approximately 150 procedures and pieces of documentation for the calibration and maintenance of equipment (“No. of Records per Recordkeeper” in table 1, row 6). FDA also estimates that preparing and maintaining these records will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 6).
Procedures should be established and records maintained concerning the source and quality of components such as raw materials or ingredients used in producing nonsterile and sterile drug products at outsourcing facilities. The revised draft guidance also states that FDA generally does not intend to take regulatory action against an outsourcing facility regarding testing components if an adequate supplier quality agreement is in place and maintained appropriately.
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 7) will individually establish and maintain approximately 150 records of testing to ensure the quality of components used in producing drug products, as recommended in the guidance (“No. of Records per Recordkeeper” in table 1, row 7). FDA also estimates that preparing and maintaining these records will take on average approximately 4 hours for each record (“Average Burden per Recordkeeping” in table 1, row 7).
Production and process documentation and procedures, such as batch records, must be established to assure the quality of drug products at outsourcing facilities (see § 211.100). Training on aseptic technique, cleanroom behavior, gowning, and procedures covering aseptic manufacturing area operations must be established (see 21 CFR 211.25(a)). The validation of sterilization operations (
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 8) will individually establish and maintain approximately 1,325 records pertaining to production and process controls, such as validation procedures and training, to ensure the quality of sterile drug products (“No. of Records per Recordkeeper” in table 1, row 8). FDA also estimates that preparing and maintaining these records, as described in the guidance, will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 8).
Drug products produced at outsourcing facilities must be tested to determine whether they meet final product specifications before release for distribution, and procedures for final release testing must be established and followed (§§ 211.165 and 211.167).
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 9) will individually establish and maintain approximately 1,725 records pertaining to final release testing of drug products, including release testing
If sterility testing is not completed before release under certain conditions described in Appendix A of the guidance, procedures should be established that specify that if the product fails to meet a criterion for sterility, all healthcare and other facilities that received the product should be immediately notified of the test results and provided with any appropriate information and recommendations to aid in the treatment of patients; the notification should be documented; and FDA should be notified in writing.
FDA estimates that annually approximately 10 outsourcing facilities (“No. of Respondents” in table 2, row 1) will individually send approximately 1 notification of test results to all healthcare and other facilities that received the drug product and provide them with any appropriate information and recommendations to aid in the treatment of patients (No. of Disclosures per Respondent” in table 2, row 1). FDA also estimates that preparing and sending each notification will take approximately 5 hours (“Average Burden per Disclosure” in table 2,row 1).
FDA also estimates that annually approximately 10 outsourcing facilities (“No. of Respondents” in table 3) will individually submit to FDA 1 notification of the test results for any drug product that fails to meet a sterility criterion (“No. of Responses per Respondent” in table 3). Preparing and submitting this information will take approximately 5 hours per notification (“Average Burden per Response” in table 3).
Each laboratory used to conduct testing of components, in-process materials, and finished drug products for outsourcing facilities must follow written procedures for the conduct of each test and must document the results; establish sampling and testing procedures to ensure that components, in-process materials, and drug products conform to the product specifications; keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays; and, if using a validated or an established compendial test, verify and document that the test procedure works under the conditions of actual use (see §§ 211.160 and 211.194).
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 10) will individually establish and maintain approximately 200 laboratory records as described in the guidance (“No. of Records per Recordkeeper” in table 1, row 10). FDA also estimates that preparing and maintaining these records will take on average approximately 0.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 10).
Stability testing is used to ensure that a drug product will retain its quality (
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 11) will individually establish and maintain approximately 75 procedures for stability studies to determine an expiration date (“No. of Records per Recordkeeper” in table 1, row 11) for drug products. FDA also estimates that preparing and maintaining these procedures as described in the guidance will take approximately 5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 11).
FDA also estimates that annually approximately 74 outsourcing facilities (“No. of Respondents” in table 2, row 2) will add approximately 540 expiration dates to the labeling of drug products (“No. of Disclosures per Respondent” in table 2, row 2). FDA also estimates that preparing the labeling will take approximately 0.25 hours (“Average Burden per Disclosure” in table 2, row 2).
Packaging of drugs must ensure the sterility, if applicable, and integrity of the product until it is administered to a patient, product labels must contain required information, and labeling operations must include controls to prevent mixups (see §§ 211.94, 211.122, 211.125, 211.130, and 211.134). The following must be implemented by outsourcing facilities for packaging and labeling operations to ensure the quality of drug products: The container, closure, and packaging systems adequately protect against foreseeable external factors in storage, shipment, and use that can cause contamination or deterioration; packaging records include specimens or copies of all labels used; adequate controls are established for issuing labels, examining issued labels, and reconciling used labels to prevent mixups; different labeling and packaging operations are adequately separated to prevent mixups; and controls are established that ensure proper identification of any filled containers of products that are stored unlabeled for any period of time (see §§ 211.94, 211.122, 211.125, 211.130, 211.134, and 211.188).
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 12) will individually establish and maintain approximately 20 procedures for packaging and labeling operations (“Records per Recordkeeper” in table 1, row 12) for drug products. FDA also estimates that preparing and maintaining these procedures as described in the guidance will take approximately 5.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 12).
An appropriately identified reserve sample that is representative of each lot or batch of drug product must be retained and stored under conditions
FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 13) will individually establish and maintain approximately 12 procedures and records for reserve samples (“Records per Recordkeeper” in table 1, row 13) for drug products. FDA also estimates that preparing and maintaining these procedures and records as described in the guidance will take approximately 0.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 13).
FDA estimates the burden of this collection of information as follows:
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Su-Chiao Kuo for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Kuo was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Kuo was given notice of the proposed
This order is applicable December 11, 2018.
Submit applications for termination of debarment to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Kenny Shade, Division of Enforcement, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640.
Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) permits debarment of an individual if FDA finds that the individual has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and if FDA finds that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.
On January 14, 2014, in the United States District Court for the Northern District of Ohio, judgment was entered against Dr. Kuo after she entered a plea of guilty to one count of misbranding, in violation of section 301(a) of the FD&C Act (21 U.S.C. 331(a)), which is a misdemeanor offense under section 303(a)(1) of the FD&C Act (21 U.S.C. 333(a)(1)).
FDA's finding that debarment is appropriate is based on the misdemeanor conviction referenced herein. The factual basis for this conviction is as follows: Between June 22, 2005, and November 18, 2008, Dr. Kuo was a physician (oncologist) in Ohio. During this time, Dr. Kuo purchased and received oncology drugs, including TAXOTERE (docetaxel) and ZOMETA (zoledronic acid), from a drug distributor located in Canada. These new drugs originated outside the United States and were not approved by FDA for introduction or delivery for introduction into interstate commerce in the United States. Thus, Dr. Kuo caused the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded for lacking adequate directions for use in their labeling.
As a result of this conviction, on July 13, 2018, FDA sent Dr. Kuo a notice by certified mail proposing to debar her for 3 years from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding under section 306(b)(2)(B)(i)(I) of the FD&C Act that Dr. Kuo was convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.
The proposal offered Dr. Kuo an opportunity to request a hearing, provided her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Dr. Kuo received the proposal on July 23, 2018. Dr. Kuo did not request a hearing within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and has waived any contentions concerning her debarment (21 CFR part 12).
Therefore, the Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to the Director (Staff Manual Guide 1410.35), finds that Dr. Su-Chiao Kuo has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.
As a result of the foregoing findings and in consideration of the factors described in section 306(c)(3) of the FD&C Act, Dr. Su-Chiao Kuo is debarred for 3 years from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see
Any application by Dr. Kuo for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA-2018-N-1990 and sent to the Dockets Management Staff (see
Publicly available submissions will be placed in the docket and will be viewable at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. David J. Fishman for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Fishman was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Fishman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Fishman failed to request a hearing. Dr. Fishman's failure to
This order is applicable December 11, 2018.
Submit applications for termination of debarment to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Kenny Shade, Division of Enforcement, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640.
Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) permits debarment of an individual if FDA finds that the individual has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and if FDA finds that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.
On November 19, 2013, in the United States District Court for the Northern District of Ohio, judgment was entered against Dr. Fishman after he entered a plea of guilty to one count of misbranding, in violation of section 301(a) of the FD&C Act (21 U.S.C. 331(a)), which is a misdemeanor offense under section 303(a)(1) of the FD&C Act (21 U.S.C. 333(a)(1)).
FDA's finding that debarment is appropriate is based on the misdemeanor conviction referenced herein. The factual basis for this conviction is as follows: Between January 10, 2006, and March 12, 2009, Dr. Fishman was a physician (oncologist) in Ohio. During this time, Dr. Fishman purchased and received oncology drugs, including TAXOTERE (docetaxel) and NOVANTRONE (mitoxantrone), from a drug distributor located in Canada. These new drugs originated outside the United States and were not approved by FDA for introduction or delivery for introduction into interstate commerce in the United States. Thus, Dr. Fishman caused the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded for lacking adequate directions for use in their labeling.
As a result of this conviction, on July 27, 2018, FDA sent Dr. Fishman a notice by certified mail proposing to debar him for 3 years from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding under section 306(b)(2)(B)(i)(I) of the FD&C Act that Dr. Fishman was convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.
The proposal offered Dr. Fishman an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Dr. Fishman received the proposal on August 2, 2018. Dr. Fishman did not request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and has waived any contentions concerning his debarment (21 CFR part 12).
Therefore, the Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to the Director (Staff Manual Guide 1410.35), finds that Dr. David J. Fishman has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.
As a result of the foregoing findings and in consideration of the factors described in section 306(c)(3) of the FD&C Act, Dr. David J. Fishman is debarred for 3 years from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see
Any application by Dr. Fishman for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA-2018-N-1994 and sent to the Dockets Management Staff (see
Publicly available submissions will be placed in the docket and will be viewable at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
The meeting will be held on February 6, 2019, from 8:30 a.m. to 5 p.m. and on February 7, 2019 from 8 a.m. to 1 p.m.
FDA White Oak Conference Center, Bldg. 31, Rm. 1503 (the Great Room), 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
Caryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, email:
• MR0000020: General Loose;
• MR0000021: General Dry Mint Portion Original Mini;
• MR0000022: General Portion Original Large;
• MR0000024: General Classic Blend Portion White Large-12ct;
• MR0000025: General Mint Portion White Large;
• MR0000027: General Nordic Mint Portion White Large-12ct;
• MR0000028: General Portion White Large; and
• MR0000029: General Wintergreen Portion White Large.
The second session will convene, after the first session has concluded, on February 6, 2019, and continue on February 7, 2019. During the second session the Committee will discuss the MRTPA, submitted by Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company LLC for the following smokeless tobacco product:
• MR0000108: Copenhagen Snuff Fine Cut.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Caryn Cohen (see:
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal Claims, 717 Madison Place NW, Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, MD 20857; (301) 443-6593, or visit our website at:
The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10
A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the
Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:
1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and
2. Any allegation in a petition that the petitioner either:
a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or
b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.
In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading “For Further Information Contact”), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of HHS) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.
Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). ACBTSA is a Federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.
All nominations must be received no later than 4:00 p.m. ET on Friday, December 28 2018 at the address listed below.
All nominations should be sent to the ACBTSA email address at
Mr. James Berger, Senior Advisor for Blood and Tissue Policy. Contact information for Mr. Berger is provided above.
A copy of the Committee charter and roster of the current membership can be obtained by contacting Mr. Berger or by
The ACBTSA provides advice to the Secretary through the Assistant Secretary for Health. The Committee advises on a range of policy issues to include: (1) Broad public health, ethical and legal issues related to transfusion and transplantation safety, (2) risk communications related to blood transfusion and tissue transplantation, and (3) the identification of public health issues that affect the availability of blood, blood products, and tissues.
The Committee consists of 23 voting members; 14 public members, including the Chair, and nine (9) individuals designated to serve as official representative members. The public members are selected from State and local organizations, patient advocacy groups, provider organizations, academic researchers, ethicists, physicians, surgeons, scientists, risk communication experts, consumer advocates, and from among communities of persons who are frequent recipients of blood or blood products or who have received tissues or organs. The nine individuals who are appointed as official representatives are selected to serve the interests of the blood, blood products, tissue and organ professional organizations or business sectors. The representative members are selected from the following groups: The AABB (formerly the American Association of Blood Banks); American Association of Tissue Banks; Eye Bank Association of America; Association of Organ Procurement Organizations; and one of either the American Red Cross or America's Blood Centers. The Committee composition can include additional representation from either the plasma protein fraction community or a trade organization; a manufacturer of blood, plasma, or other tissue/organ test kits; a manufacturer of blood, plasma or other tissue/organ equipment; a major hospital organization; or a major hospital accreditation organization. Where more than one company produces a specified product or process, representatives from those companies shall rotate on the same schedule as public members.
All ACBTSA members are authorized to receive the prescribed per diem allowance and reimbursement for travel expenses that are incurred to attend meetings and conduct Committee-related business, in accordance with Standard Government Travel Regulations. Individuals who are appointed to serve as public members are authorized also to receive a stipend for attending Committee meetings and to carry out other Committee-related business. Individuals who are appointed to serve as representative members for a particular interest group or industry are not authorized to receive a stipend for the performance of these duties.
This announcement is to solicit nominations of qualified candidates to five public member positions on the ACBTSA.
In accordance with the charter, persons nominated for appointment as members of the ACBTSA should be among authorities knowledgeable in blood banking, tissue banking, transfusion medicine, organ or tissue transplantation, plasma therapies, transfusion and transplantation safety, bioethics, socioeconomics, health policy/law, and/or related disciplines. Nominations should be typewritten. The following information should be included in the package of material submitted for each individual being nominated for consideration of appointment: (a) The name, return address, daytime telephone number and affiliation(s) of the individual being nominated, the basis for the individual's nomination, the category for which the individual is being nominated, and a statement bearing an original signature of the nominated individual that, if appointed, he or she is willing to serve as a member of the Committee; (b) the name, return address, and daytime telephone number at which the nominator may be contacted. Organizational nominators must identify a principal contact person in addition to the contact; and (c) a copy of a current curriculum vitae or resume for the nominated individual.
Individuals can nominate themselves for consideration of appointment to the Committee. All nominations must include the required information. Incomplete nominations will not be processed for consideration. The letter from the nominator and certification of the nominated individual must bear original signatures; reproduced copies of these signatures are not acceptable.
The Department is legally required to ensure that the membership of HHS Federal advisory committees is fairly balanced in terms of points of view represented and the functions to be performed by the advisory committee. Every effort is made to ensure that the views of women, all ethnic and racial groups, and people with disabilities are represented on HHS Federal Advisory committees and, therefore, the Department encourages nominations of qualified candidates from these groups. The Department also encourages geographic diversity in the composition of the committee. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status.
The Standards of Ethical Conduct for Employees of the Executive Branch are applicable to individuals who are appointed as public members of Federal advisory committees. Individuals appointed to serve as public members of Federal advisory committees are classified as special government employees (SGEs). SGEs are government employees for purposes of the conflict of interest laws. Therefore, individuals appointed to serve as public members of the ACBTSA are subject to an ethics review. The ethics review is conducted to determine if the individual has any interests and/or activities in the private sector that may conflict with performance of their official duties as a member of the Committee. Individuals appointed to serve as public members of the committee will be required to disclose information regarding financial holdings, consultancies, and research grants and/or contracts.
National Institutes of Health, HHS.
Notice.
The National Toxicology Program (NTP) announces availability of the Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin for public comment prior to peer review. In partnership with the National
NTP will also announce the meeting date in an email Listserv notice. Persons can subscribe to news updates at
Ms. Canden Byrd, ICF, 2635 Meridian Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1660, Fax: (919) 293-1645, Email:
Sarin is a highly toxic organophosphorus nerve agent that was developed for chemical warfare during World War II and continues to be used as a weapon. The draft NTP monograph presents the results of the systematic review to evaluate the evidence for long-term neurological effects in humans following acute, sub-lethal exposure to sarin with consideration of human, experimental animal, and mechanistic date.
Long-term neurological effects of acute exposure to sarin are not well characterized. Previous reviews of potential health effects of sarin have generally not assessed individual study quality or considered multiple evidence streams (human, animal, and mechanistic data). In addition, the interpretation of effects of sarin in some previous reviews was compounded by concurrent exposure to multiple chemicals, such as assessments of health effects in military personnel during the Gulf War or other conflicts.
The deadline for submission of written comments is January 17, 2019. Written public comments should be submitted through the meeting website. Persons submitting written comments should include name, affiliation, mailing address, phone, email, and sponsoring organization (if any). Written comments received in response to this notice will be posted on the NTP website, and the submitter will be identified by name, affiliation, and sponsoring organization (if any). Comments that address scientific or technical issues will be forwarded to the peer-review panel and NTP staff prior to the meeting.
The agenda will allow for one oral public comment period (up to 12 commenters, up to 5 minutes per speaker). The deadline for registration to provide oral comments will be announced at
If possible, oral public commenters will be asked to send a copy of their slides and/or statement or talking points to Canden Byrd by email:
Following the meeting, a report of the peer review will be prepared and made available on the NTP website.
National Institutes of Health, HHS.
Notice.
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs,
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Angela Jones, Program Coordinator, Center for Cancer Training, National Cancer Institute, 9609 Medical Center Drive, Room 2W-236, Bethesda, Maryland, 20892 or call non-toll-free number (240) 276-5659 or Email your request, including your address to:
This proposed information collection was previously published in the
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden are 200 hours.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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,
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until February 11, 2019.
All submissions received must include the OMB Control Number 1615-0102 in the body of the letter, the agency name and Docket ID USCIS-2008-0028. To avoid duplicate submissions, please use only
(1)
(2)
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW, Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until January 10, 2019.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at
You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW, Washington, DC 20529-2140, Telephone number (202) 272-8377 (This is not a toll-free number; comments are not accepted via telephone message.). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
The information collection notice was previously published in the
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until February 11, 2019.
All submissions received must include the OMB Control Number 1615-0051 in the body of the letter, the agency name and Docket ID USCIS-2005-0032. To avoid duplicate submissions, please use only
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USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW, Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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Office of the Assistant Secretary for Housing-Federal Housing Commissioner and Office of the Assistant Secretary for Public and Indian Housing, HUD.
Notice.
This notice announces a change to the Rental Assistance Demonstration (RAD) regarding conversions to project-based rental assistance under RAD's Second Component.
The RAD Supplemental Notice, PIH 2018-22/H 2018-11, is operative December 11, 2018.
Interested persons are invited to submit questions or comments electronically to
To assure a timely response, please direct requests for further information electronically to the email address
RAD, initially authorized by the Consolidated and Further Continuing Appropriations Act, 2012 (Pub. L. 122-55, signed November 18, 2011) (2012 Appropriations Act), allows for the conversion of assistance under the public housing, Rent Supplement (Rent Supp), Rental Assistance (RAP), Moderate Rehabilitation (Mod Rehab), and Mod Rehab Single Room Occupancy (SRO) programs (collectively, “covered programs”) to long-term, renewable assistance under the Section 8 project based voucher (PBV) or project based rental assistance (PBRA) programs. The most recent version of the RAD program notice is PIH 2012-32/Housing 2017-03, REV-3, which has been amended by supplemental guidance published July 2, 2018, is located at
This notice announces the posting of a second supplement to the most current notice PIH 2012-32/Housing 2017-03 REV-3 (RAD Supplemental Notice 3.B, PIH 2018-22/H 2018-11). As provided by the RAD Statute (Section 237 of Title II, Division L, Transportation, Housing and Urban Development, and Related Agencies, of the Consolidated Appropriations Act, 2018, Pub. L. 115-141), this notice addresses the requirement that the demonstration may proceed after HUD publishes the terms of the notice in the
In order to maximize the resources available to make property improvements for low-income households living in properties converting under the Second Component of RAD and to align RAD requirements more closely with the underlying PBRA statutory and regulatory requirements related to the Davis-Bacon Act of 1931, the Supplemental Program Notice clarifies that execution of a PBRA contract as a result of the conversion of Rent Supp, RAP, Mod Rehab, or Mod Rehab SRO contracts through RAD after the publication of this notice does not trigger Davis-Bacon prevailing wage requirements.
The RAD Supplemental Notice (PIH 2018-22/H 2018-11) can be found on RAD's website,
A Finding of No Significant Impact (FONSI) with respect to the environment has been made in accordance with HUD regulations in 24 CFR part 50, which implemented section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI is available for public inspection during regular business hours in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW, Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the FONSI by calling the Regulations Division at (202) 708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service at (800) 877-8339.
Fish and Wildlife Service, Interior.
Notice of receipt of permit applications.
We, the U.S. Fish and Wildlife Service (Service), invite the public to comment on applications to conduct certain activities with foreign species that are listed as endangered under the Endangered Species Act (ESA) and foreign or native species for which the Service has jurisdiction under the Marine Mammal Protection Act (MMPA). With some exceptions, the ESA and the MMPA prohibit activities with listed species unless Federal authorization is acquired that allows such activities. The ESA and MMPA also require that we invite public comment before issuing permits for activities involving endangered species or marine mammals.
We must receive comments by January 10, 2019.
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For more information, see Public Comment Procedures under
Brenda Tapia, by phone at 703-358-2104, via email at
You may submit your comments and materials by one of the methods in
When submitting comments, please specify the name of the applicant and the permit number at the beginning of your comment. Please make your requests or comments as specific as possible, confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Provide sufficient information to allow us to authenticate any scientific or commercial data you include. The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) those that include citations to, and analyses of, the applicable laws and regulations.
You may view and comment on others' public comments on
If you submit a comment at
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
We invite comments on the following applications.
The applicant requests a permit to import scientific samples of ocelot (
The applicant requests a permit to purchase a captive-born snow leopard (
The applicant requests a permit to import scientific samples of Verreaux's sifaka (
The applicant requests a permit to export two male and two female captive-bred African wild dogs (
The applicant requests a permit to import scientific samples of leatherback sea turtles (
The applicant requests a permit to export wild Lee County cave isopods (
The applicant requests authorization to import biological samples from captive-bred and wild orangutans (
The applicant requests a permit to import biological samples of wild roseate terns (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for barasingha (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following families:
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for Arabian oryx (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for African wild dogs (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for African wild ass (
The following applicants request permits to import sport-hunted trophies of male bontebok (
The applicant requests renewal of a permit to conduct research activities on polar bears (
If we issue permits to any of the applicants listed in this notice, we will publish a notice in the
We issue this notice under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Bureau of Indian Affairs, Interior.
Notice.
The Assistant Secretary—Indian Affairs has made a final determination to acquire 6.14 acres, more or less, into trust for the Dry Creek Rancheria Band of Pomo Indians, California on October 24, 2018.
Ms. Sharlene M. Round Face, Bureau of Indian Affairs, Division of Real Estate Services, 1849 C Street NW, MS-4642-MIB, Washington, DC 20240, telephone (202) 208-3615.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by part 209 of the Departmental Manual, and is published to comply with the requirement of 25 CFR 151.12(c)(2)(ii) that notice of the decision to acquire land in trust be promptly published in the
The Land Referred To Herein Below Is Situated In The State Of California, County Of Sonoma, Unincorporated And Described As Follows:
Being a portion of the Northwest quarter of Section 2, Township 9 North, Range 9 West Mount Diablo Meridian and lying in the Rancho Sotoyome, said portion being more particularly described as follows:
BEGINNING at a 2″ iron pipe on the Township line between Township 10 North, Range 9 West and Township 9 North, Range 9 West, said pipe marks the boundary between the lands of Basalt Rock Company, Inc., recorded in Book 1665 of Official Records, Page 241 and P. and F. Di Regolo, recorded in Book 1634 of Official Records, Page 591; thence South 35°15′ East 1679.33 feet to a 3/4″ iron pipe at the Northerly edge of the Healdsburg-Alexander Valley County Road, at Engineer's Station “A” 145 + 01.80; thence along the County Road, South 47°18′30″ West, 21.95 feet; thence South 45°22′30″ West 148.07 feet; thence South 44°18′20″ West 84.12 feet; thence South 48°43′10″ West 110.03 feet; thence North 41°16′50″ West, 4.96 feet; thence South 47°27′ West 200.00 feet; thence North 42°33′ West, 3.32 feet; thence South 47°18′30″ West, 49.0 feet; thence North 42°41′30″ West 3.0 feet; thence South 47°18′30″ West 316.0 feet; thence North 42°41′30″ West, 20.0 feet; thence South 47°18′30″ West, 178.11 feet; thence curving to the right from a tangent that bears South 47°18′30″ West with a radius of 700.00 feet for a distance of 132.0 feet; thence North 31°53′15″ West 30.0 feet; thence curving to the right from a tangent that bears South 58°06′45″ West, with a radius of 670.00 feet for a distance of 125.85 feet to the true point of beginning of the hereinafter described parcel of land.
Beginning at the point above described as the TRUE POINT OF BEGINNING: thence curving to the right along the Northerly edge of the Healdsburg-Alexander Valley County Road, from a tangent that bears South 68°52′30″ West, with a radius of 670.0 feet for a distance of 450.92 feet; thence North 76°10′10″ West, 79.51 feet; thence North 72°33′50″ West 361.76 feet to the lands of McCutchan; thence leaving said County Road, North 1°00′ East 200.33 feet to a
A nonexclusive right of way for purposes of ingress and egress over the following described parcel of land:
BEGINNING at the point above described as the true point of beginning; thence North 18°45′ East 294.58 feet to a
AN EASEMENT of access to the Russian River from all points on the Northerly boundary of the foregoing 6.14 parcel across the lands of Basalt Rock Company, Inc. contiguous to such boundary and said river. BEING the same land and Easements described as Parcel 2 in Deed recorded in Book 1721 of Official Records, at Page 81, Sonoma County Records.
APN: 091-020-016
Bureau of Land Management, Interior.
Notice of Public Meeting.
In accordance with the Federal Land Policy and Management Act, the Federal Advisory Committee Act, and the Federal Lands Recreation Enhancement Act, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Utah Resource Advisory Council (RAC)/Recreation Resource Advisory Council (RRAC) will meet as indicated below.
The Utah RAC/RRAC will hold a public meeting on January 10 and 11, 2019. The group will meet on January 10, 2019, from 1:00 p.m. to 5:00 p.m. and on January 11, 2019, from 8:00 a.m. to 3:00 p.m.
The meeting will be held at the BLM Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, Utah 84101. Written comments may be sent to the BLM Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, Utah 84101.
Lola Bird, Public Affairs Specialist, BLM Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, Utah 84101; phone (801) 539-4033; or email
Agenda topics will include BLM updates from the State Director, the planning efforts for the Grand Staircase-Escalante and Bears Ears National Monuments, Washington County issues, recreation fee proposals, and other planning updates.
A public comment period will take place on January 11, 2019, from 1:00 p.m. to 1:30 p.m., where the public may address the RAC/RRAC. Depending on the number of people who wish to speak, and the time available, the time for individual comments may be limited. Written comments may also be sent to the BLM Utah State Office at the address listed in the
The meeting is open to the public; however, transportation, lodging, and meals are the responsibility of the participating individuals.
Before including your address, phone number, email address, or other personal identifying information in your comments, please be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
43 CFR 1784.4-2.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission (the “Commission”) has determined to review in part the final initial determination (the “ID”) issued by the presiding administrative law judge (“ALJ”) on September 20, 2018, finding a violation of the Tariff Act of 1930, as amended, in connection with certain asserted patents. The Commission has also determined to extend the target date for the completion of this investigation to February 11, 2019.
Ron Traud, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone 202-205-3427. 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
On September 6, 2017, the Commission instituted this investigation based on a complaint filed by Bio-Rad Laboratories, Inc. of Hercules, CA; and Lawrence Livermore National Security, LLC of Livermore, CA (collectively, “complainants”). 82 FR 42115 (Sept. 6, 2017). The complaint (and supplement thereto) alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”) based
On March 6, 2018, the Commission terminated the investigation as to claims 14-17 of the '160 patent; claim 3 of the '664 patent; claims 2, 8, 11, and 14-15 of the '844 patent; claims 2-3 of the '682 patent; and claims 2-4, 9-10, 15, 22, and 27 of the '635 patent.
On September 20, 2018, the ALJ issued the ID, which finds 10X in violation of section 337 as to the '664 patent, the '682 patent, and the '635 patent. On September 28, 2018, the ALJ issued her recommendations on remedy, bond, and the public interest. The ALJ recommended that the Commission issue a limited exclusion order directed to 10X's infringing products and a cease and desist order directed to 10X. The ALJ also recommended a bond of 100 percent of entered value during the Presidential review period.
On October 3, 2018, Complainants and 10X each filed petitions for review. OUII did not file a petition for review. On October 11, 2018, the Complainants, 10X, and OUII filed responses to those petitions.
Having examined the record in this investigation, including the ID, the petitions for review, and the responses thereto, the Commission has determined to review the ID in part. In particular, the Commission has determined to review the following:
(1) Whether 10X indirectly infringes the '682 and '635 patents.
(2) Whether 10X's Chip GB infringes claims 1 and 14 of the '664 patent.
(3) Whether 10X's Chip SE infringes claim 20 of the '160 patent and claim 1 of the '664 patent.
As the petitions and responses thereto have adequately addressed these issues, the Commission does not request any briefing on these issues. The Commission has determined to not review the remainder of the ID.
In connection with the final disposition of this investigation, the Commission may (1) issue an order that could result in the exclusion of the subject articles from entry into the United States, and/or (2) issue a cease and desist order that could result in the respondent being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see
If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.
If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit eight true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-1068”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
December 14, 2018 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 on Inv. Nos. 701-TA-598 and 731-TA-1408 (Final)(Rubber Bands from China). The Commission is currently scheduled to complete and file its determinations and views of the Commission by December 27, 2018.
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.
Notice is hereby given pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. § 16(b)-(h), that a proposed Final Judgment, Stipulation, and Competitive Impact Statement have been filed with the United States District Court for the Western District of North Carolina in
Copies of the Complaint, proposed Final Judgment, and Competitive Impact Statement are available for inspection on the Antitrust Division's website at
Public comment is invited within 60 days of the date of this notice. Such comments, including the name of the submitter, and responses thereto, will be posted on the Antitrust Division's website, filed with the Court, and, under certain circumstances, published in the
The United States of America and the State of North Carolina bring this civil antitrust action to enjoin Defendant, The Charlotte-Mecklenburg Hospital Authority, d/b/a Carolinas HealthCare System (“CHS”), from using unlawful contract restrictions that prohibit commercial health insurers in the Charlotte area from offering patients financial benefits to use less-expensive healthcare services offered by CHS's competitors. These steering restrictions reduce competition resulting in harm to Charlotte area consumers, employers, and insurers.
1. CHS is a North Carolina not-for-profit corporation providing healthcare services with its principal place of business in Charlotte. Its flagship facility is Carolinas Medical Center, a large general acute-care hospital located in downtown Charlotte. It also operates nine other general acute-care hospitals in the Charlotte area.
2. CHS is the dominant hospital system in the Charlotte area, with approximately a 50 percent share of the relevant market, and 2014 revenue of approximately $8.7 billion. Its closest competitor by size is Novant, which owns five general acute care hospitals in the Charlotte area and has less than half
3. CHS exerts market power in its dealings with commercial health insurers (“insurers”). CHS's market power results from its large size, the comprehensive range of healthcare services that it offers, its high market share, and insurers' need to include access to CHS's hospitals-as well as its other facilities and providers-in at least some of their provider networks in insurance plans that cover people in the Charlotte area. CHS's market power is further evidenced by its ability to profitably charge prices to insurers that are higher than competitive levels across a range of services, and to impose on insurers restrictions that reduce competition.
4. CHS's market power has enabled it to negotiate high prices (in the form of high “reimbursement rates”) for treating insured patients. CHS has long had a reputation for being a high-priced healthcare provider. In a 2013 presentation, CHS's internal strategy group recognized that CHS “has enjoyed years of annual reimbursement rate increases that are premium to the market, with those increases being applied to rates that are also premium to the market.”
5. Steering is a method by which insurers offer consumers of healthcare services options to reduce some of their healthcare expenses. Steering typically occurs when an insurer offers consumers a financial incentive to use a lower-cost provider or lower-cost provider network, in order to lower their healthcare expenses.
6. Steering-and the competition from lower-priced healthcare providers that steering animates-threatens CHS's high prices and revenues. In 2013, CHS's internal strategy group surveyed a dozen of CHS's senior leaders, asking them to list the “biggest risks to CHS revenue streams.” Nine of the twelve leaders polled identified the steering of patients away from CHS as one of the biggest risks to CHS's revenues.
7. To protect itself against steering that would induce price competition and potentially require CHS to lower its high prices, CHS has imposed steering restrictions in its contracts with insurers. These restrictions impede insurers from providing financial incentives to patients to encourage them to consider utilizing lower-cost but comparable or higher-quality alternative healthcare providers.
8. Tiered networks are a popular type of steering that insurers use in healthcare markets. Typically, insurers using tiered networks place healthcare providers that offer better value healthcare services (lower cost, higher quality) in top tiers. Patients who use top-tier providers pay lower out-of-pocket costs. For example, for a procedure costing $10,000, a patient might be responsible for paying $3,600 in coinsurance at a lower-tier hospital, but only $1,800 coinsurance to have the same procedure performed at a top-tier hospital.
9. Narrow-network insurance plans are another popular steering tool. Typically, narrow networks consist of a subset of all the healthcare providers that participate in an insurer's conventional network. A consumer who chooses a narrow-network insurance plan typically pays lower premiums, and lower out-of-pocket expenses than a conventional broad-network insurance plan as long as the consumer is willing to choose from the smaller network of providers for his or her healthcare needs.
10. Providers are motivated to have insurers steer towards them, including through an insurer's narrow or tiered network, because of the increased patient volume that accompanies steering. Thus, the ability of insurers to steer gives providers a powerful incentive to be as efficient as possible, maintain low prices, and offer high quality and innovative services. By doing so, providers induce insurers to steer patient volume to them. Individuals and employers that provide health insurance to their employees benefit tremendously from this because they can lower their healthcare expenses.
11. CHS has gained patient volume from insurers steering towards CHS, and has obtained higher revenues as a result. CHS encourages insurers to steer patients toward itself by offering health insurers modest concessions on its market-power driven, premium prices.
12. However, CHS forbids insurers from allowing CHS's competitors to do the same. CHS prevents insurers from offering tiered networks that feature hospitals that compete with CHS in the top tiers, and prevents insurers from offering narrow networks that include only CHS's competitors. By restricting its competitors from competing for-and benefitting from-steered arrangements, CHS uses its market power to impede insurers from negotiating lower prices with its competitors and offering lower-premium plans.
13. CHS also imposes restrictions in its contracts with insurers that impede insurers from providing truthful information to consumers about the value (cost and quality) of CHS's healthcare services compared to CHS's competitors. CHS's restrictions on insurers' price and quality transparency are an indirect restriction on steering, because they prevent patients from accessing information that would allow them to make healthcare choices based on available price and quality information.
14. Because CHS's steering restrictions prevent its competitors from attracting more patients through lower prices, CHS's competitors have less incentive to remain lower priced and to continue to become more efficient. As a result, CHS's restrictions reduce the competition that CHS faces in the marketplace. In the instances in which insurers have steered in other markets and in the few instances in which insurers have steered in the Charlotte area despite CHS's restrictions, insurers have reduced health insurance costs for consumers.
15. Four insurers provide coverage to more than 85 percent of the commerically-insured residents of the Charlotte area. They are: Aetna Health of the Carolinas, Inc., Blue Cross Blue Shield of North Carolina, Cigna Healthcare of North Carolina, Inc., and United Healthcare of North Carolina, Inc.
16. CHS maintains and enforces steering restrictions in its contracts with all four of these insurers. In some instances, the contract language prohibits steering outright. For example, CHS secured a contractual obligation from one insurer that it “shall not directly or indirectly steer business away from” CHS. In other instances, the contract language gives CHS the right to terminate its agreement with the insurer if the insurer engages in steering, providing CHS the ability to deny the insurer and its enrollees access to its dominant hospital system unless the steering ends. Although the contractual language that CHS has imposed varies with each insurer, it consistently creates disincentives that deter insurers from providing to their enrollees truthful information about their healthcare options and the benefits of price and quality competition among healthcare providers that the insurers could offer if they had full freedom to steer.
17. The sale of general acute care inpatient hospital services to insurers (“acute inpatient hospital services”) is a relevant product market. The market includes sales of such services to insurers' individual, group, fully-insured and self-funded health plans.
18. The relevant market does not include sales of acute inpatient hospital services to government payers,
19. Acute inpatient hospital services consist of a broad group of medical and surgical diagnostic and treatment services that include a patient's overnight stay in the hospital. Although individual acute inpatient hospital services are not substitutes for each other (
20. There are no reasonable substitutes or alternatives to acute inpatient hospital services. Consequently, a hypothetical monopolist of acute inpatient hospital services would likely profitably impose a small but significant price increase for those services over a sustained period of time.
21. The relevant geographic market is no larger than the Charlotte area. In this Complaint, the Charlotte area means the Charlotte Combined Statistical Area, as defined by the U.S. Office of Management and Budget, which consists of Cabarrus, Cleveland, Gaston, Iredell, Lincoln, Mecklenburg, Rowan, Stanly, and Union counties in North Carolina, and Chester, Lancaster, and York counties in South Carolina. The Charlotte area has a population of about 2.6 million people.
22. Insurers contract to purchase acute inpatient hospital services from hospitals
23. For these reasons, it is not a viable alternative for insurers that sell health insurance plans to consumers in the Charlotte area to purchase acute inpatient hospital services from providers outside the Charlotte area. Consequently, competition from providers of acute inpatient hospital services located outside the Charlotte area would not likely be sufficient to prevent a hypothetical monopolist provider of acute inpatient hospital services located in the Charlotte area from profitably imposing small but significant price increases for those services over a sustained period of time.
24. An insurer selling health insurance plans to individuals and employers in the Charlotte area must have CHS as a participant in at least some of its provider networks, in order to have a viable health insurance business in the Charlotte area. This gives CHS the ability to impose steering restrictions in its contracts with insurers. When CHS negotiates with insurers for CHS's network participation, CHS typically negotiates the prices and terms of participation for acute inpatient hospital services and other healthcare services, such as outpatient, ancillary, and physician services, at the same time, including services that are located outside the Charlotte area. As a result, CHS's anticompetitive steering restrictions typically apply to all the negotiated services.
25. CHS's maintenance and enforcement of its steering restrictions lessen competition between CHS and the other providers of acute inpatient hospital services in the Charlotte area that would, in the absence of the restrictions, likely reduce the prices paid for such services by insurers. Thus, the restrictions help to insulate CHS from competition, by limiting the ability of CHS's competitors to win more commercially-insured business by offering lower prices.
26. Insurers want to steer towards lower-cost providers and to offer innovative insurance plans that steer. For years, insurers have tried to negotiate the removal of steering restrictions from their contracts with CHS, but cannot because of CHS's market power. In the absence of the steering restrictions, insurers would likely steer consumers to lower-cost providers more than their current contracts with CHS presently permit.
27. As a result of this reduced competition due to CHS's steering restrictions, individuals and employers in the Charlotte area pay higher prices for health insurance coverage, have fewer insurance plans from which to choose, and are denied access to consumer comparison shopping and other cost-saving innovative and more efficient health plans that would be possible if insurers could steer freely. Deprived of the option to benefit from choosing more cost-efficient providers, Charlotte area patients incur higher out-of-pocket costs for their healthcare. Insurers are directly harmed by CHS's imposition of steering restrictions.
28. CHS restricts steering to help insulate itself from price competition, which enables CHS to maintain high prices and preserve its dominant position, and not for any procompetitive purpose. Indeed, when asked under oath whether CHS should limit the ability of insurers to offer tiered networks or narrow networks that exclude CHS, Carol Lovin, CHS's Chief Strategy Officer, said that CHS should not. And when asked her view about the possibility of eliminating CHS's steering restrictions, she testified, “Would I personally be okay with getting rid of them? Yes, I would.” CHS's steering restrictions do not have any procompetitive effects. CHS can seek to avoid losses of revenues and market share from lower cost competitors by competing to offer lower prices and better value than its competitors, rather than imposing rules on insurers that reduce the benefit to its rivals from competing on price.
29. The Court has subject-matter jurisdiction over this action under Section 4 of the Sherman Act, 15 U.S.C. § 4 (as to the claim by the United States); Section 16 of the Clayton Act, 15 U.S.C. § 26 (as to the claim by the State of North Carolina); and 28 U.S.C. §§ 1331, 1337(a), and 1345.
30. The Court has personal jurisdiction over CHS under Section 12 of the Clayton Act, 15 U.S.C. § 22. CHS maintains its principal place of business and transacts business in this District.
31. Venue is proper under 28 U.S.C. § 1391 and Section 12 of the Clayton Act, 15 U.S.C. § 22. CHS transacts business and resides in this District and the events giving rise to the claims occurred in this District.
32. CHS engages in interstate commerce and in activities substantially affecting interstate commerce. CHS provides healthcare services for which employers, insurers, and individual patients remit payments across state lines. CHS also purchases supplies and equipment that are shipped across state lines, and it otherwise participates in interstate commerce.
33. Plaintiffs incorporate paragraphs 1 through 32 of this Complaint.
34. CHS has market power in the sale of acute inpatient hospital services in the Charlotte area.
35. CHS has and likely will continue to negotiate and enforce contracts containing steering restrictions with insurers in the Charlotte area. The contracts containing the steering restrictions are contracts, combinations, and conspiracies within the meaning of Section 1 of the Sherman Act, 15 U.S.C. § 1.
36. These steering restrictions have had, and will likely to continue to have, the following substantial anticompetitive effects in the relevant product and geographic market, among others:
a. protecting CHS's market power and enabling CHS to maintain at supracompetitive levels the prices of acute inpatient hospital services;
b. substantially lessening competition among providers in their sale of acute inpatient hospital services;
c. restricting the introduction of innovative insurance products that are designed to achieve lower prices and improved quality for acute inpatient hospital services;
d. reducing consumers' incentives to seek acute inpatient hospital services from more cost-effective providers; and
e. depriving insurers and their enrollees of the benefits of a competitive market for their purchase of acute inpatient hospital services.
37. Entry or expansion by other hospitals in the Charlotte area has not counteracted the actual and likely competitive harms resulting from CHS's steering restrictions. And in the future, such entry or expansion is unlikely to be rapid enough and sufficient in scope and scale to counteract these harms to competition. Building a hospital with a strong reputation that is capable of attracting physicians and patients is difficult, time-consuming, and expensive. Additionally, new facilities and programs, and typically the expansion of existing facilities and programs, are subject to lengthy licensing requirements, and in North Carolina, to certificate-of-need laws.
38. CHS did not devise its strategy of using steering restrictions for any procompetitive purpose. Nor do the steering restrictions have any procompetitive effects. Any arguable benefits of CHS's steering restrictions are outweighed by their actual and likely anticompetitive effects.
39. The challenged steering restrictions unreasonably restrain trade in violation of Section 1 of the Sherman Act, 15 U.S.C. § 1.
40. The United States and the State of North Carolina request that the Court:
a. adjudge that all of the steering restrictions in the contracts between CHS and any insurer violate Section 1 of the Sherman Act, 15 U.S.C. § 1;
b. enjoin CHS, its officers, directors, agents, employees, and successors, and all other persons acting or claiming to act on its behalf, directly or indirectly, from seeking, agreeing to, or enforcing any provision in any agreement that prohibits or restricts an insurer from engaging, or attempting to engage, in steering towards any healthcare provider;
c. enjoin CHS from retaliating, or threatening to retaliate, against any insurer for engaging or attempting to engage in steering; and
d. award Plaintiffs their costs in this action and such other relief as the Court may deem just and proper.
WHEREAS, Plaintiffs, the United States of America and the State of North Carolina (collectively “Plaintiffs”), filed their Complaint on June 9, 2016; Plaintiffs and Defendant The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health f/k/a Carolinas HealthCare System (collectively the “Parties”), by their respective attorneys, have consented to the entry of this Final Judgment without trial or adjudication of any issue of fact or law;
AND WHEREAS, this Final Judgment does not constitute any evidence against or admission by any party regarding any issue of fact or law;
AND WHEREAS, the Plaintiffs and Defendant agree to be bound by the provisions of this Final Judgment pending its approval by this Court;
AND WHEREAS, the essence of this Final Judgment is to enjoin Defendant from prohibiting, preventing, or penalizing steering as defined in this Final Judgment;
NOW THEREFORE, before any testimony is taken, without trial or adjudication of any issue of fact or law, and upon consent of the parties, it is ORDERED, ADJUDGED, AND DECREED:
The Court has jurisdiction over the subject matter of and each of the Parties to this action. The Complaint states a claim upon which relief may be granted against Defendant under Section 1 of the Sherman Act, as amended, 15 U.S.C. § 1.
For purposes of this Final Judgment, the following definitions apply:
A. “Benefit Plan” means a specific set of health care benefits and Healthcare Services that is made available to members through a health plan underwritten by an Insurer, a self-funded benefit plan, or Medicare Part C plans. The term “Benefit Plan” does not include workers' compensation programs, Medicare (except Medicare Part C plans), Medicaid, or uninsured discount plans.
B. “Carve-out” means an arrangement by which an Insurer unilaterally removes all or substantially all of a particular Healthcare Service from coverage in a Benefit Plan during the performance of a network-participation agreement.
C. “Center of Excellence” means a feature of a Benefit Plan that designates Providers of certain Healthcare Services based on objective quality or quality-and-price criteria in order to encourage patients to obtain such Healthcare Services from those designated Providers.
D. “Charlotte Area” means Cabarrus, Cleveland, Gaston, Iredell, Lincoln, Mecklenburg, Rowan, Stanly, and Union counties in North Carolina and Chester, Lancaster, and York counties in South Carolina.
E. “Co-Branded Plan” means a Benefit Plan, such as Blue Local with Carolinas HealthCare System, arising from a joint venture, partnership, or a similar formal type of alliance or affiliation beyond that present in broad network agreements involving value-based arrangements between an Insurer and Defendant in any portion of the Charlotte Area whereby both Defendant's and Insurer's brands or logos appear on marketing materials.
F. “Defendant” means The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health f/k/a Carolinas HealthCare System, a North Carolina hospital authority with its headquarters in Charlotte, North Carolina; and its directors, commissioners, officers, managers, agents, and employees; its successors and assigns; and any controlled subsidiaries (including Managed Health Resources), divisions, partnerships, and joint ventures, and their directors, commissioners, officers, managers, agents, and employees; and any Person on whose behalf Defendant negotiates contracts with, or consults in the negotiation of contracts with, Insurers. For purposes of this Final Judgment, an entity is controlled by Defendant if Defendant holds 50% or more of the entity's voting securities, has the right to 50% or more of the entity's profits, has the right to 50% or more of the entity's assets on dissolution, or has the contractual power to designate 50% or more of the directors or trustees of the entity. Also for purposes of this Final Judgment, the term “Defendant” excludes MedCost LLC and MedCost Benefits Services LLC, but it does not exclude any Atrium Health director, commissioner, officer, manager, agent, or employee who may also serve as a director, member, officer, manager, agent, or employee of MedCost LLC or MedCost Benefit Services LLC when such director, commissioner, officer, manager, agent, or employee is acting within the course of his or her duties for Atrium Health. MedCostLLC and MedCost Benefits Services LLC will remain excluded from the definition of “Defendant” as long as Atrium does not acquire any greater ownership interest in these entities than it has at the time that this Final Judgment is lodged with the Court.
G. “Healthcare Provider” or “Provider” means any Person delivering any Healthcare Service.
H. “Healthcare Services” means all inpatient services (
I. “Insurer” means any Person providing commercial health insurance or access to Healthcare Provider networks, including but not limited to managed-care organizations, and rental networks (
J. “Narrow Network” means a network composed of a significantly limited number of Healthcare Providers that offers a range of Healthcare Services to an Insurer's members for which all Providers that are not included in the network are out of network.
K. “Penalize” or “Penalty” is broader than “prohibit” or “prevent” and is intended to include any contract term or action with the likely effect of significantly restraining steering through Steered Plans or Transparency. In determining whether any contract provision or action “Penalizes” or is a “Penalty,” factors that may be considered include: the facts and circumstances relating to the contract provision or action; its economic impact; and the extent to which the contract provision or action has potential or actual procompetitive effects in the Charlotte Area.
L. “Person” means any natural person, corporation, company, partnership, joint
M. “Reference-Based Pricing” means a feature of a Benefit Plan by which an Insurer pays up to a uniformly-applied defined contribution, based on an external price selected by the Insurer, toward covering the full price charged for a Healthcare Service, with the member being required to pay the remainder. For avoidance of doubt, a Benefit Plan with Reference-Based Pricing as a feature may permit an Insurer to pay a portion of this remainder.
N. “Steered Plan” means any Narrow Network Benefit Plan, Tiered Network Benefit Plan, or any Benefit Plan with Reference-Based Pricing or a Center of Excellence as a component.
O. “Tiered Network” means a network of Healthcare Providers for which (i) an Insurer divides the in-network Providers into different sub-groups based on objective price, access, and/or quality criteria; and (ii) members receive different levels of benefits when they utilize Healthcare Services from Providers in different sub-groups.
P. “Transparency” means communication of any price, cost, quality, or patient experience information directly or indirectly by an Insurer to a client, member, or consumer.
This Final Judgment applies to Defendant, as defined above, and all other Persons in active concert with, or participation with, Defendant who receive actual notice of this Final Judgment by personal service or otherwise.
A. The contract language reproduced in Exhibit A is void, and Defendant shall not enforce or attempt to enforce it. The contract language reproduced in Exhibit B shall not be used to prohibit, prevent, or penalize Steered Plans or Transparency, but could remain enforceable for protection against Carve-outs. For the Network Participation Agreement between Blue Cross and Blue Shield of North Carolina and Defendant's wholly-owned subsidiary Managed Health Resources, effective January 1, 2014, as amended, Defendant shall exclude from the calculation of total cumulative impact pursuant to Section 6.14 of that agreement any impact to Defendant resulting from Blue Cross and Blue Shield of North Carolina disfavoring Defendant through Transparency or through the use of any Steered Plan.
B. For Healthcare Services in the Charlotte Area, Defendant will not seek or obtain any contract provision which would prohibit, prevent, or penalize Steered Plans or Transparency including:
1. express prohibitions on Steered Plans or Transparency;
2. requirements of prior approval for the introduction of new benefit plans (except in the case of Co-Branded Plans); and
3. requirements that Defendant be included in the most-preferred tier of Benefit Plans (except in the case of Co-Branded Plans). However, notwithstanding this Paragraph IV(B)(3), Defendant may enter into a contract with an Insurer that provides Defendant with the right to participate in the most-preferred tier of a Benefit Plan under the same terms and conditions as any other Charlotte Area Provider, provided that if Defendant declines to participate in the most-preferred tier of that Benefit Plan, then Defendant must participate in that Benefit Plan on terms and conditions that are substantially the same as any terms and conditions of any then-existing broad-network Benefit Plan (
C. Defendant will not take any actions that penalize, or threaten to penalize, an Insurer for (i) providing (or planning to provide) Transparency, or (ii) designing, offering, expanding, or marketing (or planning to design, offer, expand, or market) a Steered Plan.
A. Defendant may exercise any contractual right it has, provided it does not engage in any Prohibited Conduct as set forth above.
B. For any Co-Branded Plan or Narrow Network in which Defendant is the most-prominently featured Provider, Defendant may restrict steerage within that Co-Branded Plan or Narrow Network. For example, Defendant may restrict an Insurer from including at inception or later adding other Providers to any (i) Narrow Network in which Defendant is the most-prominently featured Provider, or (ii) any Co-Branded Plan.
C. With regard to information communicated as part of any Transparency effort, nothing in this Final Judgment prohibits Defendant from reviewing its information to be disseminated, provided such review does not delay the dissemination of the information. Furthermore, Defendant may challenge inaccurate information or seek appropriate legal remedies relating to inaccurate information disseminated by third parties. Also, for an Insurer's dissemination of price or cost information (other than communication of an individual consumer's or member's actual or estimated out-of-pocket expense), nothing in the Final Judgment will prevent or impair Defendant from enforcing current or future provisions, including but not limited to confidentiality provisions, that (i) prohibit an Insurer from disseminating price or cost information to Defendant's competitors, other Insurers, or the general public; and/or (ii) require an Insurer to obtain a covenant from any third party that receives such price or cost information that such third party will not disclose that information to Defendant's competitors, another Insurer, the general public, or any other third party lacking a reasonable need to obtain such competitively sensitive information. Defendant may seek all appropriate remedies (including injunctive relief) in the event that dissemination of such information occurs.
Within fifteen (15) business days of entry of this Final Judgment, Defendant, through its designated counsel, must notify in writing Aetna, Blue Cross and Blue Shield of North Carolina, Cigna, MedCost, and UnitedHealthcare, that:
A. This Final Judgment has been entered (enclosing a copy of this Final Judgment) and that it prohibits Defendant from entering into or enforcing any contract term that would prohibit, prevent, or penalize Steered Plans or Transparency, or taking any other action that violates this Final Judgment; and
B. For the term of this Final Judgment Defendant waives any right to enforce any provision listed in Exhibit A and further waives the right to enforce any provision listed in Exhibit B to prohibit, prevent, or penalize Steered Plans and Transparency.
A. It shall be the responsibility of the Defendant's designated counsel to undertake the following:
1. within fifteen (15) calendar days of entry of this Final Judgment, provide a copy of this Final Judgment to each of Defendant's commissioners and officers, and to each employee whose job responsibilities include negotiating or approving agreements with Insurers for the purchase of Healthcare Services, including personnel within the Managed Health Resources subsidiary (or any successor organization) of Defendant;
2. distribute in a timely manner a copy of this Final Judgment to any person who succeeds to, or subsequently holds, a position of commissioner, officer, or other position for which the job responsibilities include negotiating or approving agreements with Insurers for the purchase of Healthcare Services, including personnel within the Managed Health Resources subsidiary (or any successor organization) of Defendant; and
3. within sixty (60) calendar days of entry of this Final Judgment, develop and implement procedures necessary to ensure Defendant's compliance with this Final Judgment. Such procedures shall ensure that questions from any of Defendant's commissioners, officers, or employees about this Final Judgment can be answered by counsel (which may be outside counsel) as the need arises. Paragraph 21.1 of the Amended Protective Order Regarding Confidentiality shall not be interpreted to prohibit outside counsel from answering such questions.
B. For the purposes of determining or securing compliance with this Final Judgment, or any related orders, or determining whether the Final Judgment should be modified or vacated, and subject to any legally-recognized privilege, from time to time authorized representatives of the United States or the State of North Carolina, including agents and consultants retained by the United States or the State of North Carolina, shall, upon written request of an authorized representative of the Assistant Attorney General in charge of the Antitrust Division or the Attorney General for the State of North Carolina, and on reasonable notice to Defendant, be permitted:
1. access during Defendant's office hours to inspect and copy, or at the option of the
2. to interview, either informally or on the record, Defendant's officers, employees, or agents, who may have their individual counsel present, regarding such matters. The interviews shall be subject to the reasonable convenience of the interviewee and without restraint or interference by Defendant.
C. Within 270 calendar days of entry of this Final Judgment, Defendant must submit to the United States and the State of North Carolina a written report setting forth its actions to comply with this Final Judgment, specifically describing (1) the status of all negotiations between Managed Health Resources (or any successor organization) and an Insurer relating to contracts that cover Healthcare Services rendered in the Charlotte Area since the entry of the Final Judgment, and (2) the compliance procedures adopted under Paragraph VII(A)(3) of this Final Judgment.
D. Upon the written request of an authorized representative of the Assistant Attorney General in charge of the Antitrust Division or the Attorney General for the State of North Carolina, Defendant shall submit written reports or responses to written interrogatories, under oath if requested, relating to any of the matters contained in this Final Judgment as may be requested.
E. The United States may share information or documents obtained under Paragraph VII with the State of North Carolina subject to appropriate confidentiality protections. The State of North Carolina shall keep all such information or documents confidential.
F. No information or documents obtained by the means provided in Paragraph VII shall be divulged by the United States or the State of North Carolina to any Person other than an authorized representative of (1) the executive branch of the United States or (2) the Office of the North Carolina Attorney General, except in the course of legal proceedings to which the United States or the State of North Carolina is a party (including grand jury proceedings), for the purpose of securing compliance with this Final Judgment, or as otherwise required by law.
G. If at the time that Defendant furnishes information or documents to the United States or the State of North Carolina, Defendant represents and identifies in writing the material in any such information or documents to which a claim of protection may be asserted under Rule 26(c)(1)(G) of the Federal Rules of Civil Procedure, and Defendant marks each pertinent page of such material, “Subject to claim of protection under Rule 26(c)(1)(G) of the Federal Rules of Civil Procedure,” the United States and the State of North Carolina shall give Defendant ten (10) calendar days' notice prior to divulging such material in any legal proceeding (other than a grand jury proceeding).
H. For the duration of this Final Judgment, Defendant must provide to the United States and the State of North Carolina a copy of each contract and each amendment to a contract that covers Healthcare Services in the Charlotte Area that it negotiates with any Insurer within thirty (30) calendar days of execution of such contract or amendment. Defendant must also notify the United States and the State of North Carolina within thirty (30) calendar days of having reason to believe that a Provider which Defendant controls has a contract with any Insurer with a provision that prohibits, prevents, or penalizes any Steered Plans or Transparency.
The Court retains jurisdiction to enable any Party to this Final Judgment to apply to the Court at any time for further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify any of its provisions, to enforce compliance, and to punish violations of its provisions.
A. The United States retains and reserves all rights to enforce the provisions of this Final Judgment, including the right to seek an order of contempt from the Court. Defendant agrees that in any civil contempt action, any motion to show cause, or any similar action brought by the United States regarding an alleged violation of this Final Judgment, the United States may establish a violation of the decree and the appropriateness of any remedy therefor by a preponderance of the evidence, and Defendant waives any argument that a different standard of proof should apply.
B. The Final Judgment should be interpreted to give full effect to the procompetitive purposes of the antitrust laws and to restore all competition Plaintiffs alleged was harmed by the challenged conduct. Defendant agrees that it may be held in contempt of, and that the Court may enforce, any provision of this Final Judgment that, as interpreted by the Court in light of these procompetitive principles and applying ordinary tools of interpretation, is stated specifically and in reasonable detail, whether or not it is clear and unambiguous on its face. In any such interpretation, the terms of this Final Judgment should not be construed against either Party as the drafter.
C. In any enforcement proceeding in which the Court finds that Defendant has violated this Final Judgment, the United States may apply to the Court for a one-time extension of this Final Judgment, together with such other relief as may be appropriate. In connection with any successful effort by the United States to enforce this Final Judgment against Defendant, whether litigated or resolved prior to litigation, Defendant agrees to reimburse the United States for the fees and expenses of its attorneys, as well as any other costs including experts' fees, incurred in connection with that enforcement effort, including in the investigation of the potential violation.
Unless the Court grants an extension, this Final Judgment shall expire ten (10) years from the date of its entry, except that after five (5) years from the date of its entry, this Final Judgment may be terminated upon notice by the United States to the Court and Defendant that the continuation of the Final Judgment is no longer necessary or in the public interest.
Entry of this Final Judgment is in the public interest. The Parties have complied with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. § 16, including making copies available to the public of this Final Judgment, the Competitive Impact Statement, any comments thereon, and the United States' responses to comments. Based upon the record before the Court, which includes the Competitive Impact Statement and any comments and responses to comments filed with the Court, entry of this Final Judgment is in the public interest.
Section 2.8 of the Physician Hospital Organization Agreement between and among Aetna Health of the Carolinas, Inc., Aetna Life Insurance Company, Aetna Health Management, LLC, and Defendant states in part:
“Company may not . . . steer Members away from Participating PHO Providers other than instances where services are not deemed to be clinically appropriate, subject to the terms of Section 4.1.3 of this Agreement.”
In addition, Section 2.11 of the above-referenced agreement states in part:
“Company reserves the right to introduce in new Plans . . . and products during the term of this Agreement and will provide PHO with ninety (90) days written notice of such new Plans, Specialty Programs and products. . . . For purposes under (c) and (d) above, Company commits that Participating PHO Providers will be in-network Participating Providers in Company Plans and products as listed on the Product Participation Schedule. If Company introduces new products or benefit designs in PHO's market that have the effect of placing Participating PHO Providers in a non-preferred position, PHO will have the option to terminate this Agreement in accordance with Section 6.3. Notwithstanding the foregoing, if Company introduces an Aexcel performance network in PHO Provider's service area, all PHO Providers will be placed in the most preferred benefit level. As long as such Plans or products do not directly or indirectly steer Members away from a Participating PHO Provider to an alternative Participating Provider for the same service in the same level of care or same setting, the termination provision would not apply.”
The Benefit Plan Exhibit to the Network Participation Agreement between Blue Cross and Blue Shield of North Carolina and
“After meeting and conferring, if parties cannot reach agreement, then, notwithstanding Section 5.1, this Agreement will be considered to be beyond the initial term, and you may terminate this Agreement upon not less than 90 days' prior Written Notice to us, pursuant to Section 5.2.”
Section II.G.5 of the Managed Care Alliance Agreement between Cigna HealthCare of North Carolina, Inc. and Defendant states in part:
“All MHR entities as defined in Schedule 1 will be represented in the most preferred benefit level for any and all CIGNA products for all services provided under this Agreement unless CIGNA obtains prior written consent from MHR to exclude any MHR entities from representation in the most preferred benefit level for any CIGNA product. . . . As a MHR Participating Provider, CIGNA will not steer business away from MHR Participating Providers.”
Section 3.6 of the Participating Physician Hospital Organization agreement between Medcost, LLC and Defendant states in part:
“Plans shall not directly or indirectly steer patients away from MHR Participating Providers.”
Section 2 of the Hospital Participation Agreement between UnitedHealthcare of North Carolina, Inc. and Defendant states in part:
“As a Participating Provider, Plan shall not directly or indirectly steer business away from Hospital.”
Section II.G.5 of the Managed Care Alliance Agreement between Cigna HealthCare of North Carolina, Inc. and Defendant states in part:
“CIGNA may not exclude a MHR Participating Provider as a network provider for any product or Covered Service that MHR Participating Provider has the capability to provide except those carve-out services as outlined in Exhibit E attached hereto, unless CIGNA obtains prior written consent from MHR to exclude MHR Participating Provider as a network provider for such Covered Services.”
Section 2 of the Hospital Participation Agreement between UnitedHealthcare of North Carolina, Inc. and Defendant states in part:
“Plan may not exclude Hospital as a network provider for any Health Service that Hospital is qualified and has the capability to provide and for which Plan and Hospital have established a fee schedule or fixed rate, as applicable, unless mutually agreed to in writing by Plan and Hospital to exclude Hospital as a network provider for such Health Service.”
In addition, Section 3.6 of the above-referenced agreement states in part:
“During the term of this Agreement, including any renewal terms, if Plan creates new or additional products, which product otherwise is or could be a Product Line as defined in this Agreement, Hospital shall be given the opportunity to participate with respect to such new Product Line.”
Plaintiff United States of America (“United States”), pursuant to Section 2(b) of the Antitrust Procedures and Penalties Act (“APPA” or “Tunney Act”), 15 U.S.C. §§ 16(b)-(h), files this Competitive Impact Statement relating to the proposed Final Judgment submitted for entry in this civil antitrust proceeding.
I. NATURE AND PURPOSE OF THE PROCEEDING
On June 9, 2016, the United States and the State of North Carolina filed a civil antitrust lawsuit against The Charlotte-Mecklenburg Hospital Authority, formerly known as Carolinas HealthCare System and now doing business as Atrium Health (“Atrium”), to enjoin it from using steering restrictions in its agreements with health insurers in the Charlotte, North Carolina area. The Complaint alleges that Atrium's steering restrictions are anticompetitive and violate Section 1 of the Sherman Act, 15 U.S.C. § 1, because the restrictions have detrimental effects on competition among healthcare providers in the Charlotte area.
Healthcare providers charge health insurers a wide variety of prices for the same service, but insurers have generally not passed these price differences on to consumers because most commercial health plans offer coverage that is the same no matter which provider a patient chooses. This weakens the connection between price and quantity that is the essence of competition because it allows a provider to charge a high price without losing business to rivals. To control escalating healthcare costs, insurers have developed health plans and plan features that “steer” members by providing financial incentives that enable members to share savings by choosing more cost-effective providers, which stimulates competition between providers. To enable patients to choose more cost-effective providers, insurers also provide members with transparency about the prices, quality, patient experience, or anticipated out-of-pocket costs at different healthcare providers.
Atrium is the largest health system in the Charlotte area. For an insurer to maintain a competitive health insurance business in the Charlotte area, it needs to have a contractual relationship with Atrium that gives employers and consumers the option of purchasing insurance that covers care there.
Atrium has used its dominant position to demand contractual restrictions on steering and transparency that interfere with the competitive process. Insurers that contract with Atrium are prohibited from providing financial incentives or information that would encourage consumers to obtain healthcare services from competing providers. These contract provisions significantly reduce the number of additional patients that Atrium's competitors can hope to attract by agreeing to lower prices or otherwise providing greater value. These restrictions have been in Atrium's contracts for years, and remain to this day.
Atrium's steering restrictions reduce the competitive incentive that Atrium's competitors would otherwise have to lower prices in order to win more business. This interference in the competitive process has reduced competition between Atrium and other healthcare providers in the Charlotte area. In addition, because many of the most innovative healthcare plans in the country today are based on steering to more efficient providers, Atrium's steering restrictions have also curbed the introduction of such plans, and reduced choices for Charlotte-area consumers.
Plaintiffs and Atrium have entered into a Stipulation and proposed Final Judgment. The proposed Final Judgment enjoins Atrium from (1) enforcing provisions in its current insurer contracts that restrict steering and transparency; (2) seeking or obtaining contract provisions with an insurer that would prohibit, prevent, or penalize the insurer from using popular steering methods or providing transparency; and (3) penalizing, or threatening to penalize, any insurer for its use of these popular steering methods and transparency. The proposed Final Judgment is described in detail beginning with Section III below. In the Stipulation, Atrium agrees to abide by the injunctive provisions of the proposed Final Judgment while awaiting its entry by the Court.
The United States (unless it has withdrawn its consent), the State of North Carolina, and Atrium have stipulated that the Court may enter the proposed Final Judgment at any time after compliance with the APPA. Entry of the proposed Final Judgment would terminate this action, except that the Court would retain jurisdiction to construe, modify, or enforce the provisions of the proposed Final Judgment and to punish violations thereof.
Atrium is the largest healthcare system in North Carolina and one of the largest not-for-profit healthcare systems in the United States. It is the dominant hospital system in the Charlotte area. Its flagship facility is Carolinas Medical Center, a general acute-care hospital located near downtown Charlotte and the largest hospital in North Carolina. Atrium also operates nine additional general acute-care hospitals in the Charlotte area. Atrium owns, manages, or has strategic affiliations with over 40 hospitals in the Carolinas, and sells healthcare services throughout the Carolinas, including in
In addition to Atrium's ten Charlotte-area hospitals, there are eleven other general acute-care hospitals in the Charlotte area. The next largest hospital system, Novant Health (“Novant”), owns five general acute-care hospitals located in that area and had operating revenue of approximately $4.6 billion in 2017, making Novant less than half the size of Atrium. Novant's largest hospital in the Charlotte area is Novant Presbyterian Medical Center, which is the second-largest hospital in Charlotte. After Novant, the next-largest hospital in the Charlotte area is CaroMont Regional Medical Center. CaroMont Regional Medical Center is a 370-bed hospital in Gastonia, North Carolina, and is owned and operated by CaroMont Health, an independent community hospital system. In 2016, CaroMont Health had net operating revenue of approximately $529 million. The remaining hospitals in the Charlotte area are operated by Community Health Systems, Inc., Tenet Healthcare Corporation, and Iredell Health System.
The Complaint alleges that Atrium has market power in a relevant market for the sale of general acute care inpatient hospital services sold to commercial health insurers (“GAC inpatient hospital services”) in the Charlotte area. GAC inpatient hospital services consist of a broad group of medical and surgical diagnostic and treatment services that includes a patient's overnight stay in the hospital. Although individual GAC inpatient hospital services are not substitutes for each other (
The relevant geographic market for the sale of GAC inpatient hospital services is no larger than the Charlotte area.
Atrium is the dominant seller of GAC inpatient hospital services in the Charlotte area. Atrium has market power in this market. The market for GAC inpatient hospital services in the Charlotte area is highly concentrated, and Atrium's market share is more than 55 percent. By comparison, Atrium's largest rival, Novant Health, has approximately 17 percent of the licensed hospital beds in the Charlotte area. Without an attractive broad-network plan that includes Atrium, insurers would not be viable in the Charlotte area because they would not be able to attract the business of employers. Atrium's size and breadth give it significant market power because it can decline to participate in an insurer's network unless it obtains high prices and advantageous contract terms.
As a result of its market power, Atrium has been able to secure from insurers high prices relative to other hospital systems in the Charlotte area and relative to other advanced medical centers in North Carolina. These higher prices are not explained by any measure of relative high-quality. Because of high provider prices, patients' out-of-pocket healthcare costs in the Charlotte area are among the highest in North Carolina.
Employers in Charlotte and elsewhere around the country have approached health insurers about ways to address rising healthcare costs. One approach of increasing interest is the introduction of steering mechanisms into the health plans that employers offer. Steering can be one way of fostering competition among hospitals.
Steering can be accomplished in several ways. Popular types of steering in healthcare are narrow networks and tiered networks, reference-based pricing, and centers of excellence.
In addition to offering the broad-network plans that are most popular with employers, insurers in Charlotte want to introduce narrow network and tiered insurance options. Narrow networks are formed by using cost and/or quality criteria to select and contract with a subset of healthcare providers in an area. For example, a health plan sold in the Charlotte area that consists of hospitals and physicians only at Novant, CaroMont, and Community Health Systems would be a narrow-network plan. Because using an in-network provider costs a member less than using an out-of-network provider, a consumer that enrolls in a narrow-network plan is choosing to be steered to participating providers. The likely increase in patient volume realized by providers in the narrow network can help the insurer to negotiate lower prices, and then to pass those savings along in the form of lower premiums.
Tiered networks are typically created by designating network providers into different levels (or tiers) based mostly on quality and price. Tiered networks typically have two or more tiers of in-network providers: a preferred tier and one or more secondary in-network tiers. There may also be providers that remain out-of-network. In tiered networks, members are free to use any of the providers, but receive the most substantial benefits when they choose a provider in the preferred tier. This tier typically includes the providers with the best mix of quality and price. Tiered and narrow network plans are increasingly popular with employers and consumers. For example, in 2017, 19 percent of large employers that offered healthcare coverage provided a narrow-network plan to their employees and 31 percent offered a tiered plan.
Reference-based pricing and centers of excellence are forms of steering that can be used as a feature of a health benefit plan. For reference-based pricing, the insurer establishes a market-wide standard, or “reference,” price for a service. The reference price can be established by drawing from average local prices or from other sources such as the reimbursement amounts established by Medicare rules. The benefit plan covers the member's expenses up to the “reference price.” Reference-based pricing steers members towards the providers that have prices at or below the reference price. This gives higher-priced providers an incentive to reduce their prices to be closer to the reference price.
A center of excellence is a designation that an insurer applies to a provider for its quality and/or cost efficiency in delivering a particular healthcare service. The insurer often provides a financial incentive to consumers to select the center of excellence. For example, an insurer may designate a particular hospital in a metropolitan area as
Transparency is the communication of price, cost, quality, or patient experience information to a member. Transparency makes steered plans more effective by providing consumers with information to enable them to comparison shop before selecting a provider. Transparency may also be a form of steering even in the absence of differential benefits because information that identifies one provider as more cost effective than another provider may prompt consumers to choose the more cost-effective provider.
To protect its dominant share and high prices and insulate itself from competition, Atrium has used its market power to require every major insurer in the Charlotte area— Aetna Health of the Carolinas, Inc. (“Aetna”), Blue Cross and Blue Shield of North Carolina (“BCBS-NC”), Cigna Healthcare of North Carolina, Inc. (“Cigna”), and United Healthcare of North Carolina, Inc. (“UnitedHealthcare”)
Atrium's contracts with each of these insurers contain steering restrictions that either expressly prohibit the insurer from steering their members away from Atrium, or impede steering through other means, such as by imposing a financial penalty on any steering against Atrium that exceeds a specified amount or by allowing Atrium to promptly terminate the insurer's contract if the insurer steers against Atrium. Atrium used its market power to require that insurers agree to these contract provisions that restrict steering, and thereby restrict competition.
Atrium's steering restrictions restrain insurers from offering consumers the choice of narrow-network plans that do not include Atrium, and tiered-network plans that do not place Atrium in the most favorable tier. Atrium's steering restrictions also prevent insurers from offering reference-based pricing because if the reference price for a service is lower than the price that Atrium charges for that service, members will be steered away from Atrium. Insurers are also prevented from offering financial incentives for members to obtain services at non-Atrium providers that are designated centers of excellence.
These restrictions also prevent insurers from providing members transparency into the price, quality, patient experience, and anticipated out-of-pocket costs of Atrium's healthcare services compared to Atrium's competitors. Atrium's restrictions on transparency indirectly restrict steering because they inhibit consumers from accessing information that would allow them to make better-informed healthcare provider choices.
Deprived of any mechanism to reward low prices with more patient volume, insurers cannot create incentives for Atrium's rivals to compete on price. Atrium's steering restrictions, therefore, reduce competition for GAC inpatient hospital services in the Charlotte area by impeding its competitors' ability to attract patients by offering lower prices to insurers and their members. The steering restrictions prevent consumers from benefitting from lower prices, so they protect Atrium from losing patient volume in response to high prices. This reduction in competition causes prices to be higher than they would be in the absence of Atrium's steering restrictions.
The purpose of the proposed Final Judgment is to prevent Atrium from impeding insurers' steered plans and transparency, and to restore competition among healthcare providers in the Charlotte area. The proposed Final Judgment will accomplish this objective through injunctive, compliance, and enforcement provisions.
Atrium has market power in GAC inpatient hospital services, but the proposed Final Judgment applies to the broad range of healthcare services that Atrium provides and to which its steering restrictions apply. The additional healthcare services covered by the proposed Final Judgment include outpatient services (such as ambulatory surgeries and radiological services), professional services rendered by physicians, and ancillary services such as imaging and lab services. The full scope of services covered by the proposed Final Judgment falls within the proposed Final Judgment's definition of “Healthcare Services.” Because Atrium uses its market power to restrict steering away from it for any healthcare service, the proposed Final Judgment provides relief that is broader than the set of services in the relevant market.
The proposed Final Judgment also applies to a broad range of benefit plans. This includes health insurance policies sold to individuals, fully-insured and self-funded health plans sold to employers and other groups, and Medicare Advantage plans.
The proposed Final Judgment seeks to restore competition by prohibiting Atrium from engaging in specific conduct. There are three main provisions. The first stops Atrium from enforcing the current contract provisions at issue in this suit. The second stops Atrium from enforcing similar or new contractual provisions that would restrict steering in the Charlotte area. The third stops Atrium from retaliating against insurers for steering in the Charlotte area.
The proposed Final Judgment eliminates the contractual language that Plaintiffs alleged is anticompetitive. The proposed Final Judgment voids the contractual provisions listed in Exhibit A to the proposed Final Judgment that expressly prevent steering. For example, a provision stating that an insurer “will not steer business away from” Atrium is voided from that insurer's contract. Additionally, a part of a contract between Atrium and an insurer that required the insurer to give Atrium 90 days' notice before bringing a plan to market that would steer patients away from Atrium is also voided. Further, the proposed Final Judgment eliminates a provision in one insurer's contract that allows Atrium to terminate the contract on 90 days' notice if the insurer offers a plan that would steer away from Atrium.
In addition, Atrium's contracts with commercial insurers contain other provisions that require the insurer to include Atrium in all of its benefit plans. Each such provision prevents the insurer from creating narrow networks that feature Atrium's rivals, but exclude Atrium. The proposed Final Judgment lists that language in Exhibit B, and prohibits Atrium from enforcing or attempting to enforce such contractual provisions to prevent, prohibit, or penalize steered plans and transparency.
Finally, the proposed Final Judgment prevents Atrium from enforcing a “material impact” provision in its contract with BCBS-NC in a manner that reduces BCBS-NC's incentives to steer to more efficient providers.
The proposed Final Judgment also prevents Atrium from seeking or obtaining similar or new contract provisions that would prohibit, prevent, or penalize steering through steered plans or transparency in the Charlotte area.
Paragraph IV(B) of the proposed Final Judgment identifies three types of contractual provisions that, among others, would prohibit, prevent, or penalize steering through steered plans and would thus violate the terms of the proposed Final Judgment. First, Atrium may not expressly prohibit
The Final Judgment's injunction against steering restrictions also reaches beyond these three existing provisions to include any contract provision that prohibits, prevents, or penalizes steering. “Penalize” is a term in the proposed Final Judgment that includes within its definition anything that would significantly restrain an insurer's steering. Because steering away from Atrium necessarily reduces its volume and revenues, terms that punish such reductions with higher prices or other detrimental consequences may be penalties. Whether a provision or action is likely to significantly restrain steering depends on the facts and circumstances, including but not limited to its economic impact, and any procompetitive effects that would tend to lower healthcare costs or otherwise benefit consumers in the Charlotte area.
Under the terms of the proposed Final Judgment Atrium also may not seek or obtain any contract provision, or take any other action that would penalize an insurer for steering away from Atrium through steered plans or transparency. For example, Atrium may not threaten to terminate its participation in an insurer's healthcare networks because the insurer was planning to introduce a tiered-network plan that steered away from Atrium.
Paragraph V of the proposed Final Judgment sets forth conduct that Atrium may undertake without violating the terms of the proposed Final Judgment. Paragraph V(A) makes clear that nothing in the proposed Final Judgment prohibits Atrium from exercising any of its contractual rights provided it does not engage in any conduct that would violate the terms of the proposed Final Judgment.
If Atrium is the most-prominently featured provider in a narrow-network plan or co-branded plan,
Paragraph V(C) makes clear that the proposed Final Judgment does not prohibit Atrium from negotiating with insurers for the ability to review the information about Atrium that an insurer disseminates through transparency, as long as any provision for review does not delay dissemination of the information. The proposed Final Judgment does not prevent Atrium from challenging information that it believes is inaccurate, including pursuing legal remedies available to it.
Paragraph V(C) also makes clear that the proposed Final Judgment does not prohibit Atrium from seeking certain safeguards regarding the insurer's dissemination of the prices Atrium has negotiated with insurers. Atrium may seek contractual provisions with an insurer prohibiting the insurer from disseminating Atrium's negotiated prices to Atrium's competitors, other insurers, or the general public. Atrium may also seek contractual provisions with an insurer requiring the insurer to obtain a covenant from any third party receiving Atrium's negotiated prices that such third party will not disclose that information to Atrium's competitors, another insurer, the general public, or another third party lacking a reasonable need to know such information. Atrium may also seek all appropriate remedies in the event that dissemination of such information occurs.
The proposed Final Judgment also prescribes conduct that Atrium is required to undertake in order to facilitate prompt and effective relief. Paragraph VI of the proposed Final Judgment requires Atrium to provide Aetna, BCBS-NC, Cigna, MedCost and UnitedHealthcare with a copy of the Final Judgment and notify them in writing within 15 business days of the Court's entry of the proposed Final Judgment that (1) the Final Judgment has been entered; (2) the Final Judgment prohibits Atrium from entering into or enforcing any agreement provision that violates the Final Judgment; (3) Atrium waives the right to enforce any contract language reproduced in Exhibit A; and (4) Atrium waives the right to enforce any contract language reproduced in Exhibit B to the extent such language prohibits, prevents, or penalizes steered plans or transparency.
Under Paragraph VII of the proposed Final Judgment, within 15 calendar days of the entry of the Final Judgment, Atrium must provide a copy of the Final Judgment to each of its commissioners and officers as well as each employee who has responsibility to negotiate or approve contracts with insurers. Within 60 calendar days of the entry of the proposed Final Judgment, Atrium must develop and implement procedures necessary to ensure Atrium's compliance with the proposed Final Judgment, including procedures to answer questions from Atrium's commissioners and employees about abiding by the terms of the proposed Final Judgment.
Within 270 calendar days of entry of the proposed Final Judgment, Atrium must submit to the United States and the State of North Carolina a written report setting forth its actions to comply with the proposed Final Judgment. Atrium must also submit to the United States and the State of North Carolina a copy of any new or revised agreement or amendment to any agreement with any insurer that is executed during the term of the proposed Final Judgment no later than 30 calendar days after the date the agreement or amendment is executed.
Atrium must also notify the United States and the State of North Carolina within 30 calendar days of having reason to believe that a provider which Atrium controls has a contract with any insurer with a provision that prohibits, prevents, or penalizes transparency or any steered plan.
To facilitate monitoring Atrium's compliance with the proposed Final Judgment, Paragraphs VII(B) and VII(D) of the proposed Final Judgment require Atrium to grant the United States access, upon reasonable notice, to Atrium's records and documents relating to matters contained in the proposed Final Judgment. In addition Atrium must make its employees available for interviews or depositions and answer interrogatories and prepare written reports relating to matters contained in the proposed Final Judgment upon request.
The proposed Final Judgment also contains provisions that promote compliance and make the enforcement of the proposed Final Judgment as effective as possible. Paragraph IX(A) provides that the United States retains and reserves all rights to enforce the provisions of the proposed Final Judgment, including its rights to seek an order of contempt from the Court. Under the terms of this Paragraph, Atrium has agreed that in any civil contempt action, any motion to show cause, or any similar action brought by the United States regarding an alleged violation of the proposed Final Judgment, the United States may establish the violation and the appropriateness of any remedy by a preponderance of the evidence and that Atrium has waived any argument that a different standard of proof should apply. This provision aligns the standard for compliance obligations with the standard of proof that applies to the underlying offense that the compliance commitments address.
Paragraph IX(B) sets forth the parties' agreed-upon rules for interpreting the proposed Final Judgment's provisions. Because consent decrees share many attributes with ordinary contracts, they should be construed as contracts for purposes of enforcement.
Atrium also agrees that the Court may enforce any provision of the proposed Final Judgment that is stated specifically and in reasonable detail,
Paragraph IX(C) of the proposed Final Judgment provides that should the Court find in an enforcement proceeding that Atrium has violated the proposed Final Judgment, the United States may apply to the Court for a one-time extension of the proposed Final Judgment, together with such other relief as may be appropriate. In addition, in order to compensate American taxpayers for any costs associated with the investigation and enforcement of violations of the proposed Final Judgment, Paragraph IX(C) further provides that in any successful effort by the United States to enforce the proposed Final Judgment against Atrium, whether litigated or resolved prior to litigation, Atrium agrees to reimburse the United States for attorneys' fees, experts' fees, or costs incurred in connection with any enforcement effort, including the investigation of the potential violation.
Finally, Paragraph X of the proposed Final Judgment provides that the proposed Final Judgment shall expire ten years from the date of its entry, except that after five years from the date of its entry, the proposed Final Judgment may be terminated upon notice by the United States to the Court and Atrium that the continuation of the proposed Final Judgment is no longer necessary or in the public interest.
Section 4 of the Clayton Act, 15 U.S.C. § 15, provides that any person who has been injured as a result of conduct prohibited by the antitrust laws may bring suit in federal court to recover three times the damages the person has suffered, as well as costs and reasonable attorneys' fees. Entry of the proposed Final Judgment will neither impair nor assist any private antitrust damage action. Under the provisions of Section 5(a) of the Clayton Act, 15 U.S.C. § 16(a), the proposed Final Judgment has no
The United States, the State of North Carolina, and Atrium have stipulated that the proposed Final Judgment may be entered by the Court after compliance with the provisions of the APPA, provided that the United States has not withdrawn its consent. The APPA conditions entry upon the Court's determination that the proposed Final Judgment is in the public interest.
The APPA provides a period of at least 60 calendar days preceding the effective date of the proposed Final Judgment within which any person may submit to the United States written comments regarding the proposed Final Judgment. Any person who wishes to comment should do so within 60 calendar days of the date of publication of this Competitive Impact Statement in the
Written comments should be submitted to:
The proposed Final Judgment provides that the Court retains jurisdiction over this action, and the parties may apply to the Court for any order necessary or appropriate for the modification, interpretation, or enforcement of the proposed Final Judgment.
As an alternative to the proposed Final Judgment, the United States considered continuing this litigation, and proceeding to trial in May 2019 against Atrium. While the proposed Final Judgment represents a negotiated resolution to the action that necessitated compromises by Plaintiffs and Atrium, the United States is satisfied that the relief contained in the proposed Final Judgment will remedy the anticompetitive conduct identified in the Complaint. The proposed Final Judgment would achieve all or substantially all of the relief the United States would have obtained through litigation but avoids the time, expense, and uncertainty of a full trial on the merits.
The Clayton Act, as amended by the APPA, requires that proposed consent judgments in antitrust cases brought by the United States be subject to a 60-day comment period, after which the Court shall determine whether entry of the proposed Final Judgment “is in the public interest.” 15 U.S.C. § 16(e)(1). In making that determination, the Court, in accordance with the statute as amended in 2004, is required to consider:
(A) the competitive impact of such judgment, including termination of alleged violations, provisions for enforcement and modification, duration of relief sought, anticipated effects of alternative remedies actually considered, whether its terms are ambiguous, and any other competitive considerations bearing upon the adequacy of such judgment that the court deems necessary to a determination of whether the consent judgment is in the public interest; and
(B) the impact of entry of such judgment upon competition in the relevant market or markets, upon the public generally and individuals alleging specific injury from the violations set forth in the complaint including consideration of the public benefit, if any, to be derived from a determination of the issues at trial.
As the United States Court of Appeals for the District of Columbia Circuit has held, under the APPA a court considers, among other things, the relationship between the remedy secured and the specific allegations in the government's complaint, whether the decree is sufficiently clear, whether its enforcement mechanisms are sufficient, and whether the decree may positively harm third parties.
In determining whether a proposed settlement is in the public interest, a district
Moreover, a court's role under the APPA is limited to reviewing the remedy in relationship to the violations that the United States has alleged in its complaint, and does not authorize a court to “construct [its] own hypothetical case and then evaluate the decree against that case.”
In its 2004 amendments,
There are no determinative materials or documents within the meaning of the APPA that were considered by the United States in formulating the proposed Final Judgment.
National Science Foundation.
Notice of request for information.
The National Science and Technology Council (NSTC) Subcommittee on Quantum Information Science (SCQIS) release of the “National Strategic Overview for Quantum Information Science” (hereafter “Strategic Overview”) calls upon agencies to develop plans to address six key policy areas to enable continued American leadership in quantum information science. The National Science Foundation (NSF), working with the NSTC, is requesting information from the research and development community around quantum information science (QIS) to inform the subcommittee as the Government develops potential means of addressing specific policy recommendations.
Interested persons are invited to submit comments on or before 11:59 p.m. (ET) on January 25, 2019.
Comments submitted in response to this notice may be sent by either of the following methods:
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Responses to this RFI may be posted online as discussions proceed. Therefore, we request that no business proprietary information, copyrighted information, or personally identifiable information be submitted in response to this RFI.
In accordance with FAR 15.202(3), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
C. Denise Caldwell at (703)-292-7371 or
The National Science and Technology
1. What specific actions could the US Government take that would contribute best to implementing the policy recommendations in the Strategic Overview? What challenges, not listed in section 3, should also be taken into account in implementation of the Strategic Overview recommendations?
2. What are the scientific and technological challenges that, with substantial resources and focus over the next ten years, will transform the QIS research and development landscape?
3. Regarding industrial engagement, what roles can the U.S. Government play in enabling the innovation ecosystem around QIS-related technologies? Are there critical barriers for industrial innovation in this space? How can these barriers be addressed? What role can the U.S. Government play in mitigating early or premature investment risks?
4. How can the U.S. Government engage with academia and other workforce development programs and stakeholders to appropriately train and maintain researchers in QIS while expanding the size and scope of the `quantum-smart' workforce?
5. What existing infrastructure should be leveraged, and what new infrastructure could be considered, to foster future breakthroughs in QIS research and development?
6. What other activities/partnerships could the U.S. Government use to engage with stakeholders to ensure America's prosperity and economic growth through QIS research and development?
7. How can the United States continue to attract and retain the best domestic and international talent and expertise in QIS?
8. How can the United States ensure that US researchers in QIS have access to cutting-edge international technologies, research facilities, and knowledge?
Submitted by the National Science Foundation in support of the NSTC Subcommittee on Quantum Information Science on December 6, 2018.
Nuclear Regulatory Commission.
Notice of submission to the Office of Management and Budget; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “NRC Form 748, National Source Tracking Transaction Report.”
Submit comments by January 10, 2019.
Submit comments directly to the OMB reviewer at: OMB Office of Information and Regulatory Affairs (3150-0202), Attn: Desk Officer for the Nuclear Regulatory Commission, 725 17th Street NW, Washington, DC 20503; email:
David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2018-0156 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:
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The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at
If you are requesting or aggregating comments from other persons for submission to the OMB, 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 comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, “NRC Form 748, National Source Tracking Transaction Report.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The NRC published a
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For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Renewal of existing information collection; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, “Request for Information Pursuant to 10 CFR 50.54(f) Regarding Recommendations 2.1, 2.3 and 9.3, of the Near Term Task Force Review of Insights from the Fukushima Dai-ichi Event.”
Submit comments by February 11, 2019. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2018-0138 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:
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Please include Docket ID NRC-2018-0138 in the subject line of your
The NRC cautions you not to include identifying or contact information in comment submissions 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 into ADAMS.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized below.
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The NRC is seeking comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the estimate of the burden of the information collection accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
License termination; issuance; correction.
The U.S. Nuclear Regulatory Commission (NRC) is correcting a notice that was published in the
The correction is effective December 11, 2018.
Please refer to Docket ID NRC-2018-0180 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:
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Ted Carter, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5543, email:
In the
Specifically, the last word (terminated) in the first paragraph, should be replaced with “amended” to accurately reflect the action.
For the Nuclear Regulatory Commission.
On October 2, 2018, Cboe BZX Exchange, Inc. (“Exchange” or “BZX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade the Shares of the Fund under BZX Rule 14.11(i), which governs the listing and trading of Managed Fund Shares on the Exchange. The Shares will be offered by the Trust, which was established as a Delaware statutory trust on June 2, 2015. The Exchange represents that Trust is registered with the Commission as an open-end investment company and has filed a registration statement on behalf of the Fund on Form N-1A (“Registration Statement”) with the Commission.
The Fund will be an actively managed exchange-traded fund that seeks to provide a long-term total return which exceeds the total return of its Primary Benchmark Index.
The Adviser will allocate the Fund's assets based on two proprietary investment models. The Adviser's first investment model will identify trends for the individual sectors within its Primary Benchmark Index. Each month, the model will analyze the strength of the US economy and rank the sectors of its Primary Benchmark Index based on a blend of various technical momentum indicators, volatility gauges, and valuation multiples. When the economy appears healthy, sectors with the highest risk-adjusted returns (lower volatility and higher price momentum) and the lowest valuations (lower price ratios) are ranked higher. When the economy appears unhealthy, sectors with more stable price movements and lower volatility are ranked higher. The Fund will invest in the top four sectors in an equal weight. In order to achieve such exposure, the Fund will use OTC swap contracts that reference each applicable sector index (“Sector Swaps”).
The Adviser's second investment model is used to manage an active bond allocation exclusively through holding fixed income ETFs. This model analyzes various major fixed income asset classes (U.S. treasuries, investment grade U.S. bonds, high-yield U.S. bonds, high-yield municipal bonds, and floating rate bonds) based on a blend of yield spreads, interest rates, and price momentum. Following the ranking process, the Fund will invest in ETFs based on the highest-ranked asset classes, with the lowest ranked asset classes left out of the Fund.
After careful review, the Commission finds that the Exchange's proposal to list and trade the Shares, as modified by Amendment Nos. 1 and 2, is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.
According to the Exchange, apart from the exception to BZX Rule 14.11(i)(4)(C)(v) described above, the Fund's proposed investments will satisfy, on an initial and continued listing basis, all of the generic listing standards under BZX Rule 14.11(i)(4)(C) and all other applicable requirements for Managed Fund Shares under Rule 14.11(i). In addition, the Exchange represents that the Shares of the Fund will comply with all other requirements applicable to Managed Fund Shares including, but not limited to, requirements relating to the dissemination of key information such as the Disclosed Portfolio, Net Asset Value (“NAV”), and the Intraday Indicative Value, rules governing the trading of equity securities, trading hours, trading halts, surveillance, firewalls, and the information circular, as set forth in Exchange rules applicable to Managed Fund Shares and the orders approving such rules.
The Exchange also represents that the intra-day, closing, and settlement prices of exchange-traded portfolio assets, including equity securities, will be readily available from the securities exchanges trading such securities, automated quotation systems, published or other public sources, or online information services such as Bloomberg or Reuters. Intraday price quotations on OTC swaps and fixed income instruments are available from major broker-dealer firms and from third-parties, which may provide prices free with a time delay or in real-time for a paid fee. Price information for Cash Equivalents will be available from major market data vendors. In addition, the Disclosed Portfolio will be available on the issuer's website free of charge. The
The Commission notes that, in support of its proposal, the Exchange has made the following additional representations:
(1) As noted above, the Exchange represents that, apart from the exception to BZX Rule 14.11(i)(4)(C)(v) relating to holdings in OTC derivatives, the Fund will meet and be subject to all other requirements of the generic listing standards and other applicable continued listing requirements for Managed Fund Shares under BZX Rule 14.11(i), including those requirements regarding the Disclosed Portfolio and the requirement that the Disclosed Portfolio and the NAV will be made available to all market participants at the same time,
(2) Trading of the Shares through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Managed Fund Shares. All of the equity securities held by the Fund will trade on markets that are a member of Intermarket Surveillance Group (“ISG”) or affiliated with a member of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement. The Exchange, the Financial Industry Regulatory Authority, Inc. (“FINRA”), on behalf of the Exchange, or both will communicate regarding trading in the Shares and the underlying equity securities held by the Fund with the ISG, other markets or entities who are members or affiliates of the ISG, or with which the Exchange has entered into a comprehensive surveillance sharing agreement. The Exchange, FINRA, on behalf of the Exchange, or both may obtain information regarding trading in the Shares and the underlying equity securities held by the Fund via the ISG from other markets or entities who are members or affiliates of the ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement. Additionally, the Exchange or FINRA, on behalf of the Exchange, may access, as needed, trade information for certain fixed income instruments reported to FINRA's Trade Reporting and Compliance Engine. The Exchange has a policy prohibiting the distribution of material non-public information by its employees.
(3) Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (a) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (b) BZX Rule 3.7, which imposes suitability obligations on Exchange members with respect to recommending transactions in the Shares to customers; (c) how information regarding the Intraday Indicative Value and the Disclosed Portfolio is disseminated; (d) the risks involved in trading the Shares during the Pre-Opening
(4) The Fund's investments, including derivatives, will be consistent with the 1940 Act, and the Fund's investment objective and policies and will not be used to enhance leverage (although certain derivatives and other investments may result in leverage).
(5) The Fund's investments will not be used to seek performance that is the multiple or inverse multiple (
(6) The Fund will only use those derivatives included in the defined term “Sector Swaps.” The Fund's use of derivative instruments will be collateralized.
(7) The Trust is required to comply with Rule 10A-3 under the Act
(8) The Fund will attempt to limit counterparty risk in Sector Swaps by entering into such contracts only with counterparties the Adviser believes are creditworthy and by limiting the Fund's exposure to each counterparty. The Adviser will monitor the creditworthiness of each counterparty and the Fund's exposure to each counterparty on an ongoing basis.
(9) All statements and representations made in this filing regarding the description of the portfolio or reference assets, limitations on portfolio holdings or reference assets, dissemination and availability of index, reference asset, and intraday indicative values, and the applicability of Exchange rules specified in this filing shall constitute continued listing requirements for the Fund. The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund or the Shares to comply with the continued listing requirements, and, pursuant to its
This approval order is based on all of the Exchange's representations and description of the Shares and the Fund, including those set forth above and in Amendment Nos. 1 and 2 to the proposed rule change. Except as described herein, the Commission notes that the Shares must comply with all applicable requirements of BZX Rule 14.11(i) to be listed and traded on the Exchange on an initial and continuing basis.
For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment Nos. 1 and 2, is consistent with Section 6(b)(5) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to a proposal to delay a new protocol “Ouch to Trade Options” or “OTTO” on The Nasdaq Options Market LLC (“NOM”).
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Nasdaq recently filed a rule change
Both the Prior Rule Change and the Subsequent Rule Change indicated the aforementioned rule changes would be implemented for QUO and OTTO in Q4 of 2018 with the date announced via an Options Traders Alert. At this time, the Exchange proposes to immediately implement QUO and delay the introduction of new OTTO functionality until Q1 2019 by announcing the date of implementation via an Options Traders Alert. The Exchange proposes to provide for the delay of the OTTO functionality by inserting the following rule text at the beginning of NOM Rules at Chapter VI, Sections 6, 9 and 21 to make clear that OTTO functionality is not yet implemented: “OTTO functionality implementation shall be delayed until Q1 2019. The Exchange will issue an Options Trader Alert notifying Participants when this functionality will be available.”
The Exchange proposes this delay to allow the Exchange additional time to implement this functionality and for
The Exchange's current pricing at Options 7,
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposal to rename the current “OTTO Port Fee” as “QUO Port Fee” and “OTTO DROP Port Fee” as “QUO DROP Port Fee” is consistent with the Act because the amendment will reflect the name change and modification as proposed in the Prior Rule Change.
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's proposal to implement QUO and delay the adoption of new OTTO functionality does not impose an undue burden on competition. Immediately implementing the QUO protocol, which is the subject of an already effective rule change, will avoid any confusion with the implementation of the new OTTO protocol. Delaying the new OTTO functionality to allow the Exchange additional time to implement this functionality and for Participants to sign-up for this new port and test with the Exchange.
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)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
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 North Carolina (FEMA-4393-DR), dated 10/12/2018.
Issued on 11/15/2018.
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, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of North Carolina, dated 10/12/2018, 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 2.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Virginia (FEMA-4401-DR), dated 10/15/2018.
Issued on 11/14/2018.
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, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the Commonwealth of Virginia, dated 10/15/2018, 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 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4399-DR), dated 10/23/2018.
Issued on 11/15/2018.
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, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Florida, dated 10/23/2018, 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 2.
This is an amendment of the Presidential declaration of a major disaster for the Commonwealth of the Northern Mariana Islands (FEMA-4404-DR), dated 10/26/2018.
Issued on 11/10/2018.
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, (202) 205-6734.
The notice of the President's major disaster declaration for the Commonwealth of the Northern Mariana Islands, dated 10/26/2018, is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to 01/27/2019.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of California (FEMA-4407-DR), dated 11/12/2018.
Issued on 11/12/2018.
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, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 11/12/2018, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 157985 and for economic injury is 157990.
Notice is hereby given that Eagle Fund IV-A, L.P., 1 North Brentwood Blvd., Suite 1550, St. Louis, MO 63105, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Eagle Fund IV-A, L.P. is seeking a prior written exemption from SBA for loan and equity financings it made to RHI Acquisition, LLC, 2 Oliver Street, Boston, MA 02109.
The financing is brought within the purview of § 107.730(a)(1) of the Regulations because Eagle Fund III, L.P., and Eagle Fund III-A, L.P., (collectively “Eagle III”) Associates of Eagle Fund IV-A, L.P., own more than ten percent of RHI Acquisition, LLC, and therefore this transaction is considered
Notice is hereby given that any interested person may submit written comments on this transaction within fifteen days of the date of this publication to the Associate Administrator, Office of Investment and Innovation, U.S. Small Business Administration, 409 Third Street SW, Washington, DC 20416.
Notice is hereby given that Eagle Fund IV, L.P., 1 North Brentwood Blvd., Suite 1550, St. Louis, MO 63105, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Eagle Fund IV, L.P. is seeking approval prior written exemption from SBA for loan and equity financings it made to RHI Acquisition, LLC, 2 Oliver Street, Boston, MA 02109.
The financing is brought within the purview of § 107.730(a)(1) of the Regulations because Eagle Fund III, L.P., and Eagle Fund III-A, L.P., (collectively “Eagle III”) Associates of Eagle Fund IV, L.P., own more than ten percent of RHI Acquisition, LLC, and therefore this transaction is considered
Notice is hereby given that any interested person may submit written comments on this transaction within fifteen days of the date of this publication to the Associate Administrator, Office of Investment and Innovation, U.S. Small Business Administration, 409 Third Street SW, Washington, DC 20416.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Pennsylvania (FEMA-4408-DR), dated 11/27/2018.
Issued on 11/27/2018.
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, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 11/27/2018, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 158046 and for economic injury is 158050.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Tohono O'odham Nation (FEMA-4409-DR), dated 11/30/2018.
Issued on 11/30/2018.
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, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 11/30/2018, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 158256 and for economic injury is 158260.
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 Georgia (FEMA-4400-DR), dated 11/01/2018.
Issued on 11/15/2018.
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, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Georgia, dated 11/01/2018, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to February 11, 2019.
You may submit comments by any of the following methods:
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You must include the DS form number (if applicable), information collection title, and the OMB control number in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Irving Jones, PRM/Admissions, 2025 E Street NW, SA-9, 8th Floor, Washington, DC 20522-0908, who may be reached on 202-453-9248 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Form DS-234 is being added to this collection to elicit information used to determine the eligibility of Iraqis and Afghan nationals applying for special immigrant visas.
The SIV Biodata information form (DS-234) is submitted electronically by the applicant to the National Visa Center, which will forward the forms to the Refugee Processing Center of the Bureau of Population, Refugees and Migration.
On November 21, 2018, Savage, Bingham & Garfield Railroad Company
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 March 11, 2019.
Because this is a discontinuance proceeding and not an abandonment, trail use/rail banking and public use conditions are not appropriate. Similarly, no environmental or historic documentation is required under 49 CFR 1105.6(c)(5) and 1105.8(b)(3).
Any offer of financial assistance (OFA) for subsidy under 49 CFR 1152.27(b)(2) will be due no later than 120 days after the filing of the petition for exemption, or 10 days after service of a decision granting the petition for exemption, whichever occurs sooner.
All filings in response to this notice must refer to STB Docket No. AB 1271X and must be sent to: (1) Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001 and (2) Richard F. Riley Jr., Foley & Lardner LLP, 3000 K Street NW, Suite 600, Washington, DC 20007-5109. Replies to the petition are due on or before December 31, 2018.
Persons seeking further information concerning discontinuance procedures may contact the Board's Office of Public Assistance, Governmental Affairs, and Compliance at (202) 245-0238 or refer to the full abandonment and discontinuance regulations at 49 CFR part 1152. Questions concerning environmental issues may be directed to the Board's Office of Environmental Analysis at (202) 245-0305. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Board decisions and notices are available on our website at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Under Section 13 of the Surface Transportation Board Reauthorization Act of 2015 (STB Reauthorization Act), codified at 49 U.S.C. 11708, Congress directed the Board to “promulgate regulations to establish a voluntary and binding arbitration process to resolve rail rate and practice complaints” that are subject to the Board's jurisdiction. In May 2016, the Board issued a Notice of Proposed Rulemaking proposing to modify its existing regulations at 49 CFR 1108 and 1115.8 to conform to the requirements of the STB Reauthorization Act.
By decision served February 23, 2017, the Board adopted its initial roster of arbitrators and updated the roster by decision served February 14, 2018. The roster is published on the Board's website at
Under 49 CFR 1108.6(b), the Board is to update the roster of arbitrators annually. Accordingly, the Board is now requesting the names and qualifications of new arbitrators who wish to be placed on the roster. Current arbitrators who wish to remain on the roster must notify the Board of their continued availability and confirm that the biographical information on file with the Board remains accurate and if not, provide any necessary updates. Arbitrators who do not confirm their continued availability will be removed from the roster. This decision will be served on all current arbitrators.
Any person who wishes to be added to the roster should file an application describing his or her experience with rail transportation and economic regulation, as well as professional or business experience, including agriculture, in the private sector. Each applicant should also describe his or her training in dispute resolution and/or experience in arbitration or other forms of dispute resolution, including the number of years of experience. Lastly, the applicant should provide his or her contact information and fees.
All comments—including filings from new applicants, updates to existing arbitrator information, and confirmations of continued availability—should be submitted by January 11, 2019.
1. Applications from persons interested in being added to the Board's roster of arbitrators, and confirmations of continued availability (with updates, if any, to existing arbitrator information) from persons currently on the arbitration roster, are due by January 11, 2019.
2. This decision will be served on all current arbitrators and published in the
3. This decision is effective on the date of service.
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Federal Highway Administration (FHWA), DOT.
Notice of limitation on claims for judicial review of actions by the California Department of Transportation (Caltrans), pursuant to 23 U.S.C. 327.
The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans, that are final. The actions relate to the Mount Vernon Avenue Bridge Project, which would replace the existing Mount Vernon Avenue Bridge (Bridge Number 54C-066) over the Burlington Northern Santa Fe (BNSF) rail yard in the City of San Bernardino, San Bernardino County, California. Those actions grant approvals for the project.
By this notice, the FHWA, on behalf of Caltrans, is advising the public of final agency actions subject to 23 U.S.C. 139(
For Caltrans: Aaron Burton, Senior Environmental Planner, Local Assistance-Environmental Support, California Department of Transportation District 8, 464 West Fourth Street, 6th floor, MS 760, San Bernardino, CA 92401 during regular office hours from 8:00 a.m. to 5:00 p.m., Telephone number: (909) 383-2841, email:
Effective July 1, 2007, the Federal Highway Administration (FHWA) assigned, and the California Department of Transportation (Caltrans) assumed, environmental responsibilities for this project pursuant to 23 U.S.C. 327. Notice is hereby given that Caltrans has taken final agency actions subject to 23 U.S.C. 139(
Mount Vernon Avenue is considered a Major Arterial per the City of San Bernardino General Plan. Thus, it is a connecting link between economic centers both within the City and the region as a whole. Mount Vernon Avenue Bridge provides an additional access route to rail and mass transit (Metrolink) facilities in the immediate area that also interface with port and airport facilities. The bridge is currently closed to all commercial traffic, including trucks and buses. Any permanent long-term closure of the Mount Vernon Avenue Bridge would remove an important connection linking communities north and south of the BNSF railroad. Implementation of the Mount Vernon Avenue Bridge Project would replace the existing bridge to improve seismic performance, provide standard vertical clearance over the rail tracks, and comply with American Association of State Highway and Transportation Officials (AASHTO) roadway cross section standards.
The actions by the Federal agencies, and the laws under which such actions were taken, are described in the Supplemental EA for the project, approved on May 22, 2018 and the FONSI issued on October 9, 2018 and in other documents in the Caltrans' project records. The EA, FONSI and other project records are available by contacting Caltrans at the address provided above. The Caltrans EA and FONSI can be viewed and downloaded from the project website at
This notice applies to all Federal agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1. National Environmental Policy Act (NEPA) [42 U.S.C. 4321-4351]; Federal-Aid Highway Act [23 U.S.C. 109 and 23 U.S.C. 128].
2. Clean Air Act [42 U.S.C. 7401-7671(q)].
3. Section 4(f) of the U.S. Department of Transportation Act of 1966 [49 U.S.C. 303].
4. Endangered Species Act [16 U.S.C. 1531-1544 and Section 1536], Fish and Wildlife Coordination Act [16 U.S.C. 661-667(d)], Migratory Bird Treaty Act [16 U.S.C. 703-712].
5. Section 106 of the National Historic Preservation Act of 1966, as amended [16 U.S.C. 470(f)
6. Clean Water Act 33 U.S.C. 1251-1387.
7. Farmland Protection Policy Act [7 U.S.C. 4201-4209 and its regulations].
8. E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 12898 Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations; E.O. 11593 Protection and Enhancement of Cultural Resources; E.O. 13112 Invasive Species.
23 U.S.C. 139(l)(1).
Federal Highway Administration (FHWA), DOT.
Notice of limitation on claims for judicial review of actions by the California Department of Transportation (Caltrans), pursuant to 23 U.S.C. 327.
The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans that are final. The actions relate to a proposed highway project, the U.S. Highway 101 Managed Lanes Project from post miles 50.6 in Santa Clara County to 21.8 in San Mateo County, State of California. Those actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA, on behalf of Caltrans, is advising the public of final agency actions subject to 23 U.S.C. 139(
For Caltrans: Yolanda Rivas, Environmental Branch Chief, 111 Grand Avenue MS 8B, Oakland, CA 94612, 510-286-6216 (Voice), email
Effective July 1, 2007, the Federal Highway Administration (FHWA) assigned, and Caltrans assumed, environmental responsibilities for this project pursuant to 23 U.S.C. 327. Notice is hereby given that Caltrans has taken final agency actions subject to 23 U.S.C. 139(
This notice applies to all Federal agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
23 U.S.C. 139(
Maritime Administration, DOT.
Notice and request for comments.
The Maritime Administration (MARAD) invites public comments on our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The information collection is necessary for MARAD to determine whether the applicant is committed to the redevelopment plan; the plan is in the best interests of the public, and the property will be used in accordance with the terms of the conveyance and applicable statutes and regulations. We are required to publish this notice in the
Comments must be submitted on or before February 11, 2019.
You may submit comments [identified by Docket No. DOT-MARAD-2018-0179 through one of the following methods:
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Linden Houston, Office of Deepwater Ports and Offshore Activities, Maritime Administration, 1200 New Jersey Avenue SE, Washington, DC 20590;
By Order of the Maritime Administrator.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of Calendar Year 2019 Minimum Annual Percentage Rate for Random Drug Testing, Reminder for Operators to Report Contractor MIS Data, and Reminder of Method for Operators to Obtain User Name and Password for Electronic Reporting.
PHMSA has determined that the minimum random drug testing rate for covered employees will remain at 50 percent during calendar year 2019. Operators are reminded that drug and alcohol testing information must be submitted for contractors who are performing or are ready to perform covered functions. For calendar year 2018 reporting, the “user name” and “password” for the Drug and Alcohol Management Information System (DAMIS) will be available in the PHMSA Portal.
Effective January 1, 2019, through December 31, 2019.
Wayne Lemoi, Drug & Alcohol Program Manager, telephone at 909-937-7232 or by email at
Operators of natural gas, hazardous liquid, and carbon dioxide pipelines and operators of liquefied natural gas and underground natural gas storage facilities must randomly select and test a percentage of all covered employees for prohibited drug use in accordance with 49 CFR part 199. Pursuant to § 199.105(c)(1), the PHMSA minimum annual random drug testing rate for all covered employees is 50 percent. The Administrator can adjust this random drug testing rate based on the reported positive rate in the pipeline industry's random drug tests, which is submitted in operators' annual Management Information System (MIS) reports as required by § 199.119(a). In accordance with § 199.105(c)(3), if the reported positive drug test rate is below 1 percent for 2 consecutive years, the Administrator can reduce the random drug testing rate to 25 percent of all covered employees. In calendar year 2017, the random drug test positive rate for the entire pipeline industry was reported at greater than 1 percent; therefore, the minimum annual random drug testing rate for calendar year 2019 is maintained at 50 percent of all covered employees.
On January 19, 2010, (75 FR 2926) PHMSA published an advisory bulletin notifying operators of the appropriate methodology for the annual collection of contractor MIS drug and alcohol testing data to avoid duplicative reporting when a contractor works for multiple operators. If an operator is required to submit a MIS report in accordance with part 199, that report is not complete until PHMSA receives MIS data for each tested contractor that performed covered functions as defined in § 199.3. As explained in the 2010 Advisory Bulletin, operators must submit operator and contractor employee testing data in separate MIS reports to avoid duplicative reporting and inaccurate data that could affect the positive rate for the entire industry.
By early January 2019, the user name and password required for an operator to access DAMIS and enter calendar year 2018 data will be available to all operator staff with access to the PHMSA Portal. Pipeline operators have been submitting reports required by 49 CFR parts 191 and 195 through the PHMSA Portal (
When the DAMIS user name and password are available in the PHMSA Portal, all registered users will receive an email to that effect. If operator staff responsible for submitting MIS reports do not receive the DAMIS information, they should coordinate with other registered PHMSA Portal users within their company to obtain the DAMIS user name and password. Registered PHMSA Portal users for an operator typically include operator staff or consultants who submit annual and incident reports through PHMSA F 7000- and 7100-series forms. Operators that have not previously registered staff in the PHMSA Portal for the reporting purposes of parts 191 and 195 can register users by following the instructions at:
Pursuant to §§ 199.119(a) and 199.229(a), operators with 50 or more covered employees, including both operator and contractor staff, are required to submit annual MIS reports. Operators with fewer than 50 total covered employees are required to submit MIS reports only upon written request from PHMSA. If an operator with fewer than 50 total covered employees has submitted an MIS report in or after calendar year 2016, the PHMSA Portal message may state that no MIS report is required for calendar year 2018. If an operator with fewer than 50 covered employees has grown to more than 50 covered employees during calendar year 2018, the PHMSA Portal message will include instructions for
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the meeting of the National Research Advisory Council previously scheduled to be held on Wednesday, December 5, 2018, at 1100 First Street NE, Room 104, Washington, DC 20002,
For more information, please contact Ms. Rashelle Robinson, Designated Federal Officer at (202) 443-5668, or via email at
Environmental Protection Agency (EPA).
Final rule.
Under section 211 of the Clean Air Act, the Environmental Protection Agency (EPA) is required to set renewable fuel percentage standards every year. This action establishes the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel that apply to gasoline and diesel transportation fuel produced or imported in the year 2019. Relying on statutory waiver authority that is available when the projected cellulosic biofuel production volume is less than the applicable volume specified in the statute, EPA is establishing volume requirements for cellulosic biofuel, advanced biofuel, and total renewable fuel that are below the statutory volume targets. We are also establishing the applicable volume of biomass-based diesel for 2020.
This final rule is effective on February 11, 2019.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2018-0167. All documents in the docket are listed on the
Julia MacAllister, Office of Transportation and Air Quality, Assessment and Standards Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: 734-214-4131; email address:
Entities potentially affected by this final rule are those involved with the production, distribution, and sale of transportation fuels, including gasoline and diesel fuel or renewable fuels such as ethanol, biodiesel, renewable diesel, and biogas. Potentially affected categories include:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your entity would be affected by this action, you should carefully examine the applicability criteria in 40 CFR part 80. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the
The Renewable Fuel Standard (RFS) program began in 2006 pursuant to the requirements in Clean Air Act (CAA) section 211(o) that were added through the Energy Policy Act of 2005. The statutory requirements for the RFS program were subsequently modified through the Energy Independence and Security Act of 2007 (EISA), leading to the publication of major revisions to the regulatory requirements on March 26, 2010.
The statute includes annual volume targets, and requires EPA to translate those volume targets (or alternative volume requirements established by EPA in accordance with statutory waiver authorities) into compliance obligations that obligated parties must meet every year. In this action we are finalizing the applicable volumes for cellulosic biofuel, advanced biofuel, and total renewable fuel for 2019, and biomass-based diesel (BBD) for 2020.
Today, nearly all gasoline used for transportation purposes contains 10 percent ethanol (E10), and on average diesel fuel contains nearly 5 percent biodiesel and/or renewable diesel.
The resulting final volume requirements for 2019 are shown in Table I-1 below. Relative to the levels finalized for 2018, the 2019 volume requirements for advanced biofuel and total renewable fuel would be higher by 630 million gallons. Approximately 130 million gallons of this increase would be due to the increase in the projected production of cellulosic biofuel in 2019 relative to 2018. The cellulosic biofuel volume is 37 million gallons greater than the proposed cellulosic biofuel volume for 2019. The advanced biofuel and total renewable fuel volumes are each 40 million gallons higher than the proposed volumes, as a result of an increased projection of cellulosic biofuel production in 2019 (see Section III for a further discussion of our cellulosic biofuel projection). We are also establishing the volume requirement for BBD for 2020 at 2.43 billion gallons. This volume is 330 million gallons higher than the volume for 2019.
This section briefly summarizes the major provisions of this final rule. We are finalizing applicable volume requirements and associated percentage standards for cellulosic biofuel, advanced biofuel, and total renewable fuel for 2019; for BBD we are finalizing the percentage standard for 2019 and the applicable volume requirement for 2020.
For advanced biofuel and total renewable fuel, we are finalizing reductions based on the “cellulosic waiver authority” that would result in advanced biofuel and total renewable fuel volume requirements that are lower than the statutory targets by the same magnitude as the reduction in the cellulosic biofuel applicable volume. This follows the same general approach as in the 2018 final rule. The volumes for cellulosic biofuel, advanced biofuel, and total renewable fuel exceed the required volumes for these fuel types in 2018.
Section II provides a general description of our approach to setting volume requirements in today's rule, including a review of the statutory waiver authorities and our consideration of carryover Renewable Identification Numbers (RINs). Section III provides our assessment of the 2019 cellulosic biofuel volume, based on a projection of production that reflects a neutral aim at accuracy. Section IV describes our assessment of advanced biofuel and total renewable fuel. Finally, Section VI describes the 2020 BBD volume requirement, reflecting our analysis of a set of factors stipulated in CAA section 211(o)(2)(B)(ii).
EPA must annually determine the projected volume of cellulosic biofuel production for the following year. If the projected volume of cellulosic biofuel production is less than the applicable volume specified in section 211(o)(2)(B)(i)(III) of the statute, EPA must lower the applicable volume used to set the annual cellulosic biofuel percentage standard to the projected production volume. In this rule we are finalizing a cellulosic biofuel volume requirement of 418 million ethanol-equivalent gallons for 2019 based on our production projection. Our projection reflects consideration of the Energy Information Administration's (EIA) projection of cellulosic biofuel production in 2019; RIN generation data for past years and 2018 to date that is available to EPA through the EPA Moderated Transaction System (EMTS); the information we have received regarding individual facilities' capacities, production start dates, and biofuel production plans; a review of cellulosic biofuel production relative to EPA's projections in previous annual rules; and EPA's own engineering judgment. To project cellulosic biofuel production for 2019 we used the same basic methodology as in our proposed rule, described further in the 2018 final rule. However, we have used updated data to derive percentile values used in our production projection for liquid cellulosic biofuels and to derive the year-over-year change in the rate of production of compressed natural gas and liquified natural gas (CNG/LNG) derived from biogas that is used in the projection for CNG/LNG.
If we reduce the applicable volume of cellulosic biofuel below the volume specified in CAA section 211(o)(2)(B)(i)(III), we also have the authority to reduce the applicable volumes of advanced biofuel and total renewable fuel by the same or a lesser amount. We refer to this as the “cellulosic waiver authority.” The conditions that caused us to reduce the 2018 volume requirement for advanced biofuel below the statutory target remain relevant in 2019. As for 2018, we investigated the projected availability of non-cellulosic advanced biofuels in 2019. We took into account the various constraints on the ability of the market to make advanced biofuels available, the ability of the standards we set to bring about market changes in the time available, the potential impacts associated with diverting biofuels and/or biofuel feedstocks from current uses to the production of advanced biofuel used in the U.S., the fact that the biodiesel tax credit is currently not available for 2019, the tariffs on imports of biodiesel from Argentina and Indonesia, as well as the cost of advanced biofuels. Based on these considerations we are reducing the statutory volume target for advanced biofuel by the same amount as we are reducing the statutory volume target for cellulosic biofuel. This results in an advanced biofuel volume requirement for 2019 of 4.92 billion gallons, which is 630 million gallons higher than the advanced biofuel volume requirement for 2018.
We believe that the cellulosic waiver authority is best interpreted to require equal reductions in advanced biofuel and total renewable fuel. Consistent with our proposal, we are reducing total renewable fuel by the same as the reduction in advanced biofuel, such that the resulting implied volume requirement for conventional renewable fuel will be 15 billion gallons, the same as the implied volume requirement in the statute.
In EISA, Congress specified increasing applicable volumes of BBD through 2012. Beyond 2012 Congress stipulated that EPA, in coordination with DOE and USDA, was to establish the BBD volume taking into consideration implementation of the program during calendar years specified in the table in CAA 211(o)(B) and various specified factors, provided that the required volume for BBD could not be less than 1.0 billion gallons. For 2013, EPA established an applicable volume of 1.28 billion gallons. For 2014 and 2015 we established the BBD volume requirement to reflect the actual volume for each of these years of 1.63 and 1.73 billion gallons.
Given current and recent market conditions, the advanced biofuel volume requirement is driving the production and use of biodiesel and renewable diesel volumes over and above volumes required through the separate BBD standard, and we expect this to continue. While EPA continues to believe it is appropriate to maintain the opportunity for other advanced biofuels to compete for market share, the vast majority of the advanced biofuel obligations in recent years have been satisfied with BBD. Thus, after a review of the implementation of the program to date and considering the statutory factors, we are establishing, in coordination with USDA and DOE, an applicable volume of BBD for 2020 of 2.43 billion gallons.
The renewable fuel standards are expressed as a volume percentage and are used by each refiner and importer of fossil-based gasoline or diesel to determine their renewable fuel volume obligations.
Four separate percentage standards are required under the RFS program, corresponding to the four separate renewable fuel categories shown in Table I.A-1. The specific formulas we use in calculating the renewable fuel
In the rulemaking notices proposing the 2018 and 2019 RFS volume requirements, we noted that various stakeholders had raised concerns regarding lack of transparency and potential manipulation in the RIN market. We asked for comment from the public on those issues, and received multiple suggestions from stakeholders in response. Since receiving those comments, we have continued to hold meetings with stakeholders on these topics, through which we have continued to hear various perspectives on RIN market operations and potential changes.
A number of the comments received in response to the 2019 Notice of Proposed Rulemaking (NPRM) suggested increasing the amount of data related to the RIN market that EPA makes publicly available. In response to these comments, we have made additional information available through our public website.
We also received a number of comments on the potential impacts of changing the regulations related to who may purchase RINs, the duration for which RINs could be held, and other rules related to the buying, selling, or holding of RINs. On October 9, President Trump directed EPA to undertake a CAA rulemaking that would change certain elements of the RIN compliance system under the RFS program to improve both RIN market transparency and overall functioning of the RIN market. EPA is currently considering a number of regulatory reforms that could be included in the proposal, such as: Prohibiting entities other than obligated parties from purchasing separated RINs; requiring public disclosure when RIN holdings held by an individual actor exceed specified limits; limiting the length of time a non-obligated party can hold RINs; and changing the timelines that apply to obligated parties regarding when RINs must be retired for compliance purposes. We are not currently considering changing the point of obligation in the RFS program.
The CAA provides EPA with the authority to enact volume requirements below the applicable volume targets specified in the statute under specific circumstances. This section discusses those authorities. As described in the executive summary, we are finalizing the volume requirement for cellulosic biofuel at the level we project to be available for 2019, and an associated applicable percentage standard. For advanced biofuel and total renewable fuel, we are establishing volume requirements and associated applicable percent standards, based on use of the “cellulosic waiver authority” that would result in advanced biofuel and total renewable fuel volume requirements that are lower than the statutory targets by the same magnitude as the reduction in the cellulosic biofuel reduction. This would effectively maintain the implied statutory volumes for non-cellulosic advanced biofuel and conventional renewable fuel.
In CAA section 211(o)(2), Congress specified increasing annual volume targets for total renewable fuel, advanced biofuel, and cellulosic biofuel for each year through 2022, and for BBD through 2012, and authorized EPA to set volume requirements for subsequent years in coordination with USDA and DOE, and after consideration of specified factors. However, Congress also recognized that under certain circumstances it would be appropriate for EPA to set volume requirements at a lower level than reflected in the statutory volume targets, and thus provided waiver provisions in CAA section 211(o)(7).
Section 211(o)(7)(D)(i) of the CAA provides that if EPA determines that the projected volume of cellulosic biofuel production for a given year is less than the applicable volume specified in the statute, then EPA must reduce the applicable volume of cellulosic biofuel required to the projected production volume for that calendar year. In making this projection, EPA may not “adopt a methodology in which the risk of overestimation is set deliberately to outweigh the risk of underestimation” but must make a projection that “takes neutral aim at accuracy.”
CAA section 211(o)(7)(D)(i) also provides EPA with the authority to reduce the applicable volume of total renewable fuel and advanced biofuel in
EPA has used the cellulosic waiver authority to lower the cellulosic biofuel, advanced biofuel and total renewable fuel volumes every year since 2014. Further discussion of the cellulosic waiver authority, and EPA's interpretation of it, can be found in the preamble to the 2017 final rule.
In
In this action we are using the cellulosic waiver authority to reduce the statutory volume targets for advanced biofuels and total renewable fuel by equal amounts, consistent with our long-held interpretation of this provision and our approach in setting the 2014-2018 standards. This approach considers the Congressional objectives reflected in the volume tables in the statute, and the environmental objectives that generally favor the use of advanced biofuels over non-advanced biofuels. See 81 FR 89752-89753 (December 12, 2016). See also 78 FR 49809-49810 (August 15, 2013); 80 FR 77434 (December 14, 2015). We are concluding, as described in Section IV, that it is appropriate for EPA to reduce the advanced biofuel volume under the cellulosic waiver authority by the same quantity as the reduction in cellulosic biofuel, and to provide an equal reduction under the cellulosic waiver authority in the applicable volume of total renewable fuel. We are taking this action both because we do not believe that the statutory volumes can be achieved, and because we do not believe that backfilling of the shortfall in cellulosic with advanced biofuel would be appropriate due to high costs, as well as other factors such as feedstock switching and/or diversion of foreign advanced biofuels. The volumes of advanced and total renewable fuel resulting from this exercise of the cellulosic waiver authority provide for an implied volume allowance for conventional renewable fuel of 15 billion gallons, and an implied volume allowance for non-cellulosic advanced biofuel of 4.5 billion gallons, equal to the implied statutory volumes for 2019. We also believe that the volume of renewable fuel made available after reductions using the cellulosic waiver authority is attainable, as discussed in Section IV.
Section 211(o)(7)(A) of the CAA provides that EPA, in consultation with the Secretary of Agriculture and the Secretary of Energy, may waive the applicable volumes specified in the Act in whole or in part based on a petition by one or more States, by any person subject to the requirements of the Act, or by the EPA Administrator on his own motion. Such a waiver must be based on a determination by the Administrator, after public notice and opportunity for comment that: (1) Implementation of the requirement would severely harm the economy or the environment of a State, a region, or the United States; or (2) there is an inadequate domestic supply.
EPA received comments suggesting that EPA should use the general waiver to further reduce volumes under findings of inadequate domestic supply, and/or severe harm to the economy or environment. Based on our review of the comments and updated data, and consistent with EPA's rationale and decisions in setting the 2018 standards, we decline to exercise our discretion to reduce volumes under the general waiver authority. Further discussion of these issues is found in the RTC document and a memorandum to the docket.
Consistent with our approach in the final rules establishing the RFS standards for 2013 through 2018, we have also considered the availability and role of carryover RINs in evaluating whether we should exercise our discretion to use our waiver authorities in setting the volume requirements for 2019. Neither the statute nor EPA regulations specify how or whether EPA should consider the availability of carryover RINs in exercising the cellulosic waiver authority.
An adequate RIN bank serves to make the RIN market liquid. Just as the economy as a whole functions best when individuals and businesses prudently plan for unforeseen events by maintaining inventories and reserve money accounts, we believe that the RFS program functions best when sufficient carryover RINs are held in reserve for potential use by the RIN holders themselves, or for possible sale to others that may not have established their own carryover RIN reserves. Were there to be no RINs in reserve, then even minor disruptions or other shortfalls in renewable fuel production or distribution relative to petroleum fuel supply, or higher than expected transportation fuel demand (requiring greater volumes of renewable fuel to comply with the percentage standards that apply to all volumes of transportation fuel, including the unexpected volumes) could lead to the need for a new waiver of the standards, undermining the market certainty so critical to the RFS program. Moreover, a significant drawdown of the carryover RIN bank leading to a scarcity of RINs may stop the market from functioning in an efficient manner (
At the time of the 2019 NPRM, we estimated that there were approximately 3.06 billion total carryover RINs available and proposed that carryover RINs should not be counted on to avoid or minimize the need to reduce the 2019 statutory volume targets. We also proposed that the 2019 volume should not be set at levels that would intentionally lead to a drawdown in the bank of carryover RINs (
Since that time, obligated parties have performed their attest engagements and submitted revised compliance reports for the 2017 compliance year and we now estimate that there are currently approximately 2.59 billion total carryover RINs available,
The above discussion applies to total carryover RINs; we have also considered the available volume of advanced biofuel carryover RINs. At the time of the 2019 NPRM, we estimated that there were approximately 700 million advanced carryover RINs available. Since that time, obligated parties have performed their attest engagements and submitted revised compliance reports for the 2017 compliance year and we now estimate that there are currently approximately 600 million advanced carryover RINs available,
However, there remains considerable uncertainty surrounding the number of carryover RINs that will be available for use in 2019 for a number of reasons, including the potential impact of any future action to address the remand in
We have evaluated the volume of carryover RINs currently available and considered whether they would justify a reduced use of our cellulosic waiver authority in setting the 2019 volume requirements in order to intentionally draw down the carryover RIN bank. We also carefully considered the comments received, including comments on the role of carryover RINs under our waiver authorities and the policy implications of our decision.
In the past several years, production of cellulosic biofuel has continued to increase. Cellulosic biofuel production reached record levels in 2017, driven largely by CNG and LNG derived from biogas. Production volumes through September 2018 suggest production in 2018 will exceed production volumes in 2017.
In order to project the volume of cellulosic biofuel production in 2019, we considered EIA's projection of cellulosic biofuel production in 2019, the accuracy of the methodologies used to project cellulosic biofuel production in previous years, data reported to EPA through EMTS, and information we collected through meetings with representatives of facilities that have produced or have the potential to produce qualifying volumes of cellulosic biofuel in 2019 for consumption as transportation fuel, heating oil, or jet fuel in the U.S.
There are two main elements to the cellulosic biofuel production projection: Liquid cellulosic biofuel and CNG/LNG derived from biogas. To project the range of potential production volumes of liquid cellulosic biofuel we used the same general methodology as the methodology used in the proposed rule, as well as the 2018 final rule. However, we have adjusted the percentile values used to select a point estimate within a projected production range for each group of companies based on updated information (through the end of September 2018) with the objective of improving the accuracy of the projections. To project the production of cellulosic biofuel RINs for CNG/LNG derived from biogas, we used the same general year-over-year growth rate methodology as in the 2019 proposed rule and 2018 final rule, with updated RIN generation data through September 2018. This methodology reflects the mature status of this industry, the large number of facilities registered to generate cellulosic biofuel RINs from these fuels, and EPA's continued attempts to refine its methodology to yield estimates that are as accurate as possible. This methodology is an improvement on the methodology that EPA used to project cellulosic biofuel production for CNG/LNG derived from biogas in the 2017 and previous years (see Section III.B below for a further discussion of the accuracy of EPA's methodology in previous years). The methodologies used to project the production of liquid cellulosic biofuels and cellulosic CNG/LNG derived from biogas are described in more detail in Sections III.D-1 and III.D-2 below.
The balance of this section is organized as follows. Section III.A provides a brief description of the statutory requirements. Section III.B reviews the accuracy of EPA's projections in prior years, and also discusses the companies the EPA assessed in the process of projecting qualifying cellulosic biofuel production in the U.S. in 2018 in Section III.B. Section III.C discusses EIA's projection of cellulosic biofuel production for 2019 and how this projection compares to EPA's projection. Section III.D discusses the methodologies used by EPA to project cellulosic biofuel production in 2019 and the resulting projection of 381 million ethanol-equivalent gallons.
CAA section 211(o)(2)(B)(i)(III) states the statutory volume targets for cellulosic biofuel. The volume of cellulosic biofuel specified in the statute for 2019 is 8.5 billion gallons. The statute provides that if EPA determines, based on a letter provided to the EPA by EIA, that the projected volume of cellulosic biofuel production in a given year is less than the statutory volume, then EPA shall reduce the applicable volume of cellulosic biofuel to the projected volume available during that calendar year.
In addition, if EPA reduces the required volume of cellulosic biofuel below the level specified in the statute, we may reduce the applicable volumes of advanced biofuels and total renewable fuel by the same or a lesser volume,
In this section, we first explain our general approach to assessing facilities or groups of facilities (which we collectively refer to as “facilities”) that have the potential to produce cellulosic biofuel in 2019. We then review the accuracy of EPA's projections in prior years. Next, we discuss the criteria used to determine whether to include potential domestic and foreign sources of cellulosic biofuel in our projection for 2019. Finally, we provide a summary table of all facilities that we expect to produce cellulosic biofuel in 2019.
In order to project cellulosic biofuel production for 2019 we have tracked the progress of a number of potential cellulosic biofuel production facilities, located both in the U.S. and in foreign countries. As we have done in previous years, we have focused on facilities with the potential to produce commercial-scale volumes of cellulosic biofuel rather than small research and development (R&D) or pilot-scale facilities.
As an initial matter, it is useful to review the accuracy of EPA's past cellulosic biofuel projections. The record of actual cellulosic biofuel production and EPA's projected production volumes from 2015-2018 are shown in Table III.B-1 below. These data indicate that EPA's projection was lower than the actual number of cellulosic RINs made available in 2015,
EPA's projections of liquid cellulosic biofuel were higher than the actual volume of liquid cellulosic biofuel produced each year from 2015 to 2017.
We next turn to the projection of CNG/LNG derived from biogas. For 2018, EPA for the first time used an industry-wide approach, rather than an approach that projects volumes for individual companies or facilities, to project the production of CNG/LNG derived from biogas. EPA used a facility-by-facility approach to project the production of CNG/LNG derived from biogas from 2015-2017. Notably this methodology resulted in significant over-estimates of CNG/LNG production in 2016 and 2017, leading EPA to develop the alternative industry wide projection methodology first used in 2018. This updated approach reflects the fact that this industry is far more mature than the liquid cellulosic biofuel industry, with a far greater number of potential producers of CNG/LNG derived from biogas. In such cases, industry-wide projection methods can be more accurate than a facility-by-facility approach, especially as macro market and economic factors become more influential on total production than the success or challenges at any single facility. The industry wide projection methodology slightly under-projected the production of CNG/LNG derived from biogas in 2018. However, the difference between the projected and actual production volume of these fuels was smaller than in 2017.
As described in Section III.D.2 below, EPA is again projecting production of CNG/LNG derived from biogas using the industry wide approach. We calculate a year-over-year rate of growth in the renewable CNG/LNG industry by comparing RIN generation for CNG/LNG derived from biogas from October 2016-September 2017 to the RIN generation for these same fuels from October 2017-September 2018 (the most recent month for which data are available). We then apply this year-over-year growth rate to the total number of cellulosic RINs generated and available to be used for compliance with the annual standards in 2017 to estimate the production of CNG/LNG derived from biogas in 2019.
There are several companies and facilities
In addition to the potential sources of cellulosic biofuel located in the U.S., there are several foreign cellulosic biofuel companies that may produce cellulosic biofuel in 2019. These include facilities owned and operated by Beta Renewables, Enerkem, Ensyn, GranBio, and Raizen. All of these facilities use fuel production pathways that have been approved by EPA for cellulosic RIN generation provided eligible sources of renewable feedstock are used and other regulatory requirements are satisfied. These
EPA's projection of cellulosic biofuel production in 2019 includes cellulosic biofuel that is projected to be imported into the U.S. in 2019. For the purposes of this final rule we have considered all the registered foreign facilities under the RFS program to be potential sources of cellulosic biofuel in 2019. We believe that due to the strong demand for cellulosic biofuel in local markets, the significant technical challenges associated with the operation of cellulosic biofuel facilities, and the time necessary for potential foreign cellulosic biofuel producers to register under the RFS program and arrange for the importation of cellulosic biofuel to the U.S., cellulosic biofuel imports from foreign facilities not currently registered to generate cellulosic biofuel RINs are generally highly unlikely in 2019. For purposes of our 2019 cellulosic biofuel projection we have, with one exception (described below), excluded potential volumes from foreign cellulosic biofuel production facilities that are not currently registered under the RFS program.
Cellulosic biofuel produced at three foreign facilities (Ensyn's Renfrew facility, GranBio's Brazilian facility, and Raizen's Brazilian facility) generated cellulosic biofuel RINs for fuel exported to the U.S. in 2017 and/or 2018; projected volumes from each of these facilities are included in our projection of available volumes for 2019. EPA has also included projected volume from two additional foreign facilities. One of these facilities has completed the registration process as a cellulosic biofuel producer (Enerkem's Canadian facility). The other facility (Ensyn's Port-Cartier, Quebec facility), while not yet registered as a cellulosic biofuel producer, is owned by a Ensyn, a company that has previously generated cellulosic biofuel RINs using the same technology at a different facility. We believe that it is appropriate to include volume from these facilities in light of their proximity to the U.S., the proven technology used by these facilities, the volumes of cellulosic biofuel exported to the U.S. by the company in previous years (in the case of Ensyn), and the company's stated intentions to market fuel produced at these facilities to qualifying markets in the U.S. All of the facilities included in EPA's cellulosic biofuel projection for 2019 are listed in Table III.B.3-1 below.
General
Section 211(o)(3)(A) of the CAA requires EIA to “provide to the Administrator of the Environmental Protection Agency an estimate, with respect to the following calendar year, of the volumes of transportation fuel, biomass-based diesel, and cellulosic biofuel projected to be sold or introduced into commerce in the United States.” EIA provided these estimates to EPA on October 12, 2018.
In its letter, EIA did not identify the facilities on which their estimate of liquid cellulosic biofuel production was based. EIA did, however, indicate in the letter that it only included domestic production of cellulosic ethanol in their projections. These projections, therefore, do not include cellulosic biofuel produced by foreign entities and imported into the U.S., nor estimates of cellulosic heating oil or CNG/LNG produced from biogas, which together represent approximately 98 percent of our projected cellulosic biofuel volume for 2019. When limiting the scope of our projection to the companies assessed by EIA, we note that our volume projections are equal. EPA projects approximately 10 million gallons of liquid cellulosic biofuel will be produced domestically in 2019, all of which is expected to be cellulosic ethanol.
For our 2019 liquid cellulosic biofuel projection, we use the same general approach as we have in projecting these volumes in previous years. We begin by first categorizing potential liquid cellulosic biofuel producers in 2019 according to whether or not they have achieved consistent commercial scale production of cellulosic biofuel to date. We refer to these facilities as consistent producers and new producers, respectively. Next, we define a range of likely production volumes for 2019 for each group of companies. Finally, we use a percentile value to project from the established range a single projected production volume for each group of companies in 2019. As in 2018, we calculated percentile values for each group of companies based on the past performance of each group relative to our projected production ranges. This methodology is briefly described here, and is described in detail in memoranda to the docket.
We first separate the list of potential producers of cellulosic biofuel (listed in Table III.B.3-1) into two groups according to whether the facilities have achieved consistent commercial-scale production and cellulosic biofuel RIN generation. We next defined a range of likely production volumes for each group of potential cellulosic biofuel producers. For the final rule, we have updated the companies included in our projection, the categorization of these companies, and the low and high end of the potential production range for each company for 2019 based on updated information. The low end of the range for each group of producers reflects actual RIN generation data over the last 12 months for which data are available at the time our technical assessment was completed (October 2017-September 2018).
After defining likely production ranges for each group of companies, we next determined the percentile values to use in projecting a production volume for each group of companies. In this final rule we have calculated the percentile values using actual production data from January 2016 through September 2018 (the last month for which actual data is available) and projected production data for the remaining months of 2018 (October—December 2018). This approach is consistent with the approach taken in the 2018 final rule.
For each group of companies and for each year from 2016—2018, Table III.D.1-3 below shows the projected ranges for liquid cellulosic biofuel production (from the 2014-16, 2017, and 2018 final rules), actual production, and the percentile values that would have resulted in a projection equal to the actual production volume.
Based
EPA also considered whether or not to include the percentile value from 2016 in our calculation of the percentile value to use in projecting liquid cellulosic biofuel production in 2019. Including a larger number of years in our calculation of the percentile value for 2019 would result in a larger data set that is less susceptible to large fluctuations that result from unexpectedly high or low production volumes in any one year that may not be indicative of future production. However, including a larger number of years also necessarily requires including older data that may no longer reflect the likely production of liquid cellulosic biofuel in a future year, especially given the rapidly changing nature of this industry.
We ultimately decided to include data from 2016 in calculating the percentile values to project liquid cellulosic biofuel production in 2019, determining that there was significant value in including this additional data. Even though the liquid cellulosic biofuel industry has changed since 2016, these changes are not so significant as to render this data obsolete. In determining the percentile values to use for 2019 we have also decided to weight the observed actual percentile values from 2016-2018 equally. While the percentile
Commenters generally supported EPA's use of updated data (data not available at the time of the proposed rule, but expected to be available for the final rule) in calculating the percentage standards for 2019. Several commenters objected to EPA's use of a single percentile value based on historical production performance for each group of companies. These commenters often described this approach as “backwards looking” and generally requested that EPA not discount facility's projected production at all, determine a unique percentile value for each facility based on facility specific factors, or return to the percentile values used in the 2016 and 2017 rules (25th percentile for new producers and 50th percentile for consistent producers).
EPA disagrees with the commenters characterization of the projection methodology used in this final rule as “backwards looking.” As discussed above, and in more detail in a memorandum to the docket,
Finally, we used these percentile values, together with the ranges determined for each group of companies discussed above, to project a volume for each group of companies in 2019. These calculations are summarized in Table III.D.1-4 below.
For 2019, EPA is using the same methodology as in the 2018 final rule, an industry wide projection based on a year-over-year growth rate, to project production of CNG/LNG derived from biogas used as transportation fuel.
EPA then applied this 29 percent year-over-year growth rate to the total number of 2017 cellulosic RINs generated and available for compliance for CNG/LNG. This methodology results in a projection of 399 million gallons of CNG/LNG derived from biogas in 2019.
EPA has also reviewed data on potential producers of CNG/LNG derived from biogas that is used as transportation fuel. Compared to EPA, these potential producers projected greater total production of CNG/LNG derived from biogas in 2019 based on the capacity of such projects. Since producers of CNG/LNG derived from biogas have historically over-estimated their production of these fuels, it would not be appropriate to simply adopt the capacity of these projects as our projection of CNG/LNG derived from biogas for 2019. The fact that the industry projections exceed EPA's projected volume, however, indicates that the volume of these fuels projected for 2019 can be satisfied by a combination of projects currently producing CNG/LNG derived from biogas for these purposes and projects expected to product biogas by the end of 2019.
A number of commenters requested that, in addition to projecting volume of CNG/LNG derived from biogas using a year-over-year growth rate, EPA project additional volume to account for new projects and those currently in development. We believe that the industry-wide projection methodology used in this final rule already adequately accounts for new facilities and those currently in development. The growth rate used to project the production of CNG/LNG derived from biogas in 2019 includes both increased production from existing facilities, as well as new facilities that began producing fuel in the last 12 months for which data are available. Thus, adding additional volume to account for new facilities would effectively be double counting production from new facilities.
Other commenters suggested that the industry wide projection was inappropriate, and that EPA should return to a facility-by-facility assessment, as was used to project CNG/LNG derived from biogas in 2016 and 2017. We believe that the mature nature of the industry producing CNG/LNG derived from biogas lends itself well to an industry-wide projection methodology and that this methodology can be more accurate than a facility-by-facility approach, especially as macro market and economic factors have apparently become more influential on total production than the success or challenges at any single facility; especially as producers are vying for business relationships with the same pool of CNG/LNG fueled transportation fleets to enable them to generate RINs. We further note that the facility-by-facility approach used to project production of CNG/LNG produced from biogas in 2016 and 2017 significantly over-estimated production of these fuels.
While our projection methodology uses a growth rate based on historical data it adequately anticipates higher production volumes in future years, including both increased production from existing facilities as well as production from new facilities. In this way it satisfies our charge to project future cellulosic biofuel production in a reasonable manner, and with neutrality, even though it does not consider all potential producers of these fuels on a facility-by-facility basis.
After projecting production of cellulosic biofuel from liquid cellulosic biofuel production facilities and producers of CNG/LNG derived from biogas, EPA combined these projections to project total cellulosic biofuel production for 2019. These projections are shown in Table III.D.3-1. Using the methodologies described in this section, we project that 418 million ethanol-equivalent gallons of cellulosic biofuel will be produced in 2019. We believe that projecting overall production in 2019 in the manner described above results in a neutral estimate (neither biased to produce a projection that is too high nor too low) of likely cellulosic biofuel production in 2019.
Further discussion of the companies expected to produce cellulosic biofuel and make it commercially available in 2019 can be found in a memorandum to the docket.
The national volume targets for advanced biofuel and total renewable fuel to be used under the RFS program each year through 2022 are specified in CAA section 211(o)(2)(B)(i)(I) and (II). Congress set annual renewable fuel volume targets that envisioned growth at a pace that far exceeded historical growth and, for years after 2011, prioritized that growth as occurring principally in advanced biofuels (contrary to previous growth patterns where most growth was in conventional renewable fuel). Congressional intent is evident in the fact that the implied statutory volume requirement for conventional renewable fuel is 15 billion gallons for all years after 2014, while the advanced biofuel volume requirements, driven largely by growth in cellulosic biofuel, continue to grow each year through 2022 to a total of 21 billion gallons.
Due to a shortfall in the availability of cellulosic and advanced biofuel, and consistent with our long-held interpretation of the cellulosic waiver authority as best interpreted and applied by providing equal reductions in advanced biofuel and total renewable fuel, we are reducing the statutory volume targets for both advanced biofuel and total renewable fuel for 2019 using the full extent of the cellulosic waiver authority.
In this Section we discuss our use of the discretion afforded by the cellulosic waiver authority at CAA 211(o)(7)(D)(i) to reduce volumes of advanced biofuel and total renewable fuel. We first discuss our assessment of advanced biofuel and the considerations that have led us to conclude that the advanced biofuel volume target in the statute should be reduced by the full amount permitted under the cellulosic waiver authority. We then address total renewable fuel in the context of our interpretation, articulated in previous annual rulemakings, that advanced biofuel and total renewable fuel should be reduced by the same amount under the cellulosic waiver authority. We also address several comments we received in response to the July 10, 2018 proposal; the remaining comments are addressed in a separate RTC document.
To begin, we have evaluated the capabilities of the market and are making a finding that the 13.0 billion gallons specified in the statute for advanced biofuel cannot be reached in 2019. This is primarily due to the expected continued shortfall in cellulosic biofuel; production of this fuel type has consistently fallen short of the statutory targets by 95 percent or more, and as described in Section III, we project that it will fall far short of the statutory target of 8.5 billion gallons in 2019. For this and other reasons described in this section we are reducing the advanced biofuel statutory target by the full amount of the shortfall in cellulosic biofuel for 2019.
In previous years when we have used the cellulosic waiver authority, we have determined the extent to which we should reduce advanced biofuel volumes by taking into account the availability of advanced biofuels, their energy security and greenhouse gas (GHG) impacts, the availability of carryover RINs, the apparent intent of Congress as reflected in the statutory volumes tables to substantially increase the use of advanced biofuels over time, as well as factors such as increased costs associated with the use of advanced biofuels and the increasing likelihood of adverse unintended impacts associated with use of advanced biofuel volumes achieved through diversion of foreign fuels or substitution of advanced feedstocks from other uses to biofuel production. Until the 2018 standards rule, the consideration of these factors led us to conclude that it was appropriate to set the advanced biofuel standard in a manner that would allow the partial backfilling of missing cellulosic volumes with non-cellulosic advanced biofuels.
Although we continue to believe that the factors earlier considered in exercising the cellulosic waiver authority are relevant and appropriate, we project that there will be insufficient reasonably attainable volumes of non-cellulosic advanced biofuels in 2019 to allow any backfilling for missing volumes of cellulosic biofuel.
Several stakeholders commented that it was inappropriate for EPA to change its policy with regard to backfilling of missing cellulosic biofuel with other advanced biofuel as it had done prior to 2018. However, in making such comments, stakeholders misinterpreted our approach in those years. While we permitted some backfilling, we did so only after considering such factors as described above. The approach we have taken for the 2019 volume requirements is no different than it was in previous years, though the outcome of that approach is different due to the different circumstances.
We note that the predominant non-cellulosic advanced biofuels available in the near term are advanced biodiesel and renewable diesel.
Furthermore, several other factors have added uncertainty regarding the volume of advanced biofuels that we project are attainable in 2019. The first is the fact that the tax credit for biodiesel has not been renewed for 2019. The second is the final determination by the Department of Commerce that tariffs should be imposed on biodiesel imports from Argentina and Indonesia, and the potential for those tariffs to increase.
We believe that the factors and considerations noted above are all appropriate to consider under the broad discretion provided under the cellulosic waiver authority, and that consideration of these factors supports our use of this authority. Many of the considerations discussed in this final rule are related to the availability of non-cellulosic advanced biofuels (
As discussed in further detail in the following sections, our assessment of advanced biofuel suggests that achieving the implied statutory volume target for non-cellulosic advanced biofuel in 2019 (4.5 billion gallons) is attainable. While it may also be possible that a volume of non-cellulosic advanced biofuel greater than 4.5 billion gallons may be attainable, a volume equal to or higher than 4.5 billion gallons would likely result in the diversion of advanced feedstocks from other uses or diversion of advanced biofuels from foreign sources, and thus is not reasonably attainable. In that case, our assessment of other factors, such as cost and GHG impacts, indicate that while such higher volumes may be attainable, it would not be appropriate to set the advanced biofuel volume requirement so as to require use of such volumes to partially backfill for missing cellulosic volumes.
The impact of our exercise of the cellulosic waiver authority is that after waiving the cellulosic biofuel volume down to the projected available level, and applying the same volume reduction to the statutory volume target for advanced biofuel, the resulting volume requirement for advanced biofuel for 2019 would be 630 million gallons more than the applicable volume used to derive the 2018 percentage standard. Furthermore, after applying the same reduction to the statutory volume target for total renewable fuel, the volume requirement for total renewable fuel would also be 630 million gallons more than the applicable volume used to derive the 2018 percentage standard.
As described in Section II.A, when making reductions in advanced biofuel and total renewable fuel under the cellulosic waiver authority, the statute limits those reductions to no more than the reduction in cellulosic biofuel. As described in Section III.D, we are establishing a 2019 applicable volume for cellulosic biofuel of 418 million gallons, representing a reduction of 8,082 million gallons from the statutory target of 8,500 million gallons. As a result, 8,082 million gallons is the maximum volume reduction for advanced biofuel and total renewable fuel that is permissible using the cellulosic waiver authority. Use of the cellulosic waiver authority to this maximum extent would result in volumes of 4.92 and 19.92 billion gallons for advanced biofuel and total renewable fuel, respectively.
We are authorized under the cellulosic waiver authority to reduce the advanced biofuel and total renewable fuel volumes “by the same or a lesser” amount as the reduction in the cellulosic biofuel volume.
We have considered both attainable and reasonably attainable volumes of advanced biofuel to inform our exercise of the cellulosic waiver authority. As used in this rulemaking, both “reasonably attainable” and “attainable” are terms of art defined by EPA.
As in prior rulemakings, we begin by considering what volumes of advanced biofuels are reasonably attainable. In
Our individual assessments of reasonably attainable volumes of each type of advanced biofuel reflect this approach. As discussed in further detail in this section, we find that 100 million gallons of advanced ethanol, 60 million gallons of other advanced biofuels, and 2.61 billion gallons of advanced biodiesel and renewable diesel are reasonably attainable. Together with our projected volume of 418 million gallons of cellulosic biofuel, the sum of these volumes falls short of 4.92 billion gallons, which is the lowest advanced biofuel requirement that EPA can require under the cellulosic waiver authority.
Therefore, we also have considered whether the market can nonetheless make available 4.92 billion gallons of advanced biofuel, notwithstanding likely feedstock/fuel diversions. That is, we assess whether 4.92 billion gallons is merely “attainable,” as opposed to reasonably attainable. In particular, we assess whether additional volumes of advanced biodiesel and renewable diesel are attainable. We conclude that 2.8 billion gallons of advanced biodiesel and renewable diesel are attainable, notwithstanding potential feedstock/fuel diversions. This quantity of advanced biodiesel and renewable diesel, together with the cellulosic biofuel, sugarcane ethanol, and other advanced biofuels described above, would enable the market to make available 4.92 billion gallons of advanced biofuels.
The predominant available source of advanced biofuel other than cellulosic biofuel and BBD is imported sugarcane ethanol. Imported sugarcane ethanol from Brazil is the predominant form of imported ethanol and the only significant source of imported advanced ethanol. In setting the 2018 standards, we estimated that 100 million gallons of imported sugarcane ethanol would be reasonably attainable.
Since the 2018 final rule, new data reveals a continued trend of low imports. At the time of the 2018 standards final rule, we had used available data from a portion of 2017 to estimate that import volumes of sugarcane ethanol were likely to fall significantly below the 200 million gallons we had assumed when we set the 2017 standards. Import data for all of 2017 is now available, and indicates that imports of sugarcane ethanol reached just 77 million gallons. Moreover, EIA data on monthly ethanol imports in 2018 through July indicate that no ethanol was imported.
While it is difficult to predict imports for 2019, we believe it would be reasonable not to increase the assumed volume above 100 million gallons for purposes of determining whether an advanced biofuel volume requirement of 4.92 billion gallons is reasonably attainable for 2019. Although the advanced biofuel volume requirement for 2019 is about 630 million gallons higher than that for 2018, creating some incentive for increases in imports, we note that an even larger increase in the required volume of advanced biofuel between 2016 and 2017 was accompanied by only a very small increase in imports of sugarcane ethanol, from 34 million gallons in 2016 to 77 million gallons in 2017. Moreover, the E10 blendwall and the fact that imported sugarcane ethanol typically costs more than corn ethanol create disincentives for increasing imports above the levels in recent years, though the difference in RIN values between conventional and advanced ethanol may offset the cost difference to some degree.
We note that the future projection of imports of sugarcane ethanol is inherently imprecise, and that actual imports in 2019 could be lower or higher than 100 million gallons. Factors that could affect import volumes include uncertainty in the Brazilian political climate, weather and harvests in Brazil, world ethanol demand and prices, constraints associated with the E10 blendwall in the U.S., world demand for and prices of sugar, and the cost of sugarcane ethanol relative to that of corn ethanol. After considering these factors, and in light of the high degree of variability in historical imports of sugarcane ethanol, we believe that 100 million gallons is reasonably attainable for 2019.
In addition to cellulosic biofuel, imported sugarcane ethanol, and advanced biodiesel and renewable diesel, there are other advanced biofuels that can be counted in the determination of reasonably attainable volumes of advanced biofuel for 2019. These other advanced biofuels include non-cellulosic CNG, naphtha, heating oil, and domestically-produced advanced ethanol. However, the supply of these fuels has been relatively low in the last several years.
The downward trend over time in CNG/LNG from biogas as advanced biofuel with a D code of 5 is due to the re-categorization in 2014 of landfill biogas from advanced (D code 5) to cellulosic (D code 3).
We recognize that the potential exists for additional volumes of advanced biofuel from sources such as jet fuel, liquefied petroleum gas (LPG), butanol, and liquefied natural gas (as distinct from CNG), as well as non-cellulosic CNG from biogas produced in digesters. However, since they have been produced, if at all, in only de minimis and sporadic amounts in the past, we do not have a reasonable basis for projecting substantial volumes from these sources in 2019.
Having projected the production volume of cellulosic biofuel, and the reasonably attainable volumes of imported sugarcane ethanol and “other” advanced biofuels, we next assess the potential supply of advanced biodiesel and renewable diesel. First, we calculate the amount of advanced biodiesel and renewable diesel that would need to be supplied to meet the advanced requirement were we to exercise our maximum discretion under the cellulosic authority: 2.8 billion gallons. This calculation, shown in Table IV.B.3-1 below, helps inform the exercise of our waiver authorities. Second, we consider the historical supply of these fuels and the impact of the biodiesel tax policy on advanced biodiesel and renewable diesel use in the U.S. Next, we consider factors that could potentially limit the supply of advanced biodiesel including the production capacity of advanced biodiesel and renewable diesel production facilities, the ability for the market to distribute and use these fuels, the availability of feedstocks to produce these fuels, and fuel imports and exports. Based on our projection of the domestic growth in advanced biodiesel and renewable diesel feedstocks we project a reasonably attainable volume of 2.61 billion gallons of advanced biodiesel and renewable diesel in 2019. Since this volume is lower than the 2.8 billion gallons we calculated would need to be supplied to meet the advanced requirement were we to exercise our maximum discretion under the cellulosic authority, we finally consider if additional supplies of advanced biodiesel and renewable diesel are attainable. Ultimately, we conclude that a volume of at least 2.8 billion gallons of advanced biodiesel and renewable diesel is attainable in 2019. We note that we have not attempted to determine the maximum attainable volume of these fuels. While the maximum attainable volume of advanced biodiesel and renewable diesel in 2019 is greater than 2.8 billion gallons we do not believe it would be appropriate to require a greater volume of these fuels (by establishing a higher advanced biofuel volume for 2019) due to the high cost and the increased likelihood of adverse unintended impacts associated with these fuels.
Calculating the volume of advanced biodiesel and renewable diesel that would be needed to meet the volume of advanced biofuel for 2019 is an important benchmark to help inform EPA's consideration of our waiver authorities. In situations where the reasonably attainable volume of biodiesel and renewable diesel exceeds the volume of these fuels that would be needed to meet the volume of advanced biofuel after reducing the advanced biofuel volume by the same amount as the cellulosic biofuel volume, as was the case in 2017 and 2018, EPA may consider whether or not to allow additional volumes of these fuels to backfill for missing cellulosic biofuel volumes. In situations where the reasonably attainable volume of advanced biodiesel and renewable diesel is less than the volume of these fuels that would be needed to meet the volume of advanced biofuel after reducing the advanced biofuel volume by the same amount as the cellulosic biofuel volume, EPA may consider whether or not to use additional waiver authorities, to the extent available, to make further reductions to the advanced biofuel volume.
Having
In addition to a review of the volumes of advanced biodiesel and renewable diesel used in previous years, we believe the likely growth in production of feedstocks used to produce these fuels, as well as the total projected available volumes of these feedstocks, are important factors to consider. This is because while there are many factors that could potentially limit the production and availability of these fuels, the impacts of increasing production of advanced biodiesel and renewable diesel on factors such as costs, energy security, and GHG emissions are expected to vary depending on whether the feedstocks used to produce these fuels are sourced from waste sources or by-products of other industries (such as the production of livestock feed or ethanol production), are sourced from increased oilseed production, or are sourced from the diversion of feedstocks from existing uses. The energy security and GHG reduction value associated with the growth in the use of advanced biofuels is greater when these fuels are produced from waste fats and oils or feedstocks that are byproducts of other industries (such as soybean oil from soybeans primarily grown as animal feed), rather than a switching of existing advanced feedstocks from other uses to renewable fuel production or the diversion of advanced biodiesel and renewable diesel from foreign markets. This is especially true if the parties that previously used the advanced biofuel or feedstocks replace these oils with low cost palm oil
Before considering the projected growth in the production of qualifying feedstocks that could be used to produce advanced biodiesel and renewable diesel, as well as the total volume of feedstocks that could be used to produce these fuels, it is helpful to review the volumes of biodiesel and renewable diesel that have been used in the U.S. in recent years. While historic data and trends alone are insufficient to project the volumes of biodiesel and renewable diesel that could be provided in future years, historic data can serve as a useful reference in considering future volumes. Past experience suggests that a high percentage of the biodiesel and renewable diesel used in the U.S. (from both domestic production and imports) qualifies as advanced biofuel.
Since 2011, the year-over-year changes in the volume of advanced biodiesel and renewable diesel used in the U.S. have varied greatly, from a low of 127 million fewer gallons from 2016 to 2017 to a high of 779 million additional gallons from 2015 to 2016. These changes were likely influenced by multiple factors such as the cost of biodiesel feedstocks and petroleum diesel, the status of the biodiesel blenders tax credit, growth in marketing of biodiesel at high volume truck stops and centrally fueled fleet locations, demand for biodiesel and renewable diesel in other countries, biofuel policies in both the U.S. and foreign countries, and the volumes of renewable fuels (particularly advanced biofuels) required by the RFS. This historical information does not indicate that the maximum previously observed increase of 779 million gallons of advanced biodiesel and renewable diesel would be reasonable to expect from 2018 to 2019, nor does it indicate that the low (or negative) growth rates observed in other years would recur in 2019. Rather, these data illustrate both the magnitude of the changes in advanced biodiesel and renewable diesel in previous years and the significant variability in these changes.
The historic data indicates that the biodiesel tax policy in the U.S. can have a significant impact on the volume of biodiesel and renewable diesel used in the U.S. in any given year.
Some commenters stated that the tax credit has no impact on the potential supply of advanced biodiesel and renewable diesel. They generally argued that while the tax credit impacted the cost of biodiesel, as well as the RIN price needed to make advanced biodiesel and renewable diesel cost competitive with petroleum diesel, the RIN price was ultimately capable of incentivizing the production and use of advanced biodiesel and renewable diesel with or without the tax credit. We recognize that this is theoretically true; because the RIN prices vary with the supply and demand for RINs, the RIN price can rise to provide the same value as the tax credit in its absence. However, we note that it is this very aspect of the price of RINs, the potential that RIN prices may rise or fall depending on market conditions, that can hinder their ability to incentivize increased production and use of advanced biodiesel and renewable diesel. Further, higher advanced biofuel RIN prices can incentivize the production of other advanced fuels if these fuels can be produced at a price that is cost competitive with advanced biodiesel and renewable diesel. Conversely, the tax credit provides a fixed price incentive for all biodiesel and renewable diesel blended into the diesel fuel pool in the U.S., and is not available to other advanced biofuels. Ultimately, as discussed above the supply of biodiesel and renewable diesel is likely to be influenced by a number of factors, including the 2019 RFS volume requirements, the advanced and BBD RIN prices, expectations about the availability of the biodiesel blenders tax credit, and a number of other market-based factors.
The historical data suggests that the supply of advanced biodiesel and renewable diesel could potentially increase from the projected 2.54 billion gallons in 2018 to 2.8 billion gallons in 2019 (the projected volume needed to meet the advanced biofuel volume for 2019 after reducing the statutory advanced biofuel volume by the same amount as the cellulosic biofuel reduction). This would represent an increase of approximately 250 million gallons from 2018 to 2019, slightly higher than the average increase in the volume of advanced biodiesel and renewable diesel used in the U.S. from 2011 through 2017 (218 million gallons per year) and significantly less than the highest annual increase during this time (779 million gallons from 2015 to 2016).
After reviewing the historical volume of advanced biodiesel and renewable diesel used in the U.S. and considering the possible impact of the expiration of the biodiesel tax credit (discussed above), EPA next considers other factors that may impact the production, import, and use of advanced biodiesel and renewable diesel in 2019. The production capacity of registered advanced biodiesel and renewable diesel production facilities is highly unlikely to limit the production of these fuels, as the total production capacity for biodiesel and renewable diesel at registered facilities in the U.S. (4.1 billion gallons) exceeds the volume of these fuels that are projected to be needed to meet the advanced biofuel volume for 2019 after exercising the cellulosic waiver authority (2.8 billion gallons).
Conversely, the availability of advanced feedstocks that can be used to produce advanced biodiesel and renewable diesel, as well as the availability of imported advanced biodiesel and renewable diesel, may be limited in 2019. We acknowledge that an increase in the required use of advanced biodiesel and renewable diesel could be realized through a diversion of advanced feedstocks from other uses, or a diversion of advanced biodiesel and renewable diesel from existing markets in other countries. Furthermore, the volume of advanced biodiesel and renewable diesel and their corresponding feedstocks projected to be produced globally exceeds the volume projected to be required in 2019 (2.8 billion gallons of advanced biodiesel and renewable diesel and the corresponding volume of advanced feedstocks) by a significant margin.
We perceive the net benefits to be lower both because of the potential disruption and associated cost impacts to other industries resulting from feedstock switching, and the potential adverse effect on lifecycle GHG emissions associated with feedstocks for biofuel production that would have been used for other purposes and which must then be backfilled with other feedstocks. Similarly, increasing the supply of biodiesel and renewable diesel to the U.S. by diverting fuel that would otherwise have been used in other countries results in higher lifecycle GHG emissions than if the supply of these fuels was increased by an increased collection of waste fats and oils or increased production of feedstocks that are byproducts of other industries, especially if this diversion results in increased consumption of petroleum fuels in the countries that would have otherwise consumed the biodiesel or renewable diesel. By focusing our assessment of the potential growth in the attainable volume of biodiesel and renewable diesel on the expected growth in the production of advanced feedstocks (rather than the total supply of these feedstocks in 2018, which would include feedstocks currently being used for non-biofuel purposes), we are attempting to minimize the incentives for the RFS program to increase the supply of advanced biodiesel and renewable diesel through feedstock switching or diverting biodiesel and renewable diesel from foreign markets to the U.S.
Advanced biodiesel and renewable diesel feedstocks include both waste oils, fats, and greases; and oils from planted crops. We received many comments from parties projecting that
We believe the most reliable source for projecting the expected increase in vegetable oils in the U.S. is USDA's World Agricultural Supply and Demand Estimates (WASDE). At the time of our assessment for this final rule, the most current version of the WASDE is from October 2018. The projected increase in vegetable oil production in the U.S. from 2017/2018 to 2018/2019 is 0.14 million metric tons per year. This additional quantity of vegetable oils could be used to produce approximately 40 million additional gallons of advanced biodiesel or renewable diesel in 2019 relative to 2018.
A number of commenters mentioned the tariffs recently enacted by China on soybean exports from the U.S. as a potential source of additional feedstock for advanced biodiesel and renewable diesel. The potential impacts of these tariffs are significant, as approximately 25 percent of the U.S. soybean crop is currently exported to China.
The most recent WASDE report projects that exports of oilseeds will decrease by approximately 2 million metric tons (approximately 3 percent) from 2017/2018 to 2018/2019. In addition, the WASDE projects that exports of vegetable oils will decrease by 0.10 million metric tons during this same time period. The October WASDE appears to take the recent tariffs into account, as there is a notable decrease in the expected trade of oilseeds in the recent WASDE projections relative to WASDE projections made prior to the announcement of Chinese tariffs on U.S. soybeans.
In addition to virgin vegetable oils, we also expect increasing volumes of distillers corn oil
While much of the increase in advanced biodiesel and renewable diesel feedstocks produced in the U.S. from 2018 to 2019 is expected to come from virgin vegetable oils and distillers corn oil, increases in the supply of other sources of advanced biodiesel and renewable diesel feedstocks, such as biogenic waste oils, fats, and greases, may also occur. These increases, however, are expected to be modest, as many of these feedstocks that can be recovered economically are already being used to produce biodiesel or renewable diesel, or in other markets. In fact, the WAEES model projects an increase of only 5 million gallons in the volume of biodiesel produced from feedstocks other than soybean oil, canola oil, and distillers corn oil from 2018 to 2019.
In total, we expect that increases in feedstocks produced in the U.S. are sufficient to produce approximately 60 million more gallons of advanced biodiesel and renewable diesel in 2019 relative to 2018. This number includes 40 million gallons from increased vegetable oil production, 15 million gallons from increased corn oil production, and 5 million gallons from increased waste oil collection. This number does not include additional volumes related to decreases in exported volumes of soybeans to China as a result of tariffs and/or increased collection of waste oils. Decreased exports of soybeans and soybean oil, represent feedstocks diverted from use in other countries, while any increase in the collection of waste oils is highly uncertain. Our projection also does not consider factors which could potentially decrease the availability of advanced biofuel feedstocks that could be used to produce biodiesel or renewable diesel, such as an increase in the volume of vegetable oils used in food markets or other non-biofuel industries. In our 2018 final rule, we determined that 2.55 billion gallons of advanced biodiesel and renewable diesel were reasonably attainable in 2018,
EPA's projections of the growth of advanced feedstocks does not, however, suggest that the total supply of advanced biodiesel and renewable diesel to the U.S. in 2018 will be limited to 2.61 billion gallons. Rather, this is the volume of these fuels that we project could be supplied while seeking to minimize quantities of advanced feedstocks or biofuels from existing uses. The October 2018 WASDE reports that production of vegetable oil in the U.S. in the 2018/2019 market year will be sufficient to produce approximately 3.5 billion gallons of biodiesel and renewable diesel (including both advanced and conventional biofuels) if the entire volume of vegetable oil was used to produce these fuels. Additional advanced biodiesel and renewable diesel could be produced from waste fats, oils, and greases. The global production of vegetable oil projected in the 2018/2019 marketing year would be sufficient to produce approximately 58.1 billion gallons of biodiesel and renewable diesel (including both advanced and conventional biofuels).
Further, the supply of advanced biodiesel and renewable diesel to the U.S. in 2019 could be increased by
EPA next considered potential changes in the imports of advanced biodiesel and renewable diesel produced in other countries. In previous years, significant volumes of foreign produced advanced biodiesel and renewable diesel have been supplied to markets in the U.S. (see Table IV.B.2-1 above). These significant imports were likely the result of a strong U.S. demand for advanced biodiesel and renewable diesel, supported by the RFS standards, the low carbon fuel standard (LCFS) in California, the biodiesel blenders tax credit, and the opportunity for imported biodiesel and renewable diesel to realize these incentives. As in 2018, we have not included the potential for increased volumes of imported advanced biodiesel and renewable diesel in our projection of the reasonably attainable volume for 2019. There is a far higher degree of uncertainty related to the availability and production of advanced biodiesel and renewable diesel in foreign countries, as this supply can be impacted by a number of unpredictable factors such as the imposition of tariffs and increased incentives for the use of these fuels in other countries (such as tax incentives or blend mandates). EPA also lacks the data necessary to determine the quantity of these fuels that would otherwise be produced and used in other countries, and thus the degree to which the RFS standards are simply diverting this fuel from use in other countries as opposed to incentivizing additional production.
The RFS requirements and California's LCFS are expected to continue to provide an incentive for imports of advanced biodiesel and renewable diesel in 2019. Several other factors, however, may negatively impact the volume of these fuels imported in 2019. In February 2018 the biodiesel blenders tax credit, which had expired at the end of 2016, was retroactively reinstated for biodiesel blended in 2017 but was not extended to apply to biodiesel blended in 2018 or 2019.
Despite these tariffs, imports of biodiesel and renewable diesel have not ceased. From January to June 2018, biodiesel and renewable diesel imports (according to EIA data) are approximately 172 million gallons, suggesting an annual volume of approximately 390 million gallons if the current import rates and seasonal trends hold through the end of the year.
In addition to EPA's assessment of the market's ability to produce, import, distribute, and use the 2.8 billion gallons of advanced biodiesel and renewable diesel projected to be used in 2019 to meet the advanced biofuel volume requirement, EPA compared the projected increase in these fuels to the increases observed in recent years. While each year's circumstances are unique, a projected increase comparable to pas increases further confirms that the volume is attainable. Domestic production of advanced biodiesel and renewable diesel in 2016 and 2017 was approximately 1.85 billion gallons, and is expected to increase to approximately 2.15 billion gallons in 2018 based on production data through September 2018. Of this total, approximately 150 million gallons of domestically produced biodiesel was exported in 2016 and 2017. If imported biodiesel and renewable diesel volumes continue to increase through 2019 by approximately 100 million gallons per year (to approximately 500 million gallons in 2019) domestic production would need to increase by approximately 300 million gallons in 2019 to reach a total advanced biodiesel and renewable diesel supply of 2.8 billion gallons by 2019.
After a careful consideration of the factors discussed above, EPA has determined that the 2.8 billion gallons of advanced biodiesel and renewable diesel projected needed to satisfy the implied statutory volume for non-cellulosic advanced biofuel in 2019 (4.5 billion gallons) are attainable. The total
In exercising the cellulosic waiver authority for 2017 and earlier, we determined it was appropriate to require a partial backfilling of missing cellulosic volumes with volumes of non-cellulosic advanced biofuel we determined to be reasonably attainable, notwithstanding the increase in costs associated with those decisions.
We further note that while there is some uncertainty in the volume of advanced biofuel that may be attainable or reasonably attainable, even if greater volumes of advanced biofuel are attainable or reasonably attainable, the high cost of these fuels provides sufficient justification for our decision to reduce the advanced biofuel volume for 2019 by the maximum amount under the cellulosic waiver authority. In Section V we present illustrative cost projections for sugarcane ethanol and soybean biodiesel in 2019, the two advanced biofuels that would be most likely to provide the marginal increase in volumes of advanced biofuel in 2019 in comparison to 2018. Sugarcane ethanol results in a cost increase compared to gasoline that ranges from $0.39-$1.04 per ethanol-equivalent gallon. Soybean biodiesel results in a cost increase compared to diesel fuel that ranges from $0.74-$1.23 per ethanol-equivalent gallon. The cost of these renewable fuels is high as compared to the petroleum fuels they displace.
Based on the information presented above, we believe that 4.92 billion gallons of advanced biofuel is attainable in 2019. After a consideration of the projected volume of cellulosic biofuel and reasonably attainable volumes of imported sugarcane ethanol and other advanced biofuels, we determined that 2.8 billion gallons of advanced biodiesel and renewable diesel would be needed to reach 4.92 billion gallons of advanced biofuel. Based on a review of the factors relevant to the supply of advanced biodiesel and renewable diesel as discussed in Section IV.B.2 above, including historic production and import data, the production capacity of registered biodiesel and renewable diesel producers, and the availability of advanced feedstocks, we have determined that 2.8 billion gallons of advanced biodiesel and renewable diesel is attainable in 2019.
However, we also acknowledge that 2.8 billion gallons of advanced biodiesel and renewable diesel is higher than the approximately 2.5 billion gallons projected to be supplied in 2018 based on available data through September 2018. While 2.8 billion gallons would require an increase in supply of approximately 300 million gallons between 2018 and 2019, this is approximately equal to the increase in domestic production of these fuels from 2017 to 2018, and approximately 100 million gallons less than the increase in the supply of advanced biodiesel and renewable diesel between 2017 and 2018 after adjusting for imported volumes of these fuels from Argentina and Indonesia in 2017.
In the event that the market does not supply this volume, the carryover RIN bank represents a source of RINs that could help obligated parties meet an advanced biofuel volume requirement of 4.92 billion gallons in 2019 if the market fails to supply sufficient advanced biofuels in 2019. As discussed in greater detail in Section II.B.1 of the preamble, carryover RINs provide obligated parties compliance flexibility in the face of substantial uncertainties in the transportation fuel marketplace, and provide a liquid and well-functioning RIN market upon which success of the entire program depends. We currently estimate that there are approximately 620 million advanced carryover RINs available.
In response to the proposal, we received comments supporting our proposed volume requirement of 4.92 billion gallons, as well as comments requesting higher or lower volumes. EPA's assessment of these comments is provided in the RTC document.
It should be noted that by exercising the full cellulosic waiver authority for advanced biofuel, the implied statutory volume target for non-cellulosic advanced biofuel of 4.5 billion gallons in 2019 would be maintained. This represents an increase of 0.5 billion gallons from the 2018 volume requirements.
As discussed in Section II.A.1, we believe that the cellulosic waiver provision is best interpreted to reduce the advanced biofuel and total renewable fuel volumes by equal amounts. For the reasons we have previously articulated, we believe this interpretation is consistent with the statutory language and best effectuates the objectives of the statute. If we were to reduce the total renewable fuel volume requirement by a lesser amount than the advanced biofuel volume requirement, we would effectively increase the opportunity for conventional biofuels to participate in the RFS program beyond the implied statutory volume of 15 billion gallons. Applying an equal reduction of 8.12 billion gallons to both the statutory target for advanced biofuel and the statutory target for total renewable fuel results in a total renewable fuel volume of 19.92 billion gallons as shown in Table IV.A-1.
In response to the July 10, 2018 proposal, some stakeholders said that EPA had not evaluated whether 19.92 billion gallons of total renewable fuel was attainable as it did for advanced biofuel. As a result, they indicated that EPA had not fulfilled its responsibilities under the statute and had not given stakeholders meaningful opportunity to evaluate the proposed volume requirement. In response, we note first of all that we proposed, and are finalizing, the maximum reduction possible under the cellulosic waiver authority, and thus no additional reductions are possible under that authority. Secondly, while the general waiver authority does provide a means for further reductions in the applicable volume requirement for total renewable fuel, the record before us does not indicate that a waiver is warranted as described in Section II of the RTC.
Notwithstanding the fact that we did not propose to use, and in this final rule are not using the general waiver authority, we did in fact provide a description of the ways in which the market could make 19.92 billion gallons volume of total renewable fuel available in 2019 in a memorandum to the docket.
More importantly, an analysis of the volumes of E0, E15, and E85 that could be supplied in 2019 was not necessary to determine whether the volume requirement of 19.92 billion gallons could be reached.
In this section, EPA presents its assessment of the illustrative costs of the final 2019 RFS rule. It is important to note that these illustrative costs do not attempt to capture the full impacts of this final rule. We frame the analyses we have performed for this rule as “illustrative” so as not to give the impression of comprehensive estimates. These estimates are provided for the purpose of showing how the cost to produce a gallon of a “representative” renewable fuel compares to the cost of petroleum fuel. There are a significant number of caveats that must be considered when interpreting these illustrative cost estimates. For example, there are many different feedstocks that could be used to produce biofuels, and there is a significant amount of heterogeneity in the costs associated with these different feedstocks and fuels. Some renewable fuels may be cost competitive with the petroleum fuel they replace; however, we do not have cost data on every type of feedstock and every type of fuel. Therefore, we do not attempt to capture this range of potential costs in our illustrative estimates.
Illustrative cost estimates are provided below for this final rule. The volumes for which we have provided cost estimates and are described in Sections III and IV, and result from reducing the cellulosic, advanced, and total renewable fuel volume requirements using the cellulosic waiver authority under CAA section 211(o)(7)(D)(i). For this rule we examine two different cases. In the first case, we provide illustrative cost estimates by comparing the final 2019 renewable fuel volumes to 2019 statutory volumes. In the second case, we examine the final 2019 renewable fuel volumes to the final 2018 renewable fuel volumes to estimate changes in the annual costs of the final 2019 RFS volumes in comparison to the 2018 volumes.
In this section, EPA provides illustrative cost estimates that compare the final 2019 cellulosic biofuel volume requirements to the 2019 cellulosic statutory volume that would be required absent the exercise of our cellulosic waiver authority under CAA section 211(o)(7)(D)(i).
While there may be growth in other cellulosic renewable fuel sources, we believe it is appropriate to use cellulosic ethanol produced from corn kernel fiber as the representative cellulosic renewable fuel. The majority of liquid cellulosic biofuel in 2019 is expected to be produced using this technology, and application of this technology in the future could result in significant incremental volumes of cellulosic biofuel. In addition, as explained in Section III, we believe that production of the major alternative cellulosic biofuel—CNG/LNG derived from biogas—is limited to approximately 538 million gallons due to a limitation in the number of vehicles capable of using this form of fuel.
EPA uses a “bottom-up” engineering cost analysis to quantify the costs of producing a gallon of cellulosic ethanol derived from corn kernel fiber. There are multiple processes that could yield cellulosic ethanol from corn kernel fiber. EPA assumes a cellulosic ethanol production process that generates biofuel using distiller's grains, a co-product of generating corn starch ethanol that is commonly dried and sold into the feed market as distillers dried grains with solubles (DDGS), as the renewable biomass feedstock. We assume an enzymatic hydrolysis process with cellulosic enzymes to break down the cellulosic components of the distiller's grains. This process for generating cellulosic ethanol is similar to approaches currently used by industry to generate cellulosic ethanol at a commercial scale, and we believe these cost estimates are likely representative of the range of different technology options being developed to produce ethanol from corn kernel fiber. We then compare the per-gallon costs of the cellulosic ethanol to the petroleum fuels that would be replaced at the wholesale stage, since that is when the two are blended together.
These cost estimates do not consider taxes, retail margins, or other costs or transfers that occur at or after the point of blending (transfers are payments within society and are not additional costs). We do not attempt to estimate potential cost savings related to avoided infrastructure costs (
Table V.A-1 below presents the cellulosic fuel cost savings with this final rule that are estimated using this approach.
In this section, we provide illustrative cost estimates for EPA exercising its cellulosic waiver authority to reduce statutory cellulosic volumes for 2019 (with corresponding reductions to the advanced and total renewable fuel volumes) compared to the final 2018 RFS volumes. This results in an increase in cellulosic volumes for the 2019 RFS of 130 gallons (ethanol-equivalent) and an increase in the non-cellulosic advanced biofuel volumes for 2019 of 500 million gallons (ethanol-equivalent).
We anticipate that the increase in the final 2019 cellulosic biofuel volumes would be composed of 5 million gallons of liquid cellulosic biofuel and 125
For CNG/LNG-derived cellulosic biogas, we provide estimates of the cost of displacing natural gas with CNG/LNG derived from landfill biogas to produce 125 million ethanol-equivalent gallons of cellulosic fuel. To estimate the cost of production of CNG/LNG derived from landfill gas (LFG), EPA uses Version 3.2 of the Landfill Gas Energy Cost Model, or LFG cost-Web. EPA ran the financial cost calculator for projects with a design flow rate of 1,000 and 10,000 cubic feet per minute with the suggested default data. The costs estimated for this analysis exclude any pipeline costs to transport the pipeline quality gas, as well as any costs associated with compressing the gas to CNG/LNG. These costs are not expected to differ significantly between LFG or natural gas. In addition, the cost estimates excluded the gas collection and control system infrastructure at the landfill, as EPA expects that landfills that begin producing high BTU gas in 2019 are very likely to already have this infrastructure in place.
To estimate the illustrative cost impacts of the change in CNG/LNG derived from LFG, we compared the cost of production of CNG/LNG derived from LFG in each case to the projected price for natural gas in 2019 in EIA's October 2018 STEO.
EPA provides a range of illustrative cost estimates for the increases in the advanced standard of 500 million ethanol-equivalent gallons using two different advanced biofuels. In the first scenario, we assume that all the increase in advanced biofuel volumes is comprised of soybean oil BBD. In the second scenario, we assume that all the increase in the advanced volume is comprised of sugarcane ethanol from Brazil.
Consistent with the analysis in previous annual RFS volume rules, a “bottom-up” engineering cost analysis is used that quantifies the costs of producing a gallon of soybean-based biodiesel and then compares that cost to the energy-equivalent gallon of petroleum-based diesel. We compare the cost of biodiesel and diesel fuel at the wholesale stage, since that is when the two are blended together and represents the approximate costs to society absent transfer payments and any additional infrastructure costs. On this basis, EPA estimates the costs of producing and transporting a gallon of biodiesel to the blender in the U.S.
To estimate the illustrative costs of sugarcane ethanol, we compare the cost of sugarcane ethanol and gasoline at the wholesale stage, since that is when the two are blended together and represents the approximate costs to society absent transfer payments and any additional infrastructure costs (
Table V.B.2-1 below also presents estimates of per energy-equivalent gallon costs for producing: (1) Soybean biodiesel (in ethanol-equivalent gallons) and (2) Brazilian sugarcane ethanol, relative to the petroleum fuels they replace at the wholesale level. For each of the fuels, these per-gallon costs are then multiplied by the increase in the 2019 non-cellulosic advanced volume relative to the 2018 final advanced standard volume to obtain an overall cost increase of $190-$610 million.
In addition, in Table V.B.2-1, we also present estimates of the total cost of this final rule relative to 2018 RFS fuel volumes. We add the increase in cost of the final 2019 cellulosic standard volume, $(2.9)-$23 million, with the additional costs of the increase in non-cellulosic advanced biofuel volumes resulting from the final 2019 advanced standard volume, $190-$610 million. The overall total costs of this final rule range from $190-$630 million (after rounding to two significant figures).
The annual
In this section we discuss the BBD applicable volume for 2020. We are setting this volume in advance of those for other renewable fuel categories in light of the statutory requirement in CAA section 211(o)(2)(B)(ii) to establish the applicable volume of BBD for years after 2012 no later than 14 months before the applicable volume will apply. We are not at this time setting the BBD percentage standards that would apply to obligated parties in 2020 but intend to do so in late 2019, after receiving EIA's estimate of gasoline and diesel consumption for 2020. At that time, we will also set the percentage standards for the other renewable fuel types for 2020. Although the BBD applicable volume sets a floor for required BBD use, because the BBD volume requirement is nested within both the advanced biofuel and the total renewable fuel volume requirements, any BBD produced beyond the mandated 2020 BBD volume can be used to satisfy both of these other applicable volume requirements.
The statute establishes applicable volume targets for years through 2022 for cellulosic biofuel, advanced biofuel, and total renewable fuel. For BBD, applicable volume targets are specified in the statute only through 2012. For years after those for which volumes are specified in the statute, EPA is required under CAA section 211(o)(2)(B)(ii) to determine the applicable volume of BBD, in coordination with the Secretary of Energy and the Secretary of Agriculture, based on a review of the implementation of the program during calendar years for which the statute specifies the volumes and an analysis of the following factors:
1. The impact of the production and use of renewable fuels on the environment, including on air quality, climate change, conversion of wetlands, ecosystems, wildlife habitat, water quality, and water supply;
2. The impact of renewable fuels on the energy security of the United States;
3. The expected annual rate of future commercial production of renewable fuels, including advanced biofuels in each category (cellulosic biofuel and BBD);
4. The impact of renewable fuels on the infrastructure of the United States, including deliverability of materials, goods, and products other than renewable fuel, and the sufficiency of infrastructure to deliver and use renewable fuel;
5. The impact of the use of renewable fuels on the cost to consumers of transportation fuel and on the cost to transport goods; and
6. The impact of the use of renewable fuels on other factors, including job creation, the price and supply of agricultural commodities, rural economic development, and food prices.
The statute also specifies that the volume requirement for BBD cannot be less than the applicable volume specified in the statute for calendar year 2012, which is 1.0 billion gallons.
In establishing the BBD and cellulosic standards as nested within the advanced biofuel standard, Congress clearly intended to support development of BBD and especially cellulosic biofuels, while also providing an incentive for the growth of other non-specified types of advanced biofuels. In general, the advanced biofuel standard provides an
One of the primary considerations in determining the BBD volume for 2020 is a review of the implementation of the program to date, as it affects BBD. This review is required by the CAA, and also provides insight into the capabilities of the industry to produce, import, export, and distribute BBD. It also helps us to understand what factors, beyond the BBD standard, may incentivize the production and import of BBD. Table VI.B.1-1 below shows, for 2011-2017, the number of BBD RINs generated, the number of RINs retired due to export, the number of RINs retired for reasons other than compliance with the annual BBD standards, and the consequent number of available BBD RINs; and for 2011-2019, the BBD and advanced biofuel standards.
In reviewing
The prices paid for advanced biofuel and BBD RINs beginning in early 2013 through September 2018 (the last month for which data are available) also support the conclusion that advanced biofuel and/or total renewable fuel standards provide a sufficient incentive for additional biodiesel volume beyond what is required by the BBD standard. Because the BBD standard is nested within the advanced biofuel and total renewable fuel standards, and therefore can help to satisfy three RVOs, we would expect the price of BBD RINs to exceed that of advanced and conventional renewable RINs.
When examining RIN price data from 2012 through September 2018, shown in Figure VI.B.2-1 below, we see that beginning in early 2013 and through September 2018 the advanced RIN price and BBD RIN prices were approximately equal. Similarly, from early 2013 through late 2016 the conventional renewable fuel and BBD RIN prices were approximately equal. This suggests that the advanced biofuel standard and/or total renewable fuel standard are capable of incentivizing increased BBD volumes beyond the BBD standard. The advanced biofuel standard has incentivized additional volumes of BBD since 2013, while the total standard had incentivized additional volumes of BBD from 2013 through 2016.
In raising the 2013 BBD volume above the 1 billion gallon minimum mandated by Congress, the EPA sought to “create greater certainty for both producers of BBD and obligated parties” while also acknowledging that, “the potential for somewhat increased costs is appropriate in light of the additional certainty of GHG reductions and enhanced energy security provided by the advanced biofuel volume requirement of 2.75 billion gallons.”
The only advanced biofuel other than BBD available in appreciable quantities in 2012 and 2013 was advanced ethanol, the vast majority of which was imported sugarcane ethanol. EPA had significant concerns as to whether or not the supply of advanced ethanol could increase this significantly (750 million gallons) in a single year. These concerns were heightened by the approaching E10 blendwall, which had the potential to increase the challenges associated with supplying increasing volumes of ethanol to the U.S. If neither BBD volumes nor advanced ethanol volumes increased sufficiently, EPA was concerned that some obligated parties might be unable to acquire the advanced biofuel RINs necessary to demonstrate compliance with their RVOs in 2013. Therefore, as discussed above, EPA increased the volume requirement for BBD in 2013 to help create greater certainty for BBD producers (by ensuring demand for their product above the 1.0 billion gallon statutory minimum) and obligated parties (by ensuring that sufficient RINs would be available to satisfy their advanced biofuel RVOs). Since 2013, however, EPA has gained significant experience implementing the RFS program. As discussed above, RIN generation data has consistently demonstrated that the advanced biofuel volume requirement, and to a lesser degree the total renewable fuel volume requirement, are capable of incentivizing the supply of BBD above and beyond the BBD volume requirement. The RIN generation data also show that while EPA has consistently preserved the opportunity for fuels other that BBD to contribute towards satisfying the required volume of advanced biofuel, these other advanced biofuels have not been supplied in significant quantities since 2013.
In 2014 and 2015, EPA set the BBD and advanced standards at actual RIN generation, and thus the space between the advanced biofuel standard and the biodiesel standard was unlikely to provide an incentive for “other” advanced biofuels. EPA now has data on the amount of “other” advanced biofuels produced in 2016 and 2017 as shown in the table above. For 2016 and 2017, the gap between the BBD standard and the advanced biofuel provided an opportunity for “other” advanced biofuels to be generated to satisfy the advanced biofuel standard. While the RFS volumes created the opportunity for up to 530 million and 969 million gallons of “other” advanced for 2016 and 2017 respectively to be used to satisfy the advanced biofuel obligation, only 97 million and 144 million gallons of “other” advanced biofuels were generated. This is significantly less than the volumes of “other” advanced available in 2012-2013. Despite creating space within the advanced biofuel standard for “other” advanced, in recent years, only a small fraction of that space has been filled with “other” advanced, and BBD continues to fill most of the gap between the BBD standard and the advanced standard.
Thus, while the advanced biofuel standard is sufficient to drive biodiesel volume separate and apart from the BBD standard, there would not appear to be a compelling reason to increase the “space” maintained for “other” advanced biofuel volumes. The overall
At the same time, the rationale for preserving the “space” for “other” advanced biofuels remains. We note that the BBD industry in the U.S. and abroad has matured since EPA first increased the required volume of BBD beyond the statutory minimum in 2013. To assess the maturity of the biodiesel industry, EPA compared information on BBD RIN generation by company in 2012 and 2017 (the most recent year for which complete RIN generation by company is available). In 2012, the annual average RIN generation per company producing BBD was about 11 million RINs (about 7.3 million gallons) with approximately 50 percent of companies producing less than 1 million gallons of BBD a year.
We are conscious of public comments claiming that BBD volume requirements that are a significant portion of the advanced volume requirements effectively disincentivize the future development of other promising advanced biofuel pathways.
We received comments from stakeholders suggesting that the BBD volume standard is unique, as it is required to be set 14 months prior to beginning of the compliance year, in contrast to the advanced standard which is often modified only a month prior to the compliance year. These commenters suggested that EPA should therefore increase the BBD standard to allow for industry to utilize the 14-month notice to make investments. EPA acknowledges this unique aspect of the BBD volume, but still believes a volume of 2.43 billion appropriately provides a floor for guaranteed BBD volume, while also providing space for other advanced biofuels to compete in the market. Based on our review of the data, and the nested nature of the BBD standard within the advanced standard, we conclude that the advanced standard continues to drive the ultimate volume of BBD supplied. However, given that BBD has been the predominant source of advanced biofuel in recent years and the 500 million gallon increase in non-cellulosic advanced biofuel we are finalizing in this rule, we are setting a volume of 2.43 billion gallons of BBD for 2020.
We recognize that the space for other advanced biofuels in 2020 will ultimately depend on the 2020 advanced biofuel volume. While EPA is not establishing the advanced biofuel volume for 2020 in this action, we anticipate that the non-cellulosic advanced biofuel volume for 2020, when established, will be greater than 3.65 billion gallons (equivalent to 2.43 billion gallons of BBD, after applying the 1.5 equivalence ratio). This expectation is consistent with our actions in previous years. Accordingly, we expect that the 2020 advanced biofuel volume, together with the 2020 BBD volume established today, will continue to preserve a considerable portion of the advanced biofuel volume that could be satisfied by either additional gallons of BBD or by other unspecified and potentially less costly types of qualifying advanced biofuels.
The BBD volume requirement is nested within the advanced biofuel requirement, and the advanced biofuel requirement is, in turn, nested within the total renewable fuel volume requirement.
Consistent with our approach in setting the final BBD volume requirement for 2019, EPA's primary assessment of the statutory factors for the 2020 BBD applicable volume is that because the BBD requirement is nested within the advanced biofuel volume requirement, we expect that the 2020 advanced volume requirement, when set next year, will determine the level of BBD use, production and imports that occur in 2020.
As an additional assessment, we considered in the 2020 BBD docket memorandum
With the considerations discussed above in mind, as well as our analysis of the factors specified in the statute, we are setting the applicable volume of BBD at 2.43 billion gallons for 2020. This increase, in conjunction with the statutory increase of 500 million gallons of non-cellulosic advanced biofuel in 2019, would continue to preserve a significant gap between the advanced biofuel volume and the sum of the cellulosic biofuel and BBD volumes. This would allow other advanced biofuels to continue to compete with excess volumes of BBD for market share under the advanced biofuel standard. We believe this volume sets the appropriate floor for BBD, and that the volume of advanced biodiesel and renewable diesel actually used in 2020 will be driven by the level of the advanced biofuel and total renewable fuel standards that the Agency will establish for 2020. It also recognizes that while maintaining an opportunity for other advanced biofuels is important, the vast majority of the advanced biofuel used to comply with the advanced biofuel standard in recent years has been BBD. Based on information now available from 2016 and 2017, despite providing a significant degree of space for “other” advanced biofuels, smaller volumes of “other” advanced have been utilized to meet the advanced standard. EPA believes that the BBD standard we are finalizing today still provides sufficient incentive to producers of “other” advanced biofuels, while also acknowledging that the advanced standard has been met predominantly with biomass-based diesel. Our assessment of the required statutory factors, as well as the implementation of the program, supports a volume of 2.43 billion gallons.
The renewable fuel standards are expressed as volume percentages and are used by each obligated party to determine their Renewable Volume Obligations (RVOs). Since there are four separate standards under the RFS program, there are likewise four separate RVOs applicable to each obligated party. Each standard applies to the sum of all non-renewable gasoline and diesel produced or imported.
Sections II through V provide our rationale and basis for the final volume requirements for 2019.
For the purposes of converting these volumes into percentage standards, we generally use two decimal places to be consistent with the volume targets as given in the statute, and similarly two decimal places in the percentage standards. However, for cellulosic biofuel we use three decimal places in both the volume requirement and percentage standards to more precisely capture the smaller volume projections and the unique methodology that in some cases results in estimates of only a few million gallons for a single producer.
To calculate the percentage standards, we are following the same methodology for 2019 as we have in all prior years. The formulas used to calculate the percentage standards applicable to producers and importers of gasoline and diesel are provided in 40 CFR 80.1405. The formulas rely on estimates of the volumes of gasoline and diesel fuel, for both highway and nonroad uses, which are projected to be used in the year in which the standards will apply. The projected gasoline and diesel volumes are provided by EIA, and include projections of ethanol and biodiesel used in transportation fuel. Since the percentage standards apply only to the non-renewable gasoline and diesel produced or imported, the volumes of renewable fuel are subtracted out of the EIA projections of gasoline and diesel.
Transportation fuels other than gasoline or diesel, such as natural gas, propane, and electricity from fossil fuels, are not currently subject to the standards, and volumes of such fuels are not used in calculating the annual percentage standards. Since under the regulations the standards apply only to producers and importers of gasoline and diesel, these are the transportation fuels used to set the percentage standards, as well as to determine the annual volume obligations of an individual gasoline or diesel producer or importer under 40 CFR 80.1407.
As specified in the RFS2 final rule,
In CAA section 211(o)(9), enacted as part of the Energy Policy Act of 2005, and amended by the Energy Independence and Security Act of 2007, Congress provided a temporary exemption to small refineries
EPA has granted exemptions pursuant to this process in the past. However, at this time no exemptions have been approved for 2019, and therefore we have calculated the percentage standards for 2019 without any adjustment for exempted volumes. We are maintaining our approach that any exemptions for 2019 that are granted after the final rule is released will not be reflected in the percentage standards that apply to all gasoline and diesel produced or imported in 2019.
The formulas in 40 CFR 80.1405 for the calculation of the percentage standards require the specification of a total of 14 variables covering factors such as the renewable fuel volume requirements, projected gasoline and diesel demand for all states and territories where the RFS program applies, renewable fuels projected by EIA to be included in the gasoline and diesel demand, and exemptions for small refineries. The values of all the variables used for this final rule are shown in Table VII.C-1.
Projected
Using the volumes shown in Table VII.C-1, we have calculated the final percentage standards for 2019 as shown in Table VII.C-2.
The RFS regulations specify an “aggregate compliance” approach for demonstrating that planted crops and crop residue from the U.S. complies with the “renewable biomass” requirements that address lands from which qualifying feedstocks may be harvested.
In the 2010 RFS2 rulemaking, EPA committed to make an annual finding concerning whether the 2007 baseline amount of U.S. agricultural land has been exceeded in a given year. If the baseline is found to have been exceeded, then producers using U.S. planted crops and crop residue as feedstocks for renewable fuel production would be required to comply with individual recordkeeping and reporting requirements to verify that their feedstocks are renewable biomass.
The Aggregate Compliance methodology provided for the exclusion of acreage enrolled in the Grassland Reserve Program (GRP) and the Wetlands Reserve Program (WRP) from the estimated total U.S. agricultural land. However, the 2014 Farm Bill terminated the GRP and WRP as of 2013 and USDA established the Agriculture Conservation Easement Program (ACEP) with wetlands and land easement components. The ACEP is a voluntary program that provides financial and technical assistance to help conserve agricultural lands and wetlands and their related benefits. Under the Agricultural Land Easements (ACEP-ALE) component, USDA helps Indian tribes, state and local governments, and non-governmental organizations protect working agricultural lands and limit non-agricultural uses of the land. Under the Wetlands Reserve Easements (ACEP-WRE) component, USDA helps to restore, protect and enhance enrolled wetlands. The WRP was a voluntary program that offered landowners the opportunity to protect, restore, and enhance wetlands on their property. The GRP was a voluntary conservation program that emphasized support for working grazing operations, enhancement of plant and animal biodiversity, and protection of grassland under threat of conversion to other uses.
USDA and EPA concur that the ACEP-WRE and ACEP-ALE represent a continuation in basic objectives and goals of the original WRP and GRP. Therefore, in preparing this year's assessment of the total U.S. acres of agricultural land, the acreage enrolled in the ACEP-WRE and ACEP-ALE was excluded.
Based on data provided by the USDA Farm Service Agency (FSA) and Natural Resources Conservation Service (NRCS), we have estimated that U.S. agricultural land reached approximately 381 million acres in 2018, and thus did not exceed the 2007 baseline acreage. This acreage estimate is based on the same methodology used to set the 2007 baseline acreage for U.S. agricultural land in the RFS2 final rulemaking, with the GRP and WRP substitution as noted above. Specifically, we started with FSA crop history data for 2018, from which we derived a total estimated acreage of 381,694,332 acres. We then subtracted the ACEP-ALE and ACEP-WRE enrolled areas by the end of Fiscal Year 2018, 798,023 acres, to yield an estimate of 380,896,309 acres or approximately 381 million acres of U.S. agricultural land in 2018. The USDA data used to make this derivation can be found in the docket to this rule.
The RFS regulations specify a petition process through which EPA may approve the use of an aggregate compliance approach for planted crops and crop residue from foreign countries.
The total agricultural land in Canada in 2018 is estimated at 118.5 million acres; below the 2007 baseline of 123 million acres. This total agricultural land area includes 96.3 million acres of cropland and summer fallow, 12.4 million acres of pastureland and 9.8 million acres of agricultural land under conservation practices. This acreage estimate is based on the same methodology used to set the 2007 baseline acreage for Canadian agricultural land in EPA's response to Canada's petition. The data used to make this calculation can be found in the docket to this rule.
Many interested parties participated in the rulemaking process that culminates with this final rule. This process provided opportunity for submitting written public comments following the proposal that we published on July 3, 2018 (83 FR 31098), and we also held a public hearing on July 18, 2018, at which many parties provided both verbal and written testimony. All comments received, both verbal and written, are available in Docket ID No. EPA-HQ-OAR-2018-0167 and we considered these comments in developing the final rule. Public comments and EPA responses are discussed throughout this preamble and in the accompanying RTC document, which is available in the docket for this action.
This action is an economically significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket. EPA prepared an analysis of illustrative costs associated with this action. This analysis is presented in Section V of this preamble.
This action is considered an Executive Order 13771 regulatory action. Details on the estimated costs of this final rule can be found in EPA's analysis of the illustrative costs associated with this action. This analysis is presented in Section V of this preamble.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control numbers 2060-0637 and 2060-0640. The final standards will not impose new or different reporting requirements on regulated parties than already exist for the RFS program.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule.
The small entities directly regulated by the RFS program are small refiners, which are defined at 13 CFR 121.201. We have evaluated the impacts of this final rule on small entities from two perspectives: As if the 2019 standards were a standalone action or if they are a part of the overall impacts of the RFS program as a whole.
When evaluating the standards as if they were a standalone action separate and apart from the original rulemaking which established the RFS2 program, then the standards could be viewed as increasing the cellulosic biofuel volume by 130 million gallons and the advanced biofuel and total renewable fuel volume requirements by 630 million gallons between 2018 and 2019. To evaluate the impacts of the volume requirements on small entities relative to 2018, we have conducted a screening analysis
While the screening analysis described above supports a certification that this rule will not have a significant economic impact on small refiners, we continue to believe that it is more appropriate to consider the standards as a part of ongoing implementation of the overall RFS program. When considered this way, the impacts of the RFS program as a whole on small entities were addressed in the RFS2 final rule, which was the rule that implemented the entire program as required by EISA 2007.
For the SBREFA process for the RFS2 final rule, we conducted outreach, fact-finding, and analysis of the potential impacts of the program on small refiners, which are all described in the Final Regulatory Flexibility Analysis, located in the rulemaking docket (EPA-HQ-OAR-2005-0161). This analysis looked at impacts to all refiners, including small refiners, through the year 2022 and found that the program would not have a significant economic impact on a substantial number of small entities, and that this impact was expected to decrease over time, even as the standards increased. For gasoline and/or diesel small refiners subject to the standards, the analysis included a cost-to-sales ratio test, a ratio of the estimated annualized compliance costs to the value of sales per company. From this test, we estimated that all directly regulated small entities would have compliance costs that are less than one percent of their sales over the life of the program (75 FR 14862, March 26, 2010).
We have determined that this final rule will not impose any additional requirements on small entities beyond those already analyzed, since the impacts of this rule are not greater or fundamentally different than those already considered in the analysis for the RFS2 final rule assuming full implementation of the RFS program. This final rule increases the 2019 cellulosic biofuel volume requirement by 130 million gallons and the advanced biofuel and total renewable fuel volume requirements by 630 million gallons relative to the 2018 volume requirements, but those volumes remain significantly below the statutory volume targets analyzed in the RFS2 final rule. Compared to the burden that would be imposed under the volumes that we assessed in the screening analysis for the RFS2 final rule (
While the rule will not have a significant economic impact on a substantial number of small entities, there are compliance flexibilities in the program that can help to reduce impacts
Additionally, we realize that there may be cases in which a small entity may be in a difficult financial situation and the level of assistance afforded by the program flexibilities is insufficient. For such circumstances, the program provides hardship relief provisions for small entities (small refiners), as well as for small refineries.
We evaluate these petitions on a case-by-case basis and may approve such petitions if it finds that a disproportionate economic hardship exists. In evaluating such petitions, we consult with the U.S. Department of Energy and consider the findings of DOE's 2011 Small Refinery Study and other economic factors. To date, EPA has adjudicated petitions for exemption from 29 small refineries for the 2017 RFS standards (8 of which were owned by a small refiner).
In sum, this final rule will not change the compliance flexibilities currently offered to small entities under the RFS program (including the small refinery hardship provisions we continue to implement) and available information shows that the impact on small entities from implementation of this rule will not be significant viewed either from the perspective of it being a standalone action or a part of the overall RFS program. We have therefore concluded that this action will have no net regulatory burden for directly regulated small entities.
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. This action implements mandates specifically and explicitly set forth in CAA section 211(o) and we believe that this action represents the least costly, most cost-effective approach to achieve the statutory requirements.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. This action will be implemented at the Federal level and affects transportation fuel refiners, blenders, marketers, distributors, importers, exporters, and renewable fuel producers and importers. Tribal governments will be affected only to the extent they produce, purchase, or use regulated fuels. Thus, Executive Order 13175 does not apply to this action.
EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it implements specific standards established by Congress in statutes (CAA section 211(o)) and does not concern an environmental health risk or safety risk.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This action establishes the required renewable fuel content of the transportation fuel supply for 2019, consistent with the CAA and waiver authorities provided therein. The RFS program and this rule are designed to achieve positive effects on the nation's transportation fuel supply, by increasing energy independence and security and lowering lifecycle GHG emissions of transportation fuel.
This rulemaking does not involve technical standards.
EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This regulatory action does not affect the level of protection provided to human health or the environment by applicable air quality standards. This action does not relax the control measures on sources regulated by the RFS regulations and therefore will not cause emissions increases from these sources.
This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is a “major rule” as defined by 5 U.S.C. 804(2).
Statutory authority for this action comes from section 211 of the Clean Air Act, 42 U.S.C. 7545. Additional support for the procedural and compliance related aspects of this final rule comes from sections 114, 208, and 301(a) of the Clean Air Act, 42 U.S.C. 7414, 7542, and 7601(a).
Environmental protection, Administrative practice and procedure, Air pollution control, Diesel fuel, Fuel additives, Gasoline, Imports, Oil imports, Petroleum, Renewable fuel.
For the reasons set forth in the preamble, EPA is amending 40 CFR part 80 as follows:
42 U.S.C. 7414, 7521, 7542, 7545, and 7601(a).
(a) * * *
(10)
(i) The value of the cellulosic biofuel standard for 2019 shall be 0.230 percent.
(ii) The value of the biomass-based diesel standard for 2019 shall be 1.73 percent.
(iii) The value of the advanced biofuel standard for 2019 shall be 2.71 percent.
(iv) The value of the renewable fuel standard for 2019 shall be 10.97 percent.
Occupational Safety and Health Administration (OSHA); Labor.
Proposed rule; request for comment.
On January 9, 2017, OSHA issued a final rule adopting a comprehensive general industry standard for occupational exposure to beryllium and beryllium compounds. In this proposed rule, OSHA is proposing to modify the general industry standard to clarify certain provisions and simplify or improve compliance. Proposed changes would maintain safety and health protections for workers and are designed to enhance worker protections overall by ensuring that the rule is well-understood and compliance is more straightforward.
Comments to this proposal, hearing requests, and other information must be submitted (transmitted, postmarked, or delivered) by February 11, 2019. All submissions must bear a postmark or provide other evidence of the submission date.
The public can submit comments, hearing requests, and other material, identified by Docket No. OSHA-2018-0003, using any of the following methods:
On January 9, 2017, OSHA published the final rule Occupational Exposure to Beryllium and Beryllium Compounds in the
This proposal would amend the beryllium standard for general industry to clarify certain provisions—with proposed changes designed to facilitate application of the standard consistent with the intent of the 2017 final rule—and simplify or improve compliance, preventing costs that may flow from misinterpretation or misapplication of the standard. OSHA's discussion of the estimated costs and cost savings for this proposed rule can be found in the preliminary economic analysis (PEA). The 2017 Beryllium Final Rule went into effect on May 20, 2017, and some compliance obligations began on May 11, 2018. The compliance obligations affected by this rulemaking will begin on December 12, 2018 (83 FR 39351). Other compliance obligations under the standard do not commence until 2019 or 2020.
OSHA believes that the standard as modified by this proposal would provide equivalent protection to the current standard. Accordingly, while this rulemaking is pending, compliance with the standard as modified by this proposal will be accepted as compliance with the standard.
OSHA proposes to modify several of the general industry standard's definitions, along with the provisions for methods of compliance, personal protective clothing and equipment, hygiene areas and practices, housekeeping, medical surveillance, communication of hazards, and recordkeeping. OSHA believes that the proposed changes would maintain safety and health protections for workers. The proposed changes are further designed to enhance worker protections overall by ensuring that the rule is well-understood and compliance is more straightforward.
Paragraph (b) of the beryllium standard for general industry (82 FR 2470, as modified by 83 FR 19936) addresses changes to the definitions of specific key terms used in the standard. OSHA is proposing to change or add six terms in the definitions paragraph.
OSHA is proposing to add the following definition for
In the 2017 final beryllium rule (82 FR 2470), OSHA found that individuals sensitized through either the dermal or inhalation exposure pathways respond to beryllium through the formation of a beryllium-protein complex, which then binds to T-cells stimulating a beryllium-specific immune response (82 FR 2494). The formation of the T-cell-beryllium-protein complex that results in beryllium sensitization may not manifest in any outward clinical symptoms in the lung (82 FR 2491), and most who are sensitized may not show any symptoms at all. While it may be rare for those sensitized through dermal exposure to exhibit any outward signs or symptoms, dermal sensitization has been associated with skin granulomas and contact dermatitis. Dermal exposure may also result in dermal irritation, which can be indistinguishable from contact dermatitis (82 FR 2527-2528). It should be noted that beryllium, beryllium oxide, and other soluble and poorly soluble forms of beryllium have been classified as a skin irritant (category 2) in accordance with the EU Classification, Labelling and Packaging Regulation (Document ID OSHA-H005C-2006-0870-1669, p. 2).
As OSHA determined in the final beryllium rule, after an individual has been sensitized, subsequent beryllium exposures via inhalation can progress to serious lung disease through the formation of granulomas and fibrosis (82 FR 2491-2498). Since the pathogenesis of CBD involves a beryllium-specific, cell-mediated immune response, CBD cannot occur in the absence of sensitization (NAS, 2008, Document ID OSHA-H005C-2006-0870-1355). Therefore, the proposed definition explaining that beryllium sensitization is essential for development of CBD is consistent with the agency's findings in the final rule.
Paragraph (b) of the general industry beryllium standard defines
OSHA proposes to modify this definition to clarify when an area of a workplace must be considered a beryllium work area. The proposed revision would define
This proposed modification to the definition of
Based on a joint model standard that OSHA received from Materion and the United Steelworkers (USW) that included a similar provision (Document ID OSHA-H005C-2006-0870-0754), OSHA's original NPRM for the beryllium standard proposed that
In the final standard, OSHA modified the definition of
OSHA further modified the definition of
Additional feedback from stakeholders has led OSHA to believe that the definition of
In response to this feedback, OSHA is proposing to further modify the definition of
Unlike the current definition, the proposed definition of
The proposed revised criteria for establishing a beryllium work area would continue to protect workers directly exposed in beryllium work areas, while also reducing potential exposure for workers who work outside these areas through the following provisions that apply in beryllium work areas:
• The requirement to establish, implement, and maintain a written exposure control plan, including procedures for minimizing cross-contamination within beryllium work areas and minimizing migration of beryllium from beryllium work areas to other areas (paragraphs (f)(1)(i)(D), (f)(1)(i)(F));
• The requirement to provide at least one method of exposure control (material or process substitution, isolation, local exhaust ventilation, or process control) for each operation in a beryllium work area that releases airborne beryllium (paragraph (f)(2)(ii)), unless exempt under paragraph (f)(2)(iii);
• The requirement to provide and ensure the use of washing facilities for employees working in a beryllium work area (paragraph (i)(1));
• The requirements to maintain surfaces in beryllium work areas as free as practicable of beryllium and ensure surfaces are appropriately cleaned (paragraphs (j)(1)(i) and (j)(2)); and
• The requirement to ensure that employees know where beryllium work areas in the facility are located (paragraph (m)(4)(ii)(B)).
Moreover, the standard's PPE requirements to protect against dermal exposure to beryllium do not depend on the existence of a beryllium work area. The standard requires employers to provide and ensure the use of appropriate PPE whenever there is a reasonable expectation of dermal contact with beryllium, regardless of whether or not the area is a beryllium work area (see paragraph (h)(1)(ii)). OSHA is not proposing to change that requirement.
OSHA is also proposing to add two references to dermal contact with beryllium to paragraph (i), Hygiene areas and practices, to account for the proposed removal of the potential for dermal contact with beryllium from the definition of beryllium work area (see Discussion of Proposed Changes to paragraph (i)). Paragraph (i) currently requires employers to provide washing facilities and a designated change room to each employee working in a beryllium work area (see paragraphs (i)(1)(i) and (i)(2)). Because OSHA still intends for the requirements to provide washing facilities and change rooms to apply to employees who can reasonably be expected to have dermal contact with beryllium, regardless of whether they work in a beryllium work area, OSHA is proposing (1) to revise paragraphs (i)(1) so that its requirement to provide washing facilities also applies to any employee who can reasonably be expected to have dermal contact with beryllium; and (2) to revise paragraph (i)(2) so that employers must provide change rooms to employees who are required to use personal protective clothing or equipment under paragraph (h)(1)(ii), which requires the use of PPE where there is a reasonable expectation of dermal contact with beryllium. As explained above, OSHA expects that, under the proposed revisions to the definitions, employees working in a beryllium work area would reasonably be expected to have dermal contact with beryllium. Thus, should the reference to potential dermal contact with beryllium be removed from the definition of beryllium work area as proposed, OSHA believes that these proposed modifications to paragraph (i), together with the existing requirements for PPE where dermal contact with beryllium is reasonably anticipated, would continue to protect employees from the effects of skin exposure to beryllium (see discussion of proposed revisions to the definition of
In summary, OSHA believes that these proposed changes would improve employers' ability to comply with the standard by clarifying where beryllium work areas exist, while maintaining the agency's intent to establish beryllium work areas where processes release significant amounts of airborne beryllium and to protect employees from skin exposure to beryllium. OSHA expects that these proposed changes would maintain safety and health protections for workers. OSHA requests comment on these proposed changes, including whether the list of operations in proposed Appendix A adequately covers the operations where airborne exposures are likely and whether operations that trigger the creation of a beryllium work area also give rise to a reasonable expectation of dermal contact with beryllium within the beryllium work area.
OSHA is also proposing to amend the definition of
The proposed definition includes the following changes to the current definition of
An additional proposed change to
The agency is also proposing a clarification to the definition of
First, OSHA proposes to alter the current definition by adding the term “granulomatous” to better distinguish this disease from other occupationally associated chronic pulmonary diseases of inflammatory origin. A granulomatous lung formation is a focal collection of inflammatory cells (
An additional proposed clarification to the definition of
OSHA is proposing to modify the definition of
First, the agency is proposing to change the definition of
The term
An additional proposed change to
As outlined in paragraph (k)(3)(ii)(E), an employee must be offered a follow-up BeLPT within 30 days if the initial test result is anything other than normal, unless the employee has been confirmed positive (
Examples of the potential types of results a worker may receive from BeLPT testing, including information obtained from split blood samples sent to separate labs or from a blood sample sent to a single lab, can be found in the docket (Document ID 0015).
OSHA is proposing to modify the standard's definition for
OSHA is proposing to make two further changes to the definition of
OSHA is proposing to add the term “visible” to clarify when skin exposure to beryllium-containing dust, fumes, or mist should be considered dermal contact with beryllium. Several of the standard's provisions are triggered where an employee has, or can be reasonably expected to have, dermal contact with beryllium. OSHA is concerned that, under the current definition, employers will be unable to accurately identify when dermal contact with beryllium has occurred, or should be reasonably expected to occur, for the purposes of compliance with this standard. Beryllium-generating processes can release beryllium in varying particle sizes and amounts, some of which are visible to the naked eye and some of which are not. OSHA is concerned that employers could reasonably interpret the provisions triggered by dermal contact with beryllium (
OSHA believes that modifying the definition of
OSHA previously proposed using the visibility of beryllium contamination as a trigger for the use of PPE in the proposed rule that preceded the promulgation of the beryllium standard, based in part on the recommendations of a joint model standard that Materion and USW developed in 2012 (80 FR 47566 (Aug. 7, 2015)). That proposed rule would have required employers to provide appropriate PPE where employee exposure exceeds or can reasonably be expected to exceed the TWA PEL or STEL; where work clothing or skin may become visibly contaminated with beryllium; and where employees' skin is reasonably expected to be exposed to soluble beryllium compounds (80 FR at 47791-94).
In the final rule (82 FR 2470 (Jan. 9, 2017)), OSHA modified the provision based in part on comments from several public health experts who objected to using the phrase “visibly contaminated.” In particular, public health experts from NIOSH, National Jewish Health (NJH), and the American Thoracic Society, stated that beryllium can accumulate on the skin and on work surfaces without becoming visible, and beryllium sensitization can result from contact with small quantities of beryllium that are not visible to the naked eye (82 FR at 2679-80). Materion, on the other hand, supported using the phrase because relying on visual cues of contamination would make it easier for employers to comply with the PPE provision (82 FR at 2680).
OSHA ultimately agreed that skin contact with even small amounts of beryllium can cause beryllium sensitization and that triggering the use of PPE on visible contamination of the skin and clothing would not be sufficiently protective (82 FR at 2680-81). OSHA was concerned that employers might interpret the proposed “may become visibly contaminated” language as only requiring the use of PPE after work processes release quantities of beryllium sufficient to create deposits visible to the naked eye, by which time workers may have already had skin exposure sufficient to cause beryllium sensitization (82 FR at 2680). Employees should already be using PPE to prevent dermal contact by that time. Thus, to avoid the potential use of “may become visibly contaminated” as a lagging indicator triggering PPE, in the final rule the agency modified the provision to require the use of PPE wherever there is a “reasonable expectation of dermal contact” with beryllium (82 FR at 2680).
The current proposal continues to address this concern in two ways. First,
The current proposal also better addresses the practical aspects of a “reasonable expectation” trigger for PPE. OSHA's 2017 final rule did not address the practical aspects of complying with a trigger that required PPE when any dermal contact with beryllium might be reasonably expected. Although OSHA did not intend beryllium work areas to extend facility-wide, the 2017 final rule could nonetheless be read as effectively requiring employees to wear PPE facility-wide, even when not in proximity to beryllium generating processes (
OSHA expects that the use of PPE will always be required in beryllium work areas because both the operations listed in Appendix A and those that can be reasonably expected to generate exposure at or above the action level would create a reasonable expectation of dermal contact with beryllium. This expectation is based, in part, on a study conducted by NIOSH and Materion and published in the Journal of Occupational and Environmental Hygiene. This study identified a strong correlation between airborne beryllium concentrations and the amount measured on gloves worn by workers at multiple beryllium facilities and jobs, indicating the potential for skin exposure where airborne beryllium is present (Document ID OSHA-H005C-2006-0870-0502). The expectation is also based on OSHA's review of data collected during site visits conducted by the agency that cover a wide range of processes (
OSHA requests comment on all aspects of this discussion. In particular, OSHA is interested in learning about any alternative approaches that have been used to trigger PPE use and the basis for them. OSHA is also interested in learning of other reasonable ways to identify non-visible dermal exposures of concern outside of beryllium work areas. OSHA also requests information on the ways employers have implemented the PPE requirements of the current rule, including any difficulties they may have had in this regard.
OSHA notes that the record is unclear on whether facilities that process beryllium have any employees who work away from beryllium-releasing processes (
OSHA believes that the proposed change to the definition will likewise render more workable the additional provisions in the standard in which
Similarly, the proposed definition will facilitate employer compliance with the requirement to provide information and training (in accordance with the Hazard Communication standard (29 CFR 1910.1200(h)) to each
Because the change would allow employers to more accurately identify the employees who have had dermal contact with beryllium, the proposed definition would also facilitate proper compliance with paragraph (i)(1)(ii), which requires employers to ensure that employees who have dermal contact with beryllium wash any exposed skin at the end of the activity, process, or work shift and prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet. The addition of the term “visible” to the definition would prevent employers from speculating that all employees in a facility, including those employees who do not work near beryllium-releasing processes (
The proposed definition would further improve employer compliance with the requirements in paragraph (k) to offer employees a medical examination including a medical and work history that emphasizes past and present airborne exposure to or dermal contact with beryllium (paragraph (k)(3)(ii)(A)), and to provide the examining physician or other licensed health care professional (PLHCP) (and the agreed-upon CBD diagnostic center, if such an evaluation is required) with a description of the employee's former and current duties that relate to the employee's airborne exposure to and dermal contact with beryllium (paragraph (k)(4)(i)). Because it would improve employers' ability to identify when dermal contact with beryllium has occurred or could occur, this change would permit employers to accurately complete employee medical and work histories and the reports that they must provide to examining PLHCPs or CBD diagnostic centers. Similar to the change's effect on the provisions discussed above, adding the term “visible” would prevent employers from including superfluous information in these medical and work histories and reports because they are concerned that an employee might have conceivably come into contact with solely non-visible beryllium particulate outside of a beryllium work area. Such an expansive interpretation would be contrary to OSHA's intent. OSHA requests comment on whether this change would cause employers to omit needed information from these medical and work histories and reports, and, as a result, undermine the effectiveness of the medical examinations.
OSHA is also proposing to add two additional references to dermal contact with beryllium in paragraph (i), Hygiene areas and practices, to account for additional proposed changes to the definition of
OSHA intends for the requirements to provide washing facilities and change rooms to apply to employees who can reasonably be expected to have dermal contact with beryllium, regardless of whether they work in a beryllium work area as defined in this proposal. As discussed above, there may be
As discussed above, it is unclear from the existing record whether there are employees working outside of beryllium work areas who could come into contact with solely
The second change that OSHA is proposing to the definition of
The proposed addition to the definition of
Paragraph (f)(1) of the beryllium standard for general industry (29 CFR 1910.1024(f)(1)) addresses the written exposure control plan that the employer must establish, implement, and maintain. Paragraph (f)(1)(i) specifies the information that must be included in the plan and paragraph (f)(1)(ii) addresses the requirements for employers to review each plan at least annually and update it under specified circumstances.
OSHA is proposing two wording changes to these provisions. Paragraph (f)(1)(i)(D) addresses procedures for minimizing cross-contamination within beryllium work areas. This includes the transfer of beryllium between surfaces, equipment, clothing, materials, and articles. This proposal would remove the word “preventing” from the text to clarify that these procedures may not totally eliminate the transfer of beryllium, but should minimize cross-contamination of beryllium, including between surfaces, equipment, clothing, materials, and articles.
Paragraph (f)(1)(ii)(B) specifies that when an employer is notified that an employee is eligible for medical removal, referred for evaluation at a CBD diagnostic center, or shows signs or symptoms associated with airborne exposure to or dermal contact with beryllium, the employer must update the written exposure control plan as necessary. OSHA is proposing to replace the phrase “airborne exposure to and dermal contact with beryllium” with “exposure to beryllium.” This would simplify the language of the provision while still capturing all potential exposure scenarios currently covered. Because these proposed changes are merely clarifying, OSHA expects they would maintain safety and health protections for workers.
OSHA is proposing two revisions to paragraph (h) of the beryllium standard for general industry, personal protective clothing and equipment (29 CFR 1910.1024(h)). The first proposed revision relates to paragraph (h)(2)(i), which addresses removal and storage of personal protective clothing and equipment (PPE). This provision requires employers to ensure that each employee removes all beryllium-contaminated PPE at the end of the work shift, at the completion of tasks involving beryllium, or when PPE becomes visibly contaminated with beryllium, whichever comes first. OSHA is proposing to modify the phrase “at the completion of tasks involving beryllium” in paragraph (h)(2)(i) by changing “tasks” to “all tasks.”
This revision would clarify the trigger for when employees must remove beryllium-contaminated PPE. OSHA's intent, expressed in the final rule, is that PPE contaminated with beryllium should not be worn when tasks involving beryllium exposure have been completed for the day (82 FR 2682). Thus, when employees perform multiple tasks involving beryllium successively or intermittently
Paragraph (h)(3)(iii) requires the employer to inform in writing the persons or the business entities who launder, clean or repair the PPE required by this standard of the potentially harmful effects of airborne exposure to and dermal contact with beryllium and that the PPE must be handled in accordance with this standard. OSHA is proposing to replace the phrase “airborne exposure to and dermal contact with beryllium” with “exposure to beryllium.” This would simplify the language of the provision while still capturing all potential exposure scenarios currently covered. An identical language change is being proposed in the methods of compliance paragraph, (f)(1)(ii)(B). Because these changes would merely clarify OSHA's original intent for these provisions of the standard, the agency anticipates that the proposed revisions to paragraph (h) would maintain safety and health protections for workers.
OSHA is proposing three changes to paragraph (i) of the general industry standard, Hygiene areas and practices (29 CFR 1910.1024(i)). This paragraph requires that the employer provide employees with readily accessible washing facilities, change rooms, and showers when certain conditions are met; requires the employer to take certain steps to minimize exposure in eating and drinking areas; and prohibits certain practices that may contribute to beryllium exposure. OSHA is proposing the first two changes, which apply to paragraphs (i)(1) and (i)(2), to maintain the protections included in these paragraphs for employees who have dermal contact with beryllium if the proposed change to the definition of beryllium work area, discussed previously in this Summary and Explanation, is finalized. OSHA is proposing the third change, which applies to paragraph (i)(4), to clarify the requirements for cleaning beryllium-contaminated PPE prior to entering an eating or drinking area.
As explained in the previous discussion of proposed changes to the definition of
First, OSHA is proposing a change in the wording of paragraph (i)(1). As currently written, paragraph (i)(1) requires that, for each employee working in a beryllium work area, the employer must provide readily accessible washing facilities in accordance with the beryllium standard and the Sanitation standard (29 CFR 1910.141) to remove beryllium from the hands, face, and neck. The employer must also ensure that employees who have dermal contact with beryllium wash any exposed skin at the end of the activity, process, or work shift and prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet. OSHA is proposing to apply the requirements of paragraph (i)(1) to each employee who can reasonably be expected to have dermal contact with beryllium in addition to each employee working in a beryllium work area. This proposed change would ensure that, if OSHA finalizes a definition of
Second, OSHA is proposing a change in the wording of paragraph (i)(2). As currently written, paragraph (i)(2) requires that, for employees who work in a beryllium work area, the employer must provide a designated change room in accordance with the beryllium standard and the Sanitation standard (29 CFR 1910.141) where employees are required to remove their personal clothing. OSHA is proposing to apply the requirements of paragraph (i)(2) to employees who are required to use personal protective clothing or equipment under paragraph (h)(1)(ii) of the beryllium standard, instead of to employees who work in a beryllium work area. Paragraph (h)(1)(ii) of the beryllium standard requires the provision and use of appropriate PPE “[w]here there is a reasonable expectation of dermal contact with beryllium.” This proposed change would ensure that, if OSHA finalizes a definition of
OSHA is also proposing a third change, which applies to paragraph (i)(4), in order to clarify the requirements for cleaning beryllium-contaminated PPE prior to entering an eating or drinking area. Paragraph (i)(4)(ii) of the beryllium standard for general industry (29 CFR 1910.1024(i)(4)(ii)) requires the employer to ensure that no employees enter any eating or drinking area with beryllium-contaminated personal protective clothing or equipment unless, prior to entry, surface beryllium has been removed from the clothing or equipment by methods that do not disperse beryllium into the air or onto an employee's body. OSHA is proposing to modify this paragraph to require the employer to ensure that, before employees enter an eating or drinking area, beryllium-contaminated PPE is cleaned, as necessary, to be as free as practicable of beryllium by methods that do not disperse beryllium into the air or onto an employee's body. This proposed change would clarify that OSHA does not expect the methods used to clean PPE prior to entering an eating or drinking area to completely eliminate residual beryllium from the surface of the PPE if complete elimination is not practicable. This is consistent with OSHA's determination, expressed in the preamble to the final rule, that “as free
Paragraph (j)(3) of the beryllium standard for general industry (29 CFR 1910.1024(j)(3)) addresses disposal and recycling of materials that contain beryllium in concentrations of 0.1 percent by weight or more or that are contaminated with beryllium. That paragraph currently specifies that (1) materials designated for disposal must be disposed of in sealed, impermeable enclosures, such as bags or containers, that are labeled according to paragraph (m)(3) of the beryllium standard, and (2) materials designated for recycling must be cleaned to be as free as practicable of surface beryllium contamination and labeled according to paragraph (m)(3), or placed in sealed, impermeable enclosures, such as bags or containers, that are labeled according to paragraph (m)(3). The requirements do not apply to materials containing only trace amounts of beryllium (less than 0.1 percent by weight).
OSHA is proposing several changes to these provisions. Generally, OSHA is proposing that provisions pertaining to recycling and disposal also address reuse because in some cases workers may be exposed to materials containing or contaminated with beryllium that are directly reused without first being recycled into a different form. For example, a manufacturer may sell a by-product from a process to a downstream manufacturer that would reuse the by-product as a component of a new product. Recycling, on the other hand, typically involves the further processing of waste materials to separate and recover various components of value. OSHA is also proposing some minor changes in terminology and organization to improve the clarity and internal consistency of the standard.
Proposed paragraph (j)(3) would be reorganized into three subparagraphs and would identify that the provisions address reuse in addition to disposal and recycling. Proposed paragraph (j)(3)(i) would require employers to ensure that materials containing at least 0.1% beryllium by weight or contaminated with beryllium that are transferred to another party for disposal, recycling, or reuse are labeled according to paragraph (m)(3) of the standard. This reorganization of the provisions would make it clear that the labeling requirements under paragraph (m)(3) apply regardless of whether the employer transfers materials to another party for disposal, recycling, or reuse. Including that information in paragraph (j)(3)(i) avoids the need to repeat the information in paragraph (j)(3)(ii), which addresses disposal specifically, and paragraph (j)(3)(iii), which addresses recycling and reuse.
Proposed paragraph (j)(3)(ii) would require that with the exception of intra-plant transfers, materials designated for disposal that contain at least 0.1% beryllium by weight or are contaminated with beryllium be cleaned to be as free as practicable of beryllium or placed in enclosures, such as bags or containers, that prevent the release of beryllium-containing particulate or solutions under normal conditions of use, storage, or transport. Proposed paragraph (j)(3)(iii) would require that with the exception of intra-plant transfers, materials designated for recycling or reuse that contain at least 0.1% beryllium by weight or are contaminated with beryllium be cleaned to be as free as practicable of beryllium or placed in enclosures, such as bags or containers, that prevent the release of beryllium-containing particulate or solutions under normal conditions of use, storage, or transport.
The proposed addition of the term “except for intra-plant transfers” to proposed paragraphs (j)(3)(ii) and (iii) clarifies that the requirements in paragraph (j)(3) do not apply to transfers within a plant. As discussed in the preamble for the beryllium final rule (82 FR 2470, 2696), OSHA did not intend the provisions of paragraph (j)(3) of the general industry standard to require employers to clean or enclose materials to be used in another location of the same facility. Since the disposal and recycling provisions would now also address reuse under this proposal, this proposed change would make OSHA's intent explicit. Under other provisions of the beryllium standard, employers would still be required to communicate possible hazards to employees and protect employees who may be exposed to those materials during intra-plant transfer.
OSHA is also proposing that the phrase “materials that contain beryllium in concentrations of 0.1 percent by weight or more” be replaced with the phrase “materials that contain at least 0.1 percent beryllium by weight” in paragraphs (j)(3)(i)-(iii). The change in terminology is to simplify the language and does not change the meaning.
The requirement in proposed paragraphs (j)(3)(ii) and (iii) that materials not otherwise cleaned be placed in enclosures that prevent the release of beryllium-containing particulate or solutions under normal conditions of use, storage, or transport clarifies the requirement from the final standard that the materials be placed in “sealed, impermeable enclosures.” As discussed in the preamble to the final standard (82 FR 2470, 2695), OSHA disagreed with stakeholders who found the requirement for sealed, impermeable enclosures to be “problematically vague.” As the agency explained, “OSHA intends this term to be broad and the provision performance-oriented, so as to allow employers in a variety of industries flexibility to decide what type of enclosures (
Since the promulgation of the final rule in 2017, OSHA has learned from stakeholders that further clarification may help eliminate confusion regarding what types of enclosures would be acceptable under the standard. Thus, the proposed change makes explicit what had been intended in the 2017 final rulemaking. In addition, the proposed change would reinforce the requirement that employers select the appropriate type of container to prevent release based on the form of beryllium and how it is normally handled. For example, a container that prevents the release of a beryllium particulate may not be effective in preventing the release of a beryllium solution.
Proposed paragraphs (j)(3)(ii) and (iii) would also clarify the cleaning requirements of the beryllium standard by removing the phrase “of surface beryllium contamination,” which may cause confusion because the term “surface beryllium contamination” does not appear in other provisions of the standard and is not defined in the beryllium standard. Elsewhere in the standard, OSHA uses the phrase “as free as practicable of beryllium.” OSHA has
Finally, proposed paragraph (j)(3)(ii) would allow the same options for either cleaning or enclosure found in the recycling and reuse requirements for materials designated for disposal. The beryllium standard currently does not include an option of cleaning materials designated for disposal and instead requires enclosure in containers. Since the promulgation of the beryllium final rule in 2017, OSHA has learned from stakeholders that in some cases, items that contain or are contaminated with beryllium may not be suitable for enclosure prior to disposal. While OSHA agreed with ORCHSE Strategies in 2017 that municipal and commercial disposal workers should be protected from exposure to beryllium from contact with materials discarded from beryllium work areas in general industry by placing those materials in enclosed containers (82 FR 2695; Document ID OSHA-H005C-2006-0870-1691, p. 5), the agency had not considered situations where it would be impractical to require enclosure because the materials in question were large items such as machines or structures that may contain or be contaminated with beryllium, rather than more common items, such as beryllium scrap metal or shavings. For example, a machine that was used to process beryllium-containing materials may be contaminated with beryllium. Enclosing the machine in a large container prior to disposal would be less practical, and no more effective, than cleaning the machine to be as free as practicable of beryllium contamination prior to disposal. Thus, OSHA has preliminarily determined that workers handling items designated for disposal, like workers handling items designated for recycling or reuse, will be just as protected from exposure to beryllium if the items are cleaned to be as free as practicable of beryllium as if the items were placed in containers. Regardless of whether an employer chooses to clean or enclose materials designated for disposal, the labeling requirements under proposed paragraph (j)(3)(i) would still apply and would require the materials designated for disposal to be labeled in accordance with paragraph (m)(3) of this standard. OSHA expects these proposed changes to paragraph (j) to maintain safety and health protections for workers.
Paragraph (k) of the beryllium standard for general industry (29 CFR 1910.1024) addresses medical surveillance requirements. OSHA is proposing changes to two medical surveillance provisions.
Under paragraph (k)(2)(i)(B), the employer must provide a medical examination within 30 days after determining that the employee shows signs or symptoms of CBD or other beryllium-related health effects or that the employee has been exposed to beryllium in an emergency. OSHA proposes removing the requirement for a medical examination within 30 days of exposure in an emergency and adding paragraph (k)(2)(iv), which would require the employer to offer a medical examination at least one year after but no more than two years after the employee is exposed to beryllium in an emergency. OSHA has preliminarily determined that the requirement to provide a medical examination between one and two years after exposure in an emergency is more appropriate than a 30-day requirement and would enhance worker protections.
In the proposal for the 2017 beryllium rule (80 FR 47798, Summary and Explanation for proposed paragraph (k)(2)(i)(B)), OSHA proposed requiring employers to provide medical examinations to employees exposed to beryllium during an emergency, and to those showing signs or symptoms of CBD, within 30 days of the employer becoming aware that these employees met those criteria. During the public comment period for that NPRM, OSHA did not receive any comments from stakeholders about the time period to offer medical examinations following a report of symptoms or exposure in an emergency. The agency determined the 30-day trigger to be administratively convenient for post-emergency surveillance, because it is consistent with other OSHA standards and with other triggers in the beryllium standards (82 FR 2702, Summary and Explanation for paragraph (k)(2)(i)(B)). OSHA therefore retained paragraph (k)(2)(i)(B), as proposed, in the final rule.
After publication of the final rule, stakeholders suggested to OSHA that sensitization might not be detected within 30 days after exposure in individuals who may become sensitized, so a longer timeframe for medical examinations may be more appropriate. OSHA acknowledges uncertainty regarding the time period in which sensitization may occur following a one-time exposure to a significant concentration of beryllium (
Because sensitization might not be detected within 30 days after exposure in individuals who may become sensitized, OSHA believes the proposed time period of one to two years may be more likely to enable detection of sensitization in employees in the first test following exposure in an emergency. OSHA notes that, if an employee exposed during an emergency were to become sensitized and develop signs or symptoms of CBD prior to one year after exposure in an emergency, the employer would still be required to provide that employee a medical examination under paragraph (k)(2)(i)(B) of the standard. Further, OSHA does not intend this revision to preclude employers from voluntarily providing a medical examination within the first year after an emergency. However, providing a medical examination sooner would not relieve an employer of the duty to provide an exam in the one- to two-year window. For those employees who are already eligible for periodic medical surveillance, the examination for the emergency exposure could be scheduled to coincide with the next periodic examination that is within two years of the last periodic medical examination and at least one but no more than two years after the emergency exposure, satisfying the requirements of both paragraphs (k)(2)(ii) and (iv).
OSHA requests comment on the appropriateness of the change from requiring a medical examination within 30 days following an employer's determination that an employee has been exposed in an emergency to between one and two years following such exposure. Specifically, is a time frame of at least one year but not more than two years appropriate, or are there immediate health effects that would support providing an examination before one year following the emergency? What is the ideal timeframe to offer a medical examination following
As promulgated, paragraph (k)(2)(i)(B) currently requires the employer to provide a medical examination within 30 days after the employer determines that an employee has been exposed to beryllium in an emergency. Under proposed paragraph (k)(2)(iv), the time period for providing a medical examination begins to run from the date the employee is exposed during an emergency, regardless of when the employer discovers that the exposure occurred. Because under this proposal the medical examination will not occur until at least a year from the date of the exposure in an emergency, and because OSHA believes that employers typically will learn of the emergency resulting in exposure immediately or soon after it occurs, OSHA has preliminarily determined that it is appropriate to measure the time period from the date of exposure. OSHA requests comments on the appropriateness of calculating the time period for a medical examination from the occurrence of the emergency rather than from the employer's determination of eligibility.
Paragraph (k)(7)(i) currently requires that the employer provide, at no cost to the employee, an evaluation at a CBD diagnostic center that is mutually agreed upon by the employee and employer within 30 days of the employer receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or (B). OSHA is proposing a change to paragraph (k)(7)(i) to account for the proposed revision to the definition of
Accordingly, OSHA proposes expanding paragraph (k)(7)(i) to require that the employer provide, at no cost to the employee and within a reasonable time after consultation with the CBD diagnostic center, any of the following tests if deemed appropriate by the examining physician at the CBD diagnostic center: A pulmonary function test as outlined by ATS criteria; BAL; and transbronchial biopsy. The proposed changes would ensure that the employee receives those tests recommended by the examining physician and receives them at no cost and within a reasonable time. In addition, the revision would clarify OSHA's original intent that, instead of requiring all tests to be conducted after referral to a CBD diagnostic center, the standard would allow the examining physician at the CBD diagnostic center the discretion to select one or more of those tests as appropriate. OSHA further notes that, by requiring the employer to provide those tests recommended by the examining physician at the CBD diagnostic center that was previously agreed-upon by the employer and employee, OSHA intends those tests to be provided by the same CBD diagnostic center unless the employer and employee agree to a different CBD diagnostic center. OSHA expects this proposed revision to maintain safety and health protections for workers.
In the proposal for the 2017 beryllium rule, OSHA proposed to require a consultation between the employee and the licensed physician within 30 days of the employee being confirmed positive to discuss a referral to a CBD diagnostic center, but there was no time limit for the employer to provide the evaluation at the CBD diagnostic center (80 FR 47800, Summary and Explanation for proposed paragraph (k)(6)(i) and (ii)). In the final rule, OSHA altered this requirement, now in paragraph (k)(7)(i), to require that the examination at the CBD diagnostic center be provided within 30 days of the employer receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or (B). The purpose of this 30-day requirement was to ensure that employees receive the examination in a timely manner. This time period is also consistent with other OSHA standards.
However, since OSHA published the final rule, stakeholders have raised concerns that scheduling the appropriate tests with an examining physician at the CBD diagnostic center may take longer than 30 days, making compliance with this provision difficult. To address this concern, OSHA is proposing that the employer provide an initial consultation with the CBD diagnostic center, rather than the full evaluation, within 30 days of the employer receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or (B). OSHA believes that such a consultation could be scheduled with a physician within 30 days and could be provided by telephone or by virtual conferencing methods. Providing a consultation before the full examination at the CBD diagnostic center demonstrates that the employer has made an effort to begin the process for a medical examination. It also allows the employee to consult with a physician to discuss concerns and ask questions while waiting for a medical examination. This consultation would allow the physician to explain the types of tests that are recommended based on medical findings about the employee and the risks and benefits of undergoing such testing. Although this proposed change would allow the employer more time to provide the full evaluation, the proposed requirement to provide any recommended tests within a reasonable time after the initial consultation would ensure that the employer secures an appointment for the evaluation in a timely manner. And this proposed change would not prohibit the employer from providing both the consultation and the full evaluation at the same appointment, as long as the appointment is within 30 days of the employer receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or (B).
OSHA requests comments on this change, and specifically requests comment on whether it is appropriate to require the employer to provide a consultation with the CBD diagnostic center, rather than the full evaluation, within 30 days. OSHA also requests comment on whether a consultation via telephone or virtual conferencing methods is sufficient or whether it is appropriate to require the employer to provide an in-person consultation upon the employee's request.
OSHA is also proposing changes to paragraph (m), communication of hazards, of the beryllium standard for general industry (82 FR 2470). This provision sets forth the employer's obligations to comply with OSHA's Hazard Communication Standard (HCS) (29 CFR 1910.1200) relative to beryllium and to take additional steps to warn and train employees about the hazards of beryllium.
Paragraph (m)(3) addresses warning label requirements. This paragraph requires the employer to label each bag and container of clothing, equipment, and materials contaminated with beryllium, and specifies the precise wording on the label. OSHA is proposing to modify the language in paragraph (m)(3) to remove the words “bag and” and insert the descriptive adjective “immediate” to clarify that the employer need only label the immediate container of beryllium-contaminated
Paragraph (m)(4)(ii)(A) addresses employee information and training and requires the employer to ensure that each employee exposed to airborne beryllium can demonstrate knowledge and understanding of the health hazards associated with airborne exposure to and contact with beryllium, including the signs and symptoms of CBD. OSHA is proposing to modify the language in paragraph (m)(4)(ii)(A) by adding the word “dermal” to contact with beryllium. This revision would clarify OSHA's intent that employers must ensure that exposed employees can demonstrate knowledge and understanding of the health hazards caused by dermal contact with beryllium.
Similarly, paragraph (m)(4)(ii)(E) addresses employee information and training and requires the employer to ensure that each employee exposed to airborne beryllium can demonstrate knowledge and understanding of measures employees can take to protect themselves from airborne exposure to and contact with beryllium, including personal hygiene practices. OSHA is proposing to modify the language in paragraph (m)(4)(ii)(E) by adding the word “dermal” to contact with beryllium. This revision would clarify OSHA's intent that employers must ensure exposed employees can demonstrate knowledge and understanding of measures employees can take to protect themselves from dermal contact with beryllium. OSHA expects these proposed changes would maintain safety and health protections for workers.
OSHA is proposing to modify paragraph (n), Recordkeeping, by removing the requirement to include each employee's Social Security Number (SSN) in the air monitoring data ((n)(1)(ii)(F)), medical surveillance ((n)(3)((ii)(A)), and training ((n)(4)(i)) provisions.
The 2015 beryllium NPRM proposed to require inclusion of the employee's SSN in records related to air monitoring, medical surveillance, and training, similar to provisions in previous substance-specific health standards. As OSHA explained in the 2017 beryllium final rule, using an employee's SSN is a useful tool for evaluating an individual's exposure over time because an SSN is unique to an individual, is retained for a lifetime, and does not change when an employee changes employers (82 FR 2730). OSHA received several objections to the proposed requirement, citing employee privacy and identity theft concerns. OSHA recognized the privacy concerns expressed by commenters regarding this requirement, but concluded that the beryllium rule should adhere to the agency's past consistent practice of requiring an employee's SSN on records, and that any change to this requirement should be comprehensive and apply to all OSHA standards, not just the standards for beryllium (82 FR 2730). In 2016, OSHA proposed to delete the requirement that employers include SSNs in records required by its substance-specific standards in the agency's Standards Improvement Project-Phase IV (SIP-IV) proposed rule (81 FR 68504, 68526-68528 (10/4/16)). Consistent with the SIP-IV proposal, OSHA is now proposing to modify the beryllium standard for general industry by removing the requirement to include SSNs in the recordkeeping provisions in paragraphs (n)(1)(ii)(F) (air monitoring data), (n)(3)((ii)(A) (medical surveillance), and (n)(4)(i) (training).
This proposed change would not require employers to delete employee SSNs from existing records. It would also not mandate a specific type of identification method that employers should use on newly-created records, but would instead provide employers with the flexibility to develop systems that best work for their unique situations. Therefore, employers would have the option to continue to use SSNs as employee identifiers for their records or to use an alternative employee identifier system. OSHA expects this proposed change would maintain safety and health protections for workers.
The purpose of the Occupational Safety and Health Act of 1970 (“the OSH Act” or “the Act”), 29 U.S.C. 651
The Act also authorizes the Secretary to “modify” or “revoke” any occupational safety or health standard, 29 U.S.C. 655(b), and under the Administrative Procedure Act, regulatory agencies generally may revise their rules if the changes are supported by a reasoned analysis, see
The Act provides that in promulgating health standards dealing with toxic materials or harmful physical agents, such as the January 9, 2017, final rule regulating occupational exposure to beryllium:
[t]he Secretary . . . shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.
OSHA standards must also be both technologically and economically feasible. See
OSHA exercises significant discretion in carrying out its responsibilities under the Act. Indeed, “[a] number of terms of the statute give OSHA almost unlimited discretion to devise means to achieve the congressionally mandated goal” of ensuring worker safety and health. See
Although OSHA is required to set standards “on the basis of the best available evidence,” 29 U.S.C. 655(b)(5), its determinations are “conclusive” if supported by “substantial evidence in the record considered as a whole,” 29 U.S.C. 655(f). Similarly, as the Supreme Court noted in
Finally, because section 6(b)(5) of the Act explicitly requires OSHA to set health standards that eliminate risk “to the extent feasible,” OSHA uses feasibility analysis rather than cost-benefit analysis to make standards-setting decisions dealing with toxic materials or harmful physical agents (29 U.S.C. 655(b)(5)). An OSHA standard in this area must be technologically and economically feasible—and also cost effective, which means that the protective measures it requires are the least costly of the available alternatives that achieve the same level of protection—but OSHA cannot choose an alternative that provides a lower level of protection for workers' health simply because it is less costly. See
Congress itself defined the basic relationship between costs and benefits, by placing the “benefit” of worker health above all other considerations save those making attainment of this “benefit” unachievable. Any standard based on a balancing of costs and benefits by the Secretary that strikes a different balance than that struck by Congress would be inconsistent with the command set forth in § 6(b)(5).
Executive Orders 12866 and 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1532(a)) require that OSHA estimate the benefits, costs, and net benefits of regulations, and analyze the impacts of certain rules that OSHA promulgates. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. For this proposal, possible effects of each provision on costs and benefits appear to be relatively small, and OSHA has not been able to quantify them. Nor has OSHA been able to quantify the cost savings it expects from preventing misinterpretation and misapplication of the standard. OSHA expects that this rule, if finalized, will increase understanding and increase compliance with the standard. This proposed rule is expected to be an E.O. 13771 deregulatory action. Moreover, and as mentioned above, OSHA expects this proposed rule would maintain safety and health protections for workers.
OSHA has preliminarily determined that the proposed rulemaking is not an “economically significant regulatory action” under Executive Order 12866 or a “major rule” under the Congressional Review Act (5 U.S.C. 801
In promulgating the 2017 final rule, OSHA determined that the beryllium rule was both technologically and economically feasible. See 82 FR 2582-86, 2590-96, Summary of the Final Economic Analysis. The changes proposed herein are intended to align the rule more clearly with the intent of the 2017 final rule. Because OSHA has preliminarily determined that this proposal would decrease the costs of compliance by preventing misinterpretation and misapplication of the standard, OSHA has also preliminarily determined that the proposal is economically feasible.
OSHA invites public comment on all aspects of this PEA.
As previously explained in Section II, Discussion of Proposed Changes, many of the changes proposed in this NPRM are solely for purposes of clarification and therefore would not alter the requirements or scope of the beryllium standard, though they would facilitate its appropriate interpretation and application. These include: The addition of a definition of
Some proposed changes would go beyond clarification and alter certain requirements of the beryllium standard while maintaining safety and health protections for workers. The following subsections examine the provisions for which proposed changes may affect costs and the potential cost impact of these provisions, along with associated interrelated provisions. These provisions include: changes to the definitions of
The proposed definition of
OSHA expects that the proposed definition of beryllium work area would not alter the number or location of beryllium work areas that employers in general industry must establish under the current rule. The proposed modification is not intended to significantly change the operations where a beryllium work area is established. Rather, it is intended to provide greater clarity to employers on when and where beryllium work areas are required and to avoid the potential for confusion—and potential expense inconsistent with the intended application of the rule—in the triggering of a beryllium work area at “any level of exposure” or on “dermal contact with beryllium.” The current standard's definition of beryllium work area requires, first, the presence of a process or operation that can release beryllium. As discussed in Section II, Discussion of Proposed Changes, OSHA has preliminarily determined that the operations listed in Appendix A of this proposal include common operations in general industry that can release beryllium, and the agency has requested comment on additional operations capable of releasing beryllium for inclusion in Appendix A.
In the FEA supporting the 2017 beryllium final rule, OSHA estimated that, on average, one beryllium work area would need to be established for every 12 at-risk workers in the exposure profile (2017 FEA, pp. V-164-165). The FEA defined an at-risk worker as one “whose exposure to beryllium could result in disease or death” and did not account for those workers who may have skin exposure but no airborne exposure to beryllium (2017 FEA, p. III-1). Because proposed Appendix A is designed to cover the same general industry processes as the current beryllium work area definition based on Chapter IV of the 2017 Beryllium FEA, and because those with dermal contact with beryllium but no airborne exposure were not accounted for in the 2017 cost estimate, OSHA anticipates the same number of beryllium work areas as estimated for the 2017 final rule. OSHA does, however, expect that this proposed clarification would result in reduced employer time for determining which areas should be demarcated as beryllium work areas under the standard. OSHA originally estimated that the initial set-up of a beryllium work area would take a supervisor four hours. OSHA expects that under the proposed revisions to the definition of a beryllium work area, employers will have more clarity about where beryllium work areas should be established and will spend less time identifying such areas. OSHA does not have sufficient information to quantify this time reduction but believes that, overall, this revision to the definition of a beryllium work area would produce a cost savings. OSHA requests comment on this preliminary determination, including comment on how to quantify the effect of greater clarity on the cost of setting up a beryllium work area. OSHA expects the proposed revisions would maintain safety and health protections for workers.
OSHA is proposing to modify the definition of confirmed positive to require that the qualifying test results be obtained within one testing cycle (including the 30-day follow-up test period required after a first abnormal or borderline BeLPT test result), rather than over an unlimited time period that OSHA believes may lead to false positives that needlessly concern workers and their families and that do not enhance employee protections. The exact effect of this proposed change is uncertain as it is unknown how many employees would have a series of BeLPT results associated with a confirmed positive finding (two abnormal results, one abnormal and one borderline result, or three borderline
OSHA is proposing to modify the definition for
The 2017 FEA estimated the costs of provisions related to dermal contact with beryllium based on the number of employees working in application groups where beryllium is processed. Following the publication of the 2017 standard, OSHA received feedback from employers concerned that if the definition was not limited to “visible” dust, fumes, or mist, then all employees in a facility must be considered to have dermal contact with beryllium because they may have come into contact with non-visible beryllium particulate outside of a beryllium work area or when handling beryllium materials in non-particulate solid form. This was not OSHA's intent, as reflected in OSHA's previous cost estimates for the relevant beryllium work area and PPE provisions. One employer also expressed concern that handling solid beryllium would fall within the definition of dermal contact with beryllium, but again that was not OSHA's intent, and OSHA had not estimated costs arising from protection from contact with this form of beryllium. As OSHA explained in the 2017 final rule, beryllium-containing solid objects, or “articles,” with uncompromised physical integrity, are unlikely to release beryllium that would pose a health hazard for workers (82 FR at 2640). The cost of compliance with provisions triggered by dermal contact with beryllium is therefore not expected to increase as a result of either change to this definition.
OSHA is proposing two changes to the hygiene areas and practices provision to account for the proposed changes to the definition of a beryllium work area and to ensure that the hygiene provisions related to washing facilities and change rooms will still apply to employees who can reasonably be expected to have dermal contact with beryllium regardless of whether they work in beryllium work areas as defined in the revised definition. First, OSHA is proposing a change in the wording of paragraph (i)(1), which specifies the employees for whom employers must provide washing facilities. As currently written, paragraph (i)(1) applies to each employee working in a beryllium work area. OSHA is proposing to apply the requirements of paragraph (i)(1) to each employee who can reasonably be expected to have dermal contact with beryllium, in addition to each employee working in a beryllium work area, to account for the proposed removal of dermal contact with beryllium as a trigger for establishing a beryllium work area. Second, OSHA is proposing a change in the wording of paragraph (i)(2) (change rooms). As currently written, paragraph (i)(2) applies to employees who work in a beryllium work area. OSHA is proposing to apply the requirements of paragraph (i)(2) to employees who are required to use personal protective clothing or equipment under paragraph (h)(1)(ii) of the beryllium standard, instead of to employees who work in a beryllium work area.
As discussed in Section B.1 of this PEA, OSHA is proposing several changes to the definition of beryllium work area to clarify where a beryllium work area should be established. One of the changes proposed is to remove dermal contact with beryllium as one of the triggers that would require an employer to establish a beryllium work area. If this proposed change to the definition of beryllium work area is finalized, it is OSHA's intention that the hygiene provisions related to washing facilities and change rooms will still apply to employees who can reasonably be expected to have dermal contact with beryllium regardless of whether they work in beryllium work areas as defined in the revised definition. OSHA therefore expects that the proposed change to the definition of
Paragraph (j)(3) addresses disposal and recycling of materials that contain beryllium in concentrations of 0.1 percent by weight or more or that are contaminated with beryllium. That paragraph currently specifies that (1) materials designated for disposal must be disposed of in sealed, impermeable enclosures, such as bags or containers, that are labeled according to paragraph (m)(3) of the beryllium standard, and (2) materials designated for recycling must be cleaned to be as free as practicable of surface beryllium contamination and labeled according to paragraph (m)(3), or placed in sealed, impermeable enclosures, such as bags or containers, that are labeled according to paragraph (m)(3). OSHA is proposing several changes to this paragraph, changes that do not increase the costs of complying with the standard and may also result in savings to employers by preventing misinterpretation or misapplication of the rule.
First, OSHA is proposing that provisions pertaining to recycling and disposal also address reuse, in addition to disposal and recycling, because in some cases materials may be directly reused without being recycled. This is to ensure that workers exposed to materials designated for reuse are adequately protected from dermal exposure to materials containing or
Second, proposed paragraph (j)(3)(i) would clarify that labeling requirements under paragraph (m)(3) apply when the employer transfers materials to another party for disposal, recycling, or reuse. This is not a substantive change to the standard, but rather a reorganization of the existing provisions, and therefore does not impact costs of compliance with the standard.
Third, the proposed addition of the phrase “except for intra-plant transfers” to paragraphs (j)(3)(ii) and (iii) clarifies that the requirements in paragraph (j)(3) do not apply to transfers within a plant, and also would not be a substantive change to the standard. Since this proposed change would not alter the requirements of the standard, it would not affect the costs of compliance with the standard.
Fourth, proposed paragraphs (j)(3)(ii) and (iii) would require that materials not otherwise cleaned be placed in enclosures that prevent the release of beryllium-containing particulate or solutions under normal conditions of use, storage, or transport. This proposed change would clarify the final standard's requirement that the materials be placed in “sealed, impermeable enclosures.” As discussed in the preamble to the final standard (82 FR 2470, 2695), OSHA intended this requirement to be broad and the provision performance-oriented, so as to allow employers in a variety of industries flexibility to decide what type of enclosures (
Fifth, paragraph (j)(3)(iii) would also clarify the cleaning requirements of the beryllium standard by removing the requirement that contaminated areas be cleaned “of surface beryllium contamination.” Elsewhere in the standard, OSHA uses the phrase “as free as practicable of beryllium,” and OSHA proposes to use that phrase in place of “of surface beryllium contamination.” OSHA has discussed the meaning of the phrase “as free as practicable” in the summary and explanation of paragraph (j) in the 2017 final rule (82 FR 2690), as well as previously in a 2014 letter of interpretation explaining the phrase in the context of the agency's standard for hexavalent chromium.
Finally, proposed paragraph (j)(3)(ii) would incorporate a new option for cleaning materials designated for disposal, using the same “as free as practicable of beryllium” language used in the recycling and reuse provisions in proposed (j)(3)(iii). The beryllium standard currently does not include an option of cleaning materials designated for disposal and instead requires enclosure of all materials in containers. The agency had not previously considered situations where it would be impractical to require enclosure because the materials in question were large items such as machines or structures that may contain, or be contaminated with, beryllium, rather than more common items, such as beryllium scrap metal or shavings. It is OSHA's understanding that these larger items need not be enclosed when they are cleaned in accordance with the existing housekeeping provisions, which also require employers to keep their work areas as free as practicable of beryllium. Regardless of whether an employer chooses to clean or enclose materials designated for disposal, the labeling requirements under proposed paragraph (j)(3)(i) would still apply and would require the materials designated for disposal to be labeled in accordance with paragraph (m)(3) of this standard. This proposed change would merely allow another option for materials designated for disposal. Because it would impose no additional requirements beyond the existing housekeeping duties already necessary before larger beryllium-contaminated items could be moved away from beryllium work areas, there is no additional cost. OSHA expects employers to choose the lowest-cost option, so there may be cost savings in some individual cases as compared to the cost of enclosing. However, OSHA does not know how many employers may choose this option and therefore does not have sufficient information to quantify this potential cost savings at this time.
Under paragraph (k)(2)(i)(B), the employer must provide a medical examination including a BeLPT within 30 days after determining that the employee shows signs or symptoms of CBD or other beryllium-related health effects or the employee is exposed to beryllium in an emergency. The standard provides that these employees must also be offered a BeLPT every two years following their initial BeLPT unless they are confirmed positive (paragraph (k)(3)(ii)(E)).
OSHA proposes to remove the requirement for a medical examination within 30 days of determining that an employee has been exposed in an emergency and add paragraph (k)(2)(iv), which would require the employer to offer a medical examination at least one year after, but no more than two years after, the employee is exposed to beryllium in an emergency. As discussed in the Discussion of Proposed Changes, testing within the first 30 days may be premature because beryllium sensitization might not be detected within 30 days after exposure in all individuals who may become sensitized. OSHA believes that the proposed time period for providing a medical examination would be more likely to enable detection of sensitization in more employees in the first test following exposure in an emergency, providing better worker protection.
In the agency's FEA for the January 2017 final rule, the agency estimated that a very small number of employees would be affected by emergencies in a given year, likely less than 0.1 percent of the affected population, representing a small addition to the costs of medical surveillance for the standard (FEA, p. V-196). Under the current rule, some employees may require two examinations to be confirmed positive: An initial test within the initial 30-day period and (assuming the first test is normal) a second BeLPT at least two years later. Under the proposed rule, OSHA expects more of the employees who become sensitized from exposure in an emergency to be confirmed positive through a single test cycle because that test will be administered one to two years following the emergency. The general result is the elimination of one cycle of testing that appears to be premature, ensuring better detection for more employees and incidentally triggering some cost savings.
To the extent that lengthening the time period in which the test must be offered from within 30 days to between one and two years leads to earlier confirmed positive results (within two years, as opposed to within two years plus 30 days), the proposed change would slightly accelerate costs to the employer for earlier CBD diagnostic center referral and medical removal protection. OSHA estimates that this proposed change would affect a very small percentage of an already very small population. And this proposed revision would only potentially change the timing of the already-required BeLPT, CBD diagnostic center referral, and medical removal protection.
The end result from a cost perspective is that the cost savings from the potential avoidance of a premature BeLPT within 30 days following an emergency is likely to be largely canceled out by the acceleration of the cost of the CBD diagnostic center evaluation and medical removal protection. OSHA has preliminarily determined that the net cost impact would be slight, with some possible cost savings.
Paragraph (k)(7)(i) requires that the employer provide an evaluation at no cost to the employee at a CBD diagnostic center that is mutually agreed upon by the employee and employer within 30 days of the employer receiving a medical opinion or written medical report that recommends referral to a CBD diagnostic center, or a written medical report indicating that the employee has been confirmed positive or diagnosed with CBD. OSHA is proposing a change to paragraph (k)(7)(i) to account for the proposed revision to the definition of
OSHA is also proposing that the employer provide an initial consultation with the CBD diagnostic center, rather than the full evaluation, within 30 days of the employer receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or (B). As explained in Section II, Discussion of Proposed Changes, this consultation would allow the employee to speak with a physician to discuss concerns and ask questions prior to a medical evaluation for CBD, and would allow the physician to explain the types of tests that are recommended based on the employee's medical findings.
The proposed provision could result in cost savings. This initial consultation can be done in conjunction with the tests but it is not required to be. As the initial consultation may be conducted remotely, by phone or virtual conferencing, the cost of the consultation would consist only of time spent by the employee and the physician and would not have to include any travel or accommodation. This proposed change would not prohibit the employer from providing both the consultation and the full evaluation at the same appointment, as long as the appointment is within 30 days of the employer receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or (B). In the 2017 FEA, OSHA accounted for the cost of both the employee's time and a physician's time for a 15-minute discussion (2017 FEA, p. V-206). Because the consultation would replace this initial discussion, there would be no additional cost. Furthermore, OSHA expects that allowing more flexibility in scheduling the tests at the CBD diagnostic center would allow employers to find more economical travel and accommodation options. To the extent that it takes longer than 30 days to schedule the tests at the CBD diagnostic center, employers may realize a cost savings due to retaining funds during the delay. OSHA cannot quantify the effect of this flexibility on any cost savings at this time, but travel and accommodation costs related to the CBD diagnostic center evaluation are only six percent of total CBD diagnostic center referral costs. The agency therefore preliminarily concludes these changes would produce minor, if any, cost savings. OSHA invites comment on this preliminary assessment.
OSHA also notes that the proposed changes described here would maintain safety and health protections for workers.
Paragraph (m)(3) addresses warning label requirements. This paragraph requires the employer to label each bag and container of clothing, equipment, and materials contaminated with beryllium, and specifies precise wording on the label. OSHA is proposing to modify the language in paragraph (m)(3) to remove the words “bag and” and insert the descriptive adjective “immediate” to clarify that the employer need only label the immediate container of beryllium-contaminated items. The proposed clarification would be consistent with the hazard communication standard (HCS (§ 1910.1200) regarding bags or containers within larger containers. Under the HCS, only the primary or immediate container must be labeled
In the 2017 Beryllium FEA, costs were taken only for the bag label and not for the label of any larger container holding the bag. Thus, this proposed clarification has no cost implications. And the revision would maintain safety and health protections for workers.
OSHA is proposing to modify paragraph (n), Recordkeeping, by removing the requirement to include each employee's Social Security number (SSN) in the air monitoring data ((n)(1)(ii)(F)), medical surveillance ((n)(3)((ii)(A)), and training ((n)(4)(i)) provisions. This proposed change would not require employers to delete employee SSNs from existing records, or to include an alternative unique employee identifier on those records. Furthermore, it would not mandate a specific type of identification method that employers should use on newly-created records, but would instead provide employers with the flexibility to develop systems that best work for their unique situations. As a result, OSHA estimates that this proposed revision has no cost implications—and it would maintain safety and health protections for workers.
OSHA expects that if this proposal is finalized, employers will spend a small amount of time reviewing these proposed changes. This amount of time would be negligible compared to the amount of time employers spent reviewing the 2017 final beryllium rule. In addition, OSHA notes that many affected employers would already be familiar with the proposed changes because the proposed regulatory text changes were made public in April 2018 (Document ID OSHA-H005C-2006-0870-2156). OSHA therefore expects the cost of familiarization with this proposal would be de minimis and welcomes comment on this preliminary determination.
In the FEA in support of OSHA's 2017 Beryllium Final Rule, OSHA concluded that the general industry beryllium standard was economically and technologically feasible (82 FR 2471). As explained above, OSHA anticipates that none of the changes in this proposal would impose any new employer obligations or increase the overall cost of compliance, while some of the changes in this proposal would clarify and simplify compliance in such a way that results in cost savings. OSHA expects that the cost of any time spent reviewing the changes in this proposal, as described above in Section C, will be more than offset by cost savings. None of the revisions to the standard requires any new controls or other technology. OSHA has therefore preliminarily determined that this proposal is also economically and technologically feasible.
In the 2017 FEA, OSHA attributed approximately 67 percent of the beryllium sensitization cases and the CBD cases avoided, and none of the lung cancer cases avoided, solely to the ancillary provisions of the standard. (2017 FEA, Document ID OSHA-H005C-2006-0870-2042, p. VII-4-VII-5, VII-24.) This estimate was based on the ancillary provisions as a whole, rather than each provision separately.
As described in Section II, Discussion of Proposed Changes, the proposed changes are intended to clarify and simplify compliance with certain ancillary provisions of the 2017 general industry beryllium standard and facilitate employer understanding of its requirements. This NPRM does not propose to remove any ancillary provision. Thus, the group of ancillary provisions that would result from finalizing these proposed revisions to the beryllium standard includes a provision similar to each of those in the 2017 final rule.
Furthermore, the agency considered the potential effect of each proposed change to ancillary provisions on employee protections. OSHA believes that the proposed changes would maintain safety and health protections for workers while aligning the standard with the intent behind the 2017 final rule and otherwise preventing costs that could follow from misinterpretation or misapplication of the standard. Moreover, facilitating employer understanding and compliance has the benefit of enhancing worker protections overall. Because the proposed revisions to the standard would not remove or change the general nature of any ancillary provisions, and because the agency expects proposed revisions to maintain safety and health protections for workers and facilitate employer understanding and compliance, OSHA preliminarily determines that the effect of these proposed changes on benefits of the standard as a whole would be to increase them by enhancing worker protections overall and by preventing costs that follow from misunderstanding the standard.
In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601
The standard for occupational exposure to beryllium in general industry (29 CFR 1910.1024) contains information collection requirements that are subject to the Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
The PRA defines a
OSHA prepared and submitted an Information Collection Request (ICR) to OMB proposing to remove the current collection of information that requires employers to collect and record social security numbers from the existing OMB approved paperwork package in accordance with 44 U.S.C. 3507(d). The ICR also reflects proposed changes to the beryllium standard's housekeeping and medical surveillance provisions, described below. The agency solicits comments on these proposed changes to the collection of information requirements and reduction in estimated burden hours associated with these requirements, including comments on the following items:
• Whether the proposed collections of information are necessary for the proper performance of the agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and cost) of the collections of information, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the compliance burden on employers, for example, by using automated or other technological techniques for collecting and transmitting information.
As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(2), the following paragraphs provide information about this ICR.
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In addition, OSHA is proposing to update paragraph (j)(3) by clarifying the labeling requirements for beryllium-contaminated materials designated for disposal, recycling, or reuse. The proposed change will also clarify how materials designated for recycling or reuse that either contain at least 0.1% beryllium by weight or are contaminated with beryllium must be cleaned to be as free as practicable of beryllium or placed in enclosures that prevent the release of beryllium-containing particulate or solutions under normal conditions of use, storage, or transport, such as bags or containers.
OSHA is also proposing to revise both the definition of a CBD diagnostic center and paragraph (k)(7)(i) to indicate that the evaluation at the CBD diagnostic center must include a pulmonary function test as outlined by American Thoracic Society criteria, bronchoalveolar lavage (BAL), and transbronchial biopsy, only if deemed appropriate by an examining physician. These proposed changes clarify the original intent of these requirements. The agency believes that these changes would have benefits to both employees and employers and overall cost savings, but OSHA has not quantified those benefits and savings for this analysis. These proposed changes to the information collection requirements in this information collection request would affect the existing ICR but would have no measureable impact on employer burden, and would therefore impose no additional burden hours or costs for the employer.
Totals estimated for burden hours and cost:
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Members of the public who wish to comment on the paperwork requirements in this proposal must send their written comments to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor, OSHA (RIN-1218-AD20), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: 202-395-6929/Fax: 202-395-6881 (these are not toll-free numbers), email:
To access the docket to read or download comments and other materials related to this paperwork determination, including the complete ICR (containing the Supporting Statement with attachments describing the paperwork determinations in detail), use the procedures described under the section of this notice titled
OSHA reviewed this proposal in accordance with the Executive Order on Federalism (E.O. 13132, 64 FR 43255, August 10, 1999), which requires that Federal agencies, to the extent possible, refrain from limiting State policy options, consult with States prior to taking any actions that would restrict State policy options, and take such actions only when clear constitutional and statutory authority exists and the problem is national in scope. E.O. 13132 provides for preemption of State law
Under Section 18 of the OSH Act, Congress expressly provides that States and U.S. territories may adopt, with Federal approval, a plan for the development and enforcement of occupational safety and health standards. OSHA refers to such States and territories as “State Plan States” (29 U.S.C. 667). Occupational safety and health standards developed by State Plan States must be at least as effective in providing safe and healthful employment and places of employment as the Federal standards. Subject to these requirements, State Plan States are free to develop and enforce under State law their own requirements for safety and health standards.
OSHA previously concluded that promulgation of the beryllium standard complies with E.O. 13132 (82 FR at 2633), so this proposal complies with E.O. 13132. In States without OSHA-approved State Plans, Congress expressly provides for OSHA standards to preempt State occupational safety and health standards in areas addressed by the Federal standards. In these States, this proposal would limit State policy options in the same manner as every standard promulgated by OSHA. In States with OSHA-approved State Plans, this rulemaking would not significantly limit State policy options.
When Federal OSHA promulgates a new standard or more stringent amendment to an existing standard, the 28 States and U.S. Territories with their own OSHA approved occupational safety and health plans (“State Plan States”) must amend their standards to reflect the new standard or amendment, or show OSHA why such action is unnecessary,
This proposal is clarifying and simplifying in nature and would impose no new requirements. Therefore, no new State standards would be required beyond those already required by the promulgation of the January 2017 beryllium standard for general industry. State-Plan States may nonetheless choose to conform to these proposed revisions.
OSHA reviewed this proposal according to the Unfunded Mandates Reform Act of 1995 (“UMRA”; 2 U.S.C. 1501
As noted above under Section VII (“State-Plan States”), the agency's standards do not apply to State and local governments except in States that have elected voluntarily to adopt a State Plan approved by the agency. Consequently, this proposal does not meet the definition of a “Federal intergovernmental mandate” (see Section 421(5) of the UMRA (2 U.S.C. 658(5))). Therefore, for the purposes of the UMRA, the agency certifies that this proposal would not mandate that State, local, or Tribal governments adopt new, unfunded regulatory obligations of, or increase expenditures by the private sector by, more than $100 million in any year.
OSHA reviewed this proposed rule in accordance with E.O. 13175 (65 FR 67249) and determined that it does not have “tribal implications” as defined in that order. This proposal does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
OSHA has reviewed this proposed beryllium rule according to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
Beryllium, General industry, Health, Occupational safety and health.
For the reasons stated in the preamble of this notice of proposed rulemaking, OSHA is amending 29 CFR part 1910 to read as follows:
29 U.S.C. 653, 655, 657; Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912); 29 CFR part 1911; and 5 U.S.C. 553, as applicable.
Section 1910.1030 also issued under Pub. L. 106-430, 114 Stat. 1901.
Section 1910.1201 also issued under 49 U.S.C. 5101
The revisions and additions read as follows:
(b) * * *
(f) * * *
(1) * * *
(i) * * *
(D) Procedures for minimizing cross-contamination, including the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within beryllium work areas;
(ii) * * *
(B) The employer is notified that an employee is eligible for medical removal in accordance with paragraph (l)(1) of this standard, referred for evaluation at a CBD diagnostic center, or shows signs or symptoms associated with exposure to beryllium; or
(h) * * *
(2) * * *
(i) The employer must ensure that each employee removes all beryllium-contaminated personal protective clothing and equipment at the end of the work shift, at the completion of all tasks involving beryllium, or when personal protective clothing or equipment becomes visibly contaminated with beryllium, whichever comes first.
(3) * * *
(iii) The employer must inform in writing the persons or the business entities who launder, clean or repair the personal protective clothing or equipment required by this standard of the potentially harmful effects of exposure to beryllium and that the personal protective clothing and equipment must be handled in accordance with this standard.
(i) * * *
(1) General. For each employee working in a beryllium work area or who can reasonably be expected to have dermal contact with beryllium, the employer must:
(2) Change rooms. In addition to the requirements of paragraph (i)(1)(i) of this standard, the employer must provide employees who are required to use personal protective clothing or equipment under paragraph (h)(1)(ii) of this standard with a designated change room in accordance with this standard and the Sanitation standard (§ 1910.141) where employees are required to remove their personal clothing.
(4) * * *
(ii) No employees enter any eating or drinking area with beryllium-contaminated personal protective clothing or equipment unless, prior to entry, it is cleaned, as necessary, to be as free as practicable of beryllium by methods that do not disperse beryllium into the air or onto an employee's body; and
(j) * * *
(3)
(i) When the employer transfers materials that contain at least 0.1% beryllium by weight or are contaminated with beryllium to another party for disposal, recycling, or reuse, the employer must label the materials in accordance with paragraph (m)(3) of this standard;
(ii) Except for intra-plant transfers, materials designated for disposal that contain at least 0.1% beryllium by weight or are contaminated with beryllium must be cleaned to be as free as practicable of beryllium or placed in enclosures that prevent the release of beryllium-containing particulate or solutions under normal conditions of use, storage, or transport, such as bags or containers; and
(iii) Except for intra-plant transfers, materials designated for recycling or reuse that contain at least 0.1% beryllium by weight or are contaminated with beryllium must be cleaned to be as free as practicable of beryllium or placed in enclosures that prevent the release of beryllium-containing particulate or solutions under normal conditions of use, storage, or transport, such as bags or containers.
(k) * * *
(2) * * *
(i) * * *
(B) An employee meets the criteria of paragraph (k)(1)(i)(B).
(iv) At least one year but no more than two years after an employee meets the criteria of paragraph (k)(1)(i)(C).
(7) * * *
(i) The employer must provide an evaluation at no cost to the employee at a CBD diagnostic center that is mutually agreed upon by the employer and the employee. The employer must also provide, at no cost to the employee and within a reasonable time after the initial consultation with the CBD diagnostic center, any of the following tests if deemed appropriate by the examining physician at the CBD diagnostic center: Pulmonary function testing (as outlined by the American Thoracic Society criteria), bronchoalveolar lavage (BAL), and transbronchial biopsy. The initial consultation with the CBD diagnostic center must be provided within 30 days of:
(m) * * *
(3) Warning labels. Consistent with the HCS (§ 1910.1200), the employer must label each immediate container of clothing, equipment, and materials contaminated with beryllium, and must, at a minimum, include the following on the label:
(4) * * *
(ii) * * *
(A) The health hazards associated with airborne exposure to and dermal contact with beryllium, including the signs and symptoms of CBD;
(E) Measures employees can take to protect themselves from airborne exposure to and dermal contact with beryllium, including personal hygiene practices;
(n) * * *
(1) * * *
(ii) * * *
(F) The name and job classification of each employee represented by the monitoring, indicating which employees were actually monitored.
(3) * * *
(ii) * * *
(A) Name and job classification;
(4) * * *
(i) At the completion of any training required by this standard, the employer must prepare a record that indicates the name and job classification of each employee trained, the date the training was completed, and the topic of the training.
(p) Appendix. Appendix A to § 1910.1024—Operations for Establishing Beryllium Work Areas
Paragraph (b) of this standard defines a beryllium work area as any work area where materials that contain at least 0.1 percent beryllium by weight are processed (1) during any of the operations listed in Appendix A of this Standard, or (2) where employees are, or can reasonably be expected to be, exposed to airborne beryllium at or above the action level. Table A.1 in this appendix sets forth the operations that, where performed under the circumstances described in the column heading above the particular operations, trigger the requirement for a beryllium work area.
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 |