| Page Range | 49485-49736 | |
| FR Document |
| Page and Subject | |
|---|---|
| 82 FR 49735 - Minority Enterprise Development Week, 2017 | |
| 82 FR 49654 - Indian Gaming; Tribal-State Class III Gaming Compact Taking Effect in the State of New Mexico | |
| 82 FR 49694 - Agency Information Collection Activities: Proposed Request | |
| 82 FR 49611 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 82 FR 49539 - Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area | |
| 82 FR 49704 - Lon F. Alexander, M.D.; Decision and Order | |
| 82 FR 49665 - Harinder Takyar, M.D.; Decision and Order | |
| 82 FR 49609 - Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID) | |
| 82 FR 49609 - Advisory Council for the Elimination of Tuberculosis Meeting | |
| 82 FR 49611 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-State, Tribal, Local and Territorial (STLT) Subcommittee | |
| 82 FR 49610 - Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH); Meeting | |
| 82 FR 49658 - National Register of Historic Places; Notification of Pending Nominations and Related Actions | |
| 82 FR 49657 - National Register of Historic Places; Notification of Pending Nominations and Related Actions | |
| 82 FR 49656 - National Register of Historic Places; Notification of Pending Nominations and Related Actions | |
| 82 FR 49663 - Yoon H. Choi, M.D.; Decision and Order | |
| 82 FR 49663 - Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc. | |
| 82 FR 49598 - Names of Members of the Performance Review Board for the Department of the Air Force | |
| 82 FR 49692 - Privacy Act of 1974; Matching Program | |
| 82 FR 49695 - Savage Companies-Continuance in Control Exemption-Savage Davenport Railroad Company | |
| 82 FR 49586 - Meetings | |
| 82 FR 49510 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Indian River, Titusville, FL | |
| 82 FR 49550 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, St. Augustine, FL | |
| 82 FR 49510 - Drawbridge Operation Regulation; Snake Creek; Islamorada, FL | |
| 82 FR 49600 - Environmental Impact Statement Withdrawal and Availability of an Environmental Assessment for the Souris River Basin Flood Risk Management Feasibility Study, Ward County, North Dakota | |
| 82 FR 49652 - National Protection and Programs Directorate; Notification of Issuance of Binding Operational Directive 18-01 | |
| 82 FR 49690 - Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978 | |
| 82 FR 49659 - Lined Paper School Supplies From China and India; Scheduling of an Expedited Five-Year Review | |
| 82 FR 49661 - Tin- and Chromium-Coated Steel Sheet From Japan; Scheduling of a Full Five-Year Review | |
| 82 FR 49660 - Foundry Coke From China; Scheduling of a Full Five-Year Review | |
| 82 FR 49596 - Atlantic Highly Migratory Species; Exempted Fishing, Scientific Research, Display, and Shark Research Fishery; Letters of Acknowledgment | |
| 82 FR 49659 - Notice of Availability of the Proposed Notice of Sale for Gulf of Mexico Outer Continental Shelf Oil and Gas Region-Wide Lease Sale 250; MMAA 104000 | |
| 82 FR 49586 - Foreign-Trade Zone 295-Central Pennsylvania; Application for Subzone; North American Höganäs Company; Johnstown, Hollsopple and St, Mary's, Pennsylvania | |
| 82 FR 49592 - Polytetrafluoroethylene Resin From India: Initiation of Countervailing Duty Investigation | |
| 82 FR 49587 - Polytetrafluoroethylene Resin From India and the People's Republic of China: Initiation of Less-Than-Fair-Value Investigations | |
| 82 FR 49653 - Statutorily Mandated Designation of Difficult Development Areas and Qualified Census Tracts: Revision of Effective Date for 2015 Designations | |
| 82 FR 49681 - Notice of the Task Force on Apprenticeship Expansion Charter Establishment and Public Meeting | |
| 82 FR 49636 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0020 | |
| 82 FR 49640 - Information Collection Request to Office of Management and Budget; OMB | |
| 82 FR 49636 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0029 | |
| 82 FR 49641 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0109 | |
| 82 FR 49638 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0058 | |
| 82 FR 49686 - Notice of Intent To Award-Grant Awards for the Provision of Civil Legal Services to Eligible Low-Income Clients Beginning January 1, 2018 | |
| 82 FR 49637 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0022 | |
| 82 FR 49605 - MS Solar 3, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 82 FR 49603 - Midcontinent Independent System Operator, Inc.; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 82 FR 49606 - Midcontinent Independent System Operator, Inc.; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 82 FR 49607 - South Central MCN LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 82 FR 49605 - Midwest Power Transmission Arkansas, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 82 FR 49604 - Transource Kansas, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 82 FR 49602 - Combined Notice of Filings #1 | |
| 82 FR 49606 - Buchanan Energy Services Company, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 82 FR 49607 - Kanstar Transmission, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 82 FR 49604 - ATX Southwest, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 82 FR 49541 - Revised Critical Infrastructure Protection Reliability Standard CIP-003-7-Cyber Security-Security Management Controls | |
| 82 FR 49501 - Policy Statement on Establishing License Terms for Hydroelectric Projects | |
| 82 FR 49604 - Combined Notice of Filings #2 | |
| 82 FR 49606 - Combined Notice of Filings #1 | |
| 82 FR 49604 - Combined Notice of Filings | |
| 82 FR 49642 - Commercial Customs Operations Advisory Committee (COAC) | |
| 82 FR 49655 - Notice of National Petroleum Reserve in Alaska Oil and Gas Lease Sale 2017; Notice of Availability of the Detailed Statement of Sale for the NPR-A 2017 Oil and Gas Lease Sale | |
| 82 FR 49691 - Privacy Act of 1974; Matching Program | |
| 82 FR 49680 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of Currently Approved Collection | |
| 82 FR 49695 - Third RTCA SC-236 Joint Plenary With EUROCAE WG-96 | |
| 82 FR 49601 - Notice of Availability of a Draft Integrated General Reevaluation Report and Environmental Assessment and Draft Finding of No Significant Impact for the Proposed Lower Pajaro River Flood Risk Management Project, Monterey and Santa Cruz Counties, CA | |
| 82 FR 49634 - Matthew Schroeder; Denial of Hearing; Final Debarment Order | |
| 82 FR 49595 - Judges Panel of the Malcolm Baldrige National Quality Award | |
| 82 FR 49689 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 | |
| 82 FR 49608 - Proposed Agency Information Collection Activities; Comment Request | |
| 82 FR 49668 - Federal Law Protections for Religious Liberty | |
| 82 FR 49655 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Procedures for State, Tribal, and Local Government Historic Preservation Programs | |
| 82 FR 49691 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To List and Trade Shares of the Hartford Municipal Opportunities ETF Under NYSE Arca Rule 8.600-E | |
| 82 FR 49690 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Amend Section 202.06 of the NYSE Listed Company Manual To Prohibit Listed Companies From Issuing Material News After the Official Closing Time for the Exchange's Trading Session Until the Earlier of Publication of Such Company's Official Closing Price on the Exchange or Five Minutes After the Official Closing Time | |
| 82 FR 49683 - Petitions for Modification of Application of Existing Mandatory Safety Standards | |
| 82 FR 49599 - Submission for OMB Review; Comment Request | |
| 82 FR 49682 - Preparations for the 34th Session of the UN Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS) | |
| 82 FR 49680 - Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act | |
| 82 FR 49492 - Special Conditions: Boeing Model 777-300ER Airplanes; Passenger-Cabin High-Wall Suites | |
| 82 FR 49643 - Proposed Flood Hazard Determinations | |
| 82 FR 49651 - Wisconsin; Major Disaster and Related Determinations | |
| 82 FR 49651 - Wisconsin; Amendment No. 1 to Notice of a Major Disaster Declaration | |
| 82 FR 49645 - Puerto Rico; Amendment No. 2 to Notice of an Emergency Declaration | |
| 82 FR 49652 - Puerto Rico; Amendment No. 1 to Notice of an Emergency Declaration | |
| 82 FR 49646 - Puerto Rico; Amendment No. 5 to Notice of a Major Disaster Declaration | |
| 82 FR 49607 - 2017 Fall Joint Meeting of the Ozone Transport Commission and the Mid-Atlantic Northeast Visibility Union | |
| 82 FR 49645 - Puerto Rico; Amendment No. 3 to Notice of a Major Disaster Declaration | |
| 82 FR 49645 - Louisiana; Emergency and Related Determinations | |
| 82 FR 49533 - Hazardous Waste Management System; Identification and Listing of Hazardous Waste | |
| 82 FR 49651 - Louisiana; Amendment No. 2 to Notice of an Emergency Declaration | |
| 82 FR 49696 - Petition for Waiver of Compliance | |
| 82 FR 49697 - Petition for Waiver of Compliance | |
| 82 FR 49698 - Petition for Waiver of Compliance | |
| 82 FR 49662 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
| 82 FR 49563 - Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants; City of Philadelphia; Control of Emissions From Existing Sewage Sludge Incineration Units | |
| 82 FR 49647 - Changes in Flood Hazard Determinations | |
| 82 FR 49511 - Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants; City of Philadelphia; Control of Emissions From Existing Sewage Sludge Incineration Units | |
| 82 FR 49649 - Proposed Flood Hazard Determinations | |
| 82 FR 49646 - Final Flood Hazard Determinations | |
| 82 FR 49564 - Mercury; Reporting Requirements for the TSCA Mercury Inventory | |
| 82 FR 49612 - Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability | |
| 82 FR 49632 - Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
| 82 FR 49602 - Agency Information Collection Activities; Comment Request; State Educational Agency and Local Educational Agency-School Data Collection and Reporting Under ESEA, Title I, Part A | |
| 82 FR 49701 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Alcohol and Tobacco Tax and Trade Bureau Information Collection Requests | |
| 82 FR 49639 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0040 | |
| 82 FR 49608 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 82 FR 49504 - Schedules of Controlled Substances: Temporary Placement of ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl Into Schedule I | |
| 82 FR 49485 - Softwood Lumber Research, Promotion, Consumer Education and Industry Information Order; De Minimis Quantity Exemption Threshold | |
| 82 FR 49698 - Sanctions Action Pursuant to Executive Order 13067 and Executive Order 13412 | |
| 82 FR 49513 - National Emission Standards for Hazardous Air Pollutants: Publicly Owned Treatment Works Residual Risk and Technology Review | |
| 82 FR 49550 - Exemptions To Permit Circumvention of Access Controls on Copyrighted Works | |
| 82 FR 49498 - Airworthiness Directives; Bombardier, Inc., Airplanes | |
| 82 FR 49494 - Airworthiness Directives; The Boeing Company Airplanes | |
| 82 FR 49508 - Dividend Equivalents From Sources Within the United States; Correction | |
| 82 FR 49549 - Revision of Regulations Under Chapter 3 Regarding Withholding of Tax on Certain U.S. Source Income Paid to Foreign Persons; Correction |
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Agricultural Marketing Service, USDA.
Final rule.
This rule establishes a de minimis quantity exemption threshold under the U.S. Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) regulations regarding a national research and promotion program for softwood lumber. In response to a 2016 federal district court decision, the U.S. Department of Agriculture (USDA) conducted a new analysis to determine a reasonable and appropriate de minimis threshold. Based on that analysis, this rule establishes the de minimis quantity threshold at 15 million board feet (mmbf) and entities manufacturing (and domestically shipping) or importing less than 15 mmbf per year will be exempt from paying assessments under the regulations.
Maureen T. Pello, Marketing Specialist, Promotion and Economics Division, Specialty Crops Program, AMS, USDA, P.O. Box 831, Beavercreek, Oregon, 97004; telephone: (503) 632-8848; facsimile (503) 632-8852; or electronic mail:
This rule, affecting 7 CFR part 1217, is authorized under the Commodity Promotion, Research and Information Act of 1996 (1996 Act) (7 U.S.C. 7411-7425).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771.
This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this rule will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. Section 524 of the 1996 Act (7 U.S.C. 7423) provides that it shall not affect or preempt any other Federal or State law authorizing promotion or research relating to an agricultural commodity.
Under section 519 of the 1996 Act (7 U.S.C. 7418), a person subject to an order may file a written petition with USDA stating that an order, any provision of an order, or any obligation imposed in connection with an order, is not established in accordance with the law, and request a modification of an order or an exemption from an order. Any petition filed challenging an order, any provision of an order, or any obligation imposed in connection with an order, shall be filed within two years after the effective date of an order, provision, or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, USDA will issue a ruling on the petition. The 1996 Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have the jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of the entry of USDA's final ruling.
This rule establishes a de minimis quantity exemption threshold under the Softwood Lumber Research, Promotion, Consumer Education and Industry Information Order (Order), codified at 7 CFR part 1217. This part is administered by the Softwood Lumber Board (Board) with oversight by USDA's Agricultural Marketing Service (AMS). In
To address the court's decision, USDA conducted a new analysis to determine a reasonable and appropriate de minimis quantity exemption. USDA analyzed various thresholds of exemption: 10, 15, 20, 25, and 30 mmbf. USDA also considered proposing no de minimis exemption. USDA's analysis of the data resulted in a determination that a de minimis level of 15 mmbf is reasonable and appropriate. The analysis was published in a proposed rule on May 30, 2017 (82 FR 24583). This final rule establishes the de minimis quantity threshold under part 1217 at 15 mmbf.
The 1996 Act authorizes USDA to establish agricultural commodity research and promotion orders which may include a combination of promotion, research, industry
The 1996 Act provides for a number of optional provisions that allow the tailoring of orders for different commodities. Section 516 of the 1996 Act provides permissive terms for orders. Section 516 states that an order may include an exemption of de minimis quantities of an agricultural commodity. Further, section 516(g) of the 1996 Act provides authority for other action that is consistent with the purpose of the statute and necessary to administer a program.
The softwood lumber program took effect in August 2011 (76 FR 46185) and assessment collection began in January 2012. Under part 1217, assessments are collected from domestic (U.S.) manufacturers and importers and are used by the Board for projects that promote market growth for softwood lumber products used in single and multi-family dwellings as well as commercial construction. The Board is composed of 19 industry members (domestic manufacturers and importers) who are appointed by the Secretary of Agriculture. The purpose of the program is to strengthen the position of softwood lumber in the marketplace, maintain and expand markets for softwood lumber, and develop new uses for softwood lumber within the United States.
The term `domestic manufacturer' is defined in § 1217.8 to mean any person who is a first handler engaged in the manufacturing, sale and shipment of softwood lumber in the United States during a fiscal period and who owns, or shares in the ownership and risk of loss of manufacturing of softwood lumber or a person who is engaged in the business of manufacturing, or causes to be manufactured, sold and shipped such softwood lumber in the United States beyond personal use. The term does not include persons who re-manufacture softwood lumber that has already been subject to assessment. The term `manufacture' is defined in § 1217.13 to mean the process of transforming (or turning) softwood logs into softwood lumber.
Domestic manufacturers are essentially sawmills that turn softwood logs into lumber. A domestic manufacturer may be a company that is a single sawmill, or it may be a company that is composed of multiple sawmills.
The term `importer' is defined in § 1217.11 to mean any person who imports softwood lumber from outside the United States for sale in the United States as a principal or as an agent, broker, or consignee of any person who manufactures softwood lumber outside the United States for sale in the United States, and who is listed in the import records as the importer of record for such softwood lumber. Import records are maintained by the U.S. Customs and Border Protection (Customs or CBP). Both domestic manufacturers and importers may be referred to in this rulemaking as “entities.”
Pursuant to § 1217.50, the Board is authorized to incur expenses for research and promotion projects as well as administration. The Board's expenses are paid by assessments upon domestic manufacturers and importers. Pursuant to § 1217.52(b), and subject to the exemptions specified in § 1217.53, each domestic manufacturer and importer must pay an assessment to the Board at the rate of $0.35 per thousand board feet of softwood lumber, except that no entity has to pay an assessment on the first 15 mmbf of softwood lumber otherwise subject to assessment in a fiscal year. Domestic manufacturers pay assessments based on the volume of softwood lumber shipped within the United States and importers pay assessments based on the volume of softwood lumber imported to the United States. Pursuant to paragraphs (d) and (j) in § 1217.52, respectively, domestic manufacturers and importers who pay their assessments to the Board must do so no later than the 30th calendar day of the month following the end of the quarter in which the softwood lumber was shipped or imported.
Section 1217.53 prescribes exemptions from assessment. Pursuant to paragraph (a) of that section, the original de minimis quantity exemption threshold under part 1217 was 15 mmbf. Thus, U.S. manufacturers and importers that domestically ship and/or import less than 15 mmbf feet annually have been exempt from paying assessments. Domestic manufacturers and importers that ship or import less than the de minimis quantity of softwood lumber must apply to the Board each year for a certificate of exemption and provide documentation as appropriate to support their request.
Pursuant to paragraph (b) of § 1217.53, domestic manufacturers and importers that ship or import 15 mmbf or more annually do not pay assessments on their first 15 mmbf domestically shipped or imported. This
Pursuant to § 1217.70, domestic manufacturers and importers who pay their assessments directly to the Board must submit with their payment a report that specifies the quantity of softwood lumber domestically shipped or imported. Pursuant to § 1217.71, all domestic manufacturers and importers must maintain books and records necessary to verify reports for a period of 2 years beyond the fiscal year to which they apply, including those exempt. These records must be made available during normal business hours for inspection by Board staff or USDA.
The original 15 mmbf quantity exemption threshold is referenced in other Order provisions. Section 1217.40 specifies that the Board is composed of domestic manufacturers and importers who domestically ship or import 15 mmbf or more of softwood lumber annually. Section 1217.41 specifies that
The softwood lumber program was implemented after notice and comment rulemaking and a May 2011 referendum demonstrating strong support for the program. Pursuant to § 1217.81(a), the program had to pass by a majority of those voting in the referendum who also represented a majority of the volume voted. Sixty-seven percent of the entities who voted, who together represented 80 percent of the volume, in the referendum favored implementation of the program. Entities that domestically shipped or imported 15 mmbf or more of softwood lumber annually were eligible to vote in the referendum. As previously mentioned, the program took effect in August 2011 and assessment collection began in January 2012.
The softwood lumber program has continued to operate at the 15 mmbf exemption threshold since its inception. During these years, the Board has funded a variety of activities designed to increase the demand for softwood lumber. The Board funded a U.S. Tall Wood Building Prize Competition that is helping to showcase the benefits of building tall structures with wood. The Board also funds research on wood standards; a communications program, which includes continuing education courses for architects and engineers; and a construction and design program that provides technical support to architects and structural engineers about using wood.
The Secretary has authority under section 516 of the 1996 Act to exempt any de minimis quantity of an agricultural commodity otherwise covered by an order: “An order issued under this subchapter may contain . . . authority for the Secretary to exempt from the order any de minimis quantity of an agricultural commodity otherwise covered by the order. . . .” 7 U.S.C. 7415(a). A de minimis quantity exemption allows an industry to exempt from assessment small entities that could be unduly burdened from an order's requirements (
In evaluating the merits of a de minimis quantity for the softwood lumber program, USDA considered several factors. These factors include: an estimate of the total quantity of softwood lumber covered under part 1217 (quantity assessed and quantity exempted); available funding to support a viable program; free rider implications; and the impact of program requirements on entities (above and below a de minimis threshold). USDA reviewed such factors in light of all available data and information to determine whether a de minimis quantity is reasonable. USDA balanced the multiple factors to assess whether one exemption threshold would work better than another when the factors are considered collectively. The analysis was based on the current assessment rate of $0.35 per thousand board feet.
The following tables are republished from USDA's analysis of the de minimis quantity under the softwood lumber program contained in the May 2017 proposed rule (82 FR 24583).
Table 1 shows the estimate of the supply of U.S. softwood lumber used in the analysis, accounting for both U.S. shipments and imports. U.S. shipments were estimated using capacity
Table 2 shows assessable volume and revenue at exemption levels of 30, 25, 20, 15 and 10 mmbf, as well as with no exemptions. The table accounts for both the de minimis and equity exemptions under part 1217, and an assessment rate of $0.35 per thousand board feet.
Table 3 is the inverse of Table 2 in that it shows exempt volume at de minimis and equity exemptions of 30, 25, 20, 15 and 10 mmbf.
Table 4 shows the number of entities (domestic manufacturers and importers) that would be assessed and the number of entities that would be exempt at the exemption thresholds of 30, 25, 20, 15 and 10 mmbf.
Based on its analysis, USDA determined the following: Exemption thresholds of 10 to 15 mmbf would exempt 10 to 13 percent of the total volume of softwood lumber (taking into account both the de minimis and equity exemptions). This is close to the range exempt under other research and promotion programs. While all of the exemption thresholds analyzed would generate sufficient revenue for a viable program, the additional revenue that could be collected if the de minimis level were reduced much lower than 15 mmbf would likely not be worth the additional costs. At this threshold, free rider implications would be minimal because only 4 percent of the volume of softwood lumber would be exempted as de minimis. Applying both the de minimis and equity exemptions at 15 mmbf would allow the program to assess almost 90 percent of the total volume of softwood lumber.
Further, the program functioned successfully in 2015 with assessment revenue of $12.905 million with de minimis and equity exemptions of 15 mmbf. The Board has conducted activities at this level of funding that have helped build demand for softwood lumber, including a prize competition for tall wood buildings, research on wood standards, and an education program for architects and engineers on building with wood. An independent evaluation completed in 2016 concluded that activities of the Board increased sales of softwood lumber between 2011 and 2015 by 1.683 bbf or $596 million. This equates to a return on investment of $15.55 of additional sales for every $1 spent on promotion by the Board.
Therefore, when considering all of the factors collectively, USDA concludes that 15 mmbf is a reasonable and most appropriate de minimis quantity under part 1217.
In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS is required to examine the impact of this final rule on small entities as defined by the Small Business Administration (SBA). The classification of a business as small, as defined by the SBA, varies by industry. If a business is defined as “small” by SBA size standards, then it is “eligible for government programs and preferences reserved for `small business' concerns.”
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. The SBA defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms (domestic manufacturers and importers) as those having annual receipts of no more than $7.5 million.
Using an average price of $330 per thousand board feet,
This action establishes a de minimis quantity exemption threshold under part 1217. Part 1217 is administered by the Board with oversight by USDA. In response to a federal district court decision in
Regarding the economic impact of the de minimis exemption, the exemption allows the Board to exempt from assessment small entities that would be unduly burdened by the program's obligations. At the 15 mmbf exemption threshold, small manufacturers and importers that domestically ship or import less than 15 mmbf of softwood lumber will not have to pay assessments under the program.
Additionally, larger manufacturers and importers will not have to pay assessments on the first 15 mmbf of softwood lumber domestically shipped or imported each year. This exemption is intended for the purpose of equity, whereby all entities who must pay assessments may reduce their assessable volume by 15 mmbf. This exemption benefits smaller manufacturers and importers whose annual shipments or imports are above the de minimis threshold of 15 mmbf. With this exemption, an entity that ships or imports a quantity of softwood lumber equal to the RFA-small business definition of 23 mmbf, would only pay assessments on no more than 8 mmbf of softwood lumber.
To calculate the impact of the assessment rate on the revenue of an assessment payer, the assessment rate is divided by an average price. Using an average 2015 price of $330 per thousand board feet, the assessment rate as a percentage of price could range from 0.106 percent at the current assessment rate to 0.151 percent at the maximum assessment rate. This analysis helps identify the impact of the assessment rate on the revenues of assessment payers. At the current assessment rate of $0.35 per thousand board feet to the maximum assessment rate of $0.50 per thousand board feet, assessment payers would owe between 0.106 percent and 0.151 percent of their revenues, respectively.
In its analysis of alternatives, USDA evaluated five different exemption thresholds—30, 25, 20, 15 and 10 mmbf using 2015 data—accounting for both the de minimis and equity exemptions, as well as having no exemptions under the program. USDA evaluated these alternatives based on the following factors: an estimate of quantity of softwood lumber covered under the program (quantity assessed and quantity exempted); available funding to support a viable program; free rider implications; and the impact of program requirements on entities (above and below a de minimis threshold). USDA conducted a balancing test among these factors to assess whether one exemption threshold works better than another when the factors are considered collectively.
In reviewing the quantity of assessable versus exempt softwood lumber at the alternative exemption thresholds, USDA found that at an exemption threshold of 30 mmbf, a total of 32.805 bbf would be assessed with 3.284 bbf, or 8 percent, exempt as de minimis, plus an additional 5.16 bbf exempt as equity for 20 percent of total volume exempt; at 25 mmbf, a total of 33.694 bbf would be assessed with 2.93 bbf, or 7 percent, exempt as de minimis, plus an additional 4.625 bbf exempt as equity for 18 percent total volume exempt; at a threshold of 20 mmbf, a total of 34.69 bbf would be assessed with 2.259 bbf, or 5 percent, exempt as de minimis, plus an additional 4.3 bbf exempt as equity for 16 percent total volume exempt; at a threshold of 15 mmbf, a total of 35.854 bbf would be assessed with 1.57 bbf, or 4 percent, exempt as de minimis, plus an additional 3.825 bbf exempt as equity for 13 percent total volume exempt; at a threshold of 10 mmbf, a total of 37.183 bbf would be assessed, with 1.236 bbf, or 3 percent, exempt as de minimis, plus an additional 2.83 bbf exempt as equity for 10 percent total volume exempt; and with no exemptions, a total of 41.249 bbf would be assessed. In reviewing the total volume exempt under the softwood lumber program (taking into account both the de minimis and equity exemptions), thresholds of 10 to 15 mmbf exempt between 10 and 13 percent of the volume, which is close to the range exempt under other programs.
In reviewing available funding to support a viable program at the alternative exemption thresholds, at an exemption threshold of 30 mmbf, estimated assessment revenue is $11.482 million; at 25 mmbf, estimated assessment revenue is $11.793 million (an additional $311,243); at a threshold of 20 mmbf, estimated assessment revenue is $12.141 million (an additional $348,408); at a threshold of 15 mmbf, estimated assessment revenue is $12.549 million (an additional $407,444); at a threshold of 10 mmbf, estimated assessment revenue is $13.014 million (an additional $465,267); and with no exemptions, estimated assessment revenue is $14.437 million (an additional $1.423 million).
Assessment revenue under the current softwood lumber program has ranged from about $10.638 million in 2012 to $12.905 million in 2015. At this level of revenue, the current program has seen success. The revenues reviewed at the different exemption thresholds are comparable to these levels or higher. Thus, all of the exemption thresholds analyzed would generate sufficient revenue for a viable program.
Regarding free riders, USDA notes that the key to assessing the free rider implications of a de minimis quantity is not the number of entities exempt under a program but rather the
In evaluating the impact of the program's requirements at the alternative exemption thresholds, entities that ship or import at or above the de minimis threshold must pay assessments to the Board. Assessment payers must also submit a report to the Board each quarter of the volume of softwood lumber shipped or imported for the respective quarter. Entities that ship or import below the de minimis threshold must apply to the Board each year for a certificate of exemption and provide documentation as appropriate to support their request. The reporting and recordkeeping requirements are detailed in the section below titled Paperwork Reduction Act.
At an exemption threshold of 30 mmbf, 172 entities would pay assessments and 882 would be exempt; at 25 mmbf, 185 entities would pay assessments and 869 would be exempt; at 20 mmbf, 215 entities would pay assessments and 839 would be exempt; at 15 mmbf, 255 entities would pay assessments and 799 would be exempt; at 10 mmbf, 283 entities would pay assessments and 771 would be exempt. Thus, as the exemption threshold is reduced, more entities would be subject to the assessment and quarterly reporting obligation under part 1217.
Further, in considering program compliance costs, USDA estimates the cost of an on-site audit of a single entity at $5,000 or more. Thus, the cost to pursue a compliance case against an entity that shipped less than 10 mmbf, 9 mmbf for example, would outweigh the revenue that would be collected from that entity of $3,150. Similarly, the assessment revenue that would be collected from an entity that shipped less than 15 mmbf, 12 mmbf for example, would amount to $4,200. The benefit of assessing smaller manufacturers, $3,150 at 9 mmbf and $4,200 at 12 mmbf, does not outweigh the cost of pursuing compliance cases against them at $5,000 per entity. The point at which the assessment revenue that would be collected from an entity outweighs the estimated cost of $5,000 to pursue a compliance case is an entity with volume equal to or greater than 14.3 mmbf.
Analysis of the 23 mmbf-RFA small business threshold as a reasonable option for de minimis shows that 190 entities would be subject to assessment and 864 entities would be exempt. In terms of volume, 38.44 bbf would be assessed, or 93 percent of total volume, and 2.809 bbf would be exempt, or 7 percent of total volume.
Based upon the analysis contained herein, any of the exemption thresholds reviewed would be reasonable because they would exempt from 3 to 8 percent of the volume of softwood lumber as de minimis. However, when the total volume exempt under the softwood lumber program is considered (taking into account both the de minimis and equity exemptions), thresholds of 10 to 15 mmbf exempt between 10 and 13 percent of the volume, which is close to the range exempt under other programs. While all of the exemption thresholds analyzed would generate sufficient revenue for a viable program, the additional revenue that could be collected if the de minimis level were reduced much lower than 15 mmbf would likely not be worth the additional costs. The softwood lumber program operated successfully since its inception at an exemption threshold of 15 mmbf.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements imposed by part 1217 have been approved previously under OMB control number 0581-0093. This rule imposes no additional reporting and recordkeeping burden on domestic manufacturer and importers of softwood lumber. The reporting requirements pertaining to this rule are described in the following paragraphs.
As previously mentioned, pursuant to § 1217.53(a), domestic manufacturers and importers who domestically ship or import less than the de minimis threshold must apply to the Board each year for a certificate of exemption and provide documentation as appropriate to support their request. The reporting burden for this collection of information is estimated to average 0.25 hours per domestic manufacturer or importer per report, or 0.25 hours per year (1 request per year per exempt entity). This computes to a total annual burden of 199.75 hours (0.25 hours times 799 exempt entities at the 15 mmbf de minimis exemption threshold from Table 4).
Further, pursuant to § 1217.70, domestic manufacturers and importers that ship or import at or over the de minimis exemption level and pay their assessments directly to the Board must submit a shipment/import report for each quarter when assessments are due. The reporting burden for this collection of information is estimated to average 0.5 hours per domestic manufacturer or importer per report, or 2 hours per year (4 reports per year times 0.5 hours per report). This computes to a total annual burden of 510 hours (255 assessed entities (from Table 4—No. of Assessed Entities at 15 mmbf) at 2 hours each equals 510 hours).
All domestic manufacturers and importers must also maintain records sufficient to verify their reports. The recordkeeping burden for keeping this information is estimated to average 0.5 hours per record keeper maintaining such records, or 527 hours (1,054 total entities assessed (from Table 4—No. of Assessed Entities at no exemption) times 0.5 hours).
As with all Federal promotion programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. Finally, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.
USDA is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
Regarding outreach efforts, USDA initiated this action in response to a May 2016 federal court decision in
A proposed rule concerning this action was published in the
Thirty-three comments were received in response to the proposed rule. Of those 33 comments, one was outside the scope of the rulemaking and the remaining 32 supported the 15 mmbf exemption threshold. The following is an analysis of those 32 comments.
Several commenters reiterated the data presented in the proposed rule. They cited Table 3 which shows that, at the 15 mmbf threshold, entities that pay into the program account for 96 percent of the U.S. softwood lumber market volume. Thus, free rider concerns are minimal. Reducing the exemption level by a third (down to 10 mmbf) would only increase that number to 97 percent of the U.S. market and would not be worth the additional effort. There are a large number of small manufacturers and importers who account for a small percentage of the softwood lumber shipped in the United States. The commenters opined that the cost of collecting an assessment from such a large number of entities outweighs the revenue that could be collected from such a small amount of volume. They agreed that Board staff time would be better spent on promotion activities than trying to collect a small amount of revenue from several small entities.
One commenter opined that the methodology used by USDA to determine the de minimis threshold was comprehensive and explored tradeoffs involved in setting a threshold below which it is counterproductive to the collection of assessments to further the program. The commenter stated that “. . . USDA dealt with a large amount of data on imports that it appropriately scrubbed to exclude obvious errors and outliers.” Within the populations of domestic manufacturers and importers categorized based on volume, USDA conducted a series of “what if” analyses to determine the impact of various de minimis levels on revenue in terms of “. . . administrative costs, the compliance burden on respondents and the potential for “free rider” benefits.” The commenter also observed that USDA compared the results to other federal promotion programs authorized under the 1996 Act and overseen by USDA where it found that 8 of 10 programs exempt a de minimis quantity from assessment, and that half of those programs exempt between 3 and 11 percent of the total quantity covered by the program as de minimis. Among the range of alternatives that USDA analyzed, the 10 and 15 mmbf thresholds came closest to this range. The commenter stated that USDA also compared the benefits derived from these thresholds with the likely compliance costs incurred, which USDA estimated at $5,000 per entity. The point at which revenues collected from entities that would fall below the compliance cost was found to be at 14.3 mmbf, which is closest to the 15 mmbf threshold. The combination of these results led USDA to conclude that 15 mmbf is the most appropriate benchmark between volumes assessed and not assessed. The commenter concluded that, “. . . while there is no special formula for computing a de minimis threshold . . . ,” the commenter believes that USDA selected a reasonable exemption amount based on the industry's structure and the program's benefits and costs.
Six commenters opined that the 15 mmbf threshold appropriately separates the high production manufacturers from small entities that manufacture specialty products and sell into mostly local and niche markets. They agreed that specialty products do not benefit as much from a national promotion program, and that growth in market share benefits entities that manufacture larger volumes to a greater degree than those that fall below the 15 mmbf threshold.
Several commenters expressed concern with the administrative burden that complying with a mandatory promotion program could place on small entities below the 15 mmbf threshold. One commenter stated that, on a per board foot ratio, the costs to participate in the program are lower for larger entities than smaller entities. Many small entities still record their shipments by hand. Larger entities, on the other hand, can afford to invest in automated computer reporting systems and can have personnel dedicated to efficiently analyzing their reporting. Thus, the administrative costs for smaller entities to participate in the program are higher than the costs for larger entities.
Two commenters also referenced the part's 8 percent cap on administrative expenses. They opined that the revenue gained from collecting assessments from numerous small entities would not be sufficient to justify the additional costs and administrative complexities.
Three commenters expressed support for the equity exemption. They opined that the equity exemption makes the program fair for everyone. One commenter opined that the equity exemption mitigates the free rider problem because larger entities do not have to pay assessments on their first 15 mmbf shipped. Without the equity exemption, assessment payers would pay more, thereby increasing the free rider impact.
Two commenters discussed the efforts of the Blue Ribbon Commission (BRC), the proponent group, in promulgating the program. They stated that the BRC surveyed the industry on issues related to the program, including the de minimis exemption threshold. They stated that the BRC sought a level that would generate maximum revenue for the program while being mindful of the cost of administering the program and collecting assessments. The BRC's survey found that 15 mmbf was the appropriate level that was broadly accepted by the industry.
Several commenters also expressed their overall support for the softwood lumber program. They agreed that the program provides a strong, unified voice for the industry. One commenter stated that the program has contributed significantly to strengthening the position of softwood lumber in the market place as well as expanding and developing new markets for softwood lumber. The commenters also agreed that funding for the program has been appropriate since assessment collection began in 2012. None of the commenters supported increasing the exemption threshold thereby reducing funding for the program.
No changes have been made to the proposed rule based on the comments received.
After consideration of all relevant matters presented, including the available information and comments received, it is hereby found that this rule, is consistent with and will effectuate the purposes of the 1996 Act.
Administrative practice and procedure, Advertising, Consumer information, Marketing agreements, Promotion, Reporting and recordkeeping requirements, Softwood lumber.
The authority citation for 7 CFR part 1217 continues to read as follows:
7 U.S.C. 7411-7425; 7 U.S.C. 7401.
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for Boeing Model 777-300ER airplanes with high-wall suites installed in the passenger cabin. This installation is novel or unusual, and the applicable airworthiness regulations do not contain adequate or appropriate safety standards for this interior configuration. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
This action is effective on Boeing on October 26, 2017. Send your comments by December 11, 2017.
Send comments identified by docket number FAA-2017-0862 using any of the following methods:
John Shelden, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-2785; facsimile 425-227-1232; email
The substance of these special conditions has been subject to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the airplane, the FAA has determined that prior public notice and comment are unnecessary and impracticable.
In addition, since the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received, the FAA finds it unnecessary to delay the effective date and finds that good cause exists for adopting these special conditions upon publication in the
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On December 19, 2014, Boeing applied for a type certificate design change to Type Certificate (TC) No. T00001SE to install high-wall suites in the passenger compartment of Boeing Model 777-300ER airplanes.
The Model 777 series airplane is a swept-wing, conventional-tail, twin-engine, turbofan- powered, transport-category airplane. The airplane has seating for 365 passengers and a maximum takeoff weight of 775,000 pounds.
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Boeing must show that the Model 777-300ER airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. T00001SE or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 777-300ER airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of
The Boeing Model 777-300ER airplane will incorporate the following novel or unusual design features:
A passenger cabin with six high-wall suites arranged in two rows of three suites each.
The Boeing Model 777-300ER airplane will include, as a customer option, a passenger cabin with six high-wall suites arranged in two rows of three suites each, in a 1-1-1 configuration. The suites have doors and walls that are taller than has been previously certified by the FAA on Boeing 777 series airplanes. The walls extend from the floor to the ceiling or close to the ceiling.
The characteristics of the suite design are unique such that the suites are not fully open to the cabin, as are conventional mini-suites with partial-height surrounds, and they are not remote from the main cabin, as are overhead crew rests. Likewise, unique but suitable fire-protection requirements for smoke detection and firefighting are needed for this configuration. Furthermore, the proposed suite design necessitates the development of additional conditions that do not currently exist within associated airworthiness standards, including, but not limited to, alerting and lighting when oxygen masks are needed, crew procedures for managing hazards and suite occupants, and maintaining cabin-egress route dimensions after deformations of the walls and seats.
These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to the Boeing Model 777-300ER airplane with high-wall, single-occupant suites with doors installed. Should Boeing apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on one model series of airplane. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Model 777-300ER airplanes.
Note: In these special conditions, “suite” means high-wall suite.
1. Where suites are installed, a supplemental oxygen system must provide the following:
a. The supplemental oxygen system for each suite must include a minimum of two oxygen masks and meet the same 14 CFR part 25 regulations as do the supplemental oxygen system for the main passenger-cabin occupants.
b. An aural alert to warn occupants and to indicate the need to don oxygen masks in the event of decompression. The aural alert must activate concurrently with deployment of the oxygen masks in the main passenger cabin.
c. The illumination level of the normal suite lighting system must be activated automatically and must be sufficient for each occupant to locate a deployed oxygen mask.
d. If a chemical oxygen generator is used as the oxygen supply source, the suite oxygen installation must meet §§ 25.795(d) and 25.1450.
2. A smoke-detection or fire-detection system (or systems) must be provided that monitors each occupiable space within the suite. Flight tests must be conducted to show compliance with this requirement. If a fire occurs, each system (or systems) in the affected suite must provide:
a. A visual indication to the flight deck within one minute after the start of a fire.
b. An aural warning in the suite area where detection has occurred.
c. A warning in the main passenger cabin. This warning must be readily detectable by a flight attendant, taking into consideration the locations of flight attendants throughout the main passenger compartment during various phases of flight.
3. Passenger-management procedures must be provided should occupants need to be moved in the event of smoke detection, or firefighting within the suite or where suites are installed:
a. A limitation must be included in the airplane flight manual (AFM) or other suitable means requiring that crewmembers be trained in the suite passenger-management procedures.
b. Approved procedures describing methods for suite passenger management must be established. These procedures must be transmitted to the operator for incorporation into its training programs and appropriate operational manuals.
4. The design of each suite, and the location of the firefighting equipment where suites are installed, must allow the crewmembers to conduct effective firefighting in the suite. For a manual, hand-held extinguishing system (designed as the sole means to fight a fire) for the suite:
a. A limitation must be included in the AFM or other suitable means requiring that crewmembers be trained in the firefighting procedures.
b. Each suite design must allow crewmembers equipped for firefighting to have unrestricted access to all parts of the suite compartment.
c. The time for a crewmember in the main passenger cabin to react to the fire alarm and gain access to the suite must not exceed the time it would take for the compartment to become filled with smoke, thus making it difficult to locate the fire source(s).
d. Approved procedures describing methods for searching the suite compartment for fire source(s) must be established. These procedures must be transmitted to the operator for incorporation into its training programs and appropriate operational manuals.
5. A means must be provided to prevent hazardous quantities of smoke or extinguishing agent originating in each suite from entering any other occupiable compartments.
a. Small quantities of smoke may penetrate from the suite into other occupied areas during the one-minute smoke detection time.
b. Hazardous quantities of smoke may not enter any occupied compartment during access to manually fight a fire in the suite. A small amount of smoke may enter the occupied compartments while a firefighter enters and exits the suite, and is not considered hazardous provided the smoke dissipates quickly.
c. Flight tests must be conducted to show compliance with this requirement.
6. If waste-disposal receptacles are fitted in the suite, the suite must be equipped with an automatic fire-extinguishing system that meets the performance requirements of § 25.854(b).
7. Each stowage compartment in the suite must be completely enclosed. All enclosed stowage compartments within the suite compartment that are not
8. Where suites are installed, the design of each suite must:
a. Maintain minimum main aisle(s), cross aisle(s), and passageway(s) requirements of § 25.815 when subjected to the ultimate inertia forces listed in § 25.561(d).
b. Prevent structural failure or deformation of components that could block access to the available evacuation routes (
9. In addition to the requirements of § 25.562 for seat systems, which are occupiable during taxi, takeoff, and landing, the suite structure must be designed for the additional loads imposed by the seats as a result of the conditions specified in § 25.562(b).
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 737-200, -200C, -300, -400, and -500 series airplanes. This AD was prompted by reports of skin doublers that disbonded from their skin panels. This AD requires repetitive inspections of fuselage skin panels, and applicable on-condition actions. We are issuing this AD to address the unsafe condition on these products.
This AD is effective November 30, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of November 30, 2017.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110 SK57, Seal Beach, CA 90740 5600; telephone 562-797-1717; Internet
You may examine the AD docket on the Internet at
Jennifer Tsakoumakis, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5264; fax: 562-627-5210; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 737-200, -200C, -300, -400, and -500 series airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.
Aviation Partners Boeing stated that accomplishing Supplemental Type Certificate (STC) ST01219SE does not affect the ability to accomplish the actions specified in the NPRM.
We concur with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) and added paragraph (c)(2) to this AD to state that installation of STC ST01219SE does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01219SE is installed, a “change in product” alternative methods of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.
Boeing requested that the “Explanation of Certain Compliance Times” section in the preamble of the NPRM be revised to clarify that only disbonded skin panels need to be replaced. Boeing noted that, if a panel is disbonded, it is considered a suspect panel that went through improper processing during the phosphoric acid anodization phase of manufacturing. Boeing stated that the suspect panel could develop an additional disbond, which could lead to further damage, and then the inspections described in the service information might not be adequate.
We acknowledge the commenter's request to clarify that only disbonded skin panels need to be replaced, for the reasons provided by the commenter. We agree with the rationale for the request. However, the “Explanation of Certain Compliance Times” section only appears in the preamble of the NPRM and is not carried over into this final rule; therefore, no change to this final rule is necessary regarding this issue.
Qantas requested that we include previously accomplished repairs as terminating actions in paragraph (i) of the proposed AD. Qantas requested that paragraph (i) of the proposed AD be revised to include a provision for previously installed repairs (solid skin panel replacements) that were approved by an authorized representative of the Boeing Commercial Airplanes Organization Designation Authorization (ODA) via FAA Form 8110-3, “Statement of Compliance with the Federal Aviation Regulations.” Qantas stated that Boeing ODA-approved repairs completed prior to issuance of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, were not addressed in the NPRM. Qantas also suggested that solid skin panel replacements approved via FAA Form 8100-9, “Statement of Compliance with Airworthiness Standards,” be included as terminating action. Qantas stated that including skin panel replacements approved via FAA Form 8100-9 as terminating action could help avoid operators' requests for AMOCs. In addition, Qantas recommended that the language used for approved repairs by an authorized representative of the Boeing ODA be revised, as it is not specific to FAA Form 8110-3 or FAA Form 8100-9.
We agree with the commenter's request. Paragraph (i)(1) of this AD (paragraph (i) of the proposed AD) addresses previously installed repairs approved by an authorized representative of the Boeing ODA. Existing Boeing ODA-approved repairs or preventative modifications are included in notes in Part 1, Part 2, and Part 8 of the Accomplishment Instruction and in note (a) to tables 1 through 8 in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016. Note (a) states, “If any Boeing ODA approved preventative modification or repair was previously installed via FAA Form 8100-9 or [structural repair manual] SRM repair doubler (except disbond repair), initial and repeat inspections are not required at the repaired location only.”
However, repairs that were not approved by the Boeing ODA and replacements not done using Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, were not addressed in the proposed AD. Therefore, we have redesignated paragraph (i) (in the proposed AD) as paragraph (i)(1) and added paragraph (i)(2) to this AD to state that any skin panel replacement done before the effective date of this AD terminates the inspections required by paragraph (g) of this AD for that skin panel only, provided the replacement was done using a skin panel manufactured on or after April 1, 1997, and the replacement was done using an FAA-approved method. A replacement accomplished using an FAA-approved method would still address the unsafe condition and the need for the inspections required by paragraph (g) of this AD would be terminated.
We have also added paragraph (i)(3) to this AD to state that any FAA-approved reinforced repair doubler (except disbond repair) installed before the effective date of this AD terminates the inspections required by paragraph (g) of this AD at the repaired location only.
Southwest Airlines (SWA) requested that we allow the terminating action specified in paragraph (i) of the proposed AD to terminate the initial inspections in paragraph (g) of the proposed AD and not only the repetitive inspections in paragraph (g) of the proposed AD. Specifically, SWA requested that paragraph (i) of the proposed AD be revised to include the provision that replacement of any skin panel in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, except as specified in paragraph (h)(2) of the proposed AD, terminates the requirement for the initial inspection specified in paragraph (g) of the proposed AD, for the replaced skin panel only. SWA noted that an operator could replace a skin panel prior to doing
We agree with the commenters' requests. We have clarified paragraph (i)(1) of this AD (paragraph (i) of the proposed AD) to state that accomplishment of any skin panel replacement using a skin panel manufactured on or after April 1, 1997, terminates the inspections required by paragraph (g) of this AD for that skin panel only, provided the replacement is done as specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, except as required by paragraph (h)(2) of this AD.
SWA requested that paragraph (j) of the proposed AD be revised to include a provision that replacement of skin panels, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, except as required by paragraph (h)(2) of the proposed AD, terminates all of the requirements of AD 2003-14-06, Amendment 39-13225 (68 FR 40759, July 9, 2003; corrected July 21, 2003 (68 FR 42596) (“AD 2003-14-06”)). SWA noted that an operator could replace a skin panel prior to doing the initial inspection specified in paragraph (g) of the proposed AD; therefore, the operator would not be required to do the initial or repetitive inspections specified in paragraph (g) of the proposed AD, and all of the requirements of AD 2003-14-06 would be terminated.
We agree with the commenter's request. We redesignated paragraph (j) in the proposed AD as paragraph (j)(1) and added paragraph (j)(2) to this AD to include a statement that replacement of any skin panel with a skin panel manufactured on or after April 1, 1997, as specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, except as required by paragraph (h)(2) of this AD, terminates all of the requirements of AD 2003-14-06 for that skin panel only.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.
We reviewed Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016. The service information describes procedures for repetitive inspections of fuselage skin panels for cracking, corrosion, and existing disbond repairs; and applicable on-condition actions. 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 169 airplanes of U.S. registry. We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary on-condition actions that will be required based on the results of the inspections. We have no way of determining the number of aircraft that might need these on-condition actions:
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
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 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 November 30, 2017.
This AD affects AD 2003-14-06, Amendment 39-13225 (68 FR 40759, July 9, 2003; corrected July 21, 2003 (68 FR 42956)) (“AD 2003-14-06”).
(1) This AD applies to The Boeing Company Model 737-200, -200C, -300, -400, and -500 series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016.
(2) Installation of Supplemental Type Certificate (STC) ST01219SE (
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by reports of skin doublers that disbonded from their skin panels. We are issuing this AD to detect and correct disbonded skin panels, which could result in fuselage skin cracking, rapid decompression, and loss of structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as required by paragraph (h) of this AD: Do all applicable actions identified as required for compliance (“RC”) in, and in accordance with, the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016. Do the actions at the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016.
(1) Where Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, uses the phrase “after the original issue of this service bulletin,” for purposes of determining compliance with the requirements of this AD, the phrase “after the effective date of this AD” must be used.
(2) Where Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, specifies contacting Boeing for instructions, and specifies that action as “RC” (Required for Compliance): This AD requires using a method approved in accordance with the procedures specified in paragraph (k) of this AD.
(3) For replaced skin panels identified in table 9 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, on which the one-time internal inspection specified in Boeing Service Bulletin 737-53-1179, Revision 2, dated October 25, 2001, has not been done: The compliance time for accomplishment of the actions specified in Part 8 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, is at the latest of the times specified in paragraphs (h)(3)(i), (h)(3)(ii), and (h)(3)(iii) of this AD.
(i) Within 50,000 flight cycles after the skin panel replacement.
(ii) Within 20,000 flight cycles after July 14, 2003 (the effective date of AD 2003-14-16).
(iii) Within 4,500 flight cycles after the effective date of this AD.
(1) Accomplishment of any skin panel replacement using a skin panel manufactured on or after April 1, 1997, terminates the inspections required by paragraph (g) of this AD for that skin panel only, provided the replacement is done as specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, except as required by paragraph (h)(2) of this AD.
(2) Accomplishment of any skin panel replacement done before the effective date of this AD terminates the inspections required by paragraph (g) of this AD for that skin panel only, provided the conditions specified in paragraphs (i)(2)(i) and (i)(2)(ii) of this AD are met.
(i) The replacement was done using a skin panel manufactured on or after April 1, 1997.
(ii) The replacement was done using an FAA-approved method.
(3) Installation of an FAA-approved reinforced repair doubler (except disbond repair) before the effective date of this AD terminates the inspections required by paragraph (g) of this AD at the repaired location only.
(1) Accomplishment of the initial inspections required by paragraph (g) of this AD terminates all requirements of AD 2003-14-06.
(2) Accomplishment of any skin panel replacement with a skin panel manufactured on or after April 1, 1997, as specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016, except as required by paragraph (h)(2) of this AD, terminates all requirements of AD 2003-14-06 for that skin panel only.
(1) The Manager, Los Angeles 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 (l) 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.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO Branch, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) Except as required by paragraph (h)(2) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (k)(4)(i) and (k)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
For more information about this AD, contact Jennifer Tsakoumakis, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5264; fax: 562-627-5210; 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 the AD specifies otherwise.
(i) Boeing Alert Service Bulletin 737-53A1349, dated August 23, 2016.
(ii) Reserved.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
(4) You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(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), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes. This AD was prompted by reports of fuel leaks in the engine and auxiliary power unit (APU) electrical fuel pump (EFP) cartridge/canister electrical connectors and conduits. This AD requires repetitive inspections for fuel leakage at the engine and APU fuel pumps, and related investigative and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products.
This AD is effective November 30, 2017.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of November 30, 2017.
For service information identified in this final rule, 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
Steven Dzierzynski, Aerospace Engineer, Avionics and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7367; fax 516-794-5531.
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 CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes. The NPRM published in the
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2016-32R1, dated October 12, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes. The MCAI states:
Fuel leaks have been reported in the engine and auxiliary power unit (APU) electrical fuel pump (EFP) cartridge/canister electrical connectors and conduits on production aeroplanes. Initially, Bombardier had determined that the subject discrepancy was limited to the new pump canister installations on 24 production aeroplanes. Bombardier also reported the possibility of cut insulation on the electric harness wires of the newly installed canister housing assemblies.
Emergency [Canadian] AD CF-2014-17 [which corresponds to FAA AD 2014-15-17, Amendment 39-17919 (79 FR 44268, July 31, 2014)] was issued to limit landing light operation on-ground in order to address a potential fire hazard as result of a possible fuel leak from the APU, EFP electrical conduit in the landing light compartment. In addition, [Canadian] AD CF-2014-21 [which corresponds to FAA AD 2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014), superseded by FAA AD 2016-10-10, Amendment 39-18521 (81 FR 31497, May 19, 2016) (“AD 2016-10-10”)] was issued to mandate removal of then identified 24 discrepant EFP canister assemblies from service.
Bombardier has recently determined that the subject fuel leaks may not be limited to the 24 units affected by [Canadian] AD CF-2014-21 [(AD 2016-10-10)], but may potentially affect other in-service [Bombardier Model] CL-600-2B16 aeroplanes. Until such time that a final fix for the fuel leak problem is realized, Bombardier as an interim mitigating action, has issued [Service Bulletin] SB 604-28-022 and SB 605-28-010 that introduces [a] repeat [general visual] inspection and if required, rectification [related investigative and corrective actions] of subject fuel leaks on affected aeroplanes. [Canadian] AD CF-2016-32 was issued on 29 September 2016 to mandate compliance with applicable Bombardier SBs, to mitigate any potential safety hazard resulting from fuel leaks.
Revision 1 of this [Canadian] AD is being issued to correct a typographic error in paragraph B.1. of the [Canadian AD] Corrective Actions.
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM and the FAA's response.
Request To Delay Issuance Until the Release of New Service Information
Bombardier, Inc., indicated its intent to revise Bombardier Service Bulletin 604-28-022, dated October 19, 2015; and Bombardier Service Bulletin 605-28-010, dated October 19, 2015. Bombardier, Inc., stated that these revisions will change the inspection instructions. Bombardier, Inc., further added that it plans to publish new service information to introduce similar inspections on Model CL-650 airplanes.
We infer that Bombardier, Inc., is requesting that we delay the issuance of this final rule until after the revised service information is released and then refer to the revised service information. We disagree with the commenter's request. We do not consider that delaying this action until release of the planned service information is warranted since the service information incorporated by reference in this AD adequately addresses the unsafe condition. We might consider additional rulemaking once the revised service information is released, or if new service information is issued for Model CL-650 airplanes, which are not included in the applicability of this AD. We have not changed this AD in this regard.
We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD 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 correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
Bombardier, Inc., has issued Service Bulletin 604-28-022, dated October 19, 2015; and Service Bulletin 605-28-010, dated October 19, 2015. This service information describes procedures for repetitive general visual inspections for fuel leakage at the engine and APU fuel pumps, and related investigative and corrective actions if necessary. These documents are distinct since they apply to airplanes in different 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 121 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
For Model CL-600-2B16 airplanes having serial numbers 5701 through 5955 inclusive, 5957, 5960 through 5966 inclusive, 5968 through 5971 inclusive, and 5981, we estimate the following costs to do any necessary replacements that would be required based on the results of the required inspection. We have no way of determining the number of aircraft that might need these replacements:
For Model CL-600-2B16 airplanes having serial numbers 5301 through 5665 inclusive, we have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
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 to the Director of the System Oversight Division.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify 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 November 30, 2017.
None.
This AD applies to Bombardier, Inc., Model CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes, certificated in any category, having serial numbers 5301 through 5665 inclusive, 5701 through 5955 inclusive, 5957, 5960 through 5966 inclusive, 5968 through 5971 inclusive, and 5981.
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by reports of fuel leaks in the engine and auxiliary power unit (APU) electrical fuel pump (EFP) cartridge/canister electrical connectors and conduits. We are issuing this AD to detect and correct fuel leaks in certain fuel pumps to remove a potential fuel ignition hazard.
Comply with this AD within the compliance times specified, unless already done.
For Model CL-600-2B16 airplanes having serial numbers 5301 through 5665 inclusive: Within 600 flight hours or 12 months, whichever occurs first, after the effective date of this AD, do the inspections specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 604-28-022, dated October 19, 2015; except where Bombardier Service Bulletin 604-28-022, dated October 19, 2015, specifies to contact the manufacturer, before further flight accomplish corrective actions in accordance with the procedures specified in paragraph (i)(2) of this AD. Do all applicable corrective actions before further flight. Repeat the inspections at intervals not to exceed 600 flight hours or 12 months, whichever occurs first.
(1) Do a general visual inspection for traces of fuel coming from the right-hand engine boost pump at the location of the belly fairing screw (FS412, BL 0.0).
(2) Do a general visual inspection for traces of fuel coming from the left-hand engine boost pump at the location of the belly fairing screw (FS412, BL 0.0).
(3) Do a general visual inspection for traces of fuel coming from the EFP electrical wiring conduit outlet at the lower body fairing area for engine EFPs and at the right-hand landing light compartment for the APU EFP.
For Model CL-600-2B16 airplanes having serial numbers 5701 through 5955 inclusive, 5957, 5960 through 5966 inclusive, 5968 through 5971 inclusive, and 5981: Within 600 flight hours or 12 months, whichever occurs first, after the effective date of this AD, do the inspections specified in paragraphs (h)(1), (h)(2), and (h)(3) of this AD, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions in Bombardier Service Bulletin 605-28-010, dated October 19, 2015; except where Bombardier Service Bulletin 605-28-010, dated October 19, 2015, specifies to contact the manufacturer, before further flight accomplish corrective actions in accordance with the procedures specified in paragraph (i)(2) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspections at intervals not to exceed 600 flight hours or 12 months, whichever occurs first.
(1) Do a general visual inspection for traces of fuel coming from the right-hand engine boost pump at the location of the belly fairing screw (FS412, BL 0.0).
(2) Do a general visual inspection for traces of fuel coming from the left-hand engine boost pump at the location of the belly fairing screw (FS412, BL 0.0).
(3) Do a general visual inspection of the right-hand landing light compartment for traces of fuel coming from the APU EFP.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian AD CF-2016-32R1, dated October 12, 2016, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Steven Dzierzynski, Aerospace Engineer, Avionics and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7367; fax 516-794-5531.
(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (k)(3) and (k)(4) of this AD.
(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 604-28-022, dated October 19, 2015.
(ii) Bombardier Service Bulletin 605-28-010, dated October 19, 2015.
(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
(4) You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(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 Energy Regulatory Commission, Department of Energy.
Policy statement.
The Federal Energy Regulatory Commission (Commission) is giving notice of a new policy on establishing license terms for hydroelectric projects. In this Policy Statement, the Commission adopts a 40-year default license term for original and new licenses for hydropower projects located at non-federal dams. The Policy Statement also sets forth when the Commission will consider issuing those projects a license with a term for less or more than 40 years.
This policy statement will be applicable as of October 26, 2017.
1. In this Policy Statement, the Commission sets forth a new policy on establishing license terms for original and new licenses for hydropower projects located at non-federal dams. The goal of this action is to provide more certainty for stakeholders regarding the Commission's regulatory process, reduce regulatory burden, increase administrative efficiency for all stakeholders, and further encourage licensees to negotiate settlement agreements and promptly seek authorization to implement voluntary environmental, recreational, and developmental enhancements.
2. Section 6 of the Federal Power Act (FPA)
3. It is current Commission policy to set a 50-year term for licenses issued for projects located at federal dams.
4. Determining whether the measures required under a license are minimal, moderate, or extensive is highly case-
5. The length of an original license has not been contested on rehearing for some time; however, licensees and other parties have recently contested the length of a new license in several relicensing proceedings. The arguments raised in these cases include that the Commission, when establishing the license term, should have considered, or given more weight to: Previously-authorized capacity-related investments or environmental enhancements made by the licensee before issuance of the new license;
6. On November 17, 2016, the Commission issued a notice of inquiry (NOI) to seek comments on whether, and if so how, the Commission should revise its current license term policy. The NOI invited comments on five potential license term policy options: (1) Retain the current policy; (2) modify the current policy to consider voluntary authorized actions implemented under the prior license (“previously-authorized voluntary actions”); (3) replace the current license term policy with a policy for a 50-year default license term unless a lesser license term would be in the public interest (for example, to better coordinate the license terms of projects in the same river basin); (4) add a more quantitative cost-based analysis to the current policy; and (5) alter the current policy to accept license terms agreed upon in settlement agreements, when appropriate. Comments on alternative policy options were also encouraged. The NOI established January 24, 2017, as the deadline for comments, which staff extended to March 24, 2017.
7. Industry members, federal and state resource agencies, environmental and recreation groups, and individuals filed comments. Most commenters support revising the current policy. Several commenters state that under the current policy stakeholders lack certainty, and, consequently, license applicants lack guidance on what measures will yield longer license terms and are deterred from proposing additional protection, mitigation, and enhancement measures. Further, many commenters state that because the policy is forward-looking, licensees delay seeking authorizations for capacity upgrades and environmental and recreational enhancements until they apply for a new license. Some industry commenters state that under the current policy, license applicants and settlement parties cannot use the license term as a bargaining chip because the Commission might reject that term in the license order. To address these concerns, many commenters recommend that the Commission consider previously-authorized voluntary actions and defer to the license term that was negotiated as part of a settlement agreement.
8. Commenters disagree on the 50-year default license term policy option. Industry commenters generally support the 50-year default license term because they state it would provide a clear, predictable standard. Industry commenters add that such policy would eliminate the current “penalty” for efficient, well-maintained, and relatively low-impact projects that do not require substantial environmental or developmental measures and therefore only receive a 30-year license.
9. In contrast, environmental groups, individuals, and most resource agencies oppose the 50-year default license term option. Several resource agencies argue that this option would provide little incentive for a license applicant to voluntarily propose or agree to mitigation measures because such measures would no longer factor into the Commission's license term decision. The resource agencies also contend that such policy would result in applicants focusing their license application study efforts on disproving project effects rather than on identifying potential mitigation measures.
10. Most commenters recommend against the policy option to adopt a more quantitative cost-based analysis. Many commenters state that it would be difficult to develop a quantitative cost-based analysis that takes into account the diverse hydropower fleet and environmental and recreational values.
11. As an alternative to the five policy options, several industry commenters recommend that the Commission adopt a 40-year default license term with credit (up to an additional 10 years) for previously-authorized actions and deference to settlement agreements. They state that under this alternative, licenses should be issued for less than 40 years only when a license applicant has agreed to a settlement agreement with a negotiated license term of less than 40 years, or voluntarily coordinates its license term with other projects in a river basin.
12. The extensive comments received have given the Commission a deeper understanding of the effects that the current license term policy has on stakeholders in hydropower licensing proceedings. The Commission recognizes the importance of providing license applicants and other stakeholders as much certainty as possible. License applicants expend significant financial resources on preparing their license applications and complying with their licenses thereafter.
13. The current policy also affects the Commission's staff and resources needed to review and process license applications. Staff anticipate that over 300 projects will enter the relicensing process through 2025. Under the current policy, staff would establish the license term for each of those projects case by case.
14. After considering this matter and the comments on the NOI, the Commission has decided it is in the public interest to change its license term policy. With this Policy Statement, the Commission establishes a 40-year default license term policy for original and new licenses for hydropower projects located at non-federal dams.
15. There are three circumstances where the Commission will consider issuing a license for less or more than 40 years. First, the Commission will establish a shorter or longer term if necessary to coordinate license terms for projects located in the same river basin. Second, the Commission will defer to a shorter or longer term explicitly agreed upon in a generally-supported comprehensive settlement agreement, provided that such term does not conflict with coordination. Settlement agreements that state the settlement signatories would not oppose a certain term or would support a term within a range of years will not be considered to include an explicitly agreed upon license term.
16. Third, the Commission will consider a longer license term—provided that doing so is consistent with coordinating license terms within a basin—when a license applicant specifically requests a longer license term based on significant measures expected to be required under the new license or significant measures implemented during the prior license term that were not required by that license or other legal authority
17. There are a number of reasons for establishing a 40-year default license term with exceptions for coordination, deference to generally-supported comprehensive settlement agreements, and consideration of previously-authorized voluntary actions. This policy will provide significant certainty to licensees, resource agencies, and other stakeholders. A 40-year default license term will provide a simpler method for Commission staff to establish license terms, and, thus, increase administrative efficiencies. A case-specific assessment will only be required for those license applications that request a longer license term, and are not explicitly supported by a generally-supported comprehensive settlement agreement. Because many projects would be relicensed less frequently, the policy would also lower administrative costs for all stakeholders, provide licensees longer license terms to recoup costs, and reduce regulatory burden. Further, the policy will place efficient, low-impact projects that require minimal measures—and thus, would receive a 30-year term under the current policy—on more equal footing with projects that require more measures.
18. The policy may also encourage licensees to voluntarily make capacity upgrades and enhance recreational and environmental resources during the prior license term. Affected resources will benefit from licensees undertaking preventative or remedial measures sooner rather than later. In addition, the policy may further encourage license applicants to engage with stakeholders to negotiate a license settlement agreement. Because a generally-supported comprehensive settlement agreements represent stakeholder values, terms negotiated as part of those agreements are in the public interest, provided they do not conflict with coordination.
19. A 40-year default license term will not adversely affect environmental and recreation resources. All of our licenses contain extensive environmental and recreation measures. While under our new policy some projects may be relicensed less frequently and unanticipated project effects on environmental resources may go unmitigated for longer durations of time than before, there are many tools available to address these unanticipated effects in a timely manner. The Commission may address serious, unanticipated environmental effects using its standard reopener article,
20. This Policy Statement will apply to all licenses issued following its publication in the
21. In addition to publishing the full text of this document in the
22. From FERC's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field. User assistance is available for eLibrary and the Commission's Web site during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
By the Commission.
Drug Enforcement Administration, Department of Justice.
Temporary amendment; temporary scheduling order.
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioids,
This temporary scheduling order is effective October 26, 2017, until October 28, 2019. If this order is extended or made permanent, the DEA will publish a document in the
Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into Schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling
Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance into Schedule I of the CSA.
To find that placing a substance temporarily into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
A substance meeting the statutory requirements for temporary scheduling may only be placed into Schedule I. 21 U.S.C. 811(h)(1). Substances in Schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1).
Available data and information for
The recreational abuse of fentanyl-like substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes.
On October 1, 2014, the DEA implemented STARLiMS (a web-based, commercial laboratory information management system) to replace the System to Retrieve Information from Drug Evidence (STRIDE) as its laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and STARLiMS were queried on June 19, 2017. STARLiMS registered four reports containing
The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by other federal, state, and local forensic laboratories across the country. Data from NFLIS was queried on June 20, 2017. NFLIS registered three reports containing
Evidence suggests that the pattern of abuse of fentanyl analogues, including
Reports collected by the DEA demonstrate
The population likely to abuse
Based on information received by the DEA, the misuse and abuse of
In accordance with 21 U.S.C. 811(h)(3), based on the available data and information, summarized above, the continued uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of
In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule
Because the Administrator hereby finds it necessary to temporarily place these synthetic opioids into Schedule I to avoid an imminent hazard to the public safety, this temporary order scheduling
The CSA sets forth specific criteria for scheduling a drug or other substance. Permanent scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The permanent scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the permanent scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6).
Upon the effective date of this temporary order,
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Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in Schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the
Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of the Administrative Procedure Act (APA) at 5 U.S.C. 553, do not apply to this temporary scheduling action. In the alternative, even assuming that this action might be subject to 5 U.S.C. 553, the Administrator finds that there is good cause to forgo the notice and comment requirements of 5 U.S.C. 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.
Further, the DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget.
This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient
As noted above, this action is an order, not a rule. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, if this were a rule, pursuant to the Congressional Review Act, “any rule for which an agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the federal agency promulgating the rule determines.” 5 U.S.C. 808(2). It is in the public interest to schedule these substances immediately to avoid an imminent hazard to the public safety. This temporary scheduling action is taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) exempts the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to move quickly to place these substances into Schedule I because it poses an imminent hazard to the public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order shall take effect immediately upon its publication. The DEA has submitted a copy of this temporary order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 because, as noted above, this action is an order, not a rule.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, the DEA amends 21 CFR part 1308 as follows:
21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.
(h) * * *
Internal Revenue Service (IRS), Treasury.
Final regulations and temporary regulations; Correcting amendments.
This document contains corrections to final and temporary regulations (TD TD 9815), which were published in the
D. Peter Merkel or Karen Walny at 202-317-6938 (not a toll-free number).
The final and temporary regulations that are the subject of these corrections are §§ 1.871-15, 1.871-15T, 1.1441-1, 1.1441-2, 1.1441-7, and 1.1461-1, promulgated under sections 871(m) and 7805 of the Internal Revenue Code. These regulations affect foreign persons that hold certain financial products providing for payments that are contingent upon or determined by reference to U.S. source dividends, as well withholding agents with respect to dividend equivalents and certain other parties to section 871(m) transactions and their agents.
As published, TD 9815 contains errors that may prove to be misleading and are in need of clarification.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:
26 U.S.C. 7805 * * *
(f) * * *
(1) * * * Paragraph (e)(7) of this section applies on or after January 19, 2017.
(c) * * *
(2) * * *
(iii)
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Snake Creek Bridge across Snake Creek, at Islamorada, FL. The deviation is necessary to alleviate the increased traffic congestion on US 1 Highway resulting from relief efforts after the passing of Hurricane Irma. This deviation allows the bridge to open once every two hours verses the current operating regulation. Local officials are requesting this action to assist in reducing the long line of traffic backups caused by the bridge openings.
This deviation is effective without actual notice from October 26, 2017, through 7 a.m. on November 1, 2017. For the purposes of enforcement, actual notice will be used from 7 a.m. on September 29, 2017, until October 26, 2017.
The docket for this deviation, USCG-2017-0936 is available at
If you have questions on this temporary deviation, call or email LT Scott Ledee, Chief Waterways Management Division, U.S. Coast Guard Sector Key West, Coast Guard; telephone (305) 292-8768, email;
The Village of Islamorada Florida with concurrence of Florida Department of Transportation, the bridge owner, has requested a temporary change in the operating regulation for the Snake Creek Bridge on US Highway 1 crossing Snake Creek in Islamorada, Florida. The bridge has a vertical clearance of 27 feet in the closed position. With the passing of Hurricane Irma, the lower Keys have been devastated. With this increased time between openings, this deviation will allow a more uninterrupted flow of vehicle traffic carrying restorative supplies into the lower Keys without severely hindering vessel traffic. The Snake Creek Drawbridge currently operates under 33 CFR 117.331.
The deviation period is from 7 a.m. on September 29, 2017 to 7 a.m. on November 1, 2017. During this period, the bridge will open on signal, except that from 7 a.m. to 7 p.m. the draw need only open every two hours, on the hour.
Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation; modification.
The Coast Guard has modified a temporary deviation from the operating schedule that governs the NASA Railroad Bridge (Jay Jay Bridge) across the Atlantic Intracoastal Waterway (Indian River), mile 876.6, Titusville, Florida. This modified deviation is necessary to allow the bridge owner, National Aeronautics and Space Administration (NASA) to continue repairs to the bridge. Due to delays and damage caused by Hurricane Irma, additional repairs will be required causing the bridge to remain closed to navigation periodically throughout the day. This deviation is deemed necessary for the continued safe operation of the bridge.
This modified deviation is effective without actual notice from October 26, 2017 through 4 p.m. on October 31, 2017. For the purposes of enforcement, actual notice will be used from 8 a.m. on September 27, 2017 until October 26, 2017.
The docket for this deviation, USCG-2017-0778 is available at
If you have questions on this modified temporary deviation, call or email LT Allan Storm, U.S. Coast Guard Sector Jacksonville, Waterways Management Division; telephone 904-714-7616, email
On August 22, 2017, the Coast Guard published a temporary deviation entitled, “Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Indian River, Titusville, FL” in the
The deviation period is from 8 a.m. on September 27, 2017 to 4 p.m. on October 31, 2017. During this period, the bridge is allowed to remain closed to navigation from 8 a.m. to noon and from 1 p.m. to 4 p.m., Monday through Friday.
Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to notify the public that it has received a negative declaration for sewage sludge incineration (SSI) units within the City of Philadelphia. This negative declaration certifies that SSI units subject to the requirements of sections 111(d) and 129 of the Clean Air Act (CAA) do not exist within the jurisdictional boundaries of the Philadelphia Air Management Service (AMS). EPA is accepting the negative declaration in accordance with the requirements of the CAA.
This rule is effective on December 26, 2017 without further notice, unless EPA receives adverse written comment by November 27, 2017. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID Number EPA-R03-OAR-2017-0509 at
Mike Gordon, (215) 814-2039, or by email at
Sections 111(d) and 129 of the CAA require states to submit plans to control certain pollutants (designated pollutants) at existing solid waste combustor facilities (designated facilities) whenever standards of performance have been established under section 111(b) for new sources of the same type, and EPA has established emission guidelines (EG) for such existing sources. A designated pollutant is any pollutant for which no air quality criteria have been issued, and which is not included on a list published under section 108(a) or section 112(b)(1)(A) of the CAA, but emissions of which are subject to a standard of performance for new stationary sources. On March 21, 2011 (76 FR 15372), EPA promulgated SSI unit new source performance standards, 40 CFR part 60, subpart LLLL, and emission guidelines, subpart MMMM. The designated facilities to which the EG apply are existing SSI units that: (1) Commenced construction on or before October 14, 2010; (2) that meet the definition of a SSI unit as defined in § 60.5250; and (3) are not exempt under § 60.5065.
Subpart B of 40 CFR part 60 establishes procedures to be followed and requirements to be met in the development and submission of state plans for controlling designated pollutants. Also, 40 CFR part 62 provides the procedural framework for the submission of these plans. When designated facilities are located in a state, the state must then develop and submit a plan for the control of the designated pollutant. However, 40 CFR 60.23(b) and 62.06 provide that if there are no existing sources of the designated pollutant in the state, the state may submit a letter of certification to that effect (
Philadelphia AMS has determined that there are no SSI units subject to the requirements of Sections CAA 111(d) and 129 of the CAA in their respective air pollution control jurisdiction. Accordingly, Philadelphia AMS submitted a negative declaration letter to EPA certifying this fact on March 28, 2012. The negative declaration letter and EPA's technical support document for this action are available in the docket for this the docket for this rulemaking and available online at
In this direct final action, EPA is amending part 62 to reflect receipt of the negative declaration letter from Philadelphia AMS. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely notifies the public of EPA receipt of a negative declaration from an air pollution control agency without any existing SSI units in their jurisdiction. This action imposes no requirements. Accordingly, EPA certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
With regard to negative declarations for designated facilities received by EPA from states, EPA's role is to notify the public of the receipt of such negative declarations and revise 40 CFR part 62 accordingly. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to approve or disapprove a CAA section 111(d)/129 plan negative declaration submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a CAA section 111(d)/129 negative declaration, to use VCS in place of a section 111(d)/129 negative declaration that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 26, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's
This action approving a negative declaration submitted by Philadelphia AMS for SSI units may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements, Waste treatment and disposal.
40 CFR part 62 is amended as follows:
42 U.S.C. 7401
Letter from the City of Philadelphia, Department of Public Health, submitted March 28, 2012, certifying that there are no existing sewage sludge incineration units within the City of Philadelphia, Pennsylvania that are subject to 40 CFR part 60, subpart Ce.
Environmental Protection Agency (EPA).
Final rule.
This action finalizes the residual risk and technology review (RTR) conducted for the Publicly Owned Treatment Works (POTW) source category regulated under national emission standards for hazardous air pollutants (NESHAP). In addition, we are taking final action addressing revised names and definitions of the subcategories, revisions to the applicability criteria, revised regulatory provisions pertaining to emissions during periods of startup, shutdown, and malfunction (SSM), initial notification requirements for existing Group 1 and Group 2 POTW, revisions to the requirements for new Group 1 POTW, requirements for electronic reporting, and other miscellaneous edits and technical corrections. While we do not anticipate any emission reductions as a result of these revisions, the changes should provide clarity for sources determining applicability and ensuring compliance.
This final rule is effective on October 26, 2017.
The Environmental Protection Agency (EPA) has established a docket for this action under Docket ID No. EPA-HQ-OAR-2016-0490. All documents in the docket are listed on the
For questions about this final action, contact Katie Hanks, Sector Policies and Programs Division (E143-03), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, 27711; telephone number: (919) 541-2159; fax number: (919) 541-0516; and email address:
Preamble acronyms and abbreviations. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:
CAA Clean Air Act
CBI confidential business information
CDX Central Data Exchange
CEDRI Compliance and Emissions Data Reporting Interface
ERT Electronic Reporting Tool
HAP hazardous air pollutants(s)
HQ hazard quotient
H
ICR Information Collection Request
MACT maximum achievable control technology
MGD million gallons per day
MIR maximum individual risk
NESHAP national emission standards for hazardous air pollutants
NPDES National Pollutant Discharge Elimination System
NTTAA National Technology Transfer and Advancement Act
PB-HAP Hazardous air pollutants known to be persistent and bio-accumulative in the environment
POTW Publicly Owned Treatment Works
RFA Regulatory Flexibility Act
RIN Regulatory Information Number
RTR Risk and Technology Review
SSM startup, shutdown and malfunction
TOSHI Target Organ Specific Hazard Index
UMRA Unfunded Mandates Reform Act
Table 1 of this preamble is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by the final action for the source category listed. The standards are directly applicable to the affected sources. Federal, state, local, and tribal governments are affected as discussed below. By definition, a POTW is owned by a municipality, state, intermunicipal or interstate agency, or any department, agency, or instrumentality of the federal government (see 40 CFR 63.1595 of subpart VVV). To determine whether your facility is affected, you should examine the applicability criteria in the POTW NESHAP. Specifically, if a POTW is a Group 2 POTW
In addition to being available in the docket, an electronic copy of this final action will also be available on the Internet. Following signature by the EPA Administrator, the EPA will post a copy of this final action at
Additional information is available on the RTR Web site at
Under Clean Air Act (CAA) section 307(b)(1), judicial review of this final action is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by December 26, 2017. Under CAA section 307(b)(2), the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings brought by the EPA to enforce the requirements.
Section 307(d)(7)(B) of the CAA further provides that only an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review. This section also provides a mechanism for the EPA to reconsider the rule if the person raising an objection can demonstrate to the Administrator that it was impracticable to raise such objection within the period for public comment or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule. Any person seeking to make such a demonstration should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, EPA WJC South Building, 1200 Pennsylvania Ave. NW., Washington, DC 20460, with a copy to both the person(s) listed in the preceding
Section 112 of the CAA establishes a two-stage regulatory process to address emissions of HAP from stationary sources. In the first stage, we must identify categories of sources emitting one or more of the HAP listed in CAA section 112(b) and then promulgate technology-based NESHAP for those sources. “Major sources” are those that emit, or have the potential to emit, any single HAP at a rate of 10 tons per year (tpy) or more, or 25 tpy or more of any combination of HAP. For major sources, these standards are commonly referred to as maximum achievable control technology (MACT) standards and must reflect the maximum degree of emission reductions of HAP achievable (after considering cost, energy requirements, and non-air quality health and environmental impacts). In developing MACT standards, CAA section 112(d)(2) directs the EPA to consider the application of measures, processes, methods, systems, or techniques, including but not limited to those that reduce the volume of or eliminate HAP emissions through process changes, substitution of materials, or other modifications; enclose systems or
For these MACT standards, the statute specifies certain minimum stringency requirements, which are referred to as MACT floor requirements, and which may not be based on cost considerations.
In the second stage of the regulatory process, the CAA requires the EPA to undertake two different analyses, which we refer to as the technology review and the residual risk review. Under the technology review, we must review the technology-based standards and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less frequently than every 8 years, pursuant to CAA section 112(d)(6). Under the residual risk review, we must evaluate the risk to public health remaining after application of the technology-based standards and revise the standards, if necessary, to provide an ample margin of safety to protect public health or to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect. The residual risk review is required within 8 years after promulgation of the technology-based standards, pursuant to CAA section 112(f). In conducting the residual risk review, if the EPA determines that the current standards provide an ample margin of safety to protect public health, it is not necessary to revise the MACT standards pursuant to CAA section 112(f).
The EPA promulgated the NESHAP for the POTW source category (henceforth referred to as the “POTW NESHAP”) on October 26, 1999 (64 FR 57572). The standards are codified at 40 CFR part 63, subpart VVV. The POTW NESHAP was amended on October 21, 2002 (67 FR 64742). As amended in 2002, the POTW source category consists of new and existing POTW treatment plants that are located at a POTW that is a major source of HAP emissions and that meets the criteria for development and implementation of a pretreatment program as defined by 40 CFR 403.8 under the Clean Water Act (CWA). Additional information about the National Pretreatment Program can be found in the December 27, 2016, RTR proposal (81 FR 95374). The source category covered by this MACT standard currently includes thirteen facilities.
As used in this regulation, the term POTW refers to both any POTW that is owned by a state, municipality, or intermunicipal or interstate agency and, therefore, eligible to receive grant assistance under the Subchapter II of the CWA, and any federally owned treatment works as that term is described in section 3023 of the Solid Waste Disposal Act. For more information see the December 27, 2016, RTR proposal (81 FR 95352). The source category includes any intercepting sewers, outfall sewers, sewage collection systems, pumping, power, and other equipment. The wastewater treated by these facilities is generated by industrial, commercial, and domestic sources.
The 2002 POTW NESHAP is subcategorized based on whether the POTW is providing treatment for wastewaters received from an industrial user as the means by which that industrial user complies with another NESHAP. The 2002 POTW NESHAP defined an “industrial POTW” as “a POTW that accepts a waste stream regulated by another NESHAP and provides treatment and controls as an agent for the industrial discharger. The industrial discharger complies with its NESHAP by using the treatment and controls located at the POTW. For example, an industry discharges its benzene-containing waste stream to the POTW for treatment to comply with 40 CFR part 61, subpart FF—National Emission Standards for Benzene Waste Operations. This definition does not include POTW treating waste streams not specifically regulated under another NESHAP.” An “industrial POTW” is subject to the 2002 POTW NESHAP regardless of the HAP emissions (
The amount and type of HAP emitted from a POTW is dependent on the composition of the wastewater streams discharged to a POTW by industrial users. The primary HAP emitted from the POTW that were identified as subject to the POTW NESHAP include acetaldehyde, acetonitrile, chloroform, ethylene glycol, formaldehyde, methanol, methylene chloride, tetratchloroethylene, toluene, and xylenes. The HAP present in the wastewater entering a POTW can biodegrade, adhere to sewage sludge, volatilize to the air, or pass through (remain in the wastewater discharge) to receiving waters. Emissions can occur at any point at the POTW, including collection systems and wastewater treatment units located at the POTW treatment plant.
The POTW NESHAP specifies requirements for the industial and non-industrial POTW subcategories. Under the 2002 POTW NESHAP, an existing “industrial POTW” must meet the requirements of the industrial user's NESHAP. A new or reconstructed “industrial POTW” must meet the requirements of the industrial user's
There are no control requirements in the 2002 POTW NESHAP for existing “non-industrial POTW.” However, new or reconstructed “non-industrial POTW” must equip each treatment unit up to, but not including, the secondary influent pumping station, with a cover. In addition, all covered units, except the primary clarifier, must route the air in the headspace above the surface of the wastewater to a control device that meets the requirements for closed-vent systems and control devices found in the NESHAP from Off-Site Waste and Recovery Operations (40 CFR part 63, subpart DD). As an alternative, a new or reconstructed “non-industrial POTW” can demonstrate that all units up to, but not including, the secondary influent pumping station emit a HAP fraction of 0.014 or less. The HAP fraction emitted is the fraction of HAP in the wastewater entering the POTW that is emitted to the atmosphere. For additional information, see the December 27, 2016, RTR proposal (81 FR 95357).
On December 27, 2016, the EPA published a proposed rule in the
This action finalizes the EPA's determinations pursuant to the RTR provisions of CAA section 112 for the POTW source category. This action also finalizes other changes to the NESHAP, including revised names and definitions of the subcategories, clarified applicability criteria, revised regulatory provisions pertaining to emissions during periods or SSM, initial notification requirements for existing Group 1 and Group 2 POTW, requirements for new or reconstructed Group 1 POTW to comply with both the requirements in the POTW NESHAP and those in the applicable NESHAP for which the POTW acts as a control agent, requirements for electronic reporting, and other miscellaneous edits and technical corrections. As explained in section IV of this preamble, we are not taking final action at this time on several provisions that were proposed, including standards for pretreatment, the inclusion of collection systems in the major source determination, and the HAP fraction emission limit for existing Group 1 and Group 2 POTW.
We determined that risks resulting from emissions from the POTW source category are acceptable. Specifically, the maximum individual cancer risk (MIR) is 2-in-1 million based on allowable emissions and 1-in-1 million based on actual emissions, well below the presumptive limit of acceptability (100-in-1 million), and other health information indicates there is no appreciable risk of adverse chronic or acute non-cancer health effects due to HAP emissions from the source category. Additionally, emissions of 2-methylnaphthalene, the only HAP emitted from the POTW source category that is known to be persistent and bio-accumulative in the environment (PB-HAP), did not exceed the worst-case Tier I screening emission rate or any ecological benchmarks. Therefore, revisions to the standards are not necessary to reduce risk to an acceptable level or to prevent an adverse environmental effect. Further, considering risk and non-risk factors, we determined that the 2002 POTW NESHAP requirements provide an ample margin of safety to protect public health. Therefore, we are not finalizing revisions to the standards under CAA section 112(f)(2).
We determined that there are no developments in practices, processes, and control technologies that warrant revisions to the MACT standards for this source category. Therefore, we are not finalizing revisions to the MACT standards under CAA section 112(d)(6).
Consistent with
The EPA is not revising the applicability of 40 CFR part 63, subpart VVV as proposed on December 27, 2016. Instead, the EPA is finalizing minor clarifying changes to the applicability criteria that are in the 2002 POTW NESHAP. The renaming of the subcategories (from “industrial” to “Group 1” and from “non-industrial” to “Group 2) and the definitions of Group
As proposed, the EPA is revising the names and definitions for the subcategories identified in the POTW NESHAP. The EPA is renaming an “industrial POTW treatment plant” as a “Group 1” POTW treatment plant and a “non-industrial POTW treatment plant” as a “Group 2” POTW treatment plant. The EPA expects that this clarification will address any confusion that could have been caused by the previous subcategory names “industrial POTW treatment plant” and “non-industrial treatment plant” because POTW in both subcategories treat wastewater from industrial users. The key difference between Group 1 and Group 2 is that a Group 1 POTW acts as an agent for an industrial user by accepting and controling the industrial user's waste stream regulated under another NESHAP. By contrast, a Group 2 POTW may treat the waste stream from an industrial user, but does not act as the industrial user's agent to comply with another NESHAP.
In the final rule (40 CFR 63.1586(a)), existing Group 1 and Group 2 POTW treatment plants must comply with the initial notification requirements in 40 CFR 63.1591(a) of subpart VVV. This notification requirement was not required for these existing sources in the 2002 POTW NESHAP, but was proposed in the December 27, 2016, proposal, and is consistent with notification requirements that were applicable to new or reconstructed Group 2 sources under the 2002 POTW NESHAP.
The EPA is finalizing, as proposed, the requirement that new Group 1 POTW comply with both the requirements of the other NESHAP for which they act as an agent of control for an industrial user and the requirements for new Group 2 POTW in this final rule. The requirements for new Group 2 POTW are unchanged from the 2002 POTW NESHAP and provide the option of complying with either (a) cover all primary treatment units and route emissions through a closed vent system to a control device or (b) meet a HAP fraction emission limit of 0.014 for emissions from all primary treatment units.
The EPA is finalizing electronic reporting requirements for new POTW consistent with the proposed rule. Specifically, new POTW must electroncally submit all annual reports and certain performance test reports. The EPA believes that the electronic submittal of these reports will increase the usefulness of data contained in those reports, is in keeping with current trends in data availability, will further assist in the protection of public health and the environment, and will ultimately result in less burden on the regulated community.
The EPA is finalizing the following technical corrections as proposed:
• Revising all references to “new or reconstructed POTW” to refer to “new POTW” because the definition of “new” includes reconstructed POTW.
• Combining text from 40 CFR 63.1581 and 63.1582 because the language was redundant and confusing. This includes revising 40 CFR 63.1581 to include all combined text and revising 40 CFR 63.1583(c) to include the text from the current 40 CR 63.1582(c).
• Revising 40 CFR 63.1586(b)(1) to require covers “designed and operated to prevent exposure of the wastewater to the atmosphere” instead of “designed and operated to minimize exposure of the wastewater to the atmosphere.” This clarification has also been made to the definition of “cover” in 40 CFR 63.1595.
• Revising 40 CFR 63.1587 to include compliance requirements that are currently found in 40 CFR 64.1584 and 63.1587, and deleting 40 CFR 63.1584.
• Clarifying the method for calculating the HAP fraction emitted and moving the detailed instructions for calculating the HAP fraction emitted from 40 CFR 63.1588(c)(4) to 40 CFR 63.1588(c)(3). The requirements remaining in 40 CFR 63.1588(c)(4) address monitoring for continuous compliance.
• Revising 40 CFR 63.1588(a)(3) to clarify that a cover defect must be repaired within 45 “calendar” days; currently the paragraph says “45 days.”
• Adding definitions of existing source/POTW and new source/POTW to 40 CFR 63.1595 to clarify the date that determines whether a POTW is existing or new.
• Renaming the title of 40 CFR 63.1588 to “How do Group 1 and Group 2 POTW treatment plants demonstrate compliance?” from “What inspections must I conduct?” The new title better reflects the contents of this section.
• Removing the details on how to calculate the HAP fraction emitted from the definition of HAP fraction emitted. The procedure for how to calculate the HAP fraction emitted is provided within the text of the rule. Having a summarized version of this procedure in the definition could cause confusion.
• Revising two references to dates to insert the actual dates. The phrase “six months after October 26, 1999” was replaced with “April 26, 2000”; and the phrase “60 days after October 26, 1999” was replaced with “December 27, 1999.” These changes do not result in a change in the date, but only clarify the specific dates being referenced.
• Clarifying that the reports required in 40 CFR 63.1589(b)(1) include the records associated with the HAP loading and not just the records associated with the HAP emissions determination.
• Removing the definition of “Reconstruction” in 40 CFR 63.1595 as “Reconstruction” is already defined in the General Provisions of 40 CFR 63.2.
The revisions to the MACT standards being promulgated in this action are effective on October 26, 2017.
The compliance date for existing Group 1 POTW is found in the applicable NESHAP for which the industrial user is subject to wastewater requirements. The compliance date for existing Group 2 POTW constructed or reconstructed on or before December 1, 1998, remains April 26, 2000. While we do not expect any additional existing Group 1 or Group 2 POTW beyond the 13 identified, we have chosen to include an additional compliance date of October 26, 2018 for existing Group 1 and Group 2 sources to submit their initial notification. We understand from public comments that POTW are evaluating their potential emissions and additional POTW may find they are subject to the rule. These POTW are only required to submit a notification that they are subject to the rule, and the additional time given for compliance of
As we proposed, the EPA is finalizing the requirement for owners and operators of POTW to submit electronic copies of certain required performance test reports and annual reports through the EPA's Central Data Exchange (CDX) using the Compliance and Emissions Data Reporting Interface (CEDRI). The electronic submittal of the reports addressed in this rulemaking will increase the usefulness of the data contained in those reports, is in keeping with current trends in data availability and transparency, will further assist in the protection of public health and the environment, will improve compliance by facilitating the ability of regulated facilities to demonstrate compliance with requirements and by facilitating the ability of delegated state, local, tribal, and territorial air agencies and the EPA to assess and determine compliance, and will ultimately reduce burden on regulated facilities, delegated air agencies, and the EPA. Electronic reporting also eliminates paper-based, manual processes, thereby saving time and resources, simplifying data entry, eliminating redundancies, minimizing data reporting errors, and providing data quickly and accurately to the affected facilities, air agencies, the EPA, and the public.
The EPA Web site that stores the submitted electronic data, WebFIRE, is easily accessible and provides a user-friendly interface. By making records, data, and reports addressed in this rulemaking readily available, the EPA, the regulated community, and the public will benefit when the EPA conducts its CAA-required technology reviews. As a result of having reports readily accessible, our ability to carry out comprehensive reviews will increase and be achieved within a shorter period of time.
We anticipate fewer or less substantial Information Collection Requests (ICRs) in conjunction with prospective CAA-required technology reviews may be needed, which results in a decrease in time spent by industry to respond to data collection requests. We also expect the ICRs to contain less extensive stack testing provisions, as we will already have stack test data electronically. Reduced testing requirements would be a cost savings to industry. The EPA should also be able to conduct these required reviews more quickly. While the regulated community may benefit from a reduced burden of ICRs, the general public benefits from the agency's ability to provide these required reviews more quickly, resulting in increased public health and environmental protection.
Air agencies, as well as the EPA, can benefit from more streamlined and automated review of the electronically submitted data. Standardizing report formats allows air agencies to review reports and data more quickly. Having reports and associated data in electronic format facilitates review through the use of software “search” options, as well as the downloading and analyzing of data in spreadsheet format. Additionally, air agencies and the EPA can access reports wherever and whenever they want or need, as long as they have access to the Internet. The ability to access and review reports electronically assists air agencies in determining compliance with applicable regulations more quickly and accurately, potentially allowing a faster response to violations, which could minimize harmful air emissions. This benefits both air agencies and the general public.
For a more thorough discussion of electronic reporting required by this rule, see the discussion in the preamble of the proposal. In summary, in addition to supporting regulation development, control strategy development, and other air pollution control activities, having an electronic database populated with performance test data will save industry, air agencies, and the EPA significant time, money, and effort while improving the quality of emission inventories and air quality regulations and enhancing the public's access to this important information.
For each decision or amendment, this section provides a description of what we proposed and what we are finalizing, the EPA's rationale for the final decisions and amendments, and a summary of key comments and responses. Comments not discussed in this preamble, comment summaries, and the EPA's responses can be found in the comment summary and response document available in the docket (Docket ID No. EPA-HQ-OAR-2016-0490).
Pursuant to CAA section 112(f), we conducted a residual risk review and presented the results of the review, along with our proposed decisions regarding risk acceptability and ample margin of safety, in the December 27, 2016, RTR proposal (81 FR 95372). The residual risk review for the POTW source category included assessment of cancer risk, chronic non-cancer risk, and acute non-cancer risk due to inhalation exposure, as well as multipathway exposure risk and environmental risk. The results of the risk assessment are presented briefly in this preamble and in more detail in the residual risk document,
The results indicated that maximum inhalation cancer risk to the individual most exposed is 2-in-1 million based on allowable emissions and 1-in-1 million based on actual emissions, which is well below the presumptive limit of acceptability (
The risk assessment conducted for the POTW proposal estimated cancer, chronic noncancer, and acute noncancer risk for six of the 13 facilities in the source category and is summarized and referenced above. We confirmed the existence of seven additional POTW subject to the rule that were identified through public comments. For these seven POTW, we conducted a facility-wide risk assessment of potential cancer and chronic noncancer health effects. The results of this assessment indicate that all seven POTW have a facility-wide noncancer TOSHI less than 1, four of the POTW have a facility-wide cancer risk estimated less than 1-in-1 million, and three of the POTW have a facility-wide cancer risk estimated at or above 10-in-1 million. The highest facility-wide MIR was 60-in-1 million driven by formaldehyde from internal combustion engines which are covered under the NESHAP for the Stationary Reciprocating Internal Combustion Engines source category. For this POTW with the highest facility-wide MIR, the facility-wide emissions of formaldehyde are 22 tpy while the source category emissions of formaldehyde are 0.0026 tpy, which indicates that almost 100 percent of the estimated cancer risk is from emissions sources that are not part of the POTW source category. This ratio of source category emissions relative to facility-wide emissions of formaldehyde is the same for the other two POTW with facility-wide cancer risk estimated at or above 10-in-1 million. Therefore, it is reasonable to conclude that all 13 POTW have estimated cancer risk close to or below 1-in-1 million from source category emissions and we retain our proposed determination that risk is acceptable. Further, as discussed in the December 27, 2016, RTR proposal (81 FR 95373), we retain our determination that, considering the costs, economic impacts and technological feasibility of additional standards to reduce risk further, the 2002 POTW NESHAP provides an ample margin of safety to protect public health and prevents an adverse environmental effect. Details of this risk assessment are described in the
Most of the commenters on the proposed risk review supported our risk acceptability and ample margin of safety determinations for the POTW NESHAP. Some commenters requested that we make changes to our residual risk review approach. However, we evaluated the comments and determined that no changes to our risk assessment methods or conclusions are warranted. A summary of these comments and responses are in the comment summary and response document, available in the docket for this action (Docket ID No. EPA-HQ-OAR-2016-0490).
Since proposal, our risk assessment has been broadened to include additional POTW; however, the conclusions of our risk assessment and our determinations regarding risk acceptability, ample margin of safety, and adverse environmental effects have not changed. For the reasons explained in the proposed rule and discussed above, we determined that the risks from the POTW source category are acceptable, and that the current standards provide an ample margin of safety to protect public health and prevent an adverse environmental effect.
As described in the December 27, 2016, RTR proposal (81 FR 95373), and as provided by CAA section 112(d)(6), our technology review focused on identifying developments in the practices, processes, and control technologies for the POTW source category. We concluded that there are two different control options that may be used at a POTW to reduce HAP emissions: pretreatment programs and add-on controls (
As stated in section III.B of this preamble, we did not identify any developments in practices, processes, or control technology with respect to programs and controls already in use when the 2002 POTW NESHAP was promulgated that warrant revisions to the standards as part of the technology review of the POTW NESHAP.
The 2002 POTW NESHAP established three criteria (40 CFR 63.1580(a)(1), (2), and (3)) for determining what POTW are subject to the rule. Specifically, the following criteria must all be true: (1) You own or operate a POTW that includes a POTW treatment plant; (2) the POTW is a major source of HAP emissions, or an industrial POTW regardless of the HAP emissions; and (3) the POTW is required to develop and implement a pretreatment program as defined by 40 CFR 403.8. The EPA proposed to revise the applicability criteria in order to clarify the original intent of the rule. Specifically, we proposed to revise the first and second criteria in 40 CFR 63.1580(a)(1) and (2) to state that your POTW is subject to the POTW NESHAP if “(1) You own or operate a POTW that is a major source of HAP emissions; or (2) you own or operate a Group 1 POTW regardless of whether or not it is a major source of HAP.” As stated in the proposal, we proposed this revision because we found several instances where a POTW might not realize they are subject to the standards, or where the applicability criteria could be misinterpreted to exclude facilities that are covered by the rule. See 81 FR 95377.
The third applicability criterion in the 2002 POTW NESHAP states that “(3) Your POTW is required to develop and implement a pretreatment program as defined by 40 CFR 403.8 (for a POTW owned or operated by a municipality, state, or intermunicipal or interstate agency), or your POTW would meet the general criteria for development and implementation of a pretreatment program (for a POTW owned or operated by a department, agency, or instrumentality of the Federal government).” We proposed revising the third criterion in 40 CFR 63.1580(a)(3) to state “You are subject to this subpart if your POTW has a design capacity to treat at least 5 million gallons of wastewater per day (MGD) and treats wastewater from an industrial user, and either paragraph (a)(1) or (a)(2) is true.” This proposed revision removed the requirement that a POTW must already have a pretreatment program in place in order to be subject to the rule. The proposed revisions were intended to clarify the intent of the rule, which was to limit applicability to POTW that treat at least 5 MGD and wastewater from industrial users.
Several commenters specifically objected to the proposed change that removed pretreatment from the third applicability criterion and made it a requirement of the rule. These commenters stated that removing pretreatment as an applicability criterion and making it a requirement changes the source category that the EPA intended to control. One state commented that this proposed change would cause an additional 12 POTW in their state to become subject to the rule. The commenter explained that because the state (not the POTW) implements the National Pollutant Discharge Elimination System (NPDES) pretreatment program, the original rule does not apply to any POTW in that state.
In response to the apparent potential for misinterpretation of the regulatory text that is reflected in the state's comment, we are making one minor change to clarify our interpretation and the intent of 40 CFR 63.1580(a)(3). In developing the 2002 POTW NESHAP, we wrote the rule to apply to POTW that receive a significant amount of HAP-containing waste from industrial or commercial facilities. In developing the rule language, we sought to define such POTW by using a regulatory criterion that was already established and well understood in the industry. We selected the criterion that the POTW be subject to a pretreatment program under the NPDES program because this criterion would encompass industrial and commercial wastes with HAP that pass through the POTW untreated and that could present a safety or health concern to POTW workers. In adopting this criterion, we did not limit applicability based on the entity that administers the program. In other words, the criterion encompasses every POTW that receives a waste stream that is subject to pretreatment standards, regardless of whether the standards are prescribed by the POTW itself or by a state or federal regulatory body. Thus, to make sure that the regulatory text is properly read, we have revised 40 CFR 63.1581(a)(3) to make clear that a POTW is subject to this rule if either (1) the POTW is required to develop and implement a pretreatment program as defined by 40 CFR 403.8, or (2) the POTW meets the general criteria for development and implementation of a pretreatment program, even if does not develop and implement the pretreatment program itself. Specifically, we have removed the parenthetical text in 40 CFR 63.1580(a)(3) that limited the first part of the third criterion to POTW owned or operated by a municipality, state, or intermunicipal or interstate agency and limited the second part of the third criterion to POTW owned or operated by a department, agency, or instrumentality of the federal government.
In the 2016 proposal, we stated that HAP emissions from collection systems should be included when determining whether the POTW is a major source, and therefore, subject to the rule. Specifically, we stated that the 2002 applicability criteria in 40 CFR 63.1580(a)(2) provided that emissions from the entire POTW source category must be considered when determining whether the POTW is a major source of HAP emissions, and not just the emissions from the POTW treatment plant (
We also received comments that stated the inclusion of emissions from collection systems for major source determination is inconsistent with the federal definition of a major source. One commenter stated that expansion of the major source definition to include collection sewers as part of the affected source is not authorized under section 112 of the CAA. The commenter also stated that the equipment that collect and convey wastewater to a POTW treatment plant do not reasonably constitute a “building, structure, facility, or installation” as specified in the definition of a stationary source in section 112(a)(3) of the CAA, are clearly not within a contiguous area under common control, and should not be considered a single source. Commenters noted that the determination of a major source of HAP emissions should be limited to emission sources within the fence line of each treatment plant, which would be consistent with the fact that the emission fraction requirement of the proposed POTW NESHAP is limited to emissions within the treatment plant. Further, one commenter contended that excluding collection system emissions in POTW major source determinations is also supported by
Commenters also noted that the emission data reviewed by the EPA in developing the proposed rule represented the HAP emissions from the POTW treatment plant only. One commenter noted that the risk assessment did not include emissions from collection systems. Several commenters disagreed with the EPA's statement in the preamble to the proposed rule that collection systems may have significant HAP emissions. Some commenters suggested that emissions from collection systems are insignificant and in some cases collection systems are operated under a vacuum to control odors. However, none of the commenters provided data to demonstrate the level of HAP emissions from collection systems.
With respect to new sources, we expect new sources to consult their permitting authorities on these matters as they plan for new construction. The EPA considers these determinations on source boundaries to be appropriately under the jurisdiction of the permitting authority. Accordingly, to avoid regulatory disruption, this final rule takes no action to change the definition of POTW. The definition of POTW remains the same as originally promulgated and continues to include “. . . any intercepting sewers, outfall sewers, sewage collection systems, pumping, power and other equipment.” Likewise, we are not taking final action at this time to revise the originally promulgated definition of the affected source. The definition of affected source continues to mean the “group of all equipment that comprise the POTW treatment plant.”
As stated in section IV.C of this preamble, the EPA proposed removing pretreatment from the applicability criteria and making it a control requirement for new and existing sources. We proposed adding pretreatment requirements in the rule because pretreatment would reduce HAP emissions from the entire source category (
Additionally, several commenters opposed requiring POTW to develop local limits and expressed concerns about the way in which local limits should be determined. Instead, commenters suggested that the EPA establish wastewater concentration limits for HAP to identify pollutants that may need local limits. One commenter stated that the EPA should either “regulate industrial users directly for HAP or provide technically-based wastewater concentrations for HAP that POTW could use for screening (where analytical methods exist under 40 CFR part 136)” to determine the need for establishing local limits.
Commenters also expressed concerns about the costs related to requiring pretreatment programs wherein POTW evaluate and set local limits for volatile organic HAP. The commenters stated that developing local limits to identify pollutants of concern, as well as identify potential pretreatment controls, would require significant time and that the significant costs these requirements would impose on POTW have not been quantified or justified. In contrast, one commenter stated that categorical limits set by the EPA pursuant to the CWA for certain industries could merit consideration, but additional analysis is required.
The EPA Office of Water is responsible for administering the pretreatment program and updates the requirements of the pretreatment program based on the best available technology and taking into account cost effectiveness. As the pretreatment requirements are modified through future updates, additional HAP reductions may occur. Because all of the POTW that are subject to the rule already have pretreatment programs, specifically requiring pretreatment under the NESHAP would not reduce HAP emissions further, but could cause confusion and increase compliance costs. Thus, we are not finalizing any revisions at this time to impose additional pretreatment requirements prior to discharging a wastewater stream to a receiving POTW. Pretreatment will continue to be handled under the authority of the CWA. By retaining the existing regulatory structure of the NESHAP, the EPA avoids redundancy and confusion in having pretreatment requirements included in both air and water permits.
In the 2016 proposal, we proposed that existing Group 1 and Group 2 POTW operate with an annual rolling average HAP fraction emitted from primary treatment units of 0.08 or less. As stated in the proposal, we believed that the existing POTW we knew about could meet this standard without the need for additional control.
Several commenters objected that merely doubling the single largest HAP fractions from the two available sources was not a scientifically or statistically valid method for setting the emission limit and stated that the EPA had provided no support for using the 2x factor to account for variability of emissions. For example, the commenters collectively pointed out that the two POTW on which the proposed standard was based were operating at half capacity, that the available data represent merely a snapshot in time, that other potentially regulated POTW might emit higher HAP fractions, and that the specific combination of HAP measured by the two POTW might not be representative of HAP emitted by other POTW. One commenter suggested that due to the uncertainty associated with such a small data set, the EPA should use a larger multiplier for setting a standard.
Additionally, commenters stated that the EPA had underestimated the cost of achieving compliance with the 0.08 HAP fraction emitted standard. Specifically, commenters stated that in order to comply, they would incur capital and operating costs, in addition to the recordkeeping and reporting costs that the EPA accounted for in the proposal. One commenter stated that they would potentially need to install covers and controls in order to meet the HAP fraction emitted limit, which would be an expense of $20 to $30 million with negligible emission reductions. Two commenters argued that the compliance cost for the proposed standard was not warranted given the low public health risk that the EPA estimated. Commenters further recommended that the EPA gather more complete data from the universe of affected sources, conduct statistical analysis of those data, and determine a suitable standard based on an acceptable level of risk and variability of the data.
In addition to proposing a HAP fraction for existing Group 1 POTW, we also proposed other changes to the requirements for Group 1 POTW.
The 2002 POTW NESHAP required existing Group 1 POTW to comply only with the requirements of the other NESHAP for which they are acting as an agent of control for the industrial user. We proposed that existing Group 1 POTW must meet both the requirements of the other NESHAP for which they are acting as an agent of control for an industrial user and the proposed requirements for existing Group 2 POTW in the POTW NESHAP (
The 2002 POTW NESHAP required new and reconstructed (which we are now referring to as “new”) Group 1 POTW to comply with the more stringent of the following: (1) The requirements of the other NESHAP for which they are acting as an agent of control for the industrial user; or (2) the requirements applicable to new Group 2 POTW, which allowed the POTW to choose to meet either a requirement to (a) cover all equipment and route emissions through a closed vent system to a control device; or (b) meet a HAP fraction emission limit of 0.014 for emissions from all primary treatment units. We proposed that new Group 1 POTW comply with the other NESHAP for which they are acting as an agent of control for an industrial user and the requirements for new Group 2 POTW in the 2002 POTW NESHAP. (Note that we did not propose, and are not finalizing, any revisions to the requirements for new Group 2 POTW.)
Comment: We received comments from one of the existing Group 1 POTW that expressed concern that by imposing the HAP fraction emitted limit on the existing Group 1 POTW with no alternative compliance option, the EPA had ignored existing POTW with covers and controls already in place. The commenter stated that new Group 1 POTW have the option of either installing covers or complying with the HAP fraction limit. However, the EPA did not provide that flexibility to
Response: The EPA is not taking final action on the proposed changes for existing Group 1 sources at this time. As explained in section IV.F of this preamble, we are not setting a HAP fraction limit for existing Group 1 or Group 2 POTW at this time; therefore, no additional requirements are being added for existing Group 1 POTW in the POTW NESHAP. Thus, as required by the 2002 POTW NESHAP, an existing Group 1 POTW must comply with the control requirements as specified in the appropriate NESHAP for the industrial user(s).
We did not receive any comment on our proposed revision to the requirements for new Group 1 POTW. We proposed, and are finalizing, that new Group 1 POTW must (1) meet the requirements of the other NESHAP for which they act as an agent of control for an industrial user and (2) either (a) cover all equipment and route emissions through a closed vent system to a control device or (b) meet a HAP fraction emission limit of 0.014 for emissions from all primary treatment units. See 81 FR 95375 for our rationale for this change. Because we received no adverse comment on our proposal, we are finalizing these requirements as proposed.
The EPA estimates, based on the responses to the 2015 ICR, the 2011 and 2014 National Emissions Inventory (NEI), and public comments received, that there are 13 POTW that are engaged in treatment of industrial wastewater and are currently subject to the POTW NESHAP. Two of these facilities are considered Group 1 POTW, while the remaining eleven are considered Group 2 POTW. All 13 currently subject to the POTW NESHAP have already met the notification requirements for existing Group 1 and Group 2 POTW. The EPA is not currently aware of any planned new Group 1 or Group 2 POTW that will be constructed or any existing Group 1 or Group 2 POTW that will be reconstructed.
The EPA estimates that annual organic HAP emissions from the 13 POTW subject to the rule are approximately 35 tpy. We expect no emissions of inorganic HAP from this category. The EPA does not anticipate any additional emission reductions from the final changes to the rule, and there are no anticipated new or reconstructed facilities.
The 13 entities subject to this proposal will incur only minimal costs related to familiarizing themselves with this rule—estimated to be a one-time total cost of $790 for all 13 entities. For further information on the requirements of this rule, see section IV of this preamble. For further information on the costs associated with the requirements of this rule, see the document titled
The economic impact analysis is designed to inform decision makers about the potential economic consequences of a regulatory action. For this rule, the EPA estimated the annual cost of recordkeeping and reporting as a percentage of reported sewage fees received by the affected POTW. For the revisions promulgated in this final rule, costs are expected to be less than 0.001 percent of collected sewage fees, based on publicly available financial reports from the fiscal year ending in 2015 for the affected entities.
In addition, the EPA performed a screening analysis for impacts on small businesses by comparing estimated population served by the affected entities to the population limit set forth by the U.S. Small Business Administration. The screening analysis found that the population served for all affected entities is greater than the limit qualifying a public entity as a small business.
More information and details of the EPA's analysis of the economic impacts, including the conclusions stated above, are provided in the technical document,
We do not anticipate any significant reductions in HAP emissions as a result of these final amendments. However, we think that the amendments will help to enhance the clarity of the rule, which can improve compliance and minimize emissions.
We examined the potential for any environmental justice concerns that might be associated with this source category by performing a demographic analysis of the population close to the six POTW that were modeled for source category risk.
The results of the POTW source category demographic analysis indicate that actual emissions from the source category expose no person to a cancer risk at or above 1-in-1 million or to a chronic non-cancer TOSHI greater than 1. Therefore, we conclude that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. However, this final rule may provide additional benefits to these demographic groups by improving the compliance and implementation of the NESHAP. The demographics of the population living within 50 km of POTW can be found in Table 2 of the document titled
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The results of the POTW source category demographic analysis indicate that actual emissions from the source category expose no person to a cancer risk at or above 1-in-1 million or to a chronic non-cancer TOSHI greater than 1. Therefore, the analysis shows that actual emissions from the POTW source category are not expected to have an adverse human health effect on children.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
This action is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.
The information collection activities in this rule have been submitted for approval to the OMB under the PRA. The ICR document that the EPA prepared has been assigned EPA ICR number 1891.08. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.
The information to be collected includes the initial notification that the POTW is subject to the rule. However, as stated in this preamble, the 13 sources that we already know about have already met this initial notification requirement and are not required to submit an additional notification. The information will be used to identify sources subject to the standards.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce that approval in the
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. There are no small entities affected in this regulated industry. See the technical document,
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. As discussed in section II.B.1 of this preamble, we have identified only 13 POTW that are subject to this final rule and none of those POTW are owned or operated by tribal governments. Thus, Executive Order 13175 does not apply to this action.
The action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's health and risk assessments are contained in sections III.A and B and sections IV.A and B of this preamble and the
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes that this action does
The documentation for this decision is contained in section III.A.6 of this preamble and in the corresponding
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Administrative practice and procedures, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, the Environmental Protection Agency amends part 63 of title 40, chapter I, of the Code of Federal Regulations as follows:
42 U.S.C. 7401,
(a) You are subject to this subpart if the following are all true:
(1) You own or operate a publicly owned treatment works (POTW) that includes an affected source (§ 63.1595);
(2) The affected source is located at a Group 2 POTW which is a major source of HAP emissions, or at any Group 1 POTW regardless of whether or not it is a major source of HAP; and
(3) Your POTW is required to develop and implement a pretreatment program as defined by 40 CFR 403.8, or your POTW meets the general criteria for development and implementation of a pretreatment program.
(b) If your existing POTW treatment plant is not located at a major source as of October 26, 1999, but thereafter becomes a major source for any reason other than reconstruction, then, for the purpose of this subpart, your POTW treatment plant would be considered an existing source.
See § 63.2 of the National Emission Standards for Hazardous Air Pollutants (NESHAP) General Provisions in subpart A of this part for the definitions of major source and area source.
(c) If you commence construction or reconstruction of your POTW treatment plant after December 1, 1998, then the requirements for a new POTW apply.
Yes, POTW treatment plants are divided into two subcategories: Group 1 POTW treatment plants and Group 2 POTW treatment plants, as described in paragraphs (a) through (c) of this section.
(a) Your POTW is a Group 1 POTW treatment plant if an industrial user complies with its NESHAP by using the treatment and controls located at your POTW treatment plant. Your POTW treatment plant accepts the regulated waste stream and provides treatment and controls as an agent for the industrial user. Group 1 POTW treatment plant is defined in § 63.1595.
(b) Your POTW is a Group 2 POTW treatment plant if your POTW treats wastewater that is not subject to control by another NESHAP or the industrial user does not comply with its NESHAP by using the treatment and controls located at your POTW treatment plant. “Group 2 POTW treatment plant” is defined in § 63.1595.
(c) If, in the future, an industrial user complies with its NESHAP by using the treatment and controls located at your POTW treatment plant, then your Group 2 POTW treatment plant becomes a Group 1 POTW treatment plant on the date your POTW begins treating that regulated industrial wastewater stream.
(a) The emission points and control requirements for an existing Group 1 POTW treatment plant are specified in the appropriate NESHAP for the industrial user(s).
(b) The emission points and control requirements for a new Group 1 POTW treatment plant are both those specified by the appropriate NESHAP which apply to the industrial user(s) who discharge their waste for treatment to the POTW, and those emission points and control requirements set forth in § 63.1586(b) or (c), as applicable.
(c) If your existing or new Group 1 POTW treatment plant accepts one or more specific regulated industrial waste streams as part of compliance with one or more other NESHAP, then you are subject to all the requirements of each appropriate NESHAP for each waste stream.
(d) At all times, the POTW must operate and maintain any affected source, including associated air
(a) An existing Group 1 POTW treatment plant demonstrates compliance by operating treatment and control devices which meet all requirements specified in the appropriate NESHAP. Requirements may include performance tests, routine monitoring, recordkeeping, and reporting.
(b) A new Group 1 POTW treatment plant demonstrates compliance by operating treatment and control devices which meet all requirements specified in the appropriate NESHAP and by meeting the requirements specified in § 63.1586, as applicable, as well as the applicable requirements in §§ 63.1588 through 63.1595.
(a) An existing Group 1 or Group 2 POTW treatment plant must comply with the initial notification requirements in § 63.1591(a).
(b)
(1) Covers must be tightly fitted and designed and operated to prevent exposure of the wastewater to the atmosphere. This includes, but is not limited to, the absence of visible cracks, holes, or gaps in the roof sections or between the roof and the supporting wall; broken, cracked, or otherwise damaged seals or gaskets on closure devices; and broken or missing hatches, access covers, caps, or other closure devices.
(2) If wastewater is in a treatment unit, each opening in the cover must be maintained in a closed, sealed position, unless plant personnel are present and conducting wastewater or sludge sampling, or equipment inspection, maintenance, or repair.
(c)
(d) At all times, the POTW must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require the POTW to make any further efforts to reduce emissions if the requirements of the applicable standard have been met. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator, which may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the source.
Sources subject to this subpart are required to achieve compliance on or before the dates specified in table 2 of this subpart.
(a) If you are complying with § 63.1586(b) by using covers, you must conduct the following inspections:
(1) You must visually check the cover and its closure devices for defects that could result in air emissions. Defects include, but are not limited to, visible cracks, holes, or gaps in the roof sections or between the roof and the supporting wall; broken, cracked, or otherwise damaged seals or gaskets on closure devices; and broken or missing hatches, access covers, caps, or other closure devices.
(2) You must perform an initial visual inspection within 60 calendar days of becoming subject to this NESHAP and perform follow-up inspections at least once per year, thereafter.
(3) In the event that you find a defect on a cover on a treatment unit in use, you must repair the defect within 45 calendar days. If you cannot repair within 45 calendar days, you must notify the EPA or the delegated authority immediately and report the reason for the delay and the date you expect to complete the repair. If you find a defect on a cover on a treatment unit that is not in service, you must repair the defect prior to putting the treatment unit back in wastewater service.
(b) If you own or operate a control device used to meet the requirements for § 63.1586(b), you must comply with the inspection and monitoring requirements of § 63.695(c) of subpart DD of this part.
(c) To comply with the HAP fraction emitted standard specified in § 63.1586(c), you must develop, to the satisfaction of the Administrator, an Inspection and Monitoring Plan. This Inspection and Monitoring Plan must include, at a minimum, the following:
(1) A method to determine the influent HAP mass loading,
(2) A method to determine your POTW treatment plant's annual HAP emissions for all units up to, but not including, the secondary influent pumping station or the secondary treatment units. The method you use to determine your HAP emissions, such as modeling or direct source measurement, must:
(i) Be approved by the Administrator for use at your POTW;
(ii) Account for all factors affecting emissions from your POTW treatment plant including, but not limited to, emissions from wastewater treatment units; emissions resulting from inspection, maintenance, and repair activities; fluctuations (
(iii) Include documentation that the values and sources of all data, operating conditions, assumptions, etc., used in your method result in an accurate estimation of annual emissions from your POTW treatment plant.
(3) A method to demonstrate that your POTW treatment plant meets the HAP fraction emitted standard specified in § 63.1586(c),
(i) Determine the average daily flow in million gallons per day (MGD) of the wastewater entering your POTW treatment plant for the month;
(ii) Determine the flow-weighted monthly concentration of each HAP listed in Table 1 to subpart DD of this part that is reasonably anticipated to be present in your influent;
(iii) Using the information in paragraphs (c)(3)(i) and (ii) of this section, determine a total annual flow-weighted loading in pounds per day (lbs/day) of each HAP entering your POTW treatment plant;
(iv) Sum up the values for each individual HAP loading in paragraph (c)(3)(iii) of this section and determine a total annual flow-weighted loading value (lbs/day) for all HAP entering your POTW treatment plant for the current month;
(v) Based on the current month's information in paragraph (c)(3)(iii) of this section along with source testing and emission modeling, for each HAP, determine the annual emissions (lbs/day) from all wastewater units up to, but not including, secondary treatment units;
(vi) Sum up the values in paragraph (c)(3)(v) of this section and calculate the total annual emissions value for the month for all HAP from all wastewater treatment units up to, but not including, secondary treatment units;
(vii) Calculate the HAP fraction emitted value for the month, using Equation 1 of this section as follows:
(viii) Average the HAP fraction emitted value for the month determined in paragraph (c)(3)(vii) of this section, with the values determined for the previous 11 months, to calculate an annual rolling average of the HAP fraction emitted.
(4) A method to demonstrate, to the satisfaction of the Administrator, that your POTW treatment plant is in continuous compliance with the requirements of § 63.1586(c). Continuous compliance means that your emissions, when averaged over the course of a year, do not exceed the level of emissions that allows your POTW to comply with § 63.1586(c). For example, you may identify a parameter(s) that you can monitor that assures your emissions, when averaged over the entire year, will meet the requirements in § 63.1586(c). Some example parameters that may be considered for monitoring include your wastewater influent HAP concentration and flow, industrial loading from your permitted industrial users, and your control device performance criteria. Where emission reductions are due to proper operation of equipment, work practices, or other operational procedures, your demonstration must specify the frequency of inspections and the number of days to completion of repairs.
(d) Prior to receiving approval on the Inspection and Monitoring Plan, you must follow the plan submitted to the Administrator as specified in § 63.1590(f).
(a) To comply with the cover and control standard specified in § 63.1586(b), you must prepare and maintain the records required in paragraphs (a)(1) through (4) of this section:
(1) A record for each treatment unit inspection required by § 63.1588(a). You must include a treatment unit identification number (or other unique identification description as selected by you) and the date of inspection.
(2) For each defect detected during inspections required by § 63.1588(a), you must record the location of the defect, a description of the defect, the date of detection, the corrective action taken to repair the defect, and the date the repair to correct the defect is completed.
(3) If repair of the defect is delayed as described in § 63.1588(a)(3), you must also record the reason for the delay and the date you expect to complete the repair.
(4) If you own or operate a control device used to meet the requirements for § 63.1586(b), you must comply with the recordkeeping requirements of § 63.696(a), (b), (g), and (h).
(b) To comply with the HAP fraction emitted standard specified in § 63.1586(c), you must prepare and maintain the records required in paragraphs (b)(1) through (3) of this section:
(1) A record of the methods and data used to determine your POTW treatment plant's annual HAP loading and HAP emissions as determined in § 63.1588(c)(1) and (2) as part of your Inspection and Monitoring Plan;
(2) A record of the methods and data used to determine that your POTW treatment plant meets the HAP fraction emitted standard of 0.014 or less, as determined in § 63.1588(c)(3) as part of your Inspection and Monitoring Plan; and
(3) A record of the methods and data that demonstrates that your POTW treatment plant is in continuous compliance with the requirements of § 63.1588(c)(4) to calculate annual emissions as specified in your Inspection and Monitoring Plan.
(c) The POTW must record the malfunction information specified in paragraphs (c)(1) through (3) of this section.
(1) In the event that an affected unit fails to meet an applicable standard, record the number of failures. For each failure, record the date, time, and duration of the failure.
(2) For each failure to meet an applicable standard, record and retain a list of the affected sources or equipment,
(3) Record actions taken to minimize emissions in accordance with § 63.1583(d) or § 63.1586(d) and any corrective actions taken to return the affected unit to its normal or usual manner of operation.
(d) Any records required to be maintained by this part that are submitted electronically via the EPA's Compliance and Emissions Data Reporting Interface (CEDRI) may be maintained in electronic format. This ability to maintain electronic copies does not affect the requirement for facilities to make records, data, and reports available upon request to a delegated air agency or the EPA as part of an on-site compliance evaluation.
(a) An existing Group 1 POTW must meet the reporting requirements specified in the appropriate NESHAP for the industrial user(s).
(b) A new Group 1 or Group 2 POTW must submit annual reports containing the information specified in paragraphs (b)(1) through (4) of this section, if applicable. You must submit annual reports following the procedure specified in paragraph (b)(5) of this section. For new units, the initial annual report is due 15 months after your POTW becomes subject to the requirements in this subpart and must cover the first 12 months of operation after your POTW becomes subject to the requirements of this subpart. Subsequent annual reports are due by the same date each year as the initial annual report and must contain information for the 12-month period following the 12-month period included in the previous annual report.
(1) The general information specified in paragraphs (b)(1)(i) and (ii) of this section must be included in all reports.
(i) The company name, POTW treatment plant name, and POTW treatment plant address, including county where the POTW is located; and
(ii) Beginning and ending dates of the reporting period.
(2) If you use covers to comply with the requirements of § 63.1586(b), you must submit the following:
(i) The dates of each visual inspection conducted;
(ii) The defects found during each visual inspection; and
(iii) For each defect found during a visual inspection, how the defects were repaired, whether the repair has been completed, and either the date each repair was completed or the date each repair is expected to be completed.
(3) If you comply with the HAP fraction emitted standard in § 63.1586(c), you must submit each value of the annual rolling average HAP fraction emitted as calculated in § 63.1588(c)(3)(vii) for the period covered by the annual report. Identify each value by the final month included in the calculation.
(4) If a source fails to meet an applicable standard, report such events in the annual report. Report the number of failures to meet an applicable standard. For each instance, report the start date, start time, and duration of each failure, as well as a list of the affected sources or equipment. If you comply with the cover and control standard in § 63.1586(b), for each failure, the report must include the percent control achieved. If you comply with the HAP fraction emitted standard in § 63.1586(c), for each failure, the report must include the HAP fraction emitted. You must include an estimate of the tons per year of each regulated pollutant emitted over the emission limit and a description of the method used to estimate the emissions in the report.
(5) You must submit the report to the Administrator at the appropriate address listed in § 63.13, unless the Administrator agrees to or species an alternate reporting method. Beginning on October 28, 2019 or once the reporting form has been available in CEDRI for 1 year, whichever is later, you must submit subsequent annual reports to the EPA via CEDRI. (CEDRI can be accessed through the EPA's Central Data Exchange (CDX)(
(c) If you own or operate a control device used to meet the cover and control standard in § 63.1586(b), you must submit the notifications and reports required by § 63.697(b), including a notification of performance tests; a performance test report; a malfunction report; and a summary report. These notifications and reports must be submitted to the Administrator, except for performance test reports. Within 60 calendar days after the date of completing each performance test (as defined in § 63.2) required by subpart DD of this part, you must submit the results of the performance test following the procedure specified in paragraphs (c)(1) through (3) of this section.
(1) For data collected using test methods supported by the EPA's Electronic Reporting Tool (ERT) as listed on the EPA's ERT Web site (
(2) For data collected using test methods that are not supported by the EPA's ERT as listed on the EPA's ERT Web site at the time of the test, you must submit the results of the performance test to the Administrator at the appropriate address listed in § 63.13 of subpart A of this part, unless the Administrator agrees to or specifies an alternate reporting method.
(3) If you claim that some of the performance test information being submitted under paragraph (b)(1) of this section is CBI, you must submit a complete file generated through the use of the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT Web site, including information claimed to be CBI, on a compact disc, flash drive, or other commonly used electronic storage medium to the EPA. The electronic medium must be clearly marked as CBI and mailed to U.S. EPA/
(d) You must comply with the delay of repair reporting required in § 63.1588(a)(3).
(e) You may apply to the Administrator for a waiver of recordkeeping and reporting requirements by complying with the requirements of § 63.10(f). Electronic reporting to the EPA cannot be waived.
(f) To comply with the HAP fraction emitted standard specified in § 63.1586(c), you must submit, for approval by the Administrator, an Inspection and Monitoring Plan explaining your compliance approach 90 calendar days prior to beginning operation of your new POTW or by April 24, 2018, whichever is later.
(g) If you are required to electronically submit a report through the CEDRI in the EPA's CDX, and due to a planned or actual outage of either the EPA's CEDRI or CDX systems within the period of time beginning 5 business days prior to the date that the submission is due, you will be or are precluded from accessing CEDRI or CDX and submitting a required report within the time prescribed, you may assert a claim of EPA system outage for failure to timely comply with the reporting requirement. You must submit notification to the Administrator in writing as soon as possible following the date you first knew, or through due diligence should have known, that the event may cause or caused a delay in reporting. You must provide to the Administrator a written description identifying the date, time and length of the outage; a rationale for attributing the delay in reporting beyond the regulatory deadline to the EPA system outage; describe the measures taken or to be taken to minimize the delay in reporting; and identify a date by which you propose to report, or if you have already met the reporting requirement at the time of the notification, the date you reported. In any circumstance, the report must be submitted electronically as soon as possible after the outage is resolved. The decision to accept the claim of EPA system outage and allow an extension to the reporting deadline is solely within the discretion of the Administrator.
(h) If you are required to electronically submit a report through CEDRI in the EPA's CDX and a force majeure event is about to occur, occurs, or has occurred or there are lingering effects from such an event within the period of time beginning five business days prior to the date the submission is due, the owner or operator may assert a claim of force majeure for failure to timely comply with the reporting requirement. For the purposes of this section, a force majeure event is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents you from complying with the requirement to submit a report electronically within the time period prescribed. Examples of such events are acts of nature (
(a) You must submit an initial notification that your POTW treatment plant is subject to these standards as specified in paragraphs (a)(1) and (2) of this section.
(1) If you have an existing Group 1 or Group 2 POTW treatment plant, you must submit an initial notification by October 26, 2018.
(2) If you have a new Group 1 or Group 2 POTW treatment plant, you must submit an initial notification upon startup.
(b) The initial notification must include the information included in paragraphs (b)(1) through (4) of this section.
(1) Your name and address;
(2) The address (
(3) An identification of these standards as the basis of the notification and your POTW treatment plant's compliance date; and
(4) A brief description of the nature, size, design, and method of operation of your POTW treatment plant, including its operating design capacity and an identification of each point of emission for each HAP, or if a definitive identification is not yet possible, a preliminary identification of each point of emission for each HAP.
(c) You must submit a notification of compliance status as required in § 63.9(h), as specified below:
(1) If you comply with § 63.1586(b) and use covers on the emission points and route air in the headspace underneath the cover to a control device, you must submit a notification of compliance status as specified in § 63.9(h) that includes a description of the POTW treatment units and installed covers, as well as the information required for control devices including the performance test results.
(2) If you comply with § 63.1586(c) by meeting the HAP fraction emitted standard, submission of the Inspection and Monitoring Plan as required in § 63.1588(c) and § 63.1590(f) meets the requirement for submitting a notification of compliance status report in § 63.9(h).
(d) You must notify the Administrator, within 30 calendar days of discovering that you are out of compliance with an applicable requirement of this subpart, including the following:
(1) The requirement to route the air in the headspace underneath the cover of all units equipped with covers, except primary clarifiers, to a control device as specified in § 63.1586(b).
(2) The HAP fraction emitted standard as specified in § 63.1586(c).
(3) The requirement to operate and maintain the affected source as specified in § 63.1586(d).
(4) The requirement to inspect covers annually and repair defects as specified in § 63.1588(a).
(5) The requirement to comply with the inspection and monitoring requirements of § 63.695(c) as specified in § 63.1588(b).
(6) The procedures specified in an Inspection and Monitoring Plan prepared as specified in § 63.1588(c).
(7) The requirements specified in an appropriate NESHAP for which the Group 1 POTW treatment plan treats regulated industrial waste as specified in § 63.1583(a) or (b), as applicable.
(a) Table 1 to this subpart lists the General Provisions (40 CFR part 63, subpart A) which do and do not apply to POTW treatment plants.
(b) Unless a permit is otherwise required by law, the owner or operator of a Group 1 POTW treatment plant which is not a major source is exempt from the permitting requirements established by 40 CFR part 70.
(a) This subpart can be implemented and enforced by the U.S. EPA, or a delegated authority such as the applicable state, local, or tribal agency. If the U.S. EPA Administrator has delegated authority to a state, local, or tribal agency, then that agency, in addition to the U.S. EPA, has the authority to implement and enforce this subpart. Contact the applicable U.S. EPA Regional Office to find out if implementation and enforcement of this subpart is delegated to a state, local, or tribal agency.
(b) In delegating implementation and enforcement authority of this subpart to a state, local, or tribal agency under subpart E of this part, the authorities contained in paragraphs (b)(1) through (5) of this section are retained by the Administrator of U.S. EPA and cannot be delegated to the state, local, or tribal agency.
(1) Approval of alternatives to the requirements in §§ 63.1580, 63.1583, and 63.1586 through 63.1588.
(2) Approval of major alternatives to test methods under § 63.7(e)(2)(ii) and (f), as defined in § 63.90, and as required in this subpart.
(3) Approval of major alternatives to monitoring under § 63.8(f), as defined in § 63.90, and as required in this subpart.
(4) Approval of major alternatives to recordkeeping and reporting under § 63.10(f), as defined in § 63.90, and as required in this subpart.
(5) Approval of an alternative to any electronic reporting to the EPA required by this subpart.
As used in this subpart:
(1) Not specifically regulated by another NESHAP, or
(2) From an industrial user that complies with the specific wastewater requirements in their applicable NESHAP prior to discharging the waste stream to the POTW.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is granting a petition submitted by ExxonMobil Oil Corporation Beaumont Refinery (ExxonMobil) to exclude from hazardous waste control (or delist) a certain solid waste. This final rule responds to the petition submitted by ExxonMobil to have the secondary impoundment basin (SIB) solids excluded, or delisted from the definition of a hazardous waste. The SIB solids are listed as F037 (primary oil/water/solids separation sludge); and F038 (secondary oil/water/solids separation sludge).
After careful analysis and evaluation of comments submitted by the public, the EPA has concluded that the petitioned wastes are not hazardous waste when disposed of in Subtitle D landfills. This exclusion applies to the surface impoundment solids generated at ExxonMobil's Beaumont, Texas facility. Accordingly, this final rule excludes the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act (RCRA) when disposed of in Subtitle D landfills but imposes testing conditions to ensure that the future-generated wastes remain qualified for delisting.
Effective October 26, 2017.
The EPA has established a docket for this action under Docket ID No. EPA-R06-RCRA-2017-0153. All documents in the docket are listed on the
For technical information regarding the ExxonMobil Beaumont Refinery petition, contact Michelle Peace at 214-665-7430 or by email at
The information in this section is organized as follows:
The EPA is finalizing:
(1) The decision to grant ExxonMobil's Beaumont Refinery's petition to have its surface impoundment basin solids excluded, or delisted, from the definition of a hazardous waste, subject to certain continued verification and monitoring conditions; and
(2) to use the Delisting Risk Assessment Software to evaluate the potential impact of the petitioned waste on human health and the environment. The Agency used this model to predict the concentration of hazardous constituents released from the petitioned waste, once it is disposed.
After evaluating the petition, EPA proposed rule, on May 31, 2017, to exclude the ExxonMobil Beaumont Refinery waste from the lists of hazardous wastes under §§ 261.31 and 261.32. The comments received on this rulemaking will be addressed as part of this decision.
ExxonMobil's petition requests an exclusion from the F037 and F038 waste listings pursuant to 40 CFR 260.20 and 260.22. ExxonMobil does not believe that the petitioned waste meets the criteria for which EPA listed it. ExxonMobil also believes no additional constituents or factors could cause the waste to be hazardous. EPA's review of this petition included consideration of the original listing criteria and the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA). See section 3001(f) of RCRA, 42 U.S.C. 6921(f), and 40 CFR 260.22 (d)(1)-(4) (hereinafter, all sectional references are to 40 CFR unless otherwise indicated). In making the initial delisting determination, EPA evaluated the petitioned waste against the listing criteria and factors cited in §§ 261.11(a)(2) and (a)(3). Based on this review, EPA agrees with the petitioner that the waste is non-hazardous with respect to the original listing criteria. If EPA had found, based on this review, that the waste remained hazardous based on the factors for which the waste was originally listed, EPA would have proposed to deny the petition. EPA evaluated the waste with respect to other factors or criteria to assess whether there is a reasonable basis to believe that such additional factors could cause the waste to be hazardous. EPA considered whether the waste is acutely toxic, the concentration of the constituents in the waste, their tendency to migrate and to bioaccumulate, their persistence in the environment once released from the waste, plausible and specific types of management of the petitioned waste, the quantities of waste generated, and waste variability. EPA believes that the petitioned waste does not meet the listing criteria and thus should not be a listed waste. EPA's proposed decision to delist waste from ExxonMobil is based on the information submitted in support of this rule, including descriptions of the wastes and analytical data from the Beaumont, Texas facility.
This exclusion applies to the waste described in the petition only if the requirements described in Table 1 of part 261, Appendix IX, and the conditions contained herein are satisfied. The one-time exclusion applies to 400,000 cubic yards of surface impoundment basin solids.
Storage containers with SIB solids will be transported to an authorized solid waste landfill (
This rule is effective October 26, 2017. The Hazardous and Solid Waste Amendments of 1984 amended Section 3010 of RCRA to allow rules to become effective in less than six months when the regulated community does not need the six-month period to come into compliance. That is the case here because this rule reduces, rather than increases, the existing requirements for persons generating hazardous wastes. These reasons also provide a basis for making this rule effective immediately, upon publication, under the Administrative Procedure Act, pursuant to 5 U.S.C. 553(d).
Because EPA is issuing this exclusion under the Federal RCRA delisting program, only states subject to Federal RCRA delisting provisions would be affected. This would exclude two categories of States: States having a dual system that includes Federal RCRA requirements and their own requirements, and States who have received our authorization to make their own delisting decisions.
EPA has also authorized some States (for example, Louisiana, Georgia, Illinois) to administer a delisting program in place of the Federal program, that is, to make State delisting decisions. Therefore, this exclusion does not apply in those authorized States. If Beaumont Refinery transports the petitioned waste to or manages the waste in any State with delisting authorization, Beaumont Refinery must obtain delisting authorization from that State before they can manage the waste as nonhazardous in the State.
A delisting petition is a request from a generator to EPA or another agency with jurisdiction to exclude from the list of hazardous wastes, wastes the generator does not consider hazardous under RCRA.
Under 40 CFR 260.20 and 260.22, facilities may petition the EPA to remove their wastes from hazardous waste control by excluding them from the lists of hazardous wastes contained in §§ 261.31 and 261.32. Specifically, § 260.20 allows any person to petition the Administrator to modify or revoke any provision of Parts 260 through 266, 268 and 273 of Title 40 of the Code of Federal Regulations. Section 260.22 provides generators the opportunity to petition the Administrator to exclude a waste on a “generator-specific” basis from the hazardous waste lists.
Petitioners must provide sufficient information to EPA to allow the EPA to
In August 2016, ExxonMobil petitioned EPA to exclude from the lists of hazardous wastes contained in §§ 261.31 and 261.32, SIB solids (F037, F038) generated from its facility located in Beaumont, Texas. The waste falls under the classification of listed waste pursuant to §§ 261.31 and 261.32. Specifically, in its petition, ExxonMobil requested that EPA grant a one-time exclusion for 400,000 cubic yards of SIB solids.
The 40 CFR part 261 Appendix VII hazardous constituents which are the basis for listing can be found in Table 1.
To support its petition, ExxonMobil submitted:
(1) Historical information on waste generation and management practices; and
(2) analytical results from thirty-nine samples for total and TCLP concentrations of compounds of concern (COC)s;
The EPA received four anonymous public comments on the May 31, 2017, proposed rule via
The delisting risk analysis performed using the Delisting Risk Assessment Software evaluates the worst case scenario for the petitioned waste and risk pathways are evaluated. All chemical constituents detected in the waste are individually assessed for their impact on human health and the environment.
Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this rule is not of general applicability and therefore, is not a regulatory action subject to review by the Office of Management and Budget (OMB). This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Similarly, because this rule will affect only a particular facility, this proposed rule does not have tribal implications, as specified in Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does not apply to this rule. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The basis for this belief is that the Agency used DRAS, which considers health and safety risks to children, to calculate the maximum allowable concentrations for this rule. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866. This rule does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988, “Civil Justice Reform”, (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.
The Congressional Review Act, 5 U.S.C. 801
EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. The Agency's risk assessment did not identify risks from management of this material in an authorized, solid waste landfill (
Environmental protection, Hazardous waste, Recycling, Reporting and recordkeeping requirements.
Sec. 3001(f) RCRA, 42 U.S.C. 6921(f).
For the reasons set out in the preamble, 40 CFR part 261 is amended as follows:
42 U.S.C. 6905, 6912(a), 6921, 6922, and 6938.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; reallocation.
NMFS is exchanging unused flathead sole and rock sole Community Development Quota (CDQ) for yellowfin sole CDQ acceptable biological catch (ABC) reserves in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2017 total allowable catch of yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.
Effective October 26, 2017 through December 31, 2017.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands management area (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2017 flathead sole, rock sole, and yellowfin sole CDQ reserves specified in the BSAI are 1,288 metric tons (mt), 5,310 mt, and 16,472 mt as established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) and revised by flatfish exchange (82 FR 48460; October 18, 2017). The 2017 flathead sole, rock sole, and yellowfin sole CDQ ABC reserves are 6,018 mt, 11,286 mt and 11,434 mt as established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) and revised by flatfish exchange (82 FR 48460; October 18, 2017).
The Yukon Delta Fisheries Development Association has requested that NMFS exchange 60 mt of flathead sole CDQ reserves and 145 mt of rock sole CDQ reserves for 205 mt of yellowfin sole CDQ ABC reserves under § 679.31(d). Therefore, in accordance with § 679.31(d), NMFS exchanges 60 mt of flathead sole CDQ reserves and 145 mt of rock sole CDQ reserves for 205 mt of yellowfin sole CDQ ABC reserves in the BSAI. This action also decreases and increases the TACs and CDQ ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017), and revised by flatfish exchange (82 FR 48460; October 18, 2017) are further revised as follows:
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Yukon Delta Fisheries Development Association in the BSAI. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 11, 2017.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Energy Regulatory Commission, DOE.
Notice of proposed rulemaking.
The Federal Energy Regulatory Commission (Commission) proposes to approve Critical Infrastructure Protection (CIP) Reliability Standard CIP-003-7 (Cyber Security—Security Management Controls), submitted by the North American Electric Reliability Corporation (NERC). Proposed Reliability Standard CIP-003-7 improves upon the current Commission-approved CIP Reliability Standards by clarifying the obligations pertaining to electronic access control for low impact BES Cyber Systems; adopting mandatory security controls for transient electronic devices (
Comments are due December 26, 2017.
Comments, identified by docket number, may be filed in the following ways:
•
•
Matthew Dale (Technical Information), Office of Electric Reliability, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-6826,
1. Pursuant to section 215 of the Federal Power Act (FPA),
2. Proposed Reliability Standard CIP-003-7 is designed to mitigate the cybersecurity risks to bulk electric system facilities, systems, and equipment, which, if destroyed, degraded, or otherwise rendered unavailable as a result of a cybersecurity incident, would affect the reliable operation of the bulk electric system.
3. In addition, pursuant to FPA section 215(d)(5), the Commission proposes to direct NERC to develop certain modifications to the CIP Reliability Standards. As discussed below, while proposed Reliability Standard CIP-003-7 improves electronic access control for low impact BES Cyber Systems and enhances security controls for transient electronic
4. Section 215 of the FPA requires a Commission-certified ERO to develop mandatory and enforceable Reliability Standards, subject to Commission review and approval. Reliability Standards may be enforced by the ERO, subject to Commission oversight, or by the Commission independently.
5. The Commission approved the “Version 1” CIP standards in January 2008, and subsequently acted on revised versions of the CIP standards.
6. In addition, in Order No. 822, pursuant to section 215(d)(5) of the FPA, the Commission directed NERC,
7. On March 3, 2017, NERC submitted a petition seeking approval of Reliability Standard CIP-003-7 and the associated violation risk factors and violation severity levels, implementation plan and effective dates. NERC states that proposed Reliability Standard CIP-003-7 satisfies the criteria set forth in Order No. 672 that the Commission applies when reviewing a proposed Reliability Standard.
8. NERC states that proposed Reliability Standard CIP-003-7 improves upon the existing protections that apply to low impact BES Cyber Systems. NERC avers that the proposed modifications address the Commission's directives from Order No. 822 by: 1. Clarifying electronic access control requirements applicable to low impact BES Cyber Systems; and 2. adding requirements for the protection of transient electronic devices used for low impact BES Cyber Systems. In addition, while not required by Order No. 822, NERC proposes a CIP Exceptional Circumstances policy for low impact BES Cyber Systems.
9. In response to the Commission's directive to develop modifications to eliminate ambiguity surrounding the term “direct” as it is used in the LERC definition, NERC proposes to: 1. Retire the terms LERC and LEAP from the NERC Glossary; and 2. modify Section 3 of Attachment 1 to proposed Reliability Standard CIP-003-7 “to more clearly delineate the circumstances under which Responsible Entities must establish access controls for low impact BES Cyber Systems.”
10. With regard to the Commission's directive to develop modifications to the CIP Reliability Standards to provide mandatory protection for transient electronic devices used at low impact BES Cyber Systems, NERC proposes to add a new section to Attachment 1 to proposed Reliability Standard CIP-003-7 to require responsible entities to include controls in their cyber security plans to mitigate the risk of the introduction of malicious code to low impact BES Cyber Systems that could result from the use of “Transient Cyber Assets or Removable Media.” Specifically, proposed Section 5 of Attachment 1 lists controls to be applied to Transient Cyber Assets and Removable Media that NERC contends “will provide enhanced protections against the propagation of malware from transient devices.”
11. NERC also proposes a modification that was not directed by the Commission in Order No. 822. Namely, NERC proposes revisions in Requirement R1 of proposed Reliability Standard CIP-003-7 to require responsible entities to have a policy for declaring and responding to CIP Exceptional Circumstances related to low impact BES Cyber Systems.
12. NERC requests that proposed Reliability Standard CIP-003-7 and the revised definitions of Transient Cyber Asset and Removable Media become effective the first day of the first calendar quarter that is eighteen months after the effective date of the Commission's order approving the proposed Reliability Standard.
13. Pursuant to section 215(d)(2) of the FPA, we propose to approve Reliability Standard CIP-003-7 as just, reasonable, not unduly discriminatory or preferential, and in the public interest. Proposed Reliability Standard CIP-003-7 largely addresses the Commission's directives in Order No. 822 and is an improvement over the current Commission-approved CIP Reliability Standards. Specifically, the modifications to Section 3 of Attachment 1 to Reliability Standard CIP-003-7 clarify the obligations pertaining to electronic access control for low impact BES Cyber Systems. In addition, the modifications to Attachment 1 to Reliability Standard CIP-003-7 require mandatory security controls for transient electronic devices used at low impact BES Cyber Systems. We also propose to approve the new provision in Reliability Standard CIP-003-7, Requirement R1 requiring responsible entities to have a policy for declaring and responding to CIP Exceptional Circumstances related to low impact BES Cyber Systems. While Order No. 822 did not direct NERC to expand the scope of the CIP Exceptional Circumstances policy, the revision aligns the treatment of low impact BES Cyber Systems with that of high and medium impact BES Cyber Systems if and when a CIP Exceptional Circumstance occurs.
14. We also propose to approve the revisions to the NERC Glossary definitions of Transient Cyber Asset and Removable Media, as well as the retirement of the NERC Glossary definitions for LERC and LEAP since the proposed modifications to Reliability Standard CIP-003-7 obviate the need for the two terms. We further propose to approve the violation risk factor and violation severity level assignments associated with proposed Reliability Standard CIP-003-7 as well as NERC's proposed implementation plan and effective dates.
15. In addition, as discussed below, pursuant to section 215(d)(5) of the FPA, the Commission proposes to direct NERC to develop certain modifications to the CIP Reliability Standards. While proposed Reliability Standard CIP-003-7 improves electronic access control for low impact BES Cyber Systems and enhances security controls for transient electronic devices used at low impact BES Cyber Systems, we propose to direct that NERC modify Reliability Standard CIP-003-7 to: 1. Provide clear, objective criteria for electronic access controls for low impact BES Cyber Systems; and 2. address the need to mitigate the risk of malicious code that could result from third-party transient electronic devices.
16. Below, we discuss the following issues: A. Electronic access controls for low impact BES Cyber Systems; B. protection of transient electronic devices; C. proposed retirement and modification of definitions; D. NERC's proposed implementation plan and effective dates; and E. proposed violation severity level and violation risk factor assignments.
17. In Order No. 822, the Commission directed NERC to modify the LERC definition to eliminate ambiguity surrounding the term “direct” as it is used in the LERC definition.
18. In addition, the Commission explained that the directive was also intended to eliminate a loophole that would have allowed transitive connections to out-of-scope cyber assets (
19. In its Petition, NERC proposes to: 1. Retire the terms LERC and LEAP from the NERC Glossary; and 2. modify Section 3 of Attachment 1 to Reliability Standard CIP-003-7 “to more clearly delineate the circumstances under which Responsible Entities must establish access controls for low impact BES Cyber Systems.”
20. NERC states that proposed Reliability Standard CIP-003-7 would require responsible entities to implement electronic access controls for any communication, direct or indirect (
21. NERC explains that Section 3.1 of Attachment 1 to proposed Reliability Standard CIP-003-7 is composed of three basic elements: 1. Identifying routable protocol communications from outside the asset containing the low impact BES Cyber System; 2. determining necessary inbound and outbound electronic access; and 3. implementing electronic access controls to permit only necessary inbound and outbound electronic access to the low impact BES Cyber System.
22. With regard to the first element, NERC states that Section 3.1 of Attachment 1 defines the circumstances where communications require electronic access controls. The three characteristics are:
1. The communication is between the low impact BES Cyber System and a Cyber Asset outside the asset containing low impact BES Cyber System(s);
2. the communication uses a routable protocol when entering or leaving the asset containing the low impact BES Cyber System(s); and
3. the communication is not used for time-sensitive protection or control functions between intelligent electronic devices.
NERC states further that each of the three characteristics were included in the original LERC definition.
23. NERC asserts that the first characteristic helps to properly focus the electronic access controls in light of “the wide array of low impact BES Cyber Systems and the risk-based approach to protecting different types of BES Cyber Systems.”
24. According to NERC, the second characteristic of Section 3.1 of Attachment 1 provides that responsible entities may permit only necessary inbound and outbound electronic access to low impact BES Cyber Systems as determined by the responsible entity. NERC explains that Section 3.1 does not specify a bright line as to what constitutes “necessary inbound and outbound access” due to “the wide array of assets containing low impact BES Cyber Systems and the myriad of reasons a Responsible Entity may need to allow electronic access to and from a low impact BES Cyber Systems.”
25. NERC explains that “a Responsible Entity must document the necessity of its inbound and outbound electronic access permissions and provide justification of the need for such access” in order to demonstrate compliance with Section 3.1 of Attachment 1.
26. In support of its position, NERC cites the draft Reliability Standard Audit Worksheet (RSAW) for proposed Reliability Standard CIP-003-7, which provides the following language in the Note to Auditor section for Requirement R2:
The entity must document its determination as to what is necessary inbound and outbound electronic access and provide justification of the business need for such access. Once this determination has been made and documented, the audit team's professional judgment cannot override the determination made by the Responsible Entity.
NERC also provides a list of Commission-approved CIP Reliability Standards where the phrase “as determined by the Responsible Entity” or similar language is used. NERC states that in all circumstances where the phrase “as determined by the Responsible Entity” or similar language is used, “the ERO has the authority to evaluate the reasonableness of the Responsible Entity's determination when assessing compliance to ensure it is consistent with the reliability objective of the requirement. To interpret this language otherwise would be inconsistent with NERC's statutory obligation to engage in meaningful compliance oversight . . .”
27. The Commission proposes to approve Reliability Standard CIP-003-7 because, as discussed above, the proposed Reliability Standard largely addresses the directives in Order No. 822 and is an improvement over the current Commission-approved CIP Reliability Standards. However, NERC's proposed revisions to Reliability Standard CIP-003-7 regarding the LERC
28. We are concerned that the proposed revisions may not provide adequate electronic access controls for low impact BES Cyber Systems. Specifically, proposed Reliability Standard CIP-003-7 does not provide clear, objective criteria or measures to assess compliance by independently confirming that the access control strategy adopted by a responsible entity would reasonably meet the security objective of permitting only “necessary inbound and outbound electronic access” to its low impact BES Cyber Systems.
29. Section 3.1 of Attachment 1 to proposed Reliability Standard CIP-003-7 does not appear to contain clear criteria or objective measures to determine whether the electronic access control strategy chosen by the responsible entity would be effective for a given low impact BES Cyber System to permit only necessary inbound and outbound connections. In order to ensure an objective and consistently-applied requirement, the electronic access control plan required in Attachment 1 should require the responsible entity to articulate its access control strategy for a particular set of low impact BES Cyber Systems and provide a technical rationale rooted in security principles explaining how that strategy will reasonably restrict electronic access. Attachment 1 should also outline basic security principles in order to provide clear, objective criteria or measures to assist in assessing compliance. Without such a requirement, auditors will not necessarily have adequate information to assess the reasonableness of the responsible entity's decision with respect to how the responsible entity identified necessary communications or restricted electronic access to specific low impact BES Cyber Systems. And absent such information, it is possible that an auditor could assess a violation where an entity adequately protected its low impact BES Cyber Systems or fail to recognize a situation where additional protections are necessary to meet the security objective of the standard.
30. As the Commission stated in Order No. 672, there “should be a clear criterion or measure of whether an entity is in compliance with a proposed Reliability Standard. It should contain or be accompanied by an objective measure of compliance so that it can be enforced and so that enforcement can be applied in a consistent and non-preferential manner.”
31. As a possible model, the electronic access control requirements that are applied to medium and high impact BES Cyber systems provide a number of criteria that can be used to assess the sufficiency of a responsible entity's electronic access control strategy. For medium and high impact BES Cyber Systems, auditors use the following criteria to review whether the access control strategy is reasonable: 1. Whether the electronic access was granted through an authorized and monitored electronic access point (Reliability Standard CIP-005-5, Requirement R1); 2. whether the electronic access granted to individuals/devices was evaluated based on need (Reliability Standard CIP-005-5, Requirement R1.3); 3. whether the entity has mechanisms to enforce authentication of users with electronic access (Reliability Standard CIP-007-6, Requirement R5); and 4. whether the responsible entity routinely uses strong passwords and manages password changes (Reliability Standard CIP-007-6, Requirement R5). Absent similar criteria in the low impact electronic access control plan that are appropriately tailored to the risks posed by low impact BES Cyber Systems, responsible entities may adopt electronic access controls that do not meet the overarching security objective of restricting inbound and outbound electronic access.
32. Therefore, pursuant to section 215(d)(5) of the FPA, we propose to direct NERC to develop modifications to Reliability Standard CIP-003-7 to provide clear, objective criteria for electronic access controls for low impact BES Cyber Systems consistent with the above discussion. The Commission seeks comment on this proposal.
33. In Order No. 822, the Commission directed NERC to develop modifications to provide mandatory protection for transient electronic devices used at low impact BES Cyber Systems based on the risk posed to bulk electric system reliability. The Commission stated that such modifications “will provide an important enhancement to the security posture of the bulk electric system by reinforcing the defense-in-depth nature of the CIP Reliability Standards at
34. In its Petition, NERC proposes to add a new section to Attachment 1 to proposed Reliability Standard CIP-003-7 to require responsible entities to include controls in their cyber security plans to mitigate the risk of the introduction of malicious code to low impact BES Cyber Systems through the
35. NERC states that the language in proposed Section 5 to Attachment 1 parallels the language in Attachment 1 to Reliability Standard CIP-010-2, which addresses mitigation of the risks of the introduction of malicious code to high and medium impact BES Cyber Systems through the use of Transient Cyber Assets or Removable Media. NERC states further that, as in Reliability Standard CIP-010-2, proposed Section 5 distinguishes between Transient Cyber Assets managed by a responsible entity and those managed by a third-party; the distinction arising because of a responsible entity's lack of control over Transient Cyber Assets managed by a third-party. NERC explains that the proposed controls for Removable Media do not distinguish between the responsible entity-managed assets and third-party managed assets due to the functionality of Removable Media. NERC provides the example of a thumb drive that can be scanned prior to use regardless of which party manages the asset.
36. NERC explains that proposed Section 5 of Attachment 1 requires responsible entities to meet the security objectives “by implementing the controls that the Responsible Entity determines necessary to meet its affirmative obligation to mitigate the risks of the introduction of malicious code.”
37. NERC outlines certain distinctions between proposed Section 5 of Attachment 1 to proposed Reliability Standard CIP-003-7 and Attachment 1 to Reliability Standard CIP-010-2. Specifically, NERC states that proposed Section 5 does not include requirements relating to authorization or software vulnerabilities, as are contained in Attachment 1 to Reliability Standard CIP-010-2. NERC explains that this difference is consistent with the risk-based approach of the CIP Reliability Standards and “the underlying principle of concentrating limited industry resources on protecting those BES Cyber Systems with greater risk to the BES.” NERC states that Section 5 focuses on the risk associated with the introduction of malicious code.
38. In addition, NERC states that proposed Section 5 to Attachment 1 does not include language requiring a responsible entity to determine whether additional mitigation actions are necessary where a third party manages a Transient Cyber Asset, nor does it include language requiring a responsible entity to implement additional mitigation actions in such situations. NERC states that it nonetheless expects “that if another party's processes and practices for protecting its Transient Cyber Assets do not provide reasonable assurance that they are designed to effectively meet the security objective of mitigating the introduction of malicious code, the Responsible Entity must take additional steps to meet the stated objective.”
39. NERC's proposed modifications in Reliability Standard CIP-003-7, Requirement R2, Attachment 1, Section 5 that include malware detection and prevention controls for responsible entity-managed Transient Cyber Assets and Removable Media should improve the cybersecurity posture of responsibility entities compared to currently-effective Reliability Standard CIP-003-6. The revisions in Section 5.2, however, do not address one aspect of the reliability gap identified in Order No. 822 regarding low impact BES Cyber Systems. Specifically, as noted above, proposed Reliability Standard CIP-003-7 does not explicitly require mitigation of the introduction of malicious code from third-party managed Transient Cyber Assets, even if the responsible entity determines that the third-party's policies and procedures are inadequate.
40. The proposed Reliability Standard may, therefore, contain a reliability gap where a responsible entity contracts with a third-party but fails to mitigate potential deficiencies discovered in the third-party's malicious code detection and prevention practices prior to a Transient Cyber Asset being connected to a low impact BES Cyber System. That is because the proposed Reliability Standard does not contain: 1. A requirement for the responsible entity to mitigate any malicious code found during the third-party review(s); or 2. a requirement that the responsible entity take reasonable steps to mitigate the risks of third party malicious code on their systems, if an arrangement cannot be made for the third-party to do so. Without these obligations, we are concerned that responsible entities could, without compliance consequences, simply accept the risk of deficient third-party transient electronic device management practices.
41. Therefore, pursuant to section 215(d)(5) of the FPA, we propose to direct that NERC develop modifications to proposed Reliability Standard CIP-003-7 to address the need to mitigate the risk of malicious code that could result from third-party Transient Cyber Assets consistent with the above discussion. The Commission seeks comment on this proposal.
42. Proposed Reliability Standard CIP-003-7 includes two revised definitions for inclusion in the NERC Glossary. Specifically, NERC proposes to revise the definitions of Transient Cyber Asset and Removable Media in order to accommodate the use of the terms at all impact levels. NERC explains that the original definitions include references to concepts or requirements associated only with high and medium impact BES Cyber Systems and the definitions were modified to avoid confusion because protections for Transient Electronic Devices will now be extended to low impact BES Cyber Systems.
43. In addition, NERC proposes to retire the definitions of LERC and LEAP. NERC states that the proposed retirement of the NERC Glossary terms LERC and LEAP accords with the proposed modifications to Section 3 of Attachment 1 to proposed Reliability Standard CIP-003-7 and is intended to simplify the electronic access control requirements for low impact BES Cyber Systems by avoiding the ambiguities associated with the term “direct.” NERC explains further that it “recognized that distinguishing between `direct' and `indirect' electronic access within the LERC definition added a layer of unnecessary complexity.”
44. We propose to approve the revised definitions of Transient Cyber Asset and Removable Media, as well as the retirement of the definitions of LERC and LEAP.
45. NERC requests an effective date for proposed Reliability Standard CIP-003-7 and the revised definitions of Transient Cyber Asset and Removable Media on the first day of the first calendar quarter that is eighteen months after the effective date of the Commission's order approving the proposed Reliability Standard. NERC explains that the proposed implementation plan does not alter the previously-approved compliance dates for Reliability Standard CIP-003-6 other than the compliance date for Reliability Standard CIP-003-6, Requirement R2, Attachment 1, Sections 2 and 3, which would be replaced with the effective date for proposed Reliability Standard CIP-003-7. NERC also proposes that the retirement of Reliability Standard CIP-003-6 and the associated definitions become effective on the effective date of proposed Reliability Standard CIP-003-7.
46. We propose to approve NERC's implementation plan for proposed Reliability Standard CIP-003-7, as described above.
47. NERC requests approval of two violation risk factors and violation severity levels assigned to proposed Reliability Standard CIP-003-7. Specifically, NERC requests approval of violation risk factor and violation severity level assignments associated with Requirements R1 and R2 of Reliability Standard CIP-003-7.
48. The FERC-725B information collection requirements contained in this proposed rule are subject to review by the Office of Management and Budget (OMB) under section 3507(d) of the Paperwork Reduction Act of 1995.
49. The Commission bases its paperwork burden estimates on the changes in paperwork burden presented by the proposed revision to CIP Reliability Standard CIP-003-7 as compared to the current Commission-approved Reliability Standard CIP-003-6. The Commission has already addressed the burden of implementing Reliability Standard CIP-003-6.
50. The NERC Compliance Registry, as of September 2017, identifies approximately 1,320 U.S. entities that are subject to mandatory compliance with Reliability Standards. Of this total, we estimate that 1,100 entities will face an increased paperwork burden under proposed Reliability Standard CIP 003-7, estimating that a majority of these entities will have one or more low impact BES Cyber Systems. Based on these assumptions, we estimate the following reporting burden:
51. The following
Legal (Occupation Code: 23-0000): $143.68.
Electrical Engineer (Occupation Code: 17-2071): $68.12.
Office and Administrative Support (Occupation Code: 43-0000): $40.89 ($143.68 + $68.12 + $40.89) ÷ 3 = $84.23. The figure is rounded to $84.00 for use in calculating wage figures in this NOPR.
Updates to managed low TCA assets: 15 minutes (0.25 hours) per response.
Updates to unmanaged low TCA assets: 60 minutes (1 hour) per response.
Reviews of low TCA applicable controls: 15 minutes (0.25 hours) per response.
• Year 1: $3,696,000.
• Years 2 and 3: $43,428,000.
• The paperwork burden estimate includes costs associated with the initial development of a policy to address requirements relating to: 1. Clarifying the obligations pertaining to electronic access control for low impact BES Cyber Systems; 2. adopting mandatory security controls for transient electronic devices (
52.
53. Interested persons may obtain information on the reporting requirements by contacting the following: Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426 [Attention: Ellen Brown, Office of the Executive Director, email:
54. For submitting comments concerning the collection(s) of information and the associated burden estimate(s), please send your comments to the Commission, and to the Office of Management and Budget, Office of Information and Regulatory Affairs, Washington, DC 20503 [Attention: Desk Officer for the Federal Energy Regulatory Commission, phone: (202) 395-4638, fax: (202) 395-7285]. For security reasons, comments to OMB should be submitted by email to:
55. The Regulatory Flexibility Act of 1980 (RFA) generally requires a description and analysis of proposed rules that will have significant economic impact on a substantial number of small entities.
56. Of the 1,100 affected entities discussed above, we estimate that approximately 857 or 78 percent
57. Based on the above analysis, we propose to certify that the proposed Reliability Standard will not have a significant economic impact on a substantial number of small entities.
58. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment.
59. The Commission invites interested persons to submit comments on the matters and issues proposed in this notice to be adopted, including any related matters or alternative proposals that commenters may wish to discuss. Comments are due December 26, 2017. Comments must refer to Docket No. RM17-11-000, and must include the commenter's name, the organization they represent, if applicable, and address.
60. The Commission encourages comments to be filed electronically via the eFiling link on the Commission's Web site at
61. Commenters that are not able to file comments electronically must send an original of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE., Washington, DC 20426.
62. All comments will be placed in the Commission's public files and may be viewed, printed, or downloaded remotely as described in the Document Availability section below. Commenters on this proposal are not required to serve copies of their comments on other commenters.
63. In addition to publishing the full text of this document in the
64. From the Commission's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number of this document, excluding the last three digits, in the docket number field.
65. User assistance is available for eLibrary and the Commission's Web site during normal business hours from the Commission's Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
By direction of the Commission.
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking; correction.
This document corrects a correction to a notice of proposed rulemaking (REG-134247-16) that was published in the
The correction published on September 15, 2017 (82 FR 43314), is corrected as of October 26, 2017 and is applicable beginning January 6, 2017.
Kamela Nelan at (202) 317- 6942 (not a toll-free number).
The notice of proposed rulemaking (REG-134247-16) that is the subject of this correction is under section 1441 of the Code.
As published, the notice of proposed rulemaking (REG-134247-16) contains an error which may prove to be misleading and needs to be corrected.
Accordingly, the notice of proposed rulemaking published at 82 FR 43314, September 15, 2017, is corrected as follows:
On page 43314, in the third column, under the heading “Correction of Publication”, in the fourth line, the
Coast Guard, DHS.
Advance notice of proposed rulemaking; withdrawal.
The Coast Guard is withdrawing its advance notice of proposed rulemaking (ANPRM) concerning the Bridge of Lions (SR A1A) across the Atlantic Intracoastal Waterway, mile 777.9, at St. Augustine, Florida. The City of St. Augustine proposed to modify the bridge operating schedule to alleviate vehicle traffic congestion. However, the Coast Guard has determined it would be inappropriate to move forward with a notice of proposed rulemaking. The Coast Guard believes placing additional restrictions to the bridge would add additional hazards to mariners and effect the safe navigation of vessels awaiting bridge openings.
The notice of proposed rulemaking published on March 15, 2017 (82 FR 13785), is withdrawn on October 26, 2017.
The docket for this document, USCG-2016-0723 is available at
If you have questions about this document, call or email LT Allan Storm, Sector Jacksonville, Waterways Management Division, U.S. Coast Guard; telephone 904-714-7616, email
On March 15, 2017, the Coast Guard published an ANPRM entitled “Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, St. Augustine, FL” in the
The Coast Guard received 386 comments, of those, 62 comments were duplicate entries, 204 comments were in favor for the requested change and 120 were against the requested change. The comments in favor of the change generally felt the additional restrictions to the bridge would help alleviate vehicular traffic on or around the bridge and the surrounding area. For the comments that opposed the change, by and large, the main concern was safety of mariners due to strong tidal currents and the high level of vessel activities occurring in the waters near the bridge. Strong currents, the close proximity of mooring fields and marinas would hamper the ability to “keep on station” while waiting for a bridge opening. Also, sailing vessels waiting for bridge opening would be required to be moving constantly all the while avoiding other waiting vessel traffic. The requested change to the operating schedule would extend the twice an hour draw opening schedule by an additional three hours into the evening. Concern was expressed by having to wait for an opening in darkness, stating this would cause additional hazards due to vessels already underway, traffic lights against the city and vehicular lights adjacent to the waterway. The Coast Guard acknowledges all of the above safety concerns, and for that reason, we find that any benefits of the possible additional restrictions to the Bridge of Lions do not outweigh the additional hazards to vessels and mariners transiting the area around the bridge. The current regulation as written in 33 CFR 117.261(d) will remain in effect.
U.S. Copyright Office, Library of Congress.
Notice of proposed rulemaking.
The United States Copyright Office (“Copyright Office” or “Office”) is conducting the seventh triennial rulemaking proceeding under the Digital Millennium Copyright Act (“DMCA”), concerning possible temporary exemptions to the DMCA's prohibition against circumvention of technological measures that control access to copyrighted works. In this proceeding, the Copyright Office has established a new, streamlined procedure for the renewal of exemptions that were granted during the sixth triennial rulemaking. It is also considering petitions for new exemptions to engage in activities not currently permitted by existing exemptions. On June 30, 2017, the Office published a Notice of Inquiry requesting petitions to renew existing exemptions and comments in response to those petitions, as well as petitions for new exemptions to engage in activities not currently permitted by existing exemptions. The Office has carefully considered the comments received in response to that Notice. With this Notice of Proposed Rulemaking (“NPRM”), the Office intends to recommend each of the existing exemptions for readoption. This NPRM also initiates three rounds of public comment on the newly-proposed exemptions. Interested parties are invited to make full legal and evidentiary submissions in support of or in opposition to the proposed exemptions, in accordance with the requirements set forth below.
Initial written comments (including documentary evidence) and multimedia evidence from proponents and other members of the public who support the adoption of a proposed exemption, as well as parties that
The Copyright Office is using the
Sarang Vijay Damle, General Counsel and Associate Register of Copyrights, by email at
On June 30, 2017, the Office published a Notice of Inquiry requesting petitions to renew current exemptions, oppositions to the renewal petitions, and petitions for newly proposed exemptions (the “Notice of Inquiry”) in connection with the seventh triennial section 1201 rulemaking.
With this NPRM, the Office sets forth the exemptions the Register of Copyrights intends to recommend for readoption without the need for further development of the administrative record, and outlines the proposed classes for new exemptions for which the Office initiates three rounds of public comment.
As the Notice of Inquiry explained, for a temporary exemption from the prohibition on circumvention to be granted through the triennial rulemaking, it must be established that “persons who are users of a copyrighted work are, or are likely to be in the succeeding 3-year period, adversely affected by the prohibition . . . in their ability to make noninfringing uses under [title 17] of a particular class of copyrighted works.”
In evaluating the evidence, the Register must consider the following statutory factors: 1. The availability for use of copyrighted works; 2. the availability for use of works for nonprofit archival, preservation, and educational purposes; 3. the impact that the prohibition on the circumvention of technological measures applied to copyrighted works has on criticism, comment, news reporting, teaching, scholarship, or research; 4. the effect of circumvention of technological measures on the market for or value of copyrighted works; and 5. such other factors as the Librarian considers appropriate.”
The Office has previously articulated the substantive legal and evidentiary standard for the granting of an exemption under section 1201(a)(1) multiple times, including in its recently-issued video and PowerPoint tutorials, the 1201 Study, and in prior recommendations of the Register concerning proposed classes of exemptions, each of which is accessible from the Office's 1201 rulemaking Web page at
• The proposed class includes at least some works protected by copyright.
• The uses at issue are noninfringing under title 17.
• Users are adversely affected in their ability to make such noninfringing uses or, alternatively, users are likely to be adversely affected in their ability to make such noninfringing uses during the next three years. This element is analyzed in reference to section 1201(a)(1)(C)'s five statutory factors.
• The statutory prohibition on circumventing access controls is the cause of the adverse effects.
The Register will consider the Copyright Act and relevant judicial precedents when analyzing whether a proposed use is likely to be noninfringing.
During this rulemaking, the Office initiated a new streamlined process for recommending readoption of previously-adopted exemptions to the Librarian. As the Office explained in its recent 1201 Study, the “Register must apply the same evidentiary standards in recommending the renewal of exemptions as for first-time exemption requests,” and the statute requires that “a determination must be made specifically for each triennial period.”
Based on this understanding of the statutory scheme, the Office solicited petitions for the renewal of exemptions as they are currently formulated, without modification. Thus, if a proponent sought to engage in any activities not currently permitted by an existing exemption, a petition for a new exemption had to have been submitted. This is because streamlined renewal is based upon a determination that, due to a lack of legal, marketplace, or technological changes, the factors that led the Register to recommend adoption of the exemption in the prior rulemaking will continue into the forthcoming triennial period.
The Office received thirty-nine petitions to renew existing exemptions, including at least one petition to renew each currently-adopted exemption. Each petition to renew an existing exemption included an explanation summarizing the basis for claiming a continuing need and justification for the exemption. In each case, petitioners also signed a declaration stating that, to the best of their personal knowledge, there has not been any material change in the facts, law, or other circumstances set forth in the prior rulemaking record such that renewal of the exemption would not be justified.
The Office also received six comments in response to the renewal petitions; five did not oppose renewal, but offered more general comments, and one was styled as an opposition to renewal. One general comment filed by the Entertainment Software Association, the Motion Picture Association of America, Inc., and the Recording Industry Association of America, Inc. (collectively, “Joint Creators”) raised some overarching issues with the renewal petitions. Specifically, Joint Creators expressed concern that many of the renewal petitions “were based on what the petitioners attest they have been told by others, rather than on their own personal knowledge.”
As detailed below, after reviewing the petitions for renewal and comments in response, the Office concludes that it has received a sufficient petition to renew each existing exemption and it does not find any meaningful opposition to renewal. Accordingly, the Register intends to recommend readoption of all existing exemptions in their current form.
Multiple organizations petitioned to renew the exemption for literary works distributed electronically (
Based on the information provided in the renewal petitions and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Hugo Campos, member of the Coalition of Medical Device Patients and Researchers, and represented by the Harvard Law School Cyberlaw Clinic, petitioned to renew the exemption covering access to patient data on networked medical devices (codified at 37 CFR 201.40(b)(10)).
Based on the information provided in the renewal petition and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Multiple organizations petitioned to renew the exemption for computer programs that operate cellphones, tablets, mobile hotspots, or wearable devices (
Based on the information provided in the renewal petitions and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Multiple organizations petitioned to renew the exemptions for computer programs that operate smartphones, smart TVs, tablets, or other all-purpose mobile computing devices, to allow the device to interoperate with or to remove software applications (“jailbreaking”) (codified at 37 CFR 201.40(b)(4)-(5)).
In a brief two-page comment, BSA | The Software Alliance (“BSA”) opposed the readoption of this exemption, stating that “alternatives to circumvention exist,” and that “jailbreaking can undermine the integrity and security of a platform's operating system in a manner than facilitates copyright infringement and exposes users to heightened risks of privacy violations.”
As the Office explained in the Notice of Inquiry, “[o]pposition to a renewal petition must be meaningful, such that, from the evidence provided, it would be reasonable for the Register to conclude that the prior rulemaking record and any further information provided in the renewal petition are insufficient to support recommending renewal of an exemption.”
The Office finds that BSA's comment largely re-articulates a general opposition to a jailbreaking exemption, and notes that the past three rulemakings have adopted some form of an exemption for jailbreaking certain types of mobile computing devices.
The Office therefore concludes that BSA's opposition is not sufficiently meaningful to draw the conclusion that the past rulemaking record is no longer reliable, or that the reasoning adopted in the Register's 2015 Recommendation cannot be relied upon for the next three-year period.
Based on the information provided in the renewal petitions and the lack of meaningful opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Multiple organizations petitioned to renew the exemption for computer programs that control motorized land vehicles, including farm equipment, for purposes of diagnosis, repair, and modification of the vehicle (codified at 37 CFR 201.40(b)(6)).
Although not opposing readoption of this exemption, in response to Auto Care, CTA, iFixit, and ORI's renewal petition, the Auto Alliance submitted comments to clarify that the Office “should reject any part of the . . . petition that argues for expanding the current temporary exemption . . . in section 201.40(b)(6), and should only consider the petition to the extent it seeks renewal of the current exemption as it is currently formulated, without modification.”
Based on the information provided in the renewal petitions and the lack of opposition to the specific exemption, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Multiple organizations and security researchers petitioned to renew the exemption for purposes of good-faith security research (codified at 37 CFR 201.40(b)(7)).
No oppositions were filed against readoption of this exemption. To the contrary, MEMA, which during the sixth triennial rulemaking initially opposed any exemption that would impact the software and TPMs in vehicles, now supports renewal of this exemption because it strikes “an appropriate balance between encouraging marketplace competition and innovation while mitigating the impact on safety, regulatory, and environmental compliance.”
Based on the information provided in the renewal petitions and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Michael Weinberg and ORI jointly petitioned to renew the exemption for computer programs that operate 3D printers to allow use of alternative feedstock (codified at 37 CFR 201.40(b)(9)).
Based on the information provided in the renewal petition and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Multiple organizations petitioned to renew the exemption for video games for which outside server support has been discontinued (codified at 37 CFR 201.40(b)(8)).
Based on the information provided in the renewal petitions and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Multiple individuals and organizations petitioned to renew the exemption for motion pictures for educational uses by college and university instructors and students (codified at 37 CFR 201.40(b)(1)(iv)).
The DVD Copy Control Association (“DVD CCA”) and The Advanced Access Content System Licensing Administrator (“AACS LA”) submitted comments regarding readoption of this exemption. Although DVD CCA and AACS LA did not oppose readoption, they stated that the exemption is “predicated on the need for close analysis of the film in uses that constitute criticism or comment,” and suggested that Joint Educators, AAUP, ICA, DCSUM, SCMS, and LCA did “not focus on the need for close analysis of the film” in their renewal petition.
As noted above, the Office's Notice of Inquiry stated that renewal petitions are to seek readoption of current exemptions as they are currently formulated, without modification. Therefore, the Office focused on whether the renewal petition provided sufficient information to warrant readoption of the exemption in its current form. In this case, Joint Educators, AAUP, ICA, DCSUM, SCMS, and LCA did state that “
Based on the information provided in the renewal petitions and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
To the extent petitioners seek a broader exemption, the Office notes that petitions for new exemptions were filed seeking modification of the existing exemptions for educational uses of motion pictures. This NPRM initiates public comment on such modification through Proposed Class 1 described below, which combines multiple petitions for modified exemptions, including one by Joint Educators.
Multiple organizations petitioned to renew the exemption for motion pictures for educational uses by K-12 instructors and students (codified at 37 CFR 201.40(b)(1)(vi)).
Based on the information provided in the renewal petitions and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Joint Educators, ICA, DCSUM, SCMS, and LCA petitioned to renew the exemption for motion pictures for educational uses in massive open online courses (“MOOCs”) (codified at 37 CFR 201.40(b)(1)(v)).
Based on the information provided in the renewal petition and the lack of opposition, the Register believes that the
Multiple organizations petitioned to renew the exemption for motion pictures for educational uses in digital and literacy programs offered by libraries, museums, and other nonprofits (codified at 37 CFR 201.40(b)(1)(viii)).
Based on the information provided in the renewal petitions and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
A professor and two organizations collectively petitioned to renew the exemption for motion pictures for multimedia e-books offering film analysis (codified at 37 CFR 201.40(b)(1)(iii)).
Based on the information provided in the renewal petition and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Multiple organizations petitioned to renew the exemption for motion pictures for uses in documentary films (codified at 37 CFR 201.40(b)(1)(i)).
Based on the information provided in the renewal petitions and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
Two organizations petitioned to renew the exemption for motion pictures for uses in noncommercial videos (codified at 37 CFR 201.40(b)(1)(ii)).
Although no oppositions were filed against readoption of the exemption as it currently exists, Joint Creators submitted comments expressing concern that OTW's renewal petition proposed using language from the triennial rulemaking initiated in 2008 instead of readopting the exemption without modification.
As noted above, the Office's Notice of Inquiry stated that renewal petitions are to seek readoption of current exemptions as they are currently formulated, without modification. As a result, the Office did not consider, as part of the renewal process, sections of renewal petitions to the extent that they proposed uses beyond the current exemptions. The Office concludes, however, that OTW's submission, fairly read, did sufficiently petition for renewal of the exemption as it currently exists, providing detailed information
Based on the information provided in the renewal petitions and the lack of opposition, the Register believes that the conditions that led to adoption of this exemption are likely to continue during the next triennial period. Accordingly, the Register intends to recommend renewal of this exemption.
To the extent OTW seeks modification of the existing noncommercial video exemption, the Office notes that a petition for a new exemption was filed seeking such modification. This NPRM initiates public comment on that modification through the proposed class described below.
Having addressed the petitions to renew existing exemptions, the Office now turns to the petitions for new or expanded exemptions. The Office received twenty-three petitions, which it has organized into twelve classes, as described below. Before turning to a description of those classes, the Office first explains the process and standards for submission of written comments.
Persons wishing to address proposed exemptions in written comments should familiarize themselves with the substantive legal and evidentiary standards for the granting of an exemption under section 1201(a)(1), which are also described in more detail on the Office's form for submissions of longer comments, available on its Web site. In addressing factual matters, commenters (both proponents and opponents) should be aware that the Office favors specific, “real-world” examples supported by evidence over speculative, hypothetical observations. In cases where the technology at issue is not apparent from the requested exemption, it can be helpful for commenters to describe the TPM(s) that control access to the work and method of circumvention.
Commenters' legal analysis should explain why the proposal meets or fails to meet the criteria for an exemption under section 1201(a)(1), including, without limitation, why the uses sought are or are not noninfringing as a matter of law. The legal analysis should also discuss statutory or other legal provisions that could impact the necessity for or scope of the proposed exemption (for example, the Unlocking Consumer Choice and Wireless Competition Act (“Unlocking Act”), or 17 U.S.C. 117). Legal assertions should be supported by statutory citations, relevant case law, and other pertinent authority. In cases where a class proposes to expand an existing exemption, commenters should focus their comments on the legal and evidentiary bases for modifying the exemption, rather than the underlying exemption; as discussed above, the Register intends to recommend each current temporary exemption for renewal.
To ensure a clear and definite record for each of the proposals, commenters are required to provide a separate submission for each proposed class during each stage of the public comment period. Although a single comment may not address more than one proposed class, the same party may submit multiple written comments on different proposals. The Office acknowledges that the requirement of separate submissions may require commenters to repeat certain information across multiple submissions, but the Office believes that the administrative benefits of creating a self-contained, separate record for each proposal will be worth the modest amount of added effort.
The first round of public comment is limited to submissions from proponents (
Proponents of exemptions should present their complete affirmative case for an exemption during the initial round of public comment, including all legal and evidentiary support for the proposal. Members of the public who oppose an exemption should present the full legal and evidentiary basis for their opposition in the second round of public comment. The third round of public comment will be limited to supporters of particular proposals and those who neither support nor oppose a proposal, who, in either case, seek to reply to points made in the earlier rounds of comments. Reply comments should not raise new issues, but should instead be limited to addressing arguments and evidence presented by others.
As noted above, the Office has reviewed and classified the proposed exemptions set forth in the twenty-three petitions received in response to its Notice of Inquiry. Any exemptions adopted as part of this rulemaking must be based on “a particular class of works”
Each proposed class is briefly described below; additional information can be found in the underlying petitions posted on
In addition, after examining the petitions, the Office has preliminarily identified some initial legal and factual areas of interest with respect to certain proposed classes. The Office stresses, however, that these areas are not exhaustive, and
Several petitions seek expansion of existing exemptions for circumvention of access controls protecting excerpts of motion pictures on DVDs, Blu-Ray discs, and digitally transmitted video for purposes of criticism and comment by various users, including creators of noncommercial videos, college and university faculty and students, faculty of massive open online courses (“MOOCs”), documentary filmmakers, and for multimedia e-books offering film analysis.
Because the new proposals raise some shared concerns, including the impact of TPMs on the alleged noninfringing uses of motion pictures and whether alternative methods of accessing the content could alleviate potential adverse impacts, the Office has grouped these petitions into one class. This grouping is without prejudice to further refinement of this class, including whether it should be parsed back into subclasses based on specific uses, following the approach of past rulemakings. This approach also accounts for a joint petition by EFF, NMR, and OTW, which seeks to collapse (essentially) the existing exemptions for excerpts of motion pictures to eliminate limitations on the types of user or use, instead allowing circumvention so long as the purpose is for criticism and comment.
Motion Pictures (including television shows and videos), as defined in 17 U.S.C. 101, where circumvention is undertaken solely in order to make use of short portions of the works for the purpose of criticism or comment, where the motion picture is lawfully made and acquired on a DVD protected by the Content Scrambling System, on a BluRay disc protected by the Advanced Access Control System, via a digital transmission protected by a technological measure, or a similar technological protection measure intended to control access to a work, where the person engaging in circumvention reasonably believes that non-circumventing alternatives are unable to produce the required level of high-quality source material.
Beyond EFF, NMR, and OTW's proposal, the other petitions seek to expand upon existing exemptions for purposes of criticism and comment, but in a more limited way. Specifically, Professor Buster, Authors Alliance, and OTW propose expanding the exemption for multimedia e-books offering film analysis (codified at 37 CFR 201.40(b)(1)(iii)) by removing the “nonfiction” and “offering film analysis” limitations, and removing references to screen-capture technology.
The two remaining petitions seek to expand the current exemptions for educational uses. Brigham Young University (“BYU”) and BYU—Idaho, Intellectual Property Office (“BYU IPO”) seek expansion of the exemption for educational uses by college and university students and instructors to more broadly cover “uses where circumvention is undertaken to facilitate performance of motion pictures in the course of face-to-face teaching activities, as set forth in 17 U.S.C. 110(1)”; “use of more than short portions of motion picture excerpts”; and “uses beyond film studies or other courses requiring close analysis of film and media excerpts.”
Joint Educators seek to expand the exemption for motion pictures for educational uses in MOOCs; specifically, they propose removing the “accredited non-profit educational institutions” and “massive open online courses” limitations, and extending the exemption to “
In addition, two petitioners seek clarification that “the use of screen-capture technology does not constitute circumvention,” which presumably might result in the removal of current regulatory exemptions for screen capture technology, as they would be unnecessary.
This proposed class would permit circumvention of TPMs for motion pictures by “disability services offices, organizations that support people with disabilities, libraries, and other units at educational institutions that are responsible for fulfilling those institutions' legal and ethical obligations to make works accessible to people with disabilities,” “where circumvention is undertaken for the purpose of making a motion picture accessible to people with disabilities, including through the provision of closed and open captions and audio description.”
The Office seeks comment on whether this proposed exemption should be adopted, including any proposed regulatory language.
This proposed class would allow circumvention of access controls on lawfully made and acquired audiovisual works for the purpose of noncommercial space-shifting or format-shifting. The Office received two petitions seeking an exemption permitting circumvention of TPMs on DVDs and Blu-ray discs for space-shifting or format-shifting for personal use.
This proposed class would allow circumvention of TPMs “to make noninfringing uses of audiovisual works that are subject to High-bandwidth Digital Content Protection (“HDCP”),” which restricts access to audiovisual works passing over High-Definition Multimedia Interface (“HDMI”) connections, such as through an HDMI cable.
The Office seeks comment on whether this proposed exemption should be adopted, including any proposed regulatory language. The Office encourages commenters, in the course of detailing whether the proposed exemption meets the requirements of section 1201(a)(1), to address the specific types of audiovisual works that would be accessed by this exemption, to provide examples of the types of noninfringing uses implicated, to address whether viable alternatives to circumvention exist, and to detail the effect circumvention might have on the market for or value of copyrighted works.
The proposed class would permit the circumvention of TPMs for computer programs that operate new and used “wireless devices” to allow connection to an alternative wireless network (a process commonly known as “unlocking”).
The Office seeks comment on whether this proposed exemption should be adopted, including specific examples demonstrating adverse effects stemming from a consumer's inability to choose the mobile wireless communications provider for a new wireless device.
The proposed class would allow circumvention of TPMs protecting “general-purpose portable computing devices” to allow the devices to interoperate with or to remove software applications (“jailbreaking”).
Computer programs that enable smartphones and general-purpose portable computing devices to execute lawfully obtained software applications, where circumvention is accomplished solely for one or more of the following purposes: to enable interoperability of such applications with computer programs on the smartphone or device, to enable or disable hardware features of the smartphone or device, or to permit removal of software from the smartphone or device. For purposes of this exemption, a “general-purpose portable computing device” is a portable device that is primarily designed or primarily used to run a wide variety of programs rather than for consumption of a particular type of media content, is equipped with
The Office notes that during the 2015 rulemaking, the Register recommended the adoption of the current exemption for “portable all-purpose mobile computing devices,” in part, because the record “meaningfully defined” such devices.
The Office seeks comment on whether this proposed exemption should be adopted, including on the definitions of “portable,” “carried,” and “used in the home” that would govern the proposed exemption. The Office welcomes examples of specific types of devices that would be encompassed by the exemption other than those enumerated in the existing exemption codified at 37 CFR 201.40(b)(4).
Multiple organizations petitioned for exemptions relating to diagnosis, repair, and modification.
Three petitions seek to expand the existing exemption to allow third parties to provide services on behalf of owners of motorized land vehicles, an issue that also raises potential issues with respect to the anti-trafficking prohibitions under section 1201(a)(2) and (b).
Similarly, two petitions raise the question of potential interaction with anti-trafficking rules under section 1201(a)(2) and (b) by proposing to expand the exemption to allow the “development and sale of repair tools,”
The Office seeks comment on whether an expanded exemption to cover additional repair and related activities should be adopted, including any proposed regulatory language.
The proposed class would expand upon the current exemption (codified at 37 CFR 201.40(b)(8)) permitting circumvention “by an eligible library, archives, or museum,” of TPMs protecting video games, for which outside server support has been discontinued. Specifically, The Museum of Art and Digital Entertainment (“MADE”) proposes expanding the existing exemption “to further include multiplayer online games, video games with online multiplayer features, and massively multiplayer online games (MMOs), whether stored physically or in downloadable formats, and [to] add preservationists affiliated with archival institutions as users.”
The Office seeks comment on whether this proposed expanded exemption for abandoned video games should be adopted, including any proposed regulatory language. Specifically, the Office welcomes discussion of how the existing exemption excludes
The proposed class would allow circumvention of TPMs “on lawfully acquired software” by “libraries, archives, museums, and other cultural heritage institutions” “for the purposes of preserving software and software-dependent materials.”
Unlike many of the other classes, this proposal represents an entirely new exemption. The Office seeks comment on whether this proposed exemption should be adopted, including specific examples of the types of noninfringing uses that are, or in the next three years, likely to be adversely affected by the prohibition on circumvention, whether viable alternatives to circumvention exist, discussion of the types of works sought to be accessed, and the specific TPMs implicated by the proposed exemption. The Office specifically seeks comment as to whether or how the exception in section 108 for libraries and archives is relevant to this exemption.
The Office received three petitions to expand the exemption for good-faith security research of computer programs that operate devices and machines primarily designed for use by individual consumers (including voting machines), motorized land vehicles, or medical devices designed for implantation in patients and corresponding personal monitoring systems (codified at 37 CFR 201.40(b)(7)).
Two petitions propose removing the specific security research categories listed under section 201.40(b)(7)(i)(A)-(C), as well as the following limitations: 1. The “lawfully acquired device or machine” limitation; 2. the “solely” limitation (
The Office notes that during the 2015 triennial rulemaking, the Register determined that the then-existing record did not support adopting an exemption that encompassed all computer programs on all systems and devices, and her recommendation discusses the rationale for the other current limitations.
The Office seeks comment on whether an expanded exemption for security research should be adopted, including discussion of the proposed regulatory language, contrasted with the current temporary and permanent exemptions for this activity.
This proposed class would allow circumvention of TPMs to access data output by electronic systems used on aircraft, artificial satellites, and spacecraft; such systems are referred to as “avionics.” Specifically, Air Informatics LLC (“AI”) proposed an exemption to circumvent computer programs protecting “access to aircraft flight, operations, maintenance and security data captured by computer programs or firmware.”
The Office seeks comment on whether this exemption should be adopted, including 1. specific examples of the types of noninfringing uses that are, or in the next three years, likely to be adversely affected by a prohibition on circumvention; 2. a description of the specific TPMs sought to be circumvented; 3. the methods for circumvention; 4. the environment in which the circumvention would be accomplished; and 5. whether the proposed exemption could have negative repercussions with respect to safety or security with respect to the works at issue, or otherwise in a manner relevant to section 1201(a)(1)'s statutory factors (for example, by making it easier for wrongdoers to access sensitive data or databases).
This proposed class would expand the current exemption for computer programs that operate 3D printers (codified at 37 CFR 201.40(b)(9)) to allow use of non-manufacturer-approved feedstock in the printers, regardless of whether the 3D printers produce goods or materials for use in commerce the physical production of which is subject to legal or regulatory oversight, or where the circumvention is otherwise unlawful. Specifically, the
The Office seeks comment on whether this expanded exemption for 3D printing should be adopted.
As in prior rulemakings, after receipt of written comments, the Office will continue to solicit public engagement to create a comprehensive record. Described below are the future phases of the administrative process that will be employed for this rulemaking, so that parties may use this information in their planning.
The Copyright Office intends to hold public hearings following the last round of written comments. The hearings will be conducted in Washington DC during the week of April 9, 2018 and in California with a date and location to be determined. A separate notice providing details about the hearings and how to participate will be published in the
As with previous rulemakings, following the hearings, the Copyright Office may request additional information with respect to particular classes from rulemaking participants. The Office may rely on this process in cases where it would be useful for participants to supply missing information for the record or otherwise resolve issues that the Office believes are material to particular exemptions. Such requests for information will take the form of a letter from the Copyright Office and will be addressed to individual parties involved in the proposal as to which more information is sought. While responding to such a request will be voluntary, any response will need to be supplied by a specified deadline. After the receipt of all responses, the Office will post the questions and responses on the Office's Web site as part of the public record.
In its 1201 Study, the Office noted that, in response to stakeholder requests, it would consider in this rulemaking whether to utilize informal meetings to discuss proposed regulatory language or address discrete issues prior to issuing a recommendation, including by establishing guidelines for
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to notify the public that it has received a negative declaration for the City of Philadelphia Air Management Services (Philadelphia AMS) for sewage sludge incineration (SSI) units. This negative declaration certifies that SSI units subject to the requirements of sections 111(d) and 129 of the Clean Air Act (CAA) do not exist within the City of Philadelphia in the Commonwealth of Pennsylvania. EPA is accepting the negative declaration in accordance with the requirements of the CAA. In the Final Rules section of this issue of the
Comments must be received in writing by November 27, 2017.
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2017-0509 at
Michael Gordon, (215) 814-2039, or by email at
For further information regarding the negative declaration submitted by Philadelphia AMS for SSI units, please see the information provided in the technical support document in the rulemaking docket and in the direct final action, with the same title, that is located in the “Rules and Regulations” section of this issue of the
Environmental Protection Agency (EPA).
Proposed rule.
As required under section 8(b)(10)(D) of the Toxic Substances Control Act (TSCA), EPA is proposing reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound.” The requirements would be applicable to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process. Based on the inventory of information collected, the Agency is directed to “identify any manufacturing processes or products that intentionally add mercury; and . . . recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.” At this time, EPA is not making such identifications or recommendations.
Comments must be received on or before December 26, 2017.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0421, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
You may be potentially affected by this action if you manufacture (including import) mercury or mercury-added products, or if you otherwise intentionally use mercury in a manufacturing process. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Gold ore mining (NAICS code 212221)
• Lead ore and zinc ore mining (NAICS code 212231)
• All other metal ore mining (NAICS code 212299)
• Asphalt shingle and coating materials manufacturing (NAICS code 324122)
• Synthetic dye and pigment manufacturing (NAICS code 325130)
• Other basic inorganic chemical manufacturing (NAICS code 325180)
• All other basic organic chemical manufacturing (NAICS code 325199)
• Plastics material and resin manufacturing (NAICS code 325211)
• Pesticide and other agricultural chemical manufacturing (NAICS code 325320)
• Medicinal and botanical manufacturing (NAICS code 325411)
• Pharmaceutical preparation manufacturing (NAICS code 325412)
• Biological product (except diagnostic) manufacturing (NAICS code 325414)
• Paint and coating manufacturing (NAICS code 325510)
• Adhesive manufacturing (NAICS code 325520)
• Custom compounding of purchased resins (NAICS code 325991)
• Photographic film, paper, plate, and chemical manufacturing (NAICS code 325992)
• All other miscellaneous chemical product and preparation manufacturing (NAICS code 325998)
• Unlaminated plastics film and sheet (except packaging) manufacturing (NAICS code 326113)
• Unlaminated plastics profile shape manufacturing (NAICS code 326121)
• Urethane and other foam product (except polystyrene) manufacturing (NAICS code 326150)
• All other plastics product manufacturing (NAICS code 326199)
• Tire manufacturing (NAICS code 326211)
• All other rubber product manufacturing (NAICS code 326299)
• Iron and steel mills and ferroalloy manufacturing (NAICS code 331110)
• Rolled steel shape manufacturing (NAICS code 331221)
• Alumina refining and primary aluminum production (NAICS code 331313)
• Secondary smelting and alloying of aluminum (NAICS code 331314)
• Nonferrous metal (except aluminum) smelting and refining (NAICS code 331410)
• Secondary smelting, refining, and alloying of nonferrous metal (except copper and aluminum) (NAICS code 331492)
• Iron foundries (NAICS code 331511)
• Steel foundries (except investment) (NAICS code 331513)
• Fabricated structural metal manufacturing (NAICS code 332312)
• Industrial valve manufacturing (NAICS code 332911)
• Ammunition except small arms manufacturing (NAICS code 332993)
• Small arms, ordnance, and ordnance accessories manufacturing (NAICS code 332994)
• All other miscellaneous fabricated metal product manufacturing (NAICS code 332999)
• Food product machinery manufacturing (NAICS code 333294)
• Office machinery manufacturing (NAICS code 333313)
• Other commercial and service industry machinery manufacturing (NAICS code 333319)
• Heating equipment (except warm air furnaces) manufacturing (NAICS code 333414)
• Air-conditioning and warm air heating equipment and commercial and industrial refrigeration equipment manufacturing (NAICS code 333415)
• Pump and pumping equipment manufacturing (NAICS code 333911)
• Bare printed circuit board manufacturing (NAICS code 334412)
• Semiconductor and related device manufacturing (NAICS code 334413)
• Other electronic component manufacturing (NAICS code 334419)
• Electromedical and electrotherapeutic apparatus manufacturing (NAICS code 334510)
• Search, detection, navigation, guidance, aeronautical, and nautical system and instrument manufacturing (NAICS code 334511)
• Automatic environmental control manufacturing for residential, commercial, and appliance use (NAICS code 334512)
• Instruments and related products manufacturing for measuring, displaying, and controlling industrial process variables (NAICS code 334513)
• Totalizing fluid meter and counting device manufacturing (NAICS code 334514)
• Instrument manufacturing for measuring and testing electricity and electrical signals (NAICS code 334515)
• Analytical laboratory instrument manufacturing (NAICS code 334516)
• Watch, clock, and part manufacturing (NAICS code 334518)
• Other measuring and controlling device manufacturing (NAICS code 334519)
• Electric lamp bulb and part manufacturing (NAICS code 335110)
• Commercial, industrial, and institutional electric lighting fixture manufacturing (NAICS code 335122)
• Other lighting equipment manufacturing (NAICS code 335129)
• Electric house wares and household fan manufacturing (NAICS code 335211)
• Household vacuum cleaner manufacturing (NAICS code 335212)
• Household cooking appliance manufacturing (NAICS code 335221)
• Household refrigerator and home freezer manufacturing (NAICS code 335222)
• Household laundry equipment manufacturing (NAICS code 335224)
• Other major household appliance manufacturing (NAICS code 335228)
• Switchgear and switchboard apparatus manufacturing (NAICS code 335313)
• Relay and industrial control manufacturing (NAICS code 335314)
• Primary battery manufacturing (NAICS code 335912)
• Current-carrying wiring device manufacturing (NAICS code 335931)
• All other miscellaneous electrical equipment and component manufacturing (NAICS code 335999)
• Light truck and utility vehicle manufacturing (NAICS code 336112)
• Heavy duty truck manufacturing (NAICS code 336120)
• Motor home manufacturing (NAICS code 336213)
• Travel trailer and camper manufacturing (NAICS code 336214)
• Other aircraft parts and auxiliary equipment manufacturing (NAICS code 336413)
• Boat building (NAICS code 336612)
• Motorcycles and parts manufacturing (NAICS code 336991)
• Surgical and medical instrument manufacturing (NAICS code 339112)
• Costume jewelry and novelty manufacturing (NAICS code 339914)
• Game, toy, and children's vehicle manufacturing (NAICS code 339932)
• Sign manufacturing (NAICS code 339950)
• Other chemical and allied products merchant wholesalers (NAICS code 424690)
• Research and development in the physical, engineering, and life sciences (except biotechnology) (NAICS code 541712)
• Hazardous waste treatment and disposal (NAICS code 562211)
• Other nonhazardous waste treatment and disposal (NAICS code 562219)
• Materials recovery facilities (NAICS code 562920)
• National security (NAICS code 928110)
EPA is issuing a proposed rule under TSCA section 8(b)(10) to require reporting to assist in the preparation of “an inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound.” Hereinafter “mercury” will refer to both elemental mercury and mercury compounds collectively, except where separately identified. This proposed rule would require reporting from any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process. EPA published its initial inventory report in the
In addition, this information could be used by the U.S. Government to assist in its national reporting regarding its implementation of the Minamata
EPA is proposing that supply, use, and trade of mercury include reporting requirements for activities comparable to established TSCA terms: Manufacture, import, distribution in commerce, storage, and export. The reporting requirements also would apply to otherwise intentional use of mercury in a manufacturing process. Persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process, would report amounts of mercury in pounds (lbs.) used in such activities during a designated reporting year. Reporters also would identify specific mercury compounds, mercury-added products, manufacturing processes, and how mercury is used in manufacturing processes, as applicable, from pre-selected lists. For certain activities, reporters would provide additional, contextual data (
The proposed reporting requirements would not apply to persons engaged in the generation, handling, or management of mercury-containing waste, unless that person manufactures or recovers mercury in the management of that waste with the intent to use the recovered mercury or store it for use. In addition, persons engaged in trade (
In addition to topics where EPA notes that we are seeking specific comment, the Agency also encourages comment on all aspects of this proposal.
EPA is issuing a proposed rule under TSCA section 8(b)(10) to require reporting to assist in the preparation of the statutorily-required inventory of mercury supply, use, and trade in the United States. This proposed rule would require reporting from any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process. After the publication of its initial inventory report in the
EPA is issuing this proposed rule pursuant to TSCA section 8(b)(10)(D) to implement the direction at TSCA section 8(b)(10)(B) that “[n]ot later than April 1, 2017, and every 3 years thereafter, the Administrator shall carry out and publish in the
In addition, the Paperwork Reduction Act (PRA) requires Federal agencies to manage information resources to reduce information collection burdens on the public; increase program efficiency and effectiveness; and improve the integrity, quality, and utility of information to all users within and outside an agency, including capabilities for ensuring dissemination of public information, public access to Federal Government information, and protections for privacy and security (44 U.S.C. 3506).
Section 2 of TSCA expresses the intent of Congress that EPA carry out TSCA in a reasonable and prudent manner, and in consideration of the impacts that any action taken under TSCA may have on the environment, the economy, and society (15 U.S.C. 2601). EPA is proposing to manage and leverage its information resources, including information technology, to require the use of electronic reporting in order to implement the mercury inventory reporting requirements of TSCA section 8(b)(10)(D) in a reasonable and prudent manner.
EPA has prepared an economic analysis of the potential impacts associated with this rulemaking (Ref. 3). The chief benefit of the proposed rule is the collection of detailed data on mercury, which will serve as a basis to recommend actions to further reduce mercury use in the United States, as required at TSCA section 8(b)(10)(C). Another benefit is the use of information collected under the proposed rule to help the United States implement its obligations under the Minamata Convention. There are no quantified benefits for the proposed rule. The statutory mandate specifically calls for and authorizes a rule to support an inventory of mercury supply, use, and trade in the United States, in order to identify any manufacturing processes or products that intentionally add mercury and recommend actions to achieve further reductions in mercury use. As described in the Agency's economic analysis, unquantified
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2.
Mercury is a naturally occurring element that originates in the earth's crust and can be found in air, water, fish, and other biota. Mercury exists in three forms: Elemental, organic compounds, and inorganic compounds.
Elemental mercury (Chemical Abstracts Service Registry Number (CASRN) 7439-97-6) is a shiny, silver-white metal that is liquid at room temperature. Mercury compounds are formed when elemental mercury reacts with another substance, either in nature or intentionally by humans. Organic mercury compounds are formed in the environment when mercury combines with carbon. Inorganic mercury compounds take the form of mercury salts. EPA's TSCA Chemical Substance Inventory lists 69 mercury compounds (Ref. 4).
In the United States, elemental mercury and mercury compounds are used in the manufacture of mercury-added products and certain manufacturing processes. The typical lifecycle of products includes manufacture, distribution in commerce (including transport and storage), use, and waste management (landfilling or recycling). At any point in the product lifecycle, there is potential for mercury to be released. Globally, the major anthropogenic sources of released elemental mercury are the combustion of coal and use of elemental mercury in artisanal gold mining (Ref. 5). Emitted elemental mercury can be transported in the atmosphere on local, regional, and global scales as it cycles through air, land, and water (Ref. 6). Some of the emitted elemental mercury following deposition and transformation into divalent mercury can be biotransformed into methylmercury (Ref. 6).
Methylmercury is a persistent and bioaccumulative neurotoxicant. Exposure to methylmercury most commonly occurs when people eat kinds of fish and shellfish that have high levels of methylmercury in their tissues (Ref. 7). Almost all people have at least small amounts of methylmercury in their bodies, reflecting the widespread presence of methylmercury in the environment (Ref. 7). People exposed to high levels of methylmercury may experience adverse health effects (Ref. 7). Generally, the subtlest indicators of methylmercury toxicity are neurological changes (Ref. 7). Neurotoxic effects at comparatively low doses include subtle decrements in motor skills and sensory ability, while extremely high exposures can cause tremors, inability to walk, convulsions, and death (Ref. 7). Exposure to mercury can also cause adverse ecological effects
The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) (Pub. L. 114-182, 130 Stat. 448), enacted on June 22, 2016, implemented reforms to TSCA. Among other changes to TSCA, the Lautenberg Act amended TSCA section 8(b) to require EPA to establish: (1) An inventory of mercury supply, use, and trade in the United States; and (2) reporting requirements by rule applicable to any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process not later than June 22, 2018. (15 U.S.C. 2607(b)(10)). Information collected per the proposed reporting requirements would be used to periodically update the mercury inventory; identify any manufacturing processes or products that intentionally add mercury; and recommend actions, including proposed revisions of federal law or regulations, to achieve further reductions in mercury use (15 U.S.C. 2607(b)(10)). The Lautenberg Act also added certain mercury compounds to the TSCA section 12(c) ban on exporting of elemental mercury and authorized EPA to ban the export of additional mercury compounds by rule (15 U.S.C. 2611(c)). The Lautenberg Act also implemented other changes to the Mercury Export Ban Act of 2008 (MEBA) (Pub. L. 110-414, 122 Stat. 4341). Additional information on the Lautenberg Act is available on EPA's Web site at
Humans have mined, refined, and used mercury for a wide variety of purposes over thousands of years. In the United States, mercury was mined until 1991, but today is produced only as a byproduct of metals mining or by recovering mercury from waste (Ref. 8). In recent decades, mercury served as a catalyst in the chlor-alkali industry and in a variety of industrial, commercial, and consumer products (Ref. 8). Due to its toxicity and replacement by new technologies, many uses of mercury have been discontinued in the United States, and the overall quantity used has fallen dramatically in recent decades. For example, over the past three decades there has been a strong downward trend of more than 97 percent in the use of mercury in mercury-added products sold in the United States. In 1980, the United States used more than 1,800 metric tons of mercury in mercury-added products annually (Ref. 8). As described in the initial inventory conducted by EPA in 2017, by 2013, only approximately 40 metric tons of mercury in products were sold in the United States (Ref. 1). Many of these products sold have cost-effective, non-mercury substitutes (Ref. 1). The United States also has traded elemental mercury and mercury compounds worldwide, although MEBA prohibited the export of elemental mercury as of January 1, 2013 and prohibits the export of certain mercury compounds as of January 1, 2020.
Prior to developing its initial inventory, EPA reviewed federal and state reports and databases, among other sources, in order to assemble a collection of available information on mercury, mercury-added products, and manufacturing processes involving mercury (Ref. 1). In reviewing data obtained, the Agency found that its baseline of data lacked the specificity and level of detail required to develop a mercury inventory responsive to TSCA section 8(b)(10)(D) or to be useful to inform mercury use reduction efforts for both the public and private sectors (Ref. 1). For example, in 2015, to develop its understanding of domestic mercury supply and trade, the Agency collected information on the quantity of mercury sold in the United States for the years 2010 and 2013 from five companies identified as the primary recyclers and distributors of mercury in the United States (Ref. 9). Comparing totals for mercury sold in products and the amount of bulk mercury sold in the United States in 2013 revealed a significant data gap of approximately 26 metric tons. IMERC data showed approximately 40 metric tons of mercury in mercury-added products sold in the United States in 2013. The information collected by the Agency for bulk elemental mercury manufactured and processed in the United States in the same year was approximately 66 metric tons. In this instance, EPA determined that mercury may be used in manufacturing processes, including as a reactant or formulation component, which may not be reflected in the amount of mercury reported as sold in products. An additional data gap identified was the amount of mercury in exported mercury-added products. The Agency is also seeking to be able to differentiate between the amount of mercury in imported mercury-added products and the amount in mercury-added products manufactured in the United States. For example, importation or domestic manufacture of mercury-added products may or may not be reflected in data reported as domestic sale of mercury-added products. EPA is committed to further addressing such data gaps and considers the national mercury inventory mandated by Congress to be an instrumental means to establish the requisite body of information to support achievement of that goal.
In developing the proposed rule, the agency coordinated with the Northeast Waste Management Officials' Association, which administers the IMERC database, as directed by TSCA section 8(b)(10)(D)(ii), to avoid duplication.
This proposed rule, when finalized, would provide for the collection of information that allows EPA to implement statutory requirements at TSCA section 8(b)(10)(B), which directs that “[n]ot later than April 1, 2017, and every 3 years thereafter, the Administrator shall carry out and publish in the
TSCA section 8(b)(10)(A) states “notwithstanding [TSCA] section 3(2)(B), the term `mercury' means . . . elemental mercury; and . . . a mercury compound” (15 U.S.C. 2607(b)(10)(A)). As such, the definition for mercury at TSCA section 8(b)(10)(A) supersedes the exclusions for “chemical substances” described in TSCA section 3(2)(B) that would otherwise apply to mercury, mercury-added products, or otherwise intentional uses of mercury in manufacturing processes. For example, any “drug, cosmetic, or device” as described in TSCA section 3(2)(B)(vi),
For purposes of the proposed rule, the Agency proposes that where EPA distinguishes between elemental mercury and mercury compounds, elemental mercury be limited to elemental mercury (CASRN 7439-97-6) and mercury compounds be inclusive of all instances where elemental mercury or a mercury compound is reacted with another chemical substance. Examples of mercury compounds from the TSCA Chemical Substance Inventory are listed in Table 2.
Pursuant to TSCA section 8(b)(10)(B), EPA interprets the scope of the mercury inventory to include activities within the domestic and global commodity mercury market that would fall under “supply, use, and trade of mercury in the United States.” An inventory that adequately accounts for mercury in supply, use, and trade includes activities of persons who must report as described in TSCA section 8(b)(10)(d)(i): Manufacture, import, and otherwise intentionally use mercury in a manufacturing process. In addition, the Agency proposes that persons required to report to the mercury inventory also include information on distribution in commerce, storage, and export in order to provide for the requisite inventory of mercury supply, use, and trade in the United States. EPA proposes that reporting to cover “supply” include manufacture and storage of mercury, reporting to cover “use” include use of mercury to manufacture a mercury-added product or otherwise intentional use of mercury in a manufacturing process, and reporting to cover “trade” include import, export, and distribution in commerce of mercury or mercury-added products. EPA proposes that obtaining information related to such activities, including reporting quantities of mercury, as well as qualitative information related to supply, use, and trade, is necessary to create the inventory described at TSCA section 8(b)(10)(B). Examples of such qualitative information include: Country of origin (for imports of mercury or mercury-added products), destination country (for exported mercury-added products or certain mercury compounds), and identification of purchasing or receiving industry sectors via NAICS codes (for mercury or mercury-added products distributed in domestic commerce).
In addition to using this information for the mercury inventory, this information would be used by the U.S. Government to assist in its implementation of the Minamata Convention (Ref. 2), in particular with respect to mercury supply sources and trade, mercury-added products, manufacturing processes in which mercury is used, and reporting. The United States is a Party to the Minamata Convention, which is a multilateral environmental agreement that addresses the supply, use, and trade in mercury by, among other actions, not allowing the introduction of new mercury mines and the phasing out of existing ones, phasing out and phasing down the use of mercury in a number of products and industrial processes, placing control measures on emissions to air and on releases to land and water, and taking action to reduce the use of mercury in the informal sector of artisanal and small-scale gold mining. EPA seeks comment on the proposed limited data collection requirements, such as the identification of countries that manufacture, import, or export mercury-added products (
In regard to certain exports of mercury, the Agency notes that the export of elemental mercury has been prohibited since January 1, 2013 (15 U.S.C. 2611(c)(1)) and therefore the Agency is not proposing to require reporting on the export of elemental mercury from the United States. TSCA, as of January 1, 2020, will also prohibit the export of certain mercury compounds: Mercury (I) chloride or calomel; mercury (II) oxide; mercury (II) sulfate; mercury (II) nitrate; and cinnabar or mercury sulphide (the statute uses the term “mercury sulphide” which is an alternative spelling of “mercury sulfide” as found in the table above) (15 U.S.C. 2611(c)(7)). EPA recognizes that a complete inventory would include at least one cycle of reporting prior to the effective date of the prohibition for export of the five mercury compounds subject to 15 U.S.C. 2611(c)(7). As such, the inventory would benefit from the recent totals of at least one cycle of reporting prior to the effective date of the prohibition for export of mercury compounds subject to 15 U.S.C. 2611(c)(7) to (1) measure trends in supply, use, and trade; and (2) provide a baseline for comparison of the changes in the amounts of other mercury compounds exported after the 2020 effective date. The Agency also recognizes that the 2020 effective date of 15 U.S.C. 2611(c)(7) is such that any reporting on those five compounds will not assist the Agency in recommending further actions to achieve further reductions in mercury use because the export ban will be in effect as of 2020. Therefore, EPA requests public comment on whether to require one-time reporting for exports of the mercury compounds prohibited from export by 15 U.S.C. 2611(c)(7). It should be noted that reporting for exports of mercury compounds that are not prohibited from export by 15 U.S.C. 2611(c)(7), as well as products that contain intentionally-added elemental mercury and/or any mercury compounds (including the compounds prohibited from export) will be required.
In order to obtain information for the mercury inventory with the necessary level of detail, EPA is proposing to require reporting on activities that are subsets of defined terms. For example, “manufacture” is defined in TSCA section 3(9) to mean: “import into the customs territory of the United States (as defined in general note 2 of the Harmonized Tariff Schedule of the United States), produce, or manufacture” (15 U.S.C. 2602(9)). While both manufacture and import are described in the statutory definition of “manufacture,” the Agency proposes to separate reporting for these activities of the mercury market in order to capture distinct actions by persons who handle and trade mercury. As such, EPA is proposing that persons required to report specify distinct amounts, if any, of imported or otherwise manufactured mercury, as well as amounts of mercury in imported or otherwise manufactured mercury-added products.
Conversely, the activity “otherwise intentionally uses mercury in a manufacturing process” is not defined under TSCA. The Agency considers this activity to be similar, but not identical to the definition for “process” at TSCA section 3(13): “preparation of a chemical substance or mixture, after its
Finally, TSCA section 8(f) states “[f]or purposes of [TSCA section 8], the terms `manufacture' and `process' mean manufacture or process for commercial purposes” (15 U.S.C. 2607(f)). Under a TSCA section 8(a) reporting rule, EPA has previously defined “manufacture for commercial purposes” for the purposes of other information gathering rules to include “import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer” and “substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including both byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture . . . [that] may, or may not, in themselves have commercial value” (40 CFR 704.3). In the same rule, similarly, EPA has defined “process for commercial purposes” as “the preparation of a chemical substance or mixture after its manufacture for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included in this definition. If a chemical substance or mixture containing impurities is processed for commercial purposes, then the impurities also are processed for commercial purposes” (40 CFR 704.3). EPA notes that there is a separate definition for “import for commercial purposes” at 40 CFR 704.3, but finds it to be substantially similar to germane portions of “manufacture for commercial purposes.”
EPA is proposing that the terms “manufacture,” “import,” and “otherwise intentional use of mercury in a manufacturing process” be interpreted for the purposes of mercury inventory reporting based on the aforementioned definitions in 40 CFR 704.3 and the statutory text at TSCA section 8(f). In regard to the manufacture (including import) of mercury as a byproduct, impurity, or similar occurrence, EPA considered whether such chemical substances are intentionally generated and whether such substances are used for commercial purposes. To synthesize these concepts, EPA is proposing to require reporting on mercury or mercury-containing byproducts manufactured for commercial purposes. Mercury generated as a byproduct not used for commercial purposes would not be subject to the proposed rule.
In addition, EPA is proposing that mercury that exists as an impurity would not be subject to the proposed rule, except where such impurities are present in a final product produced by persons who otherwise intentionally use mercury in a manufacturing process. EPA is distinguishing between the manufacture of mercury-added products versus the final products containing mercury that result from the intentional use of mercury in a manufacturing process. First, EPA considers the addition and presence of mercury in the final products of the former process to be intentional and, therefore, not an impurity. Conversely, EPA considers the presence of mercury in the final product resulting from the intentional use of mercury during the manufacturing processes identified in this proposed rule (see Unit III.D.5.) to be unintentional (
EPA determined that actions described in the definition of “distribution in commerce” at TSCA section 3(5): “to sell, or the sale of, the substance, mixture, or article in commerce; to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce of, the substance, mixture, or article; or to hold, or the holding of, the substance, mixture, or article after its introduction into commerce” (15 U.S.C. 2602(5)), are adequate to describe both distribution in commerce and storage for the proposed rule. In particular, the Agency is interested in quantities of mercury sold or transferred between facilities in the United States. As such, EPA is proposing to incorporate the concept of “domestic” as defined at 40 CFR 704.3 to activities considered to be distribution in commerce, as opposed to international import and export, which would be covered separately. Where “to hold” or “holding of” (
The Agency considered “export” in the context of “exporter” as defined in the TSCA section 12(b) export notification rule at 40 CFR part 707 Subpart D: “determining and controlling the sending of the chemical substance or mixture to a destination out of the customs territory of the United States” 40 CFR 707.63(b). For purposes of the proposed rule, however, the Agency believes that it is necessary to collect export data not only on certain mercury compounds, but also mercury-added products that are exported from the United States. As such, EPA would include articles in the reporting required for export.
Therefore, in summary, the Agency proposes to require reporting for the following activities:
• Import of mercury or a mercury-added product with the purpose of obtaining an immediate or eventual commercial advantage for the importer, except where such mercury is generated as a byproduct not used for commercial purposes or an impurity.
• Manufacture (other than import) of mercury or a mercury-added product with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, except where such mercury is generated as a byproduct not used for commercial purposes or an impurity. In this context, EPA considers manufacture to be the intentional production of mercury, a mercury compound, or a mercury-added product, as opposed to the uses described for “otherwise intentionally uses mercury in a manufacturing process.” Incidental manufacture of mercury (
• Otherwise intentional use of mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product, with the purpose of obtaining an immediate or eventual commercial advantage for the user, except where such mercury is generated as a byproduct not used for commercial purposes.
• Distribution in commerce, including domestic sale or transfer, of mercury or a mercury-added product.
• Storage of mercury after manufacture (including import).
• Export of mercury or a mercury-added product, including the determining and controlling the sending of mercury (unless specifically prohibited) or a mercury-added product to a destination out of the customs territory of the United States.
These proposed interpretations of terms are intended to align with the structure and logical flow of reporting requirements described in Unit III.E. Nonetheless, EPA requests comment on the proposed interpretations of activities to be considered as part of supply, use, and trade of mercury in the United States.
TSCA section 8(b)(10)(D)(ii) directs the Agency to “coordinate the reporting . . . with the Interstate Mercury Education and Reduction Clearinghouse” to avoid duplication (15 U.S.C. 2607(b)(10)(D)(ii)). Furthermore, TSCA section 8(a)(5)(a) states “[i]n carrying out [TSCA section 8], the Administrator shall, to the extent feasible . . . not require reporting which is unnecessary or duplicative” (15 U.S.C. 2607(a)(5)(a)). The Agency seeks to avoid collecting data on mercury that would duplicate information already reported to existing state and federal programs, and to coordinate with and complement those reporting programs as much as possible. While developing this proposed rule, EPA reviewed four data collection systems applicable to supply, use, and trade of mercury (including mercury-added products and mercury used in manufacturing processes): IMERC, the TSCA section 8(a) Chemical Data Reporting rule, the Toxics Release Inventory (TRI) program, and the U.S. International Trade Commission Interactive Trade DataWeb (USITC DataWeb).
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While developing this proposed rule, the Agency coordinated with IMERC and NEWMOA to ensure that data collected in accordance with the proposed reporting requirements and existing IMERC reporting requirements would not be duplicative and that information collected would be shared to the greatest extent practicable. The Agency is designing the electronic reporting application for the mercury inventory that would automatically skip certain reporting requirement fields when users indicate they report to the IMERC Mercury-Added Products Database. Such users would automatically bypass mercury inventory reporting requirements that are comparable to those reported to IMERC. Specifically, those that report to IMERC would not be required to report the amount of mercury distributed in commerce under this proposed rule because EPA believes that information is captured by IMERC as national sales data. However, those that report to IMERC would still be required to provide qualitative data—NAICS codes related to sales data—as part of the distribution in commerce reporting requirement (see Table 4—Information to Report—Mercury-Added Products).
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In general, CDR reporters do not report information on chemical substances in articles, unless they first import or domestically manufacture the chemical substance that they then incorporate into an article or product (Ref. 12). As discussed in regard to coordinating with IMERC to avoid duplicative reporting, the Agency's intended design for the reporting application for the mercury inventory would allow a CDR reporter to automatically skip certain reporting requirement fields that would be considered duplicative. As an example, those that report to CDR would not be required to provide the amount of mercury imported, however, they would be required to provide qualitative information—in this example the country of origin—as part of the reporting requirement (see Table 3—Information to Report—Mercury).
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After reviewing these reporting programs, EPA has sought to design the proposed reporting requirements to be least burdensome for reporters already familiar with IMERC, CDR, TRI, and USITC DataWeb protocol. Therefore, the Agency is proposing to incorporate comparable reporting concepts and tools from each program, as well as propose some exemptions, in an attempt to increase the efficacy of while decreasing the burden to the greatest extent practicable for reporting to a national mercury inventory. EPA is seeking comment on the incorporation of the reporting concepts and tools from each program, as well as the proposed exemptions.
TSCA section 8(b)(10)(D)(i) states “any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process shall make periodic reports to the Administrator” (15 U.S.C. 2607(b)(10)(D)(i)). As explained in Unit III.B., EPA interprets the statutory text at TSCA sections 8(b)(10)(B), 8(b)(10)(D)(i), and 8(b)(10)(D)(iii) as applying to intentional acts that introduce mercury into supply, use, and trade in the United States. Furthermore, EPA reads TSCA section 8(b)(10)(D)(i) to narrow potential reporters to persons who first manufacture mercury or mercury-added products or otherwise intentionally use mercury in a manufacturing process. As such, EPA determined that persons who merely trade (
EPA considers the following examples of persons and waste types to be exempt from reporting to the proposed rule:
• Hazardous waste treatment facilities that stabilize and landfill low-concentration mercury-containing waste.
• Manufacturing facilities that:
• A person who uses a mercury-added product but does not manufacture mercury or mercury-added products and does not intentionally use mercury in a manufacturing process.
• Hazardous waste treatment facilities that recover elemental mercury from mercury-containing waste and manage that elemental mercury as a waste. There are currently two primary ways in which recovered elemental mercury can be managed as a waste: Placed in long-term storage at a facility with a RCRA permit as allowed under Section 5(g) of MEBA, or converted to mercury sulfide and exported for disposal.
• A generator producing mercury incidentally from the beneficiation or processing of ore or related pollution control activities, who accumulates this mercury on-site.
• A generator who temporarily stores waste elemental mercury for up to 90 or 180 days pending shipment for long-term storage or for treatment and disposal. The elemental mercury in all of these cases is not subject to the proposed rule.
EPA seeks comments on the examples provided and requests input on other relevant examples that may be useful.
The exemption at 15 U.S.C. 2607(b)(10)(D)(iii) does not apply to persons who manufacture or recover elemental mercury in the management of mercury-containing waste with the intent to use it or store it for use. For example, if a waste treatment facility retorts or distills mercury-containing waste to recover elemental mercury and then sells or stores the mercury for later sale, that person is considered to be a manufacturer of mercury and must report to the proposed rule for the amount of elemental mercury it sells or stores. If any manufacturer covered by the proposed rule decides at any time to manage the elemental mercury as a waste, that mercury is subject to the RCRA, but not to the proposed rule. Elemental mercury that is stored under MEBA or converted to a mercury compound and disposed of remains a waste, that is, its status cannot change from waste to commodity mercury.
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The statutory text at TSCA section 8(b)(10) is silent on a reporting threshold; however, TSCA section 8(b)(10)(C) directs the Agency to “identify any manufacturing processes or products that intentionally add mercury” (15 U.S.C. 2607(10)(b)(C)). The Agency interprets the direction to “identify any” to apply to any amount of mercury in a manufacturing process or product. When considered in light of the statutory text at TSCA section 8(b)(10)(C), as well as concerns related to the potential adverse effects on human health and the environment resulting from releases of mercury, the Agency finds that it would be inappropriate to propose a threshold under which reporting would not be required. Therefore, EPA proposes to apply the proposed reporting requirements to any person who manufactures (including imports) mercury, mercury-added products or otherwise intentionally uses mercury in a manufacturing process regardless of the amount of mercury at issue. EPA seeks comment on this approach.
The absence of a reporting threshold is consistent with IMERC reporting requirements, which apply to the intentional addition of mercury to a product, including where “mercury is intentionally added for any reason or that incorporates a component to which mercury was intentionally added” (Ref. 14). Because of the similarities in the intentional addition of mercury to manufacture a product and otherwise intentional use of mercury in a manufacturing process, EPA determined that all quantities of mercury used in both activities should be reported without a reporting threshold. EPA seeks comment on this approach.
By comparison, the CDR rule contains reporting thresholds for chemical substances, including elemental mercury and mercury compounds. EPA interprets the mandate in TSCA section 8(b)(10)(B) to call for a comprehensive inventory such that existing data gaps would be eliminated, where feasible. The Agency also seeks as much as possible to complement amounts of quantitative mercury data already collected by, but without overlapping with, reporting requirements of the CDR rule. In general, the Agency seeks to require reporting for persons who manufacture (including import) mercury in quantities less than the CDR thresholds for elemental mercury (2,500 lbs.) and mercury compounds (25,000 lbs.). The coordination between additional, proposed reporting requirements and the CDR rule are discussed in “
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• Mining (including extraction and beneficiation processes) mercury;
• Generating or isolating mercury during ore, petroleum, or natural gas refining;
• Retorting, recovering, or recycling (including purifying) mercury from waste streams;
• Chemical manufacturing of mercury;
• Importing mercury; or
• Capturing mercury using methods to reduce emissions of hazardous air pollutants, unless the captured mercury is generated, handled, or managed as a waste or is identified as an impurity.
As described in Unit III.C., the Agency is seeking to decrease the burden of reporting to the greatest extent practicable by, among other things, complementing without overlapping existing reporting requirements related to mercury and mercury-added products. As such, EPA proposes that persons who manufacture (including import) for commercial purposes in excess of 2,500 lbs. for elemental mercury or in excess of 25,000 lbs. for mercury compounds for a specific reporting year would not be required to report amounts manufactured (including imported) or exported that are already reported per the CDR rule. Such persons would, however, be required to provide quantitative data on storage and distribution in commerce, as well as qualitative and contextual information related to all applicable data elements under the proposed rule. In further efforts to decrease reporting burdens, the Agency intends to provide pre-selected lists of mercury compounds to streamline reporting requirements as much as possible.
4.
EPA also is concerned that requiring reporting for a product that contains a mercury-added component could create undue burden for certain importers. For example, the Agency concluded that it is more likely that an importer of batteries would know if the specific kind of battery contained mercury, as opposed to an importer of toys that may or may not contain a mercury-added battery. However, EPA requests comment on whether persons who manufacture (including import) items that contain components that are mercury-added products should also report under the proposed rule.
In addition, the Agency is aware of transactions where a consumer directly orders mercury-added drugs (
Although not exhaustive, persons who engage in the following activities would be required to report under the proposed rule (see Table 4. Information to Report—Mercury-Added Products):
• Importing mercury-added products (except the import of a product that contains a component that is a mercury-added product); or
• Producing mercury-added products (
Examples of persons who would not be required to report to this proposed rule include:
• Manufacturers of concrete made from coal ash that contains mercury, but where such mercury originated from coal burned as a fuel source (
• Fuel blenders who combine materials that might contain mercury, but are not chosen for blending because they contain mercury;
• Consumers who purchase and import mercury-added products for personal use from a foreign vendor; or,
• Persons engaged in the delivery of mercury-added products to an individual consumer, unless the delivery service intentionally specializes in part or whole in the import and distribution in commerce of mercury-added products.
For mercury-added products, the Agency seeks not only to balance efforts to increase the efficacy of reporting while decreasing the burden to the greatest extent practicable, but also to fully describe applicable sectors of the mercury market. As described in Unit III.C., persons who report to IMERC identify the amount of mercury sold in mercury-added products that may be manufactured, distributed, or imported. The Agency considers the amount of mercury reported to IMERC as sold to be comparable to the amount of mercury to be reported under the proposed rule as distributed in commerce. As such, EPA proposes that persons reporting to IMERC would not need to report amounts of mercury distributed in commerce under the proposed rule. However, those persons would need to report quantitative and qualitative information for other applicable data elements. Under the proposed rule, such persons also would be required to report contextual information applicable to amounts, if any, of mercury manufactured, imported, distributed in commerce, or exported. In further efforts to decrease reporting burdens, the Agency intends to provide pre-selected lists of mercury-added product categories to streamline reporting requirements as much as possible.
5.
• Producers of chlorine (
• Producers of polyurethane elastomer; or
• Producers of other commercial chemicals (except mercury compounds).
Unlike manufacturers (including importers) of mercury and mercury-added products, the Agency believes that persons who otherwise intentionally use mercury in a manufacturing process may currently report to existing data collection programs in the United States; however, the reporting requirements for those programs cover only some of the data elements that would be required of EPA for the mercury inventory. As such, the general, specific, and contextual reporting requirements proposed by EPA are intended to provide a complete picture of uses for which little information is currently available. In further efforts to decrease reporting burdens, the Agency intends to provide pre-selected lists of manufacturing processes and attendant uses of mercury to streamline reporting requirements as much as possible.
To the extent that the proposed persons who must report and descriptions and examples of the kinds of information to be reported can be clarified, the Agency welcomes comment on the aforementioned discussion and tables. In addition, the Agency requests comment on whether other persons should be required to report or, in the alternative, if any of the proposed persons should not report.
6.
In addition, the Agency is considering the development of compliance guides tailored to small entities that will be required to comply with the reporting requirements. EPA requests public comment on what kinds of information would be particularly important to address for small entities in such compliance guides. EPA expects to conduct outreach and webinars for small businesses to introduce the reporting database, explain requirements, and offer Q&A and other support. Under TSCA section 26(d), EPA also provides specialized assistance to respondents, particularly to small entities, including technical and other non-financial assistance to manufacturers and processors of chemical substances. EPA's TSCA Hotline assists small businesses complying with TSCA rules and provides various materials such as copies of
TSCA section 8(b)(10)(B) sets the general scope of the inventory as the “mercury supply, use, and trade in the
1.
a.
b.
c.
d.
e.
EPA understands that certain persons may report for multiple activities associated with supply, use, and trade of mercury. For example, a person may import mercury and manufacture mercury-added products. As such, the Agency attempted to design the proposed quantitative data elements for reporting requirements such that a person could report both as an “importer of mercury” and “manufacturer of mercury-added products,” but only report for the specific activity in which they engage. The Agency expects there may be certain persons engaged in the supply, use, and trade of mercury who might not be accounted for in the inventory, but EPA views this omission of prospective reporters as an opportunity to limit undue burden and avoid double-counting. Thus, the Agency is proposing to limit the persons who must report at TSCA section 8(b)(10)(D)(i) to only those persons described in Unit III.D. However, EPA requests comment on whether the proposed reporting requirements should apply to persons who do not manufacture or import mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process, but engage in the supply, use, and trade of mercury in the United States.
2.
a.
•
•
•
•
•
•
•
•
b.
EPA proposes the following list of uses of mercury in the aforementioned manufacturing processes: Catalyst; Reactant; Reagent; Other (specify).
3.
a.
b.
c.
The Agency determined that the combination of general, specific, and contextual reporting requirements provides for the body of information required to fulfill statutory mandates of TSCA sections 8(b)(10)(B) and (C). As much as possible, the Agency would design all requirements to be answered only where a reporter engages in the specific activity from the inclusive list of options. In fact, EPA believes that it is unlikely that the typical reporter would be engaged in and, as a result, be required to answer all, or even many, of the proposed reporting requirements. Nonetheless, to the extent that the proposed reporting process can be streamlined, the Agency welcomes comment on the proposed general, specific, and contextual reporting requirements. In addition, the Agency requests comment on whether such reporting requirements should be added or eliminated.
TSCA section 8(b)(10)(B) sets the date for publication of initial and subsequent, triennial iterations of the mercury inventory to commence on April 1, 2017 (15 U.S.C. 8(b)(10)(B)). Therefore, EPA expects to publish the first mercury inventory supported by the proposed reporting requirements by April 1, 2020 and every three years thereafter.
TSCA section 8(b)(10)(D) provides the authority to promulgate the rule being proposed here to assist in the preparation of the triennial inventory publication (15 U.S.C. 8(b)(10)(D)), but TSCA offers no guidance on the frequency of collection or reporting deadline. To attempt to minimize reporting obligations, the Agency compared the respective collection frequencies and reporting deadlines for IMERC, the CDR rule, and the TRI program to when EPA is required to publish the mercury inventory. TSCA section 8(b)(10)(B), (15 U.S.C. 8(b)(10)(B)), sets a publication date for the mercury inventory that falls on the reporting deadline for IMERC: April 1 in a triennial cycle starting in April 2017. Data collected under the CDR rule is submitted to the Agency on a quadrennial cycle; the next reporting cycle will occur in 2020, with a reporting deadline of September 2020. The TRI program collects and publishes data on an annual cycle with a reporting deadline of July 1 of each year.
EPA recognizes that the mercury inventory reporting deadline would need to allow for an appropriate amount of time for quality control and assurance to be performed by EPA staff before the inventory is published. As such, the Agency concluded that the proposed reporting deadline would need to occur at least several months in advance of the publication deadline (April 1). The Agency then considered whether it was feasible to select a date and reporting frequency that would coincide with the IMERC, CDR rule, and TRI program reporting deadlines, so as not to impose an additional date for those that might be required to report to multiple systems. Due to the incongruities of frequency of collection among the proposed rule (triennial cycle—publication date of April 1), IMERC (triennial cycle—reporting deadline of April 1), the CDR rule (quadrennial cycle—reporting deadline of September 30), and TRI program (annual cycle—reporting deadline of July 1), the Agency determined that attempting to coordinate with each program would be more confusing for reporters, would not allow for ample time to review and coordinate similar data (
Based on such considerations, the Agency determined that coinciding with the triennial IMERC frequency of collection is appropriate given the mercury inventory publication schedule is also triennial. In addition, the Agency is proposing to set the mercury inventory reporting deadline to coincide with the TRI program deadline in an effort to align with a date with which certain, potential reporters might already be familiar. Therefore, EPA proposes to establish a July 1st reporting deadline for 2019 and every three years thereafter. Data submitted should cover only the calendar year preceding the year in which the reporting deadline occurs (
EPA notes that there would be some discrepancies between the proposed rule and IMERC deadlines (
Consistent with the proposed triennial reporting and publication cycle for the mercury inventory, EPA proposes that each person who is subject to the reporting requirements must retain records that document any information reported to EPA. Records relevant to reporting during a submission period must be retained for a period of 3 years beginning on the last day of the submission period. Submitters are encouraged to retain their records longer than 3 years to ensure that past records are available as a reference when new submissions are being generated.
Reporters to the information collection of the proposed rule may claim that their submitted information is CBI. The statutory provisions for CBI under TSCA are at Section 14 of the law (15 U.S.C. 2613).
EPA is proposing to require electronic reporting of the mercury inventory data, using an Agency-provided, web-based reporting software to submit mercury inventory reports through the Internet to EPA's Central Data Exchange (CDX). CDX provides the capability for submitters to access their data through the use of web services. For more information about CDX, go to
Should EPA adopt a mandatory electronic reporting requirement, submitters would be required to register with EPA's CDX, complete an electronic signature agreement, and to prepare a data file for submission. To submit electronically to EPA via CDX, individuals must first register with that system at
In addition to the areas where EPA has specifically requested comment, EPA requests comment on all other aspects of this proposed rule.
The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket for this action.
This action is expected to be subject to the requirements for regulatory actions specified in Executive Order 13771 (82 FR 9339, February 3, 2017). EPA prepared an analysis of the estimated costs and benefits associated with this action. This analysis, “Economic Analysis for the Proposed Reporting Requirements for the TSCA Mercury Inventory” (Economic Analysis, Ref. 3) is available in the docket and is summarized in Unit I.E.
The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA, 44 U.S.C. 3501
The reporting requirements identified in the proposed rule would provide EPA with information necessary to prepare and periodically update an inventory of mercury supply, use, and trade in the United States, as required by TSCA section 8(b)(10)(D). These proposed reporting requirements would help the Agency to prepare subsequent, triennial publications of the inventory, as well as to carry out the requirement of TSCA section 8(b)(10)(C) to identify any manufacturing processes or products that intentionally add mercury and recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use. EPA intends to use information collected under the rule to assist in efforts to reduce the use of mercury in products and processes and to facilitate reporting on implementation of the Minamata Convention by the United States. Respondents may claim some of the information reported to EPA under the proposed rule as CBI under TSCA section 14. TSCA section 14(c) requires a supporting statement and certification for confidentiality claims asserted after June 22, 2016.
EPA estimated total burden and costs to industry associated with the proposed rule over the first three years of its promulgation (Ref. 3). For the 750 companies anticipated to be subject to the proposed reporting requirements, the average per respondent burden hours for Year 1 (of a triennial cycle for submitting information) was estimated to be 98.94 hours (Ref. 3). Years 2 and 3 are not data collection years, so there is no cost associated with the proposed rule during these years (Ref. 3). Therefore, the average for total burden hours per the three-year reporting cycle is 32.94 hours per year (Ref. 3).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601
The small entity analysis estimated that 1 parent company (0.46 percent of total entities) would incur an impact of 3 percent or greater, and 3 parent companies (1.39 percent of total entities) would incur an impact of 1 to 3 percent. Details of this analysis are included in the accompanying Economic Analysis for this Rule (Ref. 3).
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531 through 1538, and does not significantly or uniquely affect small governments. As such, the requirements of sections 202, 203, 204, or 205 of UMRA do not apply to this action.
This action does not have federalism implications, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in the Order. Thus, EO 13175 does not apply to this action.
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 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 does not concern an environmental health risk or safety risk, nor is this action economically significant as the impact of this action will be less than $100 million.
This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not expected to affect energy supply, distribution, or use.
Since this action does not involve any technical standards, section 12(d) of NTTAA, 15 U.S.C. 272 note, does not apply to this section.
This action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This action establishes an information requirement and does not affect the level of protection provided to human health or the environment.
Environmental protection, Mercury, Elemental mercury, Mercury compounds, Inventory, Supply, Use, Trade, Manufacture, Import, Export.
Therefore, it is proposed that 40 CFR chapter I, subchapter R, be amended by adding a new part 713 to read as follows:
15 U.S.C. 2607(b)(10)(D).
(a) This part specifies reporting and recordkeeping procedures under section 8(b)(10) of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2607(b)(10)) for certain manufacturers (including importers) and processers of mercury as defined in section 8(b)(10)(A) to include elemental mercury and mercury compounds. Section 8(b)(10)(D) of TSCA authorizes the EPA Administrator to require reporting from any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process to carry out and publish in the
(b) This part applies to the activities associated with the periodic publication of information on mercury supply, use, and trade in the United States.
(c) For purposes of this part, the reporting for mercury supply, use, and trade includes the following activities:
(1) Import of mercury or a mercury-added product with the purpose of obtaining an immediate or eventual commercial advantage for the importer, except:
(A) Mercury generated as a byproduct not used for commercial purposes or an impurity; or
(B) A product that contains a component that is a mercury-added product.
(2) Manufacture (other than import) of mercury or a mercury-added product with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, except a product that contains a component that is a mercury-added product.
(3) Intentional use of mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product, with the purpose of obtaining an immediate or eventual commercial advantage for the processor, except mercury generated as a byproduct not used for commercial purposes.
(4) Distribution in commerce, including domestic sale or transfer, of mercury or a mercury-added product.
(5) Storage of mercury after manufacture (including import).
(6) Export of mercury or a mercury-added product, including the determining and controlling the sending of mercury (unless specifically prohibited) or a mercury-added product to a destination out of the customs territory of the United States.
(d) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit information required under this part. In addition, TSCA section 15(3) makes it unlawful for any person to fail to keep, and permit access to, records required by this part. Section 16 of TSCA provides that any person who violates a provision of TSCA section 15 is liable to the United States for a civil penalty and may be criminally prosecuted. Pursuant to TSCA section 17, the Federal Government may seek judicial relief to compel submission of TSCA section 8 information and to otherwise restrain any violation of TSCA section 15.
(e) Each person who reports under this part must certify the accuracy of its information and maintain records that document information reported under this part and, in accordance with TSCA, permit access to, and the copying of, such records by EPA officials.
(a) Elemental mercury (Chemical Abstracts Registry Number 7439-97-6); or
(b) A mercury compound, including but not limited to the mercury
(a) Mercury that is generated as a byproduct not used for commercial purposes; or
(b) Mercury-containing waste.
(a) Persons who manufacture (including import) mercury in amounts greater than or equal to 2,500 pounds (lbs.) for elemental mercury or greater than or equal to 25,000 lbs. for mercury compounds for a specific reporting year shall report, as applicable:
(1) Amount of mercury stored (lbs.); or
(2) Amount of mercury distributed in commerce (lbs.)
(b) All other persons who manufacture (including import) mercury shall report, as applicable:
(1) Amount of mercury manufactured (other than imported) (lbs.);
(2) Amount of mercury imported (lbs.);
(3) Amount of mercury exported (lbs.), except mercury prohibited from export at 15 U.S.C. 2611(c)(1) and (7);
(4) Amount of mercury stored (lbs.); or
(5) Amount of mercury distributed in commerce (lbs.).
(c) Persons who sell mercury-added products, except a product that contains a component that is a mercury-added product, in IMERC Notification states shall report, as applicable:
(1) Amount of mercury in manufactured (other than imported) products (lbs.);
(2) Amount of mercury in imported products (lbs.); or
(3) Amount of mercury in exported products (lbs.).
(d) All other persons who manufacture (including import) mercury-added products, except a product that contains a component that is a mercury-added product, shall report, as applicable:
(1) Amount of mercury in manufactured (other than imported) products (lbs.);
(2) Amount of mercury in imported products (lbs.);
(3) Amount of mercury in exported products (lbs.);
(4) Amount of mercury in products distributed in commerce (lbs.); or
(e) Persons who otherwise intentionally use mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product, shall report, as applicable:
(1) Amount of mercury otherwise intentionally used (lbs.) in a manufacturing process;
(2) Amount of mercury stored (lbs.);
(3) Amount of mercury in exported final product(s) (lbs.); or
(4) Amount of mercury in final product(s) distributed in commerce (lbs.).
(a) Any person who manufactures (including imports) mercury shall specify, as applicable, the specific mercury compound(s) from a pre-selected list (as listed in Table 1 of this part).
(b) Any person who manufactures (including imports) a mercury-added product, except manufacture (including import) of a product that contains a component that is a mercury-added product, shall specify as applicable, the specific category(ies) and subcategory(ies) from a pre-selected list, as listed in Table 2 of this part:
(c) Any person who otherwise intentionally uses mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product, shall specify, as applicable:
(1) The specific manufacturing process for which mercury is otherwise intentionally added from a pre-selected list, as listed in Table 3 of this part:
(2) The specific use of mercury in a manufacturing process from a pre-selected list, as listed in Table 4 of this part:
(a) Persons who manufacture (including import) mercury in amounts greater than or equal to 2,500 lbs. for elemental mercury or greater than or equal to 25,000 lbs. for mercury compounds for a specific reporting year shall report, as applicable:
(1) Country(ies) of origin for imported mercury;
(2) Country(ies) of destination for exported mercury;
(3) NAICS code(s) for mercury distributed in commerce.
(b) All other persons who manufacture (including import) mercury shall report, as applicable:
(1) Country(ies) of origin for imported mercury;
(2) Country(ies) of destination for exported mercury;
(3) NAICS code(s) for mercury distributed in commerce.
(c) Persons who sell mercury-added products, except a product that contains a component that is a mercury-added product, in IMERC Notification states shall report, as applicable:
(1) Country(ies) of origin for imported products;
(2) Country(ies) of destination for exported products; or
(3) NAICS code(s) for products distributed in commerce.
(d) All other persons who manufacture (including import) mercury-added products, except a product that contains a component that is a mercury-added product, shall report, as applicable:
(1) Country(ies) of origin for imported products;
(2) Country(ies) of destination for exported products; or
(3) NAICS code(s) for products distributed in commerce.
(e) Persons who otherwise intentionally use mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product, shall report, as applicable:
(1) Country(ies) of destination for exported final product(s); or
(2) NAICS code(s) for mercury in final product(s) distributed in commerce.
(a) Any person who manufactures (including imports) mercury;
(b) Any person who manufactures (including imports) a mercury-added product, except a product that contains a component that is a mercury-added product; or
(c) Any person who otherwise intentionally uses mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product.
(a) Any person engaged in the generation, handling, or management of mercury-containing waste, unless that person manufactures or recovers mercury in the management of that waste.
(b) Any person who engaged in trade (
Any person who must report under this part shall report for the submission period described at § 713.21:
(a) Quantities of mercury in pounds per applicable activity listed under the general requirements for which information must be reported described at § 713.9;
(b) Specific requirements for which information must be reported described at § 713.11;
(c) Contextual requirements for which information must be reported described at § 713.13; and
(d) According to the procedures described at § 713.25.
(a) Any person who must report under this part shall report for the reporting year described as follows. The 2020 reporting year is from January 1 to December 31, 2018. Subsequent recurring reporting years are from January 1 to December 31 at 3-year intervals, beginning in 2021.
(b) All information reported for an applicable reporting year must be submitted on or before the first day of July following the reporting year. The 2020 submission deadline is July 1, 2019. Subsequent recurring submission deadlines are from July 1, in 3-year intervals, beginning in 2022.
Each person who is subject to the reporting requirements of this part must retain records that document any information reported to EPA. Records relevant to a reporting year must be retained for a period of 3 years beginning on the last day of the reporting year. Submitters are encouraged to retain their records longer than 3 years to ensure that past records are available as a reference when new submissions are being generated.
(a) You must use [xxx name of application xxx] to complete and submit [xxx form? xxx]. Submissions may only be made as set forth in this section.
(b) Submissions must be sent electronically to EPA via CDX.
(c) Access [xxx name of application xxx] and instructions, as follows:
(1) By Web site. Go to the EPA [xxx name of application xxx] homepage at
(2) By phone or email. Contact the EPA TSCA Hotline at (202) 554-1404 or
Architectural and Transportation Barriers Compliance Board.
Notice of meetings.
The Architectural and Transportation Barriers Compliance Board (Access Board) plans to hold its regular committee and Board meetings in Washington, DC, Monday through Wednesday, November 13-15, 2017 at the times and location listed below.
The schedule of events is as follows:
Meetings will be held at the Access Board Conference Room, 1331 F Street NW., Suite 800, Washington, DC 20004.
For further information regarding the meetings, please contact David Capozzi, Executive Director, (202) 272-0010 (voice); (202) 272-0054 (TTY).
At the Board meeting scheduled on the afternoon of Wednesday, November 15, 2017, the Access Board will consider the following agenda items:
Members of the public can provide comments either in-person or over the telephone during the final 15 minutes of the Board meeting on Wednesday, November 15, 2017. Any individual interested in providing comment is asked to pre-register by sending an email to
All meetings are accessible to persons with disabilities. An assistive listening system, Communication Access Realtime Translation (CART), and sign language interpreters will be available at the Board meeting and committee meetings.
Persons attending Board meetings are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants (see
You may view the Wednesday, November 15, 2017 meeting through a live webcast from 1:30 p.m. to 3:00 p.m. at:
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Pennsylvania Foreign Trade Zone Corporation, grantee of FTZ 295, requesting subzone status for the facilities of North American Höganäs Company (Höganäs), located in Johnstown, Hollsopple and St. Mary's, 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 FTZ Board (15 CFR part 400). It was formally docketed on October 19, 2017.
The proposed subzone would consist of the following sites:
In accordance with the FTZ 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 FTZ Board's Executive Secretary at the address below. The closing period for their receipt is December 5, 2017. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to December 20, 2017.
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 FTZ Board's Web site, which is accessible via
For further information, contact Elizabeth Whiteman at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable October 18, 2017.
Mark Kennedy at (202) 482-7883 (India), and Catherine Cartsos (the People's Republic of China (PRC)) at (202) 482-1757, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.
On September 28, 2017, the U.S. Department of Commerce (the Department) received antidumping duty (AD) Petitions concerning imports of polytetrafluoroethylene resin (PTFE resin) from India and the PRC, filed in proper form on behalf of The Chemours Company FC LLC (the petitioner).
On October 2, 2017, and October 3, 2017, the Department requested supplemental information pertaining to certain areas of the Petitions.
In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that imports of PTFE resin from India and the PRC are being, or are likely to be, sold in the United States at less than fair value within the meaning of section 731 of the Act, and that such imports are materially injuring, or threatening material injury to, the domestic industry producing PTFE resin in the United States. Also, consistent with section 732(b)(1) of the Act, the Petitions are accompanied by information reasonably available to the petitioner supporting its allegations.
The Department finds that the petitioner is an interested party as defined in section 771(9)(C) of the Act and that the petitioner filed these Petitions on behalf of the domestic industry and demonstrated sufficient industry support with respect to the initiation of the AD investigations that the petitioner is requesting.
Because the Petitions were filed on September 28, 2017, the period of investigation (POI) for India is July 1, 2016, through June 30, 2017. Because the PRC is a non-market economy (NME) country, the POI for the PRC is January 1, 2017, through June 30, 2017.
The product covered by these investigations is PTFE resin from India and the PRC. For a full description of the scope of these investigations,
During our review of the Petitions, the petitioner submitted a revised proposed scope to ensure that the scope language in the Petitions would be an accurate reflection of the products for which the domestic industry is seeking relief.
As discussed in the preamble to the Department's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope).
The Department requests that any factual information the parties consider relevant to the scope of the investigations be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigations may be relevant, the party may contact the Department and request permission to submit the additional information. All such comments must be filed on the records of each of the concurrent AD and CVD investigations.
All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping Duty and Countervailing
The Department will provide interested parties an opportunity to comment on the appropriate physical characteristics of PTFE resin to be reported in response to the Department's AD questionnaires. This information will be used to identify the key physical characteristics of the merchandise under consideration in order to report the relevant costs of production accurately as well as to develop appropriate product-comparison criteria.
Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) General product characteristics and (2) product-comparison criteria. We note that it is not always appropriate to use all product characteristics as product-comparison criteria. We base product-comparison criteria on meaningful commercial differences among products. In other words, although there may be some physical product characteristics utilized by manufacturers to describe PTFE resin, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, the Department attempts to list the most important physical characteristics first and the least important characteristics last.
In order to consider the suggestions of interested parties in developing and issuing the AD questionnaires, all product characteristics comments must be filed by 5:00 p.m. ET on November 7, 2017. Any rebuttal comments must be filed by 5:00 p.m. ET on November 17, 2017. All comments and submissions to the Department must be filed electronically using ACCESS, as explained above, on the records of both the India and the PRC less-than-fair-value investigations.
Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigations. Based on our analysis of the information submitted on the record, we have determined that PTFE resin, as defined in the scope, constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product.
In determining whether the petitioner has standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petitions with reference to the domestic like product as defined in the “Scope of the Investigations,” in Appendix I of this notice. The petitioner provided its own production of the domestic like product in 2016, as well as estimated 2016 production data of the domestic like product by the entire U.S. industry.
Our review of the data provided in the Petitions and other information readily available to the Department indicates that the petitioner has established industry support.
The Department finds that the petitioner filed the Petitions on behalf of the domestic industry because it is an interested party as defined in section 771(9)(C) of the Act and it has demonstrated sufficient industry support with respect to the AD investigations that it is requesting that the Department initiate.
The petitioner alleges that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than normal value (NV). In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
The petitioner contends that the industry's injured condition is illustrated by a significant volume of subject imports; an increase in the volume of subject imports relative to U.S. consumption and production; reduced market share; underselling and price suppression or depression; lost sales and revenues; a negative impact on the domestic industry's capacity, capacity utilization, and employment; and a negative impact on revenues and operating profits.
The following is a description of the allegations of sales at less than fair value upon which the Department based its decision to initiate AD investigations of imports of PTFE resin from India and the PRC. The sources of data for the deductions and adjustments relating to U.S. price and NV are discussed in greater detail in the country-specific initiation checklists.
For the PRC, the petitioner based the U.S. price on export price (EP) using average unit values (AUVs) of publicly available import data and price quotes for sales of PTFE resin produced in, and exported from, the PRC and offered for sale in the United States.
For India, because the petitioner had reason to believe that the prices/offers for sale were made through a U.S. affiliate, the petitioner also based the U.S. price on constructed export price (CEP) using price quotes for sales and prices of actual sales of PTFE resin produced in, and exported from, India and offered for sale in the United States.
For India, the petitioner provided home market price information for PTFE resin produced and offered for sale in India that was obtained through market research.
With respect to the PRC, the petitioner stated that the Department has found it to be a NME country in prior administrative proceedings in which they were involved.
The petitioner claims that Mexico is an appropriate surrogate country for the PRC because it is a market economy country that is at a level of economic development comparable to that of the PRC, it is a significant producer of comparable merchandise, and public information from Mexico is available to value all material input factors.
Interested parties will have the opportunity to submit comments regarding surrogate country selection and, pursuant to 19 CFR
Because information regarding the volume of inputs consumed by the PRC producers/exporters is not available, the petitioner relied on its own production experience as an estimate of Chinese manufacturers' FOPs.
Based on the data provided by the petitioner, there is reason to believe that imports of PTFE resin from India and the PRC are being, or are likely to be, sold in the United States at less than fair value. Based on comparisons of EP and CEP to NV for India and EP to NV for the PRC in accordance with sections 772 and 773 of the Act, the estimated dumping margins for PTFE resin for each of the countries covered by this initiation are as follows: (1) PRC—23.4 to 408.9 percent,
Based upon the examination of the AD Petitions, we find that the Petitions meet the requirements of section 732 of the Act. Therefore, we are initiating AD investigations to determine whether imports of PTFE resin from India and the PRC are being, or are likely to be, sold in the United States at less than fair value. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we intend to make our preliminary determinations no later than 140 days after the date of this initiation.
Under the Trade Preferences Extension Act of 2015, numerous amendments to the AD and CVD law were made.
The petitioner named seven companies in India as producers/exporters of PTFE resin.
Interested parties may submit comments regarding the CBP data and respondent selection by 5:00 p.m. ET seven calendar days after the placement of the CBP data on the record of this investigation. Interested parties wishing to submit rebuttal comments should submit those comments five calendar days after the deadline for initial comments.
Comments must be filed electronically using ACCESS. An electronically-filed document must be received successfully, in its entirety, by ACCESS no later than 5:00 p.m. ET on the date noted above. If respondent selection is necessary, within 20 days of publication of this notice, we intend to make our decisions regarding respondent selection based upon comments received from interested parties and our analysis of the record information.
With respect to the PRC, the petitioner named 49 companies in the PRC as producers/exporters of PTFE resin.
Producers/exporters of PTFE resin from the PRC that do not receive Q&V questionnaires by mail may still submit a response to the Q&V questionnaire and can obtain a copy of the Q&V questionnaire from Enforcement & Compliance's Web site. The Q&V response must be submitted by the relevant PRC exporters/producers no later than 5:00 p.m. ET on November 2, 2017. All Q&V responses must be filed electronically via ACCESS.
In order to obtain separate-rate status in an NME investigation, exporters and producers must submit a separate-rate application.
The Department will calculate combination rates for certain respondents that are eligible for a separate rate in an NME investigation. The Separate Rates and Combination Rates Bulletin states:
In accordance with section 732(b)(3)(A)(i) of the Act and 19 CFR 351.202(f), copies of the public version of the Petitions have been provided to the governments of India and the PRC
We will notify the ITC of our initiation, as required by section 732(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petitions were filed, whether there is a reasonable indication that imports of PTFE resin from India and/or the PRC are materially injuring or threatening material injury to a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (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 the Department; and (v) evidence other than factual information described in (i)-(iv). 19 CFR 351.301(b) requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Parties should review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
This notice is issued and published pursuant to sections 732(c)(2) and 777(i) of the Act, and 19 CFR 351.203(c).
The product covered by these investigations is polytetrafluoroethylene (PTFE) resin, including but not limited to granular, dispersion, or coagulated dispersion (also known as fine powder). PTFE is covered by the scope of these investigations whether filled or unfilled, whether or not modified, and whether or not containing co-polymer additives, pigments, or other materials. Also included is PTFE wet raw polymer. The chemical formula for PTFE
PTFE further processed into micropowder, having particle size typically ranging from 1 to 25 microns, and a melt-flow rate no less than 0.1 gram/10 minutes, is excluded from the scope of these investigations.
PTFE is classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 3904.61.0010 and 3904.61.0090. Subject merchandise may also be classified under HTSUS subheading 3904.69.5000. Although the HTSUS subheadings and CAS Number are provided for convenience and Customs purposes, the written description of the scope is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable October 18, 2017.
Toby Vandall at (202) 482-1664 or Aimee Phelan at (202) 482-0697, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.
On September 28, 2017, the U.S. Department of Commerce (the Department) received a countervailing duty (CVD) Petition concerning imports of polytetrafluoroethylene (PTFE) resin from India, filed in proper form on behalf of the Chemours Company FC LLC (the petitioner).
On October 3, 2017, the Department requested supplemental information pertaining to certain areas of the Petition.
In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that the Government of India is providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to imports of PTFE resin from India and that such imports are materially injuring, or threatening material injury to, the domestic industry producing PTFE resin in the United States. Also, consistent with section 702(b)(1) of the Act, for those alleged programs on which we are initiating a CVD investigation, the Petition is accompanied by information reasonably available to the petitioner supporting its allegations.
The Department finds that the petitioner is an interested party as defined in section 771(9)(C) of the Act and that the petitioner filed this Petition on behalf of the domestic industry and demonstrated sufficient industry support with respect to the initiation of the CVD investigation that the petitioner is requesting.
Because the Petition was filed on September 28, 2017, the period of investigation (POI) is January 1, 2016, through December 31, 2016.
The product covered by this investigation is PTFE resin from India. For a full description of the scope of this investigation,
During our review of the Petition, the Department issued questions to, and received a response from, the petitioner pertaining to the proposed scope to ensure that the scope language in the Petition would be an accurate reflection of the products for which the domestic industry is seeking relief.
As discussed in the preamble to the Department's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope).
The Department requests that any factual information the parties consider relevant to the scope of the investigation be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact the Department and request permission to submit the additional information. All such comments must be filed on the records of each of the concurrent AD and CVD investigations.
All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS).
Pursuant to sections 702(b)(4)(A)(i) and (ii) of the Act, the Department notified representatives of the Government of India of the receipt of the Petition, and provided them the opportunity for consultations with respect to the CVD Petition.
Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of this investigation. Based on our analysis of the information submitted on the record, we have determined that PTFE resin, as defined in the scope, constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product.
In determining whether the petitioner has standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the Appendix to this notice. The petitioner provided its own production of the domestic like product in 2016, as well as estimated 2016 production data of the domestic like product by the entire U.S. industry.
Our review of the data provided in the Petition and other information readily available to the Department indicates that the petitioner has established industry support.
The Department finds that the petitioner filed the Petition on behalf of the domestic industry because it is an interested party as defined in section 771(9)(C) of the Act and it has demonstrated sufficient industry support with respect to the CVD investigation that it is requesting the Department initiate.
Because India is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to
The petitioner alleges that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise, which are benefitting from countervailable subsidies. In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
The petitioner contends that the industry's injured condition is illustrated by a significant volume of subject imports; an increase in the volume of subject imports relative to U.S. consumption and production; reduced market share; underselling and price suppression or depression; lost sales and revenues; a negative impact on the domestic industry's capacity, capacity utilization, and employment; and a negative impact on revenues and operating profits.
Based on the examination of the CVD Petition, we find that the Petition meets the requirements of section 702 of the Act. Therefore, we are initiating a CVD investigation to determine whether imports of PTFE resin from India benefit from countervailable subsidies conferred by the government of this country. In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we intend to make our preliminary determination no later than 65 days after the date of this initiation.
Under the Trade Preferences Extension Act of 2015, numerous amendments to the AD and CVD laws were made.
Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation on 18 of the 22 alleged programs in India. For a full discussion of the basis for our decision on whether to initiate on each program,
In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.
The petitioner named seven companies in India as producers/exporters of PTFE resin.
On October 12, 2017, the Department released CBP data under the Administrative Protective Order (APO) to all parties with access to information protected by APO and indicated that interested parties wishing to comment regarding the CBP data and respondent selection must do so within three business days of the publication date of the notice of initiation of this CVD investigation.
Comments must be filed electronically using ACCESS. An electronically filed document must be received successfully, in its entirety, by ACCESS no later than 5:00 p.m. ET on the date noted above. If respondent selection is necessary, within 20 days of publication of this notice, we intend to make our decision regarding respondent selection based upon comments received from interested parties and our analysis of the record information.
In accordance with section 702(b)(4)(A)(i) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the Government of India
We will notify the ITC of our initiation, as required by section 702(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petition were filed, whether there is a reasonable indication that imports of PTFE resin from India is materially injuring, or threatening material injury to, a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (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 the Department; and (v) evidence other than factual information described in (i)-(iv). 19 CFR 351.301(b) requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the time limit established under 19 CFR 351.301 expires. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Parties should review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
This notice is issued and published pursuant to sections 702 and 777(i) of the Act.
The product covered by this investigation is polytetrafluoroethylene (PTFE) resin, including but not limited to granular, dispersion, or coagulated dispersion (also known as fine powder). PTFE is covered by the scope of this investigation whether filled or unfilled, whether or not modified, and whether or not containing co-polymer additives, pigments, or other materials. Also included is PTFE wet raw polymer. The chemical formula for PTFE is C2F4, and the Chemical Abstracts Service Registry number is 9002-84-0.
PTFE further processed into micropowder, having particle size typically ranging from 1 to 25 microns, and a melt-flow rate no less than 0.1 gram/10 minutes, is excluded from the scope of this investigation.
PTFE is classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 3904.61.0010 and 3904.61.0090. Subject merchandise may also be classified under HTSUS subheading 3904.69.5000. Although the HTSUS subheadings and CAS Number are provided for convenience and Customs purposes, the written description of the scope is dispositive.
National Institute of Standards and Technology, Department of Commerce.
Notice of closed meeting.
The Judges Panel of the Malcolm Baldrige National Quality Award (Judges Panel) will meet in closed session Sunday, November 5, 2017 through Thursday, November 9, 2017 from 8:30 a.m. until 5:30 p.m. Eastern Time each day. The purpose of this meeting is to review recommendations from site visits, and recommend 2017 Malcolm Baldrige National Quality Award recipients. The meeting is closed to the public in order to protect the proprietary data to be examined and discussed at the meeting.
The meeting will be held Sunday, November 5, 2017 through Thursday, November 9, 2017, from 8:30 a.m. until 5:30 p.m. Eastern Time each day. The entire meeting will be closed to the public.
The meeting will be held at the National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899.
Robert Fangmeyer, Director, Baldrige Performance Excellence Program, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 1020, Gaithersburg, MD 20899-1020, telephone number (301) 975-2360, email
15 U.S.C. 3711a(d)(1) and the Federal Advisory Committee Act, as amended, 5 U.S.C. App.
Pursuant to 41 CFR 102-3.150(b), this
The Chief Financial Officer and Assistant Secretary for Administration, with the concurrence of the Assistant General Counsel for Administration and Transactions, formally determined on March 21, 2017, pursuant to Section 10(d) of the Federal Advisory Committee Act, in accordance with Section 5(c) of the Government in Sunshine Act, Public Law 94-409, that the meeting of the Judges Panel may be closed to the public in accordance with 5 U.S.C. 552b(c)(4), because the meeting is likely to disclose trade secrets and commercial or financial information obtained from a person which is privileged or confidential; and 5 U.S.C. 552b(c)(9)(B) because the meeting is likely to disclose information the premature disclosure of which would, in the case of any agency, be likely to significantly frustrate implementation of a proposed agency action. The meeting, which involves examination of current Award applicant data from U.S. organizations and a discussion of these data as compared to the Award criteria in order to recommend Award recipients, will be closed to the public.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of intent; request for comments.
NMFS announces its intent to issue exempted fishing permits (EFPs), scientific research permits (SRPs), display permits, letters of acknowledgment (LOAs), and shark research fishery permits for Atlantic highly migratory species (HMS) in 2018. EFPs and related permits would authorize collection of a limited number of tunas, swordfish, billfishes, and sharks (collectively known as HMS) from Federal waters in the Atlantic Ocean, Caribbean Sea, and Gulf of Mexico for the purposes of scientific data collection, bycatch research, public display, and to evaluate the efficacy of environmental clean-up efforts, among other things. Letters of acknowledgement acknowledge that scientific research activity aboard a scientific research vessel is being conducted. Generally, EFPs and related permits would be valid from the date of issuance through December 31, 2018, unless otherwise specified, subject to the terms and conditions of individual permits.
Written comments on these activities received in response to this notice will be considered by NMFS when issuing EFPs and related permits and must be received on or before
Comments may be submitted by any of the following methods:
•
•
Craig Cockrell, phone: (301) 427-8503
Issuance of EFPs and related permits are necessary because HMS regulations (
EFPs and related permits are issued under the authority of the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (Magnuson-Stevens Act) (16 U.S.C. 1801
While scientific research is exempt under MSA, scientific research is not exempt from regulation under ATCA. Therefore, NMFS issues SRPs that authorize researchers to collect HMS from bona fide research vessels for collection of species managed under this statute (
EFPs are issued to researchers collecting ATCA and Magnuson-Stevens Act-managed species while conducting research from commercial or recreational fishing vessels. Examples of research conducted under EFPs include collection of young-of-the-year bluefin tuna for genetic research; conducting billfish larval tows from private vessels to determine billfish habitat use, life history, and population structure; determining catch rates and gear characteristics of the swordfish buoy gear fishery and the green-stick tuna fishery; and tagging sharks caught on commercial or recreational fishing gear to determining post-release mortality rates.
NMFS is also seeking public comment on its intent to issue display permits for the collection of sharks and other HMS for public display in 2017. Collection of sharks and other HMS sought for public display in aquaria often involves collection when the commercial fishing seasons are closed, collection of otherwise prohibited species (
The majority of EFPs and related permits described in this annual notice relate to scientific sampling and tagging of Atlantic HMS within existing quotas and the impacts of the activities have been previously analyzed in various environmental assessments and environmental impact statements for Atlantic HMS. NMFS intends to issue these permits without additional opportunity for public comment beyond what is provided in this notice. Occasionally, NMFS receives applications for research activities that were not anticipated, or for research that is outside the scope of general scientific sampling and tagging of Atlantic HMS, or rarely, for research that is particularly controversial. Should NMFS receive such applications, NMFS will provide additional opportunity for public comment, consistent with the regulations at 50 CFR part 600.745.
During the comment period for the November 2016 notice of intent to issue EFPs (81 FR 80646), NMFS received numerous comments regarding previous years' white shark research in Federal waters, focusing primarily on concerns about the need for coordination among researchers regarding the potential effects of one project on another. The volume of these comments indicated that any EFPs or SRP applications involving white sharks in 2017 should be considered “controversial” and warranted additional opportunity for public comment. Subsequently, NMFS published a notice in the
During the comment period, NMFS received 722 comments related to white shark research and the applications described in the notice. The majority of the comments were in support of continuing white shark research. Other comments that were received commented on a range of issues related to white shark research including concern regarding the proper handling of white sharks and the type of gear being used for research and concern regarding tagging operations on charter and private vessels due to long fight times on light tackle rods and reels. Some of the comments also stated that NMFS should approve EFP applications for white shark research on a case-by-case basis or that NMFS should stop issuing EFPs or related permits for research on sharks. After reviewing these comments, NMFS decided to issue EFPs and related permits for white shark research as appropriate in 2017. During 2018, NMFS anticipates permits for white shark research would be undertaken with substantially the same terms and conditions and scope as last year, with no additional anticipated effects. Comments are invited specifically on these issues related to issuance of white shark permits this year.
In addition, Amendment 2 to the 2006 Consolidated HMS Fishery Management Plan (FMP) implemented a shark research fishery. This research fishery is conducted under the auspices of the exempted fishing permit program. Shark research fishery permit holders assist NMFS in collecting valuable shark life history and other scientific data required in shark stock assessments. Since the shark research fishery was established in 2008, the research fishery has allowed for: The collection of fishery dependent data for current and future stock assessments; the operation of cooperative research to meet NMFS' ongoing research objectives; the collection of updated life-history information used in the sandbar shark (and other species) stock assessment; the collection of data on habitat preferences that might help reduce fishery interactions through bycatch mitigation; the evaluation of the utility of the mid-Atlantic closed area on the recovery of dusky sharks; and the collection of hook-timer and pop-up satellite archival tag information to determine at-vessel and post-release mortality of dusky sharks. Fishermen who wish to participate must fill out an application for a shark research permit under the exempted fishing program. Shark research fishery participants are subject to 100-percent observer coverage. All non-prohibited shark species brought back to the vessel dead must be retained and will count against the appropriate quotas of the shark research fishery participant. During the 2017 shark research fishery, all participants were limited to a very small number of dusky shark mortalities on a regional basis. Once the number of mortalities occurs in a specific region all shark research fishery activities must stop within that region. Also, participants are limited to two sets per trip with, one set limited to 150 hooks and the second set limited to 300 hooks.
The authorized number of species for 2017, as well as the number of specimens collected in 2016, is summarized in Table 1. The number of specimens collected in 2017 will be available when all 2017 interim and annual reports are submitted to NMFS. In 2016, the number of specimens collected was less than the number of authorized specimens for all permit types, other than SRPs issued for shark research.
In all cases, mortality associated with an EFPs, SRPs, or display permits (except for larvae) is counted against the appropriate quota. NMFS issued a total of 39 EFPs, SRPs, display permits, and LOAs in 2016 for the collection of HMS and a total of 5 shark research fishery permits. As of October 3, 2017, NMFS has issued a total of 33 EFPs, SRPs, display permits, and LOAs and a total of 5 shark research fishery permits.
Final decisions on the issuance of any EFPs, SRPs, display permits, and shark research fishery permits will depend on the submission of all required information about the proposed activities, NMFS' review of public comments received on this notice, an applicant's reporting history on past permits, if vessels or applicants were issued any prior violations of marine resource laws administered by NOAA, consistency with relevant NEPA documents, and any consultations with appropriate Regional Fishery Management Councils, states, or Federal agencies. NMFS does not anticipate any significant environmental impacts from the issuance of these EFPs as assessed in the 1999 FMP, the 2006 Consolidated HMS FMP and its amendments, the Environmental Assessment for the 2012 Swordfish Specifications, and the Environmental Assessment for the 2015 Final Bluefin Tuna Quota and Atlantic Tuna Fisheries Management Measures.
16 U.S.C. 971
Department of the Air Force, DOD.
Notice.
Notice is given of the names of members of the 2017 Performance Review Board for the Department of the Air Force.
These appointments are effective as of November 13, 2017.
Pursuant to 5 U.S.C. 4314(c) (1-5), the Department of the Air Force (AF) announces the appointment of members to the AF's Senior Executive Service (SES) Performance Review Board (PRB). Appointments are made by the authorizing official. Each board member shall review and evaluate performance scores provided by the SES' immediate supervisor. Performance standards must be applied consistently across the AF. The board will make final recommendations to the authorizing official relative to the performance of the executive.
The members of the 2017 Performance Review Board for the Air Force are:
Additionally, all career status Air Force Tier 3 SES members not included in the above list are eligible to serve on the 2017 Performance Review Board and are hereby nominated for inclusion on an ad hoc basis in the event of absence(s).
Please direct any written comments or requests for information to Ms. Lorna Fermanis, Senior Executive Management, AF/DPS, 1040 Air Force Pentagon, Washington, DC 20330-1040 (PH: 703-697-0897; or via email at
Office of the Under Secretary of Defense for Acquisition, Technology and Logistics, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by November 27, 2017.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
Average Burden per Response: 10 minutes.
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
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Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.
Office of the Under Secretary of Defense for Acquisition, Technology and Logistics, DOD.
30-day information collection notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by November 27, 2017.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
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Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.
U.S. Army Corps of Engineers, DoD.
Notice of withdrawal of an environmental impact statement; notice of availability of an environmental assessment.
In accordance with the National Environmental Policy Act (NEPA), on September 18, 2016, the St. Paul District, U.S. Army Corps of Engineers (Corps) initiated the Environmental Impact Statement (EIS) process to identify and analyze potential impacts associated with flood risk management measures evaluated within a Federal feasibility study for the Souris River Basin within the continental United States. Currently, the Corps has identified a Tentatively Selected Plan (TSP) that includes a high-flow diversion and a 1200-ft long levee. However, preliminary analysis of the TSP indicate no significant impacts are expected, therefore the Corps is terminating the EIS process and is withdrawing the Notice of Intent published in the Thursday, September 18, 2016 issue of the
Comments on the draft FR/EA may be submitted starting October 30, 2017 through November 30, 2017. If comments are provided by mail, they must be received at the address below no later than November 30, 2017.
The draft FR/EA can be viewed online starting October 30, 2017 at
Comments may be submitted on the draft FR/EA using any of the following methods:
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Questions regarding this action can be addressed to Mr. David F. Potter, Regional Planning & Environment Division North, by phone: (651) 290-5713, by fax: (651) 290-5805, by email:
The Souris River Basin Flood Risk Management Feasibility Study (Feasibility Study) is being developed by the Corps in partnership with the Souris River Joint Water Resources Board (SRJB). The purpose of this study is to collect and evaluate pertinent engineering, economic, social, and environmental information in order to assess the potential for a federal flood risk management project within the basin. The study objective is to define a feasible and implementable project to reduce flood risk which is relatively high within the basin. Due to the potentially significant environmental effects associated with the project, the Corps issued a Notice of Intent to Prepare an EIS (76 FR 336) on September 18, 2016.
The Feasibility Study is complementary to the SRJB's local plan, the Mouse River Enhanced Flood Protection Plan (MREFPP). Because of its influence on an existing federal flood project, this non-federal effort has requested permission from the Corps of Engineers to pursue actions under 33 U.S.C. 408 (frequently referred to as Section 408). A separate Notice of Intent was published (FR Doc. 2015-17670 Filed July 16, 2015) for an EIS associated with the Corps of Engineers' decision on the Section 408 request. Additional details on the local, non-federal flood MREFPP can be found at
We are advising the public that a draft integrated FR/EA for the Feasibility Study has been prepared and is available for public review and comment. The FR/EA considers the effects of, and alternatives to, the TSP.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of availability.
The U.S. Army Corps of Engineers (USACE), San Francisco District, announces the availability for review and comment of the draft integrated General Reevaluation Report and Environmental Assessment (GRR/EA) and the draft Finding of No Significant Impact (FONSI) for the proposed Pajaro River Flood Risk Management Project, Monterey and Santa Cruz Counties, CA., USACE Procedures for Implementing [the National Environmental Policy Act] NEPA, notice of the availability of this draft GRR/EA and draft FONSI for review and comment is being provided to agencies, organizations, and the interested public.
Comments on the draft GRR/EA and draft FONSI may be submitted starting October 31, 2017, through November 30, 2017. If comments are provided by mail, they must be received at the address below no later than November 30, 2017.
The draft GRR/EA can be viewed online starting October 31, 2017, at:
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Mr. Christopher Eng, U.S. Army Corps of Engineers, San Francisco District, 1455 Market Street, San Francisco, CA 94103-1398. Telephone: (415) 503-6868. Email:
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5. A public meeting to discuss the status of the study, present the draft results of the GRR/EA, and receive questions and comments will be held on November 8, 2017, from 6:00 p.m. to 8:00 p.m. at the Watsonville Civic Plaza Community Room, 275 Main Street, 4th Floor, Watsonville, California 95076-5133.
Office of Elementary and Secondary Education (OESE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before December 26, 2017.
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 Hannah Hodel, 202-453-6448.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On October 19, 2017, the Commission issued an order in Docket No. EL18-18-000,
The refund effective date in Docket No. EL18-18-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL18-18-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
On October 19, 2017, the Commission issued an order in Docket No. EL18-12-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the formula rate protocols of ATX Southwest, LLC may be unjust, unreasonable, unduly discriminatory or preferential.
The refund effective date in Docket No. EL18-12-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL18-12-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On October 19, 2017, the Commission issued an order in Docket No. EL18-13-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the formula rate protocols of Transource Kansas, LLC may be unjust, unreasonable, unduly discriminatory or preferential.
The refund effective date in Docket No. EL18-13-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL18-13-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding MS Solar 3, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 8, 2017.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
On October 19, 2017, the Commission issued an order in Docket No. EL18-14-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the formula rate protocols of Midwest Power Transmission Arkansas, LLC may be unjust, unreasonable, unduly discriminatory or preferential.
The refund effective date in Docket No. EL18-14-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL18-14-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
On October 19, 2017, the Commission issued an order in Docket No. EL18-17-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the Open Access Transmission, Energy and Operating Reserve Markets Tariff of Midcontinent Independent System Operator, Inc. may be unjust, unreasonable, unduly discriminatory or preferential.
The refund effective date in Docket No. EL18-17-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL18-17-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding Buchanan Energy Services Company, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 8, 2017.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
On October 19, 2017, the Commission issued an order in Docket No. EL18-15-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the formula rate protocols of Kanstar Transmission, LLC may be unjust, unreasonable, unduly discriminatory or preferential.
The refund effective date in Docket No. EL18-15-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL18-15-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
On October 19, 2017, the Commission issued an order in Docket No. EL18-16-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the formula rate protocols of South Central MCN LLC may be unjust, unreasonable, unduly discriminatory or preferential.
The refund effective date in Docket No. EL18-16-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL18-16-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
Environmental Protection Agency.
Notice of meeting.
The United States Environmental Protection Agency is announcing the joint 2017 Fall Meeting of the Ozone Transport Commission (OTC) and the Mid-Atlantic Northeast Visibility Union (MANE-VU). The meeting agenda will include topics regarding reducing ground-level ozone precursors and matters relative to Regional Haze and visibility improvement in Federal Class I areas in a multi-pollutant context.
The meeting will be held on November 15, 2017 starting at 9:15 a.m. and ending at 4:00 p.m.
Location: Melrose Georgetown Hotel, 2430 Pennsylvania Avenue NW., Washington, DC 20037, 202-955-6400.
For documents and press inquiries contact: Ozone Transport Commission, 444 North Capitol Street NW., Suite 322, Washington, DC 20001; (202) 508-3840; email:
The Clean Air Act Amendments of 1990 contain at Section 184 provisions for the Control of Interstate Ozone Air Pollution. Section 184(a) establishes an Ozone Transport Region (OTR) comprised of the States of Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, parts of Virginia and the District of Columbia. The purpose of the OTC is to
The Mid-Atlantic/Northeast Visibility Union (MANE-VU) was formed at in 2001, in response to EPA's issuance of the Regional Haze rule. MANE-VU's members include: Connecticut, Delaware, the District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, the Penobscot Indian Nation, the St. Regis Mohawk Tribe along with EPA and Federal Land Managers.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. 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 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 Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before December 26, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
Board of Governors of the Federal Reserve System.
Revision to proposal.
The Board of Governors of the Federal Reserve System (Board or Federal Reserve) is modifying its proposal to extend for three years, with revision, the Banking Organization Systemic Risk Report (FR Y-15; OMB No. 7100-0352). The Board is extending the proposed implementation date for the proposed revisions to the FR Y-15 from December 31, 2017, to March 31, 2018. The Board is also reopening the
The proposed collection of information is amended effective October 18, 2017 and the public comment period shall terminate on November 23, 2017.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Board's public Web site at:
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
On August 24, 2017, the Board invited public comment on a proposal that would extend for three years the FR Y-15 and make certain revisions to the report (FR Y-15 proposal). As revised, the report would include Mexican pesos in total payments activity rather than as a memorandum item; add securities brokers to the definition of financial institutions; expressly include derivative transactions where a clearing member bank guarantees the performance of a client to a central counterparty; and, specify how certain cleared derivatives transactions are reported.
The Board has received feedback that additional time may be required for affected banking organizations to analyze the impact of, and to provide comments on, the FR Y-15 changes being proposed.
In response to the feedback, this notice hereby reopens the public comment period for the FR Y-15 proposal by 30 days, with comments due November 23, 2017, to provide additional time for comment.
This notice also amends the proposed implementation date of the FR Y-15 proposal such that the proposed changes would be effective for reports reflecting the March 31, 2018, as-of date. This revision would provide respondents with an additional 90 days to prepare their systems to reflect any changes to the FR Y-15 that the Board may adopt after reviewing the comments received.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This meeting is open to the public, limited only by 100 room seating and 100 ports for audio phone lines. Time will be available for public comment. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is Monday, December 4, 2017. Persons who desire to make an oral statement, may request it at the time of the public comment period on December 12, 2017 at 11:40 a.m. EST. This meeting is also accessible by teleconference: 1-877-927-1433 and participant passcode: 12016435.
The meeting will be held on December 11, 2017, 8:30 a.m. to 4:30 p.m., EST and December 12, 2017, 8:30 a.m. to 12:00 p.m., EST.
CDC Corporate Square Campus, 8 Corporate Square Boulevard, Atlanta, Georgia 30329.
Margie Scott-Cseh, Committee Management Specialist, CDC, 1600 Clifton Road NE., Mailstop: E-07, Atlanta, Georgia 30329, telephone (404) 639-8317;
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID). This meeting is open to the public, limited only by the space available; the meeting room will accommodate up to 100 people. The public is also welcome to listen to the meeting by telephone, limited only by the number of ports
The meeting will be held on December 6, 2017, 8:30 a.m. to 5:00 p.m., EST, and December 7, 2017, 8:30 a.m. to 12:00 p.m., EST.
CDC, Global Communications Center, 1600 Clifton Road NE., Building 19, Auditorium B3, Atlanta, Georgia 30329; also 1-877-951-7311, with a pass code of 2208740.
Robin Moseley, MAT, Designated Federal Officer, OID, CDC, 1600 Clifton Road NE., Mailstop D10, Atlanta, Georgia 30329, Telephone (404) 639-4461;
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 people. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll-free, dial-in number at 1-866-659-0537; the pass code is 9933701. The conference line has 150 ports for callers. The Web conference by which the public can view presentations as they are presented is
The meeting will be held on December 13 from 8:15 to 6:00 p.m. Mountain Time and December 14, 2017, 8:15 a.m. to 11:00 a.m. Mountain Time. A public comment session will begin on December 13 at 6:00 p.m. Mountain Time and conclude at 7:00 p.m. or following the final call for public comment, whichever comes first.
Doubletree by Hilton Albuquerque, 201 Marquette Avenue Northwest, Albuquerque, New Mexico 87102; Phone: (505) 247-7057, Fax: (505) 247-7017. Audio conference call via FTS Conferencing. The USA toll-free dial-in number is 1-866-659-0537; the pass code is 9933701. Web conference by Skype: Meeting CONNECTION:
Theodore Katz, MPA, Designated Federal Officer, NIOSH, CDC, 1600 Clifton Road, Mailstop E-20, Atlanta, Georgia 30333, Telephone (513) 533-6800, Toll Free 1 (800) CDC-INFO, Email
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the State, Tribal, Local and Territorial Subcommittee, Centers for Disease Control and Prevention (STLT, CDC). This meeting is open to the public, limited only by 100 ports for audio phone lines access available. The public is also welcome to listen to the meeting by (866) 917-2712, passcode 9418625. The public comment period is from 03:50 p.m.-03:55 p.m. EST. Please register for public comment by December 8, 2017 via email to
The meeting will be held on December 18, 2017, 2:30 p.m. to 4:00 p.m., EST.
Audio Line Access Only (866) 917-2712, passcode 9418625.
Jose Montero, MD, MPH, Director, Office for State, Tribal, Local and Territorial Support, CDC, 4770 Buford Highway, Mailstop E70, Atlanta, Georgia 30341, (404) 498-0300,
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by November 27, 2017.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
William Parham at (410) 786-4669.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
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Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Thermo Fisher Scientific and The Center for Infection and Immunity, Columbia University. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
The Authorization for Thermo Fisher Scientific is applicable as of August 2, 2017; the Authorization for The Center for Infection and Immunity, Columbia University is effective as of August 11, 2017.
Submit written requests for single copies of the EUAs to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorizations may be sent. See the
Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for
Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the
No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self-executing, regulations or guidance are not required for FDA to implement the EUA authority.
On February 26, 2016, the Secretary of HHS determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on the basis of such determination, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under section 564 of the FD&C Act. Notice of the determination and declaration of the Secretary was published in the
An electronic version of this document and the full text of the Authorizations are available on the internet at
Having concluded that the criteria for issuance of the Authorizations under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of two in vitro diagnostic devices for detection of Zika virus subject to the terms of the Authorizations. The Authorizations in their entirety (not including the authorized versions of the fact sheets and other written materials) follows and provides an explanation of the reasons for issuance, as required by section 564(h)(1) of the FD&C Act.
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public.
The meeting will be held on November 20, 2017, from 8:30 a.m. to 5 p.m. and November 21, 2017, from 8:30 a.m. to 11:30 a.m.
FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), 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:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-5818. The docket will close on November 17, 2017. Submit either electronic or written comments on this public meeting by November 17, 2017. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 17, 2017. The
Comments received on or before November 3, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the 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.”
•
Cindy Chee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email:
The Drug Quality and Security Act added a new section 503B to the FD&C Act (21 U.S.C. 353b), which created a new category of compounders termed “outsourcing facilities.” Under section 503B of the FD&C Act, outsourcing facilities are defined, in part, as facilities that meet certain conditions described in section 503B, including registration with FDA as an outsourcing facility. If these conditions are satisfied, a drug product compounded for human use by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from three sections of the FD&C Act: (1) Section 502(f)(1) (concerning the labeling of drugs with adequate directions for use); (2) section 505 (concerning the approval of human drug products under NDAs or ANDAs); and (3) section 582 (21 U.S.C. 360eee-1) (concerning the drug supply chain security requirements). Outsourcing facilities are not exempt from CGMP requirements in section 501(a)(2)(B) of the FD&C Act.
One of the conditions that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that a bulk drug substance (active pharmaceutical ingredient) used in a compounded drug product must meet one of the following criteria: (1) Complies with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if an applicable monograph does not exist, is a component of a drug approved by the Secretary of Health and Human Services (the Secretary); or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary (the “503A Bulks List”) (see section 503A(b)(1)(A)(i) of the FD&C Act).
Another condition that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that the compounded drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product (see section 503A(b)(3)(A) of the FD&C Act).
A condition that must be satisfied to qualify for the exemptions in section 503B of the FD&C Act is that the compounded drug is not identified (directly or as part of a category of drugs) on a list, published by the Secretary by regulation, of drugs or categories of drugs that present demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug or category of drugs, taking into account the risks and benefits to patients, or the drug is compounded in accordance with all applicable conditions identified on the list as conditions that are necessary to prevent the drug or category of drugs from presenting such demonstrable difficulties (see section 503B(a)(6)(A) and (B) of the FD&C Act).
FDA intends to discuss with the committee bulk drug substances nominated for inclusion on the 503A Bulks List and drug products nominated for inclusion on the list of drug products that present demonstrable difficulties for compounding under sections 503A and 503B (“Difficult to Compound List”).
The committee also intends to discuss liposome drug products and drug products produced using hot melt extrusion technology for inclusion on the Difficult to Compound List. Drug products produced “by extrusion or nanotechnology” were nominated for inclusion on the Difficult to Compound List. The nominators will be invited to make a short presentation supporting the nomination.
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 Web site 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 Web site 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 Cindy Chee at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is denying Matthew Schroeder's (Schroeder's) request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Schroeder 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 Schroeder was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Schroeder failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
This order is applicable October 26, 2017.
Any application by Schroeder for special termination of debarment under section 306(d) of the FD&C Act (application) may be submitted as follows:
•
• If you want to submit an application with confidential information that you do not wish to be made available to the public, submit the application as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For a written/paper application submitted to the Dockets Management Staff, FDA will post your application, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Julie Finegan, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4218, Silver Spring, Maryland 20993, 301-796-8618.
On October 11, 2012, the U.S. District Court for the Northern District of Georgia entered a criminal judgment against Matthew Schroeder under his guilty plea. Schroeder pled guilty to a felony under the FD&C Act, namely aiding and abetting, with the intent to defraud or mislead, in the dispensing of phenazepam without a prescription, resulting in the phenazapam being misbranded while held for sale after shipment in interstate commerce in violation of sections 301(k), 503(b)(1), 303(a)(2) of the FD&C Act (21 U.S.C. 331(k), 353(b)(1) and 333(a)(2)) and 18 U.S.C. 2. Specifically, Schroeder, through his company, Novel Research Supply, and eBay ID, “finemineralsfossilssio2” sold phenazepam and methylenedioxypyrovalerone. Both are unapproved drugs and are used by drug users for recreational purposes. According to FDA's September 24, 2014, letter to Schroeder, in August 2010, Kevin Lewis purchased phenazepam on eBay from “finemineralsfossilssio2” and later died after ingesting phenazepam through an injection.
Schroeder is subject to debarment based on a finding, under section 306(a)(2) of the FD&C Act (21 U.S.C. 335a(a)(2)), that he was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. By the letter dated September 24, 2014, FDA notified Schroeder of a proposal to permanently debar him from providing services in any capacity to a person having an approved or pending drug product application. Schroeder requested a hearing on the proposal and special termination of debarment. Schroeder acknowledges his conviction under Federal law, but argues that multiple mitigating factors merit a hearing or special termination of debarment.
Under the authority delegated to him by the Commissioner of Food and Drugs, the Director of the Office of Scientific Integrity (OSI) has considered Schroeder's request for a hearing. Hearings will not be granted on issues of policy or law, on mere allegations, denials, or general descriptions of positions and contentions, or on data and information insufficient to justify the factual determination urged (see 21 CFR 21.24(b)).
The Director of OSI considered Schroeder's arguments and concludes that they are unpersuasive and fail to raise a genuine issue of fact requiring a hearing.
In his request for hearing, Schroeder first argues that he took voluntary steps to mitigate the dangers posed by the drugs by putting warnings against human consumption on the sales packaging and Web site. Schroeder states that he discontinued drug sales after an FDA investigator contacted him and that he fully disclosed all of his wrongdoing. Schroeder next argues that he cooperated with investigations and provided testimony against the drug suppliers. Third, Schroeder argues that he ended all his activities concerning drug sales and has not violated the FD&C Act since September 2010. He also states that his phenazepam sales only spanned two months. Fourth, Schroeder addresses Kevin Lewis' death and purchases. Schroeder states that in the case against another drug supplier, the prosecutor determined that Kevin Lewis died from long-term IV drug use, rather than the phenazepam purchased from Schroeder's eBay account. Schroeder also clarifies that Kevin Lewis purchased the phenazepam by using his mother's eBay account. Finally, Schroeder alleges that he does not pose a recidivism risk.
Section 306(a)(2) of the FD&C Act provides FDA with the authority to debar an individual who has been convicted of certain Federal felonies. The only relevant factual issue is whether Schroeder was actually convicted of a felony under Federal law for conduct relating to the development or approval of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act. Schroeder does not dispute that he pled guilty to a felony under the FD&C Act, specifically aiding and abetting, with the intent to defraud and mislead, in the dispensing of phenazepam without a prescription, resulting in the phenazepam being misbranded while held for sale after shipment in interstate commerce. Accordingly, Schroeder's arguments fail to raise a genuine and substantial issue of fact as to whether he was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act.
Along with his request for a hearing, Schroeder also requested a special termination of debarment. Under section 306(d), a debarred individual may apply for special termination of debarment. While the debarment period can be limited to less than permanent, the individual must be debarred for at least 1 year. Schroeder is not yet debarred, so his request for special termination of debarment is not appropriate for consideration at this time.
Therefore, the Director of OSI, under section 306(a)(2) of the FD&C Act and under the authority delegated to him, finds that Matthew Schroeder has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act.
As a result of the foregoing findings, Matthew Schroeder is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under section 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
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0029, Self-propelled Liquefied Gas Vessels; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before December 26, 2017.
You may submit comments identified by Coast Guard docket number [USCG-2017-0953] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2017-0953], and must be received by December 26, 2017.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0020, Security Zones, Regulated Navigation Areas, and Safety Zones; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before December 26, 2017.
You may submit comments identified by Coast Guard docket
A copy of the ICR is available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2017-0902], and must be received by December 26, 2017.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0022, Application for Tonnage Measurement of Vessels; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before December 26, 2017.
You may submit comments identified by Coast Guard docket number [USCG-2017-0904] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2017-0904], and must be received by December 26, 2017.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625-0058, Application for Permit to Transport Municipal and Commercial Waste. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before December 26, 2017.
You may submit comments identified by Coast Guard docket number [USCG-2017-0899] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek reinstatement of the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2017-0899], and must be received by December 26, 2017.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625-0040, Application for Merchant Mariner Credential (MMC), Application for Merchant Mariner Medical Certificate, Applications for Merchant Mariner Medical Certificate for Entry Level Ratings, Small Vessel Sea Service Form, DOT/USCG Periodic Drug Testing Form, Disclosure Statement for Narcotics, DWI/DUI,and/or Other Convictions, Merchant Mariner Medical Certificates, Recognition of Foreign Certificate. This is a resubmission of this ICR. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before December 26, 2017.
You may submit comments identified by Coast Guard docket number USCG-2015-0694 to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the Internet at
Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
A sixty-day Notice was originally published in the
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek reinstatement of the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2015-0694], and must be received by December 26, 2017.
We encourage you to submit comments through the Federal
We accept anonymous comments. All comments received will be posted without change to
We did receive one comment on the earlier submission of this ICR. The commenter requested that we provide more detail on the progress of an application while it is being processed. Although this is not a comment directed at the collection, we do provide the following response.
The Coast Guard provides process guides for the application of mariner credentials that are available upon the National Maritime Center (NMC) Web site at [
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Control Number: 1625-0036
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0036, Plan Approval and Records for U.S. and Foreign Tank Vessels Carrying Oil in Bulk; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before December 26, 2017.
You may submit comments identified by Coast Guard docket number [USCG-2017-0901] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) the practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2017-0901], and must be received by December 26, 2017.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0109, Drawbridge Operation Regulations; without change.
Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before December 26, 2017.
You may submit comments identified by Coast Guard docket number [USCG-2017-0951] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2017-0951], and must be received by December 26, 2017.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
U.S. Customs and Border Protection (CBP), Department of Homeland Security (DHS).
Committee management; Notice of Federal Advisory Committee Meeting.
The Commercial Customs Operations Advisory Committee (COAC) will hold its quarterly meeting on Tuesday, November 14, 2017 in Washington, DC The meeting will be open to the public.
The COAC will meet on Tuesday, November 14, 2017, from 1:00 p.m. to 5:00 p.m. EST. Please note that the meeting may close early if the committee has completed its business.
The meeting will be held at U.S. Customs & Border Protection, 1717 H Street NW., Room 700, Washington, DC 20006. For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Ms. Florence Constant-Gibson, Office of Trade Relations, U.S. Customs & Border Protection, at (202) 344-1440 as soon as possible.
For members of the public who plan to attend the meeting in person, please register by 5:00 p.m. EST by November 13, 2017, either online at
For members of the public who plan to participate via webinar, please register online at
Please feel free to share this information with other interested members of your organization or association.
Members of the public who are pre-registered to attend and later need to cancel, please do so by November 13, 2017, utilizing the following links:
To facilitate public participation, we are inviting public comment on the issues the committee will consider prior to the formulation of recommendations as listed in the Agenda section below.
Comments must be submitted in writing no later than November 8, 2017, and must be identified by Docket No. USCBP-2017-0044, and may be submitted by
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There will be multiple public comment periods held during the meeting on November 14, 2017. Speakers are requested to limit their comments to two (2) minutes or less to facilitate greater participation. Contact the individual listed below to register as
Ms. Florence Constant-Gibson, Office of Trade Relations, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Room 3.5A, Washington, DC 20229; telephone (202) 344-1440; facsimile (202) 325-4290; or Mr. Bradley Hayes, Executive Director and Designated Federal Officer, can be reached at (202) 344-1440.
Notice of this meeting is given under the
The COAC will hear from the following subcommittees on the topics listed below and then will review, deliberate, provide observations, and formulate recommendations on how to proceed:
1. The Trade Enforcement & Revenue Collection (TERC) Subcommittee will discuss new TERC recommendations and provide any necessary updates from the Anti-Dumping and Countervailing Duty, Bond, Forced Labor, and Intellectual Property Rights Working Groups.
2. The Global Supply Chain Subcommittee will present the status of a pilot that will test the utilization of existing Automated Commercial Environment (ACE) automation in the pipeline mode of transportation. The committee will also discuss the progress of the Global Supply Chain Subcommittee's new Emerging Technologies Working Group.
3. The One U.S. Government Subcommittee will continue discussions on the progress of the Fish & Wildlife Service Working Group and will present the final white paper on the Harmonized Tariff Schedule (HTS) project. The subcommittee will also discuss the progress of the newly created Technical and Operational Outages Working Group.
4. The Exports Subcommittee will discuss the Post Departure Filing (PDF) Working Group's progress on the implementation plan of the PDF Proposal and will include steps to initiate a proof of concept. The subcommittee will also discuss the progress of the Manifest Working Group and progress on issues with the ongoing manifest pilots. The working group may present recommendations in the area of manifest timelines during the November meeting.
5. The Trusted Trader Subcommittee will continue the discussion for an enhanced Trusted Trader program that includes engagement with CBP to include relevant partner government agencies with a potential for international interoperability. A review of the pilot program status and benefits will also be undertaken in parallel to determine the optimum benefits that would be assigned to Trusted Trader participants.
6. The Trade Modernization Subcommittee will discuss its plans for the topics that will be addressed during the next quarter.
Meeting materials will be available by November 10, 2017, at:
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before January 24, 2018.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
You may submit comments, identified by Docket No. FEMA-B-1754, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
I. Non-watershed-based studies:
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for the Commonwealth of Puerto Rico (FEMA-3384-EM), dated September 5, 2017, and related determinations.
The change occurred on October 10, 2017.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Michael F. Byrne, of FEMA is appointed to act as the Federal Coordinating Officer for this emergency.
This action terminates the appointment of Alejandro DeLaCampa as Federal Coordinating Officer for this emergency.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the State of Louisiana (FEMA-3392-EM), dated October 6, 2017, and related determinations.
The declaration was issued October 6, 2017.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated October 6, 2017, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in certain areas of the State of Louisiana resulting from Tropical Storm Nate beginning on October 5, 2017, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), including direct Federal assistance, under the Public Assistance program.
Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, William J. Doran III, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the State of Louisiana have been designated as adversely affected by this declared emergency:
The parishes of Assumption, Iberia, Jefferson, Lafourche, Livingston, Orleans, Plaquemines, St. Bernard, St. Charles, St. James, St. John the Baptist, St. Martin, St. Mary, St. Tammany, Tangipahoa, Terrebonne, and Vermillion for emergency protective measures (Category B), including direct federal assistance, under the Public Assistance program.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Puerto Rico (FEMA-4339-DR), dated September 20, 2017, and related determinations.
The change occurred on October 10, 2017.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Michael F. Byrne, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster.
This action terminates the appointment of Alejandro DeLaCampa as Federal Coordinating Officer for this disaster.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Puerto Rico (FEMA-4336-DR), dated September 10, 2017, and related determinations.
The change occurred on October 10, 2017.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Michael F. Byrne, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster.
This action terminates the appointment of Alejandro DeLaCampa as Federal Coordinating Officer for this disaster.
Federal Emergency Management Agency, DHS.
Final Notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below.
The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
The date of January 5, 2018 has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
I. Watershed-based studies:
II. Non-watershed-based studies:
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before January 24, 2018.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
You may submit comments, identified by Docket No. FEMA-B-1751, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for the State of Louisiana (FEMA-3392-EM), dated October 6, 2017, and related determinations.
This amendment was issued October 13, 2017.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that the incident period for this emergency is closed effective October 8, 2017.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Wisconsin (FEMA-4343-DR), dated October 7, 2017, and related determinations.
The change occurred on October 8, 2017.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Janet M. Odeshoo, of FEMA is appointed to act as the Federal Coordinating Officer for this emergency.
This action terminates the appointment of Benigno Bern Ruiz as Federal Coordinating Officer for this disaster.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Wisconsin (FEMA-4343-DR), dated October 7, 2017, and related determinations.
The declaration was issued October 7, 2017.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated October 7, 2017, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Wisconsin resulting from severe storms, straight-line winds, flooding, landslides, and mudslides during the period of July 19-23, 2017, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to section 428 of the Stafford Act.
Further, you are authorized to make changes to this declaration for the approved
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Benigno Bern Ruiz, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Wisconsin have been designated as adversely affected by this major disaster:
Buffalo, Crawford, Grant, Iowa, Jackson, La Crosse, Lafayette, Monroe, Richland, Trempealeau, and Vernon Counties for Public Assistance.
All areas within the State of Wisconsin are eligible for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for the Commonwealth of Puerto Rico (FEMA-3391-EM), dated September 18, 2017, and related determinations.
The change occurred on October 10, 2017.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Michael F. Byrne, of FEMA is appointed to act as the Federal Coordinating Officer for this emergency.
This action terminates the appointment of Alejandro DeLaCampa as Federal Coordinating Officer for this emergency.
National Protection and Programs Directorate, DHS.
Issuance of a binding operational directive; notice of availability.
To safeguard Federal information and information systems, DHS has issued a binding operational directive (BOD) to all Federal, executive branch departments and agencies relating to enhanced email and web security. The BOD requires agencies to take specific actions on their information systems to improve email and web security. DHS is publishing this notice of availability to provide awareness of the BOD.
Binding Operational Directive 18-01 was issued on October 16, 2017.
The text of Binding Operational Directive 18-01 is available at
The Department of Homeland Security (“DHS” or “the Department”) has the statutory responsibility, in consultation with the Office of Management and Budget, to administer the implementation of agency information security policies and practices for information systems, which includes assisting agencies and providing certain government-wide protections. 44 U.S.C. 3553(b). As part of that responsibility, the Department is authorized to “develop[] and oversee[] the implementation of binding operational directives to agencies to implement the policies, principles, standards, and guidance developed by the Director [of the Office of Management and Budget] and [certain] requirements of [the Federal Information Security Modernization Act of 2014.]” 44 U.S.C. 3553(b)(2). A BOD is “a compulsory direction to an agency that (A) is for purposes of safeguarding Federal information and information systems from a known or reasonably suspected information security threat, vulnerability, or risk; [and] (B) [is] in accordance with policies, principles, standards, and guidelines issued by the Director[.]” 44 U.S.C. 3552(b)(1). Agencies are required to comply with these directives. 44 U.S.C. 3554(a)(1)(B)(ii).
In carrying out this statutory responsibility, the Department issued BOD 18-01, titled “Enhance Email and Web Security.” For email security, the BOD requires agencies to take specific technical actions to ensure that agency email can be encrypted in transit and is more difficult to spoof. For web security, the BOD requires agencies to take specific technical actions to ensure publicly accessible Federal Web sites and services are provided through secure connections. Across both topics, the BOD requires that agencies disable and discontinue use of certain, vulnerable ciphers and Secure Socket Layer configurations.
Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice.
This document revises the effective date for designations of “Difficult Development Areas” (DDAs) and “Qualified Census Tracts” (QCTs) for purposes of the Low-Income Housing Tax Credit (LIHTC) under Internal Revenue Code (IRC) Section 42 published on October 3, 2014 at 79 FR 59855 and amended December 17, 2015 at 80 FR 78749 in areas approved for Federal disaster-related individual assistance under the Stafford Act. This Notice extends from 730 days to 850 days the period for which the 2015 lists of QCTs and DDAs are effective for projects located in an area that was approved for individual assistance under the Stafford Act in 2017, not on subsequent lists of DDAs or QCTs; and submitted applications while the area was a 2015 QCT or DDA.
For questions on how areas are designated and on geographic definitions, contact Michael K. Hollar, Senior Economist, Economic Development and Public Finance Division, Office of Policy Development and Research, Department of Housing and Urban Development, 451 Seventh Street SW., Room 8234, Washington, DC 20410-6000; telephone number (202) 402-5878, or send an email to
This notice and additional information about DDAs and QCTs are available electronically on the Internet at
This notice extends from 730 days to 850 days the period for which the 2015 lists of QCTs and DDAs are effective for projects located in areas approved for federal individual assistance under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act) (42 U.S.C. 5170, et al.) due to a Presidentially-declared natural disaster in 2017 (hereafter, “declared counties”) and were not in areas on subsequent lists of DDAs or QCTs but submitted applications while the area was a 2015 QCT or DDA. DDAs and QCTs for 2016 were published on November 24, 2015 at 80 FR 73201. DDAs and QCTs for 2017 were published on October 17, 2016 at 81 FR 71523. DDAs and QCTs for 2018 were published on September 11, 2017 at 82 FR 42694. This applies to declared counties in each of the 50 states, the District of Columbia, Puerto Rico, American Samoa, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands. The actual designations of 2015 QCTs and DDAs are not affected by this notice. HUD is revising the effective date of the 2015 QCTs and DDAs in declared counties at this time to aid the ability of areas affected by natural disasters to place in service affordable housing.
For LIHTC and bond-financed projects located in declared counties, the sections entitled “Effective Date” and “Interpretive Examples of Effective Date” of the 2015 DDA and QCT designations as published October 3, 2014 at 79 FR 59855 and December 17, 2015 at 80 FR78749 are hereby revised to read as follows:
The 2015 lists of QCTs and DDAs are effective:
(1) For allocations of credit after December 31, 2014; or
(2) For purposes of IRC section 42(h)(4), if the bonds are issued and the building is placed in service after December 31, 2014.
If an area is not on a subsequent list of DDAs, the 2015 lists are effective for the area if:
(1) The allocation of credit to an applicant is made no later than the end of the 850-day period after the applicant submits a complete application to the LIHTC-allocating agency, and the submission is made before the effective date of the subsequent lists; or
(2) For purposes of IRC section 42(h)(4), if:
(a) The bonds are issued or the building is placed in service no later than the end of the 850-day period after the applicant submits a complete application to the bond-issuing agency, and
(b) The submission is made before the effective date of the subsequent lists, provided that both the issuance of the bonds and the placement in service of the building occur after the application is submitted.
An application is deemed to be submitted on the date it is filed if the application is determined to be complete by the credit-allocating or bond-issuing agency. A “complete application” means that no more than de minimis clarification of the application is required for the agency to make a decision about the allocation of tax credits or issuance of bonds requested in the application.
In the case of a “multiphase project,” the DDA or QCT status of the site of the project that applies for all phases of the project is that which applied when the project received its first allocation of LIHTC. For purposes of IRC section 42(h)(4), the DDA or QCT status of the site of the project that applies for all phases of the project is that which applied when the first of the following occurred: (a) The building(s) in the first phase were placed in service, or (b) the bonds were issued.
For purposes of this notice, a “multiphase project” is defined as a set of buildings to be constructed or rehabilitated under the rules of the LIHTC and meeting the following criteria:
(1) The multiphase composition of the project (
(2) The aggregate amount of LIHTC applied for on behalf of, or that would eventually be allocated to, the buildings on the site exceeds the one-year limitation on credits per applicant, as defined in the Qualified Allocation Plan (QAP) of the LIHTC-allocating agency, or the annual per-capita credit authority of the LIHTC allocating agency, and is the reason the applicant must request multiple allocations over two or more years; and
(3) All applications for LIHTC for buildings on the site are made in immediately consecutive years.
Members of the public are hereby reminded that the Secretary of Housing and Urban Development, or the
For the convenience of readers of this notice, interpretive examples are provided below to illustrate the consequences of the effective date in areas that gain or lose DDA status. The examples covering DDAs are equally applicable to QCT designations.
(Case A) Project A is located in a 2015 DDA that is NOT a designated DDA in 2016, 2017, or 2018 and is in a declared county. A complete application for tax credits for Project A is filed with the allocating agency on November 15, 2015. Credits are allocated to Project A on January 30, 2018. Project A is eligible for the increase in basis accorded a project in a 2015 DDA because the application was filed BEFORE January 1, 2016 (the effective date for the 2016 DDA lists), and because tax credits were allocated no later than the end of the 850-day period after the filing of the complete application for an allocation of tax credits.
(Case B) Project B is located in a 2015 DDA that is NOT a designated DDA in 2016, 2017, or 2018 and is in a declared county. A complete application for tax credits for Project B is filed with the allocating agency on December 1, 2015. Credits are allocated to Project B on June 30, 2018. Project B is NOT eligible for the increase in basis accorded a project in a 2015 DDA because, although the application for an allocation of tax credits was filed BEFORE January 1, 2016 (the effective date of the 2016 DDA lists), the tax credits were allocated later than the end of the 850-day period after the filing of the complete application.
(Case C) Project C is located in a 2015 DDA that was not a DDA in 2014. Project C was placed in service on November 15, 2014. A complete application for tax-exempt bond financing for Project C is filed with the bond-issuing agency on January 15, 2015. The bonds that will support the permanent financing of Project C are issued on September 30, 2015. Project C is NOT eligible for the increase in basis otherwise accorded a project in a 2015 DDA, because the project was placed in service BEFORE January 1, 2015.
(Case D) Project D is located in an area that is a DDA in 2015, but is NOT a DDA in 2016, 2017, or 2018 and is in a declared county. A complete application for tax-exempt bond financing for Project D is filed with the bond-issuing agency on October 30, 2015. Bonds are issued for Project D on January 30, 2018, but Project D is not placed in service until July 30, 2018. Project D is eligible for the increase in basis available to projects located in 2015 DDAs because: (1) One of the two events necessary for triggering the effective date for buildings described in Section 42(h)(4)(B) of the IRC (the two events being bonds issued and buildings placed in service) took place on January 30, 2018, within the 850-day period after a complete application for tax-exempt bond financing was filed, (2) the application was filed during a time when the location of Project D was in a DDA, and (3) both the issuance of the bonds and placement in service of Project D occurred after the application was submitted.
This notice involves the establishment of fiscal requirements or procedures that are related to rate and cost determinations and do not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 40 CFR 1508.4 of the regulations of the Council on Environmental Quality and 24 CFR 50.19(c)(6) of HUD's regulations, this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any policy document that has federalism implications if the document either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the document preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the executive order. This notice merely designates DDAs as required under IRC Section 42, as amended, for the use by political subdivisions of the states in allocating the LIHTC. As a result, this notice is not subject to review under the order.
Bureau of Indian Affairs, Interior.
Notice.
The notice announces that the Tribal-State Class III Gaming Compact between the Pueblo of Pojoaque and State of New Mexico is taking effect.
This notice is applicable as of October 26, 2017.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Deputy Assistant Secretary—Policy and Economic Development, Washington, DC 20240, (202) 219-4066.
Under section 11 of the Indian Gaming Regulatory Act (IGRA) Public Law 100-497, 25 U.S.C. 2701
Bureau of Land Management, Interior.
Notice.
The Bureau of Land Management's (BLM) Alaska State Office will hold an oil and gas lease sale bid opening for all available tracts in the National Petroleum Reserve in Alaska (NPR-A).
The oil and gas lease sale bid opening will be at 1 p.m. (AKST) on Wednesday, December 6, 2017. The BLM must receive all sealed bids by 4 p.m. (AKST), Monday, December 4, 2017. The Detailed Statement of Sale for the NPR-A Oil and Gas Lease Sale 2017 will be available to the public on October 26, 2017.
Sealed bids must be received at the BLM-Alaska State Office, ATTN: Carol Taylor (AK932); 222 West 7th Avenue, #13; Anchorage, AK 99513-7504. You may get the Detailed Statement of Sale from the BLM Alaska Web site at
Robert Brumbaugh, 907-271-4429. People who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The December 2017 NPR-A Oil and Gas Lease Sale will include all 900 tracts (approximately 10.3 million acres) that are available for leasing under the NPR-A Integrated Activity Plan/Environmental Impact Statement Record of Decision (ROD) that was finalized in February 2013. This is the first time that all available tracts, as designated available for development in the 2013 Record of Decision, will be offered for sale.
The opening and reading of the bids for the 2017 lease sale will be available for online public viewing via video livestreaming at
The Detailed Statement of Sale will include a description of the areas the BLM is offering for lease, as well as the lease terms, conditions, special stipulations, required operating procedures, and directions for how to submit bids. If you plan to submit a bid(s), please note that all bids must be sealed in accordance with the provisions identified in the Detailed Statement of Sale. The United States reserves the right to withdraw any tract from this sale prior to issuance of a written acceptance of a bid.
43 CFR 3131.4-1 and 42 U.S.C. 6506a.
National Park Service, Interior.
Notice of information collection; request for comments.
In accordance with the Paperwork Reduction Act of 1995, the National Park Service is proposing to renew an information collection.
Interested persons are invited to submit comments on or before November 27, 2017.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Kristine Brunsman by email at
We, the National Park Service (NPS), in accordance with the Paperwork Reduction Act of 1995, provide the general public and other Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the NPS; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the NPS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the NPS minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
This request includes information collections related to HPF grants to States and to THPOs. Section 101(b) of the National Historic Preservation Act, as amended, (54 U.S.C. 302301), specifies the role of States in the NHPP Program. Section 101(c), section 103(c), and section 301 of the Act (54 U.S.C. 302502, 54 U.S.C. 302902, and 54 U.S.C. 300301), specify the role of local governments in the NHPP program. Section 101(d) of the Act (54 U.S.C. 302701) specifies the role of tribes in the NHPP Program. Section 108 of the Act (54 U.S.C. 303101) created the HPF to support activities that carry out the purposes of the Act. Section 101(e)(1) of the Act (54 U.S.C. 302902) directs the Secretary of the Interior through the NPS to “administer a program of matching grants to the States for the purposes of carrying out” the Act. Similarly, sections 101(d) and 101(e) of the Act direct the NPS to administer a program of grants to THPOs for carrying out their responsibilities under the Act. Section 101j of the Act (54 U.S.C. 303903) directs the NPS to provide historic preservation-related education and training.
Each year Congress directs the NPS to use part of the annual appropriation from the HPF for the State grant program and the Tribal grant programs. The purpose of both the HPF State grant program and the HPF THPO grant program is to assist States and Tribes in carrying out their statutory role in the national historic preservation program. HPF grants to States and THPOs are program grants;
The NPS developed the information collections associated with 36 CFR part 61 in consultation with State, Tribal, and local government partners. The obligation to respond is required to provide information to evaluate whether or not State, Tribal, and local governments meet minimum standards and requirements for participation in the National Historic Preservation Program; and to meet program specific requirements as well as government-wide requirements for Federal grant programs.
The authorities for this action are the National Historic Preservation Act (NHPA) (54 U.S.C. 300101
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before September 23, 2017, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by November 13, 2017.
Comments may be sent via U.S. Postal Service and all other carriers to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 7228, Washington, DC 20240.
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before September 23, 2017. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we
Nominations submitted by State Historic Preservation Officers:
A request for removal has been made for the following resource(s):
Nominations submitted by Federal Preservation Officers:
The State Historic Preservation Officer reviewed the following nomination and responded to the Federal Preservation Officer within 45 days of receipt of the nomination and supports listing the property in the National Register of Historic Places.
60.13 of 36 CFR part 60.
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before September 30, 2017, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by November 13, 2017.
Comments may be sent via U.S. Postal Service and all other carriers to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 7228, Washington, DC 20240.
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before September 30, 2017. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Nominations submitted by State Historic Preservation Officers:
An owner objection received for the following resource:
A request for removal has been made for the following resources:
Additional documentation has been received for the following resources:
60.13 of 36 CFR part 60.
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before October 7, 2017, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by November 13, 2017.
Comments may be sent via U.S. Postal Service and all other carriers to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 7228, Washington, DC 20240.
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before October 7, 2017. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Nominations submitted by State Historic Preservation Officers:
Belfrage, W.L. and Winnie (Woodfield), Farmstead Historic District, 2410 Port Neal Rd., Sergeant Bluff, SG100001819
Leach Fire Lookout Tower, (Tennessee Division of Forestry Fire Lookout Towers MPS), RT 1 Leach Rd., Cedar Grove, MP100001821
A request for removal has been made for the following resources:
60.13 of 36 CFR part 60.
Bureau of Ocean Energy Management, Interior.
Notice of Availability of the Proposed Notice of Sale for Gulf of Mexico Outer Continental Shelf Oil and Gas Region-wide Lease Sale 250.
The Bureau of Ocean Energy Management (BOEM) announces the availability of the Proposed Notice of Sale (NOS) for the proposed Gulf of Mexico (GOM) Outer Continental Shelf (OCS) Oil and Gas Lease Sale 250 (GOM Region-wide Sale 250). This Notice is published pursuant to 30 CFR 556.304(c). With regard to oil and gas leasing on the OCS, the Secretary of the Interior, pursuant to section 19 of the Outer Continental Shelf Lands Act, provides affected states the opportunity to review the Proposed NOS. The Proposed NOS sets forth the proposed terms and conditions of the sale, including minimum bids, royalty rates, and rental rates.
Affected states may comment on the size, timing, and location of proposed GOM Region-wide Sale 250 within 60 days following their receipt of the Proposed NOS. The Final NOS will be published in the
The Proposed NOS for GOM Region-wide Sale 250 and Proposed NOS Package containing information essential to potential bidders may be obtained from the Public Information Unit, Gulf of Mexico Region, Bureau of Ocean Energy Management, 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123-2394; telephone: (504) 736-2519. The Proposed NOS and Proposed NOS Package also are available on BOEM's Web site at
Dr. Andrew Krueger, Chief, Sales Coordination Branch, 703-787-1554,
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of an expedited review pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the antidumping duty and countervailing duty orders on lined paper school supplies from China and India would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
October 6, 2017.
Calvin Chang (202-205-3062), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
For further information concerning the conduct of this review and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of a full review pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the antidumping duty order countervailing duty order on foundry coke from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
October 20, 2017.
Ayanna Butler (202-708-2208), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
For further information concerning the conduct of this review and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of a full review pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the antidumping duty order on tin- and chromium-coated steel sheet from Japan would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
October 20, 2017.
Robert Casanova (202-708-2719), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
For further information concerning the conduct of this review and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of PureCircle USA Inc. and PureCircle Sdn Bhd on October 20, 2017. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain glucosylated steviol glycosides, and products containing same. The complaint names as respondents Sweet Green Fields USA LLC of Bellingham, WA; Sweet Green Fields Co., Ltd of Bellingham, WA; and Ningbo Green-Health Pharma-ceutical Co., Ltd. a/k/a NB Green-Health Pharma-ceutical Co., Ltd. of China. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by
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.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 27, 2017. Such persons may also file a written request for a hearing on the application on or before November 27, 2017.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on August 2, 2017, Galephar Pharmaceutical Research, Inc., #100 Carr 198, Industrial Park, Juncos, Puerto Rico 00777-3873 applied to be registered as an importer of hydromorphone (9150), a basic class of controlled substance in schedule II.
The company plans to import the listed controlled substance in finished dosage form for clinical trials, research and analytical purposes.
The import of this class of controlled substance will be granted only for analytical testing, research, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale.
On April 4, 2017, the Assistant Administrator, Division of Diversion Control, issued an Order to Show Cause to Yoon H. Choi, M.D. (Respondent), of Brockton, Massachusetts. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration as a practitioner, on the ground that he does not have authority to dispense controlled substances in Massachusetts, the State in which he is registered with the Agency. Show Cause Order, at 1.
As to the Agency's jurisdiction, the Show Cause Order alleged that Respondent holds DEA Certificate of Registration No. BC6966381, which authorizes him to dispense controlled substances in schedules II through V as a practitioner, at the registered address of Steward Medical Group, One Pearl Street, Suite 2200, Brockton, Massachusetts.
As to the substantive ground for the proceeding, the Show Cause Order alleged that “[o]n January 5, 2017, the Commonwealth of Massachusetts Board of Registration in Medicine indefinitely suspended [his] medical license” and that “[t]his order remains in effect.”
The Show Cause Order also notified Respondent of his right to request a hearing on the allegations or to submit a written statement while waiving his right to a hearing, the procedure for electing either option, and the consequence for failing to elect either option.
On May 8, 2017, Respondent, through his counsel, timely requested a hearing.
On May 16, 2017, the Government filed its motion for summary disposition. Therein, the Government maintained that it is undisputed that Respondent lacks authority to dispense controlled substances in Massachusetts, the State in which he is registered, and that therefore, he “no longer meets the statutory definition of a practitioner.” Mot. for Summ. Disp., at 3-4. As support for the motion, the Government attached a copy of the Final Decision and Order of the Commonwealth of Massachusetts Board of Registration in Medicine, which indefinitely suspended Respondent's medical license, effective January 5, 2017. The Government also attached a printout from the Board's Web site which it obtained on May 12, 2017 and which shows that Respondent's medical license was still suspended, as well as a copy of Respondent's Corrective Action Plan and his Certificate of Registration.
Respondent did not file any pleading in response to the Government's motion. Order Granting Summary Disposition, at 2. Accordingly, on June 5, 2017, the ALJ granted the Government's motion, finding it undisputed that Respondent's state “medical license is currently suspended” and that he “lacks state authorization to handle controlled substances in Massachusetts,” the State in which he is registered.
Neither party filed exceptions to the ALJ's Order. Thereafter, on July 11, 2017, the ALJ forwarded the record to my Office for Final Agency Action.
Upon review of the record, the former Acting Administrator noted that while Respondent had filed a Corrective Action Plan the record contained no evidence as to the Assistant Administrator's decision as to the adequacy of Respondent's Corrective Action Plan. Accordingly, on September 22, 2017, the former Acting Administrator issued an Order directing the Government to notify my Office of the status of Respondent's Corrective Action Plan, and in the event the Assistant Administrator had issued a decision on review of the Plan, to provide a copy of that decision. The former Acting Administrator provided Respondent with the right to reply to the Government's submission no later than five business days from the date of receipt of the Government's submission.
On September 25, 2017, the Government submitted a copy of the former Assistant Administrator's letter of June 12, 2017 rejecting Respondent's Corrective Action Plan.
Having considered the record in its entirety, I adopt the ALJ's factual finding that Respondent's Massachusetts medical license has been suspended, as well as his legal conclusion that he currently lacks authority to dispense controlled substances in Massachusetts and thus, he “cannot maintain” his DEA registration. I also adopt the ALJ's recommended Order that I revoke his registration. I make the following factual findings.
Respondent is the holder of DEA Certificate of Registration No. BC6966381, pursuant to which he is authorized to dispense controlled substances in schedules II through V as a practitioner, at the registered address of Steward Medical Group Brockton, One Pearl Street Suite 2200, Brockton, MA 02301. GX 1. This registration does not expire until August 31, 2018.
Respondent is also the holder of Medical License No. 206555 issued by the Commonwealth of Massachusetts Board of Registration in Medicine. GX 2, at Attachment B. However, on January 5, 2017, the Board issued a Final Decision and Order which “indefinitely suspended” his medical license. GX 2, at Attachment A. According to the Board's Physician Profile Web page of which I take Official Notice,
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823, “upon a finding that the Registrant . . . has had his State license . . . suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” Moreover, DEA has held repeatedly that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration.
This rule derives from the text of two provisions of the CSA. First, Congress defined “the term `practitioner' [to] mean[] a . . . physician . . . or other
As a consequence of the Board's Final Decision and Order, Respondent is not currently authorized to dispense controlled substances in Massachusetts, the State in which he is registered. Because the CSA makes clear that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for both obtaining and maintaining a practitioner's registration, it is of no consequence that the Board's Order provided that he may petition to stay the suspension upon meeting certain conditions.
Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration No. BC6966381 issued to Yoon Choi, M.D., be, and it hereby is, revoked. Pursuant to the authority vested in me by 21 U.S.C. 823(f), I further order that any application of Yoon Choi, M.D., to renew or modify this registration, or for any other registration in the Commonwealth of Massachusetts, be, and it hereby is, denied. This Order is effective November 27, 2017.
On January 24, 2017, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause to Harinder Takyar, M.D. (hereinafter, Respondent) of Mesa, Arizona. GX 4. The Show Cause Order proposed the revocation of Respondent's Certificate of Registration on the grounds that Respondent does “not have authority to handle controlled substances in the State of Arizona,” the State in which he is registered, and that Respondent's “registration would be inconsistent with the public interest.” GX 4, at 1 (citing 21 U.S.C. 823(f), 824(a)(3) and (4)).
As to the Agency's jurisdiction, the Show Cause Order alleged that Respondent holds DEA Certificate of Registration No. BT9321150 which authorizes him to dispense controlled substances in schedules II through V as a practitioner at the registered address of 9341 East McKellips Road, Mesa, Arizona 85207. GX 4, at 1.
As the first substantive ground for the proceeding, the Show Cause Order alleged that Respondent is “currently without authority to handle controlled substances in Arizona.” GX 4, at 1. It alleged that, on December 21, 2016, Respondent “entered into an Interim Consent Agreement for Practice Restriction with the Arizona Medical Board” which “prohibited [Respondent] from engaging in the practice of medicine in the State of Arizona . . . until he applies to the Executive Director and receives permission to do so.” GX 4, at 1 and GX 3, at 5 (Interim Consent Agreement For Practice Restriction), respectively. The Show Cause Order alleged that Respondent was “still currently prohibited from practicing medicine in the state in which . . . [he is] registered with the DEA . . . [and] therefore, the DEA must revoke . . . [his] DEA . . . [registration] based upon . . . [his] lack of authority to handle controlled substances in the State of Arizona.” GX 4, at 2 (citing 21 U.S.C. 802(21), 823(f), and 824(a)(3)).
As the second substantive ground for the proceeding, the Show Cause Order alleged that the Arizona Attorney General's Office and the Pinal County (Arizona) Task Force “initiated an investigation of . . . [Respondent's] medical practice after receiving information from a cooperating source that . . . [he] routinely prescribed large quantities of oxycodone, a Schedule II controlled substance, without performing an examination.” GX 4, at 2. After summarizing two law enforcement officers' undercover visits to Respondent's medical practice, the Show Cause Order alleged that, concerning the first undercover officer, Respondent prescribed schedule II and IV controlled substances “after conducting only a cursory medical examination[, or no physical examination but falsely documenting a full physical exam] . . . without inquiring about whether the agent experienced sleeplessness, anxiety, or panic[, and without] . . . properly execut[ing] . . . a prescription . . . as required by 21 CFR 1306.05(a) by not listing the full address of the patient on the face of the prescription . . . [or] maintain[ing] an adequate patient chart.” GX 4, at 2-3.
Concerning the second undercover officer, the Show Cause Order alleged that Respondent prescribed a schedule II controlled substance the first time “despite the agent informing . . . [Respondent] that he felt no pain during . . . [Respondent's] brief examination of him . . . [, and a second time without] conduct[ing] a physical exam . . . and falsely documenting a full physical
The Show Cause Order notified Respondent of his right to request a hearing on the allegations or to submit a written statement while waiving his right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. GX 4, at 5 (citing 21 CFR 1301.43). The Show Cause Order also notified Respondent of the opportunity to submit a Corrective Action Plan. GX 4, at 5 (citing 21 U.S.C. 824(c)(2)(C)).
By letter dated February 22, 2017, Respondent, by his counsel, asked the Administrative Law Judge for “an extension of 30 days within which to file a written request for hearing concerning the Order to Show Cause.” GX 5. The letter alleged that “good cause” supported the request because Respondent's counsel “has only recently been retained,” the “discovery concerning the listed allegations is voluminous,” and counsel “needed [time] to gather necessary information concerning the allegations . . . and more effectively complete the request for hearing letter.”
By Motion dated March 27, 2017, the Government requested that further proceedings be terminated because “[a]s of the date of this filing, Respondent has not notified this tribunal or Government counsel of any request for hearing.” GX 7, at 2 (Government's Motion for Termination of Proceedings). By Order dated April 3, 2017, the Presiding Judge issued an Order Terminating Proceedings, finding that “no request for a hearing was filed.” GX 8 (Order Terminating Proceedings).
I find that the Government's service of the Show Cause Order on Respondent was legally sufficient, that the Respondent did not timely request a hearing, and that Respondent has waived his right to a hearing and his right to submit a written statement. 21 CFR 1301.43(d). I therefore issue this Decision and Order based on the record submitted by the Government. 21 CFR 1301.43(e).
Respondent currently holds DEA practitioner registration BT9321150 authorizing him to dispense controlled substances in schedules II through V at the address of Reform Physicians, 9341 E McKellips Road, Mesa, AZ 85207-8520. GX 1. This registration expires on November 30, 2019.
On December 21, 2016, Respondent and the Executive Director of the Arizona Medical Board (hereinafter, “Board”) signed an “Interim Consent Agreement for Practice Restriction.” GX 3. Pursuant to the Interim Consent Agreement for Practice Restriction, Respondent elected to relinquish all rights to a hearing and to appeal, and agreed not to dispute, but did not concede, its allegations. GX 3, at 6, 4, respectively. It contained the allegations that Respondent “deviated from the standard of care” for one patient by “failing to substantiate and justify a reason for prescribing opioids to . . . her[,] to acknowledge and deal with aberrant behavior manifested by frequent Emergency Room . . . visits usually for overdoses and documentation [sic] cocaine use[,] . . . to utilize urine drug screens[,] . . . to access [the patient's] Controlled Substance Prescription Monitoring Program (“CSPMP”) profile to monitor [the patient's] prescription medication use[, and] . . . by performing trigger point injections without identifying physical trigger points on examination, usually with a concomitant IM injection of Toradol.” GX 3, at 2. The Interim Consent Agreement for Practice Restriction contained the allegation that this patient “experienced actual harm as Respondent caused or contributed to her abuse and apparent addiction of controlled substances.”
The Interim Consent Agreement for Practice Restriction also contained allegations that Respondent deviated from the standard of care for another patient “by failing to substantiate and justify a reason for prescribing opioids to . . . [her], failing to monitor his opioid prescribing, failing to access the CSPMP, and failing to utilize urine drug screens.” GX 3, at 3. Those allegations included that Respondent “failed to identify aberrant behavior including frequent ER visits, and claims of lost or stolen medications and requests for early refills.”
The Interim Consent Agreement for Practice Restriction contained allegations concerning a third patient of Respondent's. Those allegations included that “Respondent deviated from the standard of care for . . . [the patient] by failing to identify a source of pain for . . . [him], and failing to demonstrate that the prescribing of opioids met the goals of reduction of pain and improvement of function.”
The Interim Consent Agreement for Practice Restriction explicitly stated that Respondent agreed not to dispute its allegations “[f]or the purposes of entering this Interim Consent Agreement and for these purposes only.” GX 3, at 4. It also stated that Respondent did “not concede these allegations and this Interim Consent Agreement is not intended for use in any subsequent proceeding, either civil or criminal, as evidence of any kind.”
The Interim Consent Agreement for Practice Restriction's Interim Order prohibited Respondent from engaging in the practice of medicine in the State of Arizona “until he applies to the Executive Director and receives permission to do so.” GX 3, at 5 (citing A.R.S. § 32-1401(22)). The Interim Order stated that Respondent may request release and/or modification of the Interim Consent Agreement for
On May 9, 2017, the DEA Diversion Investigator assigned to the investigation of Respondent's medical practice (hereinafter, DI) signed a Declaration. GX 9. According to that Declaration, the DI “confirmed” with the Senior Investigator for the Board that “the current prohibition on . . . [Respondent's] practice of medicine also includes a prohibition on his authorization to handle controlled substances.” GX 9, at 2. Further, as of April 24, 2017, the Declaration stated that the Board's Senior Investigator informed the DI that Respondent “remains prohibited from practicing medicine in Arizona, pending revocation proceedings currently before the Board.”
As found above, Respondent waived his right to a hearing and to submit a written statement while waiving his right to a hearing concerning the Show Cause Order. Accordingly, there is no evidence to refute the allegations of the Show Cause Order. I, therefore, find that Respondent currently is prohibited from engaging in the practice of medicine, and currently is without authority to dispense controlled substances, in Arizona, the State in which he is registered.
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (hereinafter, CSA), “upon a finding that the registrant . . . has had his State License or registration suspended [or] revoked by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, the DEA has also long held that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration.
This rule derives from the text of two provisions of the CSA. First, Congress defined the term “practitioner” [to] mean[ ] a . . . physician . . . or other person licensed, registered, or otherwise permitted, by . . . the jurisdiction in which he practices . . . , to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice . . . .” 21 U.S.C. 801(21). Second, in setting the requirements for obtaining a practitioner's registration, Congress directed that “[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.” 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess State authority in order to be deemed a practitioner under the CSA, the DEA has held repeatedly that revocation of a practitioner's registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the State in which he practices.
Under Arizona law, a “doctor of medicine” is a “natural person holding a license, registration or permit to practice medicine pursuant to this chapter.” A.R.S. § 32-1401(10) (2017).
In this case, the Arizona Medical Board and Respondent entered into an “Interim Consent Agreement for Practice Restriction” which prohibits Respondent from engaging in the practice of medicine in the State of Arizona “until he applies to the Executive Director and receives permission to do so.” GX 3, at 5 (citing A.R.S. § 32-1401(22)). Further, the unrefuted DI Declaration stated that “the current prohibition on . . . [Respondent's] practice of medicine also includes a prohibition on his authorization to handle controlled substances.” GX 9, at 2. Consequently, Respondent is not currently authorized to handle controlled substances in the State of Arizona, the State in which he is registered and, therefore, he is not entitled to maintain his DEA registration.
Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration BT9321150 issued to
Department of Justice.
Notice.
This notice provides the text of the Attorney General's Memorandum of October 6, 2017, for all executive departments and agencies entitled “Federal Law Protections for Religious Liberty” and the appendix to this Memorandum.
This notice is applicable on October 6, 2017.
Jennifer Dickey, Counsel, Office of Legal Policy, U.S. Department of Justice, 950 Pennsylvania Avenue NW., Washington, D.C. 20530, phone (202) 514-4601.
The President instructed the Attorney General to issue guidance interpreting religious liberty protections in federal law, as appropriate. Exec. Order 13798, § 4 (May 4, 2017). Pursuant to that instruction and consistent with the authority to provide advice and opinions on questions of existing law to the Executive Branch, the Attorney General issued the following memorandum to the heads of all executive departments and agencies on October 6, 2017.
The President has instructed me to issue guidance interpreting religious liberty protections in federal law, as appropriate. Exec. Order No. 13798 § 4, 82 Fed. Reg. 21675 (May 4, 2017). Consistent with that instruction, I am issuing this memorandum and appendix to guide all administrative agencies and executive departments in the execution of federal law.
Religious liberty is a foundational principle of enduring importance in America, enshrined in our Constitution and other sources of federal law. As James Madison explained in his Memorial and Remonstrance Against Religious Assessments, the free exercise of religion “is in its nature an unalienable right” because the duty owed to one's Creator “is precedent, both in order of time and in degree of obligation, to the claims of Civil Society.”
Religious liberty is enshrined in the text of our Constitution and in numerous federal statutes. It encompasses the right of all Americans to exercise their religion freely, without being coerced to join an established church or to satisfy a religious test as a qualification for public office. It also encompasses the right of all Americans to express their religious beliefs, subject to the same narrow limits that apply to all forms of speech. In the United States, the free exercise of religion is not a mere policy preference to be traded against other policy preferences. It is a fundamental right.
The Free Exercise Clause protects not just the right to believe or the right to worship; it protects the right to perform or abstain from performing certain physical acts in accordance with one's beliefs. Federal statutes, including the Religious Freedom Restoration Act of 1993 (“RFRA”), support that protection, broadly defining the exercise of religion to encompass all aspects of observance and practice, whether or not central to, or required by, a particular religious faith.
The Free Exercise Clause protects not just persons, but persons collectively exercising their religion through churches or other religious denominations, religious organizations, schools, private associations, and even businesses.
Constitutional protections for religious liberty are not conditioned upon the willingness of a religious person or organization to remain separate from civil society. Although the application of the relevant protections may differ in different contexts, individuals and organizations do not give up their religious-liberty protections by providing or receiving social services, education, or healthcare; by seeking to earn or earning a living; by employing others to do the same; by receiving government grants or contracts; or by otherwise interacting with federal, state, or local governments.
To avoid the very sort of religious persecution and intolerance that led to the founding of the United States, the Free Exercise Clause of the Constitution protects against government actions that target religious conduct. Except in rare circumstances, government may not treat the same conduct as lawful when undertaken for secular reasons but unlawful when undertaken for religious reasons. For example, government may not attempt to target religious persons or conduct by allowing the distribution of political leaflets in a park but forbidding the distribution of religious leaflets in the same park.
Much as government may not restrict actions only because of religious belief, government may not target persons or individuals because of their religion. Government may not exclude religious organizations as such from secular aid programs, at least when the aid is not being used for explicitly religious activities such as worship or proselytization. For example, the Supreme Court has held that if government provides reimbursement for scrap tires to replace child playground surfaces, it may not deny participation in that program to religious schools. Nor may government deny religious schools—including schools whose curricula and activities include religious elements—the right to participate in a voucher program, so long as the aid reaches the schools through independent decisions of parents.
Although government generally may subject religious persons and organizations to neutral, generally applicable laws—e.g., across-the-board criminal prohibitions or certain time, place, and manner restrictions on speech—government may not apply such laws in a discriminatory way. For instance, the Internal Revenue Service may not enforce the Johnson Amendment—which prohibits 501(c)(3) non-profit organizations from intervening in a political campaign on behalf of a candidate—against a religious non-profit organization under circumstances in which it would not enforce the amendment against a secular non-profit organization. Likewise, the National Park Service may not require religious groups to obtain permits to hand out fliers in a park if it does not require similarly situated secular groups to do so, and no federal agency tasked with issuing permits for land use may deny a permit to an Islamic Center seeking to build a mosque when the agency has granted, or would grant, a permit to similarly situated secular organizations or religious groups.
Together, the Free Exercise Clause and the Establishment Clause prohibit government from officially preferring one religious group to another. This principle of denominational neutrality means, for example, that government cannot selectively impose regulatory burdens on some denominations but not others. It likewise cannot favor some religious groups for participation in the Combined Federal Campaign over others based on the groups' religious beliefs.
Together, the Free Exercise Clause and the Establishment Clause also restrict governmental interference in intra-denominational disputes about doctrine, discipline, or qualifications for ministry or membership. For example, government may not impose its nondiscrimination rules to require Catholic seminaries or Orthodox Jewish yeshivas to accept female priests or rabbis.
RFRA prohibits the federal government from substantially burdening a person's exercise of religion, unless the federal government demonstrates that application of such burden to the religious adherent is the least restrictive means of achieving a compelling governmental interest. RFRA applies to all actions by federal administrative agencies, including rulemaking, adjudication or other enforcement actions, and grant or contract distribution and administration.
RFRA protects the exercise of religion by individuals and by corporations, companies, associations, firms, partnerships, societies, and joint stock companies. For example, the Supreme Court has held that Hobby Lobby, a closely held, for-profit corporation with more than 500 stores and 13,000 employees, is protected by RFRA.
RFRA applies to all sincerely held religious beliefs, whether or not central to, or mandated by, a particular religious organization or tradition. Religious adherents will often be required to draw lines in the application of their religious beliefs, and government is not competent to assess the reasonableness of such lines drawn, nor would it be appropriate for government to do so. Thus, for example, a government agency may not second-guess the determination of a factory worker that, consistent with his religious precepts, he can work on a line producing steel that might someday make its way into armaments but cannot work on a line producing the armaments themselves. Nor may the Department of Health and Human Services second-guess the determination of a religious employer that providing contraceptive coverage to its employees would make the employer complicit in wrongdoing in violation of the organization's religious precepts.
Because the government cannot second-guess the reasonableness of a religious belief or the adherent's assessment of the religious connection between the government mandate and the underlying religious belief, the substantial burden test focuses on the extent of governmental compulsion involved. In general, a government action that bans an aspect of an adherent's religious observance or practice, compels an act inconsistent with that observance or practice, or substantially pressures the adherent to modify such observance or practice, will qualify as a substantial burden on the exercise of religion. For example, a Bureau of Prisons regulation that bans a devout Muslim from growing even a half-inch beard in accordance with his religious beliefs substantially burdens his religious practice. Likewise, a Department of Health and Human Services regulation requiring employers to provide insurance coverage for contraceptive drugs in violation of their religious beliefs or face significant fines substantially burdens their religious practice, and a law that conditions receipt of significant government benefits on willingness to work on Saturday substantially burdens the religious practice of those who, as a matter of religious observance or practice, do not work on that day. But a law that infringes, even severely, an aspect of an adherent's religious observance or practice that the adherent himself regards as unimportant or inconsequential imposes no substantial
Once a religious adherent has identified a substantial burden on his or her religious belief, the federal government can impose that burden on the adherent only if it is the least restrictive means of achieving a compelling governmental interest. Only those interests of the highest order can outweigh legitimate claims to the free exercise of religion, and such interests must be evaluated not in broad generalities but as applied to the particular adherent. Even if the federal government could show the necessary interest, it would also have to show that its chosen restriction on free exercise is the least restrictive means of achieving that interest. That analysis requires the government to show that it cannot accommodate the religious adherent while achieving its interest through a viable alternative, which may include, in certain circumstances, expenditure of additional funds, modification of existing exemptions, or creation of a new program.
Although burdens imposed on third parties are relevant to RFRA analysis, the fact that an exemption would deprive a third party of a benefit does not categorically render an exemption unavailable. Once an adherent identifies a substantial burden on his or her religious exercise, RFRA requires the federal government to establish that denial of an accommodation or exemption to that adherent is the least restrictive means of achieving a compelling governmental interest.
Employers covered by Title VII may not fail or refuse to hire, discharge, or discriminate against any individual with respect to compensation, terms, conditions, or privileges of employment because of that individual's religion. Such employers also may not classify their employees or applicants in a way that would deprive or tend to deprive any individual of employment opportunities because of the individual's religion. This protection applies regardless of whether the individual is a member of a religious majority or minority. But the protection does not apply in the same way to religious employers, who have certain constitutional and statutory protections for religious hiring decisions.
Title VII defines “religion” broadly to include all aspects of religious observance or practice, except when an employer can establish that a particular aspect of such observance or practice cannot reasonably be accommodated without undue hardship to the business. For example, covered employers are required to adjust employee work schedules for Sabbath observance, religious holidays, and other religious observances, unless doing so would create an undue hardship, such as materially compromising operations or violating a collective bargaining agreement. Title VII might also require an employer to modify a no-head-coverings policy to allow a Jewish employee to wear a yarmulke or a Muslim employee to wear a headscarf. An employer who contends that it cannot reasonably accommodate a religious observance or practice must establish undue hardship on its business with specificity; it cannot rely on assumptions about hardships that might result from an accommodation.
President Clinton issued Guidelines on Religious Exercise and Religious Expression in the Federal Workplace (“Clinton Guidelines”) explaining that federal employees may keep religious materials on their private desks and read them during breaks; discuss their religious views with other employees, subject to the same limitations as other forms of employee expression; display religious messages on clothing or wear religious medallions; and invite others to attend worship services at their churches, except to the extent that such speech becomes excessive or harassing. The Clinton Guidelines have the force of an Executive Order, and they also provide useful guidance to private employers about ways in which religious observance and practice can reasonably be accommodated in the workplace.
Constitutional and statutory protections apply to certain religious hiring decisions. Religious corporations, associations, educational institutions, and societies—that is, entities that are organized for religious purposes and engage in activity consistent with, and in furtherance of, such purposes—have an express statutory exemption from Title VII's prohibition on religious discrimination in employment. Under that exemption, religious organizations may choose to employ only persons whose beliefs and conduct are consistent with the organizations' religious precepts. For example, a Lutheran secondary school may choose to employ only practicing Lutherans, only practicing Christians, or only those willing to adhere to a code of conduct consistent with the precepts of the Lutheran community sponsoring the school. Indeed, even in the absence of the Title VII exemption, religious employers might be able to claim a similar right under RFRA or the Religion Clauses of the Constitution.
Religious organizations are entitled to compete on equal footing for federal financial assistance used to support government programs. Such organizations generally may not be required to alter their religious character to participate in a government program, nor to cease engaging in explicitly religious activities outside the program, nor effectively to relinquish their federal statutory protections for religious hiring decisions.
Agencies must pay keen attention, in everything they do, to the foregoing principles of religious liberty.
Administrative agencies should review their current policies and practices to ensure that they comply
In formulating rules, regulations, and policies, administrative agencies should also proactively consider potential burdens on the exercise of religion and possible accommodations of those burdens. Agencies should consider designating an officer to review proposed rules with religious accommodation in mind or developing some other process to do so. In developing that process, agencies should consider drawing upon the expertise of the White House Office of Faith-Based and Neighborhood Partnerships to identify concerns about the effect of potential agency action on religious exercise. Regardless of the process chosen, agencies should ensure that they review all proposed rules, regulations, and policies that have the potential to have an effect on religious liberty for compliance with the principles of religious liberty outlined in this memorandum and appendix before finalizing those rules, regulations, or policies. The Office of Legal Policy will also review any proposed agency or executive action upon which the Department's comments, opinion, or concurrence are sought,
Much like administrative agencies engaged in rulemaking, agencies considering potential enforcement actions should consider whether such actions are consistent with federal protections for religious liberty. In particular, agencies should remember that RFRA applies to agency enforcement just as it applies to every other governmental action. An agency should consider RFRA when setting agency-wide enforcement rules and priorities, as well as when making decisions to pursue or continue any particular enforcement action, and when formulating any generally applicable rules announced in an agency adjudication.
Agencies should remember that discriminatory enforcement of an otherwise nondiscriminatory law can also violate the Constitution. Thus, agencies may not target or single out religious organizations or religious conduct for disadvantageous treatment in enforcement priorities or actions. The President identified one area where this could be a problem in Executive Order 13798, when he directed the Secretary of the Treasury, to the extent permitted by law, not to take any “adverse action against any individual, house of worship, or other religious organization on the basis that such individual or organization speaks or has spoken about moral or political issues from a religious perspective, where speech of
Agencies also must not discriminate against religious organizations in their contracting or grant-making activities. Religious organizations should be given the opportunity to compete for government grants or contracts and participate in government programs on an equal basis with nonreligious organizations. Absent unusual circumstances, agencies should not condition receipt of a government contract or grant on the effective relinquishment of a religious organization's Section 702 exemption for religious hiring practices, or any other constitutional or statutory protection for religious organizations. In particular, agencies should not attempt through conditions on grants or contracts to meddle in the internal governance affairs of religious organizations or to limit those organizations' otherwise protected activities.
Although not an exhaustive treatment of all federal protections for religious liberty, this appendix summarizes the key constitutional and federal statutory protections for religious liberty and sets forth the legal basis for the religious liberty principles described in the foregoing memorandum.
The people, acting through their Constitution, have singled out religious liberty as deserving of unique protection. In the original version of the Constitution, the people agreed that “no religious Test shall ever be required as a Qualification to any Office or public Trust under the United States.” U.S. Const., art. VI, cl. 3. The people then amended the Constitution during the First Congress to clarify that “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof.” U.S. Const. amend. I, cl. 1. Those protections have been incorporated against the States.
The Free Exercise Clause recognizes and guarantees Americans the “right to believe and profess whatever religious doctrine [they] desire [ ].”
The Free Exercise Clause protects beliefs rooted in religion, even if such beliefs are not mandated by a particular religious organization or shared among adherents of a particular religious tradition.
Importantly, the protection of the Free Exercise Clause also extends to acts undertaken in accordance with such sincerely-held beliefs. That conclusion flows from the plain text of the First Amendment, which guarantees the freedom to “
As with most constitutional protections, however, the protection afforded to Americans by the Free Exercise Clause for physical acts is not absolute,
Because a law cannot have as its official “object or purpose . . . the suppression of religion or religious conduct,” courts must “survey meticulously” the text and operation of a law to ensure that it is actually neutral and of general applicability.
“Neutrality and general applicability are interrelated, . . . [and] failure to satisfy one requirement is a likely indication that the other has not been satisfied.”
Second, even a neutral, generally applicable law is subject to strict scrutiny under this Clause if it restricts the free exercise of religion and another constitutionally protected liberty, such as the freedom of speech or association, or the right to control the upbringing of one's children.
Strict scrutiny is the “most rigorous” form of scrutiny identified by the Supreme Court.
Of course, even when a law is neutral and generally applicable, government may run afoul of the Free Exercise Clause if it interprets or applies the law in a manner that discriminates against religious observance and practice.
The Establishment Clause, too, protects religious liberty. It prohibits government from establishing a religion and coercing Americans to follow it.
Finally, the Religious Test Clause, though rarely invoked, provides a critical guarantee to religious adherents that they may serve in American public life. The Clause reflects the judgment of the Framers that a diversity of religious viewpoints in government would enhance the liberty of all Americans. And after the Religion Clauses were incorporated against the States, the Supreme Court shared this view, rejecting a Tennessee law that “establishe[d] as a condition of office the willingness to eschew certain protected religious practices.”
Recognizing the centrality of religious liberty to our nation, Congress has buttressed these constitutional rights with statutory protections for religious observance and practice. These protections can be found in, among other statutes, the Religious Freedom Restoration Act of 1993, 42 U.S.C. 2000bb
The Religious Freedom Restoration Act of 1993 (RFRA), 42 U.S.C. 2000bb
Subject to the exceptions identified below, a law “substantially burden[s] a person's exercise of religion,” 42 U.S.C. 2000bb-1, if it bans an aspect of the adherent's religious observance or practice, compels an act inconsistent with that observance or practice, or substantially pressures the adherent to modify such observance or practice,
As with claims under the Free Exercise Clause, RFRA does not permit a court to inquire into the reasonableness of a religious belief, including into the adherent's assessment of the religious connection between a belief asserted and what the government forbids, requires, or prevents.
Government bears a heavy burden to justify a substantial burden on the exercise of religion. “[O]nly those interests of the highest order . . . can overbalance legitimate claims to the free exercise of religion.”
The compelling-interest requirement applies even where the accommodation sought is “an exemption from a legal obligation requiring [the claimant] to
Even if the government can identify a compelling interest, the government must also show that denial of an accommodation is the least restrictive means of serving that compelling governmental interest. This standard is “exceptionally demanding.”
Although Congress's leadership in adopting RFRA led many States to pass analogous statutes, Congress recognized the unique threat to religious liberty posed by certain categories of state action and passed the Religious Land Use and Institutionalized Persons Act of 2000 (RLUIPA) to address them. RLUIPA extends a standard analogous to RFRA to state and local government actions regulating land use and institutionalized persons where “the substantial burden is imposed in a program or activity that receives Federal financial assistance” or “the substantial burden affects, or removal of that substantial burden would affect, commerce with foreign nations, among the several States, or with Indian tribes.” 42 U.S.C. 2000cc(a)(2), 2000cc-1(b).
RLUIPA's protections must “be construed in favor of a broad protection of religious exercise, to the maximum extent permitted by [RLUIPA] and the Constitution.”
With respect to land use in particular, RLUIPA also requires that government not “treat[] a religious assembly or institution on less than equal terms with a nonreligious assembly or institution,” 42 U.S.C. 2000cc(b)(1), “impose or implement a land use regulation that discriminates against any assembly or institution on the basis of religion or religious denomination,”
To incorporate religious adherents fully into society, Congress has recognized that it is not enough to limit governmental action that substantially burdens the exercise of religion. It must also root out public and private discrimination based on religion. Religious discrimination stood alongside discrimination based on race, color, and national origin, as an evil to be addressed in the Civil Rights Act of 1964, and Congress has continued to legislate against such discrimination over time. Today, the United States Code includes specific prohibitions on religious discrimination in places of public accommodation, 42 U.S.C. 2000a; in public facilities,
Invidious religious discrimination may be directed at religion in general, at a particular religious belief, or at particular aspects of religious observance and practice.
Protections for religious individuals in employment are the most obvious example of Congress's instruction that religious observance and practice be reasonably accommodated, not marginalized. In Title VII of the Civil Rights Act, Congress declared it an unlawful employment practice for a covered employer to (1) “fail or refuse to hire or to discharge any individual, or otherwise . . . discriminate against any individual with respect to his compensation, terms, conditions, or privileges of employment, because of such individual's . . . religion,” as well as (2) to “limit, segregate, or classify his employees or applicants for employment in any way which would deprive or tend to deprive any individual of employment opportunities or otherwise adversely affect his status as an employee, because of such individual's . . . religion.” 42 U.S.C. 2000e-2(a);
After several courts had held that employers did not violate Title VII when they discharged employees for refusing to work on their Sabbath, Congress amended Title VII to define “[r]eligion” broadly to include “all aspects of religious observance and practice, as well as belief, unless an employer demonstrates that he is unable to reasonably accommodate to an employee's or prospective employee's religious observance or practice without undue hardship on the conduct of the employer's business.” 42 U.S.C. 2000e(j);
Title VII's reasonable accommodation requirement is meaningful. As an initial matter, it requires an employer to consider what adjustment or modification to its policies would effectively address the employee's concern, for “[a]n
Title VII does not, however, require accommodation at all costs. As noted above, an employer is not required to accommodate a religious observance or practice if it would pose an undue hardship on its business. An accommodation might pose an “undue hardship,” for example, if it would require the employer to breach an otherwise valid collective bargaining agreement,
The area of religious speech and expression is a useful example of reasonable accommodation. Where speech or expression is part of a person's religious observance and practice, it falls within the scope of Title VII.
The federal government's approach to free exercise in the federal workplace provides useful guidance on such reasonable accommodations. For example, under the Guidelines issued by President Clinton, the federal government permits a federal employee to “keep a Bible or Koran on her private desk and read it during breaks”; to discuss his religious views with other employees, subject “to the same rules of order as apply to other employee expression”; to display religious messages on clothing or wear religious medallions visible to others; and to hand out religious tracts to other employees or invite them to attend worship services at the employee's church, except to the extent that such speech becomes excessive or harassing. Guidelines on Religious Exercise and Religious Expression in the Federal Workplace, § 1(A), Aug. 14, 1997 (hereinafter “Clinton Guidelines”). The Clinton Guidelines have the force of an Executive Order.
Time off for religious holidays is also often an area of concern. The observance of religious holidays is an “aspect[ ] of religious observance and practice” and is therefore protected by Title VII. 42 U.S.C. 2000e, 2000e-2. Examples of reasonable accommodations for that practice could include a change of job assignments or lateral transfer to a position whose schedule does not conflict with the employee's religious holidays, 29 CFR 1605.2(d)(1)(iii); a voluntary work schedule swap with another employee,
Except for certain exceptions discussed in the next section, Title VII's protection against disparate treatment, 42 U.S.C. 2000e-2(a)(1), is implicated
Congress has acknowledged, however, that religion sometimes
Because Title VII defines “religion” broadly to include “all aspects of religious observance and practice, as well as belief,” 42 U.S.C. 2000e(j), these exemptions include decisions “to employ only persons whose beliefs and conduct are consistent with the employer's religious precepts.”
Section 702 broadly exempts from its reach religious corporations, associations, educational institutions, and societies. The statute's terms do not limit this exemption to non-profit organizations, to organizations that carry on only religious activities, or to organizations established by a church or formally affiliated therewith.
In addition to these explicit exemptions, religious organizations may be entitled to additional exemptions from discrimination laws.
As a constitutional matter, religious organizations' decisions are protected from governmental interference to the extent they relate to ecclesiastical or internal governance matters.
Even if a particular associational decision could be construed to fall outside this protection, the government would likely still have to show that any interference with the religious organization's associational rights is justified under strict scrutiny.
As a statutory matter, RFRA too might require an exemption or accommodation for religious organizations from antidiscrimination laws. For example, “prohibiting religious organizations from hiring only coreligionists can `impose a significant burden on their exercise of religion, even as applied to employees in programs that must, by law, refrain from specifically religious activities.'”
Protections for religious organizations likewise exist in government contracts, grants, and other programs. Recognizing that religious organizations can make important contributions to government programs,
The President has assured religious organizations that they are “eligible to compete for Federal financial assistance used to support social service programs and to participate fully in the social services programs supported with Federal financial assistance without impairing their independence, autonomy, expression outside the programs in question, or religious character.”
With respect to government contracts in particular, Executive Order 13279, 67 Fed. Reg. 77141 (Dec. 12, 2002), confirms that the independence and autonomy promised to religious organizations include independence and autonomy in religious hiring. Specifically, it provides that the employment nondiscrimination requirements in Section 202 of Executive Order 11246, which normally apply to government contracts, do “not apply to a Government contractor or subcontractor that is a religious corporation, association, educational institution, or society, with respect to the employment of individuals of a particular religion to perform work connected with the carrying on by such corporation, association, educational institution, or society of its activities.” Exec. Order No. 13279, § 4,
Because the religious hiring protection in Executive Order 13279 parallels the Section 702 exemption in Title VII, it should be interpreted to protect the decision “to employ only persons whose beliefs and conduct are consistent with the employer's religious precepts.”
Even absent the Executive Order, however, RFRA would limit the extent to which the government could condition participation in a federal grant or contract program on a religious organization's effective relinquishment of its Section 702 exemption. RFRA applies to all government conduct, not just to legislation or regulation,
The First Amendment also “supplies a limit on Congress' ability to place conditions on the receipt of funds.”
Finally, Congress has provided an additional statutory protection for educational institutions controlled by religious organizations who provide education programs or activities receiving federal financial assistance. Such institutions are exempt from Title IX's prohibition on sex discrimination in those programs and activities where that prohibition “would not be consistent with the religious tenets of such organization[s].” 20 U.S.C. 1681(a)(3). Although eligible institutions may “claim the exemption” in advance by “submitting in writing to the Assistant Secretary a statement by the highest ranking official of the institution, identifying the provisions . . . [that] conflict with a specific tenet of the religious organization,” 34 CFR § 106.12(b), they are not required to do so to have the benefit of it,
Congress has undertaken many similar efforts to accommodate religious adherents in diverse areas of federal law. For example, it has exempted individuals who, “by reason of religious training and belief,” are conscientiously opposed to war from training and service in the armed forces of the United States. 50 U.S.C. 3806(j). It has exempted “ritual slaughter and the handling or other preparation of livestock for ritual slaughter” from federal regulations governing methods of animal slaughter. 7 U.S.C. 1906. It has exempted “private secondary school[s] that maintain [ ] a religious objection to service in the Armed Forces” from being required to provide military recruiters with access to student recruiting information. 20 U.S.C. 7908. It has exempted federal employees and contractors with religious objections to the death penalty from being required to “be in attendance at or to participate in any prosecution or execution.” 18 U.S.C. 3597(b). It has allowed individuals with religious objections to certain forms of medical treatment to opt out of such treatment.
Congress has taken special care with respect to programs touching on abortion, sterilization, and other procedures that may raise religious conscience objections. For example, it has prohibited entities receiving certain federal funds for health service programs or research activities from requiring individuals to participate in such program or activity contrary to their religious beliefs. 42 U.S.C. 300a-7(d), (e). It has prohibited discrimination against health care professionals and entities that refuse to undergo, require, or provide training in the performance of induced abortions; to provide such abortions; or to refer for such abortions, and it will deem accredited any health care professional or entity denied accreditation based on such actions.
Congress has also been particularly solicitous of the religious freedom of American Indians. In 1978, Congress declared it the “policy of the United States to protect and preserve for American Indians their inherent right of freedom to believe, express, and exercise the traditional religions of the American Indian, Eskimo, Aleut, and Native Hawaiians, including but not limited to access to sites, use and possession of sacred objects, and the freedom to worship through ceremonials and traditional rites.” 42 U.S.C. 1996. Consistent with that policy, it has passed numerous statutes to protect American Indians' right of access for religious purposes to national park lands, Scenic Area lands, and lands held in trust by the United States.
The depth and breadth of constitutional and statutory protections for religious observance and practice in America confirm the enduring importance of religious freedom to the United States. They also provide clear guidance for all those charged with enforcing federal law: The free exercise of religion is not limited to a right to hold personal religious beliefs or even to worship in a sacred place. It encompasses all aspects of religious observance and practice. To the greatest extent practicable and permitted by law, such religious observance and practice should be reasonably accommodated in all government activity, including employment, contracting, and programming.
On October 19, 2017, the Department of Justice lodged a proposed Consent Decree (“Consent Decree”) with the United States District Court for the District of Massachusetts in the lawsuit entitled
The proposed Consent Decree will settle claims of the United States (on behalf of the Department of Commerce/National Oceanic and Atmospheric Administration and the Department of the Interior/Fish and Wildlife Service), the Commonwealth of Massachusetts, and the State of Rhode Island for injuries to birds (other than piping plover) under the Oil Pollution Act, 33 U.S.C. 2701,
The publication of this notice opens a period for public comment on the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the proposed Consent Decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $22.75 (25 cents per page reproduction cost), payable to the United States Treasury.
Office of Justice Programs, Department of Justice.
60 day notice.
The Department of Justice, Bureau of Justice Assistance, is submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
The Department of Justice encourages public comment and will accept input until December 26, 2017.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Michelle Martin, Senior Management Analyst, Bureau of Justice Assistance,
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530.
Employment and Training Administration (ETA), Labor.
Notice.
The Department of Labor is publishing this notice to announce the establishment of a Charter for the Task Force on Apprenticeship Expansion (hereinafter “the Task Force” or “the panel”), a non-discretionary federal advisory committee authorized pursuant to section 8 of Executive Order 13801, entitled “Expanding Apprenticeships in America” (hereinafter “the Executive Order”), which was issued on June 15, 2017 (82 FR 28229) and which directed the Secretary of Labor to establish and chair such a panel in the Department of Labor and to provide notice, pursuant to section 10 of the Federal Advisory Committee Act (FACA), of the initial public meeting of the Task Force to be held on November 13, 2017.
The initial public meeting of the Task Force will begin at approximately 3:00 p.m. Eastern Standard Time on November 13, 2017.
The meeting will be held at the U.S. Department of Labor, Frances Perkins Building, 200 Constitution Avenue NW., Washington, DC 20210. The Department will post any updates regarding the agenda and meeting logistics to the Task Force Web site:
Mr. John V. Ladd, Administrator, Office of Apprenticeship, Employment and Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, Telephone: (202) 693-2796 (this is not a toll-free number).
The Task Force has been established in accordance with the provisions of FACA, as amended, 5 U.S.C. App. 2, and its implementing regulations (41 CFR 101-6 and 102-3). Interested parties can obtain the Task Force's charter on the Task Force Web site:
• Federal initiatives to promote apprenticeships;
• Administrative and legislative reforms that would facilitate the formation and success of apprenticeship programs;
• The most effective strategies for creating industry-recognized apprenticeships; and
• The most effective strategies for amplifying and encouraging private-sector initiatives to promote apprenticeships.
The Task Force is solely advisory in nature, and will consider testimony, reports, comments, research, evidence, and existing practices as appropriate to develop recommendations for inclusion in its final report to the President. While the Executive Order did not set forth a definite time by which the panel must complete its development of apprenticeship-related strategies and proposals and submit its final report to the President, it is important to note that the Task Force will not be continuing in nature. Additionally, given the nature and mission of the Task Force, some of the meeting proceedings could be included in a regulatory docket for an apprenticeship rulemaking, or other collection of documents made available by the agency for public viewing. Pursuant to both the Executive Order and the Charter, the Task Force shall terminate 30 days after it submits its final report to the President.
Under both the Executive Order and the Charter, the Secretary of Labor shall serve as the Chair of the Task Force. The Secretaries of Education and Commerce shall serve as Vice-Chairs of the Task Force. The Secretary of Labor has appointed the representative members of the Task Force, which consists of twenty (20) individuals who work for or represent the perspectives of trade and industry groups, companies, workforce advocacy organizations, unions, joint labor-management organizations, educational institutions, state or local governments, and such other persons as the Secretary of Labor may from time to time designate. These members include distinguished citizens from outside of the Federal Government with relevant experience concerning the development of a skilled workforce through quality apprenticeship programs. Pursuant to the Executive Order and the charter, a member of the Task Force may designate a senior member of his or her organization to attend any Task Force meeting. Members of the Task Force shall serve without compensation for their work on the Task Force, but shall be allowed travel expenses, including per diem in lieu of subsistence, to the extent permitted by law for persons serving intermittently in the Government service (5 U.S.C. 5701—5707), consistent with the availability of funds. Each member of the Task Force shall serve at the pleasure of the Secretary of Labor for a term that will cease 30 days after the delivery of the panel's final report to the President, at which time the Task Force will be disbanded officially.
In order to promote openness, and increase public participation, a viewing room will be made available for members of the public to observe the meeting proceedings. Registration is required. Instructions on how to register are listed below and will be posted prominently on the Task Force Web site:
Meeting participants should use the visitor's entrance to access the Frances Perkins Building, one block north of Constitution Avenue on 3rd and C Streets NW. For security purposes:
1. Visitors must present valid photo identification (ID) to receive a visitor badge.
2. Visitors must know the name of the event you are attending: the meeting event is the Task Force on Apprenticeship Expansion meeting.
3. Visitor badges are issued by the security officer at the Visitor Entrance located at 3rd and C Streets NW., as described above.
4. Laptops and other electronic devices may be inspected and logged for identification purposes.
5. Due to limited parking options, Metro rail is the easiest way to travel to the Frances Perkins Building. For individuals wishing to take metro rail, the closest metro stop to the building is Judiciary Square on the Red Line.
All members of the public are being asked to register for the Task Force meeting by Tuesday, November 7, 2017, via the public registration Web site using the following link:
The tentative agenda for this meeting includes the following:
Any member of the public who wishes to provide a written statement should send an email to
The agenda and meeting logistics may be updated between the time of this publication and the scheduled date of the Task Force meeting. All meeting updates will be posted to the Task Force Web site:
Occupational Safety and Health Administration, Department of Labor.
Notice of public meeting.
This notice is to advise interested persons that on Tuesday, November 14, 2017, from 1 p.m. to 4 p.m., OSHA will conduct a public meeting to discuss proposals in preparation for the 34th session of the United Nations Sub-Committee of
On Tuesday, November 14, 2017, from 9:00 a.m. to 12:00 p.m., the Department of Transportation (DOT), Pipeline and Hazardous Materials Safety Administration (PHMSA) will conduct a public meeting (See Docket No. PHMSA-2017-0037 Notice No. 2017-06) to discuss proposals in preparation for the 52nd session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCE TDG) to be held November 27 to December 6, 2017, in Geneva, Switzerland. During this meeting, PHMSA is also requesting comments relative to potential new work items that may be considered for inclusion in its international agenda. PHMSA will also provide an update on recent actions to enhance transparency and stakeholder interaction through improvements to the international standards portion of its Web site.
Tuesday, November 14, 2017.
Both meetings will be held at the DOT Headquarters Conference Center, West Building, Oklahoma City Conference Room, 1200 New Jersey Avenue SE., Washington, DC 20590.
Conference call-in and “Skype meeting” capability will be provided for both meetings. Specific information on such access will be posted when available at:
General topics on the agenda include:
The UNSCEGHS bases its decisions on Working Papers. The Working Papers for the 34th session of the UNSCEGHS are located at:
Informal Papers submitted to the UNSCEGHS provide information for the Sub-committee and are used either as a mechanism to provide information to the Sub-committee or as the basis for future Working Papers.
In addition to participating at the Public meeting, interested parties may submit comments on the Working and Informal Papers for the 34th session of the UNSCEGHS to the docket established for International/Globally Harmonized System (GHS) efforts at
PHMSA will host the meeting to gain input from the public concerning proposals submitted to the UNSCE TDG for the 21st Revised Edition of the United Nations Recommendations on the Transport of Dangerous Goods Model Regulations, which may be implemented into relevant domestic, regional, and international regulations beginning January 1, 2021. During this meeting, PHMSA is also soliciting input relative to preparing for the 52nd session of the UNSCE TDG as well as potential new work items that may be considered for inclusion in its international agenda.
Copies of working documents, informal documents, and the meeting agenda may be obtained from the United Nations Transport Division's Web site at:
This document was prepared under the direction of Loren Sweatt, Acting Deputy Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, pursuant to sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657), and Secretary's Order 1-2012 (77 FR 3912), (Jan. 25, 2012).
Mine Safety and Health Administration, Labor.
Notice.
This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.
All comments on the petitions must be received by MSHA's Office of
You may submit your comments, identified by “docket number” on the subject line, by any of the following methods:
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2.
3.
MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments.
Barbara Barron, Office of Standards, Regulations, and Variances at 202-693-9447 (Voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations Part 44 govern the application, processing, and disposition of petitions for modification.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.
(1) As a result of a dip with a steep incline on the end, a large pool of water has developed at the outby end of the Northwest Mains and extending inby approximately 1200 feet in the right-side return, in the No. 5 entry. This mine utilizes split air and there are two returns. There is a return entry in the No. 1 entry also. Currently, a 10-horse-power pump with a 2-inch discharge line is installed in the pool of water. This is a low spot in the mine with elevations rising going in each direction. The mine height in this area is approximately 12 feet. The water level is currently 4
(2) The remaining life of the reserve is approximately 10 years. Access to this reserve is only possible through the existing mine drifts, as all other approaches are blocked by abandoned mines. The procedures listed in this petition will provide a level of safety no less than equivalent to that afforded by 30 CFR 75.364(b)(2) for the remaining life of the mine.
(3) Therefore, the petitioner proposes an alternate plan to provide safe access over pooled water in the right return, No. 5 entry for approximately 70 feet at the outby end of the Northwest Mains. The petitioner states that use of the bridge as described below will keep employees from being exposed to hazardous travel in order to meet the requirements of the applicable standard:
(a) A metal catwalk bridge approximately 75 feet long with handrails will be utilized to provide safe access for travel across a pool of water.
(b) Each end of the bridge across the entry will be blocked with danger signs, flagging, and/or fencing to warn miners of the potential hazard and that travel through this area is only permitted across the bridge.
(c) A pump will be maintained in the pool to maintain the water level.
(d) Life vests will be provided and worn while traveling across the bridge.
(e) All miners at the D-1A Garmeada mine will be given notice of this request for modification during safety meetings.
Within 60 days after approval of this petition and the order becoming final, the petitioner will submit proposed revisions to the Part 48 training plan to the District Manager. These revisions will apply to initial and refresher training.
The petitioner asserts that the proposed alternative method will at all times guarantee no less than the same measure of protection afforded by the existing standard.
(1) The Slip Ridge mine is a large underground coal mine that has been permanently divided into three separate areas via the installation of MSHA-approved 120 PSI mine seals.
(2) On the East end of the mine is the Ellis Creek Side and this is the active mining side with two continuous miner sections producing 5 to 6 days a week.
(3) The West end of the mine is called the Slip Ridge Transfer and this end of the mine serves only as a belt through (
(4) The East and West ends of the mine are separated by approximately 3.66 miles of old mine works that were sealed on each end with MSHA-approved 120 PSI seals.
(5) The East and West ends of the mine are ventilated by separate mine fans.
(6) The East and West ends of the mine are monitored by separate CO systems.
(7) The East and West ends of the mine have their own dispatcher.
(8) Other than being on the opposite ends of a common sealed area, the East and West ends of the mine are effectively separate and independent underground coal mines.
(9) Currently, if the East side of the mine is scheduled to produce coal, the regulations require preshift examinations in accordance with 30 CFR 75.360 be completed on both sides of the mine, regardless of their autonomy.
(10) Application of the existing standard may result in a diminution of safety to the miners as it currently requires that preshift examination on both the East and West ends of the mine be performed on any day that either end of the mine will be active (
The petitioner proposes the following alternative method of compliance to the existing standard:
(a) Since the East and West side are separated by two sets of 120 PSI seals, ventilated with their own mine fans and monitored by independent CO systems, each end of the mine should be treated separately for purposes of 30 CFR 75.360.
(b) On any active side of the Slip Ridge Mine, a preshift examination as set forth in 30 CFR 75.360 will be performed.
(b) No preshift examination under 30 CFR 75.360 will be required on an idle side of the mine.
(c) Preshift examinations of the idle side of the mine will be performed prior to work being performed underground on the previously idle side of the mine.
(d) Marfork will update the CO monitoring systems to allow either side of the dispatcher to monitor the CO systems for both sides of the mine. This dual monitoring will allow the atmospheric conditions in the idle side of the mine to be monitored by the dispatcher on the active side of the mine.
(e) If a CO event occurs that would otherwise require evacuation, both sides will withdraw personnel.
(f) Marfork will set up dual monitoring of both mine fans so that the status of each fan can be monitored from both sides of the mine.
(g) In the event of a fan stoppage on one side of the mine, both sides will withdraw personnel.
(h) In the event of a fan stoppage on an idle side of the mine, the active side would be alerted via an alarm and personnel will be withdrawn from the active side.
The petitioner asserts that the proposed alternative method will at all times guarantee no less than the same measure of protection afforded by the existing standard by ensuring that the examinations are performed on the active side of the mine while continually monitoring the fan and CO systems on the idle side of the mine.
(1) Potential in-seam methane in the majority of the Road Fork #52 Mine reserve area has been reduced and/or extracted by the drilling operation of horizontal coalbed methane wells by CDX Gas, LLC (“CDX”). The first well in the area was put into production in January 2006 and the last in October 2006. The location of these wells in relation to the future mining for the Road Fork #52 Mine is shown on the map attached to this petition as Exhibit A. (Road Fork #52 Mine will mine coal to the left of the mining shown on the map).
(2) CDX will use the following methodology to drill these wells:
(a) A vertical wellbore (access hole) is drilled and cased to a point 150 feet or more above the coal seal;
(b) From the bottom of the casing in the access hole, a curved hole is drilled to intersect the coal seal at a tangent point;
(c) From the tangent point, a short common horizontal bore is drilled horizontally through the coal seam for a distance up to 500 feet;
(d) From the end of the common horizontal bore, several interconnected horizontal bores, ranging from 5 to 6.5 inches in diameter are drilled horizontally through the coalbed for distances up to 3500 feet;
(e) A second vertical wellbore (production hole) is drilled to intersect the common horizontal bore. The production hole is commonly cased with 7-inch O.D. casing to a point 100 feet more or less above the coal seam. The production hole is drilled 50 to 100 feet below the coal seam to provide a “rat-hole” for pumping liquid from the well; and
(f) Coal bed methane gas entering the horizontal wellbores travels through the common horizontal bore to the production hole and then to the surface.
(3) The Road Fork #52 Mine will employ the continuous mining room and pillar method of mining. It is anticipated that each lateral wellbore will be mined through at least once.
(4) Prior to mining within 50 feet (+1-degree accuracy factor) of a horizontal wellbore, the petitioner proposes to verify that the following procedures have been performed on the well:
(a) The well will be vented to outside atmosphere pressure for at least 8 hours;
(b) A volume of fresh water sufficient to fill the horizontal (lateral) wellbores will be injected into the well with sufficient pressure to attain a bottomhole pressure of approximately 500 pounds per square inch (PSI);
(c) The liquid will be bailed from the production hole, using normal bailing equipment, to a point just above the level of the coal seam;
(d) A volume of gel, made up of 2 to 4 percent bentonite and fresh water, sufficient to fill the horizontal wellbores plus 25 percent excess, will be injected into the well with sufficient pressure to attain a bottomhole pressure of approximately 500 PSI; and
(e) The wellbore will be filled to the surface with fresh water and allowed to stand for at least 72 hours, with the water level being supplemented as required. In the alternative, water will be injected into the wellbore for 72 hours at an average rate of 2 gallons per minute or more.
(5) Prior to mining through the first lateral wellbore of a horizontal coalbed methane well, the petitioner proposes to verify that the following procedures have been performed on the well:
(a) The water will be bailed from the vertical section of the wellbore, as close to the coal seam elevation as practical using normal bailing equipment;
(b) The surface wellhead will be maintained open to bring the vertical
(c) The petitioner further states that the MSHA District Manager and the appropriate West Virginia Office of Miners' Health Safety and Training representative will be notified at least 48 hours prior to the anticipated mine-through time;
(d) Drivage sights will be installed within 80 feet of the mine-through point;
(e) Firefighting equipment will be provided near the working face, including two 10-pound fire extinguishers, 240 pounds of rock dust, and fire hose of sufficient length to reach the working face and capable of delivering at least 50 gallons per minute of water at minimum pressure of 50 PSI;
(f) At least 9,000 CFM of intake air at the face will be supplied, but no less than the amount in the approved ventilation plan;
(g) The continuous miner methane monitor will be calibrated prior to use when the mine-through is anticipated or is occurring;
(h) A test for methane will be conducted with a hand-held methane detector at least every 10 minutes during the time mining commences at the minimum barrier distance line or within 30 feet of the wellbore, whichever is greater;
(i) All equipment will be deenergized and the area thoroughly examined when the wellbore is intersected;
(j) Once the area has been determined to be safe and mining has resumed, hand-held methane detector tests will continue at least every 10 minutes during production shifts, until mining has progressed 20 feet past the initial mine-through point;
(k) No persons will be permitted in the area of the mine-through operation except those persons actually engaged in the operation, including mine management, personnel from MSHA, and personnel from the appropriate State agency; and
(l) A certified official will directly supervise the mine-through operation and only the certified official in charge will issue instructions concerning the mine-through operation.
(6) Prior to mining through a lateral wellbore of a coalbed methane well which has already at least one lateral wellbore mined through, the petitioner proposes to verify the following procedures have been performed on the well:
(a) The water will be bailed from the vertical section of the wellbore, as close to the coal seam elevation as practical using normal bailing equipment;
(b) The surface well head will be maintained open to bring the vertical section of the wellbore to outside atmospheric pressure;
(c) Drivage sights will be installed within 80 feet of the mine-through point;
(d) Firefighting equipment will be provided near the working face, including two 10-pound fire extinguishers, 240 pounds of rock dust, and fire hose of sufficient length to reach the working face and capable of delivering at least 50 gallons per minute of water at minimum pressure of 50 PSI;
(e) At least 9,000 CFM of intake air at the face will be supplied, but no less than the amount in the approved ventilation plan;
(f) The continuous miner methane monitor will be calibrated on one of the five production shifts prior to the shift during which the mine-through is anticipated;
(g) A test for methane will be provided with a hand-held methane detector at least every 10 minutes during the time mining is conducted within 30 feet of the wellbore;
(h) All equipment will be deenergized and the area thoroughly examined when the wellbore is intersected;
(i) Once the area has been determined to be safe and mining has resumed, hand-held methane detector tests will continue at lease every 10 minutes during production shifts, until mining has progressed 20 feet past the initial mine-through point;
(j) No persons will be permitted in the area of the mine-through operation except those persons actually engaged in the operation, including mine management, personnel from MSHA, and personnel from the appropriate State agency;
(k) A certified official will directly supervise the mine-through operation and only the certified official in charge will issue instructions concerning the mine-through operation; and
(l) The production hole will remain open and accessible until all mining susceptible of intersecting horizontal wellbores has been completed.
The petitioner asserts that the proposed alternative method will at all times guarantee no less than the same measure of protection afforded by the existing standard.
Legal Services Corporation.
Announcement of intention to make FY 2018 Grant Awards.
The Legal Services Corporation (LSC) hereby announces its intention to award grants to provide economical and effective delivery of high quality civil legal services to eligible low-income clients, beginning January 1, 2018.
All comments and recommendations must be received on or before the close of business on November 27, 2017.
Legal Services Corporation—Grant Awards, Legal Services Corporation; 3333 K Street NW., Third Floor, Washington, DC 20007.
Reginald Haley, Office of Program Performance, at (202) 295-1545, or
Pursuant to LSC's announcement of funding availability on March 22, 2017, 82 FR 14753, and Grant Renewal applications due beginning June 5, 2017, LSC intends to award funds to provide civil legal services in the indicated service areas. Applicants for each service area are listed below. The amounts below are estimates based on the 2017 grant awards to each service area. The estimates incorporate the adjustments for the agricultural worker population as described at
LSC will post all updates and/or changes to this notice at
These grants will be awarded under the authority conferred on LSC by section 1006(a)(1) of the Legal Services Corporation Act, 42 U.S.C. 2996e(a)(l). Awards will be made so that each service area is served, although no listed organization is guaranteed an award. Grants will become effective and grant funds will be distributed on or about January 1, 2018.
This notice is issued pursuant to 42 U.S.C. 2996f(f). Comments and recommendations concerning potential grantees are invited, and should be delivered to LSC within 30 days from the date of publication of this notice.
National Science Foundation.
Notice of Permit Applications Received.
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.
Interested parties are invited to submit written data, comments, or views with respect to this permit application by November 27, 2017. This application may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Office of Polar Programs, National Science
Nature McGinn, ACA Permit Officer, at the above address, 703-292-8030, or
The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541, 45 CFR 670), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.
Permit Application: 2018-022 Jennifer Burns, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.
Harmful Interference. The applicant will be conducting programmatic oversight activities that may involve approaching seabird colonies near Palmer Station in the Antarctic Peninsula. The applicant is seeking a permit for harmful interference for incidental disturbance of penguins or petrels during the conduct of the oversight activities.
Torgersen Island; Humble Island; Palmer Basin (ASMA 7).
December 12-20, 2017.
National Science Foundation.
Notice of permit modification request.
The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated under the Antarctic Conservation Act of 1978. This is the required notice of a requested permit modification.
Interested parties are invited to submit written data, comments, or views with respect to this permit application by November 27, 2017. Permit applications may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.
Nature McGinn, ACA Permit Officer, at the above address, 703-292-8030, or
The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.
Now the applicant proposes a modification to his permit to use unmanned aircraft systems (UAS) for photogrammetry and population assessments by video of Antarctic seals. The permit holder plans overflights that may result in the disturbance of Antarctic fur seals (n=6000/year), crabeater seals (n=6000/year), leopard seals (n=2000/year), southern elephant seals (n=2000/year), and Weddell seals (n=2000/year). Authorization for the overflight of seals by UAS from the National Marine Fisheries Service under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
On August 17, 2017, New York Stock Exchange LLC (“NYSE” or the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission is extending the 45-day time period for Commission action on the proposed rule change. The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the Exchange's proposal, as described above. Accordingly, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 17, 2017, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider this proposed rule change, as modified by the recently filed amendment. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Social Security Administration (SSA).
Notice of a New Matching Program.
In accordance with the provisions of the Privacy Act, as amended, this notice announces a new computer matching program that we are currently conducting with the Internal Revenue Service (IRS).
This computer matching agreement sets forth the terms, conditions, and safeguards under which IRS will disclose to SSA certain return information for the purpose of verifying eligibility for the Prescription Drug Subsidy Program (Subsidy) and or determining the correct subsidy percentage of benefits provided under section 1860D-14 of the Social Security Act (Act).
The deadline to submit comments on the proposed matching program is 30 days from October 26, 2017. The matching program will be effective on November 11, 2017, or once a minimum of 30 days after publication of this notice has elapsed, whichever is later. The matching program will expire on May 10, 2019.
Interested parties may comment on this notice by either telefaxing to (410) 966-0869, writing to Mary Ann Zimmerman, Acting Executive Director, Office of Privacy and Disclosure, Office of the General Counsel, Social Security Administration, 617 Altmeyer Building, 6401 Security Boulevard, Baltimore, MD 21235-6401, or email at
Interested parties may submit general questions about the matching program to Mary Ann Zimmerman, Acting Executive Director, Office of Privacy and Disclosure, Office of the General Counsel, by any of the means shown above.
The Computer Matching and Privacy Protection Act of 1988 (Pub. L. 100-503), amended the Privacy Act (5 U.S.C. 552a) by describing the conditions under which computer matching involving the Federal government could be performed and adding certain protections for persons applying for, and receiving, Federal benefits. Section 7201 of the Omnibus Budget
The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records are matched with other Federal, State, or local government records. It requires Federal agencies involved in computer matching programs to:
(1) Negotiate written agreements with the other agency or agencies participating in the matching programs;
(2) Obtain approval of the matching agreement by the Data Integrity Boards of the participating Federal agencies;
(3) Publish notice of the computer matching program in the
(4) Furnish detailed reports about matching programs to Congress and OMB;
(5) Notify applicants and beneficiaries that their records are subject to matching; and
(6) Verify match findings before reducing, suspending, terminating, or denying a person's benefits or payments.
We have taken action to ensure that all of our computer matching programs comply with the requirements of the Privacy Act, as amended.
When there is a match of individual identifier, IRS discloses to us:
a. Payee Account Number,
b. Payee Name and Mailing Address,
c. Payee Taxpayer Identification Number (TIN),
d. Payer Name and Address,
e. Payer TIN, and
f. Income Type and Amount.
Social Security Administration (SSA).
Notice of a new matching program.
In accordance with the provisions of the Privacy Act, as amended, this notice announces a new computer matching program that we are currently conducting with the Office of Child Support Enforcement (OCSE).
The deadline to submit comments on the proposed matching program is 30 days from the date of publication of this notice. The matching program will be effective on November 1, 2017, or once a minimum of 30 days after publication of this notice has elapsed, whichever is later. The matching program will expire on October 31, 2018.
Interested parties may comment on this notice by either telefaxing to (410) 966-0869, writing to Mary Ann Zimmerman, Acting Executive Director, Office of Privacy and Disclosure, Office of the General Counsel, Social Security Administration, 617 Altmeyer Building, 6401 Security Boulevard, Baltimore, MD 21235-6401, or email at
Interested parties may submit general questions about the matching program to Mary Ann Zimmerman, Acting Executive Director, Office of Privacy and Disclosure, Office of the General Counsel, by any of the means shown above.
The Computer Matching and Privacy Protection Act of 1988 (Public Law (Pub. L.) 100-503), amended the Privacy Act (5 U.S.C. 552a) by describing the conditions under which computer matching involving the Federal government could be performed and adding certain protections for persons applying for, and receiving, Federal benefits. Section 7201 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) further amended the Privacy Act regarding protections for such persons.
The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records are matched with other Federal, State, or local government records. It requires Federal agencies involved in computer matching programs to:
(1) Negotiate written agreements with the other agency or agencies participating in the matching programs;
(2) Obtain approval of the matching agreement by the Data Integrity Boards of the participating Federal agencies;
(3) Publish notice of the computer matching program in the
(4) Furnish detailed reports about matching programs to Congress and OMB;
(5) Notify applicants and beneficiaries that their records are subject to matching; and
(6) Verify match findings before reducing, suspending, terminating, or denying a person's benefits or payments.
We have taken action to ensure that all of our computer matching programs comply with the requirements of the Privacy Act, as amended.
The Act provides that the determination of whether a Part D eligible individual residing in a state is a subsidy-eligible individual shall be determined under the state plan for medical assistance under section 1860D-14(a)(3)(B)(1) of the Act. 42 U.S.C. 1395w-114(a)(3)(B)(1).
SSA has independent authority to collect this information regarding Medicare Parts A-D via sections 202-205, 223, 226, 228, 1611, 1631, 1818, 1836, 1839, 1840, and 1860D-1 to 1860D-15 of the Act (42 U.S.C. 402-405, 423, 426, 428, 1382, 1383, 1395i-2, 1395o, 1395r, 1395s, and 1395w-101 to 1395w-115).
This agreement assists SSA in (1) determining eligibility of applicants for Extra Help; (2) redetermining eligibility of existing Extra Help beneficiaries during periodic screening; and (3) administering the Extra Help program.
The Privacy Act provides that no record contained in a system of record (SOR) may be disclosed for use in a computer matching program except pursuant to a written agreement containing specified provisions. 5 U.S.C. 552a(o). SSA and OCSE are executing this agreement to comply with the Privacy Act of 1974, as amended, and the regulations and guidance promulgated thereunder. OCSE and SSA have been parties to matching agreements and recertifications for this purpose since April 1, 2005. Appendix A provides background information about these prior agreements.
The SSA component responsible for this agreement and its contents is the Office of Privacy and Disclosure. The responsible component for OCSE is the Division of Federal Systems.
This agreement is applicable to personnel, facilities, and information systems of SSA and OCSE involved in the processing and storage of NDNH information. Personnel are defined as employees, contractors, or agents of OCSE and SSA.
This agreement includes a security addendum and four appendices.
SSA will provide OCSE the following data elements electronically in the Finder File:
OCSE will provide electronically to SSA the following data elements from the NDNH quarterly wage file:
OCSE will provide electronically to SSA the following data elements from the NDNH unemployment insurance file:
Data Elements SSA updates in the OCSEFITM table, if there is a match:
OCSE will match SSA information in the MDB against the quarterly wage and unemployment insurance information furnished by state and federal agencies maintained in its system of records
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
The information collections below are pending at SSA. SSA will submit them to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than December 26, 2017. Individuals can obtain copies of the collection instruments by writing to the above email address.
Surface Transportation Board.
Correction to notice of exemption.
On September 1, 2017, notice of the above exemption was served and published in the
Board decisions and notices are available on our Web site at “
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Third RTCA SC-236, Wireless Airborne Intra Communications (WAIC), joint Plenary with EUROCAE WG-96.
The FAA is issuing this notice to advise the public of a meeting of Third RTCA SC-236, Wireless Airborne Intra Communications (WAIC), joint Plenary with EUROCAE WG-96.
The meeting will be held November 28-December 1, 2017 9:00 a.m.-5:00 p.m.
The meeting will be held at: EASA Headquarters, Konrad-Adenauer-Ufer 3, D-50668 Cologne, Germany.
Rebecca Morrison at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Third RTCA SC-236 joint Plenary with EUROCAE WG-96. The agenda will include the following:
Registration is required for attendance. Attendance is open to the
Under part 211 of Title 49 Code of Federal Regulations (CFR), this provides the public notice that on October 4, 2017, the Association of American Railroads (AAR) petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal Railroad safety regulations contained at 49 CFR 229.23. FRA assigned the petition Docket Number FRA-2017-0105.
Section 229.23(a) requires each locomotive to be inspected on an interval not to exceed 92 days; section 229.23(b) allows a locomotive equipped with advanced microprocessor-based on-board electronic condition monitoring controls to be inspected on an interval not to exceed 184 days. AAR states in its petition that it believes the approximately 422 locomotives equipped with 26-L brake systems and microprocessor-based on-board pneumatic condition monitoring controls should fall within section 229.23(b), and petitions for a two-year test waiver to demonstrate the appropriateness of that categorization.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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•
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Communications received by December 11, 2017 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under part 211 of Title 49 of the Code of Federal Regulations (CFR), this document provides the public notice that on August 15, 2017, Old Augusta Railroad (OAR) petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the hours of service laws contained at Title 49 United States Code (U.S.C.) section 21103(a), in accordance with the authority of section 21102(b). FRA assigned the petition docket number FRA-2013-0019.
OAR requested an extension of its existing waiver of relief from the provisions of 49 U.S.C. 21103(a), which prohibits a train employee from remaining or going on duty for a period in excess of 12 consecutive hours. 49 U.S.C. 21102(b) allows railroads with 15 or fewer employees to be exempted from the restriction outlined at 49 U.S.C. 21103(a)(4)(B). The existing waiver allows OAR employees to initiate an on-duty period each day for seven (7) consecutive days followed by 72 hours off duty. An employee may initiate an on-duty period for an eighth consecutive day followed by 72 hours off duty, if all eight assignments do not infringe upon the 10:00 p.m. to 5:00 a.m. time period. Employees' schedules may be extended no more than one time within any 30-day period. An employee must agree to have his or her series of consecutive days extended. If an employee's series of consecutive days is extended and he or she subsequently feels fatigues, he or she may request up to 24 hours of time off duty, which OAR shall allow the employee to receive. For any employee whose series of consecutive days is extended subject to this waiver, the hours of service records for the relevant series of consecutive days must indicate that the limitation has been extended by waiver.
OAR states that its operation has not had a single incident attributable to fatigue during the effective period of the waiver. In addition, the relief has enabled the railroad to serve their customers safely and efficiently, utilizing their own experienced employees, and without having to rely on less experienced personnel obtained from other areas or entities. OAR states that its employees have unanimously consented to the waiver, and it has full support from both management and train service employees.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
•
•
•
•
Communications received December 11, 2017 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under part 211 of Title 49 of the Code of Federal Regulations (CFR), this provides the public notice that on July 28, 2017, the Canadian National Railway Company (CN), the Transportation Division of the International Association of Sheet Metal, Air, Rail, and Transportation Workers (TD-SMART) and the Brotherhood of Locomotive Engineers and Trainmen (BLET) collectively petitioned the Federal Railroad Administration (FRA) for an extension of CN's existing waiver of compliance from certain provisions of the hours of service laws contained at Title 49 United States Code (U.S.C.) section 21103(a)(4). FRA assigned the petition Docket Number FRA-2009-0074.
CN requested an extension of its existing waiver from the provisions of 49 U.S.C. 21103(a), which prohibits a train employee from remaining or going on duty after that employee has initiated an on-duty period each day for six consecutive days, unless that employee has had at least 48 consecutive hours off duty at the employee's home terminal. Specifically, CN, on behalf of its railroad operating subsidiaries based in the United States, and its unions, seeks a waiver to allow train employees to initiate an on-duty period each day for 6 consecutive days followed by 24 hours off duty. In support of the request, CN, BLET, and SMART explained that CN has operated these schedules of 6 consecutive on-duty periods followed by 24 hours off duty successfully since 2002. CN, BLET, and SMART indicate that these schedules have not had an adverse impact on safety.
CN also provided an analysis of the most current 12-month period of train-employee on-duty human factor-related accidents and injuries. CN indicates that its analyses revealed that of the 13 human factor-related accidents involving CN employees in the preceding 12 months, none involved employees covered under the waiver working 6 consecutive days followed by 24 hours off duty.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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•
•
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Communications received December 11, 2017 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under part 211 of Title 49 of the Code of Federal Regulations (CFR), this provides the public notice that on September 27, 2017, New Jersey Transit (NJT) petitioned the Federal Railroad Administration (FRA) for an extension of a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 213, Track Safety Standards. The docket number associated with this petition is FRA-2003-15196.
NJT seeks an extension of its existing waiver from 49 CFR 213.233(c), relating to the frequency of the required visual track inspections for FRA Class 3 and 4 track carrying passenger traffic. FRA issued the initial waiver that granted NJT relief on August 25, 1999 (FRA Docket No. RST-97-5), and FRA extended the waiver on April 28, 2003, May 1, 2008, and December 17, 2012 for three 5-year periods.
NJT requests an extension of its waiver for reduced frequency of required visual track inspections specifically for those tracks constructed with continuous welded rail. NJT proposes to conduct one visual track inspection per week, instead of the two inspections per week that are required in 49 CFR part 213, and to supplement its visual inspections with the operation of an automated track geometry measuring vehicle over the affected main tracks and sidings four times per year.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
•
•
•
•
Communications received by December 11, 2017 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) has removed from the Specially Designated Nationals and Blocked Persons List (SDN List) the names of persons whose property and interests in property had been blocked pursuant to Sudan sanctions authorities.
OFAC's action described in this notice was taken on October 12, 2017.
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's Web site (
Effective October 12, 2017, sections 1 and 2 of Executive Order (E.O.) 13067 of November 3, 1997, “Blocking Sudanese Government Property and Prohibiting Transactions With Sudan” and all of E.O. 13412 of October 13, 2006, “Blocking Property of and Prohibiting Transactions With the Government of Sudan” were revoked, pursuant to E.O. 13761 of January 13, 2017, “Recognizing Positive Actions by the Government of Sudan and Providing for the Revocation of Certain Sudan-Related Sanctions,” as amended by E.O. 13804 of July 11, 2017, “Allowing Additional Time for Recognizing Positive Actions by the Government of Sudan and Amending Executive Order 13761.”
Sections 1 and 2 of E.O. 13067 and E.O. 13412 blocked the property of the Government of Sudan and generally prohibited U.S. persons from engaging in transactions with Sudan and the Government of Sudan. As a result of the revocation of these sanctions provisions, effective October 12, 2017, the individuals and entities listed below are no longer subject to the blocking provisions in E.O. 13067 and E.O. 13412, and therefore were removed from the SDN List.
1. ACCOUNTS & ELECTRONICS EQUIPMENTS (a.k.a. ACCOUNTS AND
2. ADVANCED ENGINEERING WORKS, Street No. 53, P.O. Box 44690, Khartoum, Sudan [SUDAN].
3. ADVANCED MINING WORKS COMPANY LIMITED, Elmek Nimir Street, Khartoum Bahri/Industrial Area, P.O. Box 1034, Khartoum 11, Sudan; Email Address
4. ADVANCED PETROLEUM COMPANY (a.k.a. APCO), House No. 10, Block 9, Street 33, Amarat, P.O. Box 12811, Khartoum, Sudan [SUDAN].
5. ADVANCED TRADING AND CHEMICAL WORKS COMPANY LIMITED (a.k.a. ADVANCED CHEMICAL WORKS; a.k.a. ADVANCED COMMERCIAL AND CHEMICAL WORKS COMPANY LIMITED), 19 Al Amarat Street, P.O. Box 44690, Khartoum, Sudan; Email Address
6. AFRICAN DRILLING COMPANY, Khartoum, Sudan [SUDAN].
7. AFRICAN OIL CORPORATION, P.O. Box 1, Khartoum North, Sudan [SUDAN].
8. AGRICULTURAL BANK OF SUDAN, P.O. Box 1363, Khartoum, Sudan [SUDAN].
9. AL SUNUT DEVELOPMENT COMPANY (a.k.a. ALSUNUT DEVELOPMENT COMPANY), No. 1 Block 5 East, Khartoum 2, P.O. Box 1840, Khartoum, Sudan; Web site
10. ALAKTAN COTTON TRADING COMPANY (a.k.a. ALAKTAN TRADING COMPANY), P.O. Box 2067, Khartoum, Sudan [SUDAN].
11. ALFARACHEM COMPANY LIMITED (a.k.a. AL PHARAKIM; a.k.a. ALFARACHEM PHARMACEUTICALS INDUSTRIES LIMITED; a.k.a. ALFARAKIM), 27 Al Amarat Street, Khartoum, Sudan [SUDAN].
12. AMIN EL GEZAI COMPANY (a.k.a. EL AMIN EL GEZAI COMPANY), Khartoum, Sudan [SUDAN].
13. ARAB CEMENT COMPANY, Durdeib, Sudan; P.O. Box 6180, Khartoum, Sudan [SUDAN].
14. ARAB SUDANESE BLUE NILE AGRICULTURAL COMPANY, Khartoum, Sudan [SUDAN].
15. ARAB SUDANESE SEED COMPANY, Khartoum, Sudan [SUDAN].
16. ARAB SUDANESE VEGETABLE OIL COMPANY, Khartoum, Sudan [SUDAN].
17. ASSALAYA SUGAR COMPANY LIMITED, Eastern Bank of White Nile River, near Rabak town (about 300 km from Khartoum, P.O. Box 511, Khartoum, Sudan [SUDAN].
18. AUTOMOBILE CORPORATION, Khartoum, Sudan [SUDAN].
19. BABANOUSA MILK PRODUCTS FACTORY, P.O. Box 16, Babanousa, Sudan [SUDAN].
20. BANK OF SUDAN, Sharia El Gamaa, P.O. Box 313, Khartoum, Sudan; Atbara, Sudan; P.O. Box 27, El Obeid, Sudan; P.O. Box 136, Juba, Sudan; P.O. Box 73, Kosti, Sudan; Nyala, Sudan; P.O. Box 34, Port Sudan, Sudan; Wad Medani, Sudan; Wau, Sudan [SUDAN].
21. BASHAIER, Khartoum, Sudan [SUDAN].
22. BLUE NILE BREWERY, P.O. Box 1408, Khartoum, Sudan [SUDAN].
23. BLUE NILE PACKING CORPORATION, P.O. Box 385, Khartoum, Sudan [SUDAN].
24. BUILDING MATERIALS AND REFRACTORIES CORPORATION, P.O. Box 2241, Khartoum, Sudan [SUDAN].
25. COPTRADE COMPANY LIMITED—PHARMACEUTICAL AND CHEMICAL DIVISION, P.O. Box 246, Khartoum, Sudan; Port Sudan, Sudan [SUDAN].
26. COPTRADE ENG AND AUTOMOBILE SERVICES CO LTD. (f.k.a. KORDOFAN AUTOMOBILE COMPANY), P.O. Box 97, Khartoum, Sudan [SUDAN].
27. DUTY FREE SHOPS CORPORATION, P.O. Box 1789, Khartoum, Sudan [SUDAN].
28. EL GEZIRA AUTOMOBILE COMPANY (a.k.a. GEZIRA AUTOMOBILE COMPANY), P.O. Box 232, Khartoum, Sudan [SUDAN].
29. EL NILEIN BANK (n.k.a. EL NILEIN INDUSTRIAL DEVELOPMENT BANK (SUDAN); n.k.a. EL NILEIN INDUSTRIAL DEVELOPMENT BANK GROUP; n.k.a. NILEIN INDUSTRIAL DEVELOPMENT BANK (SUDAN)), Parliament Street, P.O. Box 466, Khartoum, Sudan; P.O. Box 6013, Abu Dhabi City, United Arab Emirates; P.O. Box 466/1722, United Nations Square, Khartoum, Sudan [SUDAN].
30. EL TAKA AUTOMOBILE COMPANY (a.k.a. TAKA AUTOMOBILE COMPANY), P.O. Box 221, Khartoum, Sudan [SUDAN].
31. EMIRATES AND SUDAN INVESTMENT COMPANY LIMITED, P.O. Box 7036, Khartoum, Sudan; Port Sudan, Sudan [SUDAN].
32. ENGINEERING EQUIPMENT COMPANY, P.O. Box 97, Khartoum, Sudan; c/o ENGINEERING EQUIPMENT CORPORATION, undetermined [SUDAN].
33. ENGINEERING EQUIPMENT CORPORATION, P.O. Box 97, Khartoum, Sudan [SUDAN].
34. EXPLORATION AND PRODUCTION AUTHORITY (SUDAN), Kuwait Building, Nile Avenue, Khartoum, Sudan; P.O. Box 2986, Khartoum, Sudan [SUDAN].
35. FOOD INDUSTRIES CORPORATION, P.O. Box 2341, Khartoum, Sudan [SUDAN].
36. FRIENDSHIP SPINNING FACTORY, Hassaheisa, Sudan [SUDAN].
37. GEZIRA TANNERY, Gezira, Sudan [SUDAN].
38. GEZIRA TRADE & SERVICES COMPANY LIMITED (a.k.a. GEZIRA TRADE AND SERVICES COMPANY LIMITED), P.O. Box 215, Khartoum, Sudan; P.O. Box 17, Port Sudan, Sudan; El Obeid, Sudan; Gedarit, Sudan; Juba, Sudan; Kosti, Sudan; Sennar, Sudan; Wad Medani, Sudan [SUDAN].
39. GIAD AUTOMOTIVE INDUSTRY COMPANY LIMITED (a.k.a. GIAD AUTOMOTIVE AND TRUCK; a.k.a. GIAD AUTOMOTIVE COMPANY; a.k.a. GIAD CARS & HEAVY TRUCKS COMPANY; a.k.a. GIAD CARS AND HEAVY TRUCKS COMPANY), Gazera State (40 km distance from Khartoum), P.O. Box 444/13600, Khartoum 1111, Sudan; Web site
40. GIAD MOTOR INDUSTRY COMPANY LIMITED (a.k.a. GIAD MOTOR COMPANY), Basheer Mohammad Saeed Building, Baladia Street, P.O. Box 13610, Khartoum, Sudan; Web site
41. GINEID SUGAR FACTORY, P.O. Box 1, Gineid, Sudan [SUDAN].
42. GREATER NILE PETROLEUM OPERATING COMPANY LIMITED (a.k.a. GNPOC), Hotel Palace, Room 420, El Nil Avenue, Khartoum, Sudan; El Harr Oilfield, Muglad Basin, Sudan; El Nar Oilfield, Muglad Basin, Sudan; El Toor Oilfield, Muglad Basin, Sudan; Heglig Oilfield, Muglad Basin, Sudan; Heglig Processing Facility, Muglad Basin, Sudan; Kaikang Oilfield, Muglad Basin, Sudan; Toma South Oilfield, Muglad Basin, Sudan; Unity Oilfield, Muglad Basin, Sudan; Pipeline, Heglig via El-Obeid to Port Sudan, Sudan; Red Sea Export Terminal, Marsa al-Basha'ir, Sudan [SUDAN].
43. GROUPED INDUSTRIES CORPORATION, P.O. Box 2241, Khartoum, Sudan [SUDAN].
44. GUNEID SUGAR COMPANY LIMITED (a.k.a. GUNEID SUGAR FACTORY), P.O. Box 511, Khartoum, Sudan [SUDAN].
45. HAGGAR ASSALAYA SUGAR FACTORY, Haggar Assalaya, Sudan [SUDAN].
46. HI TECH GROUP (a.k.a. HIGH TECH GROUP; a.k.a. HIGHTECH GROUP; a.k.a. HITECH GROUP), Amarat Street No. 31, P.O. Box 44690, Khartoum, Sudan; Web site
47. HICOM (a.k.a. HI-COM), Khartoum, Sudan [SUDAN].
48. HICONSULT (a.k.a. HI-CONSULT), Khartoum, Sudan [SUDAN].
49. HI-TECH CHEMICALS, Khartoum, Sudan [SUDAN].
50. HI-TECH PETROLEUM GROUP, Khartoum, Sudan [SUDAN].
51. ICDB (a.k.a. ISLAMIC CO-OPERATIVE DEVELOPMENT BANK), P.O. Box 62, Khartoum, Sudan [SUDAN].
52. INDUSTRIAL BANK COMPANY FOR TRADE & DEVELOPMENT LIMITED (a.k.a. INDUSTRIAL BANK COMPANY FOR TRADE & DEVELOPMENT LIMITED), Khartoum, Sudan [SUDAN].
53. INDUSTRIAL BANK OF SUDAN (n.k.a. EL NILEIN INDUSTRIAL DEVELOPMENT BANK GROUP), United Nations Square, P.O. Box 1722, Khartoum, Sudan [SUDAN].
54. INDUSTRIAL PRODUCTION CORPORATION, P.O. Box 1034, El Gamaa Street, Khartoum, Sudan [SUDAN].
55. INDUSTRIAL RESEARCH AND CONSULTANCY INSTITUTE, P.O. Box 268, Khartoum, Sudan [SUDAN].
56. INGASSANA MINES HILLS CORPORATION (a.k.a. INGESSANA HILLS MINES CORPORATION), P.O. Box 2241, Khartoum, Sudan; P.O. Box 1108, Khartoum, Sudan [SUDAN].
57. JUBA DUTY FREE SHOP, Juba, Sudan [SUDAN].
58. KARIMA DATE FACTORY, Karima, Sudan [SUDAN].
59. KARIMA FRUIT AND VEGETABLE CANNING FACTORY, P.O. Box 54, Karima, Sudan [SUDAN].
60. KASSALA FRUIT PROCESSING COMPANY, Khartoum, Sudan [SUDAN].
61. KASSALA ONION DEHYDRATION FACTORY, P.O. Box 22, Kassala, Sudan [SUDAN].
62. KENAF SOCKS FACTORY, Abu Naama, Sudan [SUDAN].
63. KHARTOUM CENTRAL FOUNDRY, Khartoum, Sudan [SUDAN].
64. KHARTOUM COMMERCIAL AND SHIPPING COMPANY LIMITED, Kasr Avenue, P.O. Box 221, Khartoum, Sudan [SUDAN].
65. KHARTOUM TANNERY, P.O. Box 134, Khartoum South, Sudan [SUDAN].
66. KHOR OMER ENGINEERING COMPANY, P.O. Box 305, Khartoum, Sudan [SUDAN].
67. KORDOFAN COMPANY, Khartoum, Sudan [SUDAN].
68. KRIKAH INDUSTRIES GROUP, P.O. Box 755, Khartoum North, Sudan [SUDAN].
69. LEATHER INDUSTRIES CORPORATION (a.k.a. LEATHER INDUSTRIES TANNERIES), P.O. Box 1639, Khartoum, Sudan [SUDAN].
70. MALUT SUGAR FACTORY, Malut, Sudan [SUDAN].
71. MANGALA SUGAR FACTORY, Mangala, Sudan [SUDAN].
72. MASPIO CEMENT CORPORATION, P.O. Box 96, Atbara, Sudan [SUDAN].
73. MAY ENGINEERING COMPANY, P.O. Box 97, Khartoum, Sudan; c/o ENGINEERING EQUIPMENT CORPORATION, undetermined [SUDAN].
74. MILITARY COMMERCIAL CORPORATION, P.O. Box 221, Khartoum, Sudan [SUDAN].
75. MODERN ELECTRONIC COMPANY, Khartoum, Sudan [SUDAN].
76. MODERN LAUNDRY BLUE FACTORY (a.k.a. THE MODERN LAUNDRY BLUE FACTORY), P.O. Box 2241, Khartoum, Sudan [SUDAN].
77. MODERN PLASTIC & CERAMICS INDUSTRIES COMPANY (a.k.a. MODERN PLASTIC AND CERAMICS INDUSTRIES COMPANY), Khartoum, Sudan [SUDAN].
78. NATIONAL CIGARETTES CO. LTD., P.O. Box 2083, Khartoum, Sudan; and all other branches in Sudan [SUDAN].
79. NATIONAL COTTON AND TRADE COMPANY, P.O. Box 1552, Khartoum, Sudan [SUDAN].
80. NATIONAL ELECTRICITY CORPORATION, P.O. Box 1380, Khartoum, Sudan [SUDAN].
81. NATIONAL REINSURANCE COMPANY (SUDAN) LIMITED, P.O. Box 443, Khartoum, Sudan [SUDAN].
82. NEW HAIFA SUGAR FACTORY, Kashm el Girba, Sudan [SUDAN].
83. NEW HALFA SUGAR FACTORY COMPANY LIMITED (a.k.a. NEW HALFA SUGAR COMPANY), El Gamaa Street (Aljama Street), New Halfa, P.O. Box 511/3047, Khartoum, Sudan; Email Address
84. NEW KHARTOUM TANNERY, P.O. Box 17, Khartoum, Sudan [SUDAN].
85. NORTHWEST SENNAR SUGAR FACTORY, Northwest Sennar, Sudan [SUDAN].
86. OIL CORPORATION, P.O. Box 64, Khartoum, Sudan [SUDAN].
87. OMDURMAN SHOE FACTORY, Omdurman, Sudan [SUDAN].
88. PETROHELP PETROLEUM COMPANY LIMITED, Building No. 20, Street No. 42, Al Riyadh Area, P.O. Box 44690, Khartoum, Sudan [SUDAN].
89. PETROLEUM GENERAL ADMINISTRATION, P.O. Box 2649, Khartoum, Sudan [SUDAN].
90. PORT SUDAN COTTON AND TRADE COMPANY (a.k.a. PORT SUDAN COTTON COMPANY), P.O. Box 590, Khartoum, Sudan; P.O. Box 261, Port Sudan, Sudan [SUDAN].
91. PORT SUDAN DUTY FREE SHOP, Port Sudan, Sudan [SUDAN].
92. PORT SUDAN EDIBLE OILS STORAGE CORPORATION, P.O. Box 429, Port Sudan, Sudan [SUDAN].
93. PORT SUDAN REFINERY LIMITED, P.O. Box 354, Port Sudan, Sudan [SUDAN].
94. PORT SUDAN SPINNING FACTORY, Port Sudan, Sudan [SUDAN].
95. POSTS AND TELEGRAPHS PUBLIC CORPORATION, Khartoum, Sudan [SUDAN].
96. PUBLIC CORPORATION FOR BUILDING AND CONSTRUCTION, P.O. Box 2110, Khartoum, Sudan [SUDAN].
97. PUBLIC CORPORATION FOR IRRIGATION AND EXCAVATION, P.O. Box 619, Khartoum, Sudan; P.O. Box 123, Wad Medani, Sudan [SUDAN].
98. PUBLIC CORPORATION FOR OIL PRODUCTS AND PIPELINES, Khartoum, Sudan [SUDAN].
99. PUBLIC ELECTRICITY AND WATER CORPORATION (a.k.a. CENTRAL ELECTRICITY AND WATER CORPORATION), P.O. Box 1380, Khartoum, Sudan [SUDAN].
100. RABAK OIL MILL, P.O. Box 2105, Khartoum, Sudan [SUDAN].
101. RAINBOW FACTORIES, P.O. Box 1768, Khartoum, Sudan [SUDAN].
102. RAM ENERGY COMPANY LIMITED, Altiyadh Street 131/Almashtal Street, Block 12, House No. 87, P.O. Box 802, Khartoum, Sudan [SUDAN].
103. REA SWEET FACTORY, P.O. Box 1027, Khartoum, Sudan [SUDAN].
104. RED SEA HILLS MINERALS COMPANY, P.O. Box 1034, Khartoum, Sudan; c/o SUDANESE MINING CORPORATION, undetermined [SUDAN].
105. RED SEA STEVEDORING, P.O. Box 215, Khartoum, Sudan; P.O. Box 17, Port Sudan, Sudan [SUDAN].
106. REFRIGERATION AND ENGINEERING IMPORT COMPANY, P.O. Box 1092, Khartoum, Sudan [SUDAN].
107. ROADS AND BRIDGES PUBLIC CORPORATION, P.O. Box 756, Khartoum, Sudan [SUDAN].
108. SACKS FACTORY (a.k.a. PLASTIC SACKS FACTORY), P.O. Box 2328, Khartoum, Sudan [SUDAN].
109. SENNAR SUGAR COMPANY LIMITED, P.O. Box 511, Khartoum, Sudan; Email Address
110. SHEIKAN INSURANCE AND REINSURANCE COMPANY LIMITED (a.k.a. SHEIKAN INSURANCE COMPANY), Al Souq Al Arabi, Sheikan Building, Khartoum SU001, P.O. Box 10037, Khartoum, Sudan; Email Address
111. SHEREIK MICA MINES COMPANY (a.k.a. SHERIEK MICA PROJECT), P.O. Box 1034, Khartoum, Sudan; c/o SUDANESE MINING CORPORATION, undetermined [SUDAN].
112. SILOS AND STORAGE CORPORATION, P.O. Box 1183, Khartoum, Sudan [SUDAN].
113. SPINNING AND WEAVING CORPORATION, P.O. Box 795, Khartoum, Sudan [SUDAN].
114. SRC (a.k.a. SUDAN RAILWAYS CORPORATION), P.O. Box 43, Bara, Sudan; Babanousa, Sudan; Khartoum, Sudan; Kosti, Sudan; Port Sudan, Sudan [SUDAN].
115. SRDC (a.k.a. SUDAN RURAL DEVELOPMENT COMPANY LIMITED), P.O. Box 2190, Khartoum, Sudan [SUDAN].
116. STATE CORPORATION FOR CINEMA, P.O. Box 6028, Khartoum, Sudan [SUDAN].
117. STATE TRADING COMPANY (a.k.a. STATE TRADING CORPORATION), P.O. Box 211, Khartoum, Sudan [SUDAN].
118. SUDAN ADVANCED RAILWAYS, Khartoum, Sudan [SUDAN].
119. SUDAN AIR (a.k.a. SUDAN AIRWAYS), P.O. Box 253, Khartoum, Sudan; Bahrain; Chad; Egypt; Ethiopia; Germany; Greece; Italy; Kenya; Kuwait; Nigeria; Saudi Arabia; Uganda; United Arab Emirates; United Kingdom; 211 East 43rd Street, New York, NY 10017, United States; 199 Atlantic Avenue, Brooklyn, NY 11201-5606, United States [SUDAN].
120. SUDAN COTTON COMPANY, Khartoum, Sudan [SUDAN].
121. SUDAN COTTON COMPANY LIMITED, P.O. Box 1672, Khartoum, Sudan [SUDAN].
122. SUDAN DEVELOPMENT CORPORATION, Street 21, P.O. Box 710, Khartoum, Sudan [SUDAN].
123. SUDAN EXHIBITION AND FAIRS CORPORATION, P.O. Box 2366, Khartoum, Sudan [SUDAN].
124. SUDAN GEZIRA BOARD (a.k.a. GEZIRA SCHEME), Khartum Gezira Scheme Building, 39th Street, P.O. Box 884, Khartoum, Sudan [SUDAN].
125. SUDAN MASTER TECHNOLOGY (a.k.a. GIAD INDUSTRIAL CITY; a.k.a. GIAD INDUSTRIAL GROUP; a.k.a. SUDAN MASTER TECH), SMT Building, Gamhuria Street, GIAD Industrial Complex, P.O. Box 10782, Khartoum, SU001, Sudan; Web site
126. SUDAN NATIONAL BROADCASTING CORPORATION (a.k.a. SUDAN RADIO & TV CORP.; a.k.a. SUDAN RADIO AND TV CORP.; a.k.a. SUDAN T.V. CORPORATION), P.O. Box 1094, Omdurman, Sudan [SUDAN].
127. SUDAN OIL CORPORATION, P.O. Box 2, Khartoum North, Sudan [SUDAN].
128. SUDAN OIL SEEDS COMPANY LIMITED, P.O. Box 167, Khartoum, Sudan; Nyala, Sudan; Obied, Sudan; Port Sudan, Sudan; Tandalty, Sudan [SUDAN].
129. SUDAN SOAP CORPORATION, P.O. Box 23, Khartoum North, Sudan [SUDAN].
130. SUDAN TEA COMPANY, LTD., P.O. Box 1219, Khartoum, Sudan [SUDAN].
131. SUDAN TELECOMMUNICATIONS COMPANY LIMITED (a.k.a. SUDATEL), 9th
132. SUDAN WAREHOUSING COMPANY, P.O. Box 215, Khartoum, Sudan; P.O. Box 17, Port Sudan, Sudan; El Obeid, Sudan; Gedarit, Sudan; Juba, Sudan; Kosti, Sudan; Sennar, Sudan; Wad Medani, Sudan [SUDAN].
133. SUDANESE COMPANY FOR BUILDING AND CONSTRUCTION LIMITED, P.O. Box 2110, Khartoum, Sudan [SUDAN].
134. SUDANESE ESTATES BANK, Al-Baladiya Avenue, P.O. Box 309, Khartoum, Sudan [SUDAN].
135. SUDANESE FREE ZONES AND MARKETS COMPANY (a.k.a. SFZ), P.O. Box 1789, Khartoum, Sudan; Chad; Saudi Arabia; Turkey; United Arab Emirates [SUDAN].
136. SUDANESE INTERNATIONAL TOURISM COMPANY, P.O. Box 7104, Khartoum, Sudan; c/o TOURISM AND HOTELS CORPORATION, undetermined [SUDAN].
137. SUDANESE MINING CORPORATION, P.O. Box 1034, Khartoum, Sudan [SUDAN].
138. SUDANESE PETROLEUM CORPORATION, 7th Floor, Al Kuwaitiah Building, El Nile Street, Khartoum, Sudan [SUDAN].
139. SUDANESE REAL ESTATE SERVICES COMPANY, Khartoum, Sudan [SUDAN].
140. SUDANESE SAVINGS BANK, P.O. Box 159, Wad Medani, Sudan [SUDAN].
141. SUDANESE SUGAR PRODUCTION COMPANY LIMITED (a.k.a. SUDANESE SUGAR COMPANY), El Gamaa Street (Aljama Street), Opposite the Authority of Electricity Building, P.O. Box 511, Khartoum, Sudan; P.O. Box 511, Building No. 3-Block No. 7, Alshatte Gharb-Gammaa Avenue, Khartoum, Sudan; Email Address
142. SUDAPET LTD. (a.k.a. SUDAN PETROLEUM COMPANY LIMITED; a.k.a. SUDAPET), El Nil Street, Khartoum, Sudan [SUDAN].
143. SUGAR AND DISTILLING INDUSTRY CORPORATION (a.k.a. SUGAR AND DISTILLING CORPORATION), New Mustafa El Amin Building, Barlaman Avenue, P.O. Box 511, Khartoum, Sudan [SUDAN].
144. TAHEER PERFUMERY CORPORATION, P.O. Box 2241, Khartoum, Sudan [SUDAN].
145. TAHREER PERFUMERY CORPORATION, EL, Omdurman, Sudan [SUDAN].
146. TEA PACKETING AND TRADING COMPANY, P.O. Box 369, Khartoum, Sudan [SUDAN].
147. TOURISM AND HOTELS CORPORATION, P.O. Box 7104, Khartoum, Sudan; Ed Damer, Sudan; El Fasher, Sudan; Khartoum Airport, Sudan; Port Sudan, Sudan [SUDAN].
148. WAD MADANI DUTY FREE SHOP, Wad Madani, Sudan [SUDAN].
149. WAFRA CHEMICALS & TECHNO-MEDICAL SERVICES LIMITED (a.k.a. WAFRA CHEMICALS AND TECHNO-MEDICAL SERVICES LIMITED), Khartoum, Sudan [SUDAN].
150. WAFRA PHARMA LABORATORIES (a.k.a. WAFRA PHARMACEUTICALS; a.k.a. WAFRAPHARMA LABORATORIES), Main Street, P.O. Box 2032, Omdurman, Sudan; Email Address
151. WAU FRUIT AND VEGETABLE CANNING FACTORY, P.O. Box 110, Wau, Sudan [SUDAN].
152. WHITE NILE BATTERY COMPANY, Khartoum, Sudan [SUDAN].
153. WHITE NILE BREWERY, P.O. Box 1378, Khartoum, Sudan [SUDAN].
154. WHITE NILE TANNERY, P.O. Box 4078, Khartoum, Sudan [SUDAN].
155. NILE CEMENT COMPANY LIMITED, P.O. Box 1502, Khartoum, Sudan; Factories at Rabak, St. 45-47, Khartoum Extension, Sudan [SUDAN].
156. NILE CEMENT FACTORY, Rabak, Sudan; P.O. Box 1502, Khartoum, Sudan [SUDAN].
157. FARMERS COMMERCIAL BANK (f.k.a. FARMERS BANK FOR INVESTMENT & RURAL DEVELOPMENT; a.k.a. FARMERS BANK FOR INVESTMENT AND RURAL DEVELOPMENT; f.k.a. SUDAN COMMERCIAL BANK), P.O. Box 1116, El Kasr Avenue, Khartoum, Sudan; P.O. Box 22, El Damazin, Sudan; El Fau, Sudan; P.O. Box 182, El Gadaref, Sudan; P.O. Box 1, El Hawata, Sudan; P.O. Box 8, El Nuhud, Sudan; P.O. Box 412, El Obeid, Sudan; P.O. Box 45153, El Suk Elarabi, Sudan; P.O. Box 1174, Gamhoria Avenue, Khartoum, Sudan; P.O. Box 1694, El Suk Elafrangi, Khartoum, Sudan; P.O. Box 384, Khartoum, Sudan; P.O. Box 86, Industrial Area, Khartoum, Sudan; P.O. Box 8127, Khartoum, Sudan; P.O. Box 899, Omdurman, Sudan; Wad Madani, Sudan; P.O. Box 36, New Halfa, Sudan; P.O Box 570, Port Sudan, Sudan [SUDAN].
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before November 27, 2017 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained from Jennifer Leonard by emailing
44 U.S.C. 3501
On February 4, 2016, the Deputy Assistant Administrator, of the then Office of Diversion Control, issued an Order to Show Cause to Lon F. Alexander, M.D. (hereinafter, Respondent), of Hattiesburg, Mississippi. ALJ Ex. 1, at 1. The Show Cause Order proposed the denial of Respondent's application for a DEA Certificate of Registration as a practitioner, on the ground that his “registration is inconsistent with the public interest.”
As for the Agency's jurisdiction, the Show Cause Order alleged that Respondent had previously held a registration which he surrendered for cause on January 16, 2014.
As for the substantive grounds for the proceeding, the Show Cause Order raised multiple allegations to the effect that, on numerous occasions in 2011 through 2013, Respondent violated federal and state law by issuing controlled substance prescriptions to his wife “that were nontherapeutic, were for other than a legitimate medical purpose, and were issued outside of the usual course of [his] professional practice.”
The Show Cause Order also alleged that on various occasions from 2011 through 2013, Respondent violated federal and state law by issuing his wife prescriptions for hydrocodone, then a schedule III narcotic, as well as other controlled substances, which were also nontherapeutic, for other than a legitimate medical purpose, and were outside the usual course of professional practice.
Next, the Show Cause Order alleged additional instances of non-therapeutic prescribing by Respondent to his wife in that, “[o]n at least four different occasions in 2013,” he “repeatedly issued . . . prescriptions for hydrocodone . . . zolpidem tartrate . . . and alprazolam . . . when she was concurrently being issued other controlled substances prescriptions for the same or similar drugs, as well as amphetamines, by her . . . psychiatrist, which [he] did without his knowledge or permission.”
The Show Cause Order also alleged that “[o]n at least fifteen different occasions between 2011 and 2013, [Respondent] violated state and federal law by issuing” to his wife prescriptions for hydrocodone, and/or zolpidem, and/or alprazolam, “without conducting any examination of [his] wife (or documenting such in her file) or noting the . . . prescriptions in her patient chart.”
Finally, the Show Cause Order alleged that Respondent “engaged in conduct which may threaten public health and safety . . . by attempting to mislead DEA investigators.”
Following service of the Show Cause Order, Respondent, through his counsel, requested a hearing on the allegations. ALJ Ex. 2. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to ALJ Charles Wm. Dorman. Following pre-hearing procedures, the ALJ conducted an evidentiary hearing in Jackson, Mississippi on June 29-30, 2016, at which both parties elicited testimony from witnesses and submitted various documents for the record. Following the hearing, both parties submitted briefs of their proposed findings of fact, conclusions of law, and argument.
On September 20, 2016, the ALJ issued his Recommended Decision. Therein, with respect to Factors Two (Respondent's experience in dispensing controlled substances) and Four (compliance with applicable laws related to controlled substances), the ALJ found that the Government had proved that Respondent violated 21 CFR 1306.04, Mississippi Code Sec. 73-25-29(3) and 73-25-29(13), as well as Mississippi Administrative Rules 1.7, 1.10, and 1.16 when he issued numerous controlled substance prescriptions to his wife.
Specifically, the ALJ found that during 2011, Respondent issued nine zolpidem, two alprazolam, seven hydrocodone, and one diazepam prescription(s) in violation of these provisions. R.D. at 39-40. The ALJ also found that during 2012, Respondent issued five alprazolam prescriptions, and that during 2013, he issued 11 alprazolam prescriptions in violation of these provisions.
In addition to the above, the ALJ found that between 2011 and 2013,
Turning to Factor Five (such other conduct which may threaten public health or safety), the ALJ rejected the allegation that Respondent attempted to mislead DEA investigators by providing to them the patient file containing false entries to the effect that he had made his wife's psychiatrist aware of the prescriptions.
The ALJ nonetheless concluded that “Factors Two and Four weigh substantially in favor of denying . . . Respondent's application because he prescribed controlled substances to his wife for illegitimate and nontherapeutic purposes, outside the scope of professional practice, and because he did not appropriately document examinations of, any prescriptions to, his wife.”
The ALJ acknowledged that “[t]o rebut the Government's
The ALJ concluded that “Respondent's misconduct was egregious” in that he “repeatedly and wrongfully prescribed addictive, dangerous, and potentially harmful controlled substances to his wife for approximately three years,” which “interfered with his wife's treatment and could have caused her to overdose, lose consciousness, or die.”
The ALJ also acknowledged Respondent's testimony “that he did not think that his actions increased his wife's chances of dependency, overdose, or diversion,” and that “[t]he Government's argument that that Respondent did not accept responsibility for putting his wife at risk is also understandable.”
As for the Government's contention that Respondent did not specifically acknowledge his misconduct in “failing to conduct examinations and/or conduct insufficient examinations prior to issuing” the prescriptions, the ALJ noted that this “is technically correct.”
While the ALJ acknowledged that Respondent declined “to admit that he violated federal laws because he did not want to speculate on what statutes he might have violated” and “testif[ied] that he did not know whether the prescriptions were outside the scope of his professional practice as the DEA defines those terms,” the ALJ reasoned that Respondent was not required to “identify the specific federal code provisions he violated, or interpret federal laws and apply them to his circumstances.”
The ALJ further found that Respondent had undertaken “reasonable and appropriate” remedial measures.
The Government filed Exceptions to the Recommended Decision. In its Exceptions, the Government contended that the ALJ committed error in concluding that Respondent has sufficiently accepted responsibility for his misconduct. Exceptions, at 3-15. The Government also contended that the ALJ committed error in concluding that Respondent is entitled to a new registration notwithstanding the egregiousness of his misconduct.
Thereafter, the ALJ forwarded the record to me for final agency action. Having considered the record in its
Respondent is a neurosurgeon licensed by the Mississippi State Board of Medical Licensure. R.D. 3 (citing Stipulation of Fact No. 4); Tr. 481-82. Respondent also previously held a DEA Certificate of Registration, pursuant to which he was authorized to dispense schedule II through V controlled substances as a practitioner. GX 1, at 1. However, on January 17, 2014, Respondent surrendered this registration for cause.
In 2008, Respondent referred himself to the Betty Ford Center, “when [he] realized [he] had a problem with prescription medicines” and spent 90 days in treatment. Tr. 487. According to Respondent, “[o]nce [he] went to the Betty Ford Center, [he] disclosed to the MPHP [Mississippi Physician's Health Program] and ultimately the [B]oard of [M]edicine that [he] was now a participant.”
In May 2008, Respondent entered into a Recovery Contract Agreement (hereinafter, recovery contract, contract, or RCA) with the MPHP. GE 14, at 13. The RCA's terms included that he completely abstain from mood-altering addictive substances, that he not treat himself or his family, that he undergo random drug screens, and that he be honest.
In March 30, 2012, Respondent tested positive for Tramadol. He then returned to the Betty Ford Center for one month, after which he was discharged with a diagnosis of opioid dependence. GE 14, at 14-16. The MPHP did not, however, withdraw its advocacy on his behalf, and on June 11, 2012, Respondent entered into a new RCA which contained the same terms as the previous RCA, including the prohibition on prescribing to family members.
On September 10, 2012, Respondent met with the Mississippi Professionals Health Committee due to its concerns that he had “missed callings for random drugs screens,” had failed to attend Caduceus meetings, failed to continued his aftercare therapy, failed to pay his bill for the drug screen testing, and had “fail[ed] to turn in his support group attendance records.”
While Respondent was compliant with the issues raised by the committee, the committee was unaware that Respondent had been violating his RCA by writing controlled substance prescriptions for his wife.
On October 15, 2013, the MPHP, having concluded that Respondent's “continued practice of medicine represent[ed] a definite threat to the public health” withdrew its advocacy on behalf of Respondent. GE 14, at 23. Eight days later, the Board issued Respondent an order of prohibition which barred him from practicing medicine until further notice. GE 13, at 5.
Thereafter, Respondent was charged with two counts of violating the State's Medical Practice Act, including violating an existing Board Order, Stipulation or Agreement,
On January 16, 2014, the Board held a hearing on the allegations at which Respondent appeared. As the record of the hearing shows, the allegations were based on Respondent's violations of his RCA, particularly in his prescribing of controlled substances to his wife. Also at issue was his lack of honesty in failing to disclose his prescribing to his treatment providers as well as the MPHP committee and the MPHP's staff. GE 14, at 21.
Following the hearing, the Board found Respondent guilty on both counts and suspended his medical license for one year, after which he was entitled to petition the Board for reinstatement of his license.
On January 15, 2015, Respondent appeared before the Board seeking reinstatement. At the hearing, Dr. Hambleton (the MPHP Medical Director) testified in support of Respondent's petition, stating that he “complied with all of our requirements and he's begun the treatment process at Acumen.”
At some point not clearly established on the record, a DEA Diversion Investigator (DI) assigned to the Jackson, Mississippi office opened an investigation into Respondent's
In reviewing the PMP reports, the DI found it suspicious that Respondent was prescribing controlled substances to his wife as “she was seeing a psychiatrist, Dr. Mark Webb, during that timeframe.” Tr. 30. The DI “noticed multiple prescriptions” which Respondent authorized for drugs that his wife “was receiving” from Dr. Webb.
Thereafter, the DI visited Dr. Webb and “asked him if he was aware” that Respondent's wife was “receiving these prescriptions from” Respondent.
The DI also obtained some of “the hard copy prescriptions from several different pharmacies throughout” the State.
The DI also served a subpoena on Respondent for “[a]ny and all charts, files and/or documents, written, typed or computerized, relating to” his wife. GX 4, at 1. A ten-page exhibit of Respondent's Medical Progress Notes for his wife was entered into evidence as GX 6. Tr. 67.
The Government called Dr. Mark Webb as a fact witness. Dr. Webb testified that he has practiced psychiatry in Mississippi since 1990 and that Respondent's wife has been his patient since November 2000.
According to Dr. Webb, he has “known [Respondent] for a long time” and the two “referred patients back and forth in the 90s and the early 2000[s].”
Dr. Webb testified that while he and Respondent “talked a lot in the 90s and the early 2000s,” they have “talked less and less over the last 10 years.”
According to Dr. Webb, Respondent “would call me whenever he felt [his wife] was in a crisis . . . to give me that information and to . . . garner some help from me to her.” Tr. 110. Dr. Webb testified that he never had a discussion with Respondent about the latter's prescribing controlled substances to his wife.
Dr. Webb testified that DEA Investigators showed him the ten pages of notes Respondent created with respect to the prescriptions he issued for his wife and that he compared them with the patient file he maintained on Respondent's wife.
The evidence shows that between January 1, 2011 and October 14, 2013 (when his medical license was suspended), Respondent issued the following controlled substances prescriptions for his wife.
1. January 9, 2011, eight tablets of alprazolam (Xanax) 1 mg, one tablet to be taken twice day, a four-day supply. GE 10, at 85; GE 11, at 14; GE 29, at 1-2. The record does not establish when Dr. Webb had last prescribed alprazolam to Respondent's wife.
2. January 31, 2011, 30 tablets of zolpidem tartrate (Ambien) 10 mg, a 15-day supply. GE 10, at 19; GE 11, at 14. Notably, on January 8, 2011, Respondent's wife had refilled a prescription issued by Dr. Webb on August 31, 2010 for 60 tablets, this being a 30-day supply. GE 11, at 14. Thus, if taken as directed, the refill of Dr. Webb's prescription should have last Respondent's wife until February 7, 2011. On February 3, 2011 (only three days later), Dr. Webb prescribed 60 units of zolpidem 10 to Respondent's wife. GE 11, at 13. GE 5, at 112. Respondent did not document the prescription in the patient file he maintained for his wife. GE 6. Nor did he inform Dr. Webb that he issued the prescription.
3. February 7, 2011, 20 tablets of hydrocodone/acetaminophen (Lorcet) 7.5-650, a three-day supply. GE 10, at 23; GE 11, at 13;
4. March 30, 2011, 30 tablets of zolpidem tartrate (Ambien) 10 mg, with a dosing instruction of one tablet at bedtime but “may repeat for early,” a 15-30-day supply. GE 10, at 85; GE 11, at 13; GE 30, at 1-2. Notably, the zolpidem prescription which Dr. Webb issued on February 3, 2011 (RX #949559) provided for multiple refills, as it was refilled by Respondent's wife on April 9, 2011, May 23, 2011, and July 7, 2011. GE 11, at 13; Tr. 254-55. Respondent did not document the prescription in the patient file he maintained on his wife. GE 6. Nor did he inform Dr. Webb that he issued the prescription.
5. April 8, 2011, 15 tablets of hydrocodone/acetaminophen (Lorcet) 10-650, one tablet every six hours as needed, a three-day supply. GE 10, at 85; GE 11, at 13; GE 31, at 1-2. As explained above, other than in June/July 2013, Dr. Webb did not prescribe this drug to Respondent's wife, and no other physician prescribed hydrocodone to her until November 30, 2011. Respondent did not document the prescription in the patient file. GE 6. He also did not disclose the prescription to Dr. Webb.
6. May 6, 2011, 30 tablets of zolpidem tartrate (Ambien) 10 mg, one tablet at bedtime but “may repeat,” a 30-day supply. GE 10, at 85; GE 11, at 13; GE 32, at 1-2. As discussed above, Respondent's wife still had refills available for 60 dosage units based on the prescription issued by Dr. Webb on February 3, 2011, and eventually refilled the prescription on May 23, 2011. GE 11, at 13; Tr. 255. Respondent did not document the prescription in the patient file.
7. May 14, 2011, 14 tablets of hydrocodone/acetaminophen (Lorcet) 10-650, a two-day supply. GE 10, at 19; GE 11, at 13. As explained above, other than in June/July 2013, Dr. Webb did not prescribe this drug to Respondent's wife, and no other physician prescribed hydrocodone to her until November 30, 2011. Respondent did not document the prescription in the patient file. GE 6. Nor did he disclose the prescription to Dr. Webb.
8. June 28, 2011, 30 tablets of zolpidem tartrate (Ambien) 10 mg, a 30-day supply. GE 10, at 84; GE 11, at 12. Respondent's wife still had a refill available for 60 dosage units based on the prescription issued by Dr. Webb on February 3, 2011, and eventually refilled the prescription on July 7, 2011. GE 11, at 12. Respondent did not document the prescription in the patient file.
9. July 15, 2011, prescription (assigned RX # 4002009 by the pharmacy) for 28 tablets of hydrocodone-acetaminophen (Lorcet) 10-650, a five-day supply. GE 10, at 64. This prescription also authorized a refill, which Respondent's wife obtained on July 29, 2011.
10. July 31, 2011, 12 tablets of zolpidem 10 mg, one tablet at bedtime, a 12-day supply, with one refill. GE 10, at 84; GE 11, at 12; GE 33, at 1-2. As found above, on July 7, 2011, Respondent's wife obtained a refill of a prescription for 60 zolpidem issued by Dr. Webb, which, if taken as directed, should have lasted her until August 6, 2011 (this being in addition to the 30 zolpidem prescription Respondent issued on June 28, 2011). GE 11, at 12; Tr. 251-53. Respondent did not document the prescription in the patient file.
11. August 13, 2011, 20 tablets of alprazolam (Xanax) 1 mg, one-half to one tablet, to be taken twice a day, a 10-20-day supply. GE 22, at 1-2.
12. August 28, 2011, 12 tablets of zolpidem tartrate (Ambien) 10 mg, a 12-day supply. GE 10, at 19. Notably, on August 16, 2011, Respondent's wife had obtained and filled a new prescription from Dr. Webb for 60 zolpidem, a 30-day supply. GX 11, at 12. If taken as directed, Dr. Webb's prescription should have lasted Respondent's wife until September 15, 2011. Moreover, as found above, Respondent had also provided a refill when he issued the July 31, 2011 prescription (RX# 443737), and this refill was still available to his wife on August 28, 2011. GE 11, at 12. Respondent did not document the prescription in the patient file.
13. September 6, 2011, 12 tablets of zolpidem tartrate (Ambien) 10 mg, a 12-day supply, this being a refill authorized by Respondent's July 31, 2011 prescription. GE 11, at 12. As discussed in the preceding paragraph, Dr. Webb's August 16, 2011 prescription should have lasted Respondent's wife until September 15, 2011. In addition, Respondent's August 28, 2011 prescriptions provided his wife with additional medication in excess of what Dr. Webb had prescribed. As found above, Respondent did not document the original prescription in the patient file nor disclose it to Dr. Webb.
14. September 28, 2011, 16 tablets of hydrocodone/apap 10/650, a four-day supply with one refill.
15. October 11, 2011, 20 tablets of zolpidem tartrate (Ambien) 10 mg, one tablet at bedtime, a 20-day supply. GE 10, at 84; GE 11, at 11; GE 34, at 1-2; Tr. 249. Of note, on September 19, 2011, Respondent's wife had refilled Dr. Webb's August 16, 2011 prescription and obtained 60 tablets, a 30-day supply. GE 11, at 12. If taken as directed, the September 19 refill should have lasted Respondent's wife until October 19. GE 11, at 12; Tr. 248-49. Respondent did not document the prescription in the patient file.
16. October 20, 2011, 16 tablets of hydrocodone-acetaminophen (Lorcet) 10-650, a four-day supply, this being a refill of the September 28, 2011 prescription. GE 10, at 64. As explained above, other than in June/July 2013, Dr. Webb did not prescribe this drug to Respondent's wife, and no other physician prescribed hydrocodone to her until November 30, 2011. As found above, Respondent did not document the prescription or the refill in the patient file.
17. November 13, 2011, 18 tablets of clonazepam 2mg, a six-day supply. GE 10, at 19. Notably, on November 3, 2011, Respondent's wife had refilled a prescription issued by Dr. Webb on October 19, 2011 for 45 dosage units, a 15 day supply. GE 11, at 11. If taken as directed, the November 3 refill should have lasted Respondent's wife until November 18, 2011. Moreover, on November 15, 2011, only two days after filling the prescription she obtained from her husband, Respondent's wife obtained a further refill of Dr. Webb's prescription for 45 dosage units of clonazepam. GE 11, at 11. Respondent did not document the prescription in the patient file.
18. November 25, 2011, 10 tablets of clonazepam 2 mg, a three-day supply. GE 10, at 63. If taken as directed, by itself, the November 15, 2011 refill should have lasted Respondent's wife until November 30, 2011. Respondent did not document the prescription in the patient file. GE 6. Nor did he disclose it to Dr. Webb.
19. November 29, 2011, four tablets of hydrocodone/acetaminophen (Lorcet) 10-650 mg, one tablet to be taken four to six times a day, a one-day supply. GE 26. Respondent did not document the prescription in the patient file. GE 6. He also did not disclose the prescription to Dr. Webb.
20. Also on November 29, 2011, one Diastat Acudial, 5-7.5-10 mg kit. GE 10, at 92; GE 11, at 11; GE 28, at 1. Diastat Acudial is a rectal suppository of diazepam, which is also a benzodiazepine and a schedule IV controlled substance.
21. December 5, 2011, 10 tablets of hydrocodone-acetaminophen (Lorcet) 10-650, a three-day supply. GE 10, at 63. Respondent did not document the prescription in the patient file.
22. December 27, 2011,
23. January 7, 2012, 28 tablets of zolpidem 10 mg, a 28-day supply. GE 10, at 63. As found above, on December 16, 2011, Respondent's wife had obtained a refill of Dr. Webb's prescription and obtained medication that should have lasted her until January 15, 2012. Moreover, on December 27, 2011, she filled the prescription Respondent wrote her for 30 more tablets. Respondent's patient file for his wife does not document the issuance of a zolpidem prescription on this date, but rather on January 10, 2012.
24. January 16, 2012, 30 tablets of alprazolam (Xanax) 2 mg, to be taken “as directed.”
25. February 26, 2012, 20 tablets of diazepam 5 mg, a six-day supply. GX 11, at 10. Of note, on February 23, 2012, Respondent's wife had obtained and filled a new prescription from Dr. Webb for 45 alprazolam 2 mg, a 15-day supply; this prescription (Rx# 982872) also authorized three refills.
26. March 4, 2012, 30 tablets of zolpidem10 mg, a 30-day supply. GE 10, at 13; GE 11, at 10. Of note, on February 23, 2012, Respondent's wife obtained and filled a prescription from Dr. Webb for 30 zolpidem, a 15-day supply. GE 11, at 10. If taken as directed, Dr. Webb's prescription should have lasted Respondent's wife until March 9, 2012. Moreover, Dr. Webb's Feb. 23 prescription provided for two refills, the first of which Respondent's wife obtained on March 19, 2012, respectively. GE 11, at 10. Respondent did not document the prescription in the patient file.
27. March 12, 2012, 12 tablets of alprazolam (Xanax) 2 mg, one tablet to be taken three times a day, a four-day supply. GE 10, at 80; GE 20. As found above, on February 23, 2012, Dr. Webb issued a prescription for 45 tablets of alprazolam 2 mg, a 15-day supply, which authorized three refills. GE 11, at 9-10. In the patient file, Respondent wrote: “Out of Xaax [sic] x 5 days—Jerky & twitching—feels like Extreme anxiety—digging at arms [-] delusional parasitosis? Will give 4 day supply—[illegible] talk to Dr. Webb—Xaax [sic] 2 mg #12,” followed by the dosage instruction of one tablet by mouth, three times a day.” GE 6, at 3. Respondent's wife had available a refill of Dr. Webb's February 23 prescription which she could have filled on this date (without being early) but which she did not fill until March 19, 2012. GE 11, at 10. Respondent did not disclose the prescription to Dr. Webb.
28. March 12, 2012, 30 tablets of zolpidem 10 mg, 30-day supply. GE 10, at 80. As found above, on March 4, 2012, Respondent prescribed 30 zolpidem (a 30-day supply) for his wife which she filled the same day. GE 11, at 10. If taken as directed, Respondent's March 4 prescription should have lasted until April 3, 2012. Also, Dr. Webb's Feb. 23, 2012 prescription (for 30 tablets) authorized multiple refills and Respondent's wife obtained a refill on March 19, 2012.
29. April 1, 2012, 24 tablets of zolpidem tartrate (Ambien) 10 mg, a 24-day supply. GE 10, at 13; GE 11, at 10. Putting aside that Respondent's March 4 prescription should have lasted through April 3, 2012, as found above, Respondent's wife obtained 30 tablets on March 12 when she filled his prescription and another 30 tablets on March 19, when she refilled Dr. Webb's Feb. 2, 2012 prescription. GE 11, at 10. Respondent did not document the prescription in his wife's patient file.
30. April 2, 2012, 120 units of hydrocodone-homatropine syrup (Hycodan), one teaspoon every four to six hours as needed. GE 19, at 1-2.
31. June 18, 2012, 20 tablets of alprazolam (Xanax) 2 mg, one tablet to be taken twice a day, a 10-day supply. GE 10, at 75; GE 11, at 9; GE 15, at 1-2; Tr. 262. Respondent's wife still had a refill remaining on Dr. Webb's Feb. 23, 2012 prescription for 45 alprazolam, which she filled on July 5, 2012. GE 11, at 9. Respondent did not document the prescriptions in his wife's patient file.
32. July 17, 2012, 20 tablets of alprazolam (Xanax) 2 mg, one tablet twice a day, a 10-day supply. GE 10, at 13; GE 11, at 9;
33. August 13, 2012, 30 tablets of hydrocodone/acetaminophen, 10-650, one tablet every four hours, a five-day supply. GE 10, at 80; GE 11, at 9; GE 16, at 1. Respondent did not document the prescription in his wife's patient file.
34. October 5, 2012, 12 tablets of alprazolam (Xanax) 2 mg, a four-day supply. GE 10, at 22; GE 11, at 9. On September 24, 2012, Dr. Webb prescribed and Respondent's wife filled a prescription for 45 alprazolam 2 mg, a 15-day supply, which also provided for two refills. GE 11, at 9. If taken as directed, Dr. Webb's prescription should have lasted until October 9, 2012. In his wife's patient file, Respondent wrote: “Dr. Webb Rx Xanax—She is out 2 days early—Laceration/cutting—severe anxiety & depression—arms excoriated No return call from weekend MD—I have to leave to work out of town Xanax 2 mg #12 Walgreens 3-4 day supply through weekend.” GE 6, at 5. While the note also appears to state “aware -,” Dr. Webb did not have any notes in his file regarding any calls from Respondent on October 5, 2012, Tr. 131, and I find that Respondent did not disclose the prescription to Dr. Webb. I also find that Respondent's wife did not disclose the prescription. Tr. 174-75.
35. December 22, 2012, 15 capsules of Dextroamphetamine-Amphetamine ER 20 mg, a five-day supply. GE 11, at 8. While Dr. Webb had prescribed this drug to Respondent's wife,
36. January 11, 2013, 10 tablets of alprazolam (Xanax) 2 mg, a three-day supply. GE 10, at 21; GE 11, at 8. According to the PMP report, on January 10, 2013, Respondent's wife refilled a prescription issued by Dr. Webb
37. January 11, 2013, six capsules of temazepam, a three-day supply. GE 11, at 8. According to the PMP report, on January 10, 2013, Respondent's wife refilled a prescription issued by Dr. Webb for 30 capsules of the drug, a 30-day supply.
38. January 23, 2013, 15 tablets of alprazolam 2 mg, to be taken “as directed.”
39. January 23, 2013, 30 tablets of hydrocodone/apap 10-650, a five-day supply. GE 11, at 7. Respondent's wife had obtained prescriptions on December 16, 2012 for 20 tablets for hydrocodone/apap 7.5/500 (a two-day supply) and on December 18, 2012 for 20 tablets of hydrocodone/apap 10/500 (a five-day supply) from Dr. Pecunia. GE 11, at 8. However, she was not regularly being prescribed hydrocodone.
40. February 5, 2013, eight tablets of alprazolam 2 mg, a two-day supply. GE 10, at 86; GE 11, at 7; GE 40, at 2. In his wife's patient file, Respondent wrote: “Agitated—open sore on nose & hair line—Back from attempted trip—weathered out—returned with tons of anxiety—ran out of meds while OOT
41. February 27, 2013, 10 tablets of alprazolam 2 mg, a three-day supply. GE 6, at 6; GE 10, at 86; GE 11, at 7. On February 19, 2013, Respondent's wife filled a prescription written by Dr. Webb for 45 alprazolam 2 mg, a 15-day supply. GE 5, at 70; GE 11, at 7. If taken as directed, Dr. Webb's prescription should have provided Respondent's wife with enough medication to last until March 6, 2013. In his wife's patient file, Respondent wrote: “Anxious about marital situation—sores on nose/forehead will not heal—No HI/SI—out of her meds early—Out of Xanax,” “Xanax #10 [one orally three times a day] CVS Hardy St (enough for weekend) (Monday: Dr. Webb refilled for her).” GE 6, at 6.
42. March 27, 2013, 14 tablets of alprazolam (Xanax) 2 mg, one tablet to be taken three times a day as needed, a five-day supply, which was filled the next day.
43. May 10, 2013, 14 tablets of alprazolam (Xanax) 2 mg, one tablet to be taken three times a day as needed, a four-day supply. GE 10, at 86; GE 11, at 7; GE 37, at 1-2. On April 30, 2013, Respondent's wife obtained a refill of a prescription issued by Dr. Webb for 45 alprazolam 2 mg, a 15-day supply. GE 11, at 7; Tr. 267. If taken as directed, the refill of Dr. Webb's prescription should have provided Respondent's wife with enough medication to last until May 15, 2013. Respondent did not document the prescription in his wife's patient file. GE 6. Nor did he disclose the prescription to Dr. Webb.
44. May 13, 2013, 12 tablets of alprazolam (Xanax) 2 mg, one tablet to be taken three times a day, a four-day supply. GE 10, at 21; GE 11, at 7; GE 41, at 1-2. Respondent wrote in his wife's patient file: “Out of Xanax 2 days early—she says repeated [illegible] calls—no answer—No healing on face/arm—repeated re-openings. I am scheduled OOT next 4 days—Xanax #12 [once orally three times a day].” GE 6, at 8. Respondent had already prescribed a four-day supply of Xanax to his wife on May 10; additionally, Respondent's wife still should have had two days' worth of Xanax left from Dr. Webb's April 30 refill. GE 11, at 7; Tr. 267. Respondent did not disclose the prescription to Dr. Webb. While the note also states that Respondent prescribed “Ambien 10 for sleep,” GE 6, at 8, the record does not contain a zolpidem prescription with this date.
45. May 20, 2013, 20 tablets of zolpidem 10 mg, one tablet at bedtime, a 20-day supply. GE 10, at 85; GE 11, at 7; GE 38, at 1-2. Respondent's patient file contains no note for a prescription issued on this date. GE 6, at 8. On May 23, 2013, Dr. Webb prescribed 30 du of another sleep medication, Restoril 30 mg (temazepam), with five refills, to Respondent's wife. GE 5, at 102; GE 11, at 6; Tr. 133-34. Moreover, the PMP report shows that Dr. Webb had been prescribing temazepam with refills to Respondent's wife beginning on July 26,
46. July 1, 2013, 20 tablets of hydrocodone/acetaminophen (Lorcet), 10-650, a five-day supply.
47. July 7, 2013, 12 tablets of alprazolam (Xanax) 2 mg, one tablet to be taken twice a day, a six-day supply. GE 35, at 1-4;
48. July 7, 2013, 12 tablets of hydrocodone/apap 10-650 mg, one tablet to be taken four to six times a day, a two-day supply. Respondent's note in his wife's patient file does not discuss his reason for prescribing hydrocodone.
49. July 25, 2013, 12 tablets of hydrocodone/apap, 10-650, one tablet every six hours as needed, a three-day supply. GE 10, at 21; GE 11, at 5; GE 42, at 1-2. Respondent did not document this prescription in his wife's patient file.
50. July 29, 2013, eight tablets of alprazolam 2 mg, one tablet to be taken three times a day as needed, a two-day supply. GE 10, at 85; GE 11, at 5; GE 39, at 1-2. The PMP shows that on July 19, 2013, Respondent's wife had obtained a refill of a prescription issued by Dr. Webb for 45 alprazolam 2 mg, a 15-day supply. GE 11, at 6. If taken as directed, the refill should have provided Respondent's wife with enough medication to last until August 3, 2017. In his wife's patient file, Respondent wrote: “Out of Xanax—buried her mother—funeral—Dr. Webb back Thursday. Xanax #8 [once orally three times a day].” GE 6, at 9; Tr. 136. Dr. Webb testified that he did not receive any message or have any contact with Respondent on this day, Tr. 136, and there is nothing in Dr. Webb's file for Respondent's wife that indicates that he was contacted by Respondent around July 29, 2013.
51. August 15, 2013, 14 tablets of hydrocodone/apap 10-650, one tablet every four to six hours as needed, a two-day supply. GE 10, at 21; GE 11, at 5; GE 43, at 1-2. Respondent did not document the prescription in his wife's patient file.
52. August 22, 2013, 15 tablets of alprazolam (Xanax), 2 mg, one tablet to be taken three times a day, a five-day supply. GE 10, at 67; GE 11, at 5; GE 24, at 1-2. According to the PMP report, Dr. Webb issued his last alprazolam prescription to Respondent's wife on July 31, 2013 for 45 tablets, a 15-day supply, and the PMP report contains no entry for any refill of this prescription. GE 11, at 1-5. The PMP report further shows that on August 5, 2013, Dr. Webb had re-commenced prescribing clonazepam, a different benzodiazepine. GE 11, at 5;
53. September 5, 2013, 24 tablets of alprazolam (Xanax), 2 mg, an eight-day supply. GE 10, at 21; GE 11, at 5. The Respondent recorded in his wife's patient file: “Will not leave room—depressed—needs to get back with Dr. Webb—anorexic—very anxious/depressed—Xanax #20 [once orally three times a day].” GE 6, at 10. Respondent did not disclose the prescription to Dr. Webb.
Asked if there were “any risks” in Respondent's wife “receiving prescriptions from someone other” than himself, Dr. Webb testified that “this particular patient . . . has some severe problems[,] and takes a high dose of medication. . . . my concern is that I'm keeping a close tab on it, but if there's somebody out there writing that I don't know about, that's dangerous.”
Dr. Webb also explained that the prescriptions “interfered with [my] treatment for her, because I wasn't seeing the real patient, because there's a ghost writer out there that I don't know about.”
In a July 13, 2011 entry in Respondent's wife patient file, which documents a prescription for 20 Xanax 2mg, but for which there is no corresponding prescription in either the PMP reports or the other exhibits,
Dr. Webb further testified that the file did not contain a note “from the answering service or the secretary that on [this date] a message was left.”
Dr. Webb further testified that to the best of his recollection, all of the phone call messages “should be” in the patient file for Respondent's wife.
Dr. Webb further testified that his practice has not received complaints about the clinic's “on call service” and “the inability to connect with a doctor” or to “get a request fulfilled by a doctor.”
The Government also asked Dr. Webb about Respondent's note dated “1/16/12” (prescription No. 24). The note appears as follows:
GX 6, at 2, Tr. 126. Dr. Webb testified that he was not sure if the prescription referenced in the note was “attached to the January 16 or January 26th note.” Tr. 127. He then testified that he had no contact with Respondent's wife on January 16, 2012,
The Government also asked Dr. Webb about an entry Respondent made on July 7, 2013, which states in part: “She's out of her Xanax early. Dr. Webb is aware of the tremendous stress of her mother's illness. No return on call.” GX 6, at 9;
An entry in Respondent's file dated July 29, 2013 states: “Out of Xanax—buried her mother—funeral—Dr Webb back Thursday Xanax #8” and includes dosing instructions of “po TID.” GX 6, at 9. As found above, the PMP report shows that Respondent issued his wife a prescription for eight Xanax 2 mg. GX 11, at 5. The PMP report also shows, however, that Respondent's wife refilled prescriptions for 45 Xanax (15 day supply) issued by Dr. Webb on both July 10 and 19, 2013. GX 11, at 6.
Dr. Webb testified that in his view “gap filling . . . means that there's a prescription that is used to get [the patient] to the next authorized refill.” Tr. 138. Dr. Webb then cited stolen medication as an example of when a gap fill would be appropriate.
On cross-examination, Respondent's counsel asked Dr. Webb about a statement he wrote in a memo he prepared following a January 11, 2016 meeting with DEA personnel in which he noted that Respondent's “prescriptions consisted of large quantities of controlled medications such as Xanax, [h]ydrocodone, [and] Ambien.” Tr. 151;
Dr. Webb subsequently explained that he had Respondent's wife “up to max doses of all prescriptions . . . that I had her on” and that “[a]nything over was a potentially large impact.”
Dr. Webb testified that he had been “very careful in regimenting” the prescriptions he issued for Respondent's wife based on his “years of working with her” and her visit in either 2002 or 2009 (or both years) when “she went to Sierra Tucson” to be evaluated for Xanax abuse. Tr. 146-47. According to Dr. Webb, Sierra Tucson did not diagnose her as being addicted or abusing controlled substances.
Dr. Webb subsequently testified that “[s]ince I did not know about the other prescriptions out there, it did not appear to be as big of an issue. She was early a day or two here and there. But, yes, substance dependence was on the radar.”
Asked about the notes he maintained for his phone conversations with Respondent's wife, which typically were no more than one or two lines, Dr. Webb maintained that he and Respondent's wife “always had in-depth conversations” and that “[t]hey were usually fairly long, like 20, 30, 45 minute phone conversations.”
Dr. Webb acknowledged that psychiatrists do not typically prescribe opioids such as hydrocodone; he testified that he had “written maybe less than five [prescriptions] in my last 20 years.”
Dr. Webb testified that he did not have a conversation with Respondent's wife about Respondent's prescribing controlled substances to her until either late 2015 or 2016, after he was contacted by the Diversion Investigator.
On subsequent questioning, Respondent's counsel suggested that just as the other doctors in his practice can appropriately prescribe gap fills to his patients because they can access the patient's file and see “abuse issues in the patient file . . . someone living with the patient can assess that person.”
Dr. Webb testified that Respondent's notes did not contain a patient history and specific diagnosis.
The Government called R. Andrew Chambers, M.D., to testify as an expert in psychiatry, the proper prescribing of controlled substances and their effects on patients, and on addiction; the ALJ accepted Dr. Chambers as an expert in these areas. Tr. 246. Dr. Chambers obtained his B.S. degree in Chemical Physics from Centre College, Danville, Kentucky in 1991 and his M.D. degree from the Duke University School of Medicine in 1996. GX 12, at 1. Thereafter, he completed a residency in psychiatry at the Yale University School of Medicine in 2002 and a fellowship in addiction psychiatry at the Indiana University (IU) School of Medicine in 2012.
Dr. Chambers has had appointments in the Department of Psychiatry at various hospitals including the West Haven (Connecticut) VA Hospital, Yale New-Haven Hospital, Connecticut Mental Health Center, and Indiana University Health Hospitals. GX 12, at 2. He is board certified in general adult psychiatry and addiction psychiatry. Tr. 227-28. He has also been published in the areas of psychiatry and addiction “on the order of 50 times” in peer-reviewed journals, published in multiple textbooks, and made a number of presentations to professional conferences.
Dr. Chambers testified that treating patients with mental illness and addiction is his “bread and butter work.” Tr. 231. He testified that he is “familiar with and utilize[s] a broad range of pharmacotherapies for both mental illness and addiction, as well as psychotherapies for both mental illness and addiction” and that “the vast majority of [his] patients have both mental illness and addiction.”
While Dr. Chambers had never previously testified in a proceeding based on the Mississippi law and the State Board's rules,
Turning to Respondent's October 11, 2011 prescription for 20 zolpidem (No. 15 above), Dr. Chambers noted that the refill obtained by Respondent's wife on September 19 was for 30 days and should have lasted until October 19.
According to Dr. Chambers, when a patient is obtaining a drug from other sources, “it can create a great deal of confusion on the part of the primary prescriber about the effects or side effects of the drug and the mental status of the patient.”
Dr. Chambers identified several instances in which Dr. Webb's prescriptions “overlapped” with those of Respondent.
Dr. Chambers subsequently testified that it does not matter whether Dr. Webb's prescriptions were new prescriptions or refills because the prescription “is essentially an instruction both to the pharmacist and the patient for the daily dosing and the number of days that the patient should follow that dosing.”
Next, the Government questioned Dr. Chambers about the combination of prescriptions/refills that Respondent's wife filled on November 28-29, 2011.
Dr. Chambers noted that the Diastat prescription “is a bit puzzling because it's clear [Respondent's wife] is taking oral meds and usually [Diastat] [is] reserved for people who can't take [drugs] oral[ly].”
Addressing the prescriptions which Respondent issued on both June 18 and July 17, 2012, for 20 du of alprazolam 2 mg (both being for a 10-day supply),
Another such example is Respondent's July 29, 2013 alprazolam prescription which provided eight tablets (TID). Dr. Chambers testified that Respondent's prescription provided a dosing instruction of eight milligrams a day, Tr. 271, which is supported by the PMP report which lists the prescription as providing a two-day supply. GE 11, at 5. However, the dosing instruction on the actual prescription was TID, or one tablet, three times a day. GX 39, at 1-2. Nonetheless, the prescription overlapped with the refill Respondent's wife obtained on July 19, 2013 for Dr. Webb's prescription for 45 tablets (15 days), and on July 31, 2013, she obtained a new prescription from Dr. Webb for 45 tablets (15 days). GE 11, at 5. However, even if Respondent's prescription only had a dosing instruction of 3 tablets a day, if she took the medications as prescribed by both Dr. Webb and Respondent for the period in which the prescriptions overlapped, she would have taken six tablets a day or 12 milligrams. Tr. 272.
Addressing Respondent's July 7, 2013 prescriptions (Nos. 46 and 47) for 12 du of hydrocodone/apap 10/650 (two-day supply) and 12 alprazolam 2 mg (six-day supply), Dr. Chambers characterized the latter prescription as “remarkable,” explaining that “it's prescribed at the same time [Respondent] also prescribed hydrocodone, an opioid medication, also on the same day, again introducing the risk of a potentially lethal overdose.”
Asked if he had “reach[ed] a conclusion” as to whether Respondent's prescriptions were issued “within the usual course of professional conduct,” Dr. Chambers testified:
I did. It is not [the] usual course of clinical conduct for someone with mental illness or someone without mental illness to be prescribed these combinations of drugs and to have these combinations being prescribed by different individuals who—one of who—where there's not communication or awareness that it's happening. So it's not only not usual clinical practice, but the reason it's not usual is because it's dangerous for patients and harmful. So it's actually not only is it not usual, it's essentially malpractice.
Addressing the patient file Respondent maintained on his wife, Dr. Chambers testified that “there is a paucity of data to support the diagnosis or the prescription . . . that the note is built around. There's a lack of physical or mental status exam that normally would be in a note like this to justify and direct the use of controlled substances.”
Dr. Chambers identified Respondent's entry dated January 16, 2012 (Prescription No. 24) as one such example. Tr. 278. As found above, on this date, Respondent prescribed 30 alprazolam 2 mg “to be taken as directed” and wrote in the note: “Dr. Webb wants Jill to come in. Difficult [with] transportation—will Rx 10 day supply till 1/26/12—Webb aware—Xanax 2 mg” with a dosing instruction of “po TID.” GE 6, at 2.
Dr. Chambers testified that “this note does not have a diagnosis. It doesn't have an examination to justify . . . why that prescription happened at that dose . . . was he aware of what the prescription was from another doctor? Was he continuing? Was there any plan to taper it?” Tr. 279. Dr. Chambers added that “he's kind of writing as if the reason he's doing it is because the patient can't get to Dr. Webb, and he's documenting that Webb is aware . . . but in review of Webb's chart, there no indication that Webb was ever aware that this kind of stuff was going on.”
Addressing Respondent's note of February 18, 2012, Dr. Chambers acknowledged that it contained “a little bit more of what you could call a clinical assessment” in that Respondent described his wife's symptoms.
It's not clear exactly what that means, but I take it to mean that he is prescribing because she's been out. And so, first of all, why is she out? Is it because she's using it too rapidly? It's just not clear. But he is filling the gap with an unclear amount and then suggesting by my read . . . [that] he's documenting he's contacting Dr. Webb,
But what's beginning to emerge here in this note and does come in later is that he is becoming—Dr. Alexander is becoming aware that she's running out and I assume prematurely because when you look at the PDMP data from Dr. Webb, Dr. Webb is not creating gaps. . . . He is not leaving her hanging with no medication a whole lot of times.
Continuing on to the next note (March 12, 2012), Dr. Chambers testified that this was “the first time I've seen a diagnosis in the chart.”
Respondent's note of July 14, 2012 documents a prescription for 20 alprazolam 2 mg, a “6 day supply,” and states, among other things, that his wife had been off medications for four months and had been staying with her mother-in-law. GE 6, at 4. Regarding the note, Dr. Chambers testified that “I don't know that she's even around when this prescription happens. It's just not clear where . . . she [is]. There's no evidence that she's even in front of him on July 14, and that's also a concern.” Tr. 285.
Dr. Chambers observed that, in the October 5, 2012 note (“[s]he is out 2 days early”), Respondent documented that his wife was “actually overusing the prescription that Dr. Webb ha[d] provided her. So he's documenting evidence that she's demonstrating abuse of these drugs and then he . . . say[s], `[s]he's lacerating and cutting herself, severe anxiety and depression, arms excoriated. No return call from a weekend doctor. I have to leave to work out of town.'”
Dr. Chambers offered similar testimony regarding Respondent's May 13, 2012 note.
Respondent's February 27, 2013 note states that his wife was “[a]nxious about marital situation.” As to the note, Dr. Chambers testified that “it's not considered a normal medical practice” to treat family members and “that when it comes to controlled substances it's a whole different ball game” when the prescription is “for a family member.”
Dr. Chambers also testified, however, that “[t]his standard is actually not true for other branches of medicine” such as family practice.
Dr. Chambers offered similar testimony with respect to Respondent's March 28, 2012 note, which states: “Marital/physical/mental stress sky high—Marriage workshop in Montana just accentuated” and “Out of Xanax early—rebound anxiety—self harm.” GE 6, at 7. Dr. Chambers testified that he found that entry was “interesting because the marital, physical and mental stress . . . involves him, and he's prescribing this medication to somebody who is in acute distress that's ultimately related to the medication.” Tr. 287. Dr. Chambers also testified that Respondent's notation of a prescription for “Xanax # 14” “is incomplete” because it does not state “the dose” or the patient's instructions.
Subsequently, the Government asked Dr. Chambers to address “the situation where” a primary care doctor is prescribing to a patient who is also being treated by a psychiatrist.
If you have two chefs in the kitchen, this is the kind of stuff that can happen as you get chaos and harm and polypharmacy and no one understanding what is the illness versus what is [sic] the side effects of the medications, and it can lead to escalation of mental illness, addiction, and even death.
Finally, on direct examination, Dr. Chambers testified that “[a] competent psychiatrist would document [in the patient's chart] if they knew that another doctor was prescribing controlled substances that were overlapping or representing a threat.”
On cross-examination, Dr. Chambers agreed that “[i]n many cases,” Respondent prescribed the same drugs to his wife as were prescribed by Dr. Webb.
Asked by Respondent's counsel if “providing gap fills necessarily mean[s] there's a drug abuse issue,” Dr. Chambers answered that “[i]t can mean.”
Assuming facts not in evidence, Respondent's counsel then asked Dr. Chambers if “somebody who sees [the patient] regularly five or six times a week as a patient
Dr. Chambers acknowledged that Respondent's and Dr. Webb's dosing of alprazolam were “often in the same ballpark.”
Respondent's counsel then asked Dr. Chambers if “you're saying that she was addicted or . . . was abusing controlled substances . . . wouldn't . . . the individual who prescribed her over 1500 doses of controlled substance in one year . . . be more responsible for that versus the individual who prescribed 200 doses of controlled substances a year?”
After Dr. Chambers acknowledged that “Dr. Webb prescribed a significant amount of controlled substances, Respondent's counsel asked him if he “was aware that in 2011 [Respondent] only prescribed 128 dosage units to her?”
Respondent's counsel also misstated the evidence when he asked Dr. Chambers if he was “aware [that] in 2012 Dr. Webb prescribed approximately 1720 dosage units of controlled substances versus the 132 that [Respondent] prescribed] to” is wife. Tr. 321. Rather, the evidence shows that Respondent prescribed 112 du of zolpidem, 94 du of alprazolam, 20 du of diazepam, 30 du of hydrocodone, 15 du of Adderall, as well as Hycodan cough syrup.
Following questions about the relative amounts of controlled substances prescribed by Dr. Webb and Respondent, Respondent's counsel asked Dr. Chambers if Respondent's wife had “a substance abuse issue, . . . isn't it logical that Dr. Webb would have as much, if not more, responsibility for that?”
Dr. Chambers testified that he did not see any notation in Dr. Webb's patient file that he was aware that Respondent's wife “was running out early and that [Dr. Webb] was filling earlier.”
Respondent's counsel then questioned Dr. Chambers about the alprazolam prescriptions which were issued by Dr. Webb and filled by Respondent's wife on May 14, June 10, July 4, July 21, August 4, and August 16, 2011, and whether the overlap between the prescriptions concerned him.
Respondent's counsel subsequently asked Dr. Chambers if the hydrocodone prescription which Dr. Webb issued on June 28, 2013 concerned him.
So that is a concern. When you step back from the record and you look at where—the opiate is the main threat actually, and when you look at the predominance of opiate prescribing over three years, the majority of it came from Dr. Alexander. So the number of opiates that were prescribed were quite rare. The incidents you're putting in there—you're pointing out is a concern, but . . . the relative frequency of which Webb did that was much, much, much lower than when Dr. Alexander [did] it, and that's interesting because, as you pointed out, Dr. Webb is prescribing . . . three or four times more number of prescriptions. So it's a matter of degree as well.
Asked if it is within the usual course of professional practice for a psychiatrist to prescribe an opiate, Dr. Chambers testified that a psychiatrist “may treat pain on occasion.”
Addressing the prescription for Diastat Acudial, a rectal suppository form of diazepam, Dr. Chambers testified that while Dr. Webb's file shows that Respondent's wife suffers from seizures, he did not see how administering Diastat would “be consistent with treating someone who was having a seizure.”
At the January 2014 Board hearing which resulted in the suspension of his medical license, Respondent was asked to explain why he issued the prescriptions. GE 14, at 56. Respondent explained that his wife has a “fragile” psychiatric condition, which “became even more fragile” in “about November or December of last year.”
Continuing, Respondent testified that “[w]e tried to . . . contact [Dr.] Webb, but . . . you can't get him at night, on weekends, and I don't blame him. And as he always tells [my wife], this is a matter that she shouldn't be running out prematurely.”
Apparently referring to the prescriptions he issued for hydrocodone, Respondent testified that “[w]hen that changes—there were two occasions in general” when he “called in.”
Continuing, Respondent testified that “I have never denied that I called things in for Jill . . . I always thought that if called to task for it, the context would not speak for itself but would be evidenced by number, etcetera.”
Asked about the December 2012 Adderall prescription, Respondent stated that he did not “recall ever writing” the prescription and that his wife “was in the hospital in Hattiesburg at the time.”
Respondent also told the Board that his prescribing was “not a matter of judgment” but “a matter of heart.” GE 14, at 63. He further told the Board that:
I never did anything that I didn't think at the moment . . . was necessary, and I think if you look at the record you can see that. There can be no more. There can be no more. You know, if I have to call 911 every time, then I am Jill's husband. I am not—I was never her doctor. I stopped gapped, but I can't even do that anymore. I mean, I know that is a matter of fact going forward.
During cross-examination at the Board proceeding, Respondent admitted that he did not disclose that he had been issuing the prescriptions until he was asked by the Board.
During the Board proceeding, Respondent acknowledged that he had violated his RCA and an agreement with the Board.
Before the Board, Respondent further asserted that he did not notify Dr. Webb about the prescriptions because his wife “assured [him] that [Webb] was apprised of every situation.”
The same Board member noted that “there's an insinuation that [Dr. Webb] knew something had happened and that weekend or something had happened and that emergency medicine had been called in” and asked “is that correct?”
Respondent testified that when he would call Dr. Webb's answering service, he would “ask [ ] for a call back from Dr. Webb or the doctor on call.”
Respondent's first witness was his wife. Tr. 357-401. Of consequence, the ALJ found “that her testimony was not helpful in resolving the issues in this case.” R.D. 9. Specifically, the ALJ found that “her testimony was confusing, lacked specificity, and, at times, was internally inconsistent” and that “she could not remember many details of the underlying events about which she was testifying.”
These included:
She could not recall the number of times she had called Dr. Webb's answering service and had not received a return phone call. Tr. 360-62. She could not provide an adequate explanation of why she continued to be Dr. Webb's patient even though she was dissatisfied with his failure to return her phone calls. Tr. 361-62, 382, 391. In explaining her difficulty in recalling details from 2011 to 2013, she said she could not recall because that was “seven years ago.” Tr. 372. She testified that she did not have appointments with Dr. Webb between 2011 and 2013, yet Dr. Webb's treatment notes document several appointments during that period.
Respondent's wife testified that she is known by various names including Mona Jill Graham Alexander, Mona Jill Graham, Mona Jill G. Alexander, and Jill Alexander. Tr. 357-58. She testified that she has been a patient of Dr. Webb for 16 years and she would usually see Dr. Webb three times a year and speak on the phone two to three times a month for 30 minutes to one hour.
Respondent's wife testified that during the 2011 through 2013 time period, she “would tell” Dr. Webb that Respondent was prescribing controlled substances for her, “especially if I got out of medication.”
Respondent's wife testified that “[t]he only conversation we [she and Dr. Webb] ever had about [her husband's prescribing] was to let me be the only one that prescribes you this medicine.” Tr. 363. She initially testified that this conversation “probably [occurred] towards the end” of 2013,
Regarding the Diastat prescription, Respondent's wife testified that she uses the drug because she has seizures and because “I've had seizures, I just always try to travel with it and keep some on me.”
Respondent's wife testified that she believed her husband prescribed the controlled substances because he was trying to help her.
She also testified that when her husband wrote a prescription for her, she was in crisis, and that her husband had never provided her with a controlled substance prescription when she was not in crisis.
On cross-examination, she also admitted that Respondent had written a hydrocodone prescription for her but maintained that he did so when her mother “was dying in the hospital” and she developed back pain because she sat at her “mother's bedside waiting for her to die.”
However, as found above, Respondent issued numerous hydrocodone prescriptions to her well before Dr. Webb issued the single hydrocodone prescription on June 28, 2013. Also, a substantial number of the prescriptions (especially those for zolpidem) were for quantities that far exceeded the amount necessary to provide medication until she was able to get a new prescription from Dr. Webb. Moreover, in a number of instances, Respondent issued the prescription notwithstanding that his wife had either recently refilled a prescription for the same drug or had refills outstanding which were authorized by an existing prescription issued by Dr. Webb.
On questioning by the ALJ, Respondent's wife maintained that during the period of 2011 and 2013, she “usually [did] not” get a call back from Respondent's office when she would leave a message. Tr. 387. Not only did the ALJ not find her testimony credible, her medical file contains evidence of only two phone calls she made during this period in which Dr. Webb did not document that he called back or Dr. Webb did not issue a prescription either the same day or the following day.
The second of these occurred on July 10, 2013. GX 5, 133. However, the same day, Respondent's wife refilled a prescription for 45 alprazolam 2 mg (15 days). GX 11, at 6.
Respondent called as a witness Peter Graham, Ph.D. Dr. Graham is a psychologist who works with Acumen Assessments, which provides clinical evaluations of physicians who are referred to it by physician health programs and state boards, and the Acumen Institute, which provides treatment, education and coaching to “licensed professionals who are in the process of being rehabilitated for one or another professional reason.” Tr. 403-04. Dr. Graham testified that the main focus of Acumen's evaluations is not whether a physician is competent to practice medicine, but whether the physician's “mental status, personality variables, [and] character traits . . . may impact on decision-making, ethical judgment, self-regulation, ability to remain responsible and maintain the duties of licensure.”
Dr. Graham testified that Respondent was referred to him “for evaluation of his fitness secondary to having engaged in conduct that was contrary to his [recovery] contract,” that being writing the prescriptions for his wife.
Respondent subsequently underwent treatment, which included both a three-week inpatient and one-week follow-up visits at three and six months, individual psychotherapy in his home community, and a three-day wrap up visit at the one-year mark.
Respondent also called as a witness, Scott Hambleton, M.D., the medical director of the MPHP.
As for how the MPHP monitors the provision in Respondent's contract that prohibits prescribing to family members and himself, Dr. Hambleton testified that this is done by the Board's investigators.
On cross-examination, Dr. Hambleton acknowledged that Respondent had violated his first two recovery contracts.
Dr. Hambleton testified that he supported Respondent's return to the unrestricted practice of medicine because the Board's suspension of his license was “a profound experience, especially for a neurosurgeon, with that amount of training,” and “[t]hat type of intervention has a powerful effect on the recovery process.”
Dr. Hambleton further testified that Respondent's “treatment has been effective” and that “[h]e's gaining insight, sensitivity, demonstration of more regard for others, responsibility, authenticity, the markers of recovery.”
However, on questioning by the ALJ, Dr. Hambleton testified that his “frequency of contact” with Respondent “is not what allows me to make that assessment of him.”
Dr. Hambleton testified that “[i]n the event that there is evidence of substance abuse, we will withdraw advocacy immediately, and it [will] be the end of his medical career.”
Respondent also testified on his own behalf.
Asked if his prescribing of controlled substances to his wife “violated his obligations as a licensed doctor in . . . Mississippi,” Respondent answered: “I know it violated my contract with the professionals healthcare program.”
Respondent testified that when he testified before the State Board, he accepted responsibility for prescribing to his wife.
Asked why the Agency should entrust him with a DEA registration, Respondent testified:
As I testified in my [2014] board hearing . . . , regardless of what it had come from, I thought I'd hit a brick wall. And there are no other options for me. If I can't practice medicine, conforming to every jot, tittle, to the letter of the law, I can't practice medicine. There are no more get-out-of-jail cards for me. There aren't.
I have tried to—perhaps I made enough missteps, I can provide a beacon of some sort to younger physicians that might think it's okay to prescribe outside the bounds of normal patients. I don't know what else I possibly could do at this point to convince Your Honor what more I could do to be—that I am worthy to be entrusted with a DEA registration. I will do it. If someone suggests something to me, I will gladly do it, but —.
On cross-examination, the Government asked Respondent if he understood that “DEA is alleging something slightly different than prescribing outside the contract.”
The Government followed-up by asking: “so . . . you are not admitting that you violated either federal or state law with respect to the prescriptions you issued to your wife?”
The Government asked Respondent if he understood that what he had been charged with in the DEA proceeding “had nothing to do with” his recovery contract.
After noting that Respondent was only “admitting responsibility to what the Board found” and that was not what DEA had charged him with, the Government explained that it was “trying to get a clarification as to what you're accepting responsibility for?”
As far as me as a physician testifying to what statutes I may or may not have transgressed, I can't. That would be speculative at least on some level for me.
After the ALJ sustained Respondent's objection to the Government's attempt to question him about both his testimony before the State Board and the patient file he maintained on his wife, the Government asked Respondent if he
I think I've answered that already. I don't know precisely how the DEA defines it, and to be scrupulously honest, I can't. I will once again accept the responsibility that what I did was wrong and I should not have done it. And I have done everything in my power to remediate that. But I do not know again . . . the specifics of the—of what I'm being charged with by DEA now, three years after I have assiduously striven to do everything I can to clean up and do everything right, and then you come along and ask me about new things.
What hope is there for any other physician that follows me for redemption if we do everything we can. . . . What more, I mean, that's—I'm sorry. I'm getting emotional.
The Government then attempted to ask Respondent if he accepted responsibility for failing maintain patient files in compliance with Mississippi law.
After both the Government and Respondent's counsel stated they had “[n]othing further,” the ALJ observed that he was “was just a little bit puzzled as to [Respondent's] answer about acceptance of responsibility.”
After the ALJ asked if he had read the Show Cause Order and pointed out that it “didn't say anything about [his] failure in recovery,” Respondent acknowledged that “[i]t didn't” and asserted “that's why [he] was confused.”
The ALJ then explained that he was not sure what Respondent meant; Respondent stated that it went to his “understanding of what I was charged and found guilty with by the State,” which included violating his Recovery Contract and “basically unethical behavior.”
Thereafter, the ALJ stated to Respondent's counsel that if he was “getting into an area that you don't want me to ask about, don't hesitate to object because I know I'm going beyond what your direct examination was.”
Respondent's counsel resumed questioning Respondent and asked him to “clarify . . . what specific actions [he was] accepting responsibility for?”
On re-cross, the Government asked Respondent “[w]hat portion of the prescribing to [his] wife [was] inappropriate?”
Through my education with Dr. Webb—well, first of all, prescribing for family members is a bad idea in general. I think the contract specifies it because commonly that means there's diversion going on, and I'm prescribing for someone, and they're kicking it back to me, but that's not a question, and I think my urine tests show that didn't happen.
I think that in general the objectivity required even in exigent circumstances must be called into question when it's a loved one.
Subsequently asked by the Government if “there [was] anything else wrong with your prescriptions to your wife, aside from the fact that she's a family member,” Respondent answered:
Let me think on that a minute. I'm a little almost frightened to answer because at no time do I want anyone in this courtroom thinking, exigent or not, that I'm saying it was right or that you'd have done it too if you were there. There's not a complete patient file. I mean, is that what you're asking me?
The Government then asked Respondent if he “admit[ted] that the prescriptions you issued to your wife were outside the usual course of professional practice?”
As I understand that term of art . . . if the documentation is substandard, that that renders it outside the course of professional practice, then I would accept that, if I'm—any hesitancy previously has been based on that. I mean, you know, as a physician, I don't understand that term. When you say outside the course of medical practice, it makes me think that someone just gave rat poison or something absurd like that. But when you lay the predicate about proper documentation, for instance, then, yes, I would have to accept that.
On still a further round of re-direct, Respondent acknowledged that he is “not a psychiatrist” and that “[t]hese medicines are . . . chiefly used in psychiatric conditions.
Respondent's counsel then asked if could “be trusted to not engage in such prescribing in the future?”
I will first say strongly, absolutely. I have spent the last three years trying to redeem this situation, to show everyone exactly how driven I am. And, Your Honor, I'm not trying to avoid anything. If someone shows me I've done something wrong, I will admit it. I'm not even bringing up the subtext. I did wrong. I throw myself upon the mercy of the process. I have done everything that I know to do to try to remedy this situation and I can do no more than give my sworn oath that this will not happen again.
Respondent's counsel concluded his examination by asking Respondent if his acceptance of responsibility included his “prescribing to [his wife] while she was under the care of another doctor, perhaps providing medications too soon in terms of early refills, providing gap fills, [and] not having an adequate medical file?”
Section 303(f) of the Controlled Substances Act (CSA) provides that “[t]he Attorney General may deny an application for [a practitioner's] registration . . . if the Attorney General determines that the issuance of such registration . . . would be inconsistent with the public interest.” 21 U.S.C. 823(f). With respect to a practitioner, the Act requires the consideration of the following factors in making the public interest determination:
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“[T]hese factors are . . . considered in the disjunctive.”
The Government has the burden of proving, by a preponderance of the evidence, that the requirements for denial of an application pursuant to 21 U.S.C. 823(f) are met. 21 CFR 1301.44(d). However, once the Government has made a
Having considered all of the factors, I find that the Government's evidence with respect to Factors Two and Four satisfies its
To be sure, the Agency's case law contains some older decisions which can be read as giving more than nominal weight in the public interest determination to a State Board's decision (not involving a recommendation to DEA) either restoring or maintaining a practitioner's state authority to dispense controlled substances.
Of note, these cases cannot be squared with the Agency's longstanding holding that “[t]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.”
As to factor three, I acknowledge that there is no evidence that Respondent has been convicted of an offense under either federal or Mississippi law “relating to the manufacture, distribution or dispensing of controlled substances.” 21 U.S.C. 823(f)(3). However, there are a number of reasons why even a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one.
As for factor five, because the Government did not file exceptions to the ALJ's legal conclusions with respect to this factor, I deem it unnecessary to make any findings.
Under a longstanding DEA regulation, a prescription for a controlled substance is not “effective” unless it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a).
Under the CSA, it is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to act “in the usual course of . . . professional practice” and to issue a prescription for a “legitimate medical purpose.”
Both this Agency and the federal courts have held that “establishing a violation of the prescription requirement `requires proof that the practitioner's conduct went “beyond the bounds of any legitimate medical practice, including that which would constitute civil negligence.” ' ”
“Accordingly, under the public interest standard, DEA has authority to consider those prescribing practices of a physician, which, while not rising to the level of intentional or knowing misconduct, nonetheless create a substantial risk of diversion.”
Under the Mississippi Board's Rule 1.4:
Patient Record. A physician who prescribes, dispenses, or administers a controlled substance shall maintain a complete record of his or her examination, evaluation and treatment of the patient which must include documentation of the diagnosis and reasons for prescribing, dispensing or administering of any controlled substance; the name, dose, strength, quantity of the controlled substance and the date that the controlled substance was prescribed, dispensed or administered. The record required by this rule shall be maintained in the patient's medical records, provided that such medical records are maintained at the office of the physician . . . .
No physician shall prescribe, administer or dispense any controlled substance or other drug having addiction-forming or addiction-sustaining liability without a good faith prior examination and medical indication therefore.
A determination as to whether a “good faith prior examination and medical indication therefore” exists depends upon the facts and circumstances in each case. One of the primary roles of a physician is to elicit detailed information about the signs and symptoms which a patient presents in order that he or she may recommend a course of treatment to relieve the symptoms and cure the patient of his or her ailment or maintain him or her in an apparent state of good health. In order for a physician to achieve a proper diagnosis and treatment plan, a history and physical examination consistent with the nature and complaint are necessary. . . . The paramount importance of a complete medical history in establishing a correct diagnosis is well established. Standards of proper medical practice require that, upon any encounter with a patient, in order to establish proper diagnosis and regimen of treatment, a physician must take three steps: (a) take and record an appropriate medical history, (b) carry out an appropriate physical examination, and (c) record the results. The observance of these principles as a function of the “course of legitimate professional practice” is particularly of importance in cases in which controlled substances are to play a part in the course of treatment. It is the responsibility of the physician to dispense, prescribe or administer such drugs with proper regard for the actual and potential dangers.
Rule 1.4 further notes that “[a] determination of proper `medical indication'[ ] also requires a careful examination of the nature of the drug and all circumstances surrounding dispensation.”
Here, the ALJ found that that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he issued numerous prescriptions for controlled substances included alprazolam, diazepam, hydrocodone, zolpidem, and Adderall (amphetamine). R.D. 39-44. I agree with the ALJ that Respondent violated 21 CFR 1306.04(a) in issuing the prescriptions. I further find that in issuing each of the prescriptions enumerated above (Nos. 1 through 53), Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in doing so.
Dr. Chambers provided unrefuted testimony that it is not within the usual
Dr. Chambers also offered unrefuted testimony that Respondent's prescribing resulted in “a combination of multiple overlaps of multiple classes of addictive substances that can produce overdose and severe psychiatric disturbances.”
Respondent's failure to maintain adequate records to support the prescriptions provides additional support for this conclusion, as well as the conclusion that Respondent violated Mississippi Board Rule 1.4's provisions with respect to patient records.
Before the State Board, Respondent testified that his prescribing “was sporadic” and “was always for a confined number of pills, a small amount, that bridged her gap between obviously when she was in crisis and didn't have any medicine.” GE 14, at 58. He maintained that “the majority of the medicine were Xanax, two milligrams, [and that a] three day supply were [sic] common.”
Although the Government introduced into evidence the transcript of the January 2014 state board proceeding, it did not submit the Board's order prohibiting him from practice and/or the charging document, any of the exhibits submitted in the Board proceeding which may have shown what prescriptions were at issue in the proceeding, or even the Board's order suspending his license after the January 2014 proceeding. However, while it may have been the case that Respondent's explanation as to his reasons for prescribing during the 2014 board proceeding was consistent with the evidence presented at that proceeding, it is not consistent with much of the evidence submitted in this proceeding.
As found above, the record contains numerous prescriptions which are not fairly characterized as two to three-day gap fills. With respect to Respondent's prescribing of zolpidem, they include fourteen prescriptions which clearly were not short-term gap fills. These prescriptions include numbers 2, 4, 6, 8, 22, 26, 28 (each for 30 du
With respect to Respondent's prescribing of alprazolam, they include prescription numbers 11 (20 du, a 10 to 20-day supply), 34 (30 du, a 10-day supply
Likewise before the State Board, Respondent initially offered testimony regarding his prescribing of hydrocodone which addressed only the prescriptions he wrote after a plastic surgeon had drained an abscess in his wife's thigh and when his wife had a seizure and fell. Moreover, when on cross-examination a Board member identified the multiple hydrocodone prescriptions Respondent issued in July 2013, Respondent testified that “that was an isolated incident there.”
Also, in a number of instances, Respondent issued prescriptions even though his wife had refills available under prescriptions that were previously issued by Dr. Webb. For example, on March 30, 2011, Respondent issued a prescription for 30 zolpidem. (Rx No. 4). However, Dr. Webb's February 3, 2011 zolpidem
Moreover, when Respondent issued the July 31, 2011 prescription for 12 zolpidem, he also authorized a refill, which was available to his wife on August 28, 2011 (which she did not fill until September 6, 2011), when Respondent issued her a new prescription for 12 zolpidem.
So too, Respondent's October 11, 2011 prescription for 20 zolpidem, a 20-day supply, (Rx No. 16) was issued notwithstanding that Dr. Webb's August 16, 2011 zolpidem prescription provided for five refills, one of which his wife filled on October 19, 2011.
Another such example involves Respondent's December 27, 2011 prescription for 30 zolpidem and his January 7, 2012 prescription for 28 zolpidem. (Nos. 22 & 23). Respondent's wife had obtained a refill of Dr. Webb's August 16, 2011 prescription for 60 du on December 16, 2011, only 11 days earlier (Dec. 16). Thus, there was no gap to fill. Nor was there a gap to fill on January 7, 2012, when he issued the prescription for an additional 28 dosage units given the quantity of drugs his wife had recently obtained.
Still more examples are provided by the zolpidem prescriptions Respondent issued on March 4 and 12 (both for a 30-day supply), as well April 1, 2012 (for a 24-day supply). During this period, Respondent's wife obtained a prescription for 30 du (a 15-day supply) on February 23, 2012, which provided for two refills, the first of which she obtained on March 19, 2012. Here again, the only potential gap was likely created by the failure of Respondent's wife to follow Dr. Webb's dosing instructions on the February 23rd prescription. Moreover, the March 12, 2012 prescription was not a gap fill given that Respondent issued the March 4, 2012 prescription, which provided a 30-day supply. Nor was the April 1, 2012 prescription a gap fill given Respondent's issuance of the March 12 prescription and the refill she obtained on March 19, 2012 pursuant to Dr. Webb's Feb. 23 prescription.
Similarly, the evidence shows that on January 11, 2013, Respondent issued a prescription for 10 du of alprazolam (
As one further example, on May 20, 2013, Respondent issued a prescription for 20 tablets of zolpidem (No. 45). The evidence shows, however, that Dr. Webb had not issued a zolpidem prescription since February 23, 2012, which his wife last refilled in April 2012. Here again, this was not a gap fill.
Had Respondent's prescribing been limited to a few instances of small (two to three day) gap fills, his conduct would be considerably less egregious given the circumstances of his wife's illness. The evidence shows, however, that his illicit prescribing went on for nearly three years. Even more disturbing is that the evidence shows that many of the prescriptions were not for gap fills at all, let alone for gap fills for two to three day periods as he testified before the State Board.
Notably, in this proceeding, Respondent has personally offered no explanation as to why he issued the prescriptions. Moreover, the only evidence he offered was the discredited testimony of his wife that there occasionally were times when she “might run out a day early on a weekend” and only needed a short term supply until Dr. Webb got back to her and that Respondent had never given her a prescription for a time period longer than two to four days. Tr. 379, 381, 384.
I thus conclude that the Government's evidence with respect to Factors Two and Four makes out a
Where, as here, the Government has met its
Moreover, the egregiousness and extent of a registrant's misconduct are significant factors in determining the appropriate sanction.
Finally, the Agency has also held that “ `[n]either
The ALJ acknowledged that “to rebut the Government's
The Agency has explained that where the Government has proved that a respondent has committed knowing or intentional misconduct, a respondent must fully acknowledge the misconduct that has been proved on the record to be deemed to have accepted responsibility, and absent such a showing, his evidence of remedial measures is irrelevant.
However, there are also numerous cases, that were not discussed in the Recommended Decision, which hold that where the Government has proved that a respondent committed knowing or intentional misconduct, he must unequivocally acknowledge his misconduct.
I disagree with the ALJ's conclusion that Respondent is entitled to a finding that he has accepted responsibility for his misconduct. To the contrary, I find that his testimony was equivocal and that he repeatedly attempted to minimize his misconduct. Indeed, even after the ALJ granted Respondent a second chance to explain what he was accepting responsibility for, he still did not unequivocally acknowledge his misconduct.
In this matter, Respondent was specifically charged with violating 21 CFR 1306.04(a), the CSA's prescription regulation which requires that a controlled substance prescription “be issued for a legitimate medical purpose by [a] practitioner acting in the usual course of professional practice.” ALJ Ex. 1, at 1-3 (¶¶ 3-9). Indeed, the Government specifically alleged that the prescriptions “were nontherapeutic, were for other than a legitimate medical purpose, and were outside the course of professional practice.”
Notwithstanding that the Show Cause Order clearly set forth these violations, and that Dr. Chambers offered unrefuted testimony that Respondent's prescribing was outside of the “usual course of clinical conduct,” “was dangerous and harmful,” “non-therapeutic,” not for a “legitimate medical practice,” that there was “a paucity of data to support the diagnosis or the prescriptions” and there was “a lack of physical or mental status exam” documented in the noted to justify the prescriptions, Respondent repeatedly refused to acknowledge that he violated 21 CFR 1306.04(a).
While Respondent testified that he violated his contract with the State PHP (which was not a charge in this proceeding), when asked by his counsel if he violated his obligations as a DEA registrant, he asserted that he did not “know the specific legalities of DEA registration” but was willing “to tell you what I did was wrong, . . . without any equivocation.” Tr. 484-85. While he
Indeed, throughout his testimony, Respondent asserted that he thought the charges in this proceeding simply involved the same charges that he was found guilty of in the State Board proceeding. He doggedly denied that he violated the CSA's prescription requirement, asserting that that it “would be speculative . . . on some level” for him to testify as “to what statutes I may or may not have transgressed.”
Given that the Show Cause Order provided fair notice to Respondent that he was charged with violating 21 CFR 1306.04(a) and that he heard the evidence against him and put up no defense, he was not required to speculate as to “what statutes [he] may or may not have transgressed.” Moreover, the CSA's requirement that “a prescription for a controlled substance . . . must be issued for a legitimate medical purposes by [a] practitioner acting in the usual course of professional practice” is hardly a “jot” or a “tittle” of the Act.
Notably, even after the ALJ repeatedly expressed his puzzlement as to what Respondent was accepting responsibility for, Respondent testified that he was accepting responsibility for what the State said he did and again asserted that he thought the charges in the DEA proceeding were the same as the charges which he was found guilty of by the State Board. Tr. 503-05. While the ALJ subsequently gave Respondent several chances to answer this question, his testimony continued to manifest equivocation, minimization and an unwillingness to acknowledge that he violated the CSA's prescription requirement.
For example, when asked to “clarify . . . what specific actions [he was] accepting responsibility for,” Respondent answered: “[v]iolating the previous order, right? Writing prescriptions for my wife when I wasn't a treating physician, which I think is not proper document, not fully proper documentation of those things.” Tr. 507. He subsequently testified that “if someone shows me . . . what I was saying that I'm ignorant of the specifics of a DEA charge.
However, as found above, the unrefuted evidence, including the testimony of Dr. Chambers, establishes that Respondent's prescribing did “meet the criteria” for a violation of 21 CFR 1306.04(a). Yet even when confronted with this evidence, Respondent still was unwilling to accept that he “did it.”
On further cross-examination, Respondent was again asked what he thought was “wrong with respect to the prescriptions.”
Minimizing is, however, exactly what Respondent was engaged in. And when the Government again asked Respondent if he was admitting that the prescriptions were issued outside the usual course of professional practice, Respondent maintained that “as a physician, I don't understand that term” and he was only willing to admit to acting outside of the usual course to the extent that his documentation was “substandard.”
While it is true that on a still further round of re-direct examination, Respondent testified that it was wrong for him to “prescribe controlled substances to someone who was under the care of another physician for those same ailments,” this is not a full acknowledgment of his illegal behavior. Indeed, the mere fact that a physician prescribes controlled substances to someone who is under care of another physician for the same ailments would not necessarily give rise to liability under 1306.04(a). Such prescribing would be entirely lawful under the CSA in bona fide emergency situations provided the prescriptions were limited to what was medically necessary to treat a patient before the primary physician could resume care.
Here, however, Respondent has admitted to acting outside of the usual course of professional practice only to the extent he maintained “substandard records.” Notwithstanding Dr. Chambers' testimony, Respondent has failed to acknowledge that his prescribing increased the risks of his wife become dependent, overdosing, or diverting controlled substances, his failure to conduct appropriate examinations, as well as his failure to notify Dr. Webb that he had prescribed the drugs.
Moreover, before the State Board, Respondent maintained that his prescribing “was sporadic,” “was always for a confined number of pills,” that they were simply short gap fills which “mirrored what [Dr. Webb] had done.” However, as found above, many of the prescriptions provided substantially more medication than was necessary for a two to three-day period. These include 14 zolpidem prescriptions, each of which provided at least a 12-day supply (with 11 of the prescriptions providing 20 to 30 dosage units, most of which for a 20 to 30-day supply) and five of the alprazolam prescriptions, four of which were for a ten-day supply, the other being for an eight-day supply. There were also the seven hydrocodone prescriptions and a diazepam prescription, which although they were for small amounts, did not “mirror what [Dr. Webb or any other doctor] had done,” and are unsupported by the findings of an examination and a diagnosis.
Respondent personally offered no explanation in this proceeding (or before the State Board) as to why he issued these prescriptions, which clearly provided more drugs than were medically necessary to address a two- to three-day period.
The ALJ also gave weight to Respondent's testimony during the second State Board hearing that he was “committed to `absolute and complete adherence' to applicable rules and regulations,”
The ALJ also rejected as only “technically correct” the Government's argument that Respondent did not accept responsibility for failing to conduct examinations and/or conducting insufficient examinations prior to issuing the prescriptions. R.D. 54-55. While the ALJ found that Respondent did not “specifically acknowledge that it was wrong of him to issue a prescription without first conducting an examination,” the ALJ faulted the Government for not asking this question of Respondent.
I cannot agree with this reasoning. As for the ALJ's faulting of the Government for not asking Respondent if he accepted responsibility for his failure to conduct examinations or conducting inadequate examinations, Respondent, and not the Government, had the burden of production on this issue. As for the ALJ's assertion that “the central concern of this case . . . is that the Respondent wrote prescriptions for his wife when he should not have,” the central concern of this case is what the Government alleged in the Show Cause Order and proved at the hearing.
With respect to the proven misconduct, Respondent admitted that he acted outside of the usual course of professional practice only to the extent that he failed to maintain proper records. As for the ALJ's further assertion that his acceptance of responsibility for failing to conduct examinations was “subsumed in his general acceptance of responsibility,” the cited testimony does not support this, as the question, which was asked by his counsel, made no reference to his failing to conduct examinations. Tr. 515.
The ALJ acknowledged that “[i]t is true . . . that Respondent did not plainly and expressly accept responsibility for violating specific federal regulations.” R.D. 56. Indeed, at no point did Respondent admit that he violated 21 CFR 1306.04(a) with respect to any of the prescriptions, including those which clearly were not two to three day “gap fills.” Nor did he ever admit that any of the prescriptions were non-therapeutic or lacked a legitimate medical purpose. And he denied that his prescribing increased the risks of his wife become dependent, overdosing, or diverting controlled substances. Respondent has therefore failed to “express remorse to the full extent of [his] wrongful conduct.”
The ALJ also gave weight to Respondent's having “expressed remorse and accepted responsibility for writing those prescriptions during the first three weeks of his treatment at Acumen” as well as his testimony during the second Board hearing. R.D. 55. However, whether Respondent accepted responsibility for writing the prescriptions during his treatment at Acumen is wholly irrelevant. Likewise, because the Agency was not a party in the State Board's proceedings, the weight to be given to Respondent's testimony before the Board is substantially diminished. What matters is whether he accepted responsibility for the misconduct alleged and proved in this proceeding.
The ALJ further explained that he found Respondent's remorse to be sincere and that his acceptance of responsibility was “credible.” R.D. 56-57. This case, however, is less about Respondent's credibility (although there is ample reason to question it given his testimony regarding what he thought he had been charged with in this proceeding)
While I appreciate that the ALJ closely examined Respondent's testimony both at this hearing and before the state board (as have I), I find it particularly disturbing that Respondent has never offered an explanation in any proceeding
I therefore find that Respondent has failed to produce sufficient evidence to support a finding that he accepts responsibility for his misconduct. While there are cases in which the Agency has imposed a sanction less than denial or revocation where a respondent has failed to meet his burden on acceptance of responsibility, those cases have involved considerably less egregious misconduct than the knowing and intentional diversion of controlled substances which occurred here. Because Respondent engaged in egregious misconduct which he has failed to fully acknowledge, his evidence of remedial measures cannot rebut the Government's
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Lon F. Alexander, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This Order is effective immediately.
| 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 |