Vol. 82 Thursday, No. 206 October 26, 2017
Pages 49485–49736
OFFICE OF THE FEDERAL REGISTER
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Contents Federal Register Vol. 82, No. 206
Thursday, October 26, 2017
Agricultural Marketing Service NOTICES RULES Agency Information Collection Activities; Proposals, Softwood Lumber Research, Promotion, Consumer Submissions, and Approvals, 49599–49600 Education and Industry Information Order: De Minimis Quantity Exemption Threshold, 49485–49492 Drug Enforcement Administration RULES Agriculture Department Schedules of Controlled Substances: See Agricultural Marketing Service Temporary Placement of ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Air Force Department Fentanyl into Schedule I, 49504–49508 NOTICES NOTICES Members of Performance Review Board, 49598–49599 Decisions and Orders: Harinder Takyar, M.D., 49665–49668 Architectural and Transportation Barriers Compliance Lon F. Alexander, M.D., 49704–49731 Board Yoon H. Choi, M.D., 49663–49665 Importer of Controlled Substances; Applications: NOTICES Galephar Pharmaceutical Research, Inc., 49663 Meetings, 49586
Centers for Disease Control and Prevention Education Department NOTICES NOTICES Meetings: Agency Information Collection Activities; Proposals, Advisory Board on Radiation and Worker Health, 49610– Submissions, and Approvals: 49611 School Data Collection and Reporting, 49602 Advisory Committee to Director; State, Tribal, Local and Territorial Subcommittee, 49611 Employment and Training Administration Advisory Council for Elimination of Tuberculosis, 49609 NOTICES Board of Scientific Counselors, Office of Infectious Meetings: Diseases, 49609–49610 Task Force on Apprenticeship Expansion, 49681–49682
Centers for Medicare & Medicaid Services Energy Department NOTICES See Federal Energy Regulatory Commission Agency Information Collection Activities; Proposals, Submissions, and Approvals, 49611–49612 Engineers Corps Coast Guard NOTICES Environmental Assessments; Availability, etc.: RULES Proposed Lower Pajaro River Flood Risk Management Drawbridge Operations: Project, Monterey and Santa Cruz Counties, CA, Atlantic Intracoastal Waterway, Indian River, Titusville, 49601 FL, 49510–49511 Souris River Basin Flood Risk Management Feasibility Snake Creek, Islamorada, FL, 49510 PROPOSED RULES Study, Ward County, ND, 49600–49601 Drawbridge Operations: Atlantic Intracoastal Waterway, St. Augustine, FL, 49550 Environmental Protection Agency NOTICES RULES Agency Information Collection Activities; Proposals, Air Quality State Implementation Plans; Approvals and Submissions, and Approvals, 49636–49642 Promulgations: Philadelphia; Control of Emissions from Existing Sewage Commerce Department Sludge Incineration Units, 49511–49512 See Foreign-Trade Zones Board Hazardous Waste Management System: See International Trade Administration Identification and Listing of Hazardous Waste, 49533– See National Institute of Standards and Technology 49538 See National Oceanic and Atmospheric Administration National Emission Standards for Hazardous Air Pollutants: Publicly Owned Treatment Works Residual Risk and Copyright Office, Library of Congress Technology Review, 49513–49533 PROPOSED RULES PROPOSED RULES Exemptions to Permit Circumvention of Access Controls on Air Quality State Implementation Plans; Approvals and Copyrighted Works, 49550–49563 Promulgations: Philadelphia; Control of Emissions from Existing Sewage Defense Department Sludge Incineration Units, 49563–49564 See Air Force Department Mercury; Reporting Requirements for Toxic Substances See Engineers Corps Control Act Mercury Inventory, 49564–49585
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NOTICES Midcontinent Independent System Operator, Inc., 49603– Meetings: 49604 Ozone Transport Commission and Mid-Atlantic Northeast South Central MCN, LLC, 49607 Visibility Union; 2017 Fall Joint Meeting, 49607– Transource Kansas, LLC, 49604 49608 Federal Railroad Administration Federal Aviation Administration NOTICES RULES Petitions for Waivers of Compliance: Airworthiness Directives: Association of American Railroads, 49696 Bombardier, Inc. Airplanes, 49498–49501 Canadian National Railway Co., 49697–49698 The Boeing Company Airplanes, 49494–49498 New Jersey Transit, 49698 Special Conditions: Old Augusta Railroad, 49696–49697 Boeing Model 777–300ER Airplanes; Passenger-Cabin High-Wall Suites, 49492–49494 Federal Reserve System NOTICES NOTICES Meetings: Agency Information Collection Activities; Proposals, Third RTCA SC–236 Joint Plenary with EUROCAE WG– Submissions, and Approvals, 49608–49609 96, 49695–49696 Food and Drug Administration Federal Communications Commission NOTICES NOTICES Debarment Orders: Agency Information Collection Activities; Proposals, Matthew Schroeder, 49634–49635 Submissions, and Approvals, 49608 Emergency Uses; Authorizations: In Vitro Diagnostic Devices for Detection of Zika Virus, Federal Emergency Management Agency 49612–49632 NOTICES Meetings: Emergency and Related Determinations: Pharmacy Compounding Advisory Committee, 49632– Louisiana, 49645 49634 Emergency Declarations: Louisiana; Amendment No. 2, 49651 Foreign Assets Control Office Puerto Rico; Amendment No. 1, 49652 NOTICES Puerto Rico; Amendment No. 2, 49645 Blocking or Unblocking of Persons and Properties, 49698– Flood Hazard Determinations, 49646–49647 49701 Flood Hazard Determinations; Changes, 49647–49649 Flood Hazard Determinations; Proposals, 49643–49644, Foreign-Trade Zones Board 49649–49651 NOTICES Major Disaster and Related Determinations: Subzone Applications: Wisconsin, 49651–49652 North American Hoganas Co., Foreign-Trade Zone 295, Major Disaster Declarations: Central Pennsylvania, 49586–49587 Puerto Rico; Amendment No. 3, 49645–49646 Puerto Rico; Amendment No. 5, 49646 Health and Human Services Department Wisconsin; Amendment No. 1, 49651 See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services Federal Energy Regulatory Commission See Food and Drug Administration RULES Policy Statements: Homeland Security Department Establishing License Terms for Hydroelectric Projects, See Coast Guard 49501–49504 See Federal Emergency Management Agency PROPOSED RULES See U.S. Customs and Border Protection Mandatory Reliability Standards: NOTICES Revised Critical Infrastructure Protection Reliability Binding Operational Directives, 49652 Standard CIP–003–7—Cyber Security—Security Management Controls, 49541–49549 Housing and Urban Development Department NOTICES NOTICES Combined Filings, 49602–49606 Statutorily Mandated Designation of Difficult Development Initial Market-Based Rate Filings Including Requests for Areas and Qualified Census Tracts: Blanket Section 204 Authorizations: Revision of Effective Date for 2015 Designations, 49653– Buchanan Energy Services Co., LLC, 49606–49607 49654 MS Solar 3, LLC, 49605 Institutions of Section 206 Proceedings and Refund Indian Affairs Bureau Effective Dates: NOTICES Midcontinent Independent System Operator, Inc., 49606 Indian Gaming: Institutions of Section 206 Proceedings: Tribal-State Class III Gaming Compact Taking Effect in Midwest Power Transmission Arkansas, LLC, 49605– State of New Mexico, 49654 49606 Refund Effective Dates: Interior Department ATX Southwest, LLC, 49604 See Indian Affairs Bureau Kanstar Transmission, LLC, 49607 See Land Management Bureau
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See National Park Service Legal Services Corporation See Ocean Energy Management Bureau NOTICES Funding Availability: Grant Awards for Provision of Civil Legal Services to Internal Revenue Service Eligible Low-Income Clients, 49686–49689 RULES Dividend Equivalents from Sources within United States: Correction, 49508–49510 Library of Congress PROPOSED RULES See Copyright Office, Library of Congress Revision of Regulations under Chapter 3 Regarding Withholding of Tax on Certain U.S. Source Income Mine Safety and Health Administration Paid to Foreign Persons: NOTICES Correction, 49549–49550 Petitions for Modifications: Applications of Existing Mandatory Safety Standards, 49683–49686 International Trade Administration NOTICES National Institute of Standards and Technology Antidumping or Countervailing Duty Investigations, Orders, NOTICES or Reviews: Meetings: Polytetrafluoroethylene Resin from India, 49592–49595 Judges Panel of Malcolm Baldrige National Quality Investigations of Sales at Less Than Fair Value: Award, 49595–49596 Polytetrafluoroethylene Resin from India and the People’s Republic of China, 49587–49592 National Oceanic and Atmospheric Administration RULES International Trade Commission Fisheries of the Exclusive Economic Zone Off Alaska: NOTICES Exchange of Flatfish in Bering Sea and Aleutian Islands Antidumping or Countervailing Duty Investigations, Orders, Management Area, 49539–49540 or Reviews: NOTICES Lined Paper School Supplies from China and India, Atlantic Highly Migratory Species: 49659–49660 Exempted Fishing, Scientific Research, Display, and Complaints: Shark Research Fishery Permits, 49596–49598 Certain Glucosylated Steviol Glycosides, and Products Containing Same, 49662–49663 National Park Service Investigations; Determinations, Modifications, and Rulings, NOTICES etc.: Agency Information Collection Activities; Proposals, Foundry coke from China, 49660–49661 Submissions, and Approvals: Tin- and Chromium-Coated Steel Sheet from Japan, Procedures for State, Tribal, and Local Government 49661–49662 Historic Preservation Programs, 49655–49656 National Register of Historic Places: Justice Department Pending Nominations and Related Actions, 49656–49658 See Drug Enforcement Administration See Justice Programs Office National Science Foundation NOTICES NOTICES Federal Law Protections for Religious Liberty, 49668–49680 Antarctic Conservation Act Permits, 49689–49690 Proposed Consent Decrees: Oil Pollution Act, 49680 Ocean Energy Management Bureau NOTICES Oil and Gas Lease Sales: Justice Programs Office Gulf of Mexico Outer Continental Shelf, 49659 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 49680–49681 Presidential Documents PROCLAMATIONS Special Observances: Labor Department Minority Enterprise Development Week (Proc. 9663), See Employment and Training Administration 49733–49736 See Mine Safety and Health Administration NOTICES Securities and Exchange Commission Meetings: NOTICES Preparations for UN Sub-Committee of Experts on Self-Regulatory Organizations; Proposed Rule Changes: Globally Harmonized System of Classification and New York Stock Exchange, LLC, 49690–49691 Labeling of Chemicals, 49682–49683 NYSE Arca, Inc., 49691
Land Management Bureau Social Security Administration NOTICES NOTICES Detailed Statements of Sales: Agency Information Collection Activities; Proposals, National Petroleum Reserve in Alaska 2017 Oil and Gas Submissions, and Approvals, 49694–49695 Lease Sale, 49655 Privacy Act; Computer Matching Programs, 49691–49694
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Surface Transportation Board Separate Parts In This Issue NOTICES Continuances in Control Exemptions: Savage Companies; Savage Davenport Railroad Co., 49695 Part II Justice Department, Drug Enforcement Administration, Transportation Department 49704–49731 See Federal Aviation Administration See Federal Railroad Administration Part III Treasury Department Presidential Documents, 49733–49736 See Foreign Assets Control Office See Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Reader Aids Submissions, and Approvals, 49701–49702 Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice U.S. Customs and Border Protection of recently enacted public laws. NOTICES To subscribe to the Federal Register Table of Contents Meetings: electronic mailing list, go to https://public.govdelivery.com/ Commercial Customs Operations Advisory Committee, accounts/USGPOOFR/subscriber/new, enter your e-mail 49642–49643 address, then follow the instructions to join, leave, or manage your subscription.
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CFR PARTS AFFECTED IN THIS ISSUE
A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.
3 CFR Proclamations: 9663...... 49735 7 CFR 1217...... 49485 14 CFR 25...... 49492 39 (2 documents) ...... 49494, 49498 18 CFR 4...... 49501 5...... 49501 16...... 49501 Proposed Rules: 40...... 49541 21 CFR 1308...... 49504 26 CFR 1...... 49508 Proposed Rules: 1...... 49549 33 CFR 117 (2 documents) ...... 49510 Proposed Rules: 117...... 49550 37 CFR Proposed Rules: 201...... 49550 40 CFR 62...... 49511 63...... 49513 261...... 49533 Proposed Rules: 62...... 49563 713...... 49564 50 CFR 679...... 49539
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Rules and Regulations Federal Register Vol. 82, No. 206
Thursday, October 26, 2017
This section of the FEDERAL REGISTER Executive Order 12866 and Executive obligation imposed in connection with contains regulatory documents having general Order 13563 an order, shall be filed within two years applicability and legal effect, most of which after the effective date of an order, are keyed to and codified in the Code of Executive Orders 12866 and 13563 direct agencies to assess all costs and provision, or obligation subject to Federal Regulations, which is published under challenge in the petition. The petitioner 50 titles pursuant to 44 U.S.C. 1510. benefits of available regulatory alternatives and, if regulation is will have the opportunity for a hearing The Code of Federal Regulations is sold by necessary, to select regulatory on the petition. Thereafter, USDA will the Superintendent of Documents. approaches that maximize net benefits issue a ruling on the petition. The 1996 (including potential economic, Act provides that the district court of environmental, public health and safety the United States for any district in DEPARTMENT OF AGRICULTURE which the petitioner resides or conducts effects, distributive impacts and equity). business shall have the jurisdiction to Executive Order 13563 emphasizes the Agricultural Marketing Service review a final ruling on the petition, if importance of quantifying both costs the petitioner files a complaint for that and benefits, reducing costs, 7 CFR Part 1217 purpose not later than 20 days after the harmonizing rules and promoting date of the entry of USDA’s final ruling. [Document Number AMS–SC–16–0066] flexibility. This action falls within a category of regulatory actions that the Background Softwood Lumber Research, Office of Management and Budget Promotion, Consumer Education and This rule establishes a de minimis (OMB) exempted from Executive Order Industry Information Order; De Minimis quantity exemption threshold under the 12866 review. Additionally, because Quantity Exemption Threshold Softwood Lumber Research, Promotion, this rule does not meet the definition of Consumer Education and Industry AGENCY: Agricultural Marketing Service, a significant regulatory action it does Information Order (Order), codified at 7 USDA. not trigger the requirements contained CFR part 1217. This part is administered ACTION: Final rule. in Executive Order 13771. See OMB’s by the Softwood Lumber Board (Board) Memorandum titled ‘‘Interim Guidance with oversight by USDA’s Agricultural SUMMARY: This rule establishes a de Implementing Section 2 of the Executive Marketing Service (AMS). In Resolute minimis quantity exemption threshold Order of January 30, 2017, titled Forest Products Inc., v. USDA, et al. under the U.S. Department of ‘Reducing Regulation and Controlling (Resolute), the court found that, on the Agriculture’s (USDA) Agricultural Regulatory Costs’ ’’ (February 2, 2017). basis of the estimates and information Marketing Service (AMS) regulations Executive Order 13175 submitted by the government to the regarding a national research and court for review, the selection of 15 promotion program for softwood This action has been reviewed in mmbf as the de minimis quantity (to be lumber. In response to a 2016 federal accordance with the requirements of exempted) under part 1217 was district court decision, the U.S. Executive Order 13175, Consultation arbitrary and capricious and that part Department of Agriculture (USDA) and Coordination with Indian Tribal 1217 was therefore promulgated conducted a new analysis to determine Governments. The review reveals that unlawfully. The court did not vacate (or a reasonable and appropriate de this rule will not have substantial and terminate) part 1217; the court minimis threshold. Based on that direct effects on Tribal governments and remanded the matter to USDA and analysis, this rule establishes the de will not have significant Tribal program requirements remain in effect. minimis quantity threshold at 15 implications. To address the court’s decision, million board feet (mmbf) and entities Executive Order 12988 USDA conducted a new analysis to manufacturing (and domestically determine a reasonable and appropriate shipping) or importing less than 15 This rule has been reviewed under de minimis quantity exemption. USDA mmbf per year will be exempt from Executive Order 12988, Civil Justice analyzed various thresholds of paying assessments under the Reform. It is not intended to have exemption: 10, 15, 20, 25, and 30 mmbf. regulations. retroactive effect. Section 524 of the USDA also considered proposing no de 1996 Act (7 U.S.C. 7423) provides that DATES: Effective Date: November 27, minimis exemption. USDA’s analysis of it shall not affect or preempt any other 2017. the data resulted in a determination that Federal or State law authorizing a de minimis level of 15 mmbf is FOR FURTHER INFORMATION CONTACT: promotion or research relating to an reasonable and appropriate. The Maureen T. Pello, Marketing Specialist, agricultural commodity. analysis was published in a proposed Promotion and Economics Division, Under section 519 of the 1996 Act (7 rule on May 30, 2017 (82 FR 24583). Specialty Crops Program, AMS, USDA, U.S.C. 7418), a person subject to an This final rule establishes the de P.O. Box 831, Beavercreek, Oregon, order may file a written petition with minimis quantity threshold under part 97004; telephone: (503) 632–8848; USDA stating that an order, any 1217 at 15 mmbf. facsimile (503) 632–8852; or electronic provision of an order, or any obligation mail: [email protected]. imposed in connection with an order, is Authority in the 1996 Act SUPPLEMENTARY INFORMATION: This rule, not established in accordance with the The 1996 Act authorizes USDA to affecting 7 CFR part 1217, is authorized law, and request a modification of an establish agricultural commodity under the Commodity Promotion, order or an exemption from an order. research and promotion orders which Research and Information Act of 1996 Any petition filed challenging an order, may include a combination of (1996 Act) (7 U.S.C. 7411–7425). any provision of an order, or any promotion, research, industry
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information, and consumer information turning) softwood logs into softwood Domestic manufacturers and importers activities funded by mandatory lumber. that ship or import less than the de assessments. These programs are Domestic manufacturers are minimis quantity of softwood lumber designed to maintain and expand essentially sawmills that turn softwood must apply to the Board each year for markets and uses for agricultural logs into lumber. A domestic a certificate of exemption and provide commodities. As defined under section manufacturer may be a company that is documentation as appropriate to 513(1)(D) of the 1996 Act, agricultural a single sawmill, or it may be a support their request. commodities include the products of company that is composed of multiple Pursuant to paragraph (b) of forestry, which includes softwood sawmills. § 1217.53, domestic manufacturers and importers that ship or import 15 mmbf lumber. Importers The 1996 Act provides for a number or more annually do not pay of optional provisions that allow the The term ‘importer’ is defined in assessments on their first 15 mmbf tailoring of orders for different § 1217.11 to mean any person who domestically shipped or imported. This commodities. Section 516 of the 1996 imports softwood lumber from outside exemption is intended for the purpose Act provides permissive terms for the United States for sale in the United of creating an equality amongst those orders. Section 516 states that an order States as a principal or as an agent, within the industry with regard to the may include an exemption of de broker, or consignee of any person who program’s assessment. Just as those that minimis quantities of an agricultural manufactures softwood lumber outside manufacture or import under 15 mmbf commodity. Further, section 516(g) of the United States for sale in the United do not have to pay assessments, those at the 1996 Act provides authority for States, and who is listed in the import or above this level may reduce their other action that is consistent with the records as the importer of record for assessable volume by 15 mmbf.1 For purpose of the statute and necessary to such softwood lumber. Import records example, an entity that ships or imports administer a program. are maintained by the U.S. Customs and 20 mmbf annually only has to pay Border Protection (Customs or CBP). assessments on 5 mmbf of softwood Overview of the Softwood Lumber Both domestic manufacturers and lumber. This exemption creates fairness; Program importers may be referred to in this it levels the playing field because all The softwood lumber program took rulemaking as ‘‘entities.’’ entities, regardless of size, do not have effect in August 2011 (76 FR 46185) and Expenses and Assessments to pay assessments on their first 15 assessment collection began in January mmbf shipped or imported. For 2012. Under part 1217, assessments are Pursuant to § 1217.50, the Board is purposes of this document, this collected from domestic (U.S.) authorized to incur expenses for exemption is referred to as the ‘‘equity manufacturers and importers and are research and promotion projects as well exemption.’’ Pursuant to paragraphs (c) used by the Board for projects that as administration. The Board’s expenses and (d) of § 1217.53, respectively, promote market growth for softwood are paid by assessments upon domestic exports of softwood lumber from the lumber products used in single and manufacturers and importers. Pursuant United States and organic softwood multi-family dwellings as well as to § 1217.52(b), and subject to the lumber are also exempt from commercial construction. The Board is exemptions specified in § 1217.53, each assessment. domestic manufacturer and importer composed of 19 industry members Reports and Records (domestic manufacturers and importers) must pay an assessment to the Board at Pursuant to § 1217.70, domestic who are appointed by the Secretary of the rate of $0.35 per thousand board feet manufacturers and importers who pay Agriculture. The purpose of the program of softwood lumber, except that no their assessments directly to the Board is to strengthen the position of softwood entity has to pay an assessment on the must submit with their payment a report lumber in the marketplace, maintain first 15 mmbf of softwood lumber that specifies the quantity of softwood and expand markets for softwood otherwise subject to assessment in a lumber domestically shipped or lumber, and develop new uses for fiscal year. Domestic manufacturers pay imported. Pursuant to § 1217.71, all softwood lumber within the United assessments based on the volume of domestic manufacturers and importers States. softwood lumber shipped within the United States and importers pay must maintain books and records Relevant Order Provisions assessments based on the volume of necessary to verify reports for a period of 2 years beyond the fiscal year to Domestic Manufacturers softwood lumber imported to the United States. Pursuant to paragraphs (d) and (j) which they apply, including those The term ‘domestic manufacturer’ is in § 1217.52, respectively, domestic exempt. These records must be made defined in § 1217.8 to mean any person manufacturers and importers who pay available during normal business hours who is a first handler engaged in the their assessments to the Board must do for inspection by Board staff or USDA. manufacturing, sale and shipment of so no later than the 30th calendar day Other Relevant Order Provisions softwood lumber in the United States of the month following the end of the during a fiscal period and who owns, or quarter in which the softwood lumber The original 15 mmbf quantity shares in the ownership and risk of loss was shipped or imported. exemption threshold is referenced in of manufacturing of softwood lumber or other Order provisions. Section 1217.40 a person who is engaged in the business Exemptions specifies that the Board is composed of of manufacturing, or causes to be Section 1217.53 prescribes domestic manufacturers and importers manufactured, sold and shipped such exemptions from assessment. Pursuant who domestically ship or import 15 softwood lumber in the United States to paragraph (a) of that section, the mmbf or more of softwood lumber beyond personal use. The term does not original de minimis quantity exemption annually. Section 1217.41 specifies that include persons who re-manufacture threshold under part 1217 was 15 mmbf. softwood lumber that has already been Thus, U.S. manufacturers and importers 1 USDA notes that the de minimis level and the that domestically ship and/or import equity exemption are purposefully aligned and any subject to assessment. The term change in the de minimis would result in a ‘manufacture’ is defined in § 1217.13 to less than 15 mmbf feet annually have corresponding modification to the equity mean the process of transforming (or been exempt from paying assessments. exemption.
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persons interested in serving on the which includes continuing education a viable program; free rider Board must also domestically ship or courses for architects and engineers; and implications; and the impact of program import 15 mmbf or more softwood a construction and design program that requirements on entities (above and lumber annually. Finally, § 1217.101 provides technical support to architects below a de minimis threshold). USDA regarding referendum procedures and structural engineers about using reviewed such factors in light of all specifies that eligible domestic wood. available data and information to manufacturers and importers that can determine whether a de minimis Summary of USDA’s Analysis of the De vote in referenda must domestically Minimis Quantity Under the Softwood quantity is reasonable. USDA balanced ship or import 15 mmbf or more of Lumber Program the multiple factors to assess whether softwood lumber annually. one exemption threshold would work The Secretary has authority under better than another when the factors are Initial Referendum and Summary of section 516 of the 1996 Act to exempt Board Activities considered collectively. The analysis any de minimis quantity of an was based on the current assessment The softwood lumber program was agricultural commodity otherwise rate of $0.35 per thousand board feet.2 implemented after notice and comment covered by an order: ‘‘An order issued rulemaking and a May 2011 referendum under this subchapter may contain . . . The following tables are republished demonstrating strong support for the authority for the Secretary to exempt from USDA’s analysis of the de minimis program. Pursuant to § 1217.81(a), the from the order any de minimis quantity quantity under the softwood lumber program had to pass by a majority of of an agricultural commodity otherwise program contained in the May 2017 those voting in the referendum who also covered by the order. . . .’’ 7 U.S.C. proposed rule (82 FR 24583). represented a majority of the volume 7415(a). A de minimis quantity Table 1 shows the estimate of the voted. Sixty-seven percent of the exemption allows an industry to exempt supply of U.S. softwood lumber used in entities who voted, who together from assessment small entities that the analysis, accounting for both U.S. represented 80 percent of the volume, in could be unduly burdened from an shipments and imports. U.S. shipments the referendum favored implementation order’s requirements (i.e., assessment were estimated using capacity3 data of the program. Entities that and quarterly reporting obligations). from Forest Economic Advisors (FEA). domestically shipped or imported 15 Because the 1996 Act does not prescribe Total imports was estimated using data mmbf or more of softwood lumber the methodology or formula for from CBP. annually were eligible to vote in the computing a de minimis quantity, the referendum. As previously mentioned, Secretary has discretion to determine a TABLE 1—SUPPLY OF SOFTWOOD the program took effect in August 2011 reasonable and appropriate quantity and LUMBER IN THE U.S. (MMBF) and assessment collection began in establish this level through notice and January 2012. comment rulemaking. Pursuant to Shipments 1 Imports 2 Supply 3 The softwood lumber program has section 525 of the 1996 Act, 7 U.S.C. continued to operate at the 15 mmbf 7424, the Secretary may issue such 28,754 ...... 12,495 41,249 exemption threshold since its inception. regulations as may be necessary to carry 1 FEA; 2 CBP; 3 The sum of U.S. Shipments During these years, the Board has out an order. and Imports. funded a variety of activities designed to In evaluating the merits of a de increase the demand for softwood minimis quantity for the softwood Table 2 shows assessable volume and lumber. The Board funded a U.S. Tall lumber program, USDA considered revenue at exemption levels of 30, 25, Wood Building Prize Competition that several factors. These factors include: an 20, 15 and 10 mmbf, as well as with no is helping to showcase the benefits of estimate of the total quantity of exemptions. The table accounts for both building tall structures with wood. The softwood lumber covered under part the de minimis and equity exemptions Board also funds research on wood 1217 (quantity assessed and quantity under part 1217, and an assessment rate standards; a communications program, exempted); available funding to support of $0.35 per thousand board feet.
TABLE 2—ASSESSABLE VOLUME AND ASSESSMENT REVENUE AT EXEMPTION LEVELS (MMBF) 1
De minimis De minimis Assessment Volume equal to or greater than exemption and equity revenue only exemptions ($) 2
30 ...... 37,965 32,805 $11,481,698 25 ...... 38,319 33,694 11,792,941 20 ...... 38,990 34,690 12,141,349 15 ...... 39,679 35,854 12,548,792 10 ...... 40,013 37,183 13,014,059 No exemptions ...... 41,249 41,249 14,437,099 1 2015 data from FEA and CBP were used to construct this table. 2 The product of total assessable volume, accounting for both de minimis and equity exemptions, and the assessment rate of $0.35 per thou- sand board feet.
2 If the assessment rate changes significantly, 3 A sawmill’s operating capacity is the total manufacture (or produce) if fully utilizing all of its USDA could revisit the de minimis threshold. amount of softwood lumber that it could resources (such as labor and equipment).
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Table 3 is the inverse of Table 2 in minimis and equity exemptions of 30, that it shows exempt volume at de 25, 20, 15 and 10 mmbf.
TABLE 3—EXEMPT VOLUME AT EXEMPTION LEVELS (MMBF) 1
De minimis exemption only De minimis and equity Volume less than exemptions Volume % Exempt 2 Volume % Exempt 2
30 ...... 3,284 8 8,444 20 25 ...... 2,930 7 7,555 18 20 ...... 2,259 5 6,559 16 15 ...... 1,570 4 5,395 13 10 ...... 1,236 3 4,066 10 1 2015 data from FEA and CBP were used to construct this table. 2 The quotient of total exempt volume and total 2015 U.S. supply (the sum of U.S. shipments and U.S. imports) of 41,249 MMBF.
Table 4 shows the number of entities that would be assessed and the number exemption thresholds of 30, 25, 20, 15 (domestic manufacturers and importers) of entities that would be exempt at the and 10 mmbf.
TABLE 4—ASSESSED AND EXEMPT ENTITIES AT EXEMPTION LEVELS (MMBF) 1
Assessed Exempt Volume (MMBF) Number of 2 Number of 2 entities % Assessed entities % Exempt
30 ...... 172 16 882 84 25 ...... 185 18 869 82 20 ...... 215 20 839 80 15 ...... 255 24 799 76 10 ...... 283 26 771 73 None ...... 1,054 100 ...... 0 1 2015 data from FEA and CBP were used to construct this table. 2 The quotient of No. of Entities and total domestic manufacturers and importers recorded in the industry (1,054) in 2015.
Based on its analysis, USDA for tall wood buildings, research on 612), AMS is required to examine the determined the following: Exemption wood standards, and an education impact of this final rule on small thresholds of 10 to 15 mmbf would program for architects and engineers on entities as defined by the Small exempt 10 to 13 percent of the total building with wood. An independent Business Administration (SBA). The volume of softwood lumber (taking into evaluation completed in 2016 classification of a business as small, as account both the de minimis and equity concluded that activities of the Board defined by the SBA, varies by industry. exemptions). This is close to the range increased sales of softwood lumber If a business is defined as ‘‘small’’ by exempt under other research and between 2011 and 2015 by 1.683 bbf or SBA size standards, then it is ‘‘eligible promotion programs. While all of the $596 million. This equates to a return for government programs and exemption thresholds analyzed would on investment of $15.55 of additional preferences reserved for ‘small business’ generate sufficient revenue for a viable sales for every $1 spent on promotion by concerns.’’ 6 Accordingly, AMS has program, the additional revenue that the Board.4 considered the economic impact of this could be collected if the de minimis Therefore, when considering all of the action on such entities. level were reduced much lower than 15 factors collectively, USDA concludes The purpose of the RFA is to fit mmbf would likely not be worth the that 15 mmbf is a reasonable and most regulatory actions to the scale of additional costs. At this threshold, free appropriate de minimis quantity under businesses subject to such actions so 5 rider implications would be minimal part 1217. Accordingly, this rule that small businesses will not be because only 4 percent of the volume of establishes the de minimis quantity disproportionately burdened. The SBA softwood lumber would be exempted as threshold under part 1217 at 15 mmbf. defines, in 13 CFR part 121, small de minimis. Applying both the de Thus, no amendment to part 1217 is agricultural producers as those having minimis and equity exemptions at 15 necessary. annual receipts of no more than mmbf would allow the program to Final Regulatory Flexibility Act $750,000 and small agricultural service assess almost 90 percent of the total Analysis firms (domestic manufacturers and volume of softwood lumber. importers) as those having annual In accordance with the Regulatory receipts of no more than $7.5 million.7 Further, the program functioned Flexibility Act (RFA) (5 U.S.C. 601– successfully in 2015 with assessment 6 https://www.sba.gov/contracting/getting-started- revenue of $12.905 million with de 4 Prime Consulting, Softwood Lumber Board, contractor/make-sure-you-meet-sba-size-standards/ minimis and equity exemptions of 15 Comprehensive Program ROI, 2012–2015, February small-business-size-regulations. mmbf. The Board has conducted 2016. 7 SBA does have a small business size standard 5 As stated previously, the de minimis level and for ‘‘Sawmills’’ of 500 employees (see https:// activities at this level of funding that the equity exemption are purposefully aligned, and www.sba.gov/sites/default/files/files/Size_ have helped build demand for softwood therefore this conclusion accounts for the equity Standards_Table.pdf). Based on USDA’s lumber, including a prize competition exemption at 15 mmbf. understanding of the lumber industry, using this
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Using an average price of $330 per equal to the RFA-small business a threshold of 10 mmbf, a total of 37.183 thousand board feet,8 a domestic definition of 23 mmbf, would only pay bbf would be assessed, with 1.236 bbf, manufacturer or importer who ships less assessments on no more than 8 mmbf of or 3 percent, exempt as de minimis, than about 23 mmbf per year would be softwood lumber. plus an additional 2.83 bbf exempt as considered a small entity for purposes To calculate the impact of the equity for 10 percent total volume of the RFA. As shown in Table 4, there assessment rate on the revenue of an exempt; and with no exemptions, a total were 1,054 domestic manufacturers and assessment payer, the assessment rate is of 41.249 bbf would be assessed. In importers of softwood lumber based on divided by an average price. Using an reviewing the total volume exempt 2015 data. Of these, 864 entities shipped average 2015 price of $330 per thousand under the softwood lumber program or imported less than 23 mmbf and board feet, the assessment rate as a (taking into account both the de would be considered to be small entities percentage of price could range from minimis and equity exemptions), under the SBA definition. Thus, based 0.106 percent at the current assessment thresholds of 10 to 15 mmbf exempt on the $7.5 million threshold, the rate to 0.151 percent at the maximum between 10 and 13 percent of the majority of domestic manufacturers and assessment rate. This analysis helps volume, which is close to the range importers of softwood lumber would be identify the impact of the assessment exempt under other programs. considered small entities for purposes of rate on the revenues of assessment In reviewing available funding to the RFA. payers. At the current assessment rate of support a viable program at the This action establishes a de minimis $0.35 per thousand board feet to the alternative exemption thresholds, at an quantity exemption threshold under maximum assessment rate of $0.50 per exemption threshold of 30 mmbf, part 1217. Part 1217 is administered by thousand board feet, assessment payers estimated assessment revenue is the Board with oversight by USDA. In would owe between 0.106 percent and $11.482 million; at 25 mmbf, estimated response to a federal district court 0.151 percent of their revenues, assessment revenue is $11.793 million decision in Resolute, USDA conducted respectively. (an additional $311,243); at a threshold a new analysis to determine a In its analysis of alternatives, USDA of 20 mmbf, estimated assessment reasonable and appropriate de minimis evaluated five different exemption revenue is $12.141 million (an threshold. Based on this analysis, this thresholds—30, 25, 20, 15 and 10 mmbf additional $348,408); at a threshold of final rule establishes the de minimis using 2015 data—accounting for both 15 mmbf, estimated assessment revenue quantity threshold at 15 mmbf and the de minimis and equity exemptions, is $12.549 million (an additional entities manufacturing (and as well as having no exemptions under $407,444); at a threshold of 10 mmbf, domestically shipping) or importing less the program. USDA evaluated these estimated assessment revenue is than 15 mmbf per year would be exempt alternatives based on the following $13.014 million (an additional from paying assessments under part factors: an estimate of quantity of $465,267); and with no exemptions, 1217. Authority for this action is softwood lumber covered under the estimated assessment revenue is provided in sections 516(a)(2), 516(g) program (quantity assessed and quantity $14.437 million (an additional $1.423 and 525 of the 1996 Act. exempted); available funding to support million). Regarding the economic impact of the a viable program; free rider Assessment revenue under the current de minimis exemption, the exemption implications; and the impact of program softwood lumber program has ranged allows the Board to exempt from requirements on entities (above and from about $10.638 million in 2012 to assessment small entities that would be below a de minimis threshold). USDA $12.905 million in 2015. At this level of unduly burdened by the program’s conducted a balancing test among these revenue, the current program has seen obligations. At the 15 mmbf exemption factors to assess whether one exemption success. The revenues reviewed at the threshold, small manufacturers and threshold works better than another different exemption thresholds are importers that domestically ship or when the factors are considered comparable to these levels or higher. import less than 15 mmbf of softwood collectively. Thus, all of the exemption thresholds lumber will not have to pay assessments In reviewing the quantity of analyzed would generate sufficient under the program. assessable versus exempt softwood revenue for a viable program. Additionally, larger manufacturers lumber at the alternative exemption Regarding free riders, USDA notes and importers will not have to pay thresholds, USDA found that at an that the key to assessing the free rider assessments on the first 15 mmbf of exemption threshold of 30 mmbf, a total implications of a de minimis quantity is softwood lumber domestically shipped of 32.805 bbf would be assessed with not the number of entities exempt under or imported each year. This exemption 3.284 bbf, or 8 percent, exempt as de a program but rather the volume of is intended for the purpose of equity, minimis, plus an additional 5.16 bbf product exempt. This is because whereby all entities who must pay exempt as equity for 20 percent of total assessments are based on volume assessments may reduce their assessable volume exempt; at 25 mmbf, a total of shipped or imported and not on the volume by 15 mmbf. This exemption 33.694 bbf would be assessed with 2.93 number of entities; assessments are not benefits smaller manufacturers and bbf, or 7 percent, exempt as de minimis, paid by entities on a pro rata basis. In importers whose annual shipments or plus an additional 4.625 bbf exempt as evaluating free rider implications at the imports are above the de minimis equity for 18 percent total volume alternative exemption thresholds, at an threshold of 15 mmbf. With this exempt; at a threshold of 20 mmbf, a exemption threshold of 30 mmbf, 84 exemption, an entity that ships or total of 34.69 bbf would be assessed percent of the number of entities (or imports a quantity of softwood lumber with 2.259 bbf, or 5 percent, exempt as 882) would be exempt but only 8 de minimis, plus an additional 4.3 bbf percent of the volume would be exempt criteria would be impractical as sawmills often use exempt as equity for 16 percent total as de minimis; at a threshold of 25 contractors rather than employees to operate and, volume exempt; at a threshold of 15 mmbf, 82 percent of the number of therefore, many mills would fall under this criteria mmbf, a total of 35.854 bbf would be entities (or 869) would be exempt, but while being, in reality, a large business. Therefore, assessed with 1.57 bbf, or 4 percent, only 7 percent of the volume would be USDA used agricultural service firm as a more appropriate criteria for this analysis. exempt as de minimis, plus an exempt as de minimis; at a threshold of 8 Random Lengths Publications, Inc.; additional 3.825 bbf exempt as equity 20 mmbf, 80 percent of the number of www.randomlengths.com. for 13 percent total volume exempt; at entities (or 839) would be exempt, but
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only 5 percent of the volume would be 14.3 mmbf.9 This level is close to 15 provide documentation as appropriate exempt as de minimis; at a threshold of mmbf. By this analysis, the selection of to support their request. The reporting 15 mmbf, 76 percent of the number of 15 mmbf as the de minimis quantity is burden for this collection of information entities (or 799) would be exempt, but reasonable. is estimated to average 0.25 hours per only 4 percent of the volume would be Analysis of the 23 mmbf–RFA small domestic manufacturer or importer per exempt as de minimis; and at a business threshold as a reasonable report, or 0.25 hours per year (1 request threshold of 10 mmbf, 73 percent of the option for de minimis shows that 190 per year per exempt entity). This number of entities (or 771) would be entities would be subject to assessment computes to a total annual burden of exempt, but only 3 percent of the and 864 entities would be exempt. In 199.75 hours (0.25 hours times 799 volume would be exempt as de minimis. terms of volume, 38.44 bbf would be exempt entities at the 15 mmbf de assessed, or 93 percent of total volume, minimis exemption threshold from In evaluating the impact of the and 2.809 bbf would be exempt, or 7 Table 4). program’s requirements at the percent of total volume. Further, pursuant to § 1217.70, alternative exemption thresholds, Based upon the analysis contained domestic manufacturers and importers entities that ship or import at or above herein, any of the exemption thresholds that ship or import at or over the de the de minimis threshold must pay reviewed would be reasonable because minimis exemption level and pay their assessments to the Board. Assessment they would exempt from 3 to 8 percent assessments directly to the Board must payers must also submit a report to the of the volume of softwood lumber as de submit a shipment/import report for Board each quarter of the volume of minimis. However, when the total each quarter when assessments are due. softwood lumber shipped or imported volume exempt under the softwood The reporting burden for this collection for the respective quarter. Entities that lumber program is considered (taking of information is estimated to average ship or import below the de minimis into account both the de minimis and 0.5 hours per domestic manufacturer or threshold must apply to the Board each equity exemptions), thresholds of 10 to importer per report, or 2 hours per year year for a certificate of exemption and 15 mmbf exempt between 10 and 13 (4 reports per year times 0.5 hours per provide documentation as appropriate percent of the volume, which is close to report). This computes to a total annual to support their request. The reporting the range exempt under other programs. burden of 510 hours (255 assessed and recordkeeping requirements are While all of the exemption thresholds entities (from Table 4—No. of Assessed detailed in the section below titled analyzed would generate sufficient Entities at 15 mmbf) at 2 hours each Paperwork Reduction Act. revenue for a viable program, the equals 510 hours). additional revenue that could be All domestic manufacturers and At an exemption threshold of 30 importers must also maintain records mmbf, 172 entities would pay collected if the de minimis level were reduced much lower than 15 mmbf sufficient to verify their reports. The assessments and 882 would be exempt; recordkeeping burden for keeping this at 25 mmbf, 185 entities would pay would likely not be worth the additional costs. The softwood lumber program information is estimated to average 0.5 assessments and 869 would be exempt; hours per record keeper maintaining at 20 mmbf, 215 entities would pay operated successfully since its inception at an exemption threshold of 15 mmbf.10 such records, or 527 hours (1,054 total assessments and 839 would be exempt; entities assessed (from Table 4—No. of at 15 mmbf, 255 entities would pay Paperwork Reduction Act Assessed Entities at no exemption) assessments and 799 would be exempt; In accordance with the Paperwork times 0.5 hours). at 10 mmbf, 283 entities would pay Reduction Act of 1995 (44 U.S.C. As with all Federal promotion assessments and 771 would be exempt. Chapter 35), the information collection programs, reports and forms are Thus, as the exemption threshold is and recordkeeping requirements periodically reviewed to reduce reduced, more entities would be subject imposed by part 1217 have been information requirements and to the assessment and quarterly approved previously under OMB duplication by industry and public reporting obligation under part 1217. control number 0581–0093. This rule sector agencies. Finally, USDA has not Further, in considering program imposes no additional reporting and identified any relevant Federal rules compliance costs, USDA estimates the recordkeeping burden on domestic that duplicate, overlap, or conflict with cost of an on-site audit of a single entity manufacturer and importers of softwood this rule. at $5,000 or more. Thus, the cost to lumber. The reporting requirements USDA is committed to complying with the E-Government Act, to promote pursue a compliance case against an pertaining to this rule are described in the use of the internet and other entity that shipped less than 10 mmbf, the following paragraphs. information technologies to provide 9 mmbf for example, would outweigh As previously mentioned, pursuant to increased opportunities for citizen the revenue that would be collected § 1217.53(a), domestic manufacturers access to Government information and from that entity of $3,150. Similarly, the and importers who domestically ship or import less than the de minimis services, and for other purposes. assessment revenue that would be Regarding outreach efforts, USDA collected from an entity that shipped threshold must apply to the Board each year for a certificate of exemption and initiated this action in response to a less than 15 mmbf, 12 mmbf for May 2016 federal court decision in example, would amount to $4,200. The 9 Resolute. This rule establishes the de benefit of assessing smaller This figure is computed by dividing the estimated cost to pursue a compliance case against minimis quantity exemption under part manufacturers, $3,150 at 9 mmbf and an entity of $5,000 by the assessment rate of $0.35 1217. $4,200 at 12 mmbf, does not outweigh per thousand board feet. A proposed rule concerning this 10 the cost of pursuing compliance cases An independent evaluation of the softwood action was published in the Federal against them at $5,000 per entity. The lumber program showed that the activities of the Board increased sales of softwood lumber between Register on May 30, 2017 (82 FR 24583). point at which the assessment revenue 2011 and 2015 by 1.683 bbf or $596 million. This The Board distributed copies of the that would be collected from an entity equates to a return on investment of $15.55 of proposed rule via email to domestic outweighs the estimated cost of $5,000 additional sales for every $1 spent on promotion by manufacturers and importers. The to pursue a compliance case is an entity the Board. By this metric, part 1217 to date has been effective. USDA therefore finds that 15 mmbf is a proposal was also made available with volume equal to or greater than reasonable exemption level for de minimis. through the internet by USDA and the
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Office of the Federal Register. A 60-day analyzed, the 10 and 15 mmbf have to pay assessments on their first 15 comment period ending July 31, 2017, thresholds came closest to this range. mmbf shipped. Without the equity was provided to allow interested The commenter stated that USDA also exemption, assessment payers would persons to submit comments. compared the benefits derived from pay more, thereby increasing the free these thresholds with the likely rider impact.11 Analysis of Comments compliance costs incurred, which Two commenters discussed the efforts Thirty-three comments were received USDA estimated at $5,000 per entity. of the Blue Ribbon Commission (BRC), in response to the proposed rule. Of The point at which revenues collected the proponent group, in promulgating those 33 comments, one was outside the from entities that would fall below the the program. They stated that the BRC scope of the rulemaking and the compliance cost was found to be at 14.3 surveyed the industry on issues related remaining 32 supported the 15 mmbf mmbf, which is closest to the 15 mmbf to the program, including the de exemption threshold. The following is threshold. The combination of these minimis exemption threshold. They an analysis of those 32 comments. results led USDA to conclude that 15 stated that the BRC sought a level that Several commenters reiterated the mmbf is the most appropriate would generate maximum revenue for data presented in the proposed rule. benchmark between volumes assessed the program while being mindful of the They cited Table 3 which shows that, at and not assessed. The commenter cost of administering the program and the 15 mmbf threshold, entities that pay concluded that, ‘‘. . . while there is no collecting assessments. The BRC’s into the program account for 96 percent special formula for computing a de survey found that 15 mmbf was the of the U.S. softwood lumber market minimis threshold . . . ,’’ the appropriate level that was broadly volume. Thus, free rider concerns are commenter believes that USDA selected accepted by the industry. minimal. Reducing the exemption level a reasonable exemption amount based Several commenters also expressed by a third (down to 10 mmbf) would on the industry’s structure and the their overall support for the softwood only increase that number to 97 percent program’s benefits and costs. lumber program. They agreed that the of the U.S. market and would not be Six commenters opined that the 15 program provides a strong, unified voice worth the additional effort. There are a mmbf threshold appropriately separates for the industry. One commenter stated large number of small manufacturers the high production manufacturers from that the program has contributed and importers who account for a small small entities that manufacture specialty significantly to strengthening the percentage of the softwood lumber products and sell into mostly local and position of softwood lumber in the shipped in the United States. The niche markets. They agreed that market place as well as expanding and commenters opined that the cost of specialty products do not benefit as developing new markets for softwood collecting an assessment from such a much from a national promotion lumber. The commenters also agreed large number of entities outweighs the program, and that growth in market that funding for the program has been revenue that could be collected from share benefits entities that manufacture appropriate since assessment collection such a small amount of volume. They larger volumes to a greater degree than began in 2012. None of the commenters agreed that Board staff time would be those that fall below the 15 mmbf supported increasing the exemption better spent on promotion activities threshold. threshold thereby reducing funding for than trying to collect a small amount of Several commenters expressed the program. revenue from several small entities. concern with the administrative burden No changes have been made to the One commenter opined that the that complying with a mandatory proposed rule based on the comments methodology used by USDA to promotion program could place on received. determine the de minimis threshold was small entities below the 15 mmbf After consideration of all relevant comprehensive and explored tradeoffs threshold. One commenter stated that, matters presented, including the involved in setting a threshold below on a per board foot ratio, the costs to available information and comments which it is counterproductive to the participate in the program are lower for received, it is hereby found that this collection of assessments to further the larger entities than smaller entities. rule, is consistent with and will program. The commenter stated that Many small entities still record their effectuate the purposes of the 1996 Act. ‘‘. . . USDA dealt with a large amount shipments by hand. Larger entities, on List of Subjects in 7 CFR Part 1217 of data on imports that it appropriately the other hand, can afford to invest in scrubbed to exclude obvious errors and automated computer reporting systems Administrative practice and outliers.’’ Within the populations of and can have personnel dedicated to procedure, Advertising, Consumer domestic manufacturers and importers efficiently analyzing their reporting. information, Marketing agreements, categorized based on volume, USDA Thus, the administrative costs for Promotion, Reporting and conducted a series of ‘‘what if’’ analyses smaller entities to participate in the recordkeeping requirements, Softwood to determine the impact of various de program are higher than the costs for lumber. minimis levels on revenue in terms of larger entities. ‘‘. . . administrative costs, the Two commenters also referenced the 11 For example, as explained in the May 2017 proposed rule, if the thresholds for de minimis and compliance burden on respondents and part’s 8 percent cap on administrative equity exemptions were 10 mmbf, Company A that the potential for ‘‘free rider’’ benefits.’’ expenses. They opined that the revenue ships 8 mmbf annually would pay no assessments, The commenter also observed that gained from collecting assessments from and Company B that ships 30 mmbf annually would USDA compared the results to other have to pay assessments on 20 mmbf of softwood numerous small entities would not be lumber. At an assessment rate of $0.35 per thousand federal promotion programs authorized sufficient to justify the additional costs board feet, this would compute to $7,000 in under the 1996 Act and overseen by and administrative complexities. assessments. Without the equity exemption, USDA where it found that 8 of 10 Three commenters expressed support Company A would still pay no assessments but Company B would have to pay assessments on 30 programs exempt a de minimis quantity for the equity exemption. They opined mmbf. This would compute to $10,500 in from assessment, and that half of those that the equity exemption makes the assessments, which is an additional burden of programs exempt between 3 and 11 program fair for everyone. One $3,500. Thus, the equity exemption reduces the percent of the total quantity covered by commenter opined that the equity burden of free riders on entities funding the program. It creates fairness because it exempts from the program as de minimis. Among the exemption mitigates the free rider assessment an equal volume from all entities, range of alternatives that USDA problem because larger entities do not regardless of their size.
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The authority citation for 7 CFR part Privacy: The FAA will post all recommended change, and include 1217 continues to read as follows: comments it receives, without change, supporting data. Authority: 7 U.S.C. 7411–7425; 7 U.S.C. to http://www.regulations.gov/, We will consider all comments we 7401. including any personal information the receive by the closing date for commenter provides. Using the search comments. We may change these special Dated: October 19, 2017. function of the docket Web site, anyone conditions based on the comments we Bruce Summers, can find and read the electronic form of receive. Acting Administrator. all comments received into any FAA [FR Doc. 2017–23094 Filed 10–25–17; 8:45 am] docket, including the name of the Background BILLING CODE 3410–02–P individual sending the comment (or On December 19, 2014, Boeing signing the comment for an association, applied for a type certificate design business, labor union, etc.). DOT’s change to Type Certificate (TC) No. DEPARTMENT OF TRANSPORTATION complete Privacy Act Statement can be T00001SE to install high-wall suites in found in the Federal Register published the passenger compartment of Boeing Federal Aviation Administration on April 11, 2000 (65 FR 19477–19478). Model 777–300ER airplanes. Docket: Background documents or The Model 777 series airplane is a 14 CFR Part 25 comments received may be read at swept-wing, conventional-tail, twin- engine, turbofan- powered, transport- [Docket No. FAA–2017–0862; Special http://www.regulations.gov/ at any time. Conditions No. 25–703–SC] Follow the online instructions for category airplane. The airplane has accessing the docket or go to Docket seating for 365 passengers and a Special Conditions: Boeing Model 777– Operations in Room W12–140 of the maximum takeoff weight of 775,000 300ER Airplanes; Passenger-Cabin West Building Ground Floor at 1200 pounds. High-Wall Suites New Jersey Avenue SE., Washington, Type Certification Basis DC, between 9 a.m. and 5 p.m., Monday AGENCY: Federal Aviation through Friday, except Federal holidays. Under the provisions of title 14, Code Administration (FAA), DOT. of Federal Regulations (14 CFR) 21.101, FOR FURTHER INFORMATION CONTACT: John ACTION: Final special conditions; request Boeing must show that the Model 777– Shelden, Airframe and Cabin Safety for comments. 300ER airplane, as changed, continues Section, AIR–675, Transport Standards to meet the applicable provisions of the SUMMARY: These special conditions are Branch, Policy and Innovation Division, regulations listed in Type Certificate No. issued for Boeing Model 777–300ER Aircraft Certification Service, 1601 Lind T00001SE or the applicable regulations airplanes with high-wall suites installed Avenue SW., Renton, Washington in effect on the date of application for in the passenger cabin. This installation 98057–3356; telephone 425–227–2785; the change, except for earlier is novel or unusual, and the applicable facsimile 425–227–1232; email amendments as agreed upon by the airworthiness regulations do not contain [email protected]. FAA. adequate or appropriate safety standards SUPPLEMENTARY INFORMATION: The If the Administrator finds that the for this interior configuration. These substance of these special conditions applicable airworthiness regulations special conditions contain the has been subject to the notice and (i.e., 14 CFR part 25) do not contain additional safety standards that the comment period in several prior adequate or appropriate safety standards Administrator considers necessary to instances and has been derived without for the Boeing Model 777–300ER establish a level of safety equivalent to substantive change from those airplane because of a novel or unusual that established by the existing previously issued. It is unlikely that design feature, special conditions are airworthiness standards. prior public comment would result in a prescribed under the provisions of DATES: This action is effective on Boeing significant change from the substance § 21.16. on October 26, 2017. Send your contained herein. Therefore, because a Special conditions are initially comments by December 11, 2017. delay would significantly affect the applicable to the model for which they ADDRESSES: Send comments identified certification of the airplane, the FAA are issued. Should the type certificate by docket number FAA–2017–0862 has determined that prior public notice for that model be amended later to using any of the following methods: and comment are unnecessary and include any other model that D Federal eRegulations Portal: Go to impracticable. incorporates the same novel or unusual http://www.regulations.gov/ and follow In addition, since the substance of design feature, or should any other the online instructions for sending your these special conditions has been model already included on the same comments electronically. subject to the public comment process type certificate be modified to D Mail: Send comments to Docket in several prior instances with no incorporate the same novel or unusual Operations, M–30, U.S. Department of substantive comments received, the design feature, these special conditions Transportation (DOT), 1200 New Jersey FAA finds it unnecessary to delay the would also apply to the other model Avenue SE., Room W12–140, West effective date and finds that good cause under § 21.101. Building Ground Floor, Washington, DC exists for adopting these special In addition to the applicable 20590–0001. conditions upon publication in the airworthiness regulations and special D Hand Delivery or Courier: Take Federal Register. conditions, the Boeing Model 777– 300ER airplane must comply with the comments to Docket Operations in Comments Invited Room W12–140 of the West Building fuel-vent and exhaust-emission Ground Floor at 1200 New Jersey We invite interested people to take requirements of 14 CFR part 34, and the Avenue SE., Washington, DC, between 9 part in this rulemaking by sending noise-certification requirements of 14 a.m. and 5 p.m., Monday through written comments, data, or views. The CFR part 36. Friday, except Federal holidays. most helpful comments reference a The FAA issues special conditions, as D Fax: Fax comments to Docket specific portion of the special defined in 14 CFR 11.19, in accordance Operations at 202–493–2251. conditions, explain the reason for any with § 11.38, and they become part of
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the type-certification basis under List of Subjects in 14 CFR Part 25 other suitable means requiring that § 21.101. Aircraft, Aviation safety, Reporting crewmembers be trained in the suite and recordkeeping requirements. passenger-management procedures. Novel or Unusual Design Features b. Approved procedures describing The authority citation for these methods for suite passenger The Boeing Model 777–300ER special conditions is as follows: airplane will incorporate the following management must be established. These novel or unusual design features: Authority: 49 U.S.C. 106(g), 40113, 44701, procedures must be transmitted to the 44702, 44704. A passenger cabin with six high-wall operator for incorporation into its suites arranged in two rows of three The Special Conditions training programs and appropriate operational manuals. suites each. Accordingly, pursuant to the 4. The design of each suite, and the authority delegated to me by the Discussion location of the firefighting equipment Administrator, the following special where suites are installed, must allow The Boeing Model 777–300ER conditions are issued as part of the type the crewmembers to conduct effective airplane will include, as a customer certification basis for Boeing Model firefighting in the suite. For a manual, option, a passenger cabin with six high- 777–300ER airplanes. wall suites arranged in two rows of Note: In these special conditions, hand-held extinguishing system three suites each, in a 1–1–1 ‘‘suite’’ means high-wall suite. (designed as the sole means to fight a configuration. The suites have doors 1. Where suites are installed, a fire) for the suite: and walls that are taller than has been supplemental oxygen system must a. A limitation must be included in previously certified by the FAA on provide the following: the AFM or other suitable means Boeing 777 series airplanes. The walls a. The supplemental oxygen system requiring that crewmembers be trained extend from the floor to the ceiling or for each suite must include a minimum in the firefighting procedures. close to the ceiling. of two oxygen masks and meet the same b. Each suite design must allow The characteristics of the suite design 14 CFR part 25 regulations as do the crewmembers equipped for firefighting are unique such that the suites are not supplemental oxygen system for the to have unrestricted access to all parts fully open to the cabin, as are main passenger-cabin occupants. of the suite compartment. c. The time for a crewmember in the conventional mini-suites with partial- b. An aural alert to warn occupants main passenger cabin to react to the fire height surrounds, and they are not and to indicate the need to don oxygen alarm and gain access to the suite must remote from the main cabin, as are masks in the event of decompression. not exceed the time it would take for the overhead crew rests. Likewise, unique The aural alert must activate compartment to become filled with but suitable fire-protection requirements concurrently with deployment of the smoke, thus making it difficult to locate for smoke detection and firefighting are oxygen masks in the main passenger cabin. the fire source(s). needed for this configuration. d. Approved procedures describing Furthermore, the proposed suite design c. The illumination level of the normal suite lighting system must be methods for searching the suite necessitates the development of compartment for fire source(s) must be additional conditions that do not activated automatically and must be sufficient for each occupant to locate a established. These procedures must be currently exist within associated transmitted to the operator for airworthiness standards, including, but deployed oxygen mask. d. If a chemical oxygen generator is incorporation into its training programs not limited to, alerting and lighting used as the oxygen supply source, the and appropriate operational manuals. when oxygen masks are needed, crew suite oxygen installation must meet 5. A means must be provided to procedures for managing hazards and §§ 25.795(d) and 25.1450. prevent hazardous quantities of smoke suite occupants, and maintaining cabin- 2. A smoke-detection or fire-detection or extinguishing agent originating in egress route dimensions after system (or systems) must be provided each suite from entering any other deformations of the walls and seats. that monitors each occupiable space occupiable compartments. These special conditions contain the within the suite. Flight tests must be a. Small quantities of smoke may additional safety standards that the conducted to show compliance with penetrate from the suite into other Administrator considers necessary to this requirement. If a fire occurs, each occupied areas during the one-minute establish a level of safety equivalent to system (or systems) in the affected suite smoke detection time. that established by the existing must provide: b. Hazardous quantities of smoke may airworthiness standards. a. A visual indication to the flight not enter any occupied compartment Applicability deck within one minute after the start of during access to manually fight a fire in a fire. the suite. A small amount of smoke may As discussed above, these special b. An aural warning in the suite area enter the occupied compartments while conditions are applicable to the Boeing where detection has occurred. a firefighter enters and exits the suite, Model 777–300ER airplane with high- c. A warning in the main passenger and is not considered hazardous wall, single-occupant suites with doors cabin. This warning must be readily provided the smoke dissipates quickly. installed. Should Boeing apply at a later detectable by a flight attendant, taking c. Flight tests must be conducted to date for a change to the type certificate into consideration the locations of flight show compliance with this requirement. to include another model incorporating attendants throughout the main 6. If waste-disposal receptacles are the same novel or unusual design passenger compartment during various fitted in the suite, the suite must be feature, these special conditions would phases of flight. equipped with an automatic fire- apply to that model as well. 3. Passenger-management procedures extinguishing system that meets the performance requirements of Conclusion must be provided should occupants need to be moved in the event of smoke § 25.854(b). This action affects only certain novel detection, or firefighting within the 7. Each stowage compartment in the or unusual design features on one model suite or where suites are installed: suite must be completely enclosed. All series of airplane. It is not a rule of a. A limitation must be included in enclosed stowage compartments within general applicability. the airplane flight manual (AFM) or the suite compartment that are not
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limited to stowage of emergency design criteria described in the table interior volume are not permitted by equipment or airplane- supplied below. Enclosed stowage compartments these special conditions. equipment (i.e., bedding) must meet the greater than 57 feet 3 inches cubic
DESIGN CRITERIA FOR ENCLOSED STOWAGE COMPARTMENTS NOT LIMITED TO STOWAGE OF EMERGENCY OR AIRPLANE- SUPPLIED EQUIPMENT
Applicability of fire-protection requirements by interior volume Fire protection features Less than 25 Cubic feet to 25 cubic feet less than 57 Cubic feet 57 cubic feet
Compliant Materials of Construction 1 ...... Yes ...... Yes ...... Yes. Smoke or Fire Detectors 2 ...... No ...... Yes ...... Yes. Liner 3 ...... No ...... Conditional ...... Yes. Fire Location Detector 4 ...... No ...... Yes ...... Yes. 1 Compliant Materials of Construction: The material used in constructing each enclosed stowage compartment must at least be fire resistant and must meet the flammability standards established for interior components (i.e., 14 CFR part 25 Appendix F, Parts I, IV, and V) per the re- quirements of § 25.853. For compartments less than 25 ft.3 in interior volume, the design must ensure the ability to contain a fire likely to occur within the compartment under normal use. 2 Smoke or Fire Detectors: Enclosed stowage compartments equal to or exceeding 25 ft.3 in interior volume must be provided with a smoke- or fire-detection system to ensure that a fire can be detected within a one-minute detection time. Flight tests must be conducted to show compli- ance with this requirement. Each system (or systems) must provide: b A visual indication in the flight deck within one minute after the start of a fire. b An aural warning in the suite compartment. b 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 Liner: If material used in constructing the stowage compartment can be shown to meet the flammability requirements of a liner for a Class B cargo compartment (i.e., § 25.855 at Amendment 25–116, and Appendix F, part I, paragraph (a)(2)(ii)), then no liner would be required for en- closed stowage compartments equal to or greater than 25 ft.3 but less than 57 ft.3 in interior volume. For all enclosed stowage compartments equal to 57 ft.3 in interior volume, a liner must be provided that meets the requirements of § 25.855 for a Class B cargo compartment. 4 Fire Location Detector: If a suite compartment has enclosed stowage compartments exceeding 25 ft.3 interior volume that are located sepa- rately from the other stowage compartments (located, for example, away from one central location, such as the entry to the suite compartment or a common area within the suite compartment, where the other stowage compartments are), that suite compartment would require additional fire- protection features and/or devices to assist the firefighter in determining the location of a fire.
8. Where suites are installed, the DEPARTMENT OF TRANSPORTATION ADDRESSES: For service information design of each suite must: identified in this final rule, contact Federal Aviation Administration a. Maintain minimum main aisle(s), Boeing Commercial Airplanes, cross aisle(s), and passageway(s) Attention: Contractual & Data Services 14 CFR Part 39 requirements of § 25.815 when (C&DS), 2600 Westminster Blvd., MC 110 SK57, Seal Beach, CA 90740 5600; subjected to the ultimate inertia forces [Docket No. FAA–2017–0332; Product telephone 562–797–1717; Internet listed in § 25.561(d). Identifier 2016–NM–164–AD; Amendment https://www.myboeingfleet.com. You 39–19084; AD 2017–22–04] b. Prevent structural failure or may view this referenced service deformation of components that could RIN 2120–AA64 information at the FAA, Transport block access to the available evacuation Standards Branch, 1601 Lind Avenue routes (e.g., seats, doors, contents of Airworthiness Directives; The Boeing SW., Renton, WA. For information on stowage compartments, etc.). Company Airplanes the availability of this material at the 9. In addition to the requirements of FAA, call 425–227–1221. It is also AGENCY: Federal Aviation available on the Internet at http:// § 25.562 for seat systems, which are Administration (FAA), DOT. occupiable during taxi, takeoff, and www.regulations.gov by searching for ACTION: Final rule. landing, the suite structure must be and locating Docket No. FAA–2017– 0332. designed for the additional loads SUMMARY: We are adopting a new imposed by the seats as a result of the airworthiness directive (AD) for certain Examining the AD Docket conditions specified in § 25.562(b). The Boeing Company Model 737–200, You may examine the AD docket on Issued in Renton, Washington, on October –200C, –300, –400, and –500 series the Internet at http:// 19, 2017. airplanes. This AD was prompted by www.regulations.gov by searching for reports of skin doublers that disbonded Suzanne Masterson, and locating Docket No. FAA–2017– from their skin panels. This AD requires 0332; or in person at the Docket Acting Manager, Transport Standards repetitive inspections of fuselage skin Branch, Policy and Innovation Division, Management Facility between 9 a.m. panels, and applicable on-condition and 5 p.m., Monday through Friday, Aircraft Certification Service. actions. We are issuing this AD to [FR Doc. 2017–23256 Filed 10–25–17; 8:45 am] except Federal holidays. The AD docket address the unsafe condition on these contains this final rule, the regulatory BILLING CODE 4910–13–P products. evaluation, any comments received, and DATES: This AD is effective November other information. The address for the 30, 2017. Docket Office (phone: 800–647–5527) is The Director of the Federal Register Docket Management Facility, U.S. approved the incorporation by reference Department of Transportation, Docket of a certain publication listed in this AD Operations, M–30, West Building as of November 30, 2017. Ground Floor, Room W12–140, 1200
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New Jersey Avenue SE., Washington, is disbonded, it is considered a suspect Instruction and in note (a) to tables 1 DC 20590. panel that went through improper through 8 in paragraph 1.E., FOR FURTHER INFORMATION CONTACT: processing during the phosphoric acid ‘‘Compliance,’’ of Boeing Alert Service Jennifer Tsakoumakis, Aerospace anodization phase of manufacturing. Bulletin 737–53A1349, dated August 23, Engineer, Airframe Section, FAA, Los Boeing stated that the suspect panel 2016. Note (a) states, ‘‘If any Boeing Angeles ACO Branch, 3960 Paramount could develop an additional disbond, ODA approved preventative Boulevard, Lakewood, CA 90712–4137; which could lead to further damage, and modification or repair was previously phone: 562–627–5264; fax: 562–627– then the inspections described in the installed via FAA Form 8100–9 or 5210; email: jennifer.tsakoumakis@ service information might not be [structural repair manual] SRM repair faa.gov. adequate. doubler (except disbond repair), initial We acknowledge the commenter’s and repeat inspections are not required SUPPLEMENTARY INFORMATION: request to clarify that only disbonded at the repaired location only.’’ Discussion skin panels need to be replaced, for the However, repairs that were not reasons provided by the commenter. We approved by the Boeing ODA and We issued a notice of proposed agree with the rationale for the request. replacements not done using Boeing rulemaking (NPRM) to amend 14 CFR However, the ‘‘Explanation of Certain Alert Service Bulletin 737–53A1349, part 39 by adding an AD that would Compliance Times’’ section only dated August 23, 2016, were not apply to certain The Boeing Company appears in the preamble of the NPRM addressed in the proposed AD. Model 737–200, –200C, –300, –400, and and is not carried over into this final Therefore, we have redesignated –500 series airplanes. The NPRM rule; therefore, no change to this final paragraph (i) (in the proposed AD) as published in the Federal Register on rule is necessary regarding this issue. paragraph (i)(1) and added paragraph May 2, 2017 (82 FR 20450). The NPRM (i)(2) to this AD to state that any skin Request To Include Previously was prompted by reports of skin panel replacement done before the Accomplished Actions as Terminating doublers that disbonded from their skin effective date of this AD terminates the Actions panels. The NPRM proposed to require inspections required by paragraph (g) of repetitive inspections of fuselage skin Qantas requested that we include this AD for that skin panel only, panels, and applicable on-condition previously accomplished repairs as provided the replacement was done actions. We are issuing this AD to detect terminating actions in paragraph (i) of using a skin panel manufactured on or and correct disbonded skin panels, the proposed AD. Qantas requested that after April 1, 1997, and the replacement which could result in fuselage skin paragraph (i) of the proposed AD be was done using an FAA-approved cracking, rapid decompression, and loss revised to include a provision for method. A replacement accomplished of structural integrity of the airplane. previously installed repairs (solid skin using an FAA-approved method would panel replacements) that were approved Comments still address the unsafe condition and by an authorized representative of the the need for the inspections required by We gave the public the opportunity to Boeing Commercial Airplanes paragraph (g) of this AD would be participate in developing this final rule. Organization Designation Authorization terminated. The following presents the comments (ODA) via FAA Form 8110–3, We have also added paragraph (i)(3) received on the NPRM and the FAA’s ‘‘Statement of Compliance with the to this AD to state that any FAA- response to each comment. Federal Aviation Regulations.’’ Qantas approved reinforced repair doubler stated that Boeing ODA-approved Effect of Winglets on Accomplishment (except disbond repair) installed before repairs completed prior to issuance of of the Proposed Actions the effective date of this AD terminates Boeing Alert Service Bulletin 737– the inspections required by paragraph Aviation Partners Boeing stated that 53A1349, dated August 23, 2016, were (g) of this AD at the repaired location accomplishing Supplemental Type not addressed in the NPRM. Qantas also only. Certificate (STC) ST01219SE does not suggested that solid skin panel affect the ability to accomplish the replacements approved via FAA Form Request To Allow Termination of All actions specified in the NPRM. 8100–9, ‘‘Statement of Compliance with Inspections We concur with the commenter. We Airworthiness Standards,’’ be included Southwest Airlines (SWA) requested have redesignated paragraph (c) of the as terminating action. Qantas stated that that we allow the terminating action proposed AD as paragraph (c)(1) and including skin panel replacements specified in paragraph (i) of the added paragraph (c)(2) to this AD to approved via FAA Form 8100–9 as proposed AD to terminate the initial state that installation of STC ST01219SE terminating action could help avoid inspections in paragraph (g) of the does not affect the ability to accomplish operators’ requests for AMOCs. In proposed AD and not only the repetitive the actions required by this AD. addition, Qantas recommended that the inspections in paragraph (g) of the Therefore, for airplanes on which STC language used for approved repairs by proposed AD. Specifically, SWA ST01219SE is installed, a ‘‘change in an authorized representative of the requested that paragraph (i) of the product’’ alternative methods of Boeing ODA be revised, as it is not proposed AD be revised to include the compliance (AMOC) approval request is specific to FAA Form 8110–3 or FAA provision that replacement of any skin not necessary to comply with the Form 8100–9. panel in accordance with the requirements of 14 CFR 39.17. We agree with the commenter’s Accomplishment Instructions of Boeing request. Paragraph (i)(1) of this AD Alert Service Bulletin 737–53A1349, Request To Revise ‘‘Explanation of (paragraph (i) of the proposed AD) dated August 23, 2016, except as Certain Compliance Times’’ Section addresses previously installed repairs specified in paragraph (h)(2) of the Boeing requested that the approved by an authorized proposed AD, terminates the ‘‘Explanation of Certain Compliance representative of the Boeing ODA. requirement for the initial inspection Times’’ section in the preamble of the Existing Boeing ODA-approved repairs specified in paragraph (g) of the NPRM be revised to clarify that only or preventative modifications are proposed AD, for the replaced skin disbonded skin panels need to be included in notes in Part 1, Part 2, and panel only. SWA noted that an operator replaced. Boeing noted that, if a panel Part 8 of the Accomplishment could replace a skin panel prior to doing
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the initial inspection specified in Amendment 39–13225 (68 FR 40759, We have determined that these minor paragraph (g) of the proposed AD, July 9, 2003; corrected July 21, 2003 (68 changes: therefore the operator would not be FR 42596) (‘‘AD 2003–14–06’’)). SWA • Are consistent with the intent that required to do the initial or repetitive noted that an operator could replace a was proposed in the NPRM for inspections specified in paragraph (g) of skin panel prior to doing the initial correcting the unsafe condition; and the proposed AD. inspection specified in paragraph (g) of • Do not add any additional burden We agree with the commenters’ the proposed AD; therefore, the operator upon the public than was already requests. We have clarified paragraph would not be required to do the initial proposed in the NPRM. (i)(1) of this AD (paragraph (i) of the or repetitive inspections specified in We also determined that these proposed AD) to state that paragraph (g) of the proposed AD, and accomplishment of any skin panel all of the requirements of AD 2003–14– changes will not increase the economic replacement using a skin panel 06 would be terminated. burden on any operator or increase the manufactured on or after April 1, 1997, We agree with the commenter’s scope of this final rule. terminates the inspections required by request. We redesignated paragraph (j) Related Service Information Under 1 paragraph (g) of this AD for that skin in the proposed AD as paragraph (j)(1) CFR Part 51 panel only, provided the replacement is and added paragraph (j)(2) to this AD to done as specified in the include a statement that replacement of We reviewed Boeing Alert Service Accomplishment Instructions of Boeing any skin panel with a skin panel Bulletin 737–53A1349, dated August 23, Alert Service Bulletin 737–53A1349, manufactured on or after April 1, 1997, 2016. The service information describes dated August 23, 2016, except as as specified in the Accomplishment procedures for repetitive inspections of required by paragraph (h)(2) of this AD. Instructions of Boeing Alert Service fuselage skin panels for cracking, Bulletin 737–53A1349, dated August 23, corrosion, and existing disbond repairs; Request To Include an Additional 2016, except as required by paragraph and applicable on-condition actions. Terminating Action for AD 2003–14–06 (h)(2) of this AD, terminates all of the This service information is reasonably SWA requested that paragraph (j) of requirements of AD 2003–14–06 for that available because the interested parties the proposed AD be revised to include skin panel only. have access to it through their normal a provision that replacement of skin course of business or by the means panels, in accordance with the Conclusion identified in the ADDRESSES section. Accomplishment Instructions of Boeing We reviewed the relevant data, Costs of Compliance Alert Service Bulletin 737–53A1349, considered the comments received, and dated August 23, 2016, except as determined that air safety and the We estimate that this AD affects 169 required by paragraph (h)(2) of the public interest require adopting this airplanes of U.S. registry. We estimate proposed AD, terminates all of the final rule with the changes described the following costs to comply with this requirements of AD 2003–14–06, previously and minor editorial changes. AD:
ESTIMATED COSTS
Action Labor cost Parts cost Cost per product Cost on U.S. operators
External general visual and 180 work-hours × $85 per $0 $15,300 per inspection cycle $2,585,700 per inspection detailed inspections. hour = $15,300 per inspec- cycle. tion cycle. External high frequency bond 450 work hours × $85 per 0 $38,250 inspection cycle ...... $6,464,250 per inspection test inspection. hour = $38,250 per inspec- cycle. tion cycle. Ultrasonic disbond inspection 630 work-hours × $85 per 0 $53,550 per inspection cycle $9,049,950 per inspection and internal detailed skin hour = $53,550 per inspec- cycle. inspection. tion cycle.
We estimate the following costs to do will be required based on the results of determining the number of aircraft that any necessary on-condition actions that the inspections. We have no way of might need these on-condition actions:
ON-CONDITION COSTS PER SKIN PANEL
Action Labor cost Parts cost Cost per product
On-condition inspections ...... Up to 25 work-hours × $85 per hour = $2,125 ...... $0 ...... Up to $2,125. Repairs ...... Up to 68 work-hours × $85 per hour = $5,780 ...... Up to $100 ...... Up to $5,880. Skin panel replacement ...... 304 work-hours × $85 per hour = $25,840 ...... $95,000 ...... $120,840.
Authority for This Rulemaking detail the scope of the Agency’s air commerce by prescribing regulations authority. for practices, methods, and procedures Title 49 of the United States Code We are issuing this rulemaking under the Administrator finds necessary for specifies the FAA’s authority to issue the authority described in Subtitle VII, safety in air commerce. This regulation rules on aviation safety. Subtitle I, Part A, Subpart III, Section 44701: is within the scope of that authority section 106, describes the authority of ‘‘General requirements.’’ Under that because it addresses an unsafe condition the FAA Administrator. Subtitle VII: section, Congress charges the FAA with that is likely to exist or develop on Aviation Programs, describes in more promoting safe flight of civil aircraft in
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products identified in this rulemaking (b) Affected ADs dated August 23, 2016, on which the one- action. This AD affects AD 2003–14–06, time internal inspection specified in Boeing This AD is issued in accordance with Amendment 39–13225 (68 FR 40759, July 9, Service Bulletin 737–53–1179, Revision 2, authority delegated by the Executive 2003; corrected July 21, 2003 (68 FR 42956)) dated October 25, 2001, has not been done: (‘‘AD 2003–14–06’’). The compliance time for accomplishment of Director, Aircraft Certification Service, the actions specified in Part 8 of the as authorized by FAA Order 8000.51C. (c) Applicability Accomplishment Instructions of Boeing Alert In accordance with that order, issuance (1) This AD applies to The Boeing Service Bulletin 737–53A1349, dated August of ADs is normally a function of the Company Model 737–200, –200C, –300, 23, 2016, is at the latest of the times specified Compliance and Airworthiness –400, and –500 series airplanes, certificated in paragraphs (h)(3)(i), (h)(3)(ii), and Division, but during this transition in any category, as identified in Boeing Alert (h)(3)(iii) of this AD. period, the Executive Director has Service Bulletin 737–53A1349, dated August (i) Within 50,000 flight cycles after the skin delegated the authority to issue ADs 23, 2016. panel replacement. (2) Installation of Supplemental Type (ii) Within 20,000 flight cycles after July applicable to transport category 14, 2003 (the effective date of AD 2003–14– airplanes to the Director of the System Certificate (STC) ST01219SE (http:// rgl.faa.gov/Regulatory_and_Guidance_ 16). Oversight Division. Library/rgstc.nsf/0/EBD1CEC7B301293 (iii) Within 4,500 flight cycles after the effective date of this AD. Regulatory Findings E86257CB30045557A?OpenDocument& Highlight=st01219se) does not affect the This AD will not have federalism (i) Terminating Action for Required ability to accomplish the actions required by Inspections implications under Executive Order this AD. Therefore, for airplanes on which 13132. This AD will not have a STC ST01219SE is installed, a ‘‘change in (1) Accomplishment of any skin panel substantial direct effect on the States, on product’’ alternative method of compliance replacement using a skin panel manufactured (AMOC) approval request is not necessary to on or after April 1, 1997, terminates the the relationship between the national inspections required by paragraph (g) of this government and the States, or on the comply with the requirements of 14 CFR 39.17. AD for that skin panel only, provided the distribution of power and replacement is done as specified in the responsibilities among the various (d) Subject Accomplishment Instructions of Boeing Alert levels of government. Air Transport Association (ATA) of Service Bulletin 737–53A1349, dated August For the reasons discussed above, I America Code 53, Fuselage. 23, 2016, except as required by paragraph certify that this AD: (h)(2) of this AD. (e) Unsafe Condition (1) Is not a ‘‘significant regulatory (2) Accomplishment of any skin panel action’’ under Executive Order 12866, This AD was prompted by reports of skin replacement done before the effective date of (2) Is not a ‘‘significant rule’’ under doublers that disbonded from their skin this AD terminates the inspections required by paragraph (g) of this AD for that skin DOT Regulatory Policies and Procedures panels. We are issuing this AD to detect and correct disbonded skin panels, which could panel only, provided the conditions specified (44 FR 11034, February 26, 1979), result in fuselage skin cracking, rapid in paragraphs (i)(2)(i) and (i)(2)(ii) of this AD (3) Will not affect intrastate aviation decompression, and loss of structural are met. in Alaska, and integrity of the airplane. (i) The replacement was done using a skin (4) Will not have a significant panel manufactured on or after April 1, 1997. economic impact, positive or negative, (f) Compliance (ii) The replacement was done using an on a substantial number of small entities Comply with this AD within the FAA-approved method. under the criteria of the Regulatory compliance times specified, unless already (3) Installation of an FAA-approved Flexibility Act. done. reinforced repair doubler (except disbond repair) before the effective date of this AD (g) Actions Required for Compliance List of Subjects in 14 CFR Part 39 terminates the inspections required by Except as required by paragraph (h) of this paragraph (g) of this AD at the repaired Air transportation, Aircraft, Aviation AD: Do all applicable actions identified as location only. safety, Incorporation by reference, required for compliance (‘‘RC’’) in, and in Safety. accordance with, the Accomplishment (j) Terminating Action for AD 2003–14–06 Instructions of Boeing Alert Service Bulletin (1) Accomplishment of the initial Adoption of the Amendment 737–53A1349, dated August 23, 2016. Do the inspections required by paragraph (g) of this Accordingly, under the authority actions at the applicable times specified in AD terminates all requirements of AD 2003– delegated to me by the Administrator, paragraph 1.E., ‘‘Compliance,’’ of Boeing 14–06. the FAA amends 14 CFR part 39 as Alert Service Bulletin 737–53A1349, dated (2) Accomplishment of any skin panel August 23, 2016. replacement with a skin panel manufactured follows: on or after April 1, 1997, as specified in the (h) Exceptions to Service Information Accomplishment Instructions of Boeing Alert PART 39—AIRWORTHINESS Specifications Service Bulletin 737–53A1349, dated August DIRECTIVES (1) Where Boeing Alert Service Bulletin 23, 2016, except as required by paragraph 737–53A1349, dated August 23, 2016, uses (h)(2) of this AD, terminates all requirements ■ 1. The authority citation for part 39 the phrase ‘‘after the original issue of this of AD 2003–14–06 for that skin panel only. continues to read as follows: service bulletin,’’ for purposes of determining (k) Alternative Methods of Compliance Authority: 49 U.S.C. 106(g), 40113, 44701. compliance with the requirements of this AD, the phrase ‘‘after the effective date of this (AMOCs) § 39.13 [Amended] AD’’ must be used. (1) The Manager, Los Angeles ACO Branch, ■ 2. The FAA amends § 39.13 by adding (2) Where Boeing Alert Service Bulletin FAA, has the authority to approve AMOCs the following new airworthiness 737–53A1349, dated August 23, 2016, for this AD, if requested using the procedures specifies contacting Boeing for instructions, found in 14 CFR 39.19. In accordance with directive (AD): and specifies that action as ‘‘RC’’ (Required 14 CFR 39.19, send your request to your 2017–22–04 The Boeing Company: for Compliance): This AD requires using a principal inspector or local Flight Standards Amendment 39–19084; Docket No. method approved in accordance with the District Office, as appropriate. If sending FAA–2017–0332; Product Identifier procedures specified in paragraph (k) of this information directly to the manager of the 2016–NM–164–AD. AD. certification office, send it to the attention of (3) For replaced skin panels identified in the person identified in paragraph (l) of this (a) Effective Date table 9 of paragraph 1.E., ‘‘Compliance,’’ of AD. Information may be emailed to: 9–ANM– This AD is effective November 30, 2017. Boeing Alert Service Bulletin 737–53A1349, LAACO–AMOC–[email protected].
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(2) Before using any approved AMOC, National Archives and Records SW., Renton, WA. For information on notify your appropriate principal inspector, Administration (NARA). For information on the availability of this material at the or lacking a principal inspector, the manager the availability of this material at NARA, call FAA, call 425–227–1221. It is also of the local flight standards district office/ 202–741–6030, or go to: http:// available on the Internet at http:// certificate holding district office. www.archives.gov/federal-register/cfr/ibr- www.regulations.gov by searching for (3) An AMOC that provides an acceptable locations.html. level of safety may be used for any repair, and locating Docket No. FAA–2017– Issued in Renton, Washington, on October 0521. modification, or alteration required by this 11, 2017. AD if it is approved by the Boeing Examining the AD Docket Commercial Airplanes Organization Dionne Palermo, Designation Authorization (ODA) that has Acting Director, System Oversight Division, You may examine the AD docket on been authorized by the Manager, Los Angeles Aircraft Certification Service. the Internet at http:// ACO Branch, to make those findings. To be [FR Doc. 2017–22950 Filed 10–25–17; 8:45 am] www.regulations.gov by searching for approved, the repair method, modification BILLING CODE 4910–13–P and locating Docket No. FAA–2017– deviation, or alteration deviation must meet 0521; or in person at the Docket the certification basis of the airplane, and the Management Facility between 9 a.m. approval must specifically refer to this AD. DEPARTMENT OF TRANSPORTATION and 5 p.m., Monday through Friday, (4) Except as required by paragraph (h)(2) except Federal holidays. The AD docket of this AD: For service information that Federal Aviation Administration contains steps that are labeled as Required contains this AD, the regulatory for Compliance (RC), the provisions of evaluation, any comments received, and paragraphs (k)(4)(i) and (k)(4)(ii) of this AD 14 CFR Part 39 other information. The street address for the Docket Office (telephone 800–647– apply. [Docket No. FAA–2017–0521; Product (i) The steps labeled as RC, including Identifier 2016–NM–189–AD; Amendment 5527) is Docket Management Facility, substeps under an RC step and any figures 39–19086; AD 2017–22–06] U.S. Department of Transportation, identified in an RC step, must be done to Docket Operations, M–30, West comply with the AD. If a step or substep is RIN 2120–AA64 Building Ground Floor, Room W12–140, labeled ‘‘RC Exempt,’’ then the RC 1200 New Jersey Avenue SE., requirement is removed from that step or Airworthiness Directives; Bombardier, Washington, DC 20590. substep. An AMOC is required for any Inc., Airplanes deviations to RC steps, including substeps FOR FURTHER INFORMATION CONTACT: and identified figures. AGENCY: Federal Aviation Steven Dzierzynski, Aerospace (ii) Steps not labeled as RC may be Administration (FAA), Department of Engineer, Avionics and Administrative deviated from using accepted methods in Transportation (DOT). Services Section, FAA, New York ACO accordance with the operator’s maintenance Branch, 1600 Stewart Avenue, Suite ACTION: Final rule. or inspection program without obtaining 410, Westbury, NY 11590; telephone approval of an AMOC, provided the RC steps, SUMMARY: 516–228–7367; fax 516–794–5531. including substeps and identified figures, can We are adopting a new still be done as specified, and the airplane airworthiness directive (AD) for certain SUPPLEMENTARY INFORMATION: can be put back in an airworthy condition. Bombardier, Inc., Model CL–600–2B16 Discussion (CL–601–3A, CL–601–3R, and CL–604 (l) Related Information Variants) airplanes. This AD was We issued a notice of proposed For more information about this AD, prompted by reports of fuel leaks in the rulemaking (NPRM) to amend 14 CFR contact Jennifer Tsakoumakis, Airframe engine and auxiliary power unit (APU) part 39 by adding an AD that would Section, FAA, Los Angeles ACO Branch, electrical fuel pump (EFP) cartridge/ apply to certain Bombardier, Inc., Model 3960 Paramount Boulevard, Lakewood, CA CL–600–2B16 (CL–601–3A, CL–601–3R, 90712–4137; phone: 562–627–5264; fax: 562– canister electrical connectors and conduits. This AD requires repetitive and CL–604 Variants) airplanes. The 627–5210; email: jennifer.tsakoumakis@ NPRM published in the Federal faa.gov. inspections for fuel leakage at the engine and APU fuel pumps, and Register on June 2, 2017 (82 FR 25556) (m) Material Incorporated by Reference related investigative and corrective (‘‘the NPRM’’). The NPRM was (1) The Director of the Federal Register actions if necessary. We are issuing this prompted by reports of fuel leaks in the approved the incorporation by reference AD to address the unsafe condition on engine and APU EFP cartridge/canister (IBR) of the service information listed in this these products. electrical connectors and conduits. The paragraph under 5 U.S.C. 552(a) and 1 CFR NPRM proposed to require repetitive DATES: part 51. This AD is effective November inspections for fuel leakage at the (2) You must use this service information 30, 2017. engine and APU fuel pumps, and as applicable to do the actions required by The Director of the Federal Register related investigative and corrective this AD, unless the AD specifies otherwise. approved the incorporation by reference (i) Boeing Alert Service Bulletin 737– actions if necessary. We are issuing this of certain publications listed in this AD AD to detect and correct fuel leaks in 53A1349, dated August 23, 2016. as of November 30, 2017. (ii) Reserved. certain fuel pumps to remove a potential (3) For service information identified in ADDRESSES: For service information fuel ignition hazard. this AD, contact Boeing Commercial identified in this final rule, contact Transport Canada Civil Aviation Airplanes, Attention: Contractual & Data Bombardier, Inc., 400 Coˆte-Vertu Road (TCCA), which is the aviation authority Services (C&DS), 2600 Westminster Blvd., West, Dorval, Que´bec H4S 1Y9, Canada; for Canada, has issued Canadian MC 110–SK57, Seal Beach, CA 90740–5600; Widebody Customer Response Center Airworthiness Directive CF–2016–32R1, telephone 562–797–1717; Internet https:// North America toll-free telephone 1– dated October 12, 2016 (referred to after www.myboeingfleet.com. 866–538–1247 or direct-dial telephone this as the Mandatory Continuing (4) You may view this service information 1–514–855–2999; fax 514–855–7401; Airworthiness Information, or ‘‘the at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For email [email protected]; MCAI’’), to correct an unsafe condition information on the availability of this Internet http://www.bombardier.com. for certain Bombardier, Inc., Model CL– material at the FAA, call 425–227–1221. You may view this referenced service 600–2B16 (CL–601–3A, CL–601–3R, and (5) You may view this service information information at the FAA, Transport CL–604 Variants) airplanes. The MCAI that is incorporated by reference at the Standards Branch, 1601 Lind Avenue states:
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Fuel leaks have been reported in the engine paragraph B.1. of the [Canadian AD] included in the applicability of this AD. and auxiliary power unit (APU) electrical Corrective Actions. We have not changed this AD in this fuel pump (EFP) cartridge/canister electrical regard. connectors and conduits on production You may examine the MCAI in the aeroplanes. Initially, Bombardier had AD docket on the Internet at http:// Conclusion determined that the subject discrepancy was www.regulations.gov by searching for limited to the new pump canister and locating Docket No. FAA–2017– We reviewed the relevant data, installations on 24 production aeroplanes. 0521. considered the comment received, and Bombardier also reported the possibility of determined that air safety and the Comments cut insulation on the electric harness wires public interest require adopting this AD of the newly installed canister housing We gave the public the opportunity to as proposed except for minor editorial assemblies. participate in developing this AD. The Emergency [Canadian] AD CF–2014–17 changes. We have determined that these [which corresponds to FAA AD 2014–15–17, following presents the comment minor changes: Amendment 39–17919 (79 FR 44268, July 31, received on the NPRM and the FAA’s • Are consistent with the intent that 2014)] was issued to limit landing light response. was proposed in the NPRM for operation on-ground in order to address a Request To Delay Issuance Until the correcting the unsafe condition; and potential fire hazard as result of a possible Release of New Service Information • Do not add any additional burden fuel leak from the APU, EFP electrical Bombardier, Inc., indicated its intent upon the public than was already conduit in the landing light compartment. In to revise Bombardier Service Bulletin addition, [Canadian] AD CF–2014–21 [which proposed in the NPRM. corresponds to FAA AD 2014–20–01, 604–28–022, dated October 19, 2015; Amendment 39–17974 (79 FR 59640, October and Bombardier Service Bulletin 605– Related Service Information Under 1 3, 2014), superseded by FAA AD 2016–10– 28–010, dated October 19, 2015. CFR Part 51 10, Amendment 39–18521 (81 FR 31497, May Bombardier, Inc., stated that these 19, 2016) (‘‘AD 2016–10–10’’)] was issued to revisions will change the inspection Bombardier, Inc., has issued Service mandate removal of then identified 24 instructions. Bombardier, Inc., further Bulletin 604–28–022, dated October 19, discrepant EFP canister assemblies from added that it plans to publish new 2015; and Service Bulletin 605–28–010, service. dated October 19, 2015. This service Bombardier has recently determined that service information to introduce similar inspections on Model CL–650 airplanes. information describes procedures for the subject fuel leaks may not be limited to repetitive general visual inspections for the 24 units affected by [Canadian] AD CF– We infer that Bombardier, Inc., is 2014–21 [(AD 2016–10–10)], but may requesting that we delay the issuance of fuel leakage at the engine and APU fuel potentially affect other in-service this final rule until after the revised pumps, and related investigative and [Bombardier Model] CL–600–2B16 service information is released and then corrective actions if necessary. These aeroplanes. Until such time that a final fix for refer to the revised service information. documents are distinct since they apply the fuel leak problem is realized, Bombardier We disagree with the commenter’s to airplanes in different configurations. as an interim mitigating action, has issued request. We do not consider that This service information is reasonably [Service Bulletin] SB 604–28–022 and SB available because the interested parties 605–28–010 that introduces [a] repeat delaying this action until release of the [general visual] inspection and if required, planned service information is have access to it through their normal rectification [related investigative and warranted since the service information course of business or by the means corrective actions] of subject fuel leaks on incorporated by reference in this AD identified in the ADDRESSES section. affected aeroplanes. [Canadian] AD CF– adequately addresses the unsafe Costs of Compliance 2016–32 was issued on 29 September 2016 to condition. We might consider additional mandate compliance with applicable rulemaking once the revised service We estimate that this AD affects 121 Bombardier SBs, to mitigate any potential airplanes of U.S. registry. safety hazard resulting from fuel leaks. information is released, or if new Revision 1 of this [Canadian] AD is being service information is issued for Model We estimate the following costs to issued to correct a typographic error in CL–650 airplanes, which are not comply with this AD:
ESTIMATED COSTS
Action Labor cost Parts cost Cost per product Cost on U.S. operators
Inspections ...... 1 work-hour × $85 per hour = $85 per inspec- $0 $85 per inspection $10,285 per inspection tion cycle. cycle. cycle.
For Model CL–600–2B16 airplanes and 5981, we estimate the following have no way of determining the number having serial numbers 5701 through costs to do any necessary replacements of aircraft that might need these 5955 inclusive, 5957, 5960 through 5966 that would be required based on the replacements: inclusive, 5968 through 5971 inclusive, results of the required inspection. We
ON-CONDITION COSTS
Cost per Action Labor cost Parts cost product
Replace o-ring in affected pump ...... 3 work-hours × $85 per hour = $255 ...... $17 $272 Replace cartridge in affected pump ...... 2 work-hours × $85 per hour = $170 ...... 8,618 8,788
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For Model CL–600–2B16 airplanes 2. Is not a ‘‘significant rule’’ under the (g) General Visual Inspections and having serial numbers 5301 through DOT Regulatory Policies and Procedures Corrective Actions—Model CL–600–2B16 5665 inclusive, we have received no (44 FR 11034, February 26, 1979); Airplanes, Serial Numbers 5301 through 5665 Inclusive definitive data that would enable us to 3. Will not affect intrastate aviation in For Model CL–600–2B16 airplanes having provide cost estimates for the on- Alaska; and condition actions specified in this AD. serial numbers 5301 through 5665 inclusive: 4. Will not have a significant Within 600 flight hours or 12 months, According to the manufacturer, some economic impact, positive or negative, whichever occurs first, after the effective date of the costs of this AD may be covered on a substantial number of small entities of this AD, do the inspections specified in under warranty, thereby reducing the under the criteria of the Regulatory paragraphs (g)(1), (g)(2), and (g)(3) of this AD, cost impact on affected individuals. We Flexibility Act. and do all applicable corrective actions, in do not control warranty coverage for accordance with the Accomplishment affected individuals. As a result, we List of Subjects in 14 CFR Part 39 Instructions of Bombardier Service Bulletin have included all costs in our cost 604–28–022, dated October 19, 2015; except estimate. Air transportation, Aircraft, Aviation where Bombardier Service Bulletin 604–28– safety, Incorporation by reference, 022, dated October 19, 2015, specifies to Authority for This Rulemaking Safety. contact the manufacturer, before further flight accomplish corrective actions in Title 49 of the United States Code Adoption of the Amendment accordance with the procedures specified in specifies the FAA’s authority to issue paragraph (i)(2) of this AD. Do all applicable rules on aviation safety. Subtitle I, Accordingly, under the authority corrective actions before further flight. section 106, describes the authority of delegated to me by the Administrator, Repeat the inspections at intervals not to the FAA Administrator. ‘‘Subtitle VII: the FAA amends 14 CFR part 39 as exceed 600 flight hours or 12 months, Aviation Programs,’’ describes in more follows: whichever occurs first. detail the scope of the Agency’s (1) Do a general visual inspection for traces authority. PART 39—AIRWORTHINESS of fuel coming from the right-hand engine DIRECTIVES boost pump at the location of the belly fairing We are issuing this rulemaking under screw (FS412, BL 0.0). the authority described in ‘‘Subtitle VII, ■ 1. The authority citation for part 39 (2) Do a general visual inspection for traces Part A, Subpart III, Section 44701: of fuel coming from the left-hand engine continues to read as follows: General requirements.’’ Under that boost pump at the location of the belly fairing section, Congress charges the FAA with Authority: 49 U.S.C. 106(g), 40113, 44701. screw (FS412, BL 0.0). promoting safe flight of civil aircraft in (3) Do a general visual inspection for traces § 39.13 [Amended] air commerce by prescribing regulations of fuel coming from the EFP electrical wiring conduit outlet at the lower body fairing area for practices, methods, and procedures ■ 2. The FAA amends § 39.13 by adding for engine EFPs and at the right-hand landing the Administrator finds necessary for the following new airworthiness light compartment for the APU EFP. safety in air commerce. This regulation directive (AD): is within the scope of that authority (h) General Visual Inspections and Related because it addresses an unsafe condition 2017–22–06 Bombardier, Inc.: Amendment Investigative and Corrective Actions—Model 39–19086; Docket No. FAA–2017–0521; that is likely to exist or develop on CL–600–2B16 Airplanes Having Serial Product Identifier 2016–NM–189–AD. Numbers 5701 through 5955 Inclusive, 5957, products identified in this rulemaking (a) Effective Date 5960 through 5966 Inclusive, 5968 through action. 5971 Inclusive, and 5981 This AD is effective November 30, 2017. This AD is issued in accordance with For Model CL–600–2B16 airplanes having authority delegated by the Executive (b) Affected ADs serial numbers 5701 through 5955 inclusive, Director, Aircraft Certification Service, None. 5957, 5960 through 5966 inclusive, 5968 as authorized by FAA Order 8000.51C. through 5971 inclusive, and 5981: Within In accordance with that order, issuance (c) Applicability 600 flight hours or 12 months, whichever of ADs is normally a function of the This AD applies to Bombardier, Inc., occurs first, after the effective date of this Compliance and Airworthiness Model CL–600–2B16 (CL–601–3A, CL–601– AD, do the inspections specified in Division, but during this transition 3R, and CL–604 Variants) airplanes, paragraphs (h)(1), (h)(2), and (h)(3) of this period, the Executive Director has certificated in any category, having serial AD, and do all applicable related investigative and corrective actions, in delegated the authority to issue ADs numbers 5301 through 5665 inclusive, 5701 through 5955 inclusive, 5957, 5960 through accordance with the Accomplishment applicable to transport category Instructions in Bombardier Service Bulletin airplanes to the Director of the System 5966 inclusive, 5968 through 5971 inclusive, and 5981. 605–28–010, dated October 19, 2015; except Oversight Division. where Bombardier Service Bulletin 605–28– (d) Subject Regulatory Findings 010, dated October 19, 2015, specifies to Air Transport Association (ATA) of contact the manufacturer, before further We determined that this AD will not America Code 28, Fuel. flight accomplish corrective actions in accordance with the procedures specified in have federalism implications under (e) Reason Executive Order 13132. This AD will paragraph (i)(2) of this AD. Do all applicable This AD was prompted by reports of fuel related investigative and corrective actions not have a substantial direct effect on leaks in the engine and auxiliary power unit before further flight. Repeat the inspections the States, on the relationship between (APU) electrical fuel pump (EFP) cartridge/ at intervals not to exceed 600 flight hours or the national government and the States, canister electrical connectors and conduits. 12 months, whichever occurs first. or on the distribution of power and We are issuing this AD to detect and correct (1) Do a general visual inspection for traces responsibilities among the various fuel leaks in certain fuel pumps to remove a of fuel coming from the right-hand engine levels of government. potential fuel ignition hazard. boost pump at the location of the belly fairing For the reasons discussed above, I screw (FS412, BL 0.0). (f) Compliance (2) Do a general visual inspection for traces certify that this AD: Comply with this AD within the of fuel coming from the left-hand engine 1. Is not a ‘‘significant regulatory compliance times specified, unless already boost pump at the location of the belly fairing action’’ under Executive Order 12866; done. screw (FS412, BL 0.0).
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(3) Do a general visual inspection of the 514–855–2999; fax 514–855–7401; email SUPPLEMENTARY INFORMATION: right-hand landing light compartment for [email protected]; Internet http:// 1. In this Policy Statement, the traces of fuel coming from the APU EFP. www.bombardier.com. Commission sets forth a new policy on (4) You may view this service information (i) Other FAA AD Provisions establishing license terms for original at the FAA, Transport Standards Branch, and new licenses for hydropower The following provisions also apply to this 1601 Lind Avenue SW., Renton, WA. For AD: information on the availability of this projects located at non-federal dams. (1) Alternative Methods of Compliance material at the FAA, call 425–227–1221. The goal of this action is to provide (AMOCs): The Manager, New York ACO (5) You may view this service information more certainty for stakeholders Branch, FAA, has the authority to approve that is incorporated by reference at the regarding the Commission’s regulatory AMOCs for this AD, if requested using the National Archives and Records process, reduce regulatory burden, procedures found in 14 CFR 39.19. In Administration (NARA). For information on increase administrative efficiency for all accordance with 14 CFR 39.19, send your the availability of this material at NARA, call stakeholders, and further encourage request to your principal inspector or local 202–741–6030, or go to: http:// Flight Standards District Office, as licensees to negotiate settlement www.archives.gov/federal-register/cfr/ibr- agreements and promptly seek appropriate. If sending information directly locations.html. to the manager of the certification office, authorization to implement voluntary send it to ATTN: Program Manager, Issued in Renton, Washington, on October environmental, recreational, and Continuing Operational Safety, FAA, New 17, 2017. developmental enhancements. York ACO Branch, 1600 Stewart Avenue, Jeffrey E. Duven, I. Background Suite 410, Westbury, NY 11590; telephone Director, System Oversight Division, Aircraft 516–228–7300; fax 516–794–5531. Before Certification Service. A. Current License Term Policy using any approved AMOC, notify your appropriate principal inspector, or lacking a [FR Doc. 2017–23015 Filed 10–25–17; 8:45 am] 2. Section 6 of the Federal Power Act principal inspector, the manager of the local BILLING CODE 4910–13–P (FPA) 1 provides that hydropower flight standards district office/certificate licenses shall be issued for a term not holding district office. to exceed 50 years. There is no (2) Contacting the Manufacturer: For any DEPARTMENT OF ENERGY minimum license term for original requirement in this AD to obtain corrective licenses. FPA section 15(e) 2 provides actions from a manufacturer, the action must Federal Energy Regulatory that any ‘‘new license’’ 3 shall be for a be accomplished using a method approved Commission by the Manager, New York ACO Branch, term that the Commission determines to FAA; or Transport Canada Civil Aviation be in the public interest, but not less (TCCA); or Bombardier, Inc.’s TCCA Design 18 CFR Parts 4, 5, and 16 than 30 years or more than 50 years. Approval Organization (DAO). If approved by [Docket No. PL17–3–000] 3. It is current Commission policy to the DAO, the approval must include the set a 50-year term for licenses issued for DAO-authorized signature. Policy Statement on Establishing projects located at federal dams.4 For (j) Related Information License Terms for Hydroelectric projects located at non-federal dams, the (1) Refer to Mandatory Continuing Projects Commission sets a 30-year term where Airworthiness Information (MCAI) Canadian there is little or no authorized AD CF–2016–32R1, dated October 12, 2016, AGENCY: Federal Energy Regulatory redevelopment, new construction, or for related information. This MCAI may be Commission, Department of Energy. environmental mitigation and found in the AD docket on the Internet at ACTION: Policy statement. enhancement; a 40-year term for a http://www.regulations.gov by searching for license involving a moderate amount of and locating Docket No. FAA–2017–0521. SUMMARY: The Federal Energy these activities; and a 50-year term (2) For more information about this AD, Regulatory Commission (Commission) is where there is an extensive amount of contact Steven Dzierzynski, Aerospace giving notice of a new policy on such activity.5 The Commission Engineer, Avionics and Administrative establishing license terms for Services Section, FAA, New York ACO previously established this policy to Branch, 1600 Stewart Avenue, Suite 410, hydroelectric projects. In this Policy ease the economic impact of new costs, Westbury, NY 11590; telephone 516–228– Statement, the Commission adopts a 40- promote balanced and comprehensive 7367; fax 516–794–5531. year default license term for original development of renewable power (3) Service information identified in this and new licenses for hydropower generating resources, and encourage AD that is not incorporated by reference is projects located at non-federal dams. licensees to be good environmental available at the addresses specified in The Policy Statement also sets forth stewards.6 paragraphs (k)(3) and (k)(4) of this AD. when the Commission will consider 4. Determining whether the measures (k) Material Incorporated by Reference issuing those projects a license with a required under a license are minimal, (1) The Director of the Federal Register term for less or more than 40 years. moderate, or extensive is highly case- approved the incorporation by reference DATES: This policy statement will be (IBR) of the service information listed in this applicable as of October 26, 2017. 1 16 U.S.C. 799 (2012). paragraph under 5 U.S.C. 552(a) and 1 CFR 2 FOR FURTHER INFORMATION CONTACT: 16 U.S.C. 808(e) (2012). part 51. 3 ‘‘New license’’ is the term used in the FPA to (2) You must use this service information Nicholas Jayjack, (Technical refer to a license issued to replace a project’s as applicable to do the actions required by Information), Office of Energy expiring license. this AD, unless this AD specifies otherwise. Projects, Federal Energy Regulatory 4 City of Danville, Virginia, 58 FERC ¶ 61,318, at (i) Bombardier Service Bulletin 604–28– Commission, 888 First Street NE., 62,020 (1992) (citing Little Falls Hydroelectric 022, dated October 19, 2015. Washington, DC 20426, (202) 502– Associates, 27 FERC ¶ 61,376 (1984)). 5 Id. (addressing original licenses); Consumers (ii) Bombardier Service Bulletin 605–28– 6073. 010, dated October 19, 2015. Power Co., 68 FERC ¶ 61,077, at 61,384 (1994) Carolyn Clarkin, (Legal Information), (addressing new licenses). Projects that entail (3) For service information identified in construction of a new dam have generally received this AD, contact Bombardier, Inc., 400 Coˆte- Office of the General Counsel—Energy Projects, Federal Energy Regulatory 50-year licenses. City of Danville, Virginia, 58 FERC Vertu Road West, Dorval, Que´bec H4S 1Y9, ¶ 61,318 at 62,020 (citing Little Falls Hydroelectric Canada; Widebody Customer Response Commission, 888 First Street NE., Associates, 27 FERC ¶ 61,376). Center North America toll-free telephone 1– Washington, DC 20426, (202) 502– 6 Consumers Power Co., 68 FERC ¶ 61,077 at 866–538–1247 or direct-dial telephone 1– 8563. 61,384.
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specific and largely based on a provided for in settlement agreements.14 license term that was negotiated as part qualitative analysis of the record before In each circumstance, the Commission of a settlement agreement. the Commission. In establishing the declined to extend the length of the 8. Commenters disagree on the 50- appropriate license term, staff initially license. year default license term policy option. examines the nature and extent of the Industry commenters generally support B. Notice of Inquiry on Establishing the 50-year default license term because required measures in the context of the License Terms for Hydroelectric Projects project at issue,7 and then uses the cost they state it would provide a clear, of measures as a check on a qualitative 6. On November 17, 2016, the predictable standard. Industry conclusion that the measures required Commission issued a notice of inquiry commenters add that such policy would under the license are minimal, (NOI) to seek comments on whether, eliminate the current ‘‘penalty’’ for efficient, well-maintained, and moderate, or extensive. The and if so how, the Commission should relatively low-impact projects that do Commission’s current policy takes a revise its current license term policy. not require substantial environmental or forward-looking approach, such that any The NOI invited comments on five potential license term policy options: (1) developmental measures and therefore measures adopted under a prior license only receive a 30-year license. 8 Retain the current policy; (2) modify the term are not considered. It has also 9. In contrast, environmental groups, current policy to consider voluntary been the Commission’s policy to individuals, and most resource agencies authorized actions implemented under coordinate, to the extent feasible, oppose the 50-year default license term the prior license (‘‘previously- license terms for projects in the same option. Several resource agencies argue authorized voluntary actions’’); (3) river basin to maximize consideration of that this option would provide little replace the current license term policy cumulative impacts when the projects incentive for a license applicant to are due to be relicensed.9 with a policy for a 50-year default voluntarily propose or agree to license term unless a lesser license term mitigation measures because such 5. The length of an original license would be in the public interest (for has not been contested on rehearing for measures would no longer factor into example, to better coordinate the license the Commission’s license term decision. some time; however, licensees and other terms of projects in the same river parties have recently contested the The resource agencies also contend that basin); (4) add a more quantitative cost- such policy would result in applicants length of a new license in several based analysis to the current policy; and relicensing proceedings. The arguments focusing their license application study (5) alter the current policy to accept efforts on disproving project effects raised in these cases include that the license terms agreed upon in settlement rather than on identifying potential Commission, when establishing the agreements, when appropriate. mitigation measures. license term, should have considered, or Comments on alternative policy options 10. Most commenters recommend given more weight to: Previously- were also encouraged. The NOI against the policy option to adopt a authorized capacity-related investments established January 24, 2017, as the more quantitative cost-based analysis. or environmental enhancements made deadline for comments, which staff Many commenters state that it would be by the licensee before issuance of the extended to March 24, 2017. difficult to develop a quantitative cost- 10 new license; total cost of the 7. Industry members, federal and state based analysis that takes into account 11 relicensing process; losses in resource agencies, environmental and the diverse hydropower fleet and generation value related to recreation groups, and individuals filed environmental and recreational values. environmental measures; 12 the license comments. Most commenters support 11. As an alternative to the five policy terms of projects that the license revising the current policy. Several options, several industry commenters applicant states are similarly situated to commenters state that under the current recommend that the Commission adopt its project; 13 and the license term policy stakeholders lack certainty, and, a 40-year default license term with consequently, license applicants lack credit (up to an additional 10 years) for 7 For example, one type of fishway may be more guidance on what measures will yield previously-authorized actions and expensive than another, and a fishway type that longer license terms and are deterred deference to settlement agreements. might be considered extensive for a small project could be seen as minimal for a larger one. from proposing additional protection, They state that under this alternative, 8 See, e.g., Duke Energy Carolinas, LLC, 156 FERC mitigation, and enhancement measures. licenses should be issued for less than ¶ 61,010, at P 19 (2016) (Duke Energy) (stating Further, many commenters state that 40 years only when a license applicant Commission’s long-standing policy is to only because the policy is forward-looking, has agreed to a settlement agreement consider measures required in the new license) with a negotiated license term of less (citing Alabama Power Co., 155 FERC ¶ 61,080, at licensees delay seeking authorizations P 72 (2016); Georgia Power Co., 111 FERC ¶ 61,183, for capacity upgrades and than 40 years, or voluntarily coordinates at P 12 (2005); Ford Motor Co., 110 FERC ¶ 61,236, environmental and recreational its license term with other projects in a at PP 6–8 (2005)). enhancements until they apply for a river basin. 9 18 CFR 2.23 (2017); see also Public Utility of new license. Some industry commenters District No. 1 of Chelan County, Washington, 127 II. Discussion state that under the current policy, FERC ¶ 61,152, at P 18 (2009) (Chelan PUD). 12. The extensive comments received 10 See, e.g., Duke Energy, 156 FERC ¶ 61,010 at license applicants and settlement P 12; Alabama Power Co., 155 FERC ¶ 61,080 at P parties cannot use the license term as a have given the Commission a deeper 71; Public Utility District No. 1 of Douglas County, bargaining chip because the understanding of the effects that the Washington, 143 FERC ¶ 61,130, at PP 12–13 (2013) Commission might reject that term in current license term policy has on (Douglas PUD); Chelan PUD, 127 FERC ¶ 61,152 at stakeholders in hydropower licensing PP 12–13; Georgia Power Co., 111 FERC ¶ 61,183 the license order. To address these at P 10; Ford Motor Co., 110 FERC ¶ 61,236 at P concerns, many commenters proceedings. The Commission 6. recommend that the Commission recognizes the importance of providing 11 See, e.g., Duke Energy, 156 FERC ¶ 61,010 at consider previously-authorized license applicants and other P 12. voluntary actions and defer to the stakeholders as much certainty as 12 See, e.g., id. possible. License applicants expend 13 See, e.g., id. P 20; Alabama Power Co., 155 FERC ¶ 61,080 at P 71; Duke Energy Progress, Inc., 14 See, e.g., Duke Energy Progress, Inc., 153 FERC significant financial resources on 153 FERC ¶ 61,056, at P 39 (2015); Douglas PUD, ¶ 61,056 at P 40; Douglas PUD, 143 FERC ¶ 61,130 preparing their license applications and 143 FERC ¶ 61,130 at P 15. at P 18; Chelan PUD, 127 FERC ¶ 61,152 at P 16. complying with their licenses thereafter.
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Further, stakeholders need certainty to given credit through an extension of the agreements are in the public interest, determine the protection, mitigation, prior license term. The Commission will provided they do not conflict with and enhancement measures that they consider, on a case-by-case basis, coordination. will negotiate and license applicants measures and actions that enhance non- 19. A 40-year default license term will will propose. developmental project purposes (i.e., not adversely affect environmental and 13. The current policy also affects the environmental, project recreation, water recreation resources. All of our licenses Commission’s staff and resources supply), and those that enhance power contain extensive environmental and needed to review and process license and developmental purposes, together recreation measures. While under our applications. Staff anticipate that over with the cost of those measures and new policy some projects may be 300 projects will enter the relicensing actions to determine whether they are relicensed less frequently and process through 2025. Under the current significant and warrant the granting of unanticipated project effects on policy, staff would establish the license a longer license term. Maintenance environmental resources may go term for each of those projects case by measures and measures taken to support unmitigated for longer durations of time case. the licensing process will not be than before, there are many tools 14. After considering this matter and considered. As guidance, we note that available to address these unanticipated the comments on the NOI, the the Commission has found that effects in a timely manner. The Commission has decided it is in the measures including the construction of Commission may address serious, public interest to change its license term pumped storage facilities, fish passage unanticipated environmental effects policy. With this Policy Statement, the facilities, fish hatcheries, substantial using its standard reopener article,18 Commission establishes a 40-year recreation facilities, dams, and and licensees often file applications for default license term policy for original powerhouses warranted longer license license amendments to address and new licenses for hydropower terms. significant, unanticipated projects located at non-federal dams.15 17. There are a number of reasons for environmental issues. Further, resource 15. There are three circumstances establishing a 40-year default license agencies frequently reserve authority to where the Commission will consider term with exceptions for coordination, address those effects under FPA section issuing a license for less or more than deference to generally-supported 4(e) (federal reservation) 19 and section 40 years. First, the Commission will comprehensive settlement agreements, 18 (fishway prescription),20 and in establish a shorter or longer term if and consideration of previously- water quality certifications issued under necessary to coordinate license terms for authorized voluntary actions. This section 401 of the Clean Water Act. projects located in the same river basin. policy will provide significant certainty Stakeholders have also negotiated with Second, the Commission will defer to a to licensees, resource agencies, and or encouraged licensees to propose shorter or longer term explicitly agreed other stakeholders. A 40-year default measures that include adaptive upon in a generally-supported license term will provide a simpler management approaches to allow for comprehensive settlement agreement, method for Commission staff to appropriate modifications as additional provided that such term does not establish license terms, and, thus, information is gathered, new conflict with coordination. Settlement increase administrative efficiencies. A technologies develop, and societal and agreements that state the settlement case-specific assessment will only be environmental needs change. signatories would not oppose a certain required for those license applications 20. This Policy Statement will apply term or would support a term within a that request a longer license term, and to all licenses issued following its range of years will not be considered to are not explicitly supported by a publication in the Federal Register with include an explicitly agreed upon generally-supported comprehensive no retroactive application. License license term.16 settlement agreement. Because many applicants with pending license 16. Third, the Commission will projects would be relicensed less applications may file a comprehensive consider a longer license term— frequently, the policy would also lower settlement agreement, or addendum to provided that doing so is consistent administrative costs for all stakeholders, an existing agreement, that includes an with coordinating license terms within provide licensees longer license terms to explicitly agreed upon license term or a basin—when a license applicant recoup costs, and reduce regulatory may make a filing demonstrating why specifically requests a longer license burden. Further, the policy will place the Commission should award them a term based on significant measures efficient, low-impact projects that longer license term than 40 years. The expected to be required under the new require minimal measures—and thus, Commission, however, will not license or significant measures would receive a 30-year term under the entertain applications to amend existing implemented during the prior license current policy—on more equal footing licenses to extend their license terms term that were not required by that with projects that require more simply on the basis of this new license license or other legal authority 17 and for measures. term policy. Pursuant to current policy, which the Commission has not already 18. The policy may also encourage licensees that seek to extend existing licensees to voluntarily make capacity licenses with terms of less than 50 15 This policy does not apply to pilot upgrades and enhance recreational and hydrokinetic projects, which have terms of up to environmental resources during the five years. See FERC, Licensing Hydrokinetic Pilot 18 Each license incorporates a Commission L- Projects, www.ferc.gov/industries/hydropower/gen- prior license term. Affected resources Form that includes standard reopener clauses to info/licensing/hydrokinetics/pdf/white_paper.pdf. will benefit from licensees undertaking enhance fish and wildlife resources. See 16 See, e.g., Chelan PUD, 127 FERC ¶ 61,152 at preventative or remedial measures Standardized Conditions for Inclusion in n.27 (settlement states that the signatories do not sooner rather than later. In addition, the Preliminary Permits and Licenses Issued Under Part oppose the licensee’s efforts to seek a 50-year term); I of the Federal Power Act, 54 F.P.C. 1792 (1975). Duke Energy, 156 FERC ¶ 61,010 at P 24 (settlement policy may further encourage license 19 16 U.S.C. 797(e) (2012) (licenses for projects states the signatories agree to support a license term applicants to engage with stakeholders located on federal reservations are subject to and that is not less than 40 years nor more than 50 to negotiate a license settlement contain conditions as the Secretary of the years). agreement. Because a generally- department under whose supervision such 17 See, e.g., Chelan PUD, 127 FERC ¶ 61,152, at reservation falls shall deem necessary). P 14 (stating that the licensee acted in order to supported comprehensive settlement 20 16 U.S.C. 811 (2012) (Secretaries of the Interior comply with the Endangered Species Act, not to agreements represent stakeholder and Commerce may prescribe fishway simply voluntarily resolve relicensing issues early). values, terms negotiated as part of those prescriptions).
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years, must justify such requests, for DEPARTMENT OF JUSTICE authority to temporarily place a example by proposing development, substance into Schedule I of the CSA for environmental, and recreation Drug Enforcement Administration two years without regard to the enhancements in a license amendment requirements of 21 U.S.C. 811(b) if he application accompanied by a request 21 CFR Part 1308 finds that such action is necessary to that the Commission extend their [Docket No. DEA–473] avoid an imminent hazard to the public license term.21 safety. 21 U.S.C. 811(h)(1). In addition, Schedules of Controlled Substances: if proceedings to control a substance are III. Document Availability Temporary Placement of ortho- initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the 21. In addition to publishing the full Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl temporary scheduling 1 for up to one text of this document in the Federal Into Schedule I year. 21 U.S.C. 811(h)(2). Register, the Commission provides all Where the necessary findings are interested persons an opportunity to AGENCY: Drug Enforcement made, a substance may be temporarily view and/or print the contents of this Administration, Department of Justice. scheduled if it is not listed in any other document via the Internet through ACTION: Temporary amendment; schedule under section 202 of the CSA, FERC’s Home Page (http:// temporary scheduling order. 21 U.S.C. 812, or if there is no www.ferc.gov) and in FERC’s Public exemption or approval in effect for the Reference Room during normal business SUMMARY: The Administrator of the Drug substance under section 505 of the hours (8:30 a.m. to 5:00 p.m. Eastern Enforcement Administration is issuing Federal Food, Drug, and Cosmetic Act time) at 888 First Street NE., Room 2A, this temporary scheduling order to (FDCA), 21 U.S.C. 355. 21 U.S.C. Washington, DC 20426. schedule the synthetic opioids, N-(2- 811(h)(1). The Attorney General has fluorophenyl)-N-(1-phenethylpiperidin- delegated scheduling authority under 21 22. From FERC’s Home Page on the 4-yl)propionamide (ortho-fluorofentanyl U.S.C. 811 to the Administrator of the Internet, this information is available on or 2-fluorofentanyl), N-(1- DEA. 28 CFR 0.100. eLibrary. The full text of this document phenethylpiperidin-4-yl)-N- Background is available on eLibrary in PDF and phenyltetrahydrofuran-2-carboxamide Microsoft Word format for viewing, (tetrahydrofuranyl fentanyl), and 2- Section 201(h)(4) of the CSA, 21 printing, and/or downloading. To access methoxy-N-(1-phenethylpiperidin-4-yl)- U.S.C. 811(h)(4), requires the this document in eLibrary, type the N-phenylacetamide (methoxyacetyl Administrator to notify the Secretary of docket number excluding the last three fentanyl), into Schedule I. This action is the Department of Health and Human digits of this document in the docket based on a finding by the Administrator Services (HHS) of his intention to number field. User assistance is that the placement of ortho- temporarily place a substance into available for eLibrary and the fluorofentanyl, tetrahydrofuranyl Schedule I of the CSA.2 The Commission’s Web site during normal fentanyl, and methoxyacetyl fentanyl Administrator transmitted notice of his business hours from FERC Online into Schedule I of the Controlled intent to place ortho-fluorofentanyl, Support at 202–502–6652 (toll free at Substances Act is necessary to avoid an tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl in Schedule I on 1–866–208–3676) or email at imminent hazard to the public safety. a temporary basis to the Assistant [email protected], or the As a result of this order, the regulatory controls and administrative, civil, and Secretary for Health of HHS by letter. Public Reference Room at (202) 502– Notice for these actions was transmitted 8371, TTY (202)502–8659. Email the criminal sanctions applicable to Schedule I controlled substances will be on the following dates: May 19, 2017 Public Reference Room at (ortho-fluorofentanyl) and July 5, 2017 [email protected]. imposed on persons who handle (manufacture, distribute, reverse (tetrahydrofuranyl fentanyl and By the Commission. distribute, import, export, engage in methoxyacetyl fentanyl). The Assistant Issued: October 19, 2017. research, conduct instructional Secretary responded by letters dated June 9, 2017 (ortho-fluorofentanyl) and Nathaniel J. Davis, Sr., activities or chemical analysis, or possess), or propose to handle, ortho- July 14, 2017 (tetrahydrofuranyl Deputy Secretary. fentanyl and methoxyacetyl fentanyl), [FR Doc. 2017–23286 Filed 10–25–17; 8:45 am] fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl. and advised that based on review by the BILLING CODE 6717–01–P Food and Drug Administration (FDA), DATES: This temporary scheduling order there are currently no investigational is effective October 26, 2017, until new drug applications or approved new October 28, 2019. If this order is drug applications for ortho- extended or made permanent, the DEA will publish a document in the Federal 1 Though DEA has used the term ‘‘final order’’ Register. with respect to temporary scheduling orders in the FOR FURTHER INFORMATION CONTACT: past, this document adheres to the statutory language of 21 U.S.C. 811(h), which refers to a Michael J. Lewis, Diversion Control ‘‘temporary scheduling order.’’ No substantive Division, Drug Enforcement change is intended. 21 See, e.g., Idaho Power Co., 132 FERC ¶ 62,001 Administration; Mailing Address: 8701 2 As discussed in a memorandum of (2010) (10-year extension of the license term due to Morrissette Drive, Springfield, Virginia understanding entered into by the Food and Drug the costs of replacing the project’s existing 22152; Telephone: (202) 598–6812. Administration (FDA) and the National Institute on powerhouse and increasing generating capacity); Drug Abuse (NIDA), the FDA acts as the lead agency SUPPLEMENTARY INFORMATION: within the HHS in carrying out the Secretary’s PPL Holtwood, LLC, 129 FERC ¶ 62,092 (2009) (16- scheduling responsibilities under the CSA, with the year extension of license term due to costs Legal Authority concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. associated with the constructing a new powerhouse, The Secretary of the HHS has delegated to the installing two turbine generating units at the Section 201 of the Controlled Assistant Secretary for Health of the HHS the existing powerhouse, and various environmental Substances Act (CSA), 21 U.S.C. 811, authority to make domestic drug scheduling measures). provides the Attorney General with the recommendations. 58 FR 35460, July 1, 1993.
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fluorofentanyl, tetrahydrofuranyl Secretary’s June 9, 2017 and July 14, reported in January 2017. The fentanyl, or methoxyacetyl fentanyl. The 2017 letters are available in their identification of methoxyacetyl fentanyl Assistant Secretary also stated that the entirety under the tab ‘‘Supporting in drug evidence submitted in April HHS has no objection to the temporary Documents’’ of the public docket of this 2017 was reported to DEA from a local placement of ortho-fluorofentanyl, action at www.regulations.gov under laboratory in Ohio.4 The DEA is not tetrahydrofuranyl fentanyl, or FDMS Docket ID: DEA–2017–0005 aware of any laboratory identifications methoxyacetyl fentanyl into Schedule I (Docket Number DEA–473). of ortho-fluorofentanyl prior to 2016 or of the CSA. The DEA has taken into identifications of tetrahydrofuranyl Factor 4. History and Current Pattern of consideration the Assistant Secretary’s fentanyl or methoxyacetyl fentanyl prior Abuse comments as required by 21 U.S.C. to 2017. 811(h)(4). ortho-Fluorofentanyl, The recreational abuse of fentanyl-like Evidence suggests that the pattern of tetrahydrofuranyl fentanyl, and substances continues to be a significant abuse of fentanyl analogues, including methoxyacetyl fentanyl are not concern. These substances are ortho-fluorofentanyl, tetrahydrofuranyl currently listed in any schedule under distributed to users, often with fentanyl, and methoxyacetyl fentanyl, the CSA, and no exemptions or unpredictable outcomes. ortho- parallels that of heroin and prescription approvals are in effect for ortho- Fluorofentanyl, tetrahydrofuranyl opioid analgesics. Seizures of ortho- fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have recently been encountered by law fentanyl, and methoxyacetyl fentanyl under section 505 of the FDCA, 21 enforcement and public health officials. have been encountered in powder form U.S.C. 355. The DEA has found that the Adverse health effects and outcomes are similar to fentanyl and heroin and have control of ortho-fluorofentanyl, demonstrated by fatal overdose cases been connected to fatal overdoses. tetrahydrofuranyl fentanyl, and involving these substances. The methoxyacetyl fentanyl in Schedule I on documented adverse health effects of Factor 5. Scope, Duration and a temporary basis is necessary to avoid ortho-fluorofentanyl, tetrahydrofuranyl Significance of Abuse an imminent hazard to the public safety, fentanyl, and methoxyacetyl fentanyl Reports collected by the DEA and as required by 21 U.S.C. are consistent with those of other demonstrate ortho-fluorofentanyl, 811(h)(1)(A), a notice of intent to issue opioids. tetrahydrofuranyl fentanyl, and a temporary order to schedule ortho- On October 1, 2014, the DEA methoxyacetyl fentanyl are being fluorofentanyl, tetrahydrofuranyl implemented STARLiMS (a web-based, abused for their opioid properties. fentanyl, and methoxyacetyl fentanyl commercial laboratory information Abuse of ortho-fluorofentanyl, was published in the Federal Register management system) to replace the tetrahydrofuranyl fentanyl, and on September 12, 2017. 82 FR 42754. System to Retrieve Information from methoxyacetyl fentanyl have resulted in To find that placing a substance Drug Evidence (STRIDE) as its mortality (see DEA 3-Factor Analysis for temporarily into Schedule I of the CSA laboratory drug evidence data system of full discussion). The DEA collected is necessary to avoid an imminent record. DEA laboratory data submitted post-mortem toxicology and medical hazard to the public safety, the after September 30, 2014, are reposited examiner reports on 13 confirmed Administrator is required to consider in STARLiMS. Data from STRIDE and fatalities associated with ortho- three of the eight factors set forth in STARLiMS were queried on June 19, fluorofentanyl which occurred in section 201(c) of the CSA, 21 U.S.C. 2017. STARLiMS registered four reports Georgia (1), North Carolina (11), and 811(c): The substance’s history and containing ortho-fluorofentanyl from Texas (1), two confirmed fatalities current pattern of abuse; the scope, California and five reports containing associated with tetrahydrofuranyl duration and significance of abuse; and tetrahydrofuranyl fentanyl from Florida fentanyl which occurred in New Jersey what, if any, risk there is to the public and Missouri. According to STARLiMS, (1) and Wisconsin (1), and two health. 21 U.S.C. 811(h)(3). the first laboratory submissions of ortho- confirmed fatalities associated with Consideration of these factors includes fluorofentanyl and tetrahydrofuranyl methoxyacetyl fentanyl which occurred actual abuse, diversion from legitimate fentanyl occurred in April 2016, and in Pennsylvania. It is likely that the channels, and clandestine importation, March 2017, respectively. prevalence of these substances in opioid manufacture, or distribution. 21 U.S.C. The National Forensic Laboratory related emergency room admissions and 811(h)(3). Information System (NFLIS) is a deaths is underreported as standard A substance meeting the statutory national drug forensic laboratory immunoassays may not differentiate requirements for temporary scheduling reporting system that systematically fentanyl analogues from fentanyl. may only be placed into Schedule I. 21 collects results from drug chemistry ortho-Fluorofentanyl, U.S.C. 811(h)(1). Substances in analyses conducted by other federal, tetrahydrofuranyl fentanyl, and Schedule I are those that have a high state, and local forensic laboratories methoxyacetyl fentanyl have been potential for abuse, no currently across the country. Data from NFLIS identified in drug evidence collected by accepted medical use in treatment in the was queried on June 20, 2017. NFLIS law enforcement. NFLIS and STARLiMS United States, and a lack of accepted registered three reports containing have a total of seven drug reports in safety for use under medical ortho-fluorofentanyl from state or local which ortho-fluorofentanyl was supervision. 21 U.S.C. 812(b)(1). forensic laboratories in Virginia.3 identified in drug exhibits submitted to Available data and information for According to NFLIS, the first report of forensic laboratories in 2016 from law ortho-fluorofentanyl, tetrahydrofuranyl ortho-fluorofentanyl was reported in enforcement encounters in California fentanyl, and methoxyacetyl fentanyl, September 2016. NFLIS registered two and Virginia and seven drug reports in summarized below, indicate that these reports containing tetrahydrofuranyl which tetrahydrofuranyl fentanyl was synthetic opioids have a high potential fentanyl from state or local forensic identified in drug exhibits submitted to for abuse, no currently accepted medical laboratories in New Jersey and was first forensic laboratories in 2017 from law use in treatment in the United States, and a lack of accepted safety for use 3 Data are still being collected for March 2017– 4 Email from Cuyahoga County Medical under medical supervision. The DEA’s June 2017 due to the normal lag period for labs Examiner’s Office, to DEA (May 8, 2017 02:29 p.m. three-factor analysis, and the Assistant reporting to NFLIS. EST) (on file with DEA).
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enforcement encounters in Florida, ortho-Fluorofentanyl, the Federal Register on September 12, Missouri, and New Jersey. The tetrahydrofuranyl fentanyl, and 2017. 82 FR 42754. identification of methoxyacetyl fentanyl methoxyacetyl fentanyl have been Conclusion in drug evidence submitted in April associated with numerous fatalities. At 2017 was reported to DEA from Ohio. least 13 confirmed overdose deaths In accordance with the provisions of The population likely to abuse ortho- involving ortho-fluorofentanyl abuse section 201(h) of the CSA, 21 U.S.C. fluorofentanyl, tetrahydrofuranyl have been reported from Georgia (1), 811(h), the Administrator considered fentanyl, and methoxyacetyl fentanyl North Carolina (11), and Texas (1). At available data and information, herein overlaps with the population abusing least two confirmed overdose deaths sets forth the grounds for his prescription opioid analgesics, heroin, involving tetrahydrofuranyl fentanyl determination that it is necessary to fentanyl, and other fentanyl-related have been reported from New Jersey (1) temporarily schedule ortho- substances. This is evidenced by the and Wisconsin (1). At least two fluorofentanyl, tetrahydrofuranyl routes of drug administration and drug confirmed overdose deaths involving fentanyl, and methoxyacetyl fentanyl use history documented in ortho- methoxyacetyl fentanyl have been into Schedule I of the CSA, and finds fluorofentanyl and tetrahydrofuranyl repored from Pennsylvania. As the data that placement of these synthetic fentanyl fatal overdose cases. Because demonstrate, the potential for fatal and opioids into Schedule I of the CSA is abusers of ortho-fluorofentanyl, non-fatal overdoses exists for ortho- necessary to avoid an imminent hazard tetrahydrofuranyl fentanyl, and fluorofentanyl, tetrahydrofuranyl to the public safety. methoxyacetyl fentanyl are likely to fentanyl, and methoxyacetyl fentanyl Because the Administrator hereby obtain these substances through and these substances pose an imminent finds it necessary to temporarily place unregulated sources, the identity, hazard to the public safety. these synthetic opioids into Schedule I purity, and quantity are uncertain and to avoid an imminent hazard to the inconsistent, thus posing significant Finding of Necessity of Schedule I public safety, this temporary order adverse health risks to the end user. Placement To Avoid Imminent Hazard scheduling ortho-fluorofentanyl, Individuals who initiate (i.e. use a drug to Public Safety tetrahydrofuranyl fentanyl, and for the first time) ortho-fluorofentanyl, methoxyacetyl fentanyl is effective on In accordance with 21 U.S.C. tetrahydrofuranyl fentanyl, or the date of publication in the Federal 811(h)(3), based on the available data methoxyacetyl fentanyl abuse are likely Register, and is in effect for a period of and information, summarized above, the to be at risk of developing substance use two years, with a possible extension of disorder, overdose, and death similar to continued uncontrolled manufacture, one additional year, pending that of other opioid analgesics (e.g., distribution, reverse distribution, completion of the regular (permanent) fentanyl, morphine, etc.). importation, exportation, conduct of scheduling process. 21 U.S.C. 811(h)(1) research and chemical analysis, and (2). Factor 6. What, if Any, Risk There Is to possession, and abuse of ortho- The CSA sets forth specific criteria for the Public Health fluorofentanyl, tetrahydrofuranyl scheduling a drug or other substance. ortho-Fluorofentanyl, fentanyl, and methoxyacetyl fentanyl Permanent scheduling actions in tetrahydrofuranyl fentanyl, and poses an imminent hazard to the public accordance with 21 U.S.C. 811(a) are methoxyacetyl fentanyl exhibit safety. The DEA is not aware of any subject to formal rulemaking procedures pharmacological profiles similar to that currently accepted medical uses for done ‘‘on the record after opportunity of fentanyl and other m-opioid receptor ortho-fluorofentanyl, tetrahydrofuranyl for a hearing’’ conducted pursuant to agonists. The toxic effects of ortho- fentanyl, or methoxyacetyl fentanyl in the provisions of 5 U.S.C. 556 and 557. fluorofentanyl, tetrahydrofuranyl the United States. A substance meeting 21 U.S.C. 811. The permanent fentanyl, and methoxyacetyl fentanyl in the statutory requirements for temporary scheduling process of formal humans are demonstrated by overdose scheduling, 21 U.S.C. 811(h)(1), may rulemaking affords interested parties fatalities involving these substances. only be placed in Schedule I. with appropriate process and the Abusers of ortho-fluorofentanyl, Substances in Schedule I are those that government with any additional tetrahydrofuranyl fentanyl, and have a high potential for abuse, no relevant information needed to make a methoxyacetyl fentanyl may not know currently accepted medical use in determination. Final decisions that the origin, identity, or purity of these treatment in the United States, and a conclude the permanent scheduling substances, thus posing significant lack of accepted safety for use under process of formal rulemaking are subject adverse health risks when compared to medical supervision. Available data and to judicial review. 21 U.S.C. 877. abuse of pharmaceutical preparations of information for ortho-fluorofentanyl, Temporary scheduling orders are not opioid analgesics, such as morphine and tetrahydrofuranyl fentanyl, and subject to judicial review. 21 U.S.C. oxycodone. methoxyacetyl fentanyl indicate that 811(h)(6). Based on information received by the these substances have a high potential DEA, the misuse and abuse of ortho- for abuse, no currently accepted medical Requirements for Handling fluorofentanyl, tetrahydrofuranyl use in treatment in the United States, Upon the effective date of this fentanyl, and methoxyacetyl fentanyl and a lack of accepted safety for use temporary order, ortho-fluorofentanyl, lead to the same qualitative public under medical supervision. As required tetrahydrofuranyl fentanyl, and health risks as heroin, fentanyl and by section 201(h)(4) of the CSA, 21 methoxyacetyl fentanyl will become other opioid analgesic substances. As U.S.C. 811(h)(4), the Administrator, subject to the regulatory controls and with any non-medically approved through letters dated May 19, 2017 administrative, civil, and criminal opioid, the health and safety risks for (ortho-fluorofentanyl) and July 5, 2017 sanctions applicable to the manufacture, users are high. The public health risks (tetrahydrofuranyl fentanyl and distribution, reverse distribution, attendant to the abuse of heroin and methoxyacetyl fentanyl), notified the importation, exportation, engagement in opioid analgesics are well established Assistant Secretary of the DEA’s research, and conduct of instructional and have resulted in large numbers of intention to temporarily place these activities or chemical analysis with, and drug treatment admissions, emergency substances in Schedule I. A notice of possession of Schedule I controlled department visits, and fatal overdoses. intent was subsequently published in substances including the following:
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1. Registration. Any person who an inventory of all stocks of these Regulatory Matters handles (manufactures, distributes, substances on hand, pursuant to 21 reverse distributes, imports, exports, U.S.C. 827 and 958, and in accordance Section 201(h) of the CSA, 21 U.S.C. engages in research, or conducts with 21 CFR 1304.03, 1304.04, and 811(h), provides for a temporary instructional activities or chemical 1304.11. Current DEA registrants shall scheduling action where such action is analysis with, or possesses), or who have 30 calendar days from the effective necessary to avoid an imminent hazard desires to handle, ortho-fluorofentanyl, date of this order to be in compliance to the public safety. As provided in this tetrahydrofuranyl fentanyl, and with all inventory requirements. After subsection, the Attorney General may, methoxyacetyl fentanyl must be the initial inventory, every DEA by order, schedule a substance in registered with the DEA to conduct such registrant must take an inventory of all Schedule I on a temporary basis. Such activities pursuant to 21 U.S.C. 822, controlled substances (including ortho- an order may not be issued before the 823, 957, and 958 and in accordance fluorofentanyl, tetrahydrofuranyl expiration of 30 days from (1) the with 21 CFR parts 1301 and 1312, as of fentanyl, and methoxyacetyl fentanyl) publication of a notice in the Federal October 26, 2017. Any person who on hand on a biennial basis, pursuant to Register of the intention to issue such currently handles ortho-fluorofentanyl, 21 U.S.C. 827 and 958, and in order and the grounds upon which such tetrahydrofuranyl fentanyl, and accordance with 21 CFR 1304.03, order is to be issued, and (2) the date methoxyacetyl fentanyl, and is not 1304.04, and 1304.11. that notice of the proposed temporary registered with the DEA, must submit an scheduling order is transmitted to the 6. Records. All DEA registrants must Assistant Secretary. 21 U.S.C. 811(h)(1). application for registration and may not maintain records with respect to ortho- Inasmuch as section 201(h) of the continue to handle ortho-fluorofentanyl, fluorofentanyl, tetrahydrofuranyl CSA directs that temporary scheduling tetrahydrofuranyl fentanyl, and fentanyl, and methoxyacetyl fentanyl actions be issued by order and sets forth methoxyacetyl fentanyl as of October pursuant to 21 U.S.C. 827 and 958, and the procedures by which such orders are 26, 2017, unless the DEA has approved in accordance with 21 CFR parts 1304, to be issued, the DEA believes that the that application for registration and 1312, 1317 and § 1307.11. Current notice and comment requirements of the pursuant to 21 U.S.C. 822, 823, 957, DEA registrants shall have 30 calendar Administrative Procedure Act (APA) at 958, and in accordance with 21 CFR days from the effective date of this order parts 1301 and 1312. Retail sales of 5 U.S.C. 553, do not apply to this to be in compliance with all Schedule I controlled substances to the temporary scheduling action. In the recordkeeping requirements. general public are not allowed under the alternative, even assuming that this CSA. Possession of any quantity of these 7. Reports. All DEA registrants who action might be subject to 5 U.S.C. 553, substances in a manner not authorized manufacture or distribute ortho- the Administrator finds that there is by the CSA on or after October 26, 2017 fluorofentanyl, tetrahydrofuranyl good cause to forgo the notice and is unlawful and those in possession of fentanyl, and methoxyacetyl fentanyl comment requirements of 5 U.S.C. 553, any quantity of these substances may be must submit reports pursuant to 21 as any further delays in the process for subject to prosecution pursuant to the U.S.C. 827 and in accordance with 21 issuance of temporary scheduling orders CSA. CFR parts 1304 and 1312 as of October would be impracticable and contrary to 2. Disposal of stocks. Any person who 26, 2017. the public interest in view of the does not desire or is not able to obtain 8. Order Forms. All DEA registrants manifest urgency to avoid an imminent a Schedule I registration to handle who distribute ortho-fluorofentanyl, hazard to the public safety. ortho-fluorofentanyl, tetrahydrofuranyl tetrahydrofuranyl fentanyl, and Further, the DEA believes that this fentanyl, and methoxyacetyl fentanyl, methoxyacetyl fentanyl must comply temporary scheduling action is not a must surrender all quantities of with order form requirements pursuant ‘‘rule’’ as defined by 5 U.S.C. 601(2), currently held ortho-fluorofentanyl, to 21 U.S.C. 828 and in accordance with and, accordingly, is not subject to the tetrahydrofuranyl fentanyl, and 21 CFR part 1305 as of October 26, 2017. requirements of the Regulatory methoxyacetyl fentanyl. 9. Importation and Exportation. All Flexibility Act. The requirements for the 3. Security. ortho-Fluorofentanyl, importation and exportation of ortho- preparation of an initial regulatory tetrahydrofuranyl fentanyl, and fluorofentanyl, tetrahydrofuranyl flexibility analysis in 5 U.S.C. 603(a) are methoxyacetyl fentanyl are subject to fentanyl, and methoxyacetyl fentanyl not applicable where, as here, the DEA Schedule I security requirements and must be in compliance with 21 U.S.C. is not required by the APA or any other must be handled and stored pursuant to 952, 953, 957, 958, and in accordance law to publish a general notice of 21 U.S.C. 821, 823, 871(b), and in with 21 CFR part 1312 as of October 26, proposed rulemaking. accordance with 21 CFR 1301.71– 2017. 1301.93, as of October 26, 2017. Additionally, this action is not a 4. Labeling and packaging. All labels, 10. Quota. Only DEA registered significant regulatory action as defined labeling, and packaging for commercial manufacturers may manufacture ortho- by Executive Order 12866 (Regulatory containers of ortho-fluorofentanyl, fluorofentanyl, tetrahydrofuranyl Planning and Review), section 3(f), and, tetrahydrofuranyl fentanyl, and fentanyl, and methoxyacetyl fentanyl in accordingly, this action has not been methoxyacetyl fentanyl must be in accordance with a quota assigned reviewed by the Office of Management compliance with 21 U.S.C. 825, 958(e), pursuant to 21 U.S.C. 826 and in and Budget. and be in accordance with 21 CFR part accordance with 21 CFR part 1303 as of This action will not have substantial 1302. Current DEA registrants shall have October 26, 2017. direct effects on the States, on the 30 calendar days from October 26, 2017, 11. Liability. Any activity involving relationship between the national to comply with all labeling and ortho-fluorofentanyl, tetrahydrofuranyl government and the States, or on the packaging requirements. fentanyl, and methoxyacetyl fentanyl distribution of power and 5. Inventory. Every DEA registrant not authorized by, or in violation of the responsibilities among the various who possesses any quantity of ortho- CSA, occurring as of October 26, 2017, levels of government. Therefore, in fluorofentanyl, tetrahydrofuranyl is unlawful, and may subject the person accordance with Executive Order 13132 fentanyl, and methoxyacetyl fentanyl on to administrative, civil, and/or criminal (Federalism) it is determined that this the effective date of this order must take sanctions. action does not have sufficient
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federalism implications to warrant the the temporary scheduling order from List of Subjects in 21 CFR Part 1308 preparation of a Federalism Assessment. standard notice and comment As noted above, this action is an Administrative practice and rulemaking procedures to ensure that procedure, Drug traffic control, order, not a rule. Accordingly, the the process moves swiftly. For the same Congressional Review Act (CRA) is Reporting and recordkeeping reasons that underlie 21 U.S.C. 811(h), requirements. inapplicable, as it applies only to rules. that is, the DEA’s need to move quickly For the reasons set out above, the DEA However, if this were a rule, pursuant to place these substances into Schedule amends 21 CFR part 1308 as follows: to the Congressional Review Act, ‘‘any I because it poses an imminent hazard rule for which an agency for good cause to the public safety, it would be contrary finds that notice and public procedure PART 1308—SCHEDULES OF to the public interest to delay thereon are impracticable, unnecessary, CONTROLLED SUBSTANCES or contrary to the public interest, shall implementation of the temporary ■ take effect at such time as the federal scheduling order. Therefore, this order 1. The authority citation for part 1308 agency promulgating the rule shall take effect immediately upon its continues to read as follows: determines.’’ 5 U.S.C. 808(2). It is in the publication. The DEA has submitted a Authority: 21 U.S.C. 811, 812, 871(b), public interest to schedule these copy of this temporary order to both 956(b), unless otherwise noted. substances immediately to avoid an Houses of Congress and to the ■ 2. In § 1308.11, add reserved imminent hazard to the public safety. Comptroller General, although such paragraphs (h)(15) through (18) and This temporary scheduling action is filing is not required under the Small paragraphs (h)(19), (20), and (21) to read taken pursuant to 21 U.S.C. 811(h), Business Regulatory Enforcement as follows: which is specifically designed to enable Fairness Act of 1996 (Congressional the DEA to act in an expeditious manner Review Act), 5 U.S.C. 801–808 because, § 1308.11 Schedule I. to avoid an imminent hazard to the as noted above, this action is an order, * * * * * public safety. 21 U.S.C. 811(h) exempts not a rule. (h) * * *
(19) N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: ortho-fluorofentanyl, 2-fluorofentanyl) ...... (9816) (20) N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide, its isomers, esters, ethers, salts and salts of iso- mers, esters and ethers (Other name: tetrahydrofuranyl fentanyl) ...... (9843) (21) 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: methoxyacetyl fentanyl) ...... (9825)
Dated: October 17, 2017. Applicability Date: The corrections to List of Subjects in 26 CFR Part 1 Robert W. Patterson, §§ 1.1.871–15, 1.871–15T, 1.1441– Income taxes, Reporting and 1(e)(5)(v)(B)(4), (e)(6), and (f)(5), 1.1441– Acting Administrator. recordkeeping requirements. [FR Doc. 2017–23206 Filed 10–25–17; 8:45 am] 2, 1.1441–7, and 1.1461–1 are BILLING CODE 4410–09–P applicable on January 19, 2017. Correction of Publication FOR FURTHER INFORMATION CONTACT: D. Accordingly, 26 CFR part 1 is Peter Merkel or Karen Walny at 202– corrected by making the following DEPARTMENT OF THE TREASURY 317–6938 (not a toll-free number). correcting amendments: SUPPLEMENTARY INFORMATION: Internal Revenue Service PART 1—INCOME TAXES Background 26 CFR Part 1 The final and temporary regulations ■ Paragraph 1. The authority citation that are the subject of these corrections for part 1 continues to read in part as [TD 9815] are §§ 1.871–15, 1.871–15T, 1.1441–1, follows: RIN 1545–BM33 1.1441–2, 1.1441–7, and 1.1461–1, Authority: 26 U.S.C. 7805 * * * promulgated under sections 871(m) and Dividend Equivalents From Sources 7805 of the Internal Revenue Code. § 1.871–15 [Amended] These regulations affect foreign persons Within the United States; Correction ■ Par. 2. Section 1.871–15 is amended that hold certain financial products by: AGENCY: Internal Revenue Service (IRS), providing for payments that are ■ 1. Removing paragraph (r)(2). Treasury. contingent upon or determined by ACTION: Final regulations and temporary reference to U.S. source dividends, as ■ 2. Redesignating paragraphs (r)(3), (4), regulations; Correcting amendments. well withholding agents with respect to and (5), as (r)(2), (3), and (4), dividend equivalents and certain other respectively. SUMMARY: This document contains parties to section 871(m) transactions § 1.871–15 [Amended] corrections to final and temporary and their agents. regulations (TD TD 9815), which were ■ Par. 3. For each section listed in the published in the Federal Register on Need for Correction table, remove the language in the Tuesday, January 24, 2017. As published, TD 9815 contains errors ‘‘Remove’’ column and add in its place DATES: Effective Date: These corrections that may prove to be misleading and are the language in the ‘‘Add’’ column as set are effective October 26, 2017. in need of clarification. forth below:
Section Remove Add
§ 1.871–15(a)(14)(ii)(B) ...... ELI.More ...... ELI. More § 1.871–15(l)(1), second sentence ...... described in this paragraph (l) ...... described in this paragraph (l)(1) § 1.871–15(q)(1) qualified intermediary agreement ...... qualified intermediary withholding agreement
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Section Remove Add
§ 1.871–15(q)(4) ordinary ...... ordinarily § 1.871–15(q)(5), Example (3), paragraph (ii) country that provides withholding ...... country with a treaty that provides withholding § 1.871–15(q)(5), Example (3), paragraph (ii) paid by qualified derivatives dealer ...... paid by the qualified derivatives dealer § 1.871–15(r)(1) September 18, 2015 ...... January 19, 2017
§ 1.871–15T [Amended] § 1.871–15T [Amended] the language in the ‘‘Add’’ column as set ■ Par. 4. Section 1.871–15T is amended ■ Par. 5. For each section listed in the forth below: by redesignating paragraph (r)(5) as table, remove the language in the (r)(4). ‘‘Remove’’ column and add in its place
Section Remove Add
§ 1.871–15T(p)(5) ...... Example 1...... Example. § 1.871–15T(q) through (r)(4) [Reserved] ...... (q) through (r)(4) [Reserved]. For further guid- (q) through (r)(3) [Reserved]. For further guid- ance, see § 1.871–15(r)(1) through (4). ance, see § 1.871–15(q) through (r)(3) § 1.871–15T(r)(4) newly redesignated ...... after on January ...... after January
§ 1.1441–1 [Amended] ‘‘Remove’’ column and add in its place ■ Par. 6. For each section listed in the the language in the ‘‘Add’’ column as set table, remove the language in the forth below:
Section Remove Add
§ 1.1441–1(e)(5)(v)(B)(4)(iv) ...... U.S. income tax ...... U.S. federal income tax § 1.1441–1(e)(6)(i)(B) ...... and other withholding provisions ...... and other provisions § 1.1441–1(e)(6)(i)(C) ...... underlying securities (including ...... underlying securities as defined in § 1.871– 15(a)(15) (including § 1.1441–1(e)(6)(i)(C) ...... received in the equity ...... received in its equity § 1.1441–1(e)(6)(i)(D)(3) ...... U.S. tax return ...... U.S. federal tax return § 1.1441–1(e)(6)(i)(F) ...... QDD ...... qualified derivatives dealer § 1.1441–1(e)(6)(ii)(B) introductory text ...... organized, or operates ...... organized or operates § 1.1441–1(e)(6)(ii)(B)(2) ...... pursuant to ...... with respect to § 1.1441–1(f)(5) ...... Paragraphs (e)(5)(ii)(D) ...... Paragraphs (e)(5)(ii)(C)
■ Par. 7. Section 1.1441–2 is amended § 1.1441–2 Amounts subject to § 1.1441–2 [Amended] by removing the last two sentences of withholding. ■ Par. 8. For each section listed in the paragraph (f)(1) and adding a sentence * * * * * table, remove the language in the at the end of the paragraph to read as (f) * * * ‘‘Remove’’ column and add in its place follows: (1) * * * Paragraph (e)(7) of this section applies on or after January 19, the language in the ‘‘Add’’ column as set 2017. forth below: * * * * *
Section Remove Add
§ 1.1441–2(e)(7)(ii)(A) ...... § 1.871–15(i)(3), ...... § 1.871–15(i)(3)(i), § 1.1441–2(e)(7)(iv) ...... type (securities ...... type (for example, securities § 1.1441–2(e)(7)(v) ...... the types of section 871(m) transaction ...... the type of section 871(m) transaction § 1.1441–2(e)(7)(v) ...... certifying that has notified ...... certifying that it has notified
§ 1.1441–7 [Amended] § 1.1441–7 [Amended] the language in the ‘‘Add’’ column as set ■ Par. 9. Section 1.1441–7 is amended ■ Par. 10. For each section listed in the forth below: by removing the second sentence of table, remove the language in the paragraph (a)(4). ‘‘Remove’’ column and add in its place
Section Remove Add
§ 1.1441–7(a)(3), Example 9 ...... not required withhold ...... not required to withhold § 1.1441–7(a)(4) ...... Example 8 and ...... Example 7, Example 8, and § 1.1441–7(a)(4) ...... apply to payments made on or after January apply beginning January 19 19
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■ Par. 11. Section 1.1461–1 is amended deviation, call or email LT Scott Ledee, DEPARTMENT OF HOMELAND by revising paragraph (c)(2)(iii) to read Chief Waterways Management Division, SECURITY as follows: U.S. Coast Guard Sector Key West, Coast Coast Guard § 1.1461–1 Payment and returns of tax Guard; telephone (305) 292–8768, email; [email protected]. withheld. 33 CFR Part 117 * * * * * SUPPLEMENTARY INFORMATION: The (c) * * * Village of Islamorada Florida with [Docket No. USCG–2017–0778] (2) * * * concurrence of Florida Department of Drawbridge Operation Regulation; (iii) Applicability date. Paragraph Transportation, the bridge owner, has (c)(2) of this section applies beginning Atlantic Intracoastal Waterway, Indian requested a temporary change in the January 19, 2017. River, Titusville, FL operating regulation for the Snake Creek * * * * * Bridge on US Highway 1 crossing Snake AGENCY: Coast Guard, DHS. Martin V. Franks, Creek in Islamorada, Florida. The bridge ACTION: Notice of deviation from Chief, Publications and Regulations Branch, has a vertical clearance of 27 feet in the drawbridge regulation; modification. Legal Processing Division, Associate Chief closed position. With the passing of SUMMARY: The Coast Guard has modified Counsel (Procedure and Administration). Hurricane Irma, the lower Keys have a temporary deviation from the [FR Doc. 2017–22830 Filed 10–25–17; 8:45 am] been devastated. With this increased operating schedule that governs the BILLING CODE 4830–01–P time between openings, this deviation NASA Railroad Bridge (Jay Jay Bridge) will allow a more uninterrupted flow of across the Atlantic Intracoastal vehicle traffic carrying restorative Waterway (Indian River), mile 876.6, DEPARTMENT OF HOMELAND supplies into the lower Keys without Titusville, Florida. This modified SECURITY severely hindering vessel traffic. The deviation is necessary to allow the Snake Creek Drawbridge currently Coast Guard bridge owner, National Aeronautics and operates under 33 CFR 117.331. Space Administration (NASA) to 33 CFR Part 117 The deviation period is from 7 a.m. on continue repairs to the bridge. Due to September 29, 2017 to 7 a.m. on delays and damage caused by Hurricane [Docket No. USCG–2017–0936] November 1, 2017. During this period, Irma, additional repairs will be required RIN 1625–AA09 the bridge will open on signal, except causing the bridge to remain closed to that from 7 a.m. to 7 p.m. the draw need navigation periodically throughout the Drawbridge Operation Regulation; only open every two hours, on the hour. day. This deviation is deemed necessary Snake Creek; Islamorada, FL for the continued safe operation of the Vessels able to pass through the bridge. AGENCY: Coast Guard, DHS. bridge in the closed position may do so DATES: This modified deviation is ACTION: Notice of deviation from at anytime. The bridge will be able to effective without actual notice from drawbridge regulation. open for emergencies and there is no October 26, 2017 through 4 p.m. on immediate alternate route for vessels to SUMMARY: The Coast Guard has issued a October 31, 2017. For the purposes of temporary deviation from the operating pass. The Coast Guard will also inform enforcement, actual notice will be used schedule that governs the Snake Creek the users of the waterways through our from 8 a.m. on September 27, 2017 until Bridge across Snake Creek, at Local and Broadcast Notices to Mariners October 26, 2017. Islamorada, FL. The deviation is of the change in operating schedule for ADDRESSES: The docket for this necessary to alleviate the increased the bridge so that vessel operators can deviation, USCG–2017–0778 is available traffic congestion on US 1 Highway arrange their transits to minimize any at http://www.regulations.gov. Type the resulting from relief efforts after the impact caused by the temporary docket number in the ‘‘SEARCH’’ box passing of Hurricane Irma. This deviation. and click ‘‘SEARCH’’. Click on Open deviation allows the bridge to open once In accordance with 33 CFR 117.35(e), Docket Folder on the line associated every two hours verses the current the drawbridge must return to its regular with this deviation. operating regulation. Local officials are operating schedule immediately at the FOR FURTHER INFORMATION CONTACT: If requesting this action to assist in end of the effective period of this you have questions on this modified reducing the long line of traffic backups temporary deviation. This deviation temporary deviation, call or email LT caused by the bridge openings. from the operating regulations is Allan Storm, U.S. Coast Guard Sector DATES: This deviation is effective authorized under 33 CFR 117.35. Jacksonville, Waterways Management without actual notice from October 26, Division; telephone 904–714–7616, 2017, through 7 a.m. on November 1, Dated: October 2, 2017. email [email protected]. 2017. For the purposes of enforcement, Barry L. Dragon, SUPPLEMENTARY INFORMATION: On August actual notice will be used from 7 a.m. Director, Bridge Branch, Seventh Coast Guard 22, 2017, the Coast Guard published a on September 29, 2017, until October District. temporary deviation entitled, 26, 2017. [FR Doc. 2017–23320 Filed 10–25–17; 8:45 am] ‘‘Drawbridge Operation Regulation; ADDRESSES: The docket for this BILLING CODE 9110–04–P Atlantic Intracoastal Waterway, Indian deviation, USCG–2017–0936 is available River, Titusville, FL’’ in the Federal at http://www.regulations.gov. Type the Register (82 FR 39665). Under that docket number in the ‘‘SEARCH’’ box temporary deviation, from 8 a.m. on and click ‘‘SEARCH’’. Click on Open August 17, 2017 to 4 p.m. on September Docket Folder on the line associated 26, 2017, the bridge would remain with this deviation. closed to navigation from 8 a.m. to noon FOR FURTHER INFORMATION CONTACT: If and from 1 p.m. to 4 p.m., Monday you have questions on this temporary through Friday. The bridge owner,
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NASA, has requested an extension of sewage sludge incineration (SSI) units performance have been established time for the temporary deviation from within the City of Philadelphia. This under section 111(b) for new sources of the operating schedule that governs the negative declaration certifies that SSI the same type, and EPA has established NASA Railroad Bridge (Jay Jay Bridge) units subject to the requirements of emission guidelines (EG) for such to complete bridge repairs, due to delays sections 111(d) and 129 of the Clean Air existing sources. A designated pollutant and storm damage related to Hurricane Act (CAA) do not exist within the is any pollutant for which no air quality Irma. The bridge is a single leaf bascule jurisdictional boundaries of the criteria have been issued, and which is railroad bridge with a seven foot vertical Philadelphia Air Management Service not included on a list published under clearance in the closed position. The (AMS). EPA is accepting the negative section 108(a) or section 112(b)(1)(A) of normal operating schedule for the declaration in accordance with the the CAA, but emissions of which are bridge is found in 33 CFR 117.261(j). requirements of the CAA. subject to a standard of performance for The deviation period is from 8 a.m. on DATES: This rule is effective on new stationary sources. On March 21, September 27, 2017 to 4 p.m. on December 26, 2017 without further 2011 (76 FR 15372), EPA promulgated October 31, 2017. During this period, notice, unless EPA receives adverse SSI unit new source performance the bridge is allowed to remain closed written comment by November 27, standards, 40 CFR part 60, subpart to navigation from 8 a.m. to noon and 2017. If EPA receives such comments, it LLLL, and emission guidelines, subpart from 1 p.m. to 4 p.m., Monday through will publish a timely withdrawal of the MMMM. The designated facilities to Friday. direct final rule in the Federal Register which the EG apply are existing SSI Vessels able to pass through the and inform the public that the rule will units that: (1) Commenced construction bridge in the closed position may do so not take effect. on or before October 14, 2010; (2) that at anytime. The bridge will be able to ADDRESSES: Submit your comments, meet the definition of a SSI unit as open for emergencies and there is no identified by Docket ID Number EPA– defined in § 60.5250; and (3) are not immediate alternate route for vessels to R03–OAR–2017–0509 at http:// exempt under § 60.5065. Subpart B of 40 CFR part 60 pass. The Coast Guard will also inform www.regulations.gov, or via email to establishes procedures to be followed the users of the waterways through our [email protected]. For comments and requirements to be met in the Local and Broadcast Notices to Mariners submitted at Regulations.gov, follow the development and submission of state of the change in operating schedule for online instructions for submitting plans for controlling designated the bridge so that vessel operators can comments. Once submitted, comments pollutants. Also, 40 CFR part 62 arrange their transits to minimize any cannot be edited or removed from provides the procedural framework for impact caused by the temporary Regulations.gov. For either manner of the submission of these plans. When deviation. submission, EPA may publish any designated facilities are located in a In accordance with 33 CFR 117.35(e), comment received to its public docket. state, the state must then develop and the drawbridge must return to its regular Do not submit electronically any operating schedule immediately at the submit a plan for the control of the information you consider to be designated pollutant. However, 40 CFR end of the effective period of this confidential business information (CBI) temporary deviation. This deviation 60.23(b) and 62.06 provide that if there or other information whose disclosure is are no existing sources of the designated from the operating regulations is restricted by statute. Multimedia authorized under 33 CFR 117.35. pollutant in the state, the state may submissions (audio, video, etc.) must be submit a letter of certification to that Dated: September 27, 2017. accompanied by a written comment. effect (i.e., negative declaration) in lieu Barry L. Dragon, The written comment is considered the of a plan. The negative declaration Director, Bridge Branch, Seventh Coast Guard official comment and should include exempts the state from the requirements District. discussion of all points you wish to of subpart B that require the submittal make. EPA will generally not consider [FR Doc. 2017–23322 Filed 10–25–17; 8:45 am] of a 111(d)/129 plan. comments or comment contents located BILLING CODE 9110–04–P outside of the primary submission (i.e. II. State Submittal and EPA Analysis on the Web, cloud, or other file sharing Philadelphia AMS has determined system). For additional submission ENVIRONMENTAL PROTECTION that there are no SSI units subject to the methods, please contact the person AGENCY requirements of Sections CAA 111(d) identified in the FOR FURTHER and 129 of the CAA in their respective 40 CFR Part 62 INFORMATION CONTACT section. For the air pollution control jurisdiction. full EPA public comment policy, Accordingly, Philadelphia AMS [EPA–R03–OAR–2017–0509; FRL–9969–92– information about CBI or multimedia submitted a negative declaration letter Region 3] submissions, and general guidance on to EPA certifying this fact on March 28, making effective comments, please visit Approval and Promulgation of State 2012. The negative declaration letter http://www2.epa.gov/dockets/ Air Quality Plans for Designated and EPA’s technical support document commenting-epa-dockets. Facilities and Pollutants; City of for this action are available in the Philadelphia; Control of Emissions FOR FURTHER INFORMATION CONTACT: docket for this the docket for this From Existing Sewage Sludge Mike Gordon, (215) 814–2039, or by rulemaking and available online at Incineration Units email at [email protected]. www.regulations.gov. SUPPLEMENTARY INFORMATION: AGENCY: Environmental Protection III. Final Action Agency (EPA). I. Background In this direct final action, EPA is ACTION: Direct final rule. Sections 111(d) and 129 of the CAA amending part 62 to reflect receipt of require states to submit plans to control the negative declaration letter from SUMMARY: The Environmental Protection certain pollutants (designated Philadelphia AMS. EPA is publishing Agency (EPA) is taking direct final pollutants) at existing solid waste this rule without prior proposal because action to notify the public that it has combustor facilities (designated EPA views this as a noncontroversial received a negative declaration for facilities) whenever standards of amendment and anticipates no adverse
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comment. However, in the ‘‘Proposed levels of government, as specified in Court of Appeals for the appropriate Rules’’ section of today’s Federal Executive Order 13132 (64 FR 43255, circuit by December 26, 2017. Filing a Register, EPA is publishing a separate August 10, 1999). This action merely petition for reconsideration by the document that will serve as the proposal approves the negative declaration for Administrator of this final rule does not to approve the revision if adverse existing SSI units from the Philadelphia affect the finality of this action for the comments are filed. This rule will be AMS and does not alter the relationship purposes of judicial review nor does it effective on December 26, 2017 without or the distribution of power and extend the time within which a petition further notice unless EPA receives responsibilities established in the Clean for judicial review may be filed, and adverse comment by November 27, Air Act. This action also is not subject shall not postpone the effectiveness of 2017. If EPA receives adverse comment, to Executive Order 13045 ‘‘Protection of such rule or action. Parties with EPA will publish a timely withdrawal in Children from Environmental Health objections to this direct final rule are the Federal Register informing the Risks and Safety Risks’’ (62 FR 19885, encouraged to file a comment in public that the rule will not take effect. April 23, 1997), because it is not response to the parallel notice of EPA will address all public comments economically significant. proposed rulemaking for this action in a subsequent final rule based on the With regard to negative declarations published in the proposed rules section proposed rule. EPA will not institute a for designated facilities received by EPA of today’s Federal Register, rather than second comment period on this action. from states, EPA’s role is to notify the file an immediate petition for judicial Any parties interested in commenting public of the receipt of such negative review of this direct final rule, so that must do so at this time. declarations and revise 40 CFR part 62 EPA can withdraw this direct final rule accordingly. In this context, in the and address the comment in the IV. Statutory and Executive Order absence of a prior existing requirement Reviews proposed rulemaking. for the State to use voluntary consensus This action approving a negative A. General Requirements standards (VCS), EPA has no authority declaration submitted by Philadelphia to approve or disapprove a CAA section Under Executive Order 12866 (58 FR AMS for SSI units may not be 111(d)/129 plan negative declaration 51735, October 4, 1993), this action is challenged later in proceedings to submission for failure to use VCS. It not a ‘‘significant regulatory action’’ and enforce its requirements. (See section would thus be inconsistent with therefore is not subject to review by the 307(b)(2).) applicable law for EPA, when it reviews Office of Management and Budget. For a CAA section 111(d)/129 negative List of Subjects in 40 CFR Part 62 this reason, this action is also not declaration, to use VCS in place of a Environmental protection, subject to Executive Order 13211, section 111(d)/129 negative declaration Administrative practice and procedure, ‘‘Actions Concerning Regulations That that otherwise satisfies the provisions of Air pollution control, Intergovernmental Significantly Affect Energy Supply, the Clean Air Act. Thus, the relations, Reporting and recordkeeping Distribution, or Use’’ (66 FR 28355, May requirements of section 12(d) of the requirements, Waste treatment and 22, 2001). This action merely notifies National Technology Transfer and disposal. the public of EPA receipt of a negative Advancement Act of 1995 (15 U.S.C. Dated: October 11, 2017. declaration from an air pollution control 272 note) do not apply. This action does Cecil Rodrigues, agency without any existing SSI units in not impose an information collection their jurisdiction. This action imposes burden under the provisions of the Acting Regional Administrator, Region III. no requirements. Accordingly, EPA Paperwork Reduction Act of 1995 (44 40 CFR part 62 is amended as follows: certifies that this rule will not have a U.S.C. 3501 et seq.). significant economic impact on a PART 62—APPROVAL AND substantial number of small entities B. Submission to Congress and the PROMULGATION OF STATE PLANS under the Regulatory Flexibility Act (5 Comptroller General FOR DESIGNATED FACILITIES AND U.S.C. 601 et seq.). Because this action The Congressional Review Act, 5 POLLUTANTS does not impose any additional U.S.C. 801 et seq., as added by the Small ■ enforceable duty beyond that required Business Regulatory Enforcement 1. The authority citation for part 62 by state law, it does not contain any Fairness Act of 1996, generally provides continues to read as follows: unfunded mandate or significantly or that before a rule may take effect, the Authority: 42 U.S.C. 7401 et seq. uniquely affect small governments, as agency promulgating the rule must described in the Unfunded Mandates submit a rule report, which includes a Subpart NN—Pennsylvania Reform Act of 1995 (Pub. L. 104–4). copy of the rule, to each House of the ■ 2. Add an undesignated heading and This action also does not have tribal Congress and to the Comptroller General implications because it will not have a § 62.9665 to subpart NN to read as of the United States. EPA will submit a follows: substantial direct effect on one or more report containing this action and other Indian tribes, on the relationship required information to the U.S. Senate, Emissions From Existing Sewage Sludge between the Federal Government and the U.S. House of Representatives, and Incineration Units Indian tribes, or on the distribution of the Comptroller General of the United power and responsibilities between the § 62.9665 Identification of plan—negative States prior to publication of the rule in declaration. Federal Government and Indian tribes, the Federal Register. A major rule Letter from the City of Philadelphia, as specified by Executive Order 13175 cannot take effect until 60 days after it Department of Public Health, submitted (65 FR 67249, November 9, 2000). This is published in the Federal Register. March 28, 2012, certifying that there are action also does not have Federalism This action is not a ‘‘major rule’’ as no existing sewage sludge incineration implications because it does not have defined by 5 U.S.C. 804(2). substantial direct effects on the States, units within the City of Philadelphia, on the relationship between the national C. Petitions for Judicial Review Pennsylvania that are subject to 40 CFR government and the States, or on the Under section 307(b)(1) of the CAA, part 60, subpart Ce. distribution of power and petitions for judicial review of this [FR Doc. 2017–23229 Filed 10–25–17; 8:45 am] responsibilities among the various action must be filed in the United States BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION (EST), Monday through Friday, RIN Regulatory Information Number AGENCY excluding legal holidays. The telephone RTR Risk and Technology Review number for the Public Reading Room is SSM startup, shutdown and malfunction 40 CFR Part 63 (202) 566–1744, and the telephone TOSHI Target Organ Specific Hazard Index [EPA–HQ–OAR–2016–0490; FRL–9969–95– number for the EPA Docket Center is UMRA Unfunded Mandates Reform Act OAR] (202) 566–1742. FOR FURTHER INFORMATION CONTACT: For Background information. On RIN 2060–AS85 questions about this final action, contact December 27, 2016, the EPA proposed revisions to the POTW NESHAP based National Emission Standards for Katie Hanks, Sector Policies and on our RTR. In this action, we are Hazardous Air Pollutants: Publicly Programs Division (E143–03), Office of finalizing decisions and revisions for Owned Treatment Works Residual Risk Air Quality Planning and Standards, the rule. We summarize some of the and Technology Review U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, more significant comments we timely AGENCY: Environmental Protection 27711; telephone number: (919) 541– received regarding the proposed rule Agency (EPA). 2159; fax number: (919) 541–0516; and and provide our responses in this ACTION: Final rule. email address: [email protected]. For preamble. A summary of all other public specific information regarding the risk comments on the proposal and the SUMMARY: This action finalizes the modeling methodology, contact Terri EPA’s responses to those comments is residual risk and technology review Hollingsworth, Health and available in Response to Public (RTR) conducted for the Publicly Environmental Impacts Division (C539– Comments on the EPA’s Residual Risk Owned Treatment Works (POTW) 02), Office of Air Quality Planning and and Technology Review for the Publicly source category regulated under Standards, U.S. Environmental Owned Treatment Works Source national emission standards for Protection Agency, Research Triangle Category in Docket ID No. EPA–HQ– hazardous air pollutants (NESHAP). In Park, North Carolina 27711; telephone OAR–2016–0490. A ‘‘track changes’’ addition, we are taking final action number: (919) 541–5623; fax number: version of the regulatory language that addressing revised names and (919) 541–0840; and email address: incorporates the changes in this action definitions of the subcategories, [email protected]. For is available in the docket. revisions to the applicability criteria, information about the applicability of Organization of this document. The revised regulatory provisions pertaining the NESHAP to a particular entity, information in this preamble is to emissions during periods of startup, contact Sara Ayres, Office of organized as follows: shutdown, and malfunction (SSM), Enforcement and Compliance I. General Information initial notification requirements for Assurance, U.S. Environmental A. Does this action apply to me? existing Group 1 and Group 2 POTW, Protection Agency, 77 West Jackson B. Where can I get a copy of this document revisions to the requirements for new Boulevard (E–19J), Chicago, Illinois and other related information? Group 1 POTW, requirements for 60604; telephone number: (312) 353– C. Judicial Review and Administrative electronic reporting, and other 6266; and email address: ayres.sara@ Reconsideration miscellaneous edits and technical epa.gov. II. Background corrections. While we do not anticipate A. What is the statutory authority for this SUPPLEMENTARY INFORMATION: any emission reductions as a result of action? Preamble acronyms and B. What is the POTW source category and these revisions, the changes should abbreviations. We use multiple how does the NESHAP regulate HAP provide clarity for sources determining acronyms and terms in this preamble. emissions from the source category? applicability and ensuring compliance. While this list may not be exhaustive, to C. What changes did we propose for the DATES: This final rule is effective on ease the reading of this preamble and for POTW source category in our December October 26, 2017. reference purposes, the EPA defines the 27, 2016, RTR proposal? III. What is included in this final rule? ADDRESSES: The Environmental following terms and acronyms here: A. What are the final rule amendments Protection Agency (EPA) has established CAA Clean Air Act based on the risk review for the POTW a docket for this action under Docket ID CBI confidential business information source category? No. EPA–HQ–OAR–2016–0490. All CDX Central Data Exchange B. What are the final rule amendments documents in the docket are listed on CEDRI Compliance and Emissions Data based on the technology review for the the http://www.regulations.gov Web Reporting Interface POTW source category? site. Although listed in the index, some ERT Electronic Reporting Tool C. What are the final rule amendments information is not publicly available, HAP hazardous air pollutants(s) addressing emissions during periods of e.g., confidential business information HQ hazard quotient startup, shutdown, and malfunction? (CBI) or other information whose H2S hydrogen sulfide D. What other changes have been made to ICR Information Collection Request the NESHAP? disclosure is restricted by statute. MACT maximum achievable control E. What are the effective and compliance Certain other material, such as technology dates of the standards? copyrighted material, is not placed on MGD million gallons per day F. What are the requirements for the Internet and will be publicly MIR maximum individual risk submission of performance test data to available only in hard copy form. NESHAP national emission standards for the EPA? Publicly available docket materials are hazardous air pollutants IV. What is the rationale for our final available either electronically through NPDES National Pollutant Discharge decisions and amendments for the http://www.regulations.gov, or in hard Elimination System POTW source category? copy at the EPA Docket Center, EPA NTTAA National Technology Transfer A. Residual Risk Review for the POTW and Advancement Act Source Category WJC West Building, Room Number PB–HAP Hazardous air pollutants known B. Technology Review for the POTW 3334, 1301 Constitution Ave. NW., to be persistent and bio-accumulative in the Source Category Washington, DC. The Public Reading environment C. Applicability Criteria Room hours of operation are 8:30 a.m. POTW Publicly Owned Treatment Works D. Emissions From Collection Systems to 4:30 p.m. Eastern Standard Time RFA Regulatory Flexibility Act E. Pretreatment Requirements
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F. HAP Fraction Emitted for Existing intermunicipal or interstate agency, or brought by the EPA to enforce the Group 1 and Group 2 Sources any department, agency, or requirements. G. New and Existing Group 1 POTW instrumentality of the federal Section 307(d)(7)(B) of the CAA V. Summary of Cost, Environmental, and government (see 40 CFR 63.1595 of further provides that only an objection Economic Impacts and Additional to a rule or procedure which was raised Analyses Conducted subpart VVV). To determine whether A. What are the affected facilities? your facility is affected, you should with reasonable specificity during the B. What are the air quality impacts? examine the applicability criteria in the period for public comment (including C. What are the cost impacts? POTW NESHAP. Specifically, if a any public hearing) may be raised D. What are the economic impacts? POTW is a Group 2 POTW 1 that is a during judicial review. This section also E. What are the benefits? major source of hazardous air pollutant provides a mechanism for the EPA to F. What analysis of environmental justice (HAP) emissions or a Group 1 POTW reconsider the rule if the person raising did we conduct? regardless of the HAP emissions, and an objection can demonstrate to the G. What analysis of children’s Administrator that it was impracticable environmental health did we conduct? the POTW meets the criteria for VI. Statutory and Executive Order Reviews development and implementation of a to raise such objection within the period A. Executive Order 12866: Regulatory pretreatment program according to 40 for public comment or if the grounds for Planning and Review and Executive CFR 403.8, then the POTW is affected such objection arose after the period for Order 13563: Improving Regulation and by these standards. If you have any public comment (but within the time Regulatory Review questions regarding the applicability of specified for judicial review) and if such B. Executive Order 13771: Reducing any aspect of this NESHAP, please objection is of central relevance to the Regulations and Controlling Regulatory contact the appropriate person listed in outcome of the rule. Any person seeking Costs FOR FURTHER INFORMATION to make such a demonstration should C. Paperwork Reduction Act (PRA) the preceding D. Regulatory Flexibility Act (RFA) CONTACT section of this preamble. submit a Petition for Reconsideration to E. Unfunded Mandates Reform Act the Office of the Administrator, U.S. B. Where can I get a copy of this EPA, Room 3000, EPA WJC South (UMRA) document and other related F. Executive Order 13132: Federalism Building, 1200 Pennsylvania Ave. NW., information? G. Executive Order 13175: Consultation Washington, DC 20460, with a copy to and Coordination With Indian Tribal In addition to being available in the both the person(s) listed in the Governments docket, an electronic copy of this final preceding FOR FURTHER INFORMATION H. Executive Order 13045: Protection of action will also be available on the CONTACT section, and the Associate Children From Environmental Health General Counsel for the Air and Risks and Safety Risks Internet. Following signature by the I. Executive Order 13211: Actions EPA Administrator, the EPA will post a Radiation Law Office, Office of General Concerning Regulations That copy of this final action at http:// Counsel (Mail Code 2344A), U.S. EPA, Significantly Affect Energy Supply, www.epa.gov/stationary-sources-air- 1200 Pennsylvania Ave. NW., Distribution, or Use pollution/publicly-owned-treatment- Washington, DC 20460. J. National Technology Transfer and works-potw-national-emission- II. Background Advancement Act (NTTAA) standards. Following publication in the K. Executive Order 12898: Federal Actions Federal Register, the EPA will post the A. What is the statutory authority for To Address Environmental Justice in Federal Register version and key this action? Minority Populations and Low-Income Populations technical documents at this same Web Section 112 of the CAA establishes a L. Congressional Review Act (CRA) site. two-stage regulatory process to address Additional information is available on emissions of HAP from stationary I. General Information the RTR Web site at http:// sources. In the first stage, we must A. Does this action apply to me? www.epa.gov/ttn/atw/rrisk/rtrpg.html. identify categories of sources emitting This information includes an overview one or more of the HAP listed in CAA Regulated entities. Categories and of the RTR program, links to project section 112(b) and then promulgate entities potentially regulated by this Web sites for the RTR source categories, technology-based NESHAP for those action are shown in Table 1 of this and detailed emissions and other data sources. ‘‘Major sources’’ are those that preamble. we used as inputs to the risk emit, or have the potential to emit, any assessments. single HAP at a rate of 10 tons per year TABLE 1—NESHAP AND INDUSTRIAL (tpy) or more, or 25 tpy or more of any SOURCE CATEGORIES AFFECTED BY C. Judicial Review and Administrative Reconsideration combination of HAP. For major sources, THIS FINAL ACTION these standards are commonly referred NESHAP and source NAICS 1 Under Clean Air Act (CAA) section to as maximum achievable control category NESHAP code 307(b)(1), judicial review of this final technology (MACT) standards and must action is available only by filing a reflect the maximum degree of emission Sewage Treatment Fa- Subpart VVV ..... 221320 petition for review in the United States cilities. reductions of HAP achievable (after Court of Appeals for the District of considering cost, energy requirements, 1 North American Industry Classification System. Columbia Circuit by December 26, 2017. and non-air quality health and Table 1 of this preamble is not Under CAA section 307(b)(2), the environmental impacts). In developing intended to be exhaustive, but rather to requirements established by this final MACT standards, CAA section 112(d)(2) provide a guide for readers regarding rule may not be challenged separately in directs the EPA to consider the entities likely to be affected by the final any civil or criminal proceedings application of measures, processes, action for the source category listed. The methods, systems, or techniques, standards are directly applicable to the 1 As discussed below in section III.D of this including but not limited to those that affected sources. Federal, state, local, preamble, the terms ‘‘Group 1 POTW’’ and ‘‘Group reduce the volume of or eliminate HAP and tribal governments are affected as 2 POTW’’ are replacing the previous terms ‘‘industrial POTW’’ and ‘‘nonindustrial POTW. The emissions through process changes, discussed below. By definition, a POTW ‘‘Group 1’’ and ‘‘Group 2’’ subcategories are substitution of materials, or other is owned by a municipality, state, described in the regulatory text at 40 CFR 63.1581. modifications; enclose systems or
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processes to eliminate emissions; to CAA section 112(f).2 For more user as the means by which that collect, capture, or treat HAP when information on the statutory authority industrial user complies with another released from a process, stack, storage, for this rule, see the proposed rule NESHAP. The 2002 POTW NESHAP or fugitive emissions point; are design, published on December 27, 2016 (81 FR defined an ‘‘industrial POTW’’ as ‘‘a equipment, work practice, or 95352). POTW that accepts a waste stream regulated by another NESHAP and operational standards; or any B. What is the POTW source category provides treatment and controls as an combination of the above. and how does the NESHAP regulate agent for the industrial discharger. The For these MACT standards, the statute HAP emissions from the source industrial discharger complies with its specifies certain minimum stringency category? NESHAP by using the treatment and requirements, which are referred to as 1. Definition of the POTW Source controls located at the POTW. For MACT floor requirements, and which Category and the Affected Source example, an industry discharges its may not be based on cost The EPA promulgated the NESHAP benzene-containing waste stream to the considerations. See CAA section POTW for treatment to comply with 40 112(d)(3). For new sources, the MACT for the POTW source category (henceforth referred to as the ‘‘POTW CFR part 61, subpart FF—National floor cannot be less stringent than the Emission Standards for Benzene Waste emission control achieved in practice by NESHAP’’) on October 26, 1999 (64 FR 57572). The standards are codified at 40 Operations. This definition does not the best-controlled similar source. The include POTW treating waste streams MACT standards for existing sources CFR part 63, subpart VVV. The POTW NESHAP was amended on October 21, not specifically regulated under another can be less stringent than floors for new NESHAP.’’ An ‘‘industrial POTW’’ is sources, but they cannot be less 2002 (67 FR 64742). As amended in 2002, the POTW source category subject to the 2002 POTW NESHAP stringent than the average emission regardless of the HAP emissions (i.e., limitation achieved by the best- consists of new and existing POTW treatment plants that are located at a the POTW does not have to be a major performing 12 percent of existing source). In contrast, a ‘‘non-industrial sources in the category or subcategory POTW that is a major source of HAP emissions and that meets the criteria for POTW’’ was defined in the 2002 POTW (or the best-performing five sources for development and implementation of a NESHAP as ‘‘a POTW that does not categories or subcategories with fewer pretreatment program as defined by 40 meet the definition of an industrial than 30 sources). In developing MACT CFR 403.8 under the Clean Water Act POTW as defined above.’’ A ‘‘non- standards, we must also consider (CWA). Additional information about industrial POTW’’ must be a major control options that are more stringent the National Pretreatment Program can source to be subject to the 2002 POTW than the floor under CAA section be found in the December 27, 2016, RTR NESHAP. For more information, see the 112(d)(2). We may establish standards proposal (81 FR 95374). The source December 27, 2016, RTR proposal (81 more stringent than the floor, based on category covered by this MACT FR 95357). the consideration of the cost of standard currently includes thirteen 3. HAP Emitted and HAP Emission achieving the emissions reductions, any facilities. Points non-air quality health and As used in this regulation, the term environmental impacts, and energy POTW refers to both any POTW that is The amount and type of HAP emitted requirements. owned by a state, municipality, or from a POTW is dependent on the composition of the wastewater streams In the second stage of the regulatory intermunicipal or interstate agency and, discharged to a POTW by industrial process, the CAA requires the EPA to therefore, eligible to receive grant assistance under the Subchapter II of the users. The primary HAP emitted from undertake two different analyses, which the POTW that were identified as we refer to as the technology review and CWA, and any federally owned treatment works as that term is subject to the POTW NESHAP include the residual risk review. Under the acetaldehyde, acetonitrile, chloroform, described in section 3023 of the Solid technology review, we must review the ethylene glycol, formaldehyde, Waste Disposal Act. For more technology-based standards and revise methanol, methylene chloride, information see the December 27, 2016, them ‘‘as necessary (taking into account tetratchloroethylene, toluene, and RTR proposal (81 FR 95352). The source developments in practices, processes, xylenes. The HAP present in the category includes any intercepting and control technologies)’’ no less wastewater entering a POTW can sewers, outfall sewers, sewage frequently than every 8 years, pursuant biodegrade, adhere to sewage sludge, collection systems, pumping, power, to CAA section 112(d)(6). Under the volatilize to the air, or pass through and other equipment. The wastewater residual risk review, we must evaluate (remain in the wastewater discharge) to treated by these facilities is generated by the risk to public health remaining after receiving waters. Emissions can occur at industrial, commercial, and domestic application of the technology-based any point at the POTW, including sources. standards and revise the standards, if collection systems and wastewater necessary, to provide an ample margin 2. Applicability of the 2002 POTW treatment units located at the POTW of safety to protect public health or to NESHAP treatment plant. prevent, taking into consideration costs, energy, safety, and other relevant The 2002 POTW NESHAP is 4. Regulation of HAP Emissions in the factors, an adverse environmental effect. subcategorized based on whether the 2002 POTW NESHAP POTW is providing treatment for The residual risk review is required The POTW NESHAP specifies wastewaters received from an industrial within 8 years after promulgation of the requirements for the industial and non- technology-based standards, pursuant to 2 The U.S. Court of Appeals for the District of industrial POTW subcategories. Under CAA section 112(f). In conducting the Columbia Circuit has affirmed this approach of the 2002 POTW NESHAP, an existing residual risk review, if the EPA implementing CAA section 112(f)(2)(A): NRDC v. ‘‘industrial POTW’’ must meet the determines that the current standards EPA, 529 F.3d 1077, 1083 (D.C. Cir. 2008) (‘‘If EPA requirements of the industrial user’s provide an ample margin of safety to determines that the existing technology-based standards provide an ‘ample margin of safety,’ then NESHAP. A new or reconstructed protect public health, it is not necessary the Agency is free to readopt those standards during ‘‘industrial POTW’’ must meet the to revise the MACT standards pursuant the residual risk rulemaking.’’). requirements of the industrial user’s
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NESHAP or the requirements for new or requirements for electronic reporting; B. What are the final rule amendments reconstructed non-industrial POTW, and make other miscellaneous edits and based on the technology review for the whichever is more stringent. technical corrections. POTW source category? There are no control requirements in III. What is included in this final rule? We determined that there are no the 2002 POTW NESHAP for existing developments in practices, processes, This action finalizes the EPA’s ‘‘non-industrial POTW.’’ However, new and control technologies that warrant determinations pursuant to the RTR or reconstructed ‘‘non-industrial revisions to the MACT standards for this provisions of CAA section 112 for the POTW’’ must equip each treatment unit source category. Therefore, we are not POTW source category. This action also up to, but not including, the secondary finalizing revisions to the MACT finalizes other changes to the NESHAP, influent pumping station, with a cover. standards under CAA section 112(d)(6). In addition, all covered units, except the including revised names and definitions primary clarifier, must route the air in of the subcategories, clarified C. What are the final rule amendments the headspace above the surface of the applicability criteria, revised regulatory addressing emissions during periods of wastewater to a control device that provisions pertaining to emissions startup, shutdown, and malfunction? meets the requirements for closed-vent during periods or SSM, initial Consistent with Sierra Club v. EPA, systems and control devices found in notification requirements for existing 552 F.3d 1019 (D.C. Cir. 2008), the EPA the NESHAP from Off-Site Waste and Group 1 and Group 2 POTW, has established standards in this rule Recovery Operations (40 CFR part 63, requirements for new or reconstructed that apply at all times. We have revised subpart DD). As an alternative, a new or Group 1 POTW to comply with both the Table 1 to Subpart VVV of Part 63 (the reconstructed ‘‘non-industrial POTW’’ requirements in the POTW NESHAP General Provisions applicability table) can demonstrate that all units up to, but and those in the applicable NESHAP for in several respects to eliminate the not including, the secondary influent which the POTW acts as a control agent, incorporation of those General pumping station emit a HAP fraction of requirements for electronic reporting, Provisions that stated or were tied to the 0.014 or less. The HAP fraction emitted and other miscellaneous edits and SSM exemption. These revisions to is the fraction of HAP in the wastewater technical corrections. As explained in Table 1 are explained in detail in the entering the POTW that is emitted to the section IV of this preamble, we are not proposed rule preamble at 81 FR 95780– atmosphere. For additional information, taking final action at this time on 95782. Further, in conjunction with the see the December 27, 2016, RTR several provisions that were proposed, elimination of the incorporation of these proposal (81 FR 95357). including standards for pretreatment, General Provisions requirements, we the inclusion of collection systems in C. What changes did we propose for the have (1) added a general duty to the major source determination, and the minimize emissions in 40 CFR POTW source category in our December HAP fraction emission limit for existing 27, 2016, RTR proposal? 63.1582(e) and 63.1586(e), see 81 FR at Group 1 and Group 2 POTW. 95380 (col. 2–3); (2) incorporated On December 27, 2016, the EPA performance testing requirements for published a proposed rule in the A. What are the final rule amendments control devices in 40 CFR 63.694, see 81 Federal Register for the POTW based on the risk review for the POTW FR at 95781 (col. 1); (3) added language NESHAP, 40 CFR part 63, subpart VVV, source category? to Table 1 related to monitoring that is that took into consideration the RTR We determined that risks resulting identical to 40 CFR 63.8(d)(3) (which is analyses. In the proposed rule, we from emissions from the POTW source no longer incorporated) but with certain proposed that the risks are acceptable category are acceptable. Specifically, the and the current standards provide an maximum individual cancer risk (MIR) revisions to reflect the ending of the ample margin of safety to protect public is 2-in-1 million based on allowable SSM plan requirement, see 81 FR at health. Additionally, we did not emissions and 1-in-1 million based on 95381 (col. 2); (4) made the identify any developments in practices, actual emissions, well below the recordkeeping requirements in 40 CFR processes, and control technologies for presumptive limit of acceptability (100- 63.696(h) and 63.1589(d) applicable to the POTW source category as part of the in-1 million), and other health periods that were previously covered by technology review. During this information indicates there is no SSM-related provisions, see 81 FR rulemaking, we evaluated other appreciable risk of adverse chronic or 95381 (col. 2–3); and (5) amended the revisions to the 2002 POTW NESHAP acute non-cancer health effects due to reporting requirements in 40 CFR outside of the RTR. We proposed to HAP emissions from the source 63.1590 which, in conjunction with the revise the names and definitions of the category. Additionally, emissions of 2- existing reporting requirements in 40 industrial and non-industrial methylnaphthalene, the only HAP CFR 63.693 and 63.1590(a), will subcategories to be called Group 1 and emitted from the POTW source category adequately provide for reporting that Group 2 POTW. We also proposed to that is known to be persistent and bio- was previously governed by SSM- include requirements to limit emissions accumulative in the environment (PB– related provisions, see 81 FR at 95382. from collection systems and the POTW HAP), did not exceed the worst-case D. What other changes have been made treatment plant; requirements for Tier I screening emission rate or any to the NESHAP? existing, new, or reconstructed Group 1 ecological benchmarks. Therefore, POTW to comply with both the revisions to the standards are not 1. Applicability Criteria requirements in the POTW NESHAP necessary to reduce risk to an acceptable The EPA is not revising the and those in the applicable NESHAP for level or to prevent an adverse applicability of 40 CFR part 63, subpart which the POTW acts as a control agent; environmental effect. Further, VVV as proposed on December 27, 2016. and HAP emission limits for existing considering risk and non-risk factors, Instead, the EPA is finalizing minor Group 2 POTW. In addition, we we determined that the 2002 POTW clarifying changes to the applicability proposed to clarify the applicability NESHAP requirements provide an criteria that are in the 2002 POTW criteria; require initial notification for ample margin of safety to protect public NESHAP. The renaming of the existing Group 1 and Group 2 POTW; health. Therefore, we are not finalizing subcategories (from ‘‘industrial’’ to revise regulatory provisions pertaining revisions to the standards under CAA ‘‘Group 1’’ and from ‘‘non-industrial’’ to to emissions during periods of SSM; add section 112(f)(2). ‘‘Group 2) and the definitions of Group
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1 and Group 2 POTW are being finalized which they act as an agent of control for • Revising 40 CFR 63.1588(a)(3) to as proposed, and as discussed below. an industrial user and the requirements clarify that a cover defect must be However, for clarification, the EPA has for new Group 2 POTW in this final repaired within 45 ‘‘calendar’’ days; removed the statements regarding rule. The requirements for new Group 2 currently the paragraph says ‘‘45 days.’’ ownership and operation of POTW in POTW are unchanged from the 2002 • Adding definitions of existing regards to which POTW are required to POTW NESHAP and provide the option source/POTW and new source/POTW to develop and implement a pretreatment of complying with either (a) cover all 40 CFR 63.1595 to clarify the date that program as defined by 40 CFR 403.8. primary treatment units and route determines whether a POTW is existing This change clarifies that any Group 1 emissions through a closed vent system or new. POTW (regardless of HAP emissions) or to a control device or (b) meet a HAP • Renaming the title of 40 CFR Group 2 POTW that is a major source of fraction emission limit of 0.014 for 63.1588 to ‘‘How do Group 1 and Group HAP is subject to the POTW NESHAP emissions from all primary treatment 2 POTW treatment plants demonstrate if the POTW also meets the criteria for units. compliance?’’ from ‘‘What inspections development and implementation of a must I conduct?’’ The new title better pretreatment program, regardless of 5. Requirements for Electronic reflects the contents of this section. whether the POTW, state, or other entity Reporting • Removing the details on how to implements the pretreatment program. The EPA is finalizing electronic calculate the HAP fraction emitted from reporting requirements for new POTW the definition of HAP fraction emitted. 2. Names and Definitions of the consistent with the proposed rule. The procedure for how to calculate the Subcategories Specifically, new POTW must HAP fraction emitted is provided within As proposed, the EPA is revising the electroncally submit all annual reports the text of the rule. Having a names and definitions for the and certain performance test reports. summarized version of this procedure in subcategories identified in the POTW The EPA believes that the electronic the definition could cause confusion. NESHAP. The EPA is renaming an submittal of these reports will increase • Revising two references to dates to ‘‘industrial POTW treatment plant’’ as a the usefulness of data contained in insert the actual dates. The phrase ‘‘six ‘‘Group 1’’ POTW treatment plant and a those reports, is in keeping with current months after October 26, 1999’’ was ‘‘non-industrial POTW treatment plant’’ trends in data availability, will further replaced with ‘‘April 26, 2000’’; and the as a ‘‘Group 2’’ POTW treatment plant. assist in the protection of public health phrase ‘‘60 days after October 26, 1999’’ The EPA expects that this clarification and the environment, and will was replaced with ‘‘December 27, will address any confusion that could ultimately result in less burden on the 1999.’’ These changes do not result in a have been caused by the previous regulated community. change in the date, but only clarify the subcategory names ‘‘industrial POTW specific dates being referenced. treatment plant’’ and ‘‘non-industrial 6. Other Miscellaneous Edits and • Clarifying that the reports required treatment plant’’ because POTW in both Technical Corrections in 40 CFR 63.1589(b)(1) include the subcategories treat wastewater from The EPA is finalizing the following records associated with the HAP loading industrial users. The key difference technical corrections as proposed: and not just the records associated with between Group 1 and Group 2 is that a • Revising all references to ‘‘new or the HAP emissions determination. Group 1 POTW acts as an agent for an reconstructed POTW’’ to refer to ‘‘new • Removing the definition of industrial user by accepting and POTW’’ because the definition of ‘‘new’’ ‘‘Reconstruction’’ in 40 CFR 63.1595 as controling the industrial user’s waste includes reconstructed POTW. ‘‘Reconstruction’’ is already defined in stream regulated under another • Combining text from 40 CFR the General Provisions of 40 CFR 63.2. 63.1581 and 63.1582 because the NESHAP. By contrast, a Group 2 POTW E. What are the effective and language was redundant and confusing. may treat the waste stream from an compliance dates of the standards? industrial user, but does not act as the This includes revising 40 CFR 63.1581 industrial user’s agent to comply with to include all combined text and The revisions to the MACT standards another NESHAP. revising 40 CFR 63.1583(c) to include being promulgated in this action are the text from the current 40 CR effective on October 26, 2017. 3. Initial Notification Requirements for 63.1582(c). The compliance date for existing Existing Group 1 and Group 2 POTW • Revising 40 CFR 63.1586(b)(1) to Group 1 POTW is found in the In the final rule (40 CFR 63.1586(a)), require covers ‘‘designed and operated applicable NESHAP for which the existing Group 1 and Group 2 POTW to prevent exposure of the wastewater to industrial user is subject to wastewater treatment plants must comply with the the atmosphere’’ instead of ‘‘designed requirements. The compliance date for initial notification requirements in 40 and operated to minimize exposure of existing Group 2 POTW constructed or CFR 63.1591(a) of subpart VVV. This the wastewater to the atmosphere.’’ This reconstructed on or before December 1, notification requirement was not clarification has also been made to the 1998, remains April 26, 2000. While we required for these existing sources in the definition of ‘‘cover’’ in 40 CFR 63.1595. do not expect any additional existing 2002 POTW NESHAP, but was proposed • Revising 40 CFR 63.1587 to include Group 1 or Group 2 POTW beyond the in the December 27, 2016, proposal, and compliance requirements that are 13 identified, we have chosen to include is consistent with notification currently found in 40 CFR 64.1584 and an additional compliance date of requirements that were applicable to 63.1587, and deleting 40 CFR 63.1584. October 26, 2018 for existing Group 1 new or reconstructed Group 2 sources • Clarifying the method for and Group 2 sources to submit their under the 2002 POTW NESHAP. calculating the HAP fraction emitted initial notification. We understand from and moving the detailed instructions for public comments that POTW are 4. Requirements for New Group 1 calculating the HAP fraction emitted evaluating their potential emissions and POTW from 40 CFR 63.1588(c)(4) to 40 CFR additional POTW may find they are The EPA is finalizing, as proposed, 63.1588(c)(3). The requirements subject to the rule. These POTW are the requirement that new Group 1 remaining in 40 CFR 63.1588(c)(4) only required to submit a notification POTW comply with both the address monitoring for continuous that they are subject to the rule, and the requirements of the other NESHAP for compliance. additional time given for compliance of
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this notification submittal will provide out comprehensive reviews will the EPA’s rationale for the final time for completion of the necessary increase and be achieved within a decisions and amendments, and a emission calculations. The 13 existing shorter period of time. summary of key comments and sources that are subject to the rule and We anticipate fewer or less substantial responses. Comments not discussed in were previously identified have already Information Collection Requests (ICRs) this preamble, comment summaries, and met this notification requirement and do in conjunction with prospective CAA- the EPA’s responses can be found in the not need to resubmit a notification. New required technology reviews may be comment summary and response sources constructed or reconstructed needed, which results in a decrease in document available in the docket after December 27, 2016, must comply time spent by industry to respond to (Docket ID No. EPA–HQ–OAR–2016– with all of the standards immediately data collection requests. We also expect 0490). upon the effective date of the standard, the ICRs to contain less extensive stack A. Residual Risk Review for the POTW October 26, 2017, or upon startup, testing provisions, as we will already Source Category whichever is later. While we did not have stack test data electronically. identify any new sources that are Reduced testing requirements would be Pursuant to CAA section 112(f), we subject to the rule since the original rule a cost savings to industry. The EPA conducted a residual risk review and was published in 1999, we are including should also be able to conduct these presented the results of the review, a transition period until October 26, required reviews more quickly. While along with our proposed decisions 2020 for any new sources constructed or the regulated community may benefit regarding risk acceptability and ample reconstructed between December 1, from a reduced burden of ICRs, the margin of safety, in the December 27, 1998, and December 27, 2016, to comply general public benefits from the 2016, RTR proposal (81 FR 95372). The with the revisions in this rule. agency’s ability to provide these residual risk review for the POTW required reviews more quickly, resulting source category included assessment of F. What are the requirements for in increased public health and cancer risk, chronic non-cancer risk, submission of annual reports and environmental protection. and acute non-cancer risk due to performance test data to the EPA? Air agencies, as well as the EPA, can inhalation exposure, as well as As we proposed, the EPA is finalizing benefit from more streamlined and multipathway exposure risk and the requirement for owners and automated review of the electronically environmental risk. The results of the operators of POTW to submit electronic submitted data. Standardizing report risk assessment are presented briefly in copies of certain required performance formats allows air agencies to review this preamble and in more detail in the test reports and annual reports through reports and data more quickly. Having residual risk document, Residual Risk the EPA’s Central Data Exchange (CDX) reports and associated data in electronic Assessment for Publicly Owned using the Compliance and Emissions format facilitates review through the use Treatment Works Source Category in Data Reporting Interface (CEDRI). The of software ‘‘search’’ options, as well as Support of the October 2017 Risk and electronic submittal of the reports the downloading and analyzing of data Technology Review Final Rule,3 which addressed in this rulemaking will in spreadsheet format. Additionally, air is available in the docket for this increase the usefulness of the data agencies and the EPA can access reports rulemaking. contained in those reports, is in keeping wherever and whenever they want or The results indicated that maximum with current trends in data availability need, as long as they have access to the inhalation cancer risk to the individual and transparency, will further assist in Internet. The ability to access and most exposed is 2-in-1 million based on the protection of public health and the review reports electronically assists air allowable emissions and 1-in-1 million environment, will improve compliance agencies in determining compliance based on actual emissions, which is by facilitating the ability of regulated with applicable regulations more well below the presumptive limit of facilities to demonstrate compliance quickly and accurately, potentially acceptability (i.e., 100-in-1 million). In with requirements and by facilitating allowing a faster response to violations, addition, the maximum chronic the ability of delegated state, local, which could minimize harmful air noncancer target organ specific hazard tribal, and territorial air agencies and emissions. This benefits both air index (TOSHI) due to inhalation the EPA to assess and determine agencies and the general public. exposures is less than 1. The evaluation compliance, and will ultimately reduce For a more thorough discussion of of acute noncancer risk, which was burden on regulated facilities, delegated electronic reporting required by this conservative, showed a hazard quotient air agencies, and the EPA. Electronic rule, see the discussion in the preamble at or below 1 for all but one POTW. reporting also eliminates paper-based, of the proposal. In summary, in addition Based on the results of the screening manual processes, thereby saving time to supporting regulation development, analyses for human multipathway and resources, simplifying data entry, control strategy development, and other exposure to, and environmental impacts eliminating redundancies, minimizing air pollution control activities, having from, PB–HAP, we also concluded that data reporting errors, and providing data an electronic database populated with the cancer risk to the individual most quickly and accurately to the affected performance test data will save exposed through ingestion is below the facilities, air agencies, the EPA, and the industry, air agencies, and the EPA level of concern and no ecological public. significant time, money, and effort benchmarks are exceeded. The facility- The EPA Web site that stores the while improving the quality of emission wide cancer and noncancer risks were submitted electronic data, WebFIRE, is inventories and air quality regulations estimated based on the actual emissions easily accessible and provides a user- and enhancing the public’s access to from all sources at the identified POTW friendly interface. By making records, this important information. (both MACT and non-MACT sources). data, and reports addressed in this The results indicated the cancer risk to rulemaking readily available, the EPA, IV. What is the rationale for our final the regulated community, and the decisions and amendments for the 3 This report is an update to the residual risk public will benefit when the EPA POTW source category? report provided at proposal, Residual Risk Assessment for Publicly Owned Treatment Works conducts its CAA-required technology For each decision or amendment, this Source Category in Support of the December 2016 reviews. As a result of having reports section provides a description of what Risk and Technology Review Proposed Rule, readily accessible, our ability to carry we proposed and what we are finalizing, available in the docket.
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the individual most exposed is no Residual Risk Assessment for the been no technology advances since 1998 greater than 10-in-1 million and the Publicly Owned Treatment Works that warrant a change in the original noncancer TOSHI is less than 1. Source Category in Support of the MACT analysis. Several commenters Considering the above information, as October 2017 Risk and Technology provided additional information on well as other relevant non-health factors Review Final Rule found in the docket specific control technologies, including under the Benzene NESHAP analysis for this rulemaking. biofilters, caustic scrubbers, and carbon codified in CAA 112(f)(2)(B), we Most of the commenters on the absorbers. One of these commenters proposed that the risk is acceptable and proposed risk review supported our risk stated that biofilters are not reliable the requirements in the 2002 POTW acceptability and ample margin of safety control devices in the context of a NESHAP provide an ample margin of determinations for the POTW NESHAP. POTW because they are designed for safety to protect public health and Some commenters requested that we stable operating conditions. In contrast, prevent an adverse environmental make changes to our residual risk another commenter provided effect. review approach. However, we information that biofilters might have The risk assessment conducted for the evaluated the comments and the ability to reduce HAP in addition to determined that no changes to our risk POTW proposal estimated cancer, hydrogen sulfide (H2S) and volatile chronic noncancer, and acute noncancer assessment methods or conclusions are organic compounds (VOC). Additional risk for six of the 13 facilities in the warranted. A summary of these comments on the technology review can source category and is summarized and comments and responses are in the be found in section 3 of the response to comment summary and response referenced above. We confirmed the comments document in the docket for document, available in the docket for existence of seven additional POTW this rule (EPA–HQ–OAR–2016–0490). this action (Docket ID No. EPA–HQ– subject to the rule that were identified Response: The EPA conducted a OAR–2016–0490). through public comments. For these Since proposal, our risk assessment literature review and evaluated seven POTW, we conducted a facility- has been broadened to include available studies and publications on wide risk assessment of potential cancer additional POTW; however, the the use of add-on controls and process and chronic noncancer health effects. conclusions of our risk assessment and modifications that are used to reduce The results of this assessment indicate our determinations regarding risk emissions from POTW wastewater that all seven POTW have a facility- acceptability, ample margin of safety, collection and treatment operations. As wide noncancer TOSHI less than 1, four and adverse environmental effects have noted by the commenters, these of the POTW have a facility-wide cancer not changed. For the reasons explained technologies include biotrickling filters, risk estimated less than 1-in-1 million, in the proposed rule and discussed the use of covers and ducting of the and three of the POTW have a facility- above, we determined that the risks headspace vent stream to caustic wide cancer risk estimated at or above from the POTW source category are scrubbers and carbon adsorbers, and 10-in-1 million. The highest facility- acceptable, and that the current biofiltration/biofilters. These types of wide MIR was 60-in-1 million driven by standards provide an ample margin of technologies have been used historically formaldehyde from internal combustion safety to protect public health and at POTW where they provide a engines which are covered under the prevent an adverse environmental relatively high degree of H2S control for NESHAP for the Stationary effect. the purpose of preventing odor. As Reciprocating Internal Combustion documented in the technology review Engines source category. For this POTW B. Technology Review for the POTW memorandum and reflected in the with the highest facility-wide MIR, the Source Category comments received on the proposed facility-wide emissions of formaldehyde As described in the December 27, rule, the efficacy of these technologies are 22 tpy while the source category 2016, RTR proposal (81 FR 95373), and to reduce HAP emissions is highly emissions of formaldehyde are 0.0026 as provided by CAA section 112(d)(6), variable and dependent on site-specific tpy, which indicates that almost 100 our technology review focused on operating parameters. Our conclusion is percent of the estimated cancer risk is identifying developments in the that the experience with biofilters for from emissions sources that are not part practices, processes, and control controlling organics at POTW is at the of the POTW source category. This ratio technologies for the POTW source experimental and pilot scale and that of source category emissions relative to category. We concluded that there are this technology has not been facility-wide emissions of formaldehyde two different control options that may demonstrated to be commercially is the same for the other two POTW be used at a POTW to reduce HAP available and effective for controlling with facility-wide cancer risk estimated emissions: pretreatment programs and the range of HAP emitted by POTW. at or above 10-in-1 million. Therefore, it add-on controls (i.e., covers or covers Thus, we do not consider this is reasonable to conclude that all 13 vented to a control device). While we technology to be a development in POTW have estimated cancer risk close proposed specific revisions to the practices, processes, or control to or below 1-in-1 million from source standards, none of those revisions were technologies for purposes of this category emissions and we retain our the result of any identified technology review. Scrubbers are proposed determination that risk is developments in practices, processes, or generally not used to control emissions acceptable. Further, as discussed in the control technologies beyond the of organic constituents, and while December 27, 2016, RTR proposal (81 programs and controls already in use at carbon adsorbers may be effective at FR 95373), we retain our determination the time of the promulgation of the HAP control in certain applications, as that, considering the costs, economic original 40 CFR part 63, subpart VVV used in POTW, they are generally not impacts and technological feasibility of rulemaking. designed for HAP control. Nevertheless, additional standards to reduce risk Comment: We received various 40 CFR part 63, subpart VVV allows further, the 2002 POTW NESHAP comments related to the information flexibility for POTW to develop site- provides an ample margin of safety to evaluated for the proposal. Two specific control strategies to meet any protect public health and prevents an commenters stated that there is no applicable requirements, and such adverse environmental effect. Details of technical basis that requires the EPA to strategies could include the use of this risk assessment are described in the revise the standards since there have biologic filters and carbon adsorbers
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that can achieve the required control order to be subject to the rule. The rule language, we sought to define such levels. proposed revisions were intended to POTW by using a regulatory criterion As stated in section III.B of this clarify the intent of the rule, which was that was already established and well preamble, we did not identify any to limit applicability to POTW that treat understood in the industry. We selected developments in practices, processes, or at least 5 MGD and wastewater from the criterion that the POTW be subject control technology with respect to industrial users. to a pretreatment program under the programs and controls already in use Comment: We received numerous NPDES program because this criterion when the 2002 POTW NESHAP was comments that raised specific concerns would encompass industrial and promulgated that warrant revisions to related to these proposed changes. First, commercial wastes with HAP that pass the standards as part of the technology commenters disagreed that the proposed through the POTW untreated and that review of the POTW NESHAP. changes were necessary and stated that could present a safety or health concern the proposed changes created confusion C. Applicability Criteria to POTW workers. In adopting this and changed the scope of affected criterion, we did not limit applicability The 2002 POTW NESHAP established sources. One commenter stated that the based on the entity that administers the three criteria (40 CFR 63.1580(a)(1), (2), applicability of 40 CFR part 63, subpart program. In other words, the criterion and (3)) for determining what POTW are VVV has been well-defined for over 17 encompasses every POTW that receives subject to the rule. Specifically, the years, and if sources are confused, the a waste stream that is subject to following criteria must all be true: (1) EPA has methods to correct any pretreatment standards, regardless of You own or operate a POTW that confusion without making rule changes. whether the standards are prescribed by includes a POTW treatment plant; (2) Several commenters specifically the POTW itself or by a state or federal the POTW is a major source of HAP objected to the proposed change that regulatory body. Thus, to make sure that emissions, or an industrial POTW removed pretreatment from the third the regulatory text is properly read, we regardless of the HAP emissions; and (3) applicability criterion and made it a have revised 40 CFR 63.1581(a)(3) to the POTW is required to develop and requirement of the rule. These make clear that a POTW is subject to implement a pretreatment program as commenters stated that removing this rule if either (1) the POTW is defined by 40 CFR 403.8. The EPA pretreatment as an applicability required to develop and implement a proposed to revise the applicability criterion and making it a requirement pretreatment program as defined by 40 criteria in order to clarify the original changes the source category that the CFR 403.8, or (2) the POTW meets the intent of the rule. Specifically, we EPA intended to control. One state general criteria for development and proposed to revise the first and second commented that this proposed change implementation of a pretreatment criteria in 40 CFR 63.1580(a)(1) and (2) would cause an additional 12 POTW in program, even if does not develop and to state that your POTW is subject to the their state to become subject to the rule. implement the pretreatment program POTW NESHAP if ‘‘(1) You own or The commenter explained that because itself. Specifically, we have removed the operate a POTW that is a major source the state (not the POTW) implements parenthetical text in 40 CFR of HAP emissions; or (2) you own or the National Pollutant Discharge 63.1580(a)(3) that limited the first part operate a Group 1 POTW regardless of Elimination System (NPDES) of the third criterion to POTW owned or whether or not it is a major source of pretreatment program, the original rule operated by a municipality, state, or HAP.’’ As stated in the proposal, we does not apply to any POTW in that intermunicipal or interstate agency and proposed this revision because we state. limited the second part of the third found several instances where a POTW Response: As stated in the proposal, criterion to POTW owned or operated might not realize they are subject to the the EPA did not intend to expand the by a department, agency, or standards, or where the applicability applicability criteria from the 2002 instrumentality of the federal criteria could be misinterpreted to POTW NESHAP. After consideration of government. exclude facilities that are covered by the the comments received, we agree that rule. See 81 FR 95377. implementing the proposed changes to D. Emissions From Collection Systems The third applicability criterion in the rule applicability could have caused In the 2016 proposal, we stated that 2002 POTW NESHAP states that ‘‘(3) confusion among the regulated HAP emissions from collection systems Your POTW is required to develop and community without a demonstrable should be included when determining implement a pretreatment program as environmental benefit. Therefore, at this whether the POTW is a major source, defined by 40 CFR 403.8 (for a POTW time, we are not making any substantive and therefore, subject to the rule. owned or operated by a municipality, change to the 2002 POTW NESHAP Specifically, we stated that the 2002 state, or intermunicipal or interstate third applicability criterion and are not applicability criteria in 40 CFR agency), or your POTW would meet the adopting the proposed applicability 63.1580(a)(2) provided that emissions general criteria for development and criterion of 5 MGD. However, it is from the entire POTW source category implementation of a pretreatment important to note that the requirements must be considered when determining program (for a POTW owned or in the National Pretreatment Program do whether the POTW is a major source of operated by a department, agency, or establish a 5 MGD threshold for HAP emissions, and not just the instrumentality of the Federal applicability. emissions from the POTW treatment government).’’ We proposed revising the In response to the apparent potential plant (i.e., the portion of the POTW third criterion in 40 CFR 63.1580(a)(3) for misinterpretation of the regulatory designed to provide treatment of to state ‘‘You are subject to this subpart text that is reflected in the state’s municipal sewage or industrial waste). if your POTW has a design capacity to comment, we are making one minor Comment: Several commenters treat at least 5 million gallons of change to clarify our interpretation and opposed including emissions from wastewater per day (MGD) and treats the intent of 40 CFR 63.1580(a)(3). In collection systems in the determination wastewater from an industrial user, and developing the 2002 POTW NESHAP, of whether a POTW is a major source. either paragraph (a)(1) or (a)(2) is true.’’ we wrote the rule to apply to POTW that The commenters stated that collection This proposed revision removed the receive a significant amount of HAP- systems/sewers may include hundreds requirement that a POTW must already containing waste from industrial or or thousands of miles of sewers and have a pretreatment program in place in commercial facilities. In developing the other equipment, are not always under
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the jurisdiction of the POTW, and are often a complex determination. of HAP in the wastewater before it is typically owned by another entity. Facilities work with their permitting discharged to the collection system. The We also received comments that authority to consider factors such as intent of this requirement was to reduce stated the inclusion of emissions from whether activities and equipment are in the pollutant loading into the POTW in collection systems for major source a contiguous area and whether they are order to reduce emissions throughout all determination is inconsistent with the under common control. In stages of treatment. federal definition of a major source. One contemplating the comments, the EPA Comment: Several commenters commenter stated that expansion of the has decided that we do not have enough objected to the EPA requiring a major source definition to include information on individual POTW, pretreatment program for HAP collection sewers as part of the affected including information on the emissions. Commenters disagreed with source is not authorized under section jurisdiction of the control of collection the EPA’s contention that a pretreatment 112 of the CAA. The commenter also system equipment or information on program will reduce emissions of HAP stated that the equipment that collect whether this equipment should be by reducing the presence of toxic gases. and convey wastewater to a POTW considered contiguous with the POTW Specifically, commenters noted that a treatment plant do not reasonably treatment plant. Also, data on HAP ‘‘pretreatment program under CAA constitute a ‘‘building, structure, emissions from collection systems are Section 112 is not the same as a facility, or installation’’ as specified in not well understood, and we are not pretreatment program under the Clean the definition of a stationary source in aware of accepted methods for Water Act (CWA)’’, as 40 CFR 403 section 112(a)(3) of the CAA, are clearly measuring or calculating emissions from authorizes POTW to set pretreatment not within a contiguous area under collection systems at this time. In requirements for air contaminants for common control, and should not be addition, we understand that these worker and plant safety, and to prevent considered a single source. Commenters source boundary determinations have interference and pass through. One noted that the determination of a major already been made for the commenter contended that the proposed source of HAP emissions should be approximately 16,000 POTW through rule expands the CAA regulatory limited to emission sources within the Title V applicability assessment. For framework into the CWA National fence line of each treatment plant, these reasons, we are not taking final Pretreatment Program without a legal which would be consistent with the fact action at this time to change these basis. that the emission fraction requirement determinations. We may take action in Additionally, several commenters of the proposed POTW NESHAP is the future if we obtain additional opposed requiring POTW to develop limited to emissions within the information on source boundary issues local limits and expressed concerns treatment plant. Further, one (i.e., common control, contiguous area), about the way in which local limits commenter contended that excluding HAP emissions, and other information should be determined. Instead, collection system emissions in POTW related to the issues described above. commenters suggested that the EPA major source determinations is also With respect to new sources, we establish wastewater concentration supported by Alabama Power Co. v. expect new sources to consult their limits for HAP to identify pollutants Costle and EPA’s response to that permitting authorities on these matters that may need local limits. One decision. as they plan for new construction. The commenter stated that the EPA should Commenters also noted that the EPA considers these determinations on either ‘‘regulate industrial users directly emission data reviewed by the EPA in source boundaries to be appropriately for HAP or provide technically-based developing the proposed rule under the jurisdiction of the permitting wastewater concentrations for HAP that represented the HAP emissions from the authority. Accordingly, to avoid POTW could use for screening (where POTW treatment plant only. One regulatory disruption, this final rule analytical methods exist under 40 CFR commenter noted that the risk takes no action to change the definition part 136)’’ to determine the need for assessment did not include emissions of POTW. The definition of POTW establishing local limits. from collection systems. Several remains the same as originally Commenters also expressed concerns commenters disagreed with the EPA’s promulgated and continues to include about the costs related to requiring statement in the preamble to the ‘‘. . . any intercepting sewers, outfall pretreatment programs wherein POTW proposed rule that collection systems sewers, sewage collection systems, evaluate and set local limits for volatile may have significant HAP emissions. pumping, power and other equipment.’’ organic HAP. The commenters stated Some commenters suggested that Likewise, we are not taking final action that developing local limits to identify emissions from collection systems are at this time to revise the originally pollutants of concern, as well as identify insignificant and in some cases promulgated definition of the affected potential pretreatment controls, would collection systems are operated under a source. The definition of affected source require significant time and that the vacuum to control odors. However, continues to mean the ‘‘group of all significant costs these requirements none of the commenters provided data equipment that comprise the POTW would impose on POTW have not been to demonstrate the level of HAP treatment plant.’’ quantified or justified. In contrast, one emissions from collection systems. commenter stated that categorical limits Response: Considering these E. Pretreatment Requirements set by the EPA pursuant to the CWA for comments, the EPA is not taking final As stated in section IV.C of this certain industries could merit action at this time on any changes to the preamble, the EPA proposed removing consideration, but additional analysis is emission sources that must be pretreatment from the applicability required. considered when determining if a criteria and making it a control Response: In response to these POTW is a major source of HAP requirement for new and existing comments, we are not taking final action emissions. Specifically, the EPA is not sources. We proposed adding at this time to require pretreatment as a taking action on whether emissions pretreatment requirements in the rule control requirement for the revised from collection systems should be because pretreatment would reduce NESHAP. As explained in section IV.C included in the total HAP emissions HAP emissions from the entire source of this preamble, we are not changing from a POTW. The determination of category (i.e., collection systems and the the applicability criteria for 40 CFR part source boundaries is a site-specific and treatment plant) by limiting the quantity 63, subpart VVV. The existence of a
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pretreatment program under the CWA two POTW might not be representative control costs for all affected sources or will continue to be one of the three rule of HAP emitted by other POTW. One the emissions reductions that might be applicability criteria. commenter suggested that due to the achieved. For all of these reasons, we The EPA Office of Water is uncertainty associated with such a small are not taking final action on the responsible for administering the data set, the EPA should use a larger proposed 0.08 HAP fraction at this time, pretreatment program and updates the multiplier for setting a standard. but we may in the future consider requirements of the pretreatment Additionally, commenters stated that promulgating a limit if we obtain further program based on the best available the EPA had underestimated the cost of information on the issues discussed technology and taking into account cost achieving compliance with the 0.08 above. effectiveness. As the pretreatment HAP fraction emitted standard. requirements are modified through Specifically, commenters stated that in G. New and Existing Group 1 POTW future updates, additional HAP order to comply, they would incur In addition to proposing a HAP reductions may occur. Because all of the capital and operating costs, in addition fraction for existing Group 1 POTW, we POTW that are subject to the rule to the recordkeeping and reporting costs also proposed other changes to the already have pretreatment programs, that the EPA accounted for in the requirements for Group 1 POTW. specifically requiring pretreatment proposal. One commenter stated that The 2002 POTW NESHAP required under the NESHAP would not reduce they would potentially need to install existing Group 1 POTW to comply only HAP emissions further, but could cause covers and controls in order to meet the with the requirements of the other confusion and increase compliance HAP fraction emitted limit, which NESHAP for which they are acting as an costs. Thus, we are not finalizing any would be an expense of $20 to $30 agent of control for the industrial user. revisions at this time to impose million with negligible emission We proposed that existing Group 1 additional pretreatment requirements reductions. Two commenters argued POTW must meet both the requirements prior to discharging a wastewater stream that the compliance cost for the of the other NESHAP for which they are to a receiving POTW. Pretreatment will proposed standard was not warranted acting as an agent of control for an continue to be handled under the given the low public health risk that the industrial user and the proposed authority of the CWA. By retaining the EPA estimated. Commenters further requirements for existing Group 2 existing regulatory structure of the recommended that the EPA gather more POTW in the POTW NESHAP (i.e., the NESHAP, the EPA avoids redundancy complete data from the universe of proposed 0.08 HAP fraction emitted and confusion in having pretreatment affected sources, conduct statistical limit discussed in IV.F, above). requirements included in both air and analysis of those data, and determine a The 2002 POTW NESHAP required water permits. suitable standard based on an new and reconstructed (which we are acceptable level of risk and variability of now referring to as ‘‘new’’) Group 1 F. HAP Fraction Emitted for Existing the data. POTW to comply with the more Group 1 and Group 2 Sources Response: After reviewing public stringent of the following: (1) The In the 2016 proposal, we proposed comments and re-evaluating our requirements of the other NESHAP for that existing Group 1 and Group 2 analysis, we are not taking final action which they are acting as an agent of POTW operate with an annual rolling to adopt the 0.08 HAP fraction emitted control for the industrial user; or (2) the average HAP fraction emitted from limit for existing Group 1 and Group 2 requirements applicable to new Group 2 primary treatment units of 0.08 or less. POTW at this time. The proposed HAP POTW, which allowed the POTW to As stated in the proposal, we believed fraction emitted limit did not reflect the choose to meet either a requirement to that the existing POTW we knew about performance or application of a specific (a) cover all equipment and route could meet this standard without the control technology. At proposal, we emissions through a closed vent system need for additional control. envisioned this limit as an enforceable to a control device; or (b) meet a HAP Comment: We received numerous numerical limit that would ensure fraction emission limit of 0.014 for comments that opposed the proposed performance consistent with that being emissions from all primary treatment HAP fraction emission limit, and we achieved by existing sources. However, units. We proposed that new Group 1 received additional data to suggest the after consideration of the information POTW comply with the other NESHAP proposed 0.08 HAP fraction limit was provided in public comment, we now for which they are acting as an agent of not appropriate and did not accurately recognize that we do not have the control for an industrial user and the account for variability in HAP loading at comprehensive data on existing POTW requirements for new Group 2 POTW in individual POTW. that are necessary to conduct a the 2002 POTW NESHAP. (Note that we Several commenters objected that sufficiently robust analysis. The HAP did not propose, and are not finalizing, merely doubling the single largest HAP fraction emitted by different POTW is any revisions to the requirements for fractions from the two available sources influenced by individual HAP vapor new Group 2 POTW.) was not a scientifically or statistically pressures, pollutant loadings, HAP valid method for setting the emission concentrations, sample measurement 1. Existing Group 1 POTW limit and stated that the EPA had and analytical techniques, and ambient Comment: We received comments provided no support for using the 2x conditions, which differ from POTW to from one of the existing Group 1 POTW factor to account for variability of POTW. Testing of influent loadings is that expressed concern that by imposing emissions. For example, the limited by applicable test methods, by the HAP fraction emitted limit on the commenters collectively pointed out compounds identified by dischargers, existing Group 1 POTW with no that the two POTW on which the and by the HAP for which air permits alternative compliance option, the EPA proposed standard was based were require sampling. Without sufficient had ignored existing POTW with covers operating at half capacity, that the data, we cannot determine an and controls already in place. The available data represent merely a appropriate HAP fraction emitted limit, commenter stated that new Group 1 snapshot in time, that other potentially considering the variability in operating POTW have the option of either regulated POTW might emit higher HAP conditions that is likely to occur across installing covers or complying with the fractions, and that the specific even well-operated POTW. Moreover, at HAP fraction limit. However, the EPA combination of HAP measured by the this time, we are unable to analyze the did not provide that flexibility to
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existing Group 1 POTW, thereby B. What are the air quality impacts? Final Economic Impact Analysis for the imposing an additional HAP fraction The EPA estimates that annual Publicly Owned Treatment Works limit without a cover option and more organic HAP emissions from the 13 National Emissions Standards for onerous recordkeeping and reporting POTW subject to the rule are Hazardous Air Pollutants Risk and requirements. The commenter stated approximately 35 tpy. We expect no Technology Review, which is available in the docket for this final rule (Docket that the EPA should provide existing emissions of inorganic HAP from this ID No. EPA–HQ–OAR–2016–0490). Group 1 POTW that already use covers category. The EPA does not anticipate the option of adding controls in lieu of any additional emission reductions from E. What are the benefits? complying with a HAP fraction limit. the final changes to the rule, and there Response: The EPA is not taking final We do not anticipate any significant are no anticipated new or reconstructed reductions in HAP emissions as a result action on the proposed changes for facilities. existing Group 1 sources at this time. As of these final amendments. However, we explained in section IV.F of this C. What are the cost impacts? think that the amendments will help to enhance the clarity of the rule, which preamble, we are not setting a HAP The 13 entities subject to this fraction limit for existing Group 1 or can improve compliance and minimize proposal will incur only minimal costs emissions. Group 2 POTW at this time; therefore, related to familiarizing themselves with no additional requirements are being this rule—estimated to be a one-time F. What analysis of environmental added for existing Group 1 POTW in the total cost of $790 for all 13 entities. For justice did we conduct? POTW NESHAP. Thus, as required by further information on the requirements the 2002 POTW NESHAP, an existing We examined the potential for any of this rule, see section IV of this environmental justice concerns that Group 1 POTW must comply with the preamble. For further information on control requirements as specified in the might be associated with this source the costs associated with the category by performing a demographic appropriate NESHAP for the industrial requirements of this rule, see the user(s). analysis of the population close to the document titled Economic Impact six POTW that were modeled for source 2. New Group 1 POTW Analysis for the National Emission category risk.4 In this analysis, we Standards for Hazardous Air Pollutants: We did not receive any comment on evaluated the distribution of HAP- Publicly Owned Treatment Works Risk our proposed revision to the related cancer and non-cancer risks and Technology Review, in the docket. requirements for new Group 1 POTW. from the POTW source category across The memorandum titled Technology We proposed, and are finalizing, that different social, demographic, and Review Memorandum for the Publicly new Group 1 POTW must (1) meet the economic groups within the populations Owned Treatment Works Source requirements of the other NESHAP for living near facilities identified as having Category, in the docket for this action, which they act as an agent of control for the highest risks. The methodology and presents costs estimated associated with an industrial user and (2) either (a) the results of the demographic analyses the regulatory options that were not cover all equipment and route emissions are included in a technical report, Risk selected for inclusion in this final rule through a closed vent system to a and Technology Review—Analysis of (Docket ID No. EPA–HQ–OAR–2016– control device or (b) meet a HAP Socio-Economic Factors for Populations 0490). fraction emission limit of 0.014 for Living Near POTW Facilities, available emissions from all primary treatment D. What are the economic impacts? in the docket for this action (Docket ID units. See 81 FR 95375 for our rationale No. EPA–HQ–OAR–2016–0490). The The economic impact analysis is results for various demographic groups for this change. Because we received no designed to inform decision makers adverse comment on our proposal, we are based on the estimated risks from about the potential economic actual emissions levels for the are finalizing these requirements as consequences of a regulatory action. For proposed. population living within 50 kilometers this rule, the EPA estimated the annual (km) of the facilities. V. Summary of Cost, Environmental, cost of recordkeeping and reporting as a The results of the POTW source and Economic Impacts and Additional percentage of reported sewage fees category demographic analysis indicate Analyses Conducted received by the affected POTW. For the that actual emissions from the source revisions promulgated in this final rule, A. What are the affected facilities? category expose no person to a cancer costs are expected to be less than 0.001 risk at or above 1-in-1 million or to a The EPA estimates, based on the percent of collected sewage fees, based chronic non-cancer TOSHI greater than responses to the 2015 ICR, the 2011 and on publicly available financial reports 1. Therefore, we conclude that this final 2014 National Emissions Inventory from the fiscal year ending in 2015 for rule will not have disproportionately (NEI), and public comments received, the affected entities. high and adverse human health or that there are 13 POTW that are engaged In addition, the EPA performed a environmental effects on minority or in treatment of industrial wastewater screening analysis for impacts on small low-income populations because it does and are currently subject to the POTW businesses by comparing estimated not affect the level of protection NESHAP. Two of these facilities are population served by the affected provided to human health or the considered Group 1 POTW, while the entities to the population limit set forth environment. However, this final rule remaining eleven are considered Group by the U.S. Small Business may provide additional benefits to these 2 POTW. All 13 currently subject to the Administration. The screening analysis demographic groups by improving the POTW NESHAP have already met the found that the population served for all compliance and implementation of the notification requirements for existing affected entities is greater than the limit NESHAP. The demographics of the Group 1 and Group 2 POTW. The EPA qualifying a public entity as a small population living within 50 km of is not currently aware of any planned business. POTW can be found in Table 2 of the new Group 1 or Group 2 POTW that will More information and details of the document titled Risk and Technology be constructed or any existing Group 1 EPA’s analysis of the economic impacts, or Group 2 POTW that will be including the conclusions stated above, 4 See section IV.A of this preamble for an reconstructed. are provided in the technical document, explanation of the residual risk assessment.
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Review—Analysis of Socio-Economic have already met this initial notification F. Executive Order 13132: Federalism Factors for Populations Living Near requirement and are not required to This action does not have federalism Publicly Owned Treatment Works, submit an additional notification. The implications. It will not have substantial available in the docket for this final rule information will be used to identify direct effects on the states, on the (Docket ID No. EPA–HQ–OAR–2016– sources subject to the standards. relationship between the national 0490). Respondents/affected entities: The government and the states, or on the respondents to the recordkeeping and distribution of power and G. What analysis of children’s reporting requirements are owners and environmental health did we conduct? responsibilities among the various operators of POTW. The NAICS code for levels of government. This action is not subject to Executive the respondents affected by the standard Order 13045 because it is not is 221320 (Sewage Treatment Facilities), G. Executive Order 13175: Consultation economically significant as defined in which corresponds to the United States and Coordination With Indian Tribal Executive Order 12866, and because the Standard Industrial Classification code Governments EPA does not believe the environmental 4952 (Sewerage Systems). This action does not have tribal health or safety risks addressed by this Respondent’s obligation to respond: implications as specified in Executive action present a disproportionate risk to Respondents are obligated to respond in Order 13175. As discussed in section children. The results of the POTW accordance with the notification II.B.1 of this preamble, we have source category demographic analysis requirements under 40 CFR 63.1591(a). identified only 13 POTW that are indicate that actual emissions from the Estimated number of respondents: subject to this final rule and none of source category expose no person to a Zero. those POTW are owned or operated by cancer risk at or above 1-in-1 million or Frequency of response: One response. tribal governments. Thus, Executive to a chronic non-cancer TOSHI greater Total estimated burden: 0 hours (per Order 13175 does not apply to this than 1. Therefore, the analysis shows year). Burden is defined at 5 CFR action. that actual emissions from the POTW 1320.3(b). source category are not expected to have Total estimated cost: $0 (per year), H. Executive Order 13045: Protection of an adverse human health effect on includes $0 annualized capital or Children From Environmental Health children. operation and maintenance costs. Risks and Safety Risks An agency may not conduct or The action is not subject to Executive VI. Statutory and Executive Order sponsor, and a person is not required to Order 13045 because it is not Reviews respond to, a collection of information economically significant as defined in Additional information about these unless it displays a currently valid OMB Executive Order 12866, and because the statutes and Executive Orders can be control number. The OMB control EPA does not believe the environmental found at http://www2.epa.gov/laws- numbers for the EPA’s regulations in 40 health or safety risks addressed by this regulations/laws-and-executive-orders. CFR are listed in 40 CFR part 9. When action present a disproportionate risk to OMB approves this ICR, the Agency will children. This action’s health and risk A. Executive Order 12866: Regulatory announce that approval in the Federal Planning and Review and Executive assessments are contained in sections Register and publish a technical III.A and B and sections IV.A and B of Order 13563: Improving Regulation and amendment to 40 CFR part 9 to display Regulatory Review this preamble and the Residual Risk the OMB control number for the Report memorandum contained in the This action is not a significant approved information collection docket for this rulemaking. regulatory action and was therefore not activities contained in this final rule. submitted to the Office of Management I. Executive Order 13211: Actions D. Regulatory Flexibility Act (RFA) and Budget (OMB) for review. Concerning Regulations That I certify that this action will not have Significantly Affect Energy Supply, B. Executive Order 13771: Reducing a significant economic impact on a Distribution, or Use Regulations and Controlling Regulatory substantial number of small entities Costs This action is not subject to Executive under the RFA. This action will not Order 13211 because it is not a This action is not an Executive Order impose any requirements on small significant regulatory action under 13771 regulatory action because this entities. There are no small entities Executive Order 12866. action is not significant under Executive affected in this regulated industry. See Order 12866. the technical document, Final Economic J. National Technology Transfer and Impact Analysis for the National Advancement Act (NTTAA) C. Paperwork Reduction Act (PRA) Emission Standards for Hazardous Air This rulemaking does not involve The information collection activities Pollutants: Publicly Owned Treatment technical standards. in this rule have been submitted for Works Risk and Technology Review, approval to the OMB under the PRA. which is available in the docket for this K. Executive Order 12898: Federal The ICR document that the EPA final rule (Docket ID No. EPA–HQ– Actions To Address Environmental prepared has been assigned EPA ICR OAR–2016–0490) for more detail. Justice in Minority Populations and number 1891.08. You can find a copy of Low-Income Populations the ICR in the docket for this rule, and E. Unfunded Mandates Reform Act The EPA believes that this action does it is briefly summarized here. The (UMRA) not have disproportionately high and information collection requirements are This action does not contain an adverse human health or environmental not enforceable until OMB approves unfunded mandate of $100 million or effects on minority populations, low- them. more as described in UMRA, 2 U.S.C. income populations, and/or indigenous The information to be collected 1531–1538, and does not significantly or peoples, as specified in Executive Order includes the initial notification that the uniquely affect small governments. The 12898 (59 FR 7629, February 16, 1994). POTW is subject to the rule. However, action imposes no enforceable duty on The documentation for this decision as stated in this preamble, the 13 any state, local, or tribal governments or is contained in section III.A.6 of this sources that we already know about the private sector. preamble and in the corresponding
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technical report, Risk and Technology 63.1583 What are the emission points and § 63.1581 Does the subpart distinguish Review—Analysis of Socio-Economic control requirements for a Group 1 between different types of POTW treatment Factors for Populations Living Near POTW treatment plant? plants? Publicly Owned Treatment Works, 63.1584 [Reserved] Yes, POTW treatment plants are 63.1585 How does a Group 1 POTW divided into two subcategories: Group 1 available in the docket for this action. treatment plant demonstrate The proximity results indicate, for eight compliance? POTW treatment plants and Group 2 of the 11 demographic categories, that POTW treatment plants, as described in the population percentages within 5 km Requirements for Group 1 and Group 2 paragraphs (a) through (c) of this POTW Treatment Plants and 50 km of source category emissions section. are greater than the corresponding 63.1586 What are the emission points and (a) Your POTW is a Group 1 POTW control requirements for a Group 1 or national percentage for those same treatment plant if an industrial user Group 2 POTW? complies with its NESHAP by using the demographics. However, the results of 63.1587 When do I have to comply? the risk analysis presented in section 63.1588 How do Group 1 and Group 2 treatment and controls located at your III.A.6 of this preamble and in the POTW treatment plants demonstrate POTW treatment plant. Your POTW corresponding technical report indicate compliance? treatment plant accepts the regulated that actual emissions from the source 63.1589 What records must I keep? waste stream and provides treatment category expose no person to a cancer 63.1590 What reports must I submit? and controls as an agent for the risk at or above 1-in-1 million or to a 63.1591 What are my notification industrial user. Group 1 POTW requirements? chronic non-cancer TOSHI greater than treatment plant is defined in § 63.1595. 63.1592 Which General Provisions apply to (b) Your POTW is a Group 2 POTW 1. my POTW treatment plant? treatment plant if your POTW treats L. Congressional Review Act (CRA) 63.1593 [Reserved] 63.1594 Who enforces this subpart? wastewater that is not subject to control This action is subject to the CRA, and 63.1595 List of definitions. by another NESHAP or the industrial the EPA will submit a rule report to Table 1 to Subpart VVV of Part 63— user does not comply with its NESHAP each House of the Congress and to the Applicability of 40 CFR part 63 General by using the treatment and controls Comptroller General of the United Provisions to Subpart VVV located at your POTW treatment plant. States. This action is not a ‘‘major rule’’ Table 2 to Subpart VVV of Part 63— ‘‘Group 2 POTW treatment plant’’ is Compliance Dates and Requirements as defined by 5 U.S.C. 804(2). defined in § 63.1595. (c) If, in the future, an industrial user List of Subjects in 40 CFR Part 63 Subpart VVV—National Emission Standards for Hazardous Air complies with its NESHAP by using the Environmental protection, Pollutants: Publicly Owned Treatment treatment and controls located at your Administrative practice and procedures, Works POTW treatment plant, then your Group Air pollution control, Hazardous 2 POTW treatment plant becomes a substances, Intergovernmental relations, Applicability Group 1 POTW treatment plant on the Reporting and recordkeeping date your POTW begins treating that § 63.1580 Am I subject to this subpart? requirements. regulated industrial wastewater stream. (a) You are subject to this subpart if Dated: October 16, 2017. the following are all true: Requirements for Group 1 POTW E. Scott Pruitt, (1) You own or operate a publicly Treatment Plants Administrator. owned treatment works (POTW) that § 63.1582 [Reserved] For the reasons stated in the includes an affected source (§ 63.1595); preamble, the Environmental Protection (2) The affected source is located at a § 63.1583 What are the emission points Agency amends part 63 of title 40, Group 2 POTW which is a major source and control requirements for a Group 1 chapter I, of the Code of Federal of HAP emissions, or at any Group 1 POTW treatment plant? Regulations as follows: POTW regardless of whether or not it is (a) The emission points and control a major source of HAP; and requirements for an existing Group 1 PART 63—NATIONAL EMISSION (3) Your POTW is required to develop POTW treatment plant are specified in STANDARDS FOR HAZARDOUS AIR and implement a pretreatment program the appropriate NESHAP for the POLLUTANTS FOR SOURCE as defined by 40 CFR 403.8, or your industrial user(s). CATEGORIES POTW meets the general criteria for (b) The emission points and control ■ development and implementation of a requirements for a new Group 1 POTW 1. The authority citation for part 63 pretreatment program. continues to read as follows: treatment plant are both those specified (b) If your existing POTW treatment by the appropriate NESHAP which Authority: 42 U.S.C. 7401, et seq. plant is not located at a major source as apply to the industrial user(s) who ■ 2. Part 63 is amended by revising of October 26, 1999, but thereafter discharge their waste for treatment to subpart VVV to read as follows: becomes a major source for any reason the POTW, and those emission points other than reconstruction, then, for the Subpart VVV—National Emission Standards and control requirements set forth in purpose of this subpart, your POTW § 63.1586(b) or (c), as applicable. for Hazardous Air Pollutants: Publicly treatment plant would be considered an Owned Treatment Works (c) If your existing or new Group 1 existing source. POTW treatment plant accepts one or Applicability Note to paragraph (b): See § 63.2 of the more specific regulated industrial waste Sec. National Emission Standards for Hazardous streams as part of compliance with one 63.1580 Am I subject to this subpart? Air Pollutants (NESHAP) General Provisions or more other NESHAP, then you are 63.1581 Does the subpart distinguish in subpart A of this part for the definitions subject to all the requirements of each between different types of POTW of major source and area source. appropriate NESHAP for each waste treatment plants? (c) If you commence construction or stream. Requirements for Group 1 POTW Treatment reconstruction of your POTW treatment (d) At all times, the POTW must Plants plant after December 1, 1998, then the operate and maintain any affected 63.1582 [Reserved] requirements for a new POTW apply. source, including associated air
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pollution control equipment and primary clarifiers, must have the air in operating in compliance with operation monitoring equipment, in a manner the headspace underneath the cover and maintenance requirements will be consistent with safety and good air ducted to a control device in accordance based on information available to the pollution control practices for with the standards for closed-vent Administrator, which may include, but minimizing emissions. The general duty systems and control devices in § 63.693 is not limited to, monitoring results, to minimize emissions does not require of subpart DD—National Emission review of operation and maintenance the POTW to make any further efforts to Standards for Hazardous Air Pollutants procedures, review of operation and reduce emissions if levels required by from Off-site Waste and Recovery maintenance records, and inspection of the applicable standard have been Operations of this part, except you may the source. achieved. Determination of whether a substitute visual inspections for leak source is operating in compliance with detection rather than Method 21 of § 63.1587 When do I have to comply? operation and maintenance appendix A–7 of part 60 of this chapter. Sources subject to this subpart are requirements will be based on Covers must meet the following required to achieve compliance on or information available to the requirements: before the dates specified in table 2 of Administrator, which may include, but (1) Covers must be tightly fitted and this subpart. is not limited to, monitoring results, designed and operated to prevent exposure of the wastewater to the § 63.1588 How do Group 1 and Group 2 review of operation and maintenance POTW treatment plants demonstrate procedures, review of operation and atmosphere. This includes, but is not compliance? limited to, the absence of visible cracks, maintenance records, and inspection of (a) If you are complying with the source. holes, or gaps in the roof sections or between the roof and the supporting § 63.1586(b) by using covers, you must § 63.1584 [Reserved] wall; broken, cracked, or otherwise conduct the following inspections: damaged seals or gaskets on closure (1) You must visually check the cover § 63.1585 How does a Group 1 POTW and its closure devices for defects that treatment plant demonstrate compliance? devices; and broken or missing hatches, access covers, caps, or other closure could result in air emissions. Defects (a) An existing Group 1 POTW devices. include, but are not limited to, visible treatment plant demonstrates (2) If wastewater is in a treatment cracks, holes, or gaps in the roof compliance by operating treatment and unit, each opening in the cover must be sections or between the roof and the control devices which meet all maintained in a closed, sealed position, supporting wall; broken, cracked, or requirements specified in the unless plant personnel are present and otherwise damaged seals or gaskets on appropriate NESHAP. Requirements conducting wastewater or sludge closure devices; and broken or missing may include performance tests, routine sampling, or equipment inspection, hatches, access covers, caps, or other monitoring, recordkeeping, and maintenance, or repair. closure devices. reporting. (c) HAP fraction emitted standard. As (2) You must perform an initial visual (b) A new Group 1 POTW treatment an alternative to the requirements in inspection within 60 calendar days of plant demonstrates compliance by paragraph (b) of this section, a new becoming subject to this NESHAP and operating treatment and control devices Group 1 and Group 2 POTW treatment perform follow-up inspections at least which meet all requirements specified plant may comply by demonstrating, for once per year, thereafter. in the appropriate NESHAP and by all emission points up to, but not (3) In the event that you find a defect meeting the requirements specified in including, the secondary influent on a cover on a treatment unit in use, § 63.1586, as applicable, as well as the pumping station or the secondary you must repair the defect within 45 applicable requirements in §§ 63.1588 treatment units, that the annual rolling calendar days. If you cannot repair through 63.1595. average HAP fraction emitted within 45 calendar days, you must Requirements for Group 1 and Group 2 (calculated as specified in notify the EPA or the delegated POTW Treatment Plants § 63.1588(c)(3)) does not exceed 0.014. authority immediately and report the You must demonstrate that for your reason for the delay and the date you § 63.1586 What are the emission points POTW treatment plant, the sum of all expect to complete the repair. If you and control requirements for a Group 1 or HAP emissions from these units divided find a defect on a cover on a treatment Group 2 POTW? by the sum of all HAP mass loadings to unit that is not in service, you must (a) An existing Group 1 or Group 2 the POTW treatment plant results in an repair the defect prior to putting the POTW treatment plant must comply annual rolling average of the HAP treatment unit back in wastewater with the initial notification fraction emitted of no greater than service. requirements in § 63.1591(a). 0.014. You may use any combination of (b) If you own or operate a control (b) Cover and control standard. pretreatment, wastewater treatment device used to meet the requirements Except as provided in paragraph (c) of plant modifications, and control devices for § 63.1586(b), you must comply with this section, new Group 1 and Group 2 to achieve this performance standard. the inspection and monitoring POTW treatment plants must install (d) At all times, the POTW must requirements of § 63.695(c) of subpart covers on the emission points up to, but operate and maintain any affected DD of this part. not including, the secondary influent source, including associated air (c) To comply with the HAP fraction pumping station or the secondary pollution control equipment and emitted standard specified in treatment units. These emission points monitoring equipment, in a manner § 63.1586(c), you must develop, to the are treatment units that include, but are consistent with safety and good air satisfaction of the Administrator, an not limited to, influent waste stream pollution control practices for Inspection and Monitoring Plan. This conveyance channels, bar screens, grit minimizing emissions. The general duty Inspection and Monitoring Plan must chambers, grinders, pump stations, to minimize emissions does not require include, at a minimum, the following: aerated feeder channels, primary the POTW to make any further efforts to (1) A method to determine the clarifiers, primary effluent channels, reduce emissions if the requirements of influent HAP mass loading, i.e., the and primary screening stations. In the applicable standard have been met. annual mass quantity for each HAP addition, all covered units, except Determination of whether a source is entering the wastewater treatment plant.
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(2) A method to determine your value (lbs/day) for all HAP entering § 63.1589 What records must I keep? POTW treatment plant’s annual HAP your POTW treatment plant for the (a) To comply with the cover and emissions for all units up to, but not current month; control standard specified in including, the secondary influent (v) Based on the current month’s § 63.1586(b), you must prepare and pumping station or the secondary information in paragraph (c)(3)(iii) of maintain the records required in treatment units. The method you use to this section along with source testing paragraphs (a)(1) through (4) of this determine your HAP emissions, such as and emission modeling, for each HAP, section: modeling or direct source measurement, determine the annual emissions (lbs/ (1) A record for each treatment unit must: day) from all wastewater units up to, but inspection required by § 63.1588(a). You (i) Be approved by the Administrator not including, secondary treatment must include a treatment unit for use at your POTW; units; identification number (or other unique (ii) Account for all factors affecting (vi) Sum up the values in paragraph identification description as selected by emissions from your POTW treatment (c)(3)(v) of this section and calculate the you) and the date of inspection. plant including, but not limited to, total annual emissions value for the (2) For each defect detected during emissions from wastewater treatment month for all HAP from all wastewater inspections required by § 63.1588(a), units; emissions resulting from treatment units up to, but not including, you must record the location of the inspection, maintenance, and repair secondary treatment units; defect, a description of the defect, the activities; fluctuations (e.g., daily, (vii) Calculate the HAP fraction date of detection, the corrective action monthly, annual, seasonal) in your emitted value for the month, using taken to repair the defect, and the date influent wastewater HAP Equation 1 of this section as follows: the repair to correct the defect is concentrations; annual industrial completed. loading; performance of control devices; (3) If repair of the defect is delayed as or any other factors that could affect Where: described in § 63.1588(a)(3), you must your annual HAP emissions; and also record the reason for the delay and f monthly = HAP fraction emitted for the (iii) Include documentation that the e the date you expect to complete the values and sources of all data, operating previous month èE = Total HAP emissions value from repair. conditions, assumptions, etc., used in paragraph (c)(3)(vi) of this section (4) If you own or operate a control your method result in an accurate èL = Total annual loading from paragraph device used to meet the requirements estimation of annual emissions from (c)(3)(iv) of this section for § 63.1586(b), you must comply with your POTW treatment plant. the recordkeeping requirements of (viii) Average the HAP fraction (3) A method to demonstrate that your § 63.696(a), (b), (g), and (h). POTW treatment plant meets the HAP emitted value for the month determined (b) To comply with the HAP fraction fraction emitted standard specified in in paragraph (c)(3)(vii) of this section, emitted standard specified in § 63.1586(c), i.e., the sum of all HAP with the values determined for the § 63.1586(c), you must prepare and emissions from paragraph (c)(2) of this previous 11 months, to calculate an maintain the records required in section divided by the sum of all HAP annual rolling average of the HAP paragraphs (b)(1) through (3) of this mass loadings from paragraph (c)(1) of fraction emitted. section: this section results in a fraction emitted (4) A method to demonstrate, to the (1) A record of the methods and data of 0.014 or less to demonstrate satisfaction of the Administrator, that used to determine your POTW treatment compliance with § 63.1586(c). The your POTW treatment plant is in plant’s annual HAP loading and HAP Inspection and Monitoring Plan must continuous compliance with the emissions as determined in require, at a minimum, that you perform requirements of § 63.1586(c). § 63.1588(c)(1) and (2) as part of your the calculations shown in paragraphs Continuous compliance means that your Inspection and Monitoring Plan; (c)(3)(i) through (viii) of this section emissions, when averaged over the (2) A record of the methods and data within 90 days of the end of each course of a year, do not exceed the level used to determine that your POTW month. This calculation shall of emissions that allows your POTW to treatment plant meets the HAP fraction demonstrate that your annual rolling comply with § 63.1586(c). For example, emitted standard of 0.014 or less, as average of the HAP fraction emitted is you may identify a parameter(s) that you determined in § 63.1588(c)(3) as part of 0.014 or less when demonstrating can monitor that assures your your Inspection and Monitoring Plan; compliance with § 63.1586(c). emissions, when averaged over the and (i) Determine the average daily flow in entire year, will meet the requirements (3) A record of the methods and data million gallons per day (MGD) of the in § 63.1586(c). Some example that demonstrates that your POTW wastewater entering your POTW parameters that may be considered for treatment plant is in continuous treatment plant for the month; monitoring include your wastewater compliance with the requirements of (ii) Determine the flow-weighted influent HAP concentration and flow, § 63.1588(c)(4) to calculate annual monthly concentration of each HAP industrial loading from your permitted emissions as specified in your listed in Table 1 to subpart DD of this industrial users, and your control device Inspection and Monitoring Plan. part that is reasonably anticipated to be performance criteria. Where emission (c) The POTW must record the present in your influent; reductions are due to proper operation malfunction information specified in (iii) Using the information in of equipment, work practices, or other paragraphs (c)(1) through (3) of this paragraphs (c)(3)(i) and (ii) of this operational procedures, your section. section, determine a total annual flow- demonstration must specify the (1) In the event that an affected unit weighted loading in pounds per day frequency of inspections and the fails to meet an applicable standard, (lbs/day) of each HAP entering your number of days to completion of repairs. record the number of failures. For each POTW treatment plant; (d) Prior to receiving approval on the failure, record the date, time, and (iv) Sum up the values for each Inspection and Monitoring Plan, you duration of the failure. individual HAP loading in paragraph must follow the plan submitted to the (2) For each failure to meet an (c)(3)(iii) of this section and determine Administrator as specified in applicable standard, record and retain a a total annual flow-weighted loading § 63.1590(f). list of the affected sources or equipment,
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an estimate of the tons per year of each repair was completed or the date each be CBI, on a compact disc, flash drive, regulated pollutant emitted over any repair is expected to be completed. or other commonly used electronic emission limit and a description of the (3) If you comply with the HAP storage medium to the EPA. The method used to estimate the emissions. fraction emitted standard in electronic medium shall be clearly (3) Record actions taken to minimize § 63.1586(c), you must submit each marked as CBI and mailed to U.S. EPA/ emissions in accordance with value of the annual rolling average HAP OAQPS/CORE CBI Office, Attention: § 63.1583(d) or § 63.1586(d) and any fraction emitted as calculated in Group Leader, Measurement Policy corrective actions taken to return the § 63.1588(c)(3)(vii) for the period Group, MD C404–02, 4930 Old Page Rd., affected unit to its normal or usual covered by the annual report. Identify Durham, NC 27703. The same file with manner of operation. each value by the final month included the CBI omitted shall be submitted to (d) Any records required to be in the calculation. the EPA via the EPA’s CDX as described maintained by this part that are (4) If a source fails to meet an earlier in this paragraph. submitted electronically via the EPA’s applicable standard, report such events (c) If you own or operate a control Compliance and Emissions Data in the annual report. Report the number device used to meet the cover and Reporting Interface (CEDRI) may be of failures to meet an applicable control standard in § 63.1586(b), you maintained in electronic format. This standard. For each instance, report the must submit the notifications and ability to maintain electronic copies start date, start time, and duration of reports required by § 63.697(b), does not affect the requirement for each failure, as well as a list of the including a notification of performance facilities to make records, data, and affected sources or equipment. If you tests; a performance test report; a reports available upon request to a comply with the cover and control malfunction report; and a summary delegated air agency or the EPA as part standard in § 63.1586(b), for each report. These notifications and reports of an on-site compliance evaluation. failure, the report must include the must be submitted to the Administrator, percent control achieved. If you comply except for performance test reports. § 63.1590 What reports must I submit? with the HAP fraction emitted standard Within 60 calendar days after the date (a) An existing Group 1 POTW must in § 63.1586(c), for each failure, the of completing each performance test (as meet the reporting requirements report must include the HAP fraction defined in § 63.2) required by subpart specified in the appropriate NESHAP emitted. You must include an estimate DD of this part, you must submit the for the industrial user(s). of the tons per year of each regulated results of the performance test following (b) A new Group 1 or Group 2 POTW pollutant emitted over the emission the procedure specified in paragraphs must submit annual reports containing limit and a description of the method (c)(1) through (3) of this section. the information specified in paragraphs used to estimate the emissions in the (1) For data collected using test (b)(1) through (4) of this section, if report. methods supported by the EPA’s (5) You must submit the report to the applicable. You must submit annual Electronic Reporting Tool (ERT) as Administrator at the appropriate reports following the procedure listed on the EPA’s ERT Web site address listed in § 63.13, unless the specified in paragraph (b)(5) of this (https://www.epa/gov/electronic- Administrator agrees to or species an reporting-air-emissions/electronic- section. For new units, the initial alternate reporting method. Beginning reporting-tool-ert) at the time of the test, annual report is due 15 months after on October 28, 2019 or once the you must submit the results of the your POTW becomes subject to the reporting form has been available in performance test to the EPA via CEDRI. requirements in this subpart and must CEDRI for 1 year, whichever is later, you Performance test data must be submitted cover the first 12 months of operation must submit subsequent annual reports in a file format generated through the after your POTW becomes subject to the to the EPA via CEDRI. (CEDRI can be use of the EPA’s ERT or an alternate requirements of this subpart. accessed through the EPA’s Central Data electronic file format consistent with the Subsequent annual reports are due by Exchange (CDX)(https://cdx.epa.gov/)). XML schema listed on the EPA’s ERT the same date each year as the initial You must use the appropriate electronic Web site. annual report and must contain report template on the CEDRI Web site (2) For data collected using test information for the 12-month period for this subpart or an alternate methods that are not supported by the following the 12-month period included electronic file format consistent with the EPA’s ERT as listed on the EPA’s ERT in the previous annual report. extensible markup language (XML) Web site at the time of the test, you must (1) The general information specified schema listed on the CEDRI Web site submit the results of the performance in paragraphs (b)(1)(i) and (ii) of this (https://www.epa.gov/electronic- test to the Administrator at the section must be included in all reports. reporting-air-emissions/compliance- appropriate address listed in § 63.13 of (i) The company name, POTW and-emissions-data-reporting-interface- subpart A of this part, unless the treatment plant name, and POTW cedri). The date report templates Administrator agrees to or specifies an treatment plant address, including become available in CEDRI will be listed alternate reporting method. county where the POTW is located; and on the CEDRI Web site. The reports (3) If you claim that some of the (ii) Beginning and ending dates of the must be submitted by the deadline performance test information being reporting period. specified in this subpart, regardless of submitted under paragraph (b)(1) of this (2) If you use covers to comply with the method in which the reports are section is CBI, you must submit a the requirements of § 63.1586(b), you submitted. If you claim that some of the complete file generated through the use must submit the following: information required to be submitted via of the EPA’s ERT or an alternate (i) The dates of each visual inspection CEDRI is confidential business electronic file consistent with the XML conducted; information (CBI), you shall submit a schema listed on the EPA’s ERT Web (ii) The defects found during each complete report generated using the site, including information claimed to visual inspection; and appropriate form in CEDRI or an be CBI, on a compact disc, flash drive, (iii) For each defect found during a alternate electronic file consistent with or other commonly used electronic visual inspection, how the defects were the extensible markup language (XML) storage medium to the EPA. The repaired, whether the repair has been schema listed on the EPA’s CEDRI Web electronic medium must be clearly completed, and either the date each site, including information claimed to marked as CBI and mailed to U.S. EPA/
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OAQPS/CORE CBI Office, Attention: effects from such an event within the (2) The address (i.e., physical Group Leader, Measurement Policy period of time beginning five business location) of your POTW treatment plant; Group, MD C404–02, 4930 Old Page Rd., days prior to the date the submission is (3) An identification of these Durham, NC 27703. The same ERT or due, the owner or operator may assert a standards as the basis of the notification alternate file with the CBI omitted must claim of force majeure for failure to and your POTW treatment plant’s be submitted to the EPA via the EPA’s timely comply with the reporting compliance date; and CDX as described in paragraph (c)(1) of requirement. For the purposes of this (4) A brief description of the nature, this section. section, a force majeure event is defined size, design, and method of operation of (d) You must comply with the delay as an event that will be or has been your POTW treatment plant, including of repair reporting required in caused by circumstances beyond the its operating design capacity and an § 63.1588(a)(3). control of the affected facility, its identification of each point of emission (e) You may apply to the contractors, or any entity controlled by for each HAP, or if a definitive Administrator for a waiver of the affected facility that prevents you identification is not yet possible, a recordkeeping and reporting from complying with the requirement to preliminary identification of each point requirements by complying with the submit a report electronically within the of emission for each HAP. requirements of § 63.10(f). Electronic time period prescribed. Examples of (c) You must submit a notification of reporting to the EPA cannot be waived. such events are acts of nature (e.g., compliance status as required in (f) To comply with the HAP fraction hurricanes, earthquakes, or floods), acts § 63.9(h), as specified below: emitted standard specified in of war or terrorism, or equipment failure (1) If you comply with § 63.1586(b) § 63.1586(c), you must submit, for or safety hazard beyond the control of and use covers on the emission points approval by the Administrator, an the affected facility (e.g., large scale and route air in the headspace Inspection and Monitoring Plan power outage). If you intend to assert a underneath the cover to a control explaining your compliance approach claim of force majeure, you must submit device, you must submit a notification 90 calendar days prior to beginning notification to the Administrator in of compliance status as specified in operation of your new POTW or by writing as soon as possible following the § 63.9(h) that includes a description of April 24, 2018, whichever is later. date you first knew, or through due (g) If you are required to electronically the POTW treatment units and installed diligence should have known, that the submit a report through the CEDRI in covers, as well as the information the EPA’s CDX, and due to a planned or event may cause or caused a delay in required for control devices including actual outage of either the EPA’s CEDRI reporting. You must provide to the the performance test results. or CDX systems within the period of Administrator a written description of (2) If you comply with § 63.1586(c) by time beginning 5 business days prior to the force majeure event and a rationale meeting the HAP fraction emitted the date that the submission is due, you for attributing the delay in reporting standard, submission of the Inspection will be or are precluded from accessing beyond the regulatory deadline to the and Monitoring Plan as required in CEDRI or CDX and submitting a force majeure event; describe the § 63.1588(c) and § 63.1590(f) meets the required report within the time measures taken or to be taken to requirement for submitting a prescribed, you may assert a claim of minimize the delay in reporting; and notification of compliance status report EPA system outage for failure to timely identify a date by which you propose to in § 63.9(h). comply with the reporting requirement. report, or if you have already met the (d) You must notify the You must submit notification to the reporting requirement at the time of the Administrator, within 30 calendar days Administrator in writing as soon as notification, the date you reported. In of discovering that you are out of possible following the date you first any circumstance, the reporting must compliance with an applicable knew, or through due diligence should occur as soon as possible after the force requirement of this subpart, including have known, that the event may cause majeure event occurs. The decision to the following: or caused a delay in reporting. You must accept the claim of force majeure and (1) The requirement to route the air in provide to the Administrator a written allow an extension to the reporting the headspace underneath the cover of description identifying the date, time deadline is solely within the discretion all units equipped with covers, except and length of the outage; a rationale for of the Administrator. primary clarifiers, to a control device as specified in § 63.1586(b). attributing the delay in reporting § 63.1591 What are my notification beyond the regulatory deadline to the requirements? (2) The HAP fraction emitted standard EPA system outage; describe the as specified in § 63.1586(c). (a) You must submit an initial measures taken or to be taken to (3) The requirement to operate and notification that your POTW treatment minimize the delay in reporting; and maintain the affected source as specified plant is subject to these standards as identify a date by which you propose to in § 63.1586(d). specified in paragraphs (a)(1) and (2) of report, or if you have already met the (4) The requirement to inspect covers this section. reporting requirement at the time of the annually and repair defects as specified notification, the date you reported. In (1) If you have an existing Group 1 or in § 63.1588(a). any circumstance, the report must be Group 2 POTW treatment plant, you (5) The requirement to comply with submitted electronically as soon as must submit an initial notification by the inspection and monitoring possible after the outage is resolved. The October 26, 2018. requirements of § 63.695(c) as specified decision to accept the claim of EPA (2) If you have a new Group 1 or in § 63.1588(b). system outage and allow an extension to Group 2 POTW treatment plant, you (6) The procedures specified in an the reporting deadline is solely within must submit an initial notification upon Inspection and Monitoring Plan the discretion of the Administrator. startup. prepared as specified in § 63.1588(c). (h) If you are required to (b) The initial notification must (7) The requirements specified in an electronically submit a report through include the information included in appropriate NESHAP for which the CEDRI in the EPA’s CDX and a force paragraphs (b)(1) through (4) of this Group 1 POTW treatment plan treats majeure event is about to occur, occurs, section. regulated industrial waste as specified or has occurred or there are lingering (1) Your name and address; in § 63.1583(a) or (b), as applicable.
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§ 63.1592 Which General Provisions apply Affected source means the group of all NESHAP prior to discharging the waste to my POTW treatment plant? equipment that comprise the POTW stream to the POTW. (a) Table 1 to this subpart lists the treatment plant. Industrial user means a nondomestic General Provisions (40 CFR part 63, Cover means a device that prevents or source introducing any pollutant or subpart A) which do and do not apply reduces air pollutant emissions to the combination of pollutants into a POTW. to POTW treatment plants. atmosphere by forming a continuous Industrial users can be commercial or (b) Unless a permit is otherwise barrier over the waste material managed industrial facilities whose wastes enter required by law, the owner or operator in a treatment unit. A cover may have local sewers. of a Group 1 POTW treatment plant openings (such as access hatches, New source or new POTW means any which is not a major source is exempt sampling ports, gauge wells) that are POTW that commenced construction or from the permitting requirements necessary for operation, inspection, reconstruction after December 1, 1998. established by 40 CFR part 70. maintenance, and repair of the Publicly owned treatment works treatment unit on which the cover is (POTW) means a treatment works, as § 63.1593 [Reserved] used. A cover may be a separate piece that term is defined by section 112(e)(5) of equipment which can be detached § 63.1594 Who enforces this subpart? of the Clean Air Act, which is owned by and removed from the treatment unit, or a municipality (as defined by section (a) This subpart can be implemented a cover may be formed by structural 502(4) of the Clean Water Act), a state, and enforced by the U.S. EPA, or a features permanently integrated into the an intermunicipal or interstate agency, delegated authority such as the design of the treatment unit. The cover or any department, agency, or applicable state, local, or tribal agency. and its closure devices must be made of instrumentality of the federal If the U.S. EPA Administrator has suitable materials that will prevent government. This definition includes delegated authority to a state, local, or exposure of the waste material to the any intercepting sewers, outfall sewers, tribal agency, then that agency, in atmosphere and will maintain the sewage collection systems, pumping, addition to the U.S. EPA, has the integrity of the cover and its closure power, and other equipment. The authority to implement and enforce this devices throughout its intended service wastewater treated by these facilities is subpart. Contact the applicable U.S. life. generated by industrial, commercial, EPA Regional Office to find out if Existing source or existing POTW and domestic sources. As used in this implementation and enforcement of this means a POTW that commenced subpart, the term POTW refers to both subpart is delegated to a state, local, or construction on or before December 1, any publicly owned treatment works 1998, and has not been reconstructed tribal agency. which is owned by a state, municipality, after December 1, 1998. (b) In delegating implementation and or intermunicipal or interstate agency Fraction emitted means the fraction of enforcement authority of this subpart to and, therefore, eligible to receive grant a state, local, or tribal agency under the mass of HAP entering the POTW wastewater treatment plant which is assistance under the Subchapter II of the subpart E of this part, the authorities Clean Water Act, and any federally contained in paragraphs (b)(1) through emitted prior to secondary treatment. Group 1 POTW means a POTW that owned treatment works as that term is (5) of this section are retained by the described in section 3023 of the Solid Administrator of U.S. EPA and cannot accepts a waste stream regulated by another NESHAP and provides Waste Disposal Act. be delegated to the state, local, or tribal POTW treatment plant means that agency. treatment and controls as an agent for the industrial user. The industrial user portion of the POTW which is designed (1) Approval of alternatives to the complies with its NESHAP by using the to provide treatment (including requirements in §§ 63.1580, 63.1583, treatment and controls located at the recycling and reclamation) of municipal and 63.1586 through 63.1588. POTW. For example, an industry sewage and industrial waste. (2) Approval of major alternatives to discharges its benzene-containing waste Secondary treatment means treatment test methods under § 63.7(e)(2)(ii) and stream to the POTW for treatment to processes, typically biological, designed (f), as defined in § 63.90, and as required comply with 40 CFR part 61, subpart to reduce the concentrations of in this subpart. FF—National Emission Standard for dissolved and colloidal organic matter (3) Approval of major alternatives to Benzene Waste Operations. This in wastewater. monitoring under § 63.8(f), as defined in definition does not include POTW Waste and wastewater means a § 63.90, and as required in this subpart. treating waste streams not specifically material, or spent or used water or (4) Approval of major alternatives to regulated under another NESHAP. waste, generated from residential, recordkeeping and reporting under Group 2 POTW means a POTW that industrial, commercial, mining, or § 63.10(f), as defined in § 63.90, and as does not meet the definition of a Group agricultural operations or from required in this subpart. 1 POTW. A Group 2 POTW can treat a community activities that contain (5) Approval of an alternative to any waste stream that is either: dissolved or suspended matter, and that electronic reporting to the EPA required (1) Not specifically regulated by is discarded, discharged, or is being by this subpart. another NESHAP, or accumulated, stored, or physically, (2) From an industrial user that chemically, thermally, or biologically § 63.1595 List of definitions. complies with the specific wastewater treated in a publicly owned treatment As used in this subpart: requirements in their applicable works.
TABLE 1 TO SUBPART VVV OF PART 63—APPLICABILITY OF 40 CFR PART 63 GENERAL PROVISIONS TO SUBPART VVV
General provisions reference Applicable to subpart VVV Explanation
§ 63.1 ...... Applicability. § 63.1(a)(1) ...... Yes ...... Terms defined in the Clean Air Act. § 63.1(a)(2) ...... Yes ...... General applicability explanation. § 63.1(a)(3) ...... Yes ...... Cannot diminish a stricter NESHAP.
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TABLE 1 TO SUBPART VVV OF PART 63—APPLICABILITY OF 40 CFR PART 63 GENERAL PROVISIONS TO SUBPART VVV— Continued
General provisions reference Applicable to subpart VVV Explanation
§ 63.1(a)(4) ...... Yes ...... Not repetitive. Doesn’t apply to section 112(r). § 63.1(a)(5) ...... Yes ...... Section reserved. § 63.1(a)(6)–(8) ...... Yes ...... Contacts and authorities. § 63.1(a)(9) ...... Yes ...... Section reserved. § 63.1(a)(10) ...... Yes ...... Time period definition. § 63.1(a)(11) ...... Yes ...... Postmark explanation. § 63.1(a)(12)–(14) ..... Yes ...... Time period changes. Regulation conflict. Force and effect of subpart A. § 63.1(b)(1) ...... Yes ...... Initial applicability determination of subpart A. § 63.1(b)(2) ...... Yes ...... Section reserved. § 63.1(b)(3) ...... No ...... Subpart VVV specifies recordkeeping of records of applicability determination. § 63.1(c)(1) ...... Yes ...... Requires compliance with both subparts A and subpart VVV. § 63.1(c)(2)(i) ...... No ...... State options regarding title V permit. Unless required by the State, area sources sub- ject to subpart VVV are exempted from permitting requirements. § 63.1(c)(2)(ii)–(iii) .... No ...... State options regarding title V permit. § 63.1(c)(3) ...... Yes ...... Section reserved. § 63.1(c)(4) ...... Yes ...... Extension of compliance. § 63.1(c)(5) ...... No ...... Subpart VVV addresses area sources becoming major due to increase in emissions. § 63.1(d) ...... Yes ...... Section reserved. § 63.1(e) ...... Yes ...... Title V permit before a relevant standard is established. § 63.2 ...... Yes ...... Definitions. § 63.3 ...... Yes ...... Units and abbreviations. § 63.4 ...... Prohibited activities and circumvention. § 63.4(a)(1)–(3) ...... Yes ...... Prohibits operation in violation of subpart A. § 63.4(a)(4) ...... Yes ...... Section reserved. § 63.4(a)(5) ...... Yes ...... Compliance dates. § 63.4(b) ...... Yes ...... Circumvention. § 63.4(c) ...... Yes ...... Severability. § 63.5 ...... Preconstruction review and notification requirements. § 63.5(a)(1) ...... Yes ...... Construction and reconstruction. § 63.5(a)(2) ...... Yes ...... New source—effective dates. § 63.5(b)(1) ...... Yes ...... New sources subject to relevant standards. § 63.5(b)(2) ...... Yes ...... Section reserved. § 63.5(b)(3) ...... Yes ...... No new major sources without Administrator approval. § 63.5(b)(4) ...... Yes ...... New major source notification. § 63.5(b)(5) ...... Yes ...... New major sources must comply. § 63.5(b)(6) ...... Yes ...... New equipment added considered part of major source. § 63.5(c) ...... Yes ...... Section reserved. § 63.5(d)(1) ...... Yes ...... Implementation of section 112(I)(2)—application of approval of new source construction. § 63.5(d)(2) ...... Yes ...... Application for approval of construction for new sources listing and describing planned air pollution control system. § 63.5(d)(3) ...... Yes ...... Application for reconstruction. § 63.5(d)(4) ...... Yes ...... Administrator may request additional information. § 63.5(e) ...... Yes ...... Approval of reconstruction. § 63.5(f)(1) ...... Yes ...... Approval based on State review. § 63.5(f)(2) ...... Yes ...... Application deadline. § 63.6 ...... Compliance with standards and maintenance requirements. § 63.6(a) ...... Yes ...... Applicability of compliance with standards and maintenance requirements. § 63.6(b) ...... Yes ...... Compliance dates for new and reconstructed sources. § 63.6(c) ...... Yes ...... Compliance dates for existing sources apply to existing Group 1 POTW treatment plants. § 63.6(d) ...... Yes ...... Section reserved. § 63.6(e) ...... Yes, except as noted below ... Operation and maintenance requirements apply to new sources. § 63.6(e)(1)(i) ...... No ...... General duty; See § 63.1583(d) and § 63.1586(d) for general duty requirements. § 63.6(e)(1)(ii) ...... No ...... Requirement to correct malfunctions. § 63.6(e)(3) ...... No ...... SSM plans are not required for POTW. § 63.6(f) ...... Yes, except as noted below ... Compliance with non-opacity emission standards applies to new sources. § 63.6(f)(1) ...... No ...... The POTW standards apply at all times. § 63.6(g) ...... Yes ...... Use of alternative non-opacity emission standards applies to new sources. § 63.6(h) ...... No ...... POTW treatment plants do not typically have visible emissions. § 63.6(i) ...... Yes ...... Extension of compliance with emission standards applies to new sources. § 63.6(j) ...... Yes ...... Presidential exemption from compliance with emission standards. § 63.7 ...... Performance testing requirements. § 63.7(a) ...... Yes ...... Performance testing is required for new sources. § 63.7(b) ...... Yes ...... New sources must notify the Administrator of intention to conduct performance testing. § 63.7(c) ...... Yes ...... New sources must comply with quality assurance program requirements. § 63.7(d) ...... Yes ...... New sources must provide performance testing facilities at the request of the Adminis- trator. § 63.7(e) ...... Yes, except as noted below ... Requirements for conducting performance tests apply to new sources. § 63.7(e)(1) ...... No ...... The performance testing provisions of § 63.694 for control devices are incorporated by reference into subpart DD of this part.
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TABLE 1 TO SUBPART VVV OF PART 63—APPLICABILITY OF 40 CFR PART 63 GENERAL PROVISIONS TO SUBPART VVV— Continued
General provisions reference Applicable to subpart VVV Explanation
§ 63.7(f) ...... Yes ...... New sources may use an alternative test method. § 63.7(g) ...... Yes ...... Requirements for data analysis, recordkeeping, and reporting associated with perform- ance testing apply to new sources. § 63.7(h) ...... Yes ...... New sources may request a waiver of performance tests. § 63.8 ...... Monitoring requirements. § 63.8(a) ...... Yes ...... Applicability of monitoring requirements. § 63.8(b) ...... Yes ...... Monitoring shall be conducted by new sources. § 63.8(c) ...... Yes, except as noted below ... New sources shall operate and maintain continuous monitoring systems (CMS). § 63.8(c)(1)(i) ...... No ...... See § 63.1583(d) for general duty requirement with respect to minimizing emissions and continuous monitoring requirements. § 63.8(c)(1)(iii) ...... No ...... See the applicable CMS quality control requirements under § 63.8(c) and (d). § 63.8(d) ...... Yes, except as noted below ... New sources must develop and implement a CMS quality control program. § 63.8(d)(3) ...... No ...... The owner or operator must keep these written procedures on record for the life of the affected source or until the affected source is no longer subject to the provisions of this part, and make them available for inspection, upon request, by the Administrator. If the performance evaluation plan is revised, the owner or operator must keep pre- vious (i.e., superseded) versions of the performance evaluation plan on record to be made available for inspection, upon request, by the Administrator, for a period of 5 years after each revision of the plan. The program of corrective action should be in- cluded in the plan required under § 63.8(d)(2). § 63.8(e) ...... Yes ...... New sources may be required to conduct a performance evaluation of CMS. § 63.8(f) ...... Yes ...... New sources may use an alternative monitoring method. § 63.8(g) ...... Yes ...... Requirements for reduction of monitoring data. § 63.9 ...... Notification requirements. § 63.9(a) ...... Yes ...... Applicability of notification requirements. § 63.9(b) ...... Yes, except as noted below ... Initial notification due February 23, 2000 or 60 days after becoming subject to this sub- part. § 63.9(c) ...... Yes ...... Request for extension of compliance with subpart VVV. § 63.9(d) ...... Yes ...... Notification that source is subject to special compliance requirements as specified in § 63.6(b)(3) and (4). § 63.9(e) ...... Yes ...... Notification of performance test. § 63.9(f) ...... No ...... POTW treatment plants do not typically have visible emissions. § 63.9(g) ...... Yes ...... Additional notification requirements for sources with continuous emission monitoring systems. § 63.9(h) ...... Yes, except as noted ...... Notification of compliance status when the source becomes subject to subpart VVV. See exceptions in § 63.1591(b). § 63.9(i) ...... Yes ...... Adjustments to time periods or postmark deadlines or submittal and review of required communications. § 63.9(j) ...... Yes ...... Change of information already provided to the Administrator. § 63.10 ...... Recordkeeping and reporting requirements. § 63.10(a) ...... Yes ...... Applicability of notification and reporting requirements. § 63.10(b)(1)–(2) ...... Yes, except as noted below ... General recordkeeping requirements. § 63.10(b)(2)(i) ...... No ...... Recordkeeping for occurrence and duration of startup and shutdown. § 63.10(b)(2)(ii) ...... No ...... Recordkeeping for failure to meet a standard, see § 63.696. § 63.10(b)(2)(iii) ...... Yes ...... Maintenance records. § 63.10(b)(2)(iv) ...... No ...... Actions taken to minimize emissions during SSM. § 63.10(b)(2)(v) ...... No ...... Action taken to minimize emissions during SSM. § 63.10(b)(2)(vi) ...... Yes ...... Recordkeeping for CMS malfunctions. § 63.10(b)(2)(vii)–(ix) Yes ...... Other CMS requirements. § 63.10(b)(3) ...... No ...... Recording requirement for applicability determination. § 63.10(c) ...... Yes, except as noted below ... Additional recordkeeping requirements for sources with continuous monitoring systems. § 63.10(c)(7) ...... No ...... See § 63.696(h) for recordkeeping of (1) date, time, and duration; (2) listing of affected source or equipment, and an estimate of the tons per year of each regulated pollutant emitted over the standard; and (3) actions to minimize emissions and correct the fail- ure. § 63.10(c)(8) ...... No ...... See § 63.696(h) for recordkeeping of (1) date, time, and duration; (2) listing of affected source or equipment, and an estimate of the tons per year of each regulated pollutant emitted over the standard; and (3) actions to minimize emissions and correct the fail- ure. § 63.10(c)(15) ...... No ...... Use of SSM plan. § 63.10(d) ...... Yes, except as noted below ... General reporting requirements. § 63.10(d)(5) ...... No ...... See § 63.697(b) for malfunction reporting requirements. § 63.10(e) ...... Yes ...... Additional reporting requirements for sources with continuous monitoring systems. § 63.10(f) ...... Yes, except as noted ...... Waiver of recordkeeping and reporting requirements. Electronic reporting to the EPA cannot be waived. § 63.11 ...... Yes ...... Control device and equipment leak work practice requirements. § 63.11(a) and (b) ..... Yes ...... If a new source uses flares to comply with the requirements of subpart VVV, the re- quirements of § 63.11 apply. § 63.11(c), (d) and Yes ...... Alternative work practice for equipment leaks. (e).
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TABLE 1 TO SUBPART VVV OF PART 63—APPLICABILITY OF 40 CFR PART 63 GENERAL PROVISIONS TO SUBPART VVV— Continued
General provisions reference Applicable to subpart VVV Explanation
§ 63.12 ...... Yes ...... State authority and designation. § 63.13 ...... Yes ...... Addresses of State air pollution control agencies and EPA Regional Offices. § 63.14 ...... Yes ...... Incorporation by reference. § 63.15 ...... Yes ...... Availability of information and confidentiality.
TABLE 2 TO SUBPART VVV OF PART 63—COMPLIANCE DATES AND REQUIREMENTS
If the construction/reconstruction And the owner or operator must date is Then the owner or operator must comply with achieve compliance
Group 1 POTW: (1) After December 27, 2016 ...... (i) New source requirements in §§ 63.1583(b); 63.1586(b) or (c); and Upon initial startup. 63.1588 through 63.1591. (2) After December 1, 1998 but on (i) New source requirements in § 63.1583(b) but instead of complying Upon initial startup through Octo- or before December 27, 2016. with both requirements (industrial user(s) NESHAP and the POTW ber 26, 2020. standards in §§ 63.1586(b) or (c)), you must comply with the most stringent requirement1. (ii) New source requirements in §§ 63.1586(b) or (c); and 63.1588 On or before October 26, 2020. through 63.1591. (3) On or before December 1, 1998 (i) Existing source requirements in §§ 63.1583(a) ...... By the compliance date specified in the other applicable NESHAP. (ii) Existing source requirements in §§ 63.1588 through 63.1591 ...... On or before October 26, 2018. Group 2 POTW: (4) After December 27, 2016 ...... (i) New source requirements in §§ 63.1586(b) or (c); and 63.1588 Upon initial startup. through 63.1591. (5) After December 1, 1998 but on (i) New source requirements in § 63.1586(b) or (c)1 ...... Upon initial startup through Octo- or before December 27, 2016. ber 26, 2020. (ii) New source requirements in §§ 63.1586(b) or (c); and 63.1588 On or before October 26, 2020. through 63.1591. (6) On or before December 1, 1998 (i) Existing source requirements in §§ 63.1586(a); and 63.1591(a) ...... On or before October 26, 2018. 1 Note: This represents the new source requirements in the original 1999 NESHAP, which are applicable until October 26, 2020. Between Oc- tober 26, 2017 and October 26, 2020, you must transition to the new requirements in Table 2 (2)(ii) and (5)(ii) for Group 1 and Group 2 POTW, respectively.
[FR Doc. 2017–23067 Filed 10–25–17; 8:45 am] listed as F037 (primary oil/water/solids Certain other material, such as BILLING CODE 6560–50–P separation sludge); and F038 (secondary copyrighted material, is not placed on oil/water/solids separation sludge). the Internet and will be publicly After careful analysis and evaluation available only in hard copy form. ENVIRONMENTAL PROTECTION of comments submitted by the public, Publicly available docket materials are AGENCY the EPA has concluded that the available electronically through http:// petitioned wastes are not hazardous www.regulations.gov. 40 CFR Part 261 waste when disposed of in Subtitle D FOR FURTHER INFORMATION CONTACT: For [EPA–R06–RCRA–2017–0153; SW–FRL– landfills. This exclusion applies to the technical information regarding the 9969–73–Region 6] surface impoundment solids generated ExxonMobil Beaumont Refinery at ExxonMobil’s Beaumont, Texas petition, contact Michelle Peace at 214– Hazardous Waste Management facility. Accordingly, this final rule 665–7430 or by email at System; Identification and Listing of excludes the petitioned waste from the [email protected]. Hazardous Waste requirements of hazardous waste SUPPLEMENTARY INFORMATION: regulations under the Resource The AGENCY: Environmental Protection Conservation and Recovery Act (RCRA) information in this section is organized Agency (EPA). when disposed of in Subtitle D landfills as follows: ACTION: Final rule. but imposes testing conditions to ensure I. Overview Information A. What action is EPA finalizing? SUMMARY: The Environmental Protection that the future-generated wastes remain qualified for delisting. B. Why is EPA approving this delisting? Agency (EPA) is granting a petition C. What are the limits of this exclusion? submitted by ExxonMobil Oil DATES: Effective October 26, 2017. D. How will Beaumont Refinery manage Corporation Beaumont Refinery ADDRESSES: The EPA has established a the waste if it is delisted? (ExxonMobil) to exclude from docket for this action under Docket ID E. When is the final delisting exclusion hazardous waste control (or delist) a No. EPA–R06–RCRA–2017–0153. All effective? certain solid waste. This final rule documents in the docket are listed on F. How does this final rule affect states? responds to the petition submitted by the http://www.regulations.gov Web II. Background A. What is a ‘‘delisting’’? ExxonMobil to have the secondary site. Although listed in the index, some B. What regulations allow facilities to impoundment basin (SIB) solids information is not publicly available, delist a waste? excluded, or delisted from the definition e.g., CBI or other information whose C. What information must the generator of a hazardous waste. The SIB solids are disclosure is restricted by statute. supply?
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III. EPA’s Evaluation of the Waste Data based on the factors for which the waste affected. This would exclude two A. What waste and how much did was originally listed, EPA would have categories of States: States having a dual Beaumont Refinery petition EPA to proposed to deny the petition. EPA system that includes Federal RCRA delist? requirements and their own B. How did Beaumont Refinery sample and evaluated the waste with respect to analyze the waste data in this petition? other factors or criteria to assess requirements, and States who have IV. Public Comments Received on the whether there is a reasonable basis to received our authorization to make their Proposed Exclusion believe that such additional factors own delisting decisions. A. Who submitted comments on the could cause the waste to be hazardous. Here are the details: We allow states proposed rule? EPA considered whether the waste is to impose their own non-RCRA B. Comments and Responses acutely toxic, the concentration of the regulatory requirements that are more V. Statutory and Executive Order Reviews constituents in the waste, their tendency stringent than EPA’s, under section I. Overview Information to migrate and to bioaccumulate, their 3009 of RCRA. These more stringent persistence in the environment once requirements may include a provision A. What action is EPA finalizing? released from the waste, plausible and that prohibits a Federally issued The EPA is finalizing: specific types of management of the exclusion from taking effect in the State. (1) The decision to grant petitioned waste, the quantities of waste Because a dual system (that is, both ExxonMobil’s Beaumont Refinery’s generated, and waste variability. EPA Federal (RCRA) and State (non-RCRA) petition to have its surface believes that the petitioned waste does programs) may regulate a petitioner’s impoundment basin solids excluded, or not meet the listing criteria and thus waste, we urge petitioners to contact the delisted, from the definition of a should not be a listed waste. EPA’s State regulatory authority to establish hazardous waste, subject to certain proposed decision to delist waste from the status of their wastes under the State continued verification and monitoring ExxonMobil is based on the information law. conditions; and submitted in support of this rule, EPA has also authorized some States (2) to use the Delisting Risk including descriptions of the wastes and (for example, Louisiana, Georgia, Assessment Software to evaluate the analytical data from the Beaumont, Illinois) to administer a delisting potential impact of the petitioned waste Texas facility. program in place of the Federal on human health and the environment. program, that is, to make State delisting C. What are the limits of this exclusion? The Agency used this model to predict decisions. Therefore, this exclusion the concentration of hazardous This exclusion applies to the waste does not apply in those authorized constituents released from the described in the petition only if the States. If Beaumont Refinery transports petitioned waste, once it is disposed. requirements described in Table 1 of the petitioned waste to or manages the After evaluating the petition, EPA part 261, Appendix IX, and the waste in any State with delisting proposed rule, on May 31, 2017, to conditions contained herein are authorization, Beaumont Refinery must exclude the ExxonMobil Beaumont satisfied. The one-time exclusion obtain delisting authorization from that Refinery waste from the lists of applies to 400,000 cubic yards of surface State before they can manage the waste hazardous wastes under §§ 261.31 and impoundment basin solids. 261.32. The comments received on this as nonhazardous in the State. rulemaking will be addressed as part of D. How will Beaumont Refinery manage II. Background this decision. the waste if it is delisted? A. What is a delisting? B. Why is EPA approving this delisting? Storage containers with SIB solids will be transported to an authorized A delisting petition is a request from ExxonMobil’s petition requests an solid waste landfill (e.g. RCRA Subtitle a generator to EPA or another agency exclusion from the F037 and F038 waste D landfill, commercial/industrial solid with jurisdiction to exclude from the list listings pursuant to 40 CFR 260.20 and waste landfill, etc.) for disposal. of hazardous wastes, wastes the 260.22. ExxonMobil does not believe generator does not consider hazardous that the petitioned waste meets the E. When is the final delisting exclusion under RCRA. criteria for which EPA listed it. effective? B. What regulations allow facilities to ExxonMobil also believes no additional This rule is effective October 26, delist a waste? constituents or factors could cause the 2017. The Hazardous and Solid Waste waste to be hazardous. EPA’s review of Amendments of 1984 amended Section Under 40 CFR 260.20 and 260.22, this petition included consideration of 3010 of RCRA to allow rules to become facilities may petition the EPA to the original listing criteria and the effective in less than six months when remove their wastes from hazardous additional factors required by the the regulated community does not need waste control by excluding them from Hazardous and Solid Waste the six-month period to come into the lists of hazardous wastes contained Amendments of 1984 (HSWA). See compliance. That is the case here in §§ 261.31 and 261.32. Specifically, section 3001(f) of RCRA, 42 U.S.C. because this rule reduces, rather than § 260.20 allows any person to petition 6921(f), and 40 CFR 260.22 (d)(1)–(4) increases, the existing requirements for the Administrator to modify or revoke (hereinafter, all sectional references are persons generating hazardous wastes. any provision of Parts 260 through 266, to 40 CFR unless otherwise indicated). These reasons also provide a basis for 268 and 273 of Title 40 of the Code of In making the initial delisting making this rule effective immediately, Federal Regulations. Section 260.22 determination, EPA evaluated the upon publication, under the provides generators the opportunity to petitioned waste against the listing Administrative Procedure Act, pursuant petition the Administrator to exclude a criteria and factors cited in to 5 U.S.C. 553(d). waste on a ‘‘generator-specific’’ basis §§ 261.11(a)(2) and (a)(3). Based on this from the hazardous waste lists. review, EPA agrees with the petitioner F. How does this final rule affect states? that the waste is non-hazardous with Because EPA is issuing this exclusion C. What information must the generator respect to the original listing criteria. If under the Federal RCRA delisting supply? EPA had found, based on this review, program, only states subject to Federal Petitioners must provide sufficient that the waste remained hazardous RCRA delisting provisions would be information to EPA to allow the EPA to
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determine that the waste to be excluded in Beaumont, Texas. The waste falls B. How did Beaumont Refinery sample does not meet any of the criteria under under the classification of listed waste and analyze the waste data in this which the waste was listed as a pursuant to §§ 261.31 and 261.32. petition? hazardous waste. In addition, the Specifically, in its petition, ExxonMobil Administrator must determine, where requested that EPA grant a one-time To support its petition, ExxonMobil he/she has a reasonable basis to believe exclusion for 400,000 cubic yards of SIB submitted: that factors (including additional solids. (1) Historical information on waste constituents) other than those for which The 40 CFR part 261 Appendix VII generation and management practices; the waste was listed could cause the hazardous constituents which are the and waste to be a hazardous waste, that such basis for listing can be found in Table factors do not warrant retaining the 1. (2) analytical results from thirty-nine waste as a hazardous waste. samples for total and TCLP concentrations of compounds of III. EPA’s Evaluation of the Waste Data TABLE 1—EPA WASTE CODES FOR SURFACE IMPOUNDMENT BASIN SOL- concern (COC)s; A. What waste and how much did IDS AND THE BASIS FOR LISTING Beaumont Refinery petition EPA to delist? Waste code Basis for listing In August 2016, ExxonMobil petitioned EPA to exclude from the lists F037 ...... Benzene, benzo(a)pyrene, of hazardous wastes contained in chrysene, lead, chromium. F038 ...... Benzene, benzo(a)pyrene, §§ 261.31 and 261.32, SIB solids (F037, chrysene, lead, chromium. F038) generated from its facility located
TABLE 2—ANALYTICAL RESULTS/MAXIMUM ALLOWABLE DELISTING CONCENTRATION [Secondary Impoundment Basin (SIB) Solids ExxonMobil Beaumont Refinery, Beaumont, Texas]
Maximum Maximum total Maximum TCLP Constituent concentration TCLP delisting (mg/kg) concentration level (mg/L) (mg/L)
Antimony ...... 4.84 0.023 .109 Arsenic ...... 33.6 0.077 .424 Barium ...... 455 1.47 36 Beryllium ...... 1.38 <0.002 2.0 Cadmium ...... 2.05 <0.002 0.09 Chromium ...... 697 0.205 2.27 Cobalt ...... 19.4 0.0371 0.214 Lead ...... 400 0.656 0.702 Mercury ...... 3.61 0.000049 0.068 Nickel ...... 68.2 0.152 13.5 Selenium ...... 28.7 0.0177 0.890 Silver ...... 1.23 0.002 5.0 Vanadium ...... 90.7 0.0815 3.77 Zinc ...... 2,470 5.43 197 2,4 Dimethylphenol ...... 0.97 0.0018 11.3 2-Methylphenol ...... <0.71 <.000033 28.9 3-Methylphenol ...... <0.64 0.002 28.9 4-Methylphenol ...... <0.64 0.00047 2.89 Acenaphthene ...... 1.7 0.00091 10.6 Anthracene ...... 2.9 0.00019 25.9 Benz(a)anthracene ...... 7.2 0.000034 0.07 Benz(a)pyrene ...... 5 <0.00003 26.3 Bis(2-ethylhexyl)phthalate ...... 34 0.0002 106,000 Chrysene ...... 19 0.000048 7.01 Di-n-butyl phthalate ...... 0.66 0.0013 24.6 Fluoranthene ...... 2.1 0.000078 2.46 Fluorene ...... 4.9 0.0016 4.91 Indeno(1,2,3-cd)pyrene ...... 2.6 <0.000051 73 Naphthalene ...... 26 0.02 0.0327 Phenol ...... <0.71 0.00025 173 Pyrene ...... N/A 0.00019 4.45 Benzene ...... 1.1 <0.004 0.077 Xylenes, total ...... 53 0.18 9.56 Notes: These levels represent the highest constituent concentration found in any one sample and does not necessarily represent the specific level found in one sample.
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IV. Public Comments Received on the seeping into our groundwater for our Delisting Risk Assessment Software Proposed Exclusion kids to drink. ExxonMobile needs to (DRAS) to provide scientific reasoning spend the money on research to break to the EPA for the delisting of SIB A. Who submitted comments on the down this waste sludge into something solids, I believe that more research must proposed rule? that doesn’t hurt the environment. They be conducted by the EPA itself. The EPA received four anonymous must not be allowed to put it in dumps Employees of this agency should public comments on the May 31, 2017, or store it somewhere. There probably especially check the individual proposed rule via regulations.gov. EPA are some kind of bacteria that will break components of the SIB solids and test also received comments from the facility this stuff down into something useful or for even greater possibilities than those regarding the conditions and non toxic. This stuff should NOT end proposed by the DRAS; the DRAS was nomenclature on Table 1. The up in our ground water. If you cannot not said to take into account the effects comments and responses are addressed do something positive with this waste, that chemical exposure would produce below. the process whereby this waste is on surrounding populations or even B. Comments and Responses produced MUST BE STOPPED. We need employees themselves if buildups were to move away from fossil fuel use and to occur. Risk assessment should be Comment 1. ‘‘Exxon Mobil requests towards renewable energy and issued for each individual chemical that language found on Pages 24929, sustainable products.’’ compound by the EPA. Assuming the 24931, and 24932 be revised to reflect Response 2. The Delisting Program EPA would like to work rather quickly that the SIB solids are delisted upon requires extensive waste sampling and a on this issue considering ExxonMobil’s final publication in the Federal risk assessment is performed to assess a insistence that the SIB solids are non- Register. The text in Section IV (Next wastes potential harm to human health hazardous, benefits would include Steps), Items A.(2) and A.(3) is currently and the environment. The program is reduced regulation on the industry, as structured such that additional testing designed to insure that the wastes well as, one less responsibility for the would have to be performed to verify which are deemed excluded will not be EPA. However, closer examination that delisting limits are met. Items (2), managed in a manner to harm human needs to occur, especially since this test (3), and (4) of Table 1 (Pages 24931 and health or the environment. This waste has only been conducted for Beaumont, 34932) also reflect these requirements. will be managed in a Subtitle D Texas.’’ This language appears to be a industrial waste landfill as solid waste Response 4. A waste is eligible for ‘‘holdover’’ associated with another to prevent releases to groundwater and delisting only if that waste, as generated delisting petition request. Our sampling air pathways. at a particular facility, does not meet program included collection of over 30 Comment 3. ‘‘The EPA should feel any of the criteria under which the samples to support the delisting petition obligated to ensure that there are no waste was listed as a hazardous waste. request. As such, we believe we have possible adverse effects to humans or In addition, the waste may not contain already completed a rigorous sampling the environment by approving the any other Appendix VIII constituents program in support of this request. Also, petition from ExxonMobile. The EPA that would cause the waste to be we would note in several locations that should conduct their own investigation, hazardous. RCRA § 3001(f) and 40 CFR the petition volume is listed as ‘‘400,000 take their own samples, and perform 260.22. A delisting is only intended to wet’’ cubic yards. The SIB solids will data analysis to confirm that there are address a specific waste stream contain water upon removal from the no discrepancies between their findings generated at a specific site. The risk pond. However, they will be dewatered and those provided by the Beaumont analysis is conducted specifically for (e.g. filtration, addition of cement, etc.) facility. In the list of constituents each chemical constituent of the waste to pass the paint filter test prior to provided by ExxonMobile, there are stream. If any constituent concentration disposal. As such, we suggest removing known human carcinogens such as exceeds the delisting limit, the entire the word wet in reference to the delisted arsenic, beryllium, cadmium, waste stream remains hazardous. volume.’’ chromium, nickel, and benzene, along The delisting risk analysis performed Response 1. The language found in with other harmful constituents such as using the Delisting Risk Assessment Table 1 of the exclusion has been lead and mercury. The EPA should Software evaluates the worst case revised to remove all conditional conduct an environmental impact scenario for the petitioned waste and exclusion language. The request for the assessment before approving this risk pathways are evaluated. All delisting is a one-time exclusion which petition.’’ chemical constituents detected in the is conditioned on proper disposal of up Response 3. The requirements of the waste are individually assessed for their to 400,000 cubic yards of SIB solids and Federal regulations defined in 40 CFR impact on human health and the contains the data submittals, reopener part 260.20, and 260.22, describe the environment. and disposal notification clauses for all process by which wastes may be Comment 5. ‘‘I believe there should be delisting exclusions. The conditions removed from the list of hazardous a thorough health examination of all were included in the proposed rule in waste. In addition to extensive quality employees in the facility who work error. All references regarding the wet assurance and quality control data for directly with the waste proposed for solids have been removed because the the samples taken, EPA performs a risk delisting. Some of these chemicals can waste will not be disposed of in this assessment using the Delisting Risk build-up in the system over time and if manner. The reference to wet solids was Assessment Software to ensure that our any de-regulations are to occur they in regards to the volume of solids as decision is protective of human health need science based evidence to prove generated during the removal. and the environment. The constituent the decision would not pose a human Comment 2. ‘‘Excuse me? concentrations found in the surface safety issue. If the decision would not ExxonMobile wants to dump their waste impoundment basin solids are below prove to have a high economical impact, into the landfills where it can pollute the concentrations that would pose I do not see any reason it should be our ground water? NO. Absolutely NOT. harm to human health and the considered, especially when the These waste products are toxic to the environment. decision is for only a single site.’’ environment and need to stay listed as Comment 4. ‘‘Although the tests that Response 5. A waste is eligible for hazardous. We don’t want this stuff have been run by ExxonMobil’s delisting only if that waste, as generated
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at a particular facility, does not meet government and the States, or on the parties (5 U.S.C. 804(3)). EPA is not any of the criteria under which the distribution of power and required to submit a rule report waste was listed as a hazardous waste. responsibilities among the various regarding today’s action under section In addition, the waste may not contain levels of government, as specified in 801 because this is a rule of particular any other Appendix VIII constituents Executive Order 13132, ‘‘Federalism’’, applicability. Executive Order (E.O.) that would cause the waste to be (64 FR 43255, August 10, 1999). Thus, 12898 (59 FR 7629 (Feb. 16, 1994)) hazardous. RCRA § 3001(f) and 40 CFR Executive Order 13132 does not apply establishes Federal executive policy on 260.22. A delisting is only intended to to this rule. environmental justice. Its main address a specific waste stream Similarly, because this rule will affect provision directs Federal agencies, to generated at a specific site. Since only a particular facility, this proposed the greatest extent practicable and individual waste streams may vary rule does not have tribal implications, permitted by law, to make depending on raw materials, industrial as specified in Executive Order 13175, environmental justice part of their processes, and other factors, it may be ‘‘Consultation and Coordination with mission by identifying and addressing, appropriate not to list a specific waste Indian Tribal Governments’’ (65 FR as appropriate, disproportionately high from a specific site. Therefore, while a 67249, November 9, 2000). Thus, and adverse human health or waste described in the regulations or Executive Order 13175 does not apply environmental effects of their programs, resulting from the operation of the to this rule. This rule also is not subject policies, and activities on minority mixture or derived-from rules generally to Executive Order 13045, ‘‘Protection of populations and low-income is hazardous, a specific waste from an Children from Environmental Health populations in the United States. individual facility may not be Risks and Safety Risks’’ (62 FR 19885, EPA has determined that this hazardous. For this reason, 40 CFR April 23, 1997), because it is not proposed rule will not have 260.20 and 260.22 provide an exclusion economically significant as defined in disproportionately high and adverse procedure, called delisting, which Executive Order 12866, and because the human health or environmental effects allows persons to prove that EPA should Agency does not have reason to believe on minority or low-income populations not regulate a specific waste from a the environmental health or safety risks because it does not affect the level of particular generating facility as a addressed by this action present a protection provided to human health or hazardous waste. A risk assessment of disproportionate risk to children. The the environment. The Agency’s risk the petitioned waste is completed and a basis for this belief is that the Agency assessment did not identify risks from part of the decision factors in issuing an used DRAS, which considers health and management of this material in an safety risks to children, to calculate the exclusion. Specific health examinations authorized, solid waste landfill (e.g. maximum allowable concentrations for and worker protection is covered by the RCRA Subtitle D landfill, commercial/ this rule. This rule is not subject to facility operating plans and overseen by industrial solid waste landfill, etc.). Executive Order 13211, ‘‘Actions OSHA. Worker safety during the Therefore, EPA believes that any Concerning Regulations That management of this waste to avoid populations in proximity of the landfills Significantly Affect Energy Supply, contact with this material are covered used by this facility should not be Distribution, or Use’’ (66 FR 28355 (May by the Health and Safety plans of the adversely affected by common waste petitioner. 22, 2001)), because it is not a significant management practices for this delisted regulatory action under Executive Order waste. V. Statutory and Executive Order 12866. This rule does not involve Reviews technical standards; thus, the Lists of Subjects in 40 CFR Part 261 Under Executive Order 12866, requirements of section 12(d) of the ‘‘Regulatory Planning and Review’’ (58 National Technology Transfer and Environmental protection, Hazardous FR 51735, October 4, 1993), this rule is Advancement Act of 1995 (15 U.S.C. waste, Recycling, Reporting and not of general applicability and 272 note) do not apply. As required by recordkeeping requirements. therefore, is not a regulatory action section 3 of Executive Order 12988, Authority: Sec. 3001(f) RCRA, 42 U.S.C. subject to review by the Office of ‘‘Civil Justice Reform’’, (61 FR 4729, 6921(f). Management and Budget (OMB). This February 7, 1996), in issuing this rule, Dated: October 4, 2017. rule does not impose an information EPA has taken the necessary steps to Wren Stenger, collection burden under the provisions eliminate drafting errors and ambiguity, Director, Multimedia Division, Region 6. of the Paperwork Reduction Act of 1995 minimize potential litigation, and (44 U.S.C. 3501 et seq.) because it provide a clear legal standard for For the reasons set out in the applies to a particular facility only. affected conduct. preamble, 40 CFR part 261 is amended Because this rule is of particular The Congressional Review Act, 5 as follows: applicability relating to a particular U.S.C. 801 et seq., as added by the Small facility, it is not subject to the regulatory Business Regulatory Enforcement PART 261—IDENTIFICATION AND flexibility provisions of the Regulatory Fairness Act of 1996, generally provides LISTING OF HAZARDOUS WASTE Flexibility Act (5 U.S.C. 601 et seq.), or that before a rule may take effect, the to sections 202, 204, and 205 of the agency promulgating the rule must ■ 1. The authority citation for part 261 Unfunded Mandates Reform Act of 1995 submit a rule report which includes a continues to read as follows: (UMRA) (Pub. L. 104–4). Because this copy of the rule to each House of the Authority: 42 U.S.C. 6905, 6912(a), 6921, rule will affect only a particular facility, Congress and to the Comptroller General 6922, and 6938. it will not significantly or uniquely of the United States. Section 804 ■ 2. In Table 1—Wastes Excluded From affect small governments, as specified in exempts from section 801 the following Non-Specific Sources in Appendix IX to section 203 of UMRA. Because this rule types of rules: (1) Rules of particular Part 261, add the following waste stream will affect only a particular facility, this applicability; (2) rules relating to agency in alphabetical order by facility to read proposed rule does not have federalism management or personnel; and (3) rules as follows: implications. It will not have substantial of agency organization, procedure, or direct effects on the States, on the practice that do not substantially affect Appendix IX to Part 261—Waste relationship between the national the rights or obligations of non-agency Excluded Under §§ 260.20 and 260.22
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TABLE 1—WASTES EXCLUDED FROM NON-SPECIFIC SOURCES
Facility Address Waste description
******* ExxonMobil ...... Beaumont, TX ...... Secondary Impoundment Basin Solids (SIB) (EPA Hazardous Waste Numbers F037 and F038) generated at a maximum rate of 400,000 cubic yards. (1) Delisting Levels: All concentrations for those constituents must not exceed the maximum al- lowable concentrations in mg/l specified in this paragraph. Surface Impoundment Basin Solids. Leachable Concentrations (mg/l): Antimony—0.109; Ar- senic—0.424; Barium—36; Beryllium—2.0; Cadmium—0.09; Chromium—2.27; Cobalt—0.214; Lead—0.702; Mercury—0.068; Nickel—13.5; Selenium—0.890; Silver—5.0; Vanadium—3.77; Zinc—197; 2,4 Dimethylphenol—11.3; 2-Methylphenol—28.9; 3-Methylphenol—28.9; 4-Methyl- phenol—2.89; Acenaphthene—10.6; Anthracene-—25.9; Benz(a)anthracene—0.07; Benz(a)pyrene—26.3; Bis(2-ethylhexyl) phthalate—106,000; Chrysene—7.01; Di-n-butyl phthalate—24.6; Fluoranthene—2.46; Fluorene—4.91; Indeno(1,2,3-cd) pyrene—73; Naph- thalene—0.0327; Phenol—173; Pyrene—4.45; Benzene—0.077; Xylenes, total—9.56 (2) Reopener (A) If, any time after disposal of the delisted waste ExxonMobil possesses or is otherwise made aware of any environmental data (including but not limited to underflow water data or ground water monitoring data) or any other data relevant to the delisted waste indicating that any con- stituent identified for the delisting verification testing is at level higher than the delisting level allowed by the Division Director in granting the petition, then the facility must report the data, in writing, to the Division Director within 10 days of first possessing or being made aware of that data. (B) If verification testing (and retest, if applicable) of the waste does not meet the delisting re- quirements in paragraph 1, ExxonMobil must report the data, in writing, to the Division Direc- tor within 10 days of first possessing or being made aware of that data. (C) If ExxonMobil fails to submit the information described in paragraphs (2),(3)(A) or (3)(B) or if any other information is received from any source, the Division Director will make a prelimi- nary determination as to whether the reported information requires EPA action to protect human health and/or the environment. Further action may include suspending, or revoking the exclusion, or other appropriate response necessary to protect human health and the environ- ment. (D) If the Division Director determines that the reported information requires action by EPA, the Division Director will notify the facility in writing of the actions the Division Director believes are necessary to protect human health and the environment. The notice shall include a state- ment of the proposed action and a statement providing the facility with an opportunity to present information as to why the proposed EPA action is not necessary. The facility shall have 10 days from receipt of the Division Director’s notice to present such information. (E) Following the receipt of information from the facility described in paragraph (3)(D) or (if no in- formation is presented under paragraph (3)(D)) the initial receipt of information described in paragraphs (2), (3)(A) or (3)(B), the Division Director will issue a final written determination de- scribing EPA actions that are necessary to protect human health and/or the environment. Any required action described in the Division Director’s determination shall become effective imme- diately, unless the Division Director provides otherwise. (3) Notification Requirements: ExxonMobil must do the following before transporting the delisted waste. Failure to provide this notification will result in a violation of the delisting petition and a possible revocation of the de- cision. (A) Provide a one-time written notification to any state Regulatory Agency to which or through which it will transport the delisted waste described above for disposal, 60 days before begin- ning such activities. (B) For onsite disposal, a notice should be submitted to the State to notify the State that dis- posal of the delisted materials has begun. (C) Update one-time written notification, if it ships the delisted waste into a different disposal fa- cility. (D) Failure to provide this notification will result in a violation of the delisting exclusion and a possible revocation of the decision.
*******
[FR Doc. 2017–23239 Filed 10–25–17; 8:45 am] BILLING CODE 6560–50–P
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DEPARTMENT OF COMMERCE the Bering Sea and Aleutian Islands 48460; October 18, 2017). The 2017 management area to be harvested. flathead sole, rock sole, and yellowfin National Oceanic and Atmospheric DATES: Effective October 26, 2017 sole CDQ ABC reserves are 6,018 mt, Administration through December 31, 2017. 11,286 mt and 11,434 mt as established FOR FURTHER INFORMATION CONTACT: by the final 2017 and 2018 harvest 50 CFR Part 679 Steve Whitney, 907–586–7228. specifications for groundfish in the SUPPLEMENTARY INFORMATION: NMFS BSAI (82 FR 11826, February 27, 2017) [Docket No. 161020985–7181–02] manages the groundfish fishery in the and revised by flatfish exchange (82 FR 48460; October 18, 2017). RIN 0648–XF767 Bering Sea and Aleutian Islands management area (BSAI) according to The Yukon Delta Fisheries Fisheries of the Exclusive Economic the Fishery Management Plan for Development Association has requested Zone Off Alaska; Exchange of Flatfish Groundfish of the Bering Sea and that NMFS exchange 60 mt of flathead in the Bering Sea and Aleutian Islands Aleutian Islands Management Area sole CDQ reserves and 145 mt of rock Management Area (FMP) prepared by the North Pacific sole CDQ reserves for 205 mt of Fishery Management Council under yellowfin sole CDQ ABC reserves under AGENCY: National Marine Fisheries authority of the Magnuson-Stevens § 679.31(d). Therefore, in accordance Service (NMFS), National Oceanic and Fishery Conservation and Management with § 679.31(d), NMFS exchanges 60 Atmospheric Administration (NOAA), Act. Regulations governing fishing by mt of flathead sole CDQ reserves and Commerce. U.S. vessels in accordance with the FMP 145 mt of rock sole CDQ reserves for 205 ACTION: Temporary rule; reallocation. appear at subpart H of 50 CFR part 600 mt of yellowfin sole CDQ ABC reserves and 50 CFR part 679. in the BSAI. This action also decreases SUMMARY: NMFS is exchanging unused The 2017 flathead sole, rock sole, and and increases the TACs and CDQ ABC flathead sole and rock sole Community yellowfin sole CDQ reserves specified in reserves by the corresponding amounts. Development Quota (CDQ) for yellowfin the BSAI are 1,288 metric tons (mt), Tables 11 and 13 of the final 2017 and sole CDQ acceptable biological catch 5,310 mt, and 16,472 mt as established 2018 harvest specifications for (ABC) reserves in the Bering Sea and by the final 2017 and 2018 harvest groundfish in the BSAI (82 FR 11826, Aleutian Islands management area. This specifications for groundfish in the February 27, 2017), and revised by action is necessary to allow the 2017 BSAI (82 FR 11826, February 27, 2017) flatfish exchange (82 FR 48460; October total allowable catch of yellowfin sole in and revised by flatfish exchange (82 FR 18, 2017) are further revised as follows:
TABLE 11—FINAL 2017 COMMUNITY DEVELOPMENT QUOTA (CDQ) RESERVES, INCIDENTAL CATCH AMOUNTS (ICAS), AND AMENDMENT 80 ALLOCATIONS OF THE ALEUTIAN ISLANDS PACIFIC OCEAN PERCH, AND BSAI FLATHEAD SOLE, ROCK SOLE, AND YELLOWFIN SOLE TACS [Amounts are in metric tons]
Pacific ocean perch Flathead sole Rock sole Yellowfin sole Sector Eastern Central Western Aleutian Aleutian Aleutian BSAI BSAI BSAI district district district
TAC ...... 7,900 7,000 9,000 14,176 47,225 154,199 CDQ ...... 845 749 963 1,228 5,165 16,677 ICA ...... 100 60 10 4,000 5,000 4,500 BSAI trawl limited access ...... 695 619 161 0 0 18,151 Amendment 80 ...... 6,259 5,572 7,866 8,949 37,060 114,871 Alaska Groundfish Cooperative ...... 3,319 2,954 4,171 918 9,168 45,638 Alaska Seafood Cooperative ...... 2,940 2,617 3,695 8,031 27,893 69,233 Note: Sector apportionments may not total precisely due to rounding.
TABLE 13—FINAL 2017 AND 2018 ABC SURPLUS,COMMUNITY DEVELOPMENT QUOTA (CDQ) ABC RESERVES, AND AMENDMENT 80 ABC RESERVES IN THE BSAI FOR FLATHEAD SOLE, ROCK SOLE, AND YELLOWFIN SOLE [Amounts are in metric tons]
2017 2017 2017 2018 2018 2018 Sector Flathead sole Rock sole Yellowfin sole Flathead sole Rock sole Yellowfin sole
ABC ...... 68,278 155,100 260,800 66,164 143,100 250,800 TAC ...... 14,176 47,225 154,199 14,500 47,100 154,000 ABC surplus ...... 54,102 107,875 106,601 51,664 96,000 96,800 ABC reserve ...... 54,102 107,875 106,601 51,664 96,000 96,800 CDQ ABC reserve ...... 6,078 11,431 11,229 5,528 10,272 10,358 Amendment 80 ABC reserve ...... 48,024 96,444 95,372 46,136 85,728 86,442 Alaska Groundfish Cooperative for 2017 1 ...... 4,926 23,857 37,891 n/a n/a n/a Alaska Seafood Cooperative for 2017 1 .. 43,098 72,587 57,481 n/a n/a n/a 1 The 2018 allocations for Amendment 80 species between Amendment 80 cooperatives and the Amendment 80 limited access sector will not be known until eligible participants apply for participation in the program by November 1, 2017.
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Classification Yukon Delta Fisheries Development date of this action under 5 U.S.C. Association in the BSAI. Since these 553(d)(3). This finding is based upon This action responds to the best fisheries are currently open, it is the reasons provided above for waiver of available information recently obtained important to immediately inform the prior notice and opportunity for public from the fishery. The Assistant industry as to the revised allocations. comment. Administrator for Fisheries, NOAA Immediate notification is necessary to This action is required by § 679.20 (AA), finds good cause to waive the allow for the orderly conduct and requirement to provide prior notice and efficient operation of this fishery, to and is exempt from review under opportunity for public comment allow the industry to plan for the fishing Executive Order 12866. pursuant to the authority set forth at 5 season, and to avoid potential Authority: 16 U.S.C. 1801 et seq. U.S.C. 553(b)(B) as such requirement is disruption to the fishing fleet as well as Dated: October 23, 2017. impracticable and contrary to the public processors. NMFS was unable to interest. This requirement is publish a notice providing time for Emily H. Menashes, impracticable and contrary to the public public comment because the most Acting Director, Office of Sustainable interest as it would prevent NMFS from recent, relevant data only became Fisheries, National Marine Fisheries Service. responding to the most recent fisheries available as of October 11, 2017. [FR Doc. 2017–23340 Filed 10–25–17; 8:45 am] data in a timely fashion and would The AA also finds good cause to BILLING CODE 3510–22–P delay the flatfish exchange by the waive the 30-day delay in the effective
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Proposed Rules Federal Register Vol. 82, No. 206
Thursday, October 26, 2017
This section of the FEDERAL REGISTER ADDRESSES: Comments, identified by NERC Reliability Standards (NERC contains notices to the public of the proposed docket number, may be filed in the Glossary). Further, the Commission issuance of rules and regulations. The following ways: proposes to approve the retirement of purpose of these notices is to give interested • Electronic Filing through http:// Reliability Standard CIP–003–6. persons an opportunity to participate in the www.ferc.gov. Documents created 2. Proposed Reliability Standard CIP– rule making prior to the adoption of the final electronically using word processing 003–7 is designed to mitigate the rules. software should be filed in native cybersecurity risks to bulk electric applications or print-to-PDF format and system facilities, systems, and DEPARTMENT OF ENERGY not in a scanned format. equipment, which, if destroyed, • Mail/Hand Delivery: Those unable degraded, or otherwise rendered Federal Energy Regulatory to file electronically may mail or hand- unavailable as a result of a cybersecurity Commission deliver comments to: Federal Energy incident, would affect the reliable Regulatory Commission, Secretary of the operation of the bulk electric system.3 18 CFR Part 40 Commission, 888 First Street NE., As discussed below, the Commission Washington, DC 20426. proposes to determine that proposed Instructions: For detailed instructions [Docket No. RM17–11–000] Reliability Standard CIP–003–7 is just, on submitting comments and additional reasonable, not unduly discriminatory Revised Critical Infrastructure information on the rulemaking process, or preferential, and in the public Protection Reliability Standard CIP– see the Comment Procedures section of interest and addresses the directives in 003–7—Cyber Security—Security this document. Order No. 822 by: 1. Clarifying the Management Controls FOR FURTHER INFORMATION CONTACT: obligations pertaining to electronic Matthew Dale (Technical Information), access control for low impact BES Cyber AGENCY: Federal Energy Regulatory Office of Electric Reliability, Federal Systems; 4 and 2. adopting mandatory Commission, DOE. Energy Regulatory Commission, 888 security controls for transient electronic ACTION: Notice of proposed rulemaking. First Street NE., Washington, DC 20426, devices (e.g., thumb drives, laptop (202) 502–6826, [email protected], computers, and other portable devices SUMMARY: The Federal Energy Kevin Ryan (Legal Information), Office frequently connected to and Regulatory Commission (Commission) of the General Counsel, Federal Energy disconnected from systems) used at low proposes to approve Critical Regulatory Commission, 888 First Street impact BES Cyber Systems. In addition, Infrastructure Protection (CIP) NE., Washington, DC 20426, (202) 502– by requiring responsible entities to have Reliability Standard CIP–003–7 (Cyber 6840, [email protected]. a policy for declaring and responding to Security—Security Management SUPPLEMENTARY INFORMATION: CIP Exceptional Circumstances for low Controls), submitted by the North 1. Pursuant to section 215 of the impact BES Cyber Systems, the American Electric Reliability Federal Power Act (FPA),1 the proposed Reliability Standard aligns the Corporation (NERC). Proposed Commission proposes to approve treatment of low impact BES Cyber Reliability Standard CIP–003–7 Critical Infrastructure Protection (CIP) Systems with that of high and medium improves upon the current Commission- Reliability Standard CIP–003–7 (Cyber impact BES Cyber Systems, which approved CIP Reliability Standards by Security—Security Management currently include a requirement for clarifying the obligations pertaining to Controls). The North American Electric declaring and responding to CIP electronic access control for low impact Reliability Corporation (NERC), the Exceptional Circumstances. BES Cyber Systems; adopting Commission-certified Electric Accordingly, we propose to approve mandatory security controls for Reliability Organization (ERO), proposed Reliability Standard CIP–003– transient electronic devices (e.g., thumb submitted proposed Reliability Standard 7 because the proposed modifications drives, laptop computers, and other CIP–003–7 in response to directives in improve the base-line cybersecurity portable devices frequently connected to Order No. 822.2 The Commission also posture of responsible entities compared and disconnected from systems) used at proposes to approve the associated to the current Commission-approved low impact BES Cyber Systems; and violation risk factors and violation CIP Reliability Standards. requiring responsible entities to have a severity levels, implementation plan 3. In addition, pursuant to FPA policy for declaring and responding to and effective dates proposed by NERC. section 215(d)(5), the Commission CIP Exceptional Circumstances related In addition, the Commission proposes to proposes to direct NERC to develop to low impact BES Cyber Systems. In approve the modified definitions of certain modifications to the CIP addition, the Commission proposes to Transient Cyber Asset and Removable Reliability Standards. As discussed direct NERC to develop certain Media as well as the retirement of the below, while proposed Reliability modifications to the NERC Reliability definitions for Low Impact External Standard CIP–003–7 improves Standards to provide clear, objective Routable Connectivity (LERC) and Low electronic access control for low impact criteria for electronic access controls for Impact Electronic Access Point (LEAP) BES Cyber Systems and enhances low impact BES Cyber Systems; and in the NERC Glossary of Terms Used in security controls for transient electronic address the need to mitigate the risk of malicious code that could result from 1 16 U.S.C. 824o (2012). 3 See NERC Petition at 2. third-party transient electronic devices. 2 Revised Critical Infrastructure Protection 4 NERC defines ‘‘BES Cyber System’’ as one or Reliability Standards, Order No. 822, 154 FERC ¶ more BES Cyber Assets logically grouped by a DATES: Comments are due December 26, 61,037, reh’g denied, Order No. 822–A, 156 FERC responsible entity to perform one or more reliability 2017. ¶ 61,052 (2016). tasks for a functional entity.
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devices used at low impact BES Cyber the CIP Reliability Standards and Circumstances policy for low impact Systems, we propose to direct that addressed the directives in Order No. BES Cyber Systems. NERC modify Reliability Standard CIP– 791 by, among other things, addressing 9. In response to the Commission’s 003–7 to: 1. Provide clear, objective in an equally effective and efficient directive to develop modifications to criteria for electronic access controls for manner the need for a NERC Glossary eliminate ambiguity surrounding the low impact BES Cyber Systems; and 2. definition for the term ‘‘communication term ‘‘direct’’ as it is used in the LERC address the need to mitigate the risk of networks’’ and providing controls to definition, NERC proposes to: 1. Retire malicious code that could result from address the risks posed by transient the terms LERC and LEAP from the third-party transient electronic devices. electronic devices (e.g., thumb drives NERC Glossary; and 2. modify Section We believe that modifications and laptop computers) used at high and 3 of Attachment 1 to proposed addressing these two concerns will medium impact BES Cyber Systems.9 Reliability Standard CIP–003–7 ‘‘to address potential gaps and improve the 6. In addition, in Order No. 822, more clearly delineate the cyber security posture of responsible pursuant to section 215(d)(5) of the circumstances under which Responsible entities that must comply with the CIP FPA, the Commission directed NERC, Entities must establish access controls standards. inter alia, to: 1. Develop modifications for low impact BES Cyber Systems.’’ 12 I. Background to the LERC definition to eliminate NERC states that the proposed revisions ambiguity surrounding the term are designed to simplify the electronic A. Section 215 and Mandatory ‘‘direct’’ as it is used in the LERC access control requirements associated Reliability Standards definition; and 2. develop modifications with low impact BES Cyber Systems in 4. Section 215 of the FPA requires a to the CIP Reliability Standards to order to avoid ambiguities associated Commission-certified ERO to develop provide mandatory protection for with the term ‘‘direct.’’ NERC explains mandatory and enforceable Reliability transient electronic devices used at low that it recognized the ‘‘added layer of Standards, subject to Commission impact BES Cyber Systems.10 unnecessary complexity’’ introduced by distinguishing between ‘‘direct’’ and review and approval. Reliability C. NERC Petition Standards may be enforced by the ERO, ‘‘indirect’’ access within the LERC subject to Commission oversight, or by 7. On March 3, 2017, NERC submitted definition and asserts that the proposed the Commission independently.5 a petition seeking approval of Reliability revisions will ‘‘help ensure that Pursuant to section 215 of the FPA, the Standard CIP–003–7 and the associated Responsible Entities implement the Commission established a process to violation risk factors and violation required security controls select and certify an ERO,6 and severity levels, implementation plan effectively.’’ 13 subsequently certified NERC.7 and effective dates. NERC states that 10. With regard to the Commission’s proposed Reliability Standard CIP–003– directive to develop modifications to the B. Order No. 822 7 satisfies the criteria set forth in Order CIP Reliability Standards to provide 5. The Commission approved the No. 672 that the Commission applies mandatory protection for transient ‘‘Version 1’’ CIP standards in January when reviewing a proposed Reliability electronic devices used at low impact 2008, and subsequently acted on revised Standard.11 NERC also sought approval BES Cyber Systems, NERC proposes to versions of the CIP standards.8 On of revisions to NERC Glossary add a new section to Attachment 1 to January 21, 2016, in Order No. 822, the definitions for the terms Removable proposed Reliability Standard CIP–003– Commission approved seven CIP Media and Transient Cyber Asset, as 7 to require responsible entities to Reliability Standards: CIP–003–6 well as the retirement of the NERC include controls in their cyber security (Security Management Controls), CIP– Glossary definitions of LERC and LEAP. plans to mitigate the risk of the 004–6 (Personnel and Training), CIP– In addition, NERC proposed the introduction of malicious code to low 006–6 (Physical Security of BES Cyber retirement of Commission-approved impact BES Cyber Systems that could Systems), CIP–007–6 (Systems Security Reliability Standard CIP–003–6. result from the use of ‘‘Transient Cyber Management), CIP–009–6 (Recovery 8. NERC states that proposed Assets or Removable Media.’’ Plans for BES Cyber Systems), CIP–010– Reliability Standard CIP–003–7 Specifically, proposed Section 5 of 2 (Configuration Change Management improves upon the existing protections Attachment 1 lists controls to be applied and Vulnerability Assessments), and that apply to low impact BES Cyber to Transient Cyber Assets and CIP–011–2 (Information Protection). The Systems. NERC avers that the proposed Removable Media that NERC contends Commission determined that the modifications address the Commission’s ‘‘will provide enhanced protections Reliability Standards under directives from Order No. 822 by: 1. against the propagation of malware from consideration at that time were an Clarifying electronic access control transient devices.’’ 14 improvement over the prior iteration of requirements applicable to low impact 11. NERC also proposes a BES Cyber Systems; and 2. adding modification that was not directed by 5 16 U.S.C. 824o(e) (2012). requirements for the protection of the Commission in Order No. 822. 6 Rules Concerning Certification of the Electric Reliability Organization; and Procedures for the transient electronic devices used for low Namely, NERC proposes revisions in Establishment, Approval, and Enforcement of impact BES Cyber Systems. In addition, Requirement R1 of proposed Reliability Electric Reliability Standards, Order No. 672, FERC while not required by Order No. 822, Standard CIP–003–7 to require Stats. & Regs. ¶ 31,204, order on reh’g, Order No. NERC proposes a CIP Exceptional 672–A, FERC Stats. & Regs. ¶ 31,212 (2006). responsible entities to have a policy for 7 North American Electric Reliability Corp., 116 declaring and responding to CIP FERC ¶ 61,062, order on reh’g and compliance, 117 9 Order No. 822, 154 FERC ¶ 61,037 at P 17; see Exceptional Circumstances related to FERC ¶ 61,126 (2006), aff’d sub nom. Alcoa, Inc. also Version 5 Critical Infrastructure Protection low impact BES Cyber Systems.15 NERC v. FERC, 564 F.3d 1342 (D.C. Cir. 2009). Reliability Standards, Order No. 791, 78 FR 72755 8 Mandatory Reliability Standards for Critical (Dec. 3, 2013), 145 FERC ¶ 61,160 (2013), order on 12 Id. at 16. Infrastructure Protection, Order No. 706, 122 FERC clarification and reh’g, Order No. 791–A, 146 FERC 13 ¶ 61,040, order on reh’g, Order No. 706–A, 123 ¶ 61,188 (2014). Id. at 16. FERC ¶ 61,174 (2008), order on clarification, Order 10 Order No. 822, 154 FERC ¶ 61,037 at P 18. 14 Id. at 26–27. No. 706–B, 126 FERC ¶ 61,229 (2009), order on 11 See NERC Petition at 2 (citing Order No. 672, 15 A CIP Exceptional Circumstance is defined in clarification, Order No. 706–C, 127 FERC ¶ 61,273 FERC Stats. & Regs. ¶ 31,204 at PP 262, 321–337); the NERC Glossary as a situation that involves or (2009). id. at Exhibit D (Order No. 672 Criteria). threatens to involve one or more of the following,
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states that a number of requirements in Exceptional Circumstances related to in the Guidelines and Technical Basis the existing CIP Reliability Standards low impact BES Cyber Systems. While section of Reliability Standard CIP–003– specify that responsible entities do not Order No. 822 did not direct NERC to 6 that electronic access controls must be have to implement or continue expand the scope of the CIP Exceptional applied to low impact BES Cyber implementing these requirements Circumstances policy, the revision Systems unless responsible entities during a CIP Exceptional Circumstance aligns the treatment of low impact BES implement a ‘‘complete security break’’ in order to avoid hindering the entities’ Cyber Systems with that of high and between the external host (cyber asset) ability to timely and effectively respond medium impact BES Cyber Systems if and any cyber asset(s) that may be used to the CIP Exceptional Circumstance. and when a CIP Exceptional to pass communications to the low NERC explains that since the proposed Circumstance occurs. impact BES Cyber System.18 The requirements relating to transient 14. We also propose to approve the Commission observed that ‘‘a suitable electronic devices used at low impact revisions to the NERC Glossary means to address our concern is to BES Cyber Systems include an definitions of Transient Cyber Asset and modify the [LERC] definition consistent exception for CIP Exceptional Removable Media, as well as the with the commentary in the Guidelines Circumstances, NERC is proposing to retirement of the NERC Glossary and Technical Basis section of CIP–003– add a requirement for responsible definitions for LERC and LEAP since the 6.’’ 19 entities to have a CIP Exceptional proposed modifications to Reliability 18. In addition, the Commission Circumstances policy that applies to Standard CIP–003–7 obviate the need explained that the directive was also low impact BES Cyber Systems, as it for the two terms. We further propose to intended to eliminate a loophole that already requires for high and medium approve the violation risk factor and would have allowed transitive impact BES Cyber Systems.16 violation severity level assignments connections to out-of-scope cyber assets 12. NERC requests that proposed associated with proposed Reliability (e.g., serial devices) to go unprotected Reliability Standard CIP–003–7 and the Standard CIP–003–7 as well as NERC’s under the LERC definition.20 revised definitions of Transient Cyber proposed implementation plan and NERC Petition Asset and Removable Media become effective dates. effective the first day of the first 15. In addition, as discussed below, 19. In its Petition, NERC proposes to: calendar quarter that is eighteen months pursuant to section 215(d)(5) of the 1. Retire the terms LERC and LEAP from after the effective date of the FPA, the Commission proposes to direct the NERC Glossary; and 2. modify Commission’s order approving the NERC to develop certain modifications Section 3 of Attachment 1 to Reliability proposed Reliability Standard. to the CIP Reliability Standards. While Standard CIP–003–7 ‘‘to more clearly proposed Reliability Standard CIP–003– delineate the circumstances under II. Discussion 7 improves electronic access control for which Responsible Entities must 13. Pursuant to section 215(d)(2) of low impact BES Cyber Systems and establish access controls for low impact the FPA, we propose to approve enhances security controls for transient BES Cyber Systems.’’ 21 NERC states that Reliability Standard CIP–003–7 as just, electronic devices used at low impact the proposed revisions are designed to reasonable, not unduly discriminatory BES Cyber Systems, we propose to simplify the electronic access control or preferential, and in the public direct that NERC modify Reliability requirements associated with low interest. Proposed Reliability Standard Standard CIP–003–7 to: 1. Provide clear, impact BES Cyber Systems in order to CIP–003–7 largely addresses the objective criteria for electronic access avoid ambiguities associated with the Commission’s directives in Order No. controls for low impact BES Cyber term ‘‘direct.’’ NERC states further that 822 and is an improvement over the Systems; and 2. address the need to it recognized the ‘‘added layer of current Commission-approved CIP mitigate the risk of malicious code that unnecessary complexity’’ introduced by Reliability Standards. Specifically, the could result from third-party transient distinguishing between ‘‘direct’’ and modifications to Section 3 of electronic devices. ‘‘indirect’’ access within the LERC Attachment 1 to Reliability Standard 16. Below, we discuss the following definition and asserts that the proposed CIP–003–7 clarify the obligations issues: A. Electronic access controls for revisions will ‘‘help ensure that pertaining to electronic access control low impact BES Cyber Systems; B. Responsible Entities implement the for low impact BES Cyber Systems. In protection of transient electronic required security controls addition, the modifications to devices; C. proposed retirement and effectively.’’ 22 Attachment 1 to Reliability Standard modification of definitions; D. NERC’s 20. NERC states that proposed CIP–003–7 require mandatory security proposed implementation plan and Reliability Standard CIP–003–7 would controls for transient electronic devices effective dates; and E. proposed require responsible entities to used at low impact BES Cyber Systems. violation severity level and violation implement electronic access controls for We also propose to approve the new risk factor assignments. any communication, direct or indirect provision in Reliability Standard CIP– (i.e., communications through an 003–7, Requirement R1 requiring A. Electronic Access Controls for Low intermediary device where no direct responsible entities to have a policy for Impact BES Cyber Systems Order No. connection is present), between a low declaring and responding to CIP 822 17. In Order No. 822, the Commission 18 Id. (citing NERC NOPR Comments at 31). or similar, conditions that impact safety or bulk directed NERC to modify the LERC 19 Id. electric system reliability: A risk of injury or death; definition to eliminate ambiguity 20 Id. (‘‘NERC’s clarification on this issue resolves a natural disaster; civil unrest; an imminent or surrounding the term ‘‘direct’’ as it is many of the concerns raised by EnergySec, APS, existing hardware, software, or equipment failure; and SPP RE regarding the proposed definition, as 17 a Cyber Security Incident requiring emergency used in the LERC definition. The a complete security break would not appear to assistance; a response by emergency services; the Commission explained that the directive permit transitive connections through one or more enactment of a mutual assistance agreement; or an was intended to codify the clarification out of scope cyber assets to go unprotected under impediment of large scale workforce availability. provided in NERC’s NOPR comments, the definition, and would appear to require the Glossary of Terms Used in NERC Reliability assets to maintain ‘separate conversations’ as Standards (August 1, 2017), http://www.nerc.com/ in which NERC referenced a statement suggested by SPP RE.’’). files/glossary_of_terms.pdf. 21 NERC Petition at 16. 16 NERC Petition at 31–32. 17 Order No. 822, 154 FERC ¶ 61,037 at P 73. 22 Id.
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impact BES Cyber System and an to the security of BES Cyber Systems that the ERO has the authority to review outside Cyber Asset that uses a routable and require additional protections. the documented justification for protocol when entering or leaving the Therefore, communications with a low permitting electronic access and to asset containing the low impact BES impact BES Cyber System involving determine whether it represents a Cyber System. NERC asserts that the routable connections require protections reasonable exercise of discretion in light proposed revisions to Section 3 of to address the risk of uncontrolled of the overall reliability objective.31 Attachment 1 to proposed Reliability communications. With regard to the 26. In support of its position, NERC Standard CIP–003–7 improve the clarity third characteristic, NERC explains that cites the draft Reliability Standard of the electronic access requirements the exclusion of communications for Audit Worksheet (RSAW) for proposed and focus responsible entities ‘‘on the time-sensitive protection and control Reliability Standard CIP–003–7, which security objective of controlling functions is intended to avoid provides the following language in the electronic access to permit only precluding the functionality of time- Note to Auditor section for Requirement necessary inbound and outbound sensitive reliability enhancing R2: electronic access to low impact BES functions. NERC states, however, that an The entity must document its Cyber Systems.’’ 23 entity invoking this exclusion may have determination as to what is necessary 21. NERC explains that Section 3.1 of to demonstrate that applying electronic inbound and outbound electronic access and Attachment 1 to proposed Reliability access controls would introduce latency provide justification of the business need for Standard CIP–003–7 is composed of that would negatively impact such access. Once this determination has three basic elements: 1. Identifying functionality.27 been made and documented, the audit team’s routable protocol communications from 24. According to NERC, the second professional judgment cannot override the outside the asset containing the low characteristic of Section 3.1 of determination made by the Responsible Entity.32 impact BES Cyber System; 2. Attachment 1 provides that responsible determining necessary inbound and entities may permit only necessary NERC also provides a list of outbound electronic access; and 3. inbound and outbound electronic access Commission-approved CIP Reliability implementing electronic access controls to low impact BES Cyber Systems as Standards where the phrase ‘‘as to permit only necessary inbound and determined by the responsible entity. determined by the Responsible Entity’’ outbound electronic access to the low NERC explains that Section 3.1 does not or similar language is used. NERC states impact BES Cyber System. specify a bright line as to what that in all circumstances where the 22. With regard to the first element, constitutes ‘‘necessary inbound and phrase ‘‘as determined by the NERC states that Section 3.1 of outbound access’’ due to ‘‘the wide Responsible Entity’’ or similar language Attachment 1 defines the circumstances array of assets containing low impact is used, ‘‘the ERO has the authority to where communications require BES Cyber Systems and the myriad of evaluate the reasonableness of the electronic access controls. The three reasons a Responsible Entity may need Responsible Entity’s determination characteristics are: to allow electronic access to and from a when assessing compliance to ensure it low impact BES Cyber Systems.’’ 28 is consistent with the reliability 1. The communication is between the low NERC maintains that responsible impact BES Cyber System and a Cyber Asset objective of the requirement. To outside the asset containing low impact BES entities ‘‘have the flexibility to identify interpret this language otherwise would Cyber System(s); the necessary electronic access to meet be inconsistent with NERC’s statutory 2. the communication uses a routable their business and operational obligation to engage in meaningful protocol when entering or leaving the asset needs.’’ 29 compliance oversight . . .’’ 33 containing the low impact BES Cyber 25. NERC explains that ‘‘a System(s); and Responsible Entity must document the Commission Proposal 3. the communication is not used for time- necessity of its inbound and outbound 27. The Commission proposes to sensitive protection or control functions electronic access permissions and approve Reliability Standard CIP–003–7 between intelligent electronic devices. provide justification of the need for because, as discussed above, the NERC states further that each of the such access’’ in order to demonstrate proposed Reliability Standard largely three characteristics were included in compliance with Section 3.1 of addresses the directives in Order No. the original LERC definition.24 Attachment 1.30 NERC states that absent 822 and is an improvement over the 23. NERC asserts that the first a documented, reasonable justification, current Commission-approved CIP characteristic helps to properly focus the ERO may find that the responsible Reliability Standards. However, NERC’s the electronic access controls in light of entity was not in compliance with proposed revisions to Reliability ‘‘the wide array of low impact BES Section 3.1. NERC asserts that the Standard CIP–003–7 regarding the LERC Cyber Systems and the risk-based purpose of the phrase ‘‘as determined by approach to protecting different types of the Responsible Entity’’ in Section 3.1 is 31 Id. at 22–23. BES Cyber Systems.’’ 25 NERC explains to indicate that the determination 32 Id. at 22, n.42. that, whether a ‘‘Responsible Entity uses whether electronic access is necessary is 33 Id. at 23–24. NERC also indicates, id at n.42, a logical border as a demarcation point to be made in the first instance by the that Footnote 1 of the draft RSAW states that ‘‘[w]hile the information included in this RSAW or some other understanding of what is responsible entity based on the facts and provides some of the methodology that NERC has inside or outside the asset, [the circumstances of each case. NERC states elected to use to assess compliance with the responsible entity] would have to further that that the phrase ‘‘as requirements of the Reliability Standard, this provide a reasonable justification for its determined by the Responsible Entity’’ document should not be treated as a substitute for the Reliability Standard or viewed as additional 26 determination.’’ On the second does not limit the ERO’s ability to Reliability Standard requirements. In all cases, the characteristic, NERC states that routable engage in effective compliance Regional Entity should rely on the language communications present increased risks oversight. Specifically, NERC contends contained in the Reliability Standard itself, and not on the language contained in the RSAW, to determine compliance with the Reliability 23 27 Id. at 17. Id. at 20. Standard.’’ Draft RSAW, http://www.nerc.com/pa/ 24 Id. at 18. 28 Id. at 21–22. Stand/Project%20201602%20Modifications%20to 25 Id. at 19. 29 Id. at 22. %20CIP%20Standards%20DL/RSAW_CIP-003-7(i)_ 26 Id. 30 Id. v2_Clean_01202017.pdf.
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directive and electronic access controls also outline basic security principles in devices was evaluated based on need for low impact BES Cyber Systems raise order to provide clear, objective criteria (Reliability Standard CIP–005–5, certain issues. In Order No. 822, the or measures to assist in assessing Requirement R1.3); 3. whether the entity Commission directed NERC to develop compliance. Without such a has mechanisms to enforce modifications to the LERC definition to requirement, auditors will not authentication of users with electronic eliminate ambiguity surrounding the necessarily have adequate information access (Reliability Standard CIP–007–6, term ‘‘direct’’ as it is used in the to assess the reasonableness of the Requirement R5); and 4. whether the definition. The directive was based on responsible entity’s decision with responsible entity routinely uses strong the concern that responsible entities respect to how the responsible entity passwords and manages password could avoid adopting adequate identified necessary communications or changes (Reliability Standard CIP–007– electronic access protections for low restricted electronic access to specific 6, Requirement R5). Absent similar impact BES Cyber Systems by simply low impact BES Cyber Systems. And criteria in the low impact electronic installing a device, such as a laptop or absent such information, it is possible access control plan that are protocol converter, in front of the BES that an auditor could assess a violation appropriately tailored to the risks posed Cyber System to ‘‘break’’ the direct where an entity adequately protected its by low impact BES Cyber Systems, routable connection. As the Commission low impact BES Cyber Systems or fail to responsible entities may adopt noted in Order No. 822, the desired recognize a situation where additional electronic access controls that do not clarification could have been made by protections are necessary to meet the meet the overarching security objective including the security concepts from the security objective of the standard. of restricting inbound and outbound Guidelines and Technical Basis section 30. As the Commission stated in electronic access. of Reliability Standard CIP–003–6 in the Order No. 672, there ‘‘should be a clear 32. Therefore, pursuant to section definition.34 Instead, NERC’s proposal criterion or measure of whether an 215(d)(5) of the FPA, we propose to comprehensively revises a responsible entity is in compliance with a proposed direct NERC to develop modifications to entity’s obligations under Requirement Reliability Standard. It should contain Reliability Standard CIP–003–7 to R2 through the revisions to Attachment or be accompanied by an objective provide clear, objective criteria for 1 by deleting the term LERC and giving measure of compliance so that it can be electronic access controls for low responsible entities significantly more enforced and so that enforcement can be impact BES Cyber Systems consistent deference in determining how they applied in a consistent and non- with the above discussion. The construct the electronic access preferential manner.’’ 35 The Commission seeks comment on this protections for low impact BES Cyber Commission reiterated this point in proposal. Order No. 791, stating that ‘‘the absence Systems. B. Protection of Transient Electronic 28. We are concerned that the of objective criteria to evaluate the Devices proposed revisions may not provide controls chosen by responsible entities adequate electronic access controls for for Low Impact assets introduces an Order No. 822 low impact BES Cyber Systems. unacceptable level of ambiguity and 33. In Order No. 822, the Commission Specifically, proposed Reliability potential inconsistency into the directed NERC to develop modifications Standard CIP–003–7 does not provide compliance process, and creates an to provide mandatory protection for 36 clear, objective criteria or measures to unnecessary gap in reliability.’’ The transient electronic devices used at low assess compliance by independently Commission also observed that impact BES Cyber Systems based on the confirming that the access control ‘‘ambiguity will make it difficult for risk posed to bulk electric system strategy adopted by a responsible entity registered entities to develop, and NERC reliability. The Commission stated that would reasonably meet the security and the regions to objectively evaluate, such modifications ‘‘will provide an objective of permitting only ‘‘necessary the effectiveness of procedures important enhancement to the security inbound and outbound electronic developed to implement’’ the Reliability posture of the bulk electric system by 37 access’’ to its low impact BES Cyber Standard. reinforcing the defense-in-depth nature Systems. 31. As a possible model, the of the CIP Reliability Standards at all 29. Section 3.1 of Attachment 1 to electronic access control requirements impact levels.’’ 38 The Commission also proposed Reliability Standard CIP–003– that are applied to medium and high stated that the proposed modifications 7 does not appear to contain clear impact BES Cyber systems provide a should be designed to effectively criteria or objective measures to number of criteria that can be used to address the risks posed by transient determine whether the electronic access assess the sufficiency of a responsible electronic devices used at low impact control strategy chosen by the entity’s electronic access control BES Cyber Systems ‘‘in a manner that is responsible entity would be effective for strategy. For medium and high impact consistent with the risk-based approach a given low impact BES Cyber System BES Cyber Systems, auditors use the reflected in the CIP version 5 to permit only necessary inbound and following criteria to review whether the Standards.’’ 39 outbound connections. In order to access control strategy is reasonable: 1. ensure an objective and consistently- Whether the electronic access was NERC Petition applied requirement, the electronic granted through an authorized and 34. In its Petition, NERC proposes to access control plan required in monitored electronic access point add a new section to Attachment 1 to Attachment 1 should require the (Reliability Standard CIP–005–5, proposed Reliability Standard CIP–003– responsible entity to articulate its access Requirement R1); 2. whether the 7 to require responsible entities to control strategy for a particular set of electronic access granted to individuals/ include controls in their cyber security low impact BES Cyber Systems and plans to mitigate the risk of the provide a technical rationale rooted in 35 Rules Concerning Certification of the Electric introduction of malicious code to low security principles explaining how that Reliability Organization and Procedures for the Establishment, Approval, and Enforcement of impact BES Cyber Systems through the strategy will reasonably restrict Electric Reliability Standards, Order No. 672, FERC electronic access. Attachment 1 should Stats. & Regs. ¶ 31,204, at P 327 (2006). 38 Order No. 822, 154 FERC ¶ 61,037 at P 32 36 Order No. 791, 145 FERC ¶ 61,160 at P 108. (emphasis in original). 34 See Order No. 822, 154 FERC ¶ 61,037 at P 73. 37 Id. 39 Id.
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use of ‘‘Transient Cyber Assets or Attachment 1 to Reliability Standard proposed Reliability Standard does not Removable Media.’’ Specifically, CIP–010–2. NERC explains that this explicitly require mitigation of the proposed Section 5 of Attachment 1 lists difference is consistent with the risk- introduction of malicious code from controls to be applied to Transient based approach of the CIP Reliability third-party managed Transient Cyber Cyber Assets and Removable Media that Standards and ‘‘the underlying Assets, NERC states that the failure to NERC states ‘‘will provide enhanced principle of concentrating limited mitigate this risk ‘‘may not constitute protections against the propagation of industry resources on protecting those compliance.’’ 48 NERC’s statement malware from transient devices.’’ 40 BES Cyber Systems with greater risk to suggests that, with regard to low impact 35. NERC states that the language in the BES.’’ NERC states that Section 5 BES Cyber Systems, the proposed proposed Section 5 to Attachment 1 focuses on the risk associated with the requirement lacks an obligation for a parallels the language in Attachment 1 introduction of malicious code.44 responsible entity to correct any to Reliability Standard CIP–010–2, 38. In addition, NERC states that deficiencies that are discovered during which addresses mitigation of the risks proposed Section 5 to Attachment 1 a review of third-party Transient Cyber of the introduction of malicious code to does not include language requiring a Asset management practices. Indeed, high and medium impact BES Cyber responsible entity to determine whether the parallel provision for high and Systems through the use of Transient additional mitigation actions are medium impact BES Cyber Systems Cyber Assets or Removable Media. necessary where a third party manages specifies that ‘‘Responsible Entities NERC states further that, as in a Transient Cyber Asset, nor does it shall determine whether any additional Reliability Standard CIP–010–2, include language requiring a responsible mitigation actions are necessary and proposed Section 5 distinguishes entity to implement additional implement such actions prior to between Transient Cyber Assets mitigation actions in such situations. connecting the Transient Cyber managed by a responsible entity and NERC states that it nonetheless expects Asset.’’ 49 Yet, such language obligating those managed by a third-party; the ‘‘that if another party’s processes and mitigation action is not proposed for distinction arising because of a practices for protecting its Transient low impact BES Cyber Assets. responsible entity’s lack of control over Cyber Assets do not provide reasonable Transient Cyber Assets managed by a assurance that they are designed to 40. The proposed Reliability Standard third-party. NERC explains that the effectively meet the security objective of may, therefore, contain a reliability gap proposed controls for Removable Media mitigating the introduction of malicious where a responsible entity contracts do not distinguish between the code, the Responsible Entity must take with a third-party but fails to mitigate responsible entity-managed assets and additional steps to meet the stated potential deficiencies discovered in the third-party managed assets due to the objective.’’ 45 NERC explains that if a third-party’s malicious code detection functionality of Removable Media. third party’s practices and policies do and prevention practices prior to a NERC provides the example of a thumb not provide reasonable assurance that Transient Cyber Asset being connected drive that can be scanned prior to use the Transient Cyber Assets would be to a low impact BES Cyber System. That regardless of which party manages the protected from malicious code, ‘‘simply is because the proposed Reliability asset.41 reviewing those policies and procedures Standard does not contain: 1. A 36. NERC explains that proposed without taking other steps to mitigate requirement for the responsible entity to Section 5 of Attachment 1 requires the risks of introduction of malicious mitigate any malicious code found responsible entities to meet the security code may not constitute compliance.’’ 46 during the third-party review(s); or 2. a objectives ‘‘by implementing the requirement that the responsible entity controls that the Responsible Entity Commission Proposal take reasonable steps to mitigate the determines necessary to meet its 39. NERC’s proposed modifications in risks of third party malicious code on affirmative obligation to mitigate the Reliability Standard CIP–003–7, their systems, if an arrangement cannot risks of the introduction of malicious Requirement R2, Attachment 1, Section be made for the third-party to do so. code.’’ 42 NERC states that the approach 5 that include malware detection and Without these obligations, we are reflected in Section 5 provides the prevention controls for responsible concerned that responsible entities flexibility to implement the controls entity-managed Transient Cyber Assets could, without compliance that best suit the needs and and Removable Media should improve consequences, simply accept the risk of characteristics of a responsible entity’s the cybersecurity posture of deficient third-party transient electronic organization. NERC explains further that responsibility entities compared to device management practices.50 ‘‘the Responsible Entity must currently-effective Reliability Standard Moreover, the requirement to ‘‘review’’ demonstrate that its selected controls CIP–003–6. The revisions in Section 5.2, methods used by third-parties to detect were designed to meet the security however, do not address one aspect of and prevent malware may fail to convey objective to mitigate the risk of the the reliability gap identified in Order the necessary next steps that a introduction of malicious code.’’ 43 No. 822 regarding low impact BES responsible entity should take.51 37. NERC outlines certain distinctions Cyber Systems. Specifically, as noted between proposed Section 5 of above, proposed Reliability Standard 48 Id. at 30. Attachment 1 to proposed Reliability CIP–003–7 does not explicitly require 49 Reliability Standard CIP–010–2 (Cyber Standard CIP–003–7 and Attachment 1 mitigation of the introduction of Security—Configuration Change Management and to Reliability Standard CIP–010–2. malicious code from third-party Vulnerability Assessments), Requirement R4, Attachment 1, Section 2.3. In contrast, the Specifically, NERC states that proposed managed Transient Cyber Assets, even if obligations to ‘‘review’’ methods used by third- Section 5 does not include requirements the responsible entity determines that parties to detect and prevent malware are similar relating to authorization or software the third-party’s policies and for lower, medium and high impact BES Cyber vulnerabilities, as are contained in procedures are inadequate.47 While the Assets. Cf. CIP–010–2, Attachment 1, Sections 2.1 and 2.2; and proposed CIP–010–3, Attachment 1, Section 3.2. 40 Id. at 26–27. 44 NERC Petition at 29. 50 See Order No. 706, 122 FERC ¶ 61,040 at P 150 41 Id. at 28. 45 Id. at 29–30. (rejecting the concept of acceptance of risk in the 42 Id. 46 Id. at 30. CIP Reliability Standards). 43 Id. at 29. 47 See NERC Petition at 29–30. 51 See Order No. 791, 145 FERC ¶ 61,160 at P 108.
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41. Therefore, pursuant to section Transient Cyber Asset and Removable requirements of this rule will not be 215(d)(5) of the FPA, we propose to Media on the first day of the first penalized for failing to respond to these direct that NERC develop modifications calendar quarter that is eighteen months collections of information unless the to proposed Reliability Standard CIP– after the effective date of the collections of information display a 003–7 to address the need to mitigate Commission’s order approving the valid OMB control number. The the risk of malicious code that could proposed Reliability Standard. NERC Commission solicits comments on the result from third-party Transient Cyber explains that the proposed Commission’s need for this information, Assets consistent with the above implementation plan does not alter the whether the information will have discussion. The Commission seeks previously-approved compliance dates practical utility, the accuracy of the comment on this proposal. for Reliability Standard CIP–003–6 other burden estimates, ways to enhance the C. Proposed NERC Glossary Definitions than the compliance date for Reliability quality, utility, and clarity of the Standard CIP–003–6, Requirement R2, information to be collected or retained, 42. Proposed Reliability Standard Attachment 1, Sections 2 and 3, which and any suggested methods for CIP–003–7 includes two revised would be replaced with the effective minimizing respondents’ burden, definitions for inclusion in the NERC date for proposed Reliability Standard including the use of automated Glossary. Specifically, NERC proposes CIP–003–7. NERC also proposes that the information techniques. to revise the definitions of Transient retirement of Reliability Standard CIP– 49. The Commission bases its Cyber Asset and Removable Media in 003–6 and the associated definitions paperwork burden estimates on the order to accommodate the use of the become effective on the effective date of changes in paperwork burden presented terms at all impact levels. NERC proposed Reliability Standard CIP–003– by the proposed revision to CIP explains that the original definitions 7.54 Reliability Standard CIP–003–7 as include references to concepts or 46. We propose to approve NERC’s compared to the current Commission- requirements associated only with high implementation plan for proposed approved Reliability Standard CIP–003– and medium impact BES Cyber Systems Reliability Standard CIP–003–7, as 6. The Commission has already and the definitions were modified to described above. addressed the burden of implementing avoid confusion because protections for Reliability Standard CIP–003–6.58 As Transient Electronic Devices will now E. Violation Risk Factor/Violation discussed above, the immediate be extended to low impact BES Cyber Severity Level Assignments rulemaking addresses three areas of Systems.52 47. NERC requests approval of two modification to the CIP Reliability 43. In addition, NERC proposes to violation risk factors and violation Standards: 1. Clarifying the obligations retire the definitions of LERC and LEAP. severity levels assigned to proposed pertaining to electronic access control NERC states that the proposed Reliability Standard CIP–003–7. for low impact BES Cyber Systems; 2. retirement of the NERC Glossary terms Specifically, NERC requests approval of adopting mandatory security controls LERC and LEAP accords with the violation risk factor and violation for transient electronic devices (e.g., proposed modifications to Section 3 of severity level assignments associated thumb drives, laptop computers, and Attachment 1 to proposed Reliability with Requirements R1 and R2 of other portable devices frequently Standard CIP–003–7 and is intended to 55 Reliability Standard CIP–003–7. We connected to and disconnected from simplify the electronic access control propose to accept these violation risk systems) used at low impact BES Cyber requirements for low impact BES Cyber factors and violation severity levels. Systems; and 3. requiring responsible Systems by avoiding the ambiguities entities to have a policy for declaring associated with the term ‘‘direct.’’ NERC III. Information Collection Statement and responding to CIP Exceptional explains further that it ‘‘recognized that 48. The FERC–725B information Circumstances related to low impact distinguishing between ‘direct’ and collection requirements contained in BES Cyber Systems. ‘indirect’ electronic access within the this proposed rule are subject to review 50. The NERC Compliance Registry, LERC definition added a layer of by the Office of Management and as of September 2017, identifies unnecessary complexity.’’ 53 Budget (OMB) under section 3507(d) of approximately 1,320 U.S. entities that 44. We propose to approve the revised the Paperwork Reduction Act of 1995.56 are subject to mandatory compliance definitions of Transient Cyber Asset and OMB’s regulations require approval of with Reliability Standards. Of this total, Removable Media, as well as the certain information collection we estimate that 1,100 entities will face retirement of the definitions of LERC requirements imposed by agency an increased paperwork burden under and LEAP. rules.57 Upon approval of a collection of proposed Reliability Standard CIP 003– information, OMB will assign an OMB D. Implementation Plan and Effective 7, estimating that a majority of these control number and expiration date. Dates entities will have one or more low Respondents subject to the filing 45. NERC requests an effective date impact BES Cyber Systems. Based on for proposed Reliability Standard CIP– 54 Id., Exhibit C (Implementation Plan). these assumptions, we estimate the 003–7 and the revised definitions of 55 Id., Exhibit F (Analysis of Violation Risk following reporting burden: Factors and Violation Severity Levels). 52 NERC Petition at 30. 56 44 U.S.C. 3507(d) (2012). 58 See Order No. 822, 154 FERC ¶ 61,037 at PP 53 Id. at 16. 57 5 CFR 1320.11 (2017). 84–88.
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RM17–11–000 NOPR [Mandatory Reliability Standards for Critical Infrastructure Protection Reliability Standards]
Annual Total num- number of Total annual burden Cost per Number of responses ber of re- Average burden & cost respondent respondents sponses per response 59 hours & total annual cost per re- (4) (3) * (4) = (5) ($) (1) spondent (1) * (2) = (5) ÷ (1) (2) (3)
Create low impact TCA assets plan (one-time) 60 ... 1,100 1 1,100 20 hrs.; $1,680 ...... 6,875 hrs.; $1,848,000 ... $1,680 Updates and reviews of low impact TCA assets 1,100 62 300 330,000 1.5 hrs. 63; $126 ...... 495,000 hrs.; 37,800 (ongoing) 61. $41,580,000. Update/modify documentation to remove LERC 1,100 1 1,100 20 hrs.; $1,680 ...... 6,875 hrs.; $1,848,000 ... 1,680 and LEAP (one-time) 60. Update paperwork for access control implementa- 1,100 1 1,100 20 hrs.; $1,680 ...... 6,875 hrs.; $1,848,000 ... 1,680 tion in Section 2 64 and Section 3 65 (ongoing) 61.
Total (one-time) 60 ...... 2,200 ...... 13,750 hrs.; $3,696,000 ......
Total (ongoing) 61 ...... 331,100 ...... 501,875 hrs.; ...... $43,428,000.
51. The following shows the annual policy development, while costs in Information and Regulatory Affairs, cost burden for each group, based on the years 2 and 3 will reflect the burden Washington, DC 20503 [Attention: Desk burden hours in the table above: associated with maintaining logs and Officer for the Federal Energy • Year 1: $3,696,000. other records to demonstrate ongoing Regulatory Commission, phone: (202) • Years 2 and 3: $43,428,000. compliance. 395–4638, fax: (202) 395–7285]. For • The paperwork burden estimate 52. Title: Mandatory Reliability security reasons, comments to OMB includes costs associated with the initial Standards, Revised Critical should be submitted by email to: oira_ development of a policy to address Infrastructure Protection Reliability [email protected]. Comments requirements relating to: 1. Clarifying Standards submitted to OMB should include the obligations pertaining to electronic Action: Proposed Collection FERC– Docket Number RM17–11–000 and access control for low impact BES Cyber 725B. OMB Control Number 1902–0248. Systems; 2. adopting mandatory security OMB Control No.: 1902–0248. controls for transient electronic devices Respondents: Businesses or other for- IV. Regulatory Flexibility Act Analysis (e.g., thumb drives, laptop computers, profit institutions; not-for-profit and other portable devices frequently institutions. 55. The Regulatory Flexibility Act of connected to and disconnected from Frequency of Responses: On 1980 (RFA) generally requires a systems) used at low impact BES Cyber Occasion. description and analysis of proposed Systems; and 3. requiring responsible Necessity of the Information: This rules that will have significant entities to have a policy for declaring proposed rule proposes to approve the economic impact on a substantial and responding to CIP Exceptional requested modifications to Reliability number of small entities.66 The Small Circumstances related to low impact Standards pertaining to critical Business Administration’s (SBA) Office BES Cyber Systems. Further, the infrastructure protection. As discussed of Size Standards develops the estimate reflects the assumption that above, the Commission proposes to numerical definition of a small approve NERC’s proposed revised CIP costs incurred in year 1 will pertain to business.67 The SBA revised its size Reliability Standard CIP–003–7 standard for electric utilities (effective 59 pursuant to section 215(d)(2) of the FPA The loaded hourly wage figure (includes January 22, 2014) to a standard based on benefits) is based on the average of three because it improves upon the currently- occupational categories for 2016 found on the effective suite of cyber security CIP the number of employees, including Bureau of Labor Statistics Web site (http:// Reliability Standards. affiliates (from the prior standard based www.bls.gov/oes/current/naics2_22.htm): 68 Internal Review: The Commission has on megawatt hour sales). Proposed Legal (Occupation Code: 23–0000): $143.68. Reliability Standard CIP–003–7 is Electrical Engineer (Occupation Code: 17–2071): reviewed the proposed Reliability $68.12. Standards and made a determination expected to impose an additional Office and Administrative Support (Occupation that its action is necessary to implement burden on 1,100 entities 69 (reliability Code: 43–0000): $40.89 ($143.68 + $68.12 + $40.89) coordinators, generator operators, ÷ 3 = $84.23. The figure is rounded to $84.00 for section 215 of the FPA. use in calculating wage figures in this NOPR. 53. Interested persons may obtain generator owners, interchange 60 This one-time burden applies in Year One only. information on the reporting coordinators or authorities, transmission 61 This ongoing burden applies in Year 2 and requirements by contacting the operators, balancing authorities, beyond. following: Federal Energy Regulatory 66 62 5 U.S.C. 601–12 (2012). We estimate that each entity will perform 25 Commission, 888 First Street NE., updates per month. 25 updates *12 months = 300 67 13 CFR 121.101 (2017). updates (i.e. responses) per year. Washington, DC 20426 [Attention: Ellen 68 SBA Final Rule on ‘‘Small Business Size 63 The 1.5 hours of burden per response is Brown, Office of the Executive Director, Standards: Utilities,’’ 78 FR 77343 (Dec. 23, 2013). comprised of three sub-categories: email: [email protected], phone: 69 Public utilities may fall under one of several Updates to managed low TCA assets: 15 minutes (202) 502–8663, fax: (202) 273–0873]. different categories, each with a size threshold (0.25 hours) per response. 54. For submitting comments based on the company’s number of employees, Updates to unmanaged low TCA assets: 60 concerning the collection(s) of including affiliates, the parent company, and minutes (1 hour) per response. information and the associated burden subsidiaries. For the analysis in this NOPR, we are Reviews of low TCA applicable controls: 15 using a 500 employee threshold due to each minutes (0.25 hours) per response. estimate(s), please send your comments affected entity falling within the role of Electric 64 Physical Security Controls. to the Commission, and to the Office of Bulk Power Transmission and Control (NAISC 65 Electronic Access Controls. Management and Budget, Office of Code: 221121).
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transmission owners, and certain Comments must refer to Docket No. Issued October 19, 2017. distribution providers). RM17–11–000, and must include the Nathaniel J. Davis, Sr., 56. Of the 1,100 affected entities commenter’s name, the organization Deputy Secretary. discussed above, we estimate that they represent, if applicable, and [FR Doc. 2017–23287 Filed 10–25–17; 8:45 am] approximately 857 or 78 percent 70 of address. BILLING CODE 6717–01–P the affected entities are small. As 60. The Commission encourages discussed above, proposed Reliability comments to be filed electronically via Standard CIP–003–7 enhances the eFiling link on the Commission’s DEPARTMENT OF THE TREASURY reliability by providing criteria against Web site at http://www.ferc.gov. The which NERC and the Commission can Commission accepts most standard Internal Revenue Service evaluate the sufficiency of an entity’s word processing formats. Documents electronic access controls for low created electronically using word 26 CFR Part 1 impact BES Cyber systems, as well as processing software should be filed in improved security controls for transient native applications or print-to-PDF [REG–134247–16] electronic devices (e.g., thumb drives, format and not in a scanned format. laptop computers, and other portable RIN 1545–BN73 Commenters filing electronically do not devices frequently connected to and need to make a paper filing. disconnected from systems). We Revision of Regulations Under Chapter estimate that each of the 857 small 61. Commenters that are not able to 3 Regarding Withholding of Tax on entities to whom the proposed file comments electronically must send Certain U.S. Source Income Paid to modifications to Reliability Standard an original of their comments to: Foreign Persons; Correction CIP–003–7 applies will incur one-time Federal Energy Regulatory Commission, AGENCY: Internal Revenue Service (IRS), costs of approximately $3,360 per entity Secretary of the Commission, 888 First Treasury. to implement this standard, as well as Street NE., Washington, DC 20426. ACTION: Notice of proposed rulemaking; the ongoing paperwork burden reflected 62. All comments will be placed in correction. in the Information Collection Statement the Commission’s public files and may (approximately $39,480 per year per be viewed, printed, or downloaded SUMMARY: This document corrects a entity). We do not consider the remotely as described in the Document correction to a notice of proposed estimated costs for these 857 small Availability section below. Commenters rulemaking (REG–134247–16) that was entities to be a significant economic on this proposal are not required to published in the Federal Register on impact. serve copies of their comments on other Friday, September 15, 2017. The notice 57. Based on the above analysis, we commenters. of proposed rulemaking, published on propose to certify that the proposed January 6, 2017, under section 1441 of VII. Document Availability Reliability Standard will not have a the Internal Revenue Code of 1986 significant economic impact on a (Code), relates to withholding of tax on substantial number of small entities. 63. In addition to publishing the full text of this document in the Federal certain U.S. source income paid to V. Environmental Analysis Register, the Commission provides all foreign persons and requirements for 58. The Commission is required to interested persons an opportunity to certain claims for refund or credit of prepare an Environmental Assessment view and/or print the contents of this income tax made by foreign persons. or an Environmental Impact Statement document via the Internet through the DATES: The correction published on for any action that may have a Commission’s Home Page (http:// September 15, 2017 (82 FR 43314), is significant adverse effect on the human www.ferc.gov) and in the Commission’s corrected as of October 26, 2017 and is environment.71 The Commission has Public Reference Room during normal applicable beginning January 6, 2017. categorically excluded certain actions business hours (8:30 a.m. to 5:00 p.m. FOR FURTHER INFORMATION CONTACT: from this requirement as not having a Eastern time) at 888 First Street NE., Kamela Nelan at (202) 317- 6942 (not a significant effect on the human Room 2A, Washington, DC 20426. toll-free number). environment. Included in the exclusion 64. From the Commission’s Home SUPPLEMENTARY INFORMATION: are rules that are clarifying, corrective, Page on the Internet, this information is or procedural or that do not available on eLibrary. The full text of Background substantially change the effect of the this document is available on eLibrary The notice of proposed rulemaking regulations being amended.72 The in PDF and Microsoft Word format for (REG–134247–16) that is the subject of actions proposed herein fall within this viewing, printing, and/or downloading. this correction is under section 1441 of categorical exclusion in the To access this document in eLibrary, the Code. Commission’s regulations. type the docket number of this Need for Correction VI. Comment Procedures document, excluding the last three digits, in the docket number field. As published, the notice of proposed 59. The Commission invites interested rulemaking (REG–134247–16) contains persons to submit comments on the 65. User assistance is available for eLibrary and the Commission’s Web site an error which may prove to be matters and issues proposed in this misleading and needs to be corrected. notice to be adopted, including any during normal business hours from the related matters or alternative proposals Commission’s Online Support at 202– Correction of Publication 502–6652 (toll free at 1–866–208–3676) that commenters may wish to discuss. Accordingly, the notice of proposed or email at [email protected], Comments are due December 26, 2017. rulemaking published at 82 FR 43314, or the Public Reference Room at (202) September 15, 2017, is corrected as 70 502–8371, TTY (202) 502–8659. Email 77.95 percent. follows: 71 Regulations Implementing the National the Public Reference Room at On page 43314, in the third column, Environmental Policy Act of 1969, Order No. 486, [email protected]. FERC Stats. & Regs. ¶ 30,783 (1987). under the heading ‘‘Correction of 72 18 CFR 380.4(a)(2)(ii) (2017). By direction of the Commission. Publication’’, in the fourth line, the
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language ‘‘On page 1636, ’’ is corrected Background Information and Dated: October 5, 2017. to read ‘‘On page 1646, ’’. Regulatory History Peter J. Brown, Martin V. Franks, Rear Admiral, U.S. Coast Guard, Commander, On March 15, 2017, the Coast Guard Seventh Coast Guard District. Chief, Publications and Regulations Branch, published an ANPRM entitled [FR Doc. 2017–23321 Filed 10–25–17; 8:45 am] Legal Processing Division, Associate Chief ‘‘Drawbridge Operation Regulation; BILLING CODE 9110–04–P Counsel (Procedure and Administration). Atlantic Intracoastal Waterway, St. [FR Doc. 2017–22815 Filed 10–25–17; 8:45 am] Augustine, FL’’ in the Federal Register BILLING CODE 4830–01–P (82 FR 13785). The advance notice of LIBRARY OF CONGRESS proposed rulemaking sought comments and information concerning a request Copyright Office from the City of St. Augustine to change DEPARTMENT OF HOMELAND the operating schedule for the Bridge of SECURITY 37 CFR Part 201 Lions across the Atlantic Intracoastal [Docket No. 2017–10] Coast Guard Waterway, St. Augustine, Florida amending the twice an hour operating Exemptions To Permit Circumvention 33 CFR Part 117 schedule to a 7 a.m. to 9 p.m. period. of Access Controls on Copyrighted The City of St. Augustine was Works concerned that vehicle traffic was [Docket No. USCG–2016–0723] becoming exponentially worse with AGENCY: U.S. Copyright Office, Library each passing season and that the current of Congress. RIN 1625–AA09 operating schedule was contributing to ACTION: Notice of proposed rulemaking. Drawbridge Operation Regulation; vehicle traffic backups. SUMMARY: The United States Copyright Atlantic Intracoastal Waterway, St. Withdrawal Office (‘‘Copyright Office’’ or ‘‘Office’’) Augustine, FL The Coast Guard received 386 is conducting the seventh triennial AGENCY: Coast Guard, DHS. comments, of those, 62 comments were rulemaking proceeding under the Digital Millennium Copyright Act (‘‘DMCA’’), ACTION: Advance notice of proposed duplicate entries, 204 comments were in concerning possible temporary rulemaking; withdrawal. favor for the requested change and 120 exemptions to the DMCA’s prohibition were against the requested change. The against circumvention of technological SUMMARY: The Coast Guard is comments in favor of the change measures that control access to withdrawing its advance notice of generally felt the additional restrictions copyrighted works. In this proceeding, proposed rulemaking (ANPRM) to the bridge would help alleviate concerning the Bridge of Lions (SR the Copyright Office has established a vehicular traffic on or around the bridge new, streamlined procedure for the A1A) across the Atlantic Intracoastal and the surrounding area. For the Waterway, mile 777.9, at St. Augustine, renewal of exemptions that were comments that opposed the change, by granted during the sixth triennial Florida. The City of St. Augustine and large, the main concern was safety proposed to modify the bridge operating rulemaking. It is also considering of mariners due to strong tidal currents petitions for new exemptions to engage schedule to alleviate vehicle traffic and the high level of vessel activities congestion. However, the Coast Guard in activities not currently permitted by occurring in the waters near the bridge. has determined it would be existing exemptions. On June 30, 2017, Strong currents, the close proximity of inappropriate to move forward with a the Office published a Notice of Inquiry mooring fields and marinas would notice of proposed rulemaking. The requesting petitions to renew existing hamper the ability to ‘‘keep on station’’ Coast Guard believes placing additional exemptions and comments in response while waiting for a bridge opening. restrictions to the bridge would add to those petitions, as well as petitions Also, sailing vessels waiting for bridge additional hazards to mariners and for new exemptions to engage in effect the safe navigation of vessels opening would be required to be moving activities not currently permitted by awaiting bridge openings. constantly all the while avoiding other existing exemptions. The Office has waiting vessel traffic. The requested carefully considered the comments DATES: The notice of proposed change to the operating schedule would received in response to that Notice. rulemaking published on March 15, extend the twice an hour draw opening With this Notice of Proposed 2017 (82 FR 13785), is withdrawn on schedule by an additional three hours Rulemaking (‘‘NPRM’’), the Office October 26, 2017. into the evening. Concern was intends to recommend each of the ADDRESSES: The docket for this expressed by having to wait for an existing exemptions for readoption. This document, USCG–2016–0723 is opening in darkness, stating this would NPRM also initiates three rounds of available at http://www.regulations.gov. cause additional hazards due to vessels public comment on the newly-proposed Type the docket number in the already underway, traffic lights against exemptions. Interested parties are ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ the city and vehicular lights adjacent to invited to make full legal and Click on Open Docket Folder on the line the waterway. The Coast Guard evidentiary submissions in support of or associated with this document. acknowledges all of the above safety in opposition to the proposed FOR FURTHER INFORMATION CONTACT: If concerns, and for that reason, we find exemptions, in accordance with the you have questions about this that any benefits of the possible requirements set forth below. document, call or email LT Allan Storm, additional restrictions to the Bridge of DATES: Initial written comments Sector Jacksonville, Waterways Lions do not outweigh the additional (including documentary evidence) and Management Division, U.S. Coast hazards to vessels and mariners multimedia evidence from proponents Guard; telephone 904–714–7616, email transiting the area around the bridge. and other members of the public who [email protected]. The current regulation as written in 33 support the adoption of a proposed SUPPLEMENTARY INFORMATION: CFR 117.261(d) will remain in effect. exemption, as well as parties that
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neither support nor oppose an the seventh triennial section 1201 the prohibition on the circumvention of exemption but seek to share pertinent rulemaking.1 In response, the Office technological measures applied to information about a proposal, are due received thirty-nine renewal petitions, copyrighted works has on criticism, December 18, 2017. Written response five comments regarding the scope of comment, news reporting, teaching, comments (including documentary the renewal petitions, and one comment scholarship, or research; 4. the effect of evidence) and multimedia evidence in opposition to renewal of a current circumvention of technological from those who oppose the adoption of exemption.2 These comments are measures on the market for or value of a proposed exemption are due February discussed further below. In addition, the copyrighted works; and 5. such other 12, 2018. Written reply comments from Office received twenty-three petitions factors as the Librarian considers supporters of particular proposals and for new exemptions, many of which appropriate.’’ 5 After developing a parties that neither support nor oppose seek to expand upon a current comprehensive administrative record, a proposal are due March 14, 2018. exemption. the Register makes a recommendation to Commenting parties should be aware With this NPRM, the Office sets forth the Librarian of Congress concerning that rather than reserving time for the exemptions the Register of whether exemptions are warranted potential extensions of time to file Copyrights intends to recommend for based on that record. comments, the Office has already readoption without the need for further The Office has previously articulated established what it believes to be the development of the administrative the substantive legal and evidentiary most generous possible deadlines record, and outlines the proposed standard for the granting of an consistent with the goal of concluding classes for new exemptions for which exemption under section 1201(a)(1) the triennial proceeding in a timely the Office initiates three rounds of multiple times, including in its recently- fashion. public comment. issued video and PowerPoint tutorials, the 1201 Study, and in prior ADDRESSES: The Copyright Office is I. Standard for Evaluating Proposed recommendations of the Register using the regulations.gov system for the Exemptions submission and posting of comments in concerning proposed classes of this proceeding. All comments are As the Notice of Inquiry explained, exemptions, each of which is accessible therefore to be submitted electronically for a temporary exemption from the from the Office’s 1201 rulemaking Web through regulations.gov. The Office is prohibition on circumvention to be page at https://www.copyright.gov/ accepting two types of comments. First, granted through the triennial 1201/. At bottom, in considering commenters who wish briefly to express rulemaking, it must be established that whether to recommend an exemption, general support for or opposition to a ‘‘persons who are users of a copyrighted the Office must inquire: ‘‘Are users of a proposed exemption may submit such work are, or are likely to be in the copyrighted work adversely affected by comments electronically by typing into succeeding 3-year period, adversely the prohibition on circumvention in the comment field on regulations.gov. affected by the prohibition . . . in their their ability to make noninfringing uses Second, commenters who wish to ability to make noninfringing uses of a class of copyrighted works, or are provide a fuller legal and evidentiary under [title 17] of a particular class of users likely to be so adversely affected basis for their position may upload a copyrighted works.’’ 3 To devise an in the next three years?’’ 6 This inquiry Word or PDF document, but such longer appropriate class of copyrighted works, breaks into the following elements: submissions must be completed using the Office begins with the broad • The proposed class includes at least the long-comment form provided on the categories of works identified in 17 some works protected by copyright. Office’s Web site at https:// U.S.C. 102 and then refines them by • The uses at issue are noninfringing www.copyright.gov/1201/2018. Specific other criteria, such as the technological under title 17. • instructions for submitting comments, protection measures (‘‘TPMs’’) used, Users are adversely affected in their including multimedia evidence that distribution platforms, and/or types of ability to make such noninfringing uses cannot be uploaded through uses or users.4 or, alternatively, users are likely to be regulations.gov, are also available on In evaluating the evidence, the adversely affected in their ability to that Web page. If a commenter cannot Register must consider the following make such noninfringing uses during meet a particular submission statutory factors: 1. The availability for the next three years. This element is requirement, please contact the Office use of copyrighted works; 2. the analyzed in reference to section availability for use of works for 1201(a)(1)(C)’s five statutory factors. using the contact information below for • special instructions. nonprofit archival, preservation, and The statutory prohibition on circumventing access controls is the FOR FURTHER INFORMATION CONTACT: educational purposes; 3. the impact that cause of the adverse effects.7 Sarang Vijay Damle, General Counsel 1 The Register will consider the and Associate Register of Copyrights, by 82 FR 29804 (June 30, 2017). 2 The comments received in response to the Copyright Act and relevant judicial email at [email protected], Regan A. Smith, Notice of Inquiry are available online at https:// precedents when analyzing whether a Deputy General Counsel, by email at www.regulations.gov/docketBrowser?rpp=25& proposed use is likely to be [email protected], Anna Chauvet, Assistant so=DESC&sb=commentDueDate&po=0&dct=PS& noninfringing.8 When considering General Counsel, by email at achau@ D=COLC-2017-0007. References to these comments are by party name (abbreviated where appropriate) whether such uses are being adversely loc.gov, or Jason E. Sloan, Attorney- followed by either ‘‘Renewal Pet.,’’ ‘‘Pet.,’’ or impacted by the prohibition on Advisor, by email at [email protected]. Each ‘‘Renewal Comment,’’ as appropriate. circumvention, the rulemaking focuses can be contacted by telephone by calling 3 17 U.S.C. 1201(a)(1)(C). 4 See H.R. Rep. No. 105–551, pt. 2, at 38 (1998) (202) 707–8350. 5 (‘‘Commerce Comm. Report’’); Register of 17 U.S.C. 1201(a)(1)(C). SUPPLEMENTARY INFORMATION: 6 On June Copyrights, Section 1201 Rulemaking: Sixth 1201 Study at 114. 30, 2017, the Office published a Notice Triennial Proceeding to Determine Exemptions to 7 Id. at 115; see also id. at 115–27. of Inquiry requesting petitions to renew the Prohibition on Circumvention, 8 Id. at 115–17. While controlling precedent current exemptions, oppositions to the Recommendation of the Register of Copyrights 17– directly on point is not required to justify an 18 (2015) (‘‘2015 Recommendation’’); U.S. exemption, there is no ‘‘rule of doubt’’ favoring an renewal petitions, and petitions for Copyright Office, Section 1201 of Title 17, at 26, exemption when it is unclear that a particular use newly proposed exemptions (the 108–10 (2017), https://www.copyright.gov/policy/ is fair or otherwise noninfringing. See 2015 ‘‘Notice of Inquiry’’) in connection with 1201/section-1201-full-report.pdf (‘‘1201 Study’’). Recommendation at 15.
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on ‘‘distinct, verifiable, and measurable This is because streamlined renewal is Office explained in its Notice of Inquiry, impacts’’ compared to ‘‘de minimis based upon a determination that, due to it expected that ‘‘a broad range of impacts.’’ 9 Taking the administrative a lack of legal, marketplace, or individuals have a sufficient level of record together, the Office will consider technological changes, the factors that knowledge and experience’’ regarding whether the preponderance of the led the Register to recommend adoption the continued need for an exemption. evidence in the record shows that the of the exemption in the prior For instance, the Notice of Inquiry noted conditions for granting an exemption rulemaking will continue into the that a renewal petition could be filed by have been met.10 forthcoming triennial period.13 That is, a relevant employee or volunteer at an the same facts and circumstances organization—like the American II. Review of Petitions To Renew underlying the previously-adopted Foundation for the Blind, which Existing Exemptions regulatory exemption may be relied on advocates for the blind, visually During this rulemaking, the Office to renew the exemption. Accordingly, to impaired, and print disabled—who is initiated a new streamlined process for the extent that any renewal petition familiar with the needs of the recommending readoption of proposed uses beyond the current community, and is well-versed previously-adopted exemptions to the exemption, the Office disregarded those specifically in the e-book accessibility Librarian. As the Office explained in its portions of the petition for purposes of issue, to make the declaration with recent 1201 Study, the ‘‘Register must considering the renewal of the regard to the current e-book assistive apply the same evidentiary standards in exemption, and instead focused on technology exemption.16 Consistent recommending the renewal of whether it provided sufficient with that direction, the Office received exemptions as for first-time exemption information to warrant readoption of the petitions from some individuals who requests,’’ and the statute requires that exemption in its current form.14 may not themselves have engaged in ‘‘a determination must be made The Office received thirty-nine circumvention, but attested to their specifically for each triennial period.’’ 11 petitions to renew existing exemptions, personal knowledge of others who have The Office further determined that ‘‘the including at least one petition to renew a continuing need for an exemption. statutory language appears to be broad each currently-adopted exemption. Each Those petitions were signed by enough to permit determinations to be petition to renew an existing exemption individuals at associations that had based upon evidence drawn from prior included an explanation summarizing actively participated in the past proceedings, but only upon a the basis for claiming a continuing need rulemaking and described specific conclusion that this evidence remains and justification for the exemption. In continued needs for the exemption.17 reliable to support granting an each case, petitioners also signed a Accordingly, the Office finds that these exemption in the current declaration stating that, to the best of petitions are formally and substantively 12 proceeding.’’ their personal knowledge, there has not sufficient for the Office to consider in Based on this understanding of the been any material change in the facts, evaluating whether renewal of the statutory scheme, the Office solicited law, or other circumstances set forth in existing exemptions exemption is petitions for the renewal of exemptions the prior rulemaking record such that appropriate.18 as they are currently formulated, renewal of the exemption would not be without modification. Thus, if a justified. 16 82 FR at 29806. The Office did suggest that it proponent sought to engage in any The Office also received six would be improper for a member of the general activities not currently permitted by an comments in response to the renewal public to petition for renewal if he or she knew existing exemption, a petition for a new petitions; five did not oppose renewal, nothing more about matters concerning e-book exemption had to have been submitted. accessibility other than what he or she might have but offered more general comments, and read in a brief newspaper article, or simply opposed one was styled as an opposition to the use of digital rights management tools as a 9 Commerce Comm. Report at 37; see also Staff of renewal. One general comment filed by matter of general principle—but none of the H. Comm. on the Judiciary, 105th Cong., Section- the Entertainment Software Association, renewal petitions raise that issue. by-Section Analysis of H.R. 2281 as Passed by the 17 the Motion Picture Association of See, e.g., The Intellectual Property & United States House of Representatives on August Technology Law Clinic of the University of 4th, 1998, at 6 (Comm. Print 1998) (using the America, Inc., and the Recording Southern California Gould School of Law (‘‘IPTC equivalent phrase ‘‘substantial adverse impact’’) Industry Association of America, Inc. U.S.C.’’) Renewal Pet. at 3 (‘‘We have personally (‘‘House Manager’s Report’’); see also, e.g., 1201 (collectively, ‘‘Joint Creators’’) raised heard from a number of farmers and farm bureaus Study at 119–21 (discussing same and citing some overarching issues with the that farmers need this exemption and anticipate application of this standard in five prior needing to use it in the future.’’); Electronic Frontier rulemakings). renewal petitions. Specifically, Joint Foundation (‘‘EFF’’) Repair Renewal Pet. at 3 10 See 17 U.S.C. 1201(a)(1)(C) (asking whether Creators expressed concern that many of (describing groups of users with continued need to users ‘‘are, or are likely to be in the succeeding 3- the renewal petitions ‘‘were based on engage in circumvention of motorized land vehicles year period, adversely affected by the prohibition what the petitioners attest they have and conversation with individual who modifies [on circumvention] in their ability to make motorized wheelchairs and mobility scooters to noninfringing uses’’) (emphasis added); 1201 Study been told by others, rather than on their tailor to the individual needs of users). The Office 15 at 111–12; see also Sea Island Broad. Corp. v. FCC, own personal knowledge.’’ But as the notes that parties demonstrated personal knowledge 627 F.2d 240, 243 (D.C. Cir. 1980) (noting that in multiple ways. One particularly helpful example ‘‘[t]he use of the ‘preponderance of evidence’ 13 Id. at 143–44. was the petition submitted by Professors Bellovin, standard is the traditional standard in civil and 14 This suffices to address concerns raised that Blaze, and Heninger, which described how they administrative proceedings’’); 70 FR 57526, 57528 some renewal petitions sought exemptions broader rely on the exemption for their own security (Oct. 3, 2005); 2015 Recommendation at 15; Register than currently formulated. See Entertainment research and will continue to do so, discussed of Copyrights, Section 1201 Rulemaking: Fifth Software Association, the Motion Picture reliance on the exemption by other security Triennial Proceeding to Determine Exemptions to Association of America, Inc. & the Recording researchers, and provided a recent example the Prohibition on Circumvention, Industry of America, Inc. (collectively, ‘‘Joint illustrating reliance on the exemption by security Recommendation of the Register of Copyrights 6 Creators’’) Renewal Comment at 2; DVD Copy researchers. Bellovin, Blaze & Heninger Renewal (2012) (‘‘2012 Recommendation’’); Register of Control Association (‘‘DVD CCA’’) & The Advanced Pet. at 3. Copyrights, Section 1201 Rulemaking: Second Access Content System Licensing Administrator 18 Joint Creators also urged that petitions that Triennial Proceeding to Determine Exemptions to (‘‘AACS LA’’) AV Noncom. Videos Renewal ‘‘expressly base their justification . . . on a need to the Prohibition on Circumvention, Comment at 1–2, 4–5; DVD CCA & AACS LA AV provide circumvention assistance that would likely Recommendation of the Register of Copyrights 19– Univ. Renewal Comment at 1–2, 5; Alliance of be prohibited by [the anti-trafficking provision of 20 (2003) (‘‘2003 Recommendation’’). Automobile Manufacturers (‘‘Auto Alliance’’) section 1201] should not be considered supportive 11 1201 Study at 142, 145. Renewal Comment at 1–2. of actual renewal.’’ Joint Creators Renewal 12 Id. at 143. 15 Joint Creators Renewal Comment at 2 n.4. Comment at 3 (referencing Auto Care Association
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As detailed below, after reviewing the institutions.22 In addition, the tablets, mobile hotspots, or wearable petitions for renewal and comments in petitioners demonstrated personal devices (e.g., smartwatches), to allow response, the Office concludes that it knowledge and experience with regard connection of a used device to an has received a sufficient petition to to the assistive technology exemption; alternative wireless network renew each existing exemption and it they are all organizations that advocate (‘‘unlocking’’) (codified at 37 CFR does not find any meaningful for the blind, visually impaired, and 201.40(b)(3)).25 No oppositions were opposition to renewal. Accordingly, the print disabled. filed against the petitions seeking to Register intends to recommend Based on the information provided in renew this exemption. The petitions readoption of all existing exemptions in the renewal petitions and the lack of demonstrate the continuing need and their current form.19 opposition, the Register believes that the justification for the exemption, stating conditions that led to adoption of this that consumers of the enumerated A. Literary Works Distributed exemption are likely to continue during products continue to need to be able to Electronically (i.e., e-Books), for Use the next triennial period. Accordingly, unlock the devices so they can switch With Assistive Technologies for Persons the Register intends to recommend network providers. For example, ISRI Who Are Blind, Visually Impaired, or renewal of this exemption. stated that its members continue to Have Print Disabilities purchase or acquire donated cell phones Multiple organizations petitioned to B. Literary Works Consisting of and tablets, and try to reuse them, but renew the exemption for literary works Compilations of Data Generated by that wireless carriers still lock devices distributed electronically (i.e., e-books), Implanted Medical Devices and to prevent them from being used on for use with assistive technologies for Corresponding Personal Monitoring other carriers.26 In addition, the persons who are blind, visually Systems, To Access Personal Data petitioners demonstrated personal impaired, or have print disabilities Hugo Campos, member of the knowledge and experience with regard (codified at 37 CFR 201.40(b)(2)).20 No Coalition of Medical Device Patients to this exemption. CCA, ORI, and ISRI oppositions were filed against and Researchers, and represented by the represent companies that rely on the readoption of this exemption. The Harvard Law School Cyberlaw Clinic, ability to unlock cellphones. A number petitions demonstrated the continuing petitioned to renew the exemption of the petitioners also participated in need and justification for the covering access to patient data on past 1201 triennial rulemakings relating exemption, stating that individuals who networked medical devices (codified at to unlocking lawfully-acquired wireless are blind, visually impaired, or print 37 CFR 201.40(b)(10)).23 No oppositions devices. disabled are significantly disadvantaged were filed against the petition to renew Based on the information provided in with respect to obtaining accessible e- this exemption. Mr. Campos’s petition the renewal petitions and the lack of book content because TPMs interfere demonstrated the continuing need and opposition, the Register believes that the with the use of assistive technologies justification for the exemption, stating conditions that led to adoption of this such as screen readers and refreshable that patients continue to need access to exemption are likely to continue during Braille displays.21 Indeed, AFB, ACB, data output from their medical devices the next triennial period. Accordingly, Samuelson-Glushko TLPC, and LCA to manage their health.24 Mr. Campos the Register intends to recommend noted that the record underpinning this demonstrated personal knowledge and renewal of this exemption. exemption ‘‘has stood and been re- experience with regard to this D. Computer Programs That Operate established in the past five triennial exemption, as he is a patient needing Smartphones, Smart TVs, Tablets, or reviews, dating back to 2003,’’ and that access to the data output from his Other All-Purpose Mobile Computing the ‘‘accessibility of ebooks is frequently medical device, and is a member of the Devices, To Allow the Device To cited as a top priority’’ by its members Coalition of Medical Device Patients Interoperate With or To Remove and the patrons of LCA’s member and Researchers, a coalition whose Software Applications (‘‘Jailbreaking’’) members research, comment on, and Multiple organizations petitioned to (‘‘Auto Care’’), Consumer Technology Association examine the effectiveness of networked renew the exemptions for computer (‘‘CTA’’), iFixit & Owners’ Rights Initiative (‘‘ORI’’) medical devices. Repair Renewal Pet.). The Office agrees that programs that operate smartphones, Based on the information provided in exemptions adopted through the triennial smart TVs, tablets, or other all-purpose the renewal petition and the lack of rulemaking cannot extend to the trafficking mobile computing devices, to allow the prohibitions in section 1201, but concludes that the opposition, the Register believes that the device to interoperate with or to remove petitions have sufficiently articulated a basis for conditions that led to adoption of this renewal of the current exemptions under the software applications (‘‘jailbreaking’’) exemption are likely to continue during statutory standard. (codified at 37 CFR 201.40(b)(4)–(5)).27 19 the next triennial period. Accordingly, Although the Office’s Notice of Inquiry stated The petitions demonstrate the that this NPRM would set forth proposed regulatory the Register intends to recommend continuing need and justification for the language for any existing exemptions the Office renewal of this exemption. intends to recommend for readoption, because exemption, and that petitioners had many of the new petitions seek to expand existing C. Computer Programs That Operate personal knowledge and experience exemptions, the Office concludes that proposing Cellphones, Tablets, Mobile Hotspots, or with regard to this exemption. regulatory language at this time would be Specifically, the petitions state that, premature; the Register may propose altering Wearable Devices (e.g., Smartwatches), current regulatory language to expand the scope of To Allow Connection of a Used Device absent an exemption, TPMs applied to an existing exemption, where the record suggests to an Alternative Wireless Network such a change is appropriate. (‘‘Unlocking’’) 25 Competitive Carriers Association (‘‘CCA’’) 20 American Foundation for the Blind (‘‘AFB’’), Renewal Pet.; Consumers Union Renewal Pet.; American Council of the Blind (‘‘ACB’’), Multiple organizations petitioned to Institute of Scrap Recycling Industries, Inc. (‘‘ISRI’’) Samuelson-Glushko Technology Law & Policy renew the exemption for computer Renewal Pet. (represented by Juelsgaard IP and Clinic at Colorado Law (‘‘Samuelson-Glushko programs that operate cellphones, Innovation Clinic, Mills Legal Clinic at Stanford TLPC’’) & Library Copyright Alliance (‘‘LCA’’) Law School); ORI Unlocking Renewal Pet. Renewal Pet.; University of Michigan Library 26 ISRI Renewal Pet. at 3. 22 Copyright Office (‘‘UMLCO’’) eBooks Renewal Pet. AFB, ACB, Samuelson-Glushko TLPC & LCA 27 New Media Rights (‘‘NMR’’) Jailbreaking 21 AFB, ACB, Samuelson-Glushko TLPC & LCA Renewal Pet. at 3. Renewal Pet.; EFF Jailbreaking Renewal Pet.; Renewal Pet. at 3; UMLCO eBooks Renewal Pet. at 23 Campos Compilations of Data Renewal Pet. Libiquity Jailbreaking Renewal Pet.; Software 3. 24 Id. at 3. Freedom Conservancy (‘‘SFC’’) Renewal Pet.
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the enumerated products would have an any specific alternatives that are computer programs on the electronic adverse effect on noninfringing uses, available now but were not available control units (‘‘ECUs’’) that control the such as being able to install third-party during the previous rulemaking. BSA functioning of the vehicles. For applications on a smartphone or also cites the same article regarding example, Auto Care, CTA, iFixit, and download third-party software on a pirated iOS apps considered by the ORI stated that ‘‘approximately 20 smart TV to enable interoperability.28 Register during sixth triennial percent of American consumers buy For example, EFF’s petition outlined its rulemaking.35 Similarly, BSA references automotive parts and products to declarant’s experience searching current Apple’s launch of its App Store in 2008 maintain and repair their own mobile computing device markets and to evidence how ‘‘access controls have vehicles.’’ 39 AFBF similarly remarked technologies, working as a software increased, rather than decreased, the that many agricultural vehicles are now engineer, and participating in four prior availability of software applications ‘‘equipped with computers that monitor 1201 rulemakings.29 Similarly, the designed for use on mobile phones.’’ 36 and control vehicle function,’’ and Libiquity petition was submitted by The sixth triennial rulemaking, many agricultural equipment someone who ‘‘work[s] with the however, considered the existence of manufacturers have adopted TPMs that operating system and many of the Apple’s App Store and third-party restrict access to such computer system libraries that lie at the core of the apps.37 Nor does BSA identify changes software.40 Indeed, MEMA, which firmware systems of a large majority of in case law or new technological during the sixth triennial rulemaking smartphones, portable all-purpose developments that might be relevant. initially opposed any exemption that mobile computing devices, and smart Each of the issues raised by BSA in would impact the software and TPMs in televisions.’’ 30 opposition to readoption had been vehicles, now supports renewal of this In a brief two-page comment, BSA | considered and evaluated in granting exemption because it strikes ‘‘an The Software Alliance (‘‘BSA’’) opposed the exemption previously. BSA provides appropriate balance between the readoption of this exemption, stating no new evidence that demonstrates a encouraging marketplace competition that ‘‘alternatives to circumvention change in circumstances. and innovation while mitigating the exist,’’ and that ‘‘jailbreaking can The Office therefore concludes that impact on safety, regulatory, and undermine the integrity and security of BSA’s opposition is not sufficiently environmental compliance.’’ 41 The a platform’s operating system in a meaningful to draw the conclusion that petitioners demonstrated personal manner than facilitates copyright the past rulemaking record is no longer knowledge and experience with regard infringement and exposes users to reliable, or that the reasoning adopted in to this exemption; each either represents heightened risks of privacy the Register’s 2015 Recommendation or gathered information from violations.’’ 31 cannot be relied upon for the next three- individuals conducting repairs or As the Office explained in the Notice year period. businesses that manufacture, distribute, of Inquiry, ‘‘[o]pposition to a renewal Based on the information provided in and sell motor vehicle parts, and petition must be meaningful, such that, the renewal petitions and the lack of perform vehicle service and repair. from the evidence provided, it would be meaningful opposition, the Register Although not opposing readoption of reasonable for the Register to conclude believes that the conditions that led to this exemption, in response to Auto that the prior rulemaking record and adoption of this exemption are likely to Care, CTA, iFixit, and ORI’s renewal any further information provided in the continue during the next triennial petition, the Auto Alliance submitted renewal petition are insufficient to period. Accordingly, the Register comments to clarify that the Office support recommending renewal of an intends to recommend renewal of this ‘‘should reject any part of the . . . exemption.’’ 32 In such a circumstance, exemption. petition that argues for expanding the the exemption would be considered E. Computer Programs That Control current temporary exemption . . . in pursuant to the more comprehensive Motorized Land Vehicles, Including section 201.40(b)(6), and should only rulemaking process (i.e., three rounds of Farm Equipment, for Purposes of consider the petition to the extent it written comment, followed by public Diagnosis, Repair, and Modification of seeks renewal of the current exemption hearings). the Vehicle as it is currently formulated, without The Office finds that BSA’s comment 42 Multiple organizations petitioned to modification.’’ The Office agrees. As largely re-articulates a general renew the exemption for computer noted above, the Office’s Notice of opposition to a jailbreaking exemption, programs that control motorized land Inquiry clearly stated that renewal and notes that the past three vehicles, including farm equipment, for petitions could only seek readoption of rulemakings have adopted some form of purposes of diagnosis, repair, and current exemptions as they are currently an exemption for jailbreaking certain modification of the vehicle (codified at formulated, without modification, and types of mobile computing devices.33 37 CFR 201.40(b)(6)).38 The petitions the Office disregarded sections of Indeed, BSA specifically raised the demonstrated the continuing need and renewal petitions to the extent that they issue of circumvention alternatives to justification for the exemption to proposed uses beyond the current jailbreaking in the 2015 triennial prevent owners of motorized land exemptions. To the extent Auto Care, rulemaking,34 and does not now identify vehicles from being adversely impacted CTA, iFixit, and ORI propose that repair in their ability to diagnose, repair, and shops should be able to ‘‘lawfully 28 NMR Jailbreaking Renewal Pet. at 1; EFF assist[ ] customers in the maintenance, Jailbreaking Renewal Pet. at 1; Libiquity modify their vehicles as a result of Jailbreaking Renewal Pet. at 1; SFC Renewal Pet. at TPMs that protect the copyrighted repair, and upgrade of their vehicles’’ 43 1. under the existing exemption, the 29 EFF Jailbreaking Renewal Pet. at 3. 35 Id. at 187 n.1211. 30 Libquity Jailbreaking Renewal Pet. at 3. 36 BSA Jailbreaking Renewal Comment at 2. 39 Auto Care, CTA, iFixit & ORI Repair Renewal 31 BSA Jailbreaking Renewal Comment at 1–2. 37 2015 Recommendation at 181–82. Pet. at 3. 40 32 82 FR at 29807. 38 Auto Care, CTA, iFixit & ORI Repair Renewal AFBF Renewal Pet. at 3. 33 80 FR 65944, 65952–53 (Oct. 28, 2015); 77 FR Pet.; American Farm Bureau Federation (‘‘AFBF’’) 41 MEMA Repair Renewal Pet. at 3. 65260, 65263–64 (Oct. 26, 2012); 75 FR 43825, Renewal Pet.; EFF Repair Renewal Pet.; Motor & 42 Auto Alliance Renewal Comment at 2. 43828–30 (July 27, 2010). Equipment Manufacturers Association (‘‘MEMA’’) 43 Auto Care, CTA, iFixit & ORI Repair Renewal 34 2015 Recommendation at 185–87. Repair Renewal Pet.; IPTC U.S.C. Renewal Pet. Pet. at 3.
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Office finds this proposition to be similarly relied on the exemption.46 the continuing need and justification for outside the bounds of the procedure for They provided an example of a recent the exemption, and the petitioner exemption renewal. The Office notes, computer security conference in which demonstrated personal knowledge and however, that iFixit petitioned for a new thousands of participants relied on the experience. Specifically, Mr. Weinberg exemption that would expand the existing exemption to examine and test petitioned for the existing exemption, existing exemption to permit electronic voting devices, during which and ‘‘continued to participate in the circumvention of TPMs to allow third- they identified ways the security of the review of that exemption . . . in his party repair services. The Office voting devices could be manipulated to personal capacity.’’ 52 In addition, the discusses iFixit’s petition below. affect election outcomes—the results of petition states that printers continue to Based on the information provided in which were reported to election officials restrict the use of third-party feedstock, the renewal petitions and the lack of to improve the security of their voting thereby requiring renewal of the 47 opposition to the specific exemption, systems. exemption. the Register believes that the conditions No oppositions were filed against Based on the information provided in that led to adoption of this exemption readoption of this exemption. To the the renewal petition and the lack of contrary, MEMA, which during the are likely to continue during the next opposition, the Register believes that the sixth triennial rulemaking initially triennial period. Accordingly, the conditions that led to adoption of this opposed any exemption that would Register intends to recommend renewal exemption are likely to continue during impact the software and TPMs in of this exemption.44 the next triennial period. Accordingly, vehicles, now supports renewal of this the Register intends to recommend F. Computer Programs That Operate exemption because it strikes ‘‘an renewal of this exemption. Devices and Machines Primarily appropriate balance between Designed for Use by Individual encouraging marketplace competition H. Video Games for Which Outside Consumers (Including Voting and innovation while mitigating the Server Support Has Been Discontinued, Machines), Motorized Land Vehicles, or impact on safety, regulatory, and To Allow Individual Play by Gamers Medical Devices Designed for environmental compliance.’’ 48 In and Preservation of Games by Libraries, Implantation in Patients and addition, BSA submitted comments in Archives, and Museums (as Well as Corresponding Personal Monitoring support of renewal of this exemption, Necessary Jailbreaking of Console Systems, for Purposes of Good-Faith noting that because the circumvention Computer Code for Preservation Uses Security Research. must be ‘‘carried out in a controlled Only) environment’’ and conducted primarily Multiple organizations and security to ‘‘promote safety and security,’’ the Multiple organizations petitioned to researchers petitioned to renew the exemption ‘‘provides important clarity renew the exemption for video games exemption for purposes of good-faith to good-faith security researchers while for which outside server support has security research (codified at 37 CFR been discontinued (codified at 37 CFR maintaining important safeguards that 53 201.40(b)(7)).45 The petitioners protect the safety, privacy and property 201.40(b)(8)). The petitions state that demonstrated the continuing need and interests of rights holders and the libraries and museums continue to need justification for the exemption, and public.’’ 49 the exemption to preserve and curate personal knowledge and experience Based on the information provided in video games in playable form. For with regard to this exemption. For the renewal petitions and the lack of example, UMCLO stated that ‘‘[m]any example, Professors Bellovin, Blaze, and opposition, the Register believes that the games still depend on connection to an Heninger stated that they have conditions that led to adoption of this external server for gameplay,’’ conducted their own security research exemption are likely to continue during suggesting that without a renewal of this in reliance on the existing exemption, the next triennial period. Accordingly, exemption the ability of gamers to play and that they ‘‘regularly engage’’ with the Register intends to recommend them would be diminished.54 In other security researchers who have renewal of this exemption.50 addition, the petitioners demonstrated personal knowledge and experience G. Computer Programs That Operate 3D 44 with regard to this exemption through The Office’s recommendation will include Printers, To Allow Use of Alternative removing language relating to a delayed effective past participation in the 1201 triennial date from the existing exemption. As noted in the Feedstock rulemaking relating to access controls Office’s 1201 Study, during the last triennial Michael Weinberg and ORI jointly on video games and consoles, and/or rulemaking the Office ‘‘implemented a twelve- month delay for certain exemptions relating to petitioned to renew the exemption for representing major library associations security research and automobile repair to allow computer programs that operate 3D with members that have relied on this other agencies to react to the new rule.’’ 1201 Study printers to allow use of alternative exemption. Readoption of this at 124; see also 2015 Recommendation at 248, 317– feedstock (codified at 37 CFR exemption was unopposed.55 18. But ‘‘now that agencies, consumers, and 51 businesses alike have had the opportunity to 201.40(b)(9)). No oppositions were consider these issues and react to [such] filed against readoption of this 52 Id. at 1. exemptions,’’ the Office ‘‘does not anticipate the exemption. The petition demonstrated 53 EFF Video Game Renewal Pet.; LCA Video Register recommending additional delays for Game Renewal Pet.; UMLCO Video Game Renewal implementation of exemptions unless necessitated Pet. 46 Bellovin, Blaze & Heninger Renewal Pet. at 3. by a grave or unusual situation.’’ 1201 Study at 54 UMCLO Video Game Renewal Pet. at 3. 47 Id. 125–26. Because the time delay for this exemption 55 Joint Creators questioned whether the petitions 48 was intended to be a one-time delay, which has MEMA Security Research Renewal Pet. at 3. sufficiently requested renewal of the portion of the now expired, the Office considers its removal to be 49 BSA Security Research Renewal Comment at 2. exemption applicable to personal gameplay. Joint a technical change. 50 The Office’s recommendation will include Creators Renewal Comment at 2, n.2. The Office 45 Bellovin, Blaze & Heninger Renewal Pet. removing language relating to a delayed effective notes that the declarations signed by the petitioners (represented by Professor Andrea Matwyshyn); date from the existing exemption. As noted above support readoption of the exemption in full. EFF Campos Security Research Renewal Pet.; Center for regarding the existing exemption for repair, because Video Game Renewal Pet.; LCA Video Game Democracy & Technology (‘‘CDT’’) Renewal Pet.; the time delay for this exemption was intended to Renewal Pet.; UMLCO Video Game Renewal Pet. Felten, Halderman & ORI Renewal Pet. (represented be a one-time delay, which has now expired, the Joint Creators themselves acknowledged that ‘‘the by Samuelson-Glushko TLPC and Jonathan Band of Office considers its removal to be a technical petitions appear to implicitly request renewal of the policbandwidth); Libiquity Security Research change. current exemption in its entirety’’ and did not Renewal Pet. 51 Weinberg & ORI Renewal Pet. Continued
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Based on the information provided in produce the required level of high- J. Motion Pictures (Including Television the renewal petitions and the lack of quality content.’’ 60 Programs and Videos): For Educational opposition, the Register believes that the The DVD Copy Control Association Uses by K–12 Instructors and Students conditions that led to adoption of this (‘‘DVD CCA’’) and The Advanced Multiple organizations petitioned to exemption are likely to continue during Access Content System Licensing renew the exemption for motion the next triennial period. Accordingly, Administrator (‘‘AACS LA’’) submitted pictures for educational uses by K–12 the Register intends to recommend comments regarding readoption of this instructors and students (codified at 37 renewal of this exemption. exemption. Although DVD CCA and CFR 201.40(b)(1)(vi)).64 No oppositions AACS LA did not oppose readoption, I. Motion Pictures (Including Television were filed against readoption of this they stated that the exemption is exemption. The petitions demonstrated Programs and Videos): For Educational ‘‘predicated on the need for close Uses by College and University the continuing need and justification for analysis of the film in uses that the exemption, stating that K–12 Instructors and Students constitute criticism or comment,’’ and instructors and students continue to rely Multiple individuals and suggested that Joint Educators, AAUP, on excerpts from digital media for class organizations petitioned to renew the ICA, DCSUM, SCMS, and LCA did ‘‘not presentations and coursework, and must focus on the need for close analysis of sometimes use screen-capture exemption for motion pictures for 61 educational uses by college and the film’’ in their renewal petition. technology. In addition, the petitioners university instructors and students DVD CCA and AACS LA asked for demonstrated personal knowledge and clarification that ‘‘renewal of this (codified at 37 CFR 201.40(b)(1)(iv)).56 experience with regard to this exemption is limited to those uses No oppositions were filed against exemption through representation of where close analysis is necessary in the readoption of this exemption. The thousands of digital and literacy particular circumstance.’’ 62 petitions demonstrated the continuing educators and/or members supporting As noted above, the Office’s Notice of need and justification for the K–12 instructors and students, Inquiry stated that renewal petitions are exemption, and personal knowledge and combined with past participation in the to seek readoption of current experience with regard to this 1201 triennial rulemaking. exemptions as they are currently Based on the information provided in exemption. For example, Joint formulated, without modification. the renewal petitions and the lack of Educators, AAUP, DCSUM, and LCA Therefore, the Office focused on opposition, the Register believes that the stated that courses on video essays (or whether the renewal petition provided conditions that led to adoption of this multimedia or videographer criticism), sufficient information to warrant exemption are likely to continue during now taught at many universities, would readoption of the exemption in its the next triennial period. Accordingly, not be able to exist without relying on current form. In this case, Joint the Register intends to recommend this exemption.57 Without this Educators, AAUP, ICA, DCSUM, SCMS, renewal of this exemption. exemption, Joint Educators, AAUP, and LCA did state that ‘‘close analysis K. Motion Pictures (Including Television DCSUM, and LCA assert that educators of digital media is being increasingly Programs and Videos): For Educational would be ‘‘unable to provide an recognized across many disciplines as a Uses in Massive Open Online Courses enriching and accurate description and fundamental tool for pedagogy,’’ (‘‘MOOCs’’) analysis of cinematic or other followed by examples of such uses.63 audiovisual works when prevented from Accordingly, the Office concludes that Joint Educators, ICA, DCSUM, SCMS, accessing such works due to Joint Educators, AAUP, ICA, DCSUM, and LCA petitioned to renew the 58 TPM[s]’’ —and their declarant, SCMS, and LCA provided sufficient exemption for motion pictures for Professor Decherney, has personally information to support renewal of the educational uses in massive open online relied upon this exemption to teach a existing exemption. courses (‘‘MOOCs’’) (codified at 37 CFR 59 course on multimedia criticism. Based on the information provided in 201.40(b)(1)(v)).65 No oppositions were Similarly, Professor Hobbs, who the renewal petitions and the lack of filed against readoption of this represents more than 17,000 digital and opposition, the Register believes that the exemption. The petition demonstrated media literacy educators, and NAMLE, conditions that led to adoption of this the continuing need and justification for an organization devoted to media exemption are likely to continue during the exemption, stating that instructors literacy with more than 3,500 members, the next triennial period. Accordingly, continue to rely on the exemption to stated that ‘‘sometimes teachers must the Register intends to recommend develop, provide, and improve MOOCs, circumvent a DVD protected by the renewal of this exemption. as well as increase the number of (and Content Scramble System when screen- To the extent petitioners seek a therefore access to) MOOCs in the field capture software or other non- broader exemption, the Office notes that of film and media studies. In addition, circumventing alternatives are unable to petitions for new exemptions were filed the declarant, Professor Decherney, seeking modification of the existing demonstrated personal knowledge by oppose such renewal. Joint Creators Renewal exemptions for educational uses of describing his reliance on the Comment at 2, n.2. motion pictures. This NPRM initiates exemption to teach MOOCs on film and 56 Decherney, Sender & Carpini (collectively, media studies, as well as his past ‘‘Joint Educators’’), American Association of public comment on such modification University Professors (‘‘AAUP’’), the International through Proposed Class 1 described participation in the 1201 triennial Communication Association (‘‘ICA’’), Department of below, which combines multiple rulemaking, along with Professor Communication Studies at the University of petitions for modified exemptions, Carpini, ICA, SCMS, and LCA. Michigan (‘‘DCSUM’’), the Society for Cinema and Based on the information provided in Media Studies (‘‘SCMS’’) & LCA AV Univ. Renewal including one by Joint Educators. Pet.; Hobbs & National Association for Media the renewal petition and the lack of Literary Education (‘‘NAMLE’’) AV Univ. Renewal 60 Hobbs & NAMLE AV Univ. Renewal Pet. at 1. opposition, the Register believes that the Pet.; UMLCO AV Univ. Renewal Pet. 61 DVD CCA & AACS LA AV Univ. Renewal 57 Joint Educators, AAUP, ICA, DCSUM, SCMS & Comment at 1–2. 64 LCA K–12 Renewal Pet.; Hobbs & NAMLE K– LCA AV Univ. Renewal Pet. at 1. 62 Id. at 4–5. 12 Renewal Pet. 58 Id. 63 Joint Educators, AAUP, ICA, DCSUM, SCMS & 65 Joint Educators, ICA, DCSUM, SCMS & LCA 59 Id. LCA AV Univ. Renewal Pet. at 3 (emphasis added). MOOCs Renewal Pet.
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conditions that led to adoption of this protection measures....’’70 In the next triennial period. Accordingly, exemption are likely to continue during addition, the petitioners demonstrated the Register intends to recommend the next triennial period. Accordingly, personal knowledge through Professor renewal of this exemption. the Register intends to recommend Buster’s continued work on an e-book renewal of this exemption. series based on her lecture series, O. Motion Pictures (Including Television ‘‘Deconstructing Master Filmmakers: Programs and Videos): For Uses in L. Motion Pictures (Including Television The Uses of Cinematic Enchantment,’’ Noncommercial Videos Programs and Videos): For Educational and Authors Alliance’s feedback that its Two organizations petitioned to Uses in Digital and Literacy Programs members continue to desire authoring e- Offered by Libraries, Museums, and renew the exemption for motion books that incorporate film for the pictures for uses in noncommercial Other Nonprofits purpose of analysis.71 videos (codified at 37 CFR Multiple organizations petitioned to Based on the information provided in 75 the renewal petition and the lack of 201.40(b)(1)(ii)). No oppositions were renew the exemption for motion filed against readoption of this pictures for educational uses in digital opposition, the Register believes that the conditions that led to adoption of this exemption. The petitions demonstrated and literacy programs offered by the continuing need and justification for libraries, museums, and other exemption are likely to continue during the exemption, and the petitioners nonprofits (codified at 37 CFR the next triennial period. Accordingly, demonstrated personal knowledge and 201.40(b)(1)(viii)).66 No oppositions the Register intends to recommend experience with regard to this were filed against readoption of this renewal of this exemption. exemption. For example, OTW has exemption. The petitions demonstrated N. Motion Pictures (Including Television advocated for the noncommercial video the continuing need and justification for Programs and Videos): For Uses in exemption in past triennial the exemption, and demonstrated Documentary Films rulemakings, and has heard from ‘‘a personal knowledge and experience number of noncommercial remix with regard to this exemption. For Multiple organizations petitioned to artists’’ who have used the exemption example, LCA stated that librarians renew the exemption for motion and anticipate needing to use it in the across the country have relied on the pictures for uses in documentary films 72 future.76 current exemption and will continue to (codified at 37 CFR 201.40(b)(1)(i)). These discussions included a do so for their digital and literacy No oppositions were filed against report from an academic that video programs.67 In addition, Professor readoption of this exemption. The quality was important in facilitating petitions summarized the continuing classroom understanding and Hobbs and NAMLE stated that librarians 77 will continue to rely on this exemption need and justification for the discussion. Similarly, NMR stated that for their digital and literacy programs, exemption, and the petitioners it has spoken to a number of and to advance the digital media demonstrated personal knowledge and noncommercial video creators who have knowledge of their patrons.68 experience with regard to this relied on this exemption, and intend to exemption. For example, Joint do so in the future.78 Based on the information provided in Filmmakers, CID, and WIFV—which the renewal petitions and the lack of Although no oppositions were filed represent thousands of independent opposition, the Register believes that the against readoption of the exemption as filmmakers across the nation—stated conditions that led to adoption of this it currently exists, Joint Creators that TPMs such as encryption continue exemption are likely to continue during submitted comments expressing to prevent filmmakers from accessing the next triennial period. Accordingly, concern that OTW’s renewal petition needed material, and that this is the Register intends to recommend proposed using language from the ‘‘especially true for the kind of high renewal of this exemption. triennial rulemaking initiated in 2008 definition motion picture material instead of readopting the exemption M. Motion Pictures (Including filmmakers need to satisfy both without modification.79 DVD CCA and 73 Television Programs and Videos): For distributors and viewers.’’ In AACS LA made a similar observation.80 Multimedia e-Books Offering Film addition, Joint Filmmakers have Analysis participated in multiple triennial As noted above, the Office’s Notice of rulemakings. Petitioners state that they Inquiry stated that renewal petitions are A professor and two organizations personally know many filmmakers who to seek readoption of current collectively petitioned to renew the have found it necessary to rely on this exemptions as they are currently exemption for motion pictures for exemption, and will continue to do so.74 formulated, without modification. As a multimedia e-books offering film Based on the information provided in result, the Office did not consider, as analysis (codified at 37 CFR the renewal petitions and the lack of part of the renewal process, sections of 201.40(b)(1)(iii)).69 No oppositions were opposition, the Register believes that the renewal petitions to the extent that they filed against readoption of this conditions that led to adoption of this proposed uses beyond the current exemption. The petition demonstrated exemption are likely to continue during exemptions. The Office concludes, the continuing need and justification for however, that OTW’s submission, fairly the exemption, stating that the 70 Id. at 3. read, did sufficiently petition for availability of video necessary for 71 See id. renewal of the exemption as it currently authors to undertake film analysis in e- 72 Film Independent, International Documentary exists, providing detailed information books continues to be ‘‘limited to Association, Kartemquin Educational Films, Inc. (collectively, ‘‘Joint Filmmakers’’), Center For formats encumbered by technological 75 Independent Documentary (‘‘CID’’) & Women in NMR Noncom. Videos Renewal Pet.; Film and Video (‘‘WIFV’’) Renewal Pet. Organization for Transformative Works (‘‘OTW’’) 66 LCA AV Nonprofit Renewal Pet.; Hobbs & (represented by Donaldson + Callif, LLP and UCI Renewal Pet. NAMLE AV Nonprofit Renewal Pet. Intellectual Property Arts and Technology Clinic at 76 OTW Renewal Pet. at 3. 67 LCA AV Nonprofit Renewal Pet. at 1. University of California, Irvine (‘‘UCI’’)); NMR AV 77 Id. 68 Hobbs & NAMLE AV Nonprofit Renewal Pet. at Documentary Renewal Pet. 78 NMR Noncom. Videos Renewal Pet. at 3. 3. 73 Joint Filmmakers, CID & WIFV Renewal Pet. at 79 Joint Creators Renewal Comment at 2 n.1. 69 Buster, Authors Alliance & AAUP Renewal Pet. 3. 80 DVD CCA & AACS LA AV Noncom. Videos (represented by Samuelson-Glushko TLPC). 74 Id.; NMR AV Documentary Renewal Pet. at 3. Renewal Comment at 4.
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supporting the continued need for an 17 U.S.C. 117). Legal assertions should adopted as part of this rulemaking must exemption for noncommercial videos.81 be supported by statutory citations, be based on ‘‘a particular class of Based on the information provided in relevant case law, and other pertinent works’’ 82; and the legislative history the renewal petitions and the lack of authority. In cases where a class explains that each class is intended to opposition, the Register believes that the proposes to expand an existing ‘‘be a narrow and focused subset of the conditions that led to adoption of this exemption, commenters should focus broad categories of works . . . identified exemption are likely to continue during their comments on the legal and in Section 102 of the Copyright the next triennial period. Accordingly, evidentiary bases for modifying the Act. . . .’’ 83 As explained in the Notice the Register intends to recommend exemption, rather than the underlying of Inquiry, the Office consolidates or renewal of this exemption. exemption; as discussed above, the groups related and/or overlapping To the extent OTW seeks modification Register intends to recommend each proposed exemptions where possible to of the existing noncommercial video current temporary exemption for simplify the rulemaking process and exemption, the Office notes that a renewal. encourage joint participation among petition for a new exemption was filed To ensure a clear and definite record parties with common interests (though seeking such modification. This NPRM for each of the proposals, commenters collaboration is not required). initiates public comment on that are required to provide a separate Accordingly, the Office has categorized modification through the proposed class submission for each proposed class the petitions into twelve proposed described below. during each stage of the public comment classes of works. period. Although a single comment may Each proposed class is briefly III. Analysis and Classification of not address more than one proposed described below; additional information Proposed New Exemptions class, the same party may submit can be found in the underlying petitions Having addressed the petitions to multiple written comments on different posted on regulations.gov. As explained renew existing exemptions, the Office proposals. The Office acknowledges that in the Notice of Inquiry, the proposed now turns to the petitions for new or the requirement of separate submissions classes ‘‘represent only a starting point expanded exemptions. The Office may require commenters to repeat for further consideration in the received twenty-three petitions, which certain information across multiple rulemaking proceeding, and will be it has organized into twelve classes, as submissions, but the Office believes that subject to further refinement based on described below. Before turning to a the administrative benefits of creating a the record.’’ 84 The Office further notes description of those classes, the Office self-contained, separate record for each that it has not put forward precise first explains the process and standards proposal will be worth the modest regulatory language for the proposed for submission of written comments. amount of added effort. classes, because any specific language The first round of public comment is A. Submission of Written Comments for exemptions that the Register limited to submissions from proponents ultimately recommends to the Librarian Persons wishing to address proposed (i.e., those parties who proposed new will depend on the full record exemptions in written comments should exemptions during the petition phase) developed during this rulemaking. familiarize themselves with the and other members of the public who Indeed, in the case of proposed substantive legal and evidentiary support the adoption of a proposed modifications to existing exemptions, as standards for the granting of an exemption, as well as any members of stated above, the Register may propose exemption under section 1201(a)(1), the public who neither support nor altering current regulatory language to which are also described in more detail oppose an exemption but seek only to expand the scope of an exemption, on the Office’s form for submissions of share pertinent information about a where the record suggests such a change longer comments, available on its Web specific proposal. is appropriate. site. In addressing factual matters, Proponents of exemptions should In addition, after examining the commenters (both proponents and present their complete affirmative case petitions, the Office has preliminarily opponents) should be aware that the for an exemption during the initial identified some initial legal and factual Office favors specific, ‘‘real-world’’ round of public comment, including all areas of interest with respect to certain examples supported by evidence over legal and evidentiary support for the proposed classes. The Office stresses, speculative, hypothetical observations. proposal. Members of the public who however, that these areas are not In cases where the technology at issue oppose an exemption should present the exhaustive, and commenters should is not apparent from the requested full legal and evidentiary basis for their consider and offer all legal argument exemption, it can be helpful for opposition in the second round of and evidence they believe necessary to commenters to describe the TPM(s) that public comment. The third round of create a complete record. These early control access to the work and method public comment will be limited to observations are offered without of circumvention. supporters of particular proposals and prejudice to the Office’s ability to raise Commenters’ legal analysis should those who neither support nor oppose a other questions or concerns at later explain why the proposal meets or fails proposal, who, in either case, seek to stages of the proceeding. Finally, to meet the criteria for an exemption reply to points made in the earlier ‘‘where an exemption request resurrects under section 1201(a)(1), including, rounds of comments. Reply comments legal or factual arguments that have without limitation, why the uses sought should not raise new issues, but should been previously rejected, the Office will are or are not noninfringing as a matter instead be limited to addressing of law. The legal analysis should also arguments and evidence presented by 82 17 U.S.C. 1201(a)(1)(B). discuss statutory or other legal others. 83 Commerce Comm. Report at 38; see also 1201 provisions that could impact the Study at 109–10 (noting that while ‘‘in some cases, B. The Proposed Classes [the Office] can make a greater effort to group necessity for or scope of the proposed similar classes together, and will do so going exemption (for example, the Unlocking As noted above, the Office has forward,’’ ‘‘in other cases, the Office’s ability to Consumer Choice and Wireless reviewed and classified the proposed narrowly define the class is what enabled it to recommend the exemption at all, and so the Office Competition Act (‘‘Unlocking Act’’), or exemptions set forth in the twenty-three will continue to refine classes when merited by the petitions received in response to its record’’). 81 OTW Renewal Pet. at 3–4. Notice of Inquiry. Any exemptions 84 82 FR at 29808.
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continue to rely on past reasoning to The Office notes that in the past, the university students and instructors to dismiss such arguments in the absence Register has at times found it necessary more broadly cover ‘‘uses where of new information.’’ 85 to define a class by a use or user in order circumvention is undertaken to to recommend an exemption,88 but also facilitate performance of motion Proposed Class 1: Audiovisual Works— recognizes that for these audiovisual pictures in the course of face-to-face Criticism and Comment exemptions in particular, participants teaching activities, as set forth in 17 Several petitions seek expansion of expressed concern that the current U.S.C. 110(1)’’; ‘‘use of more than short existing exemptions for circumvention exemptions are overly complicated and portions of motion picture excerpts’’; of access controls protecting excerpts of confusing.89 The Office invites and ‘‘uses beyond film studies or other motion pictures on DVDs, Blu-Ray comment on each aspect of these courses requiring close analysis of film discs, and digitally transmitted video for proposals, including whether this and media excerpts.’’ 94 The Office notes purposes of criticism and comment by grouping is preferable, or whether the that in the 2012 and 2015 triennial various users, including creators of existing exemptions should be rulemakings, the Register found the noncommercial videos, college and consolidated in some other manner, ‘‘short portions’’ limitation was university faculty and students, faculty such as grouping just the permitted ‘‘critical’’ in deciding to recommend of massive open online courses educational uses together.90 For exemptions for the use of motion (‘‘MOOCs’’), documentary filmmakers, commenters who may be concerned that picture excerpts.95 and for multimedia e-books offering film a single exemption is too broad, could Joint Educators seek to expand the analysis. an exemption be refined by specifically exemption for motion pictures for Because the new proposals raise some excluding types of uses or users, as educational uses in MOOCs; shared concerns, including the impact opposed to enumerating permitted users specifically, they propose removing the of TPMs on the alleged noninfringing in multiple exemptions? ‘‘accredited non-profit educational uses of motion pictures and whether Beyond EFF, NMR, and OTW’s institutions’’ and ‘‘massive open online alternative methods of accessing the proposal, the other petitions seek to courses’’ limitations, and extending the content could alleviate potential adverse expand upon existing exemptions for exemption to ‘‘all online educational impacts, the Office has grouped these purposes of criticism and comment, but institutions’’ and ‘‘for use by instructors petitions into one class. This grouping in a more limited way. Specifically, of all online educational is without prejudice to further Professor Buster, Authors Alliance, and courses....’’96 The petition also refinement of this class, including OTW propose expanding the exemption proposes to have the exempted use ‘‘no whether it should be parsed back into for multimedia e-books offering film longer be limited’’ by the TEACH Act subclasses based on specific uses, analysis (codified at 37 CFR (codified at 17 U.S.C. 110).97 The Office following the approach of past 201.40(b)(1)(iii)) by removing the notes that some of these considerations rulemakings. This approach also ‘‘nonfiction’’ and ‘‘offering film were previously addressed during the accounts for a joint petition by EFF, analysis’’ limitations, and removing 2015 triennial rulemaking, and invites NMR, and OTW, which seeks to references to screen-capture comment on changing legal or factual collapse (essentially) the existing technology.91 Similarly, Joint circumstances with respect to these 98 exemptions for excerpts of motion Filmmakers seek removal of the provisions. pictures to eliminate limitations on the ‘‘documentary’’ limitation in the current In addition, two petitioners seek types of user or use, instead allowing exemption for uses in documentary clarification that ‘‘the use of screen- circumvention so long as the purpose is films (codified at 37 CFR capture technology does not constitute for criticism and comment.86 201.40(b)(1)(i)).92 The Office notes that circumvention,’’ which presumably might result in the removal of current Specifically, EFF, NMR, and OTW seek many of these issues were previously regulatory exemptions for screen to retain the vast majority of existing considered by the Register during the capture technology, as they would be introductory text of section 201.40(b)(1), 2015 triennial rulemaking, and unnecessary.99 Again the Office notes but then eliminate the various categories encourages proponents to provide new that in 2015, the Register noted that the of specific users such that the factual or legal support for these then-existing record did not ‘‘include exemption becomes: proposed modifications.93 The two remaining petitions seek to any examples of screen-capture Motion Pictures (including television technology that holds itself out as non- shows and videos), as defined in 17 U.S.C. expand the current exemptions for educational uses. Brigham Young 101, where circumvention is undertaken 94 University (‘‘BYU’’) and BYU—Idaho, BYU & BYU IPO Class 1 Pet. at 2. solely in order to make use of short portions 95 2015 Recommendation at 99; 2012 of the works for the purpose of criticism or Intellectual Property Office (‘‘BYU Recommendation at 138–39 (also declining to comment, where the motion picture is IPO’’) seek expansion of the exemption recommend that the exemption apply to ‘‘students lawfully made and acquired on a DVD for educational uses by college and across all disciplines of study’’). protected by the Content Scrambling System, 96 Joint Educators Class 1 Pet. at 2. 97 on a BluRay disc protected by the Advanced 88 1201 Study at 109–10. Id. 98 2015 Recommendation at 102. Access Control System, via a digital 89 Id. at 151; see, e.g., EFF, NMR & OTW Class 99 transmission protected by a technological 1 Pet. at 2–3. BYU & BYU IPO Class 1 Pet. at 2; Joint Filmmakers Class 1 Pet. at 3; see 37 CFR measure, or a similar technological 90 See 1201 Study at 109 (‘‘[I]n the upcoming 201.40(b)(1)(i) (‘‘For use in documentary protection measure intended to control seventh rulemaking, the Office will consider filmmaking . . . [w]here the circumvention is access to a work, where the person engaging consolidating some of the separate classes related undertaken using screen-capture technology that to motion pictures into broader categories, such as in circumvention reasonably believes that appears to be offered to the public as enabling the one related to educational uses.’’); see also OTW non-circumventing alternatives are unable to reproduction of motion pictures after content has Renewal Pet. at 4 (requesting adoption of an produce the required level of high-quality been lawfully acquired and decrypted . . .’’); 37 exemption for noncommercial videos based on source material.87 CFR 201.40(b)(1)(iv) (‘‘By college and university regulatory language adopted in the 2008 faculty and students, for educational purposes . . . rulemaking). [w]here the circumvention is undertaken using 85 91 1201 Study at 147; see also 79 FR 55687, 55690 Buster, Authors Alliance & OTW Class 1 Pet. screen-capture technology that appears to be offered (Sept. 17, 2014). at 3. to the public as enabling the reproduction of motion 86 EFF, NMR & OTW Class 1 Pet. at 2. 92 Joint Filmmakers Class 1 Pet. at 3. pictures after content has been lawfully acquired 87 Id. 93 2015 Recommendation at 103. and decrypted. . . .’’).
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circumventing.’’ 100 The Office invites exemption, including whether, in the to an alternative wireless network (a comment on whether users are relying past three years, there has been a change process commonly known as upon the various screen capture in the legal or factual landscapes ‘‘unlocking’’).109 Specifically, ISRI exemptions for uses of motion picture regarding whether space-shifting and proposes expanding the exemption excerpts and whether there is common format-shifting are noninfringing fair codified at 37 CFR 201.40(b)(3) by understanding that screen-capture uses. eliminating the current enumerated technology is non-circumventing. categories of devices on which Proposed Class 4: Audiovisual Works— Proposed Class 2: Audiovisual Works— HDCP/HDMI circumvention may occur (i.e., to allow Accessibility the unlocking of any wireless device This proposed class would allow that connects to a wireless This proposed class would permit circumvention of TPMs ‘‘to make telecommunications network), as well circumvention of TPMs for motion noninfringing uses of audiovisual works as extending the exemption to new pictures by ‘‘disability services offices, that are subject to High-bandwidth devices (i.e., removing the requirement organizations that support people with Digital Content Protection (‘‘HDCP’’),’’ that the devices must be ‘‘used’’). The disabilities, libraries, and other units at which restricts access to audiovisual Office notes that these issues were to educational institutions that are works passing over High-Definition some extent considered in the last responsible for fulfilling those Multimedia Interface (‘‘HDMI’’) rulemaking.110 institutions’ legal and ethical connections, such as through an HDMI The Office seeks comment on whether obligations to make works accessible to cable.105 Andrew ‘‘bunnie’’ Huang has this proposed exemption should be people with disabilities,’’ ‘‘where proposed an exemption to circumvent adopted, including specific examples circumvention is undertaken for the ‘‘devices that play video discs and video demonstrating adverse effects stemming purpose of making a motion picture game software’’ using HDCP encoding to from a consumer’s inability to choose accessible to people with disabilities, ‘‘captur[e] the output for subsequent the mobile wireless communications including through the provision of noninfringing uses, such as fair use or provider for a new wireless device. closed and open captions and audio automated analysis of noncopyrightable description.’’ 101 Specifically, the elements of the content.’’ 106 The Office Proposed Class 6: Computer Programs— petition seeks to circumvent works notes that in an ongoing judicial Jailbreaking stored on ‘‘optical media, video proceeding, Huang alleged that he seeks The proposed class would allow cassettes with access control measures, to market a device called ‘‘NeTVCR,’’ circumvention of TPMs protecting and streaming services....’’102 which would circumvent HDCP ‘‘general-purpose portable computing The Office seeks comment on whether technology to, among other things, devices’’ to allow the devices to this proposed exemption should be allow people ‘‘to save content for later interoperate with or to remove software adopted, including any proposed viewing, move content to a viewing applications (‘‘jailbreaking’’).111 regulatory language. device of the user’s choice, or convert Specifically, EFF proposes to replace 107 Proposed Class 3: Audiovisual Works— content to a more useful format.’’ He the ‘‘portable all-purpose mobile Space-Shifting further alleged that NeTVCR ‘‘would computing devices’’ limitation in the allow customers to engage in new forms existing jailbreaking exemption (37 CFR This proposed class would allow of protected and noninfringing 201.40(b)(4)) with the term ‘‘general- circumvention of access controls on 108 expression using HDMI signals.’’ purpose portable computing devices,’’ lawfully made and acquired audiovisual The Office seeks comment on whether and extend the exemption to such works for the purpose of noncommercial this proposed exemption should be devices ‘‘carried’’ or ‘‘used in a home,’’ space-shifting or format-shifting. The adopted, including any proposed as well as the enabling and disabling of Office received two petitions seeking an regulatory language. The Office hardware features on such devices.112 exemption permitting circumvention of encourages commenters, in the course of TPMs on DVDs and Blu-ray discs for detailing whether the proposed 109 ISRI Class 5 Pet. #1 at 2; ISRI Class 5 Pet. #2 space-shifting or format-shifting for exemption meets the requirements of at 2. 103 personal use. The Office notes that in section 1201(a)(1), to address the 110 79 FR at 55689 (‘‘The evaluation of whether the 2006, 2012, and 2015 triennial specific types of audiovisual works that an exemption would be appropriate under section rulemakings, the Librarian rejected would be accessed by this exemption, to 1201(a)(1)(C) is likely to be different for different types of wireless devices, requiring distinct legal proposed exemptions for space-shifting provide examples of the types of and evidentiary showings. Thus, a petition or format-shifting, finding that the noninfringing uses implicated, to proposing a general exemption for ‘all wireless proponents had failed to establish under address whether viable alternatives to devices’ * * * could be quite difficult to support, applicable law that space-shifting is a circumvention exist, and to detail the in contrast to a petition that focuses on specific noninfringing use.104 The Office seeks categories of devices * * *’’); 80 FR at 65952 effect circumvention might have on the (limiting final rule to ‘‘used’’ devices). comment on all aspects of this proposed market for or value of copyrighted 111 EFF Class 6 Pet. at 2–3. works. 112 Id. EFF’s Class 6 petition proposes the 100 2015 Recommendation at 99. following language for the exemption: 101 Association of Transcribers and Speech-to-text Proposed Class 5: Computer Programs— Computer programs that enable smartphones and Providers (‘‘ATSP’’), Association of Research Unlocking general-purpose portable computing devices to Libraries (‘‘ARL’’), American Library Association execute lawfully obtained software applications, (‘‘ALA’’) & Association of College and Research The proposed class would permit the where circumvention is accomplished solely for Libraries (‘‘ACRL’’) Class 2 Pet. at 3. circumvention of TPMs for computer one or more of the following purposes: to enable 102 Id. at 3. programs that operate new and used interoperability of such applications with computer 103 OmniQ Class 3 Pet. at 2–3; De Pretis Class 3 ‘‘wireless devices’’ to allow connection programs on the smartphone or device, to enable or Pet. at 2. disable hardware features of the smartphone or 104 device, or to permit removal of software from the See 80 FR at 65960; 77 FR at 65276–77; 71 FR 105 68472, 68478 (Nov. 27, 2006). The Librarian also Huang Class 4 Pet. smartphone or device. For purposes of this 106 previously declined to adopt an exemption to allow Id. at 2. exemption, a ‘‘general-purpose portable computing motion pictures on DVDs to be played on the Linux 107 Complaint for Declaratory & Injunctive Relief device’’ is a portable device that is primarily operating system. See 68 FR 62011, 62017 (Oct. 31, ¶¶ 90–93, Green v. U.S. Dep’t of Justice, No. 16– designed or primarily used to run a wide variety of 2003). For previous discussion of OmniQ’s cv–1492 (D.D.C. July 21, 2016). programs rather than for consumption of a technology, see 2015 Recommendation at 113. 108 Id. ¶¶ 100, 101. particular type of media content, is equipped with
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The Office notes that during the 2015 recently concluded 1201 Study.117 The strong reasons to conclude that Congress rulemaking, the Register recommended Auto Care and CTA petition proposes did not intend to apply the the adoption of the current exemption keeping the limitation for motorized manufacturing bar to exemption for ‘‘portable all-purpose mobile land vehicles, but removing the beneficiaries from producing their own computing devices,’’ in part, because ‘‘telematics or entertainment systems’’ circumvention tools for personal use,’’ the record ‘‘meaningfully defined’’ such limitation, asserting that ‘‘telematics as ‘‘such a reading would render the devices.113 systems increasingly are being designed rulemaking process effectively The Office seeks comment on whether by vehicle manufacturers as the means meaningless for many users.’’ 124 The this proposed exemption should be to access the embedded software that Office did not recommend, however, adopted, including on the definitions of controls the parts and operation of the that Congress ‘‘take the additional step 118 ‘‘portable,’’ ‘‘carried,’’ and ‘‘used in the vehicle.’’ The Office notes that of allowing the distribution of necessary home’’ that would govern the proposed during the 2015 triennial rulemaking, tools to exemption beneficiaries,’’ exemption. The Office welcomes the Register concluded that the record noting that permitting the distribution examples of specific types of devices did not support extending the of tools ‘‘could significantly erode’’ the that would be encompassed by the exemption to ECUs primarily designed ability of the anti-trafficking provisions for the control of telematics or to prevent the development of exemption other than those enumerated 119 in the existing exemption codified at 37 entertainment systems. mainstream business models based Three petitions seek to expand the CFR 201.40(b)(4). around the production and sale of existing exemption to allow third circumvention tools.125 Proposed Class 7: Computer Programs— parties to provide services on behalf of The Office seeks comment on whether Repair owners of motorized land vehicles, an an expanded exemption to cover issue that also raises potential issues additional repair and related activities Multiple organizations petitioned for with respect to the anti-trafficking should be adopted, including any exemptions relating to diagnosis, repair, prohibitions under section 1201(a)(2) 114 proposed regulatory language. and modification. As noted above, and (b).120 As noted above, the statute the current exemption (codified at 37 only empowers the triennial rulemaking Proposed Class 8: Computer Programs— CFR 201.40(b)(6)) is limited to the to adopt temporary exemptions to Video Game Preservation diagnosis, repair or lawful modification section 1201(a)(1)’s prohibition on The proposed class would expand of motorized land vehicles, except for circumvention of access controls. The upon the current exemption (codified at computer programs primarily designed Office has addressed the interplay of 37 CFR 201.40(b)(8)) permitting for the control of telematics or these provisions as part of the Register’s circumvention ‘‘by an eligible library, 115 entertainment systems. Multiple recommendation during the 2015 archives, or museum,’’ of TPMs petitions seek to expand upon this triennial rulemaking, as well as its protecting video games, for which language. Specifically, EFF proposes to recent policy study on section 1201.121 outside server support has been eliminate the limitation to motorized Similarly, two petitions raise the discontinued. Specifically, The Museum land vehicles, that is, to allow question of potential interaction with of Art and Digital Entertainment circumvention of TPMs applied to a anti-trafficking rules under section (‘‘MADE’’) proposes expanding the broader range of devices including the 1201(a)(2) and (b) by proposing to existing exemption ‘‘to further include ‘‘Internet of Things,’’ appliances, expand the exemption to allow the multiplayer online games, video games computer peripherals, computers, ‘‘development and sale of repair with online multiplayer features, and storage devices, and playback devices, tools,’’ 122 and to ‘‘permit companies massively multiplayer online games toys, vehicles, and environment with expertise in software development (MMOs), whether stored physically or 116 automation systems. EFF asserts that to develop and make circumvention and in downloadable formats, and [to] add its proposed exemption ‘‘overlaps repair solutions available to servicers preservationists affiliated with archival significantly’’ with the Office’s and customers.’’ 123 As the Office noted institutions as users.’’ 126 The Office recommendation concerning a in its recent 1201 Study, ‘‘there are notes that during the 2015 triennial permanent exemption for repair in its rulemaking, the Register found that 117 EFF Class 7 Pet. at 2; see also 1201 Study at excluding uses that require access to or an operating system primarily designed for use in 88–97 (discussing issues relating to obsolescence, copying of copyrightable content stored a general purpose computing device, and is repair and modification and recommending primarily designed to be carried or worn by an legislative consideration of a ‘‘properly-tailored or previously stored on developer game individual or used in a home. exemption for repair activities,’’ but concluding that servers ‘‘to be an important Id. at 2. modification is appropriately addressed through the limitation.’’ 127 In addition, the Register 113 2015 Recommendation at 189. rulemaking process). concluded that the then-existing record 118 114 iFixit Class 7 Pet. at 2; EFF Class 7 Pet. at 2– Auto Care & CTA Class 7 Pet. at 4. did not support extension of the 3; IPTC U.S.C., AFBF, National Corn Growers 119 2015 Recommendation at 246. 120 iFixit Class 7 Pet. at 2; IPTC U.S.C., AFBF, exemption to online multiplayer Association (‘‘NCGA’’) & National Farmers Union 128 (‘‘NFU’’) Class 7 Pet. at 2; Auto Care & CTA Class NCGA & NFU Class 7 Pet. at 2; Auto Care & CTA play. 7 Pet. at 2–4. Class 7 Pet. at 3. The Office seeks comment on whether 115 37 CFR 201.40(b)(6). 121 80 FR at 65954; 2015 Recommendation at 246– this proposed expanded exemption for 116 EFF Class 7 Pet. at 2–3 (proposing the 48 (excluded circumvention ‘‘on behalf of’’ vehicle abandoned video games should be exemption ‘‘enable circumvention of access owners, noting this phrase ‘‘may implicate the anti- adopted, including any proposed controls applied to software and compilations of trafficking provisions set forth in section 1201(a)(2) data, where circumvention is for the purpose of and (b)’’); 1201 Study at 61–62 (discussing third regulatory language. Specifically, the noninfringing repair, diagnosis, or modification of party assistance generally, stating although ‘‘it Office welcomes discussion of how the a software-enabled device.’’). The Office notes that cannot affirmatively recommend exemption existing exemption excludes during its study of software-enabled products, the language that is likely to be read to authorize consensus of stakeholders revealed that drawing a unlawful trafficking activity,’’ where appropriate, 124 1201 Study at 54. legislative distinction for ‘‘software-enabled the Office will avoid recommending ‘‘unduly 125 devices’’ would be unworkable in practice. U.S. narrow definitions of exemption beneficiaries’’ in Id. at 53–56. Copyright Office, Software-Enabled Consumer the context of 1201 rulemaking). 126 MADE Class 8 Pet. at 2. Products at 10 (2016), https://www.copyright.gov/ 122 iFixit Class 7 Pet. at 2. 127 2015 Recommendation at 350. policy/software/software-full-report.pdf. 123 Auto Care & CTA Class 7 Pet. at 3. 128 Id. at 351.
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‘‘preservationists affiliated with archival monitoring systems (codified at 37 CFR exemption require that the security institutions,’’ and evidence concerning 201.40(b)(7)).132 research be conducted in a controlled whether an expanded exemption would Two petitions propose removing the setting to avoid harm to the public.136 impact the market for video games 1. by specific security research categories The Office seeks comment on whether allowing users of unlawfully acquired listed under section 201.40(b)(7)(i)(A)– an expanded exemption for security video games to similarly bypass server (C), as well as the following limitations: research should be adopted, including checks, 2. by contributing to the 1. The ‘‘lawfully acquired device or discussion of the proposed regulatory circumvention of client-server protocols machine’’ limitation; 2. the ‘‘solely’’ language, contrasted with the current for nonabandoned video games, or 3. by limitation (i.e., ‘‘solely for the purpose temporary and permanent exemptions impairing the market for older video of good-faith security research’’); 3. the for this activity. games or for licensed services or ‘‘not violate any applicable law, Proposed Class 11: Computer products facilitating the backward including without limitation the Programs—Avionics compatibility of video games. Computer Fraud and Abuse Act of 1986’’ limitation; 4. the ‘‘carried out in This proposed class would allow Proposed Class 9: Computer Programs— a controlled environment designed to circumvention of TPMs to access data Software Preservation avoid any harm to individuals or the output by electronic systems used on The proposed class would allow public’’ limitation; and 5. the aircraft, artificial satellites, and circumvention of TPMs ‘‘on lawfully requirement that ‘‘information derived spacecraft; such systems are referred to acquired software’’ by ‘‘libraries, from the activity . . . is not used or as ‘‘avionics.’’ Specifically, Air archives, museums, and other cultural maintained in a manner that facilitates Informatics LLC (‘‘AI’’) proposed an heritage institutions’’ ‘‘for the purposes copyright infringement.’’ 133 Another exemption to circumvent computer of preserving software and software- petition by Professor Matthew Green programs protecting ‘‘access to aircraft dependent materials.’’ 129 proposes adoption of the regulatory flight, operations, maintenance and Unlike many of the other classes, this language recommended by NTIA in the security data captured by computer proposal represents an entirely new last rulemaking, with the further programs or firmware.’’ 137 AI asserts exemption. The Office seeks comment clarification that the existence of an that access to such data currently on whether this proposed exemption ‘‘End User License Agreement’’ or protected by TPMs would facilitate should be adopted, including specific similar terms does not defeat person’s safety, security, and compliance with examples of the types of noninfringing status as owner of copy of computer Federal Aviation Administration uses that are, or in the next three years, program.134 regulations.138 likely to be adversely affected by the The Office notes that during the 2015 The Office seeks comment on whether prohibition on circumvention, whether triennial rulemaking, the Register this exemption should be adopted, viable alternatives to circumvention determined that the then-existing record including 1. specific examples of the exist, discussion of the types of works did not support adopting an exemption types of noninfringing uses that are, or sought to be accessed, and the specific that encompassed all computer in the next three years, likely to be TPMs implicated by the proposed programs on all systems and devices, adversely affected by a prohibition on exemption. The Office specifically seeks and her recommendation discusses the circumvention; 2. a description of the comment as to whether or how the rationale for the other current specific TPMs sought to be exception in section 108 for libraries limitations.135 For example, the Register circumvented; 3. the methods for and archives is relevant to this noted that there appeared to be circumvention; 4. the environment in exemption.130 The Office further ‘‘universal agreement’’ among which the circumvention would be welcomes any suggested regulatory proponents that testing in ‘‘live’’ accomplished; and 5. whether the language, including eligibility conditions was ‘‘wholly inappropriate,’’ proposed exemption could have requirements,131 a definition of the and so recommended that the negative repercussions with respect to proposed term ‘‘software-dependent safety or security with respect to the materials,’’ and whether the exemption 132 Felten & Halderman Class 10 Pet. at 2–3; works at issue, or otherwise in a manner should be limited to preserving works Green Class 10 Pet. at 2–3; CDT Class 10 Pet. at 2– relevant to section 1201(a)(1)’s statutory that are intended for an institution’s 3. 133 Felten & Halderman Class 10 Pet.; CDT Class factors (for example, by making it easier public collections (e.g., compared to 10 Pet. The same petitioners also recommend for wrongdoers to access sensitive data back-office licensed software). removing the delay in the effective date of the or databases). exemption adopted in 2015; however, as addressed Proposed Class 10: Computer above, the Office notes that it has already Proposed Class 12: Computer Programs—Security Research concluded that removal of a delayed effective date Programs—3D Printing would be appropriate as part of the request to renew The Office received three petitions to this petition. This proposed class would expand expand the exemption for good-faith 134 Green Class 10 Pet. at 2. Specifically, NTIA the current exemption for computer security research of computer programs recommended the following language: ‘‘Computer programs that operate 3D printers that operate devices and machines programs, in the form of firmware or software, (codified at 37 CFR 201.40(b)(9)) to primarily designed for use by individual regardless of the device on which they are run, when circumvention is initiated by the owner of the allow use of non-manufacturer- consumers (including voting machines), copy of the computer program or with the approved feedstock in the printers, motorized land vehicles, or medical permission of the owner of the copy of the regardless of whether the 3D printers devices designed for implantation in computer program, in order to conduct good faith produce goods or materials for use in patients and corresponding personal security research. This exemption does not obviate the need to comply with other applicable laws and commerce the physical production of regulations.’’ Letter from Lawrence E. Strickling, which is subject to legal or regulatory 129 The Software Preservation Network (‘‘SPN’’) & Assistant Sec’y for Commc’ns & Info., Nat’l oversight, or where the circumvention is LCA Class 9 Pet. at 2. Telecomms. & Info. Admin., U.S. Dep’t of otherwise unlawful. Specifically, the 130 See, e.g., 17 U.S.C. 108 (c), (h). Commerce, to Maria A. Pallante, Register of 131 See, e.g., U.S. Copyright Office, Section 108 of Copyrights and Dir., U.S. Copyright Office, at 89 Title 17 at 17–22 (2016), https://www.copyright.gov/ (Sept. 18, 2015), http://www.copyright.gov/1201/ 136 Id. at 318. policy/section108/discussion-document.pdf; 37 2015/2015_NTIA_Letter.pdf. 137 AI Class 11 Pet. at 2. CFR 201.40(b)(8)(iii)(D). 135 2015 Recommendation at 317–18. 138 Id. at 2–3.
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petition proposes eliminating the responses, the Office will post the record to ensure the greatest possible following limitation in the current questions and responses on the Office’s transparency. exemption: ‘‘that the exemption shall Web site as part of the public record. Dated: October 19, 2017. not extend to any computer program on Sarang V. Damle, a 3D printer that produces goods or C. Ex-Parte Communication General Counsel and Associate Register of materials for use in commerce the In its 1201 Study, the Office noted Copyrights. physical production of which is subject that, in response to stakeholder to legal or regulatory oversight or a [FR Doc. 2017–23038 Filed 10–25–17; 8:45 am] requests, it would consider in this BILLING CODE 1410–30–P related certification process, or where rulemaking whether to utilize informal the circumvention is otherwise meetings to discuss proposed regulatory unlawful.’’ 139 language or address discrete issues prior ENVIRONMENTAL PROTECTION The Office seeks comment on whether to issuing a recommendation, including this expanded exemption for 3D AGENCY by establishing guidelines for ex parte printing should be adopted. communications.140 In the past, the 40 CFR Part 62 IV. Future Phases of the Seventh Office’s communications with [EPA–R03–OAR–2017–0509; FRL–9969–91– Triennial Rulemaking participants about the ongoing triennial Region 3] As in prior rulemakings, after receipt rulemakings have not included of written comments, the Office will discussions about the substance of the Approval and Promulgation of State continue to solicit public engagement to proceeding apart from the noticed Air Quality Plans for Designated create a comprehensive record. phases of written comments and public Facilities and Pollutants; City of Described below are the future phases of hearings (although the Office has Philadelphia; Control of Emissions the administrative process that will be provided procedural guidance to From Existing Sewage Sludge employed for this rulemaking, so that participants, and has held discussions Incineration Units with other federal agencies, such as parties may use this information in their AGENCY: Environmental Protection planning. NTIA, to discuss matters within their subject matter expertise). The Office has Agency (EPA). A. Public Hearings determined that further informal ACTION: Proposed rule. The Copyright Office intends to hold communications with non- SUMMARY: The Environmental Protection public hearings following the last round governmental participants might be Agency (EPA) is proposing to notify the of written comments. The hearings will beneficial in limited circumstances public that it has received a negative be conducted in Washington DC during where the Office seeks specific declaration for the City of Philadelphia the week of April 9, 2018 and in information or follow-up regarding the Air Management Services (Philadelphia California with a date and location to be public record, such as to discuss AMS) for sewage sludge incineration determined. A separate notice providing nuances of proposed regulatory (SSI) units. This negative declaration details about the hearings and how to language. However, any such certifies that SSI units subject to the participate will be published in the communication will be limited to the requirements of sections 111(d) and 129 Federal Register at a later date. The post-hearing phase of the rulemaking. of the Clean Air Act (CAA) do not exist Office will identify specific items of The primary means to communicate within the City of Philadelphia in the inquiry to be addressed during the views in the course of the rulemaking Commonwealth of Pennsylvania. EPA is hearings. The hearings in Washington will continue to be through the accepting the negative declaration in will be live streamed online, and the submission of written comments or accordance with the requirements of the Office hopes to be able to offer the same participation in the public roundtables. CAA. In the Final Rules section of this for the California hearings. In other words, this communication will issue of the Federal Register, EPA is supplement, not substitute for, the pre- B. Post-Hearing Questions accepting the negative declaration as a existing record. While exact guidelines direct final rule without prior proposal As with previous rulemakings, governing ex parte communications because the Agency views this as a following the hearings, the Copyright with the Office regarding the triennial noncontroversial submittal and Office may request additional rulemaking will be issued at a later date, anticipates no adverse comments. If no information with respect to particular they will be similar to those followed by adverse comments are received in classes from rulemaking participants. other agencies such as the Consumer response to this action, no further The Office may rely on this process in Financial Protection Bureau or Federal activity is contemplated. If EPA receives cases where it would be useful for 141 Communications Commission. For adverse comments, the direct final rule participants to supply missing example, the participating party or will be withdrawn and all public information for the record or otherwise parties will be responsible for comments received will be addressed in resolve issues that the Office believes submitting a list of attendees and a subsequent final rule based on this are material to particular exemptions. written summary of any oral proposed rule. EPA will not institute a Such requests for information will take communication to the Office, which second comment period. Any parties the form of a letter from the Copyright will be made publicly available on the interested in commenting on this action Office and will be addressed to Office’s Web site or regulations.gov. In should do so at this time. individual parties involved in the sum, while the Office is establishing the DATES: Comments must be received in proposal as to which more information option of informal meetings in response writing by November 27, 2017. is sought. While responding to such a to stakeholder demand, it will require request will be voluntary, any response that all such communications be on the ADDRESSES: Submit your comments, will need to be supplied by a specified identified by Docket ID No. EPA–R03– OAR–2017–0509 at https:// deadline. After the receipt of all 140 1201 Study at 150–51. 141 The Office expects to continue to hold www.regulations.gov, or via email to 139 Weinberg Class 12 Pet. at 2. Compare 2015 informal intra-governmental communications, [email protected]. For comments Recommendation at 376–77. which would not be included in such guidelines. submitted at Regulations.gov, follow the
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online instructions for submitting ACTION: Proposed rule. South Clinton Ave. Rochester, NY comments. Once submitted, comments 14620; telephone number: (202) 554– cannot be edited or removed from SUMMARY: As required under section 1404; email address: TSCA-Hotline@ Regulations.gov. For either manner of 8(b)(10)(D) of the Toxic Substances epa.gov. Control Act (TSCA), EPA is proposing submission, the EPA may publish any SUPPLEMENTARY INFORMATION: comment received to its public docket. reporting requirements for applicable Do not submit electronically any persons to provide information to assist I. Executive Summary in the preparation of an ‘‘inventory of information you consider to be A. Does this action apply to me? confidential business information (CBI) mercury supply, use, and trade in the or other information whose disclosure is United States,’’ where ‘‘mercury’’ is You may be potentially affected by restricted by statute. Multimedia defined as ‘‘elemental mercury’’ and ‘‘a this action if you manufacture submissions (audio, video, etc.) must be mercury compound.’’ The requirements (including import) mercury or mercury- accompanied by a written comment. would be applicable to any person who added products, or if you otherwise The written comment is considered the manufactures (including imports) intentionally use mercury in a official comment and should include mercury or mercury-added products, or manufacturing process. The following discussion of all points you wish to otherwise intentionally uses mercury in list of North American Industrial make. EPA will generally not consider a manufacturing process. Based on the Classification System (NAICS) codes is comments or comment contents located inventory of information collected, the not intended to be exhaustive, but rather outside of the primary submission (i.e. Agency is directed to ‘‘identify any provides a guide to help readers on the web, cloud, or other file sharing manufacturing processes or products determine whether this document system). For additional submission that intentionally add mercury; and . . . applies to them. Potentially affected methods, please contact the person recommend actions, including proposed entities may include: • identified in the FOR FURTHER revisions of Federal law or regulations, Gold ore mining (NAICS code INFORMATION CONTACT section. For the to achieve further reductions in mercury 212221) • full EPA public comment policy, use.’’ At this time, EPA is not making Lead ore and zinc ore mining such identifications or (NAICS code 212231) information about CBI or multimedia • submissions, and general guidance on recommendations. All other metal ore mining (NAICS code 212299) making effective comments, please visit DATES: Comments must be received on • https://www2.epa.gov/dockets/ or before December 26, 2017. Asphalt shingle and coating materials manufacturing (NAICS code commenting-epa-dockets. ADDRESSES: Submit your comments, 324122) FOR FURTHER INFORMATION CONTACT: identified by docket identification (ID) • Synthetic dye and pigment Michael Gordon, (215) 814–2039, or by number EPA–HQ–OPPT–2017–0421, by manufacturing (NAICS code 325130) email at [email protected]. one of the following methods: • • Other basic inorganic chemical SUPPLEMENTARY INFORMATION: For Federal eRulemaking Portal: http:// manufacturing (NAICS code 325180) further information regarding the www.regulations.gov. Follow the online • All other basic organic chemical negative declaration submitted by instructions for submitting comments. manufacturing (NAICS code 325199) Philadelphia AMS for SSI units, please Do not submit electronically any • Plastics material and resin see the information provided in the information you consider to be manufacturing (NAICS code 325211) technical support document in the Confidential Business Information (CBI) • Pesticide and other agricultural rulemaking docket and in the direct or other information whose disclosure is chemical manufacturing (NAICS code final action, with the same title, that is restricted by statute. 325320) • located in the ‘‘Rules and Regulations’’ Mail: Document Control Office • Medicinal and botanical section of this issue of the Federal (7407M), Office of Pollution Prevention manufacturing (NAICS code 325411) Register. The negative declaration letter and Toxics (OPPT), Environmental • Pharmaceutical preparation submitted by Philadelphia AMS and Protection Agency, 1200 Pennsylvania manufacturing (NAICS code 325412) technical support document in support Ave. NW., Washington, DC 20460–0001. • Biological product (except • of this action are also available online Hand Delivery: To make special diagnostic) manufacturing (NAICS code at www.regulations.gov. arrangements for hand delivery or 325414) delivery of boxed information, please • Dated: October 11, 2017. Paint and coating manufacturing follow the instructions at http:// (NAICS code 325510) Cecil Rodrigues, www.epa.gov/dockets/contacts.html. • Adhesive manufacturing (NAICS Acting Regional Administrator, Region III. Additional instructions on code 325520) [FR Doc. 2017–23231 Filed 10–25–17; 8:45 am] commenting or visiting the docket, • Custom compounding of purchased BILLING CODE 6560–50–P along with more information about resins (NAICS code 325991) dockets generally, is available at http:// • Photographic film, paper, plate, and www.epa.gov/dockets. chemical manufacturing (NAICS code ENVIRONMENTAL PROTECTION FOR FURTHER INFORMATION CONTACT: 325992) AGENCY For technical information contact: • All other miscellaneous chemical Thomas Groeneveld, National Program 40 CFR Part 713 product and preparation manufacturing Chemicals Division, Office of Pollution (NAICS code 325998) [EPA–HQ–OPPT–2017–0421; FRL–9970–07] Prevention and Toxics, Environmental • Unlaminated plastics film and sheet Protection Agency, 1200 Pennsylvania (except packaging) manufacturing RIN 2070–AK22 Ave. NW., Washington, DC 20460–0001; (NAICS code 326113) • Mercury; Reporting Requirements for telephone number: (202) 566–1188; Unlaminated plastics profile shape the TSCA Mercury Inventory email address: groeneveld.thomas@ manufacturing (NAICS code 326121) epa.gov. • Urethane and other foam product AGENCY: Environmental Protection For general information contact: The (except polystyrene) manufacturing Agency (EPA). TSCA-Hotline, ABVI-Goodwill, 422 (NAICS code 326150)
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• All other plastics product commercial, and appliance use (NAICS • Game, toy, and children’s vehicle manufacturing (NAICS code 326199) code 334512) manufacturing (NAICS code 339932) • Tire manufacturing (NAICS code • Instruments and related products • Sign manufacturing (NAICS code 326211) manufacturing for measuring, 339950) • All other rubber product displaying, and controlling industrial • Other chemical and allied products manufacturing (NAICS code 326299) process variables (NAICS code 334513) merchant wholesalers (NAICS code • Iron and steel mills and ferroalloy • Totalizing fluid meter and counting 424690) manufacturing (NAICS code 331110) device manufacturing (NAICS code • Research and development in the • Rolled steel shape manufacturing 334514) physical, engineering, and life sciences (NAICS code 331221) • Instrument manufacturing for (except biotechnology) (NAICS code • Alumina refining and primary measuring and testing electricity and 541712) • aluminum production (NAICS code electrical signals (NAICS code 334515) Hazardous waste treatment and 331313) • Analytical laboratory instrument disposal (NAICS code 562211) • • Secondary smelting and alloying of manufacturing (NAICS code 334516) Other nonhazardous waste aluminum (NAICS code 331314) • Watch, clock, and part treatment and disposal (NAICS code • Nonferrous metal (except 562219) manufacturing (NAICS code 334518) • aluminum) smelting and refining • Other measuring and controlling Materials recovery facilities (NAICS code 562920) (NAICS code 331410) device manufacturing (NAICS code • • Secondary smelting, refining, and 334519) National security (NAICS code alloying of nonferrous metal (except • Electric lamp bulb and part 928110) copper and aluminum) (NAICS code manufacturing (NAICS code 335110) B. What action is the Agency taking? 331492) • Commercial, industrial, and EPA is issuing a proposed rule under • Iron foundries (NAICS code institutional electric lighting fixture TSCA section 8(b)(10) to require 331511) manufacturing (NAICS code 335122) reporting to assist in the preparation of • Steel foundries (except investment) • Other lighting equipment ‘‘an inventory of mercury supply, use, (NAICS code 331513) manufacturing (NAICS code 335129) • Fabricated structural metal • Electric house wares and household and trade in the United States,’’ where manufacturing (NAICS code 332312) fan manufacturing (NAICS code 335211) ‘‘mercury’’ is defined as ‘‘elemental • Industrial valve manufacturing • Household vacuum cleaner mercury’’ and ‘‘a mercury compound.’’ (NAICS code 332911) manufacturing (NAICS code 335212) Hereinafter ‘‘mercury’’ will refer to both • Ammunition except small arms • Household cooking appliance elemental mercury and mercury manufacturing (NAICS code 332993) manufacturing (NAICS code 335221) compounds collectively, except where • Small arms, ordnance, and • Household refrigerator and home separately identified. This proposed ordnance accessories manufacturing freezer manufacturing (NAICS code rule would require reporting from any (NAICS code 332994) 335222) person who manufactures (including • All other miscellaneous fabricated • Household laundry equipment imports) mercury or mercury-added metal product manufacturing (NAICS manufacturing (NAICS code 335224) products, or otherwise intentionally code 332999) • Other major household appliance uses mercury in a manufacturing • Food product machinery manufacturing (NAICS code 335228) process. EPA published its initial manufacturing (NAICS code 333294) • Switchgear and switchboard inventory report in the Federal Register • Office machinery manufacturing apparatus manufacturing (NAICS code on March 29, 2017 (Ref. 1), which noted (NAICS code 333313) 335313) data gaps and limitations encountered • Other commercial and service • Relay and industrial control by the Agency in its historic reliance on industry machinery manufacturing manufacturing (NAICS code 335314) publicly available data on the mercury (NAICS code 333319) • Primary battery manufacturing market in the United States. As stated in • Heating equipment (except warm (NAICS code 335912) the initial inventory report, ‘‘[f]uture air furnaces) manufacturing (NAICS • Current-carrying wiring device triennial inventories of mercury supply, code 333414) manufacturing (NAICS code 335931) use, and trade are expected to include • Air-conditioning and warm air • All other miscellaneous electrical data collected directly from persons heating equipment and commercial and equipment and component who manufacture or import mercury or industrial refrigeration equipment manufacturing (NAICS code 335999) mercury-added products, or otherwise manufacturing (NAICS code 333415) • Light truck and utility vehicle intentionally use mercury in a • Pump and pumping equipment manufacturing (NAICS code 336112) manufacturing process’’ (Ref. 1). These manufacturing (NAICS code 333911) • Heavy duty truck manufacturing proposed reporting requirements would • Bare printed circuit board (NAICS code 336120) help the Agency narrow such data gaps, manufacturing (NAICS code 334412) • Motor home manufacturing (NAICS as well as to prepare subsequent, • Semiconductor and related device code 336213) triennial publications of the inventory, manufacturing (NAICS code 334413) • Travel trailer and camper and to execute the mandate to ‘‘identify • Other electronic component manufacturing (NAICS code 336214) any manufacturing processes or manufacturing (NAICS code 334419) • Other aircraft parts and auxiliary products that intentionally add • Electromedical and equipment manufacturing (NAICS code mercury; and . . . recommend actions, electrotherapeutic apparatus 336413) including proposed revisions of Federal manufacturing (NAICS code 334510) • Boat building (NAICS code 336612) law or regulations, to achieve further • Search, detection, navigation, • Motorcycles and parts reductions in mercury use’’ (15 U.S.C. guidance, aeronautical, and nautical manufacturing (NAICS code 336991) 2607(b)(10)(C)). system and instrument manufacturing • Surgical and medical instrument In addition, this information could be (NAICS code 334511) manufacturing (NAICS code 339112) used by the U.S. Government to assist • Automatic environmental control • Costume jewelry and novelty in its national reporting regarding its manufacturing for residential, manufacturing (NAICS code 339914) implementation of the Minamata
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Convention on Mercury (Minamata management of mercury-containing manufactures mercury or mercury- Convention), to which the United States waste, unless that person manufactures added products or otherwise is a Party (Ref. 2). The Minamata or recovers mercury in the management intentionally uses mercury in a Convention is an international of that waste with the intent to use the manufacturing process to assist in the environmental agreement that has as its recovered mercury or store it for use. In preparation of the inventory (15 U.S.C. objective the protection of human health addition, persons engaged in trade (e.g., 2607(b)(10)(D)). However, persons and the environment from brokering, selling wholesale, shipping, ‘‘engaged in the generation, handling, or anthropogenic emissions and releases of warehousing, repackaging, or retail management of mercury-containing elemental mercury and mercury sale), but who do not first manufacture waste, unless that person manufactures compounds. Article 21 of the mercury or mercury-added products, or or recovers mercury in the management Convention requires Parties to include otherwise intentionally use mercury in of that waste’’ are not required to report in their national reports, among other a manufacturing process, are not to the mercury inventory (15 U.S.C. information, information demonstrating required to report. Finally, in an effort 2607(b)(10)(D)(iii)). that the Party has met the requirements to avoid reporting that is unnecessary or In addition, the Paperwork Reduction of Article 3 on Mercury Supply Sources duplicative, the Agency is proposing Act (PRA) requires Federal agencies to and Trade and of Article 5 on certain exemptions for persons who manage information resources to reduce Manufacturing Processes in Which already report for mercury and mercury- information collection burdens on the Mercury or Mercury Compounds Are added products to the TSCA section 8(a) public; increase program efficiency and Used. As proposed, the reporting Chemical Data Reporting (CDR) rule and effectiveness; and improve the integrity, requirements of the proposed rule will the Interstate Mercury Education and quality, and utility of information to all further enhance the understanding of Reduction Clearinghouse (IMERC). users within and outside an agency, the use of mercury in the United States, In addition to topics where EPA notes including capabilities for ensuring in particular with respect to mercury that we are seeking specific comment, dissemination of public information, supply sources and trade, mercury- the Agency also encourages comment on public access to Federal Government added products, and manufacturing all aspects of this proposal. information, and protections for privacy and security (44 U.S.C. 3506). processes, thus providing a body of C. Why is the Agency taking this action? information that will assist the United Section 2 of TSCA expresses the States in its implementation of the EPA is issuing a proposed rule under intent of Congress that EPA carry out reporting requirements of the Minamata TSCA section 8(b)(10) to require TSCA in a reasonable and prudent Convention. EPA intends to use the reporting to assist in the preparation of manner, and in consideration of the collected information to implement the statutorily-required inventory of impacts that any action taken under TSCA and shape the Agency’s efforts to mercury supply, use, and trade in the TSCA may have on the environment, reduce the use of mercury in commerce. United States. This proposed rule would the economy, and society (15 U.S.C. In so doing, the Agency would conduct require reporting from any person who 2601). EPA is proposing to manage and a timely evaluation and refinement of manufactures (including imports) leverage its information resources, these reporting requirements so that mercury or mercury-added products, or including information technology, to they are efficient and non-duplicative otherwise intentionally uses mercury in require the use of electronic reporting in for reporters. a manufacturing process. After the order to implement the mercury EPA is proposing that supply, use, publication of its initial inventory report inventory reporting requirements of and trade of mercury include reporting in the Federal Register on March 29, TSCA section 8(b)(10)(D) in a reasonable requirements for activities comparable 2017 (Ref. 1), the Agency is proposing and prudent manner. this rule to support future, triennial to established TSCA terms: E. What are the estimated incremental publications of the mercury inventory. Manufacture, import, distribution in impacts of the proposed rule? commerce, storage, and export. The In administering this mercury reporting requirements also would inventory, the Agency would ‘‘identify EPA has prepared an economic apply to otherwise intentional use of any manufacturing processes or analysis of the potential impacts mercury in a manufacturing process. products that intentionally add associated with this rulemaking (Ref. 3). Persons who manufacture (including mercury; and . . . recommend actions, The chief benefit of the proposed rule is import) mercury or mercury-added including proposed revisions of Federal the collection of detailed data on products, or otherwise intentionally use law or regulations, to achieve further mercury, which will serve as a basis to mercury in a manufacturing process, reductions in mercury use’’ (15 U.S.C. recommend actions to further reduce would report amounts of mercury in 2607(b)(10)(C)). mercury use in the United States, as pounds (lbs.) used in such activities required at TSCA section 8(b)(10)(C). D. What is the Agency’s authority for during a designated reporting year. Another benefit is the use of taking this action? Reporters also would identify specific information collected under the mercury compounds, mercury-added EPA is issuing this proposed rule proposed rule to help the United States products, manufacturing processes, and pursuant to TSCA section 8(b)(10)(D) to implement its obligations under the how mercury is used in manufacturing implement the direction at TSCA Minamata Convention. There are no processes, as applicable, from pre- section 8(b)(10)(B) that ‘‘[n]ot later than quantified benefits for the proposed selected lists. For certain activities, April 1, 2017, and every 3 years rule. The statutory mandate specifically reporters would provide additional, thereafter, the Administrator shall carry calls for and authorizes a rule to support contextual data (e.g., country(ies) of out and publish in the Federal Register an inventory of mercury supply, use, origin/destination for imports/exports an inventory of mercury supply, use, and trade in the United States, in order and NAICS codes for mercury or and trade in the United States’’ (15 to identify any manufacturing processes mercury-added products distributed in U.S.C. 2607(b)(10)(B)). TSCA section or products that intentionally add commerce). 8(b)(10)(D) requires EPA to promulgate mercury and recommend actions to The proposed reporting requirements a final rule by June 22, 2018 that achieve further reductions in mercury would not apply to persons engaged in establishes reporting requirements use. As described in the Agency’s the generation, handling, or applicable to any person who economic analysis, unquantified
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benefits include providing increased the extent that the information gathered result from a reduction in exposure. information on mercury and assisting in through this rule is used to reduce EPA seeks public comment on all the reduction of mercury use (Ref. 3). To mercury use, benefits to society will aspects of the economic analysis.
TABLE 1—SUMMARY OF COSTS AND BENEFITS OF PROPOSAL
Category Description
Benefits ...... The proposed rule would provide information on mercury and mercury-added products to which the Agency (and the public) does not currently have access. To the extent that the information gath- ered through this proposed rule is used to reduce mercury use, benefits to society will result from a reduction in risk. Costs ...... Estimated industry costs and burden total $5.96 million and 74,000 hours (for up to 750 respondents) for the first year of reporting, with an individual estimate of $7,900 and 99 hours. For future triennial reporting cycles, industry costs and burden would be $4.37 million and 54,300 hours, with an indi- vidual estimate of $5,800 and 72 hours. These estimates include compliance determination, rule fa- miliarization, CBI substantiation, electronic reporting, and recordkeeping, in addition to completing reporting requirements. Effects on State, Local, and Tribal Gov- Government entities are not expected to be subject to the rule’s requirements, which apply to entities ernments. that manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process. The proposed rule does not have a significant intergov- ernmental mandate, significant or unique effect on small governments, or have Federalism implica- tions. Small Entity Impacts ...... The proposed rule would impact 211 companies that meet the U.S. Small Business Administration (SBA) definitions for their respective NAICS classifications: 4 small entities (1.85%) are expected to incur impacts of 1% percent or greater, and 1 of the small entities assessed is expected to incur impacts of greater than 3%. Furthermore, even if the entities whose status is ‘‘undetermined’’ were assumed to be impacted small entities, this would result in only 9 entities (4.17%). Therefore, EPA certifies that this action will not have a significant economic impact on a substantial number of small entities. Environmental Justice and Protection of The information obtained from the reporting required by this proposed rule would be used to inform Children. the Agency’s decision-making process regarding chemicals to which minority or low-income popu- lations or children may be disproportionately exposed. This information would also assist the Agen- cy and others in determining whether elemental mercury and mercury compounds addressed in this proposed rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.
F. What should I consider as I prepare crust and can be found in air, water, of coal and use of elemental mercury in my comments for EPA? fish, and other biota. Mercury exists in artisanal gold mining (Ref. 5). Emitted three forms: Elemental, organic elemental mercury can be transported in 1. Submitting CBI. Do not submit this compounds, and inorganic compounds. the atmosphere on local, regional, and information to EPA through global scales as it cycles through air, regulations.gov or email. Clearly mark Elemental mercury (Chemical land, and water (Ref. 6). Some of the the part or all of the information that Abstracts Service Registry Number emitted elemental mercury following you claim to be CBI. For CBI (CASRN) 7439–97–6) is a shiny, silver- deposition and transformation into information in a disk or CD–ROM that white metal that is liquid at room divalent mercury can be biotransformed you mail to EPA, mark the outside of the temperature. Mercury compounds are into methylmercury (Ref. 6). disk or CD–ROM as CBI and then formed when elemental mercury reacts identify electronically within the disk or with another substance, either in nature Methylmercury is a persistent and CD–ROM the specific information that or intentionally by humans. Organic bioaccumulative neurotoxicant. is claimed as CBI. In addition to one mercury compounds are formed in the Exposure to methylmercury most complete version of the comment that environment when mercury combines commonly occurs when people eat includes information claimed as CBI, a with carbon. Inorganic mercury kinds of fish and shellfish that have copy of the comment that does not compounds take the form of mercury high levels of methylmercury in their contain the information claimed as CBI salts. EPA’s TSCA Chemical Substance tissues (Ref. 7). Almost all people have must be submitted for inclusion in the Inventory lists 69 mercury compounds at least small amounts of public docket. Information so marked (Ref. 4). methylmercury in their bodies, will not be disclosed except in In the United States, elemental reflecting the widespread presence of accordance with procedures set forth in mercury and mercury compounds are methylmercury in the environment (Ref. 40 CFR part 2. used in the manufacture of mercury- 7). People exposed to high levels of added products and certain methylmercury may experience adverse 2. Tips for preparing your comments. manufacturing processes. The typical health effects (Ref. 7). Generally, the When preparing and submitting your lifecycle of products includes subtlest indicators of methylmercury comments, see the commenting tips at manufacture, distribution in commerce toxicity are neurological changes (Ref. http://www.epa.gov/dockets/ (including transport and storage), use, 7). Neurotoxic effects at comparatively comments.html. and waste management (landfilling or low doses include subtle decrements in II. Background recycling). At any point in the product motor skills and sensory ability, while lifecycle, there is potential for mercury extremely high exposures can cause A. Background on Mercury to be released. Globally, the major tremors, inability to walk, convulsions, Mercury is a naturally occurring anthropogenic sources of released and death (Ref. 7). Exposure to mercury element that originates in the earth’s elemental mercury are the combustion can also cause adverse ecological effects
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in plants, birds, fish, and mammals (Ref. mercury-added products sold in the United States. For example, importation 6). United States. In 1980, the United States or domestic manufacture of mercury- used more than 1,800 metric tons of added products may or may not be B. Recent Amendments to TSCA mercury in mercury-added products reflected in data reported as domestic The Frank R. Lautenberg Chemical annually (Ref. 8). As described in the sale of mercury-added products. EPA is Safety for the 21st Century Act initial inventory conducted by EPA in committed to further addressing such (Lautenberg Act) (Pub. L. 114–182, 130 2017, by 2013, only approximately 40 data gaps and considers the national Stat. 448), enacted on June 22, 2016, metric tons of mercury in products were mercury inventory mandated by implemented reforms to TSCA. Among sold in the United States (Ref. 1). Many Congress to be an instrumental means to other changes to TSCA, the Lautenberg of these products sold have cost- establish the requisite body of Act amended TSCA section 8(b) to effective, non-mercury substitutes (Ref. information to support achievement of require EPA to establish: (1) An 1). The United States also has traded that goal. inventory of mercury supply, use, and elemental mercury and mercury D. Stakeholder Involvement trade in the United States; and (2) compounds worldwide, although MEBA reporting requirements by rule prohibited the export of elemental In developing the proposed rule, the applicable to any person who mercury as of January 1, 2013 and agency coordinated with the Northeast manufactures mercury or mercury- prohibits the export of certain mercury Waste Management Officials’ added products or otherwise compounds as of January 1, 2020. Association, which administers the intentionally uses mercury in a IMERC database, as directed by TSCA manufacturing process not later than Prior to developing its initial section 8(b)(10)(D)(ii), to avoid June 22, 2018. (15 U.S.C. 2607(b)(10)). inventory, EPA reviewed federal and duplication. Information collected per the proposed state reports and databases, among other III. Summary of Proposed Rule reporting requirements would be used sources, in order to assemble a to periodically update the mercury collection of available information on This proposed rule, when finalized, inventory; identify any manufacturing mercury, mercury-added products, and would provide for the collection of processes or products that intentionally manufacturing processes involving information that allows EPA to add mercury; and recommend actions, mercury (Ref. 1). In reviewing data implement statutory requirements at including proposed revisions of federal obtained, the Agency found that its TSCA section 8(b)(10)(B), which directs law or regulations, to achieve further baseline of data lacked the specificity that ‘‘[n]ot later than April 1, 2017, and reductions in mercury use (15 U.S.C. and level of detail required to develop every 3 years thereafter, the 2607(b)(10)). The Lautenberg Act also a mercury inventory responsive to Administrator shall carry out and added certain mercury compounds to TSCA section 8(b)(10)(D) or to be useful publish in the Federal Register an the TSCA section 12(c) ban on exporting to inform mercury use reduction efforts inventory of mercury supply, use, and of elemental mercury and authorized for both the public and private sectors trade in the United States’’ (15 U.S.C. EPA to ban the export of additional (Ref. 1). For example, in 2015, to 2607(b)(10)(B)). TSCA section mercury compounds by rule (15 U.S.C. develop its understanding of domestic 8(b)(10)(D) directs the Agency to 2611(c)). The Lautenberg Act also mercury supply and trade, the Agency promulgate this reporting rule no later implemented other changes to the collected information on the quantity of than two years after the date of Mercury Export Ban Act of 2008 mercury sold in the United States for enactment of the June 2016 TSCA (MEBA) (Pub. L. 110–414, 122 Stat. the years 2010 and 2013 from five amendments. Based on the inventory, 4341). Additional information on the companies identified as the primary the Agency is directed to ‘‘identify any Lautenberg Act is available on EPA’s recyclers and distributors of mercury in manufacturing processes or products Web site at https://www.epa.gov/ the United States (Ref. 9). Comparing that intentionally add mercury; and . . . assessing-and-managing-chemicals- totals for mercury sold in products and recommend actions, including proposed under-tsca/frank-r-lautenberg-chemical- the amount of bulk mercury sold in the revisions of Federal law or regulations, safety-21st-century-act. United States in 2013 revealed a to achieve further reductions in mercury significant data gap of approximately 26 use.’’ At this time, EPA is not making C. Trends in Mercury Supply, Use, and metric tons. IMERC data showed such identifications or Trade in the United States approximately 40 metric tons of recommendations. EPA’s proposal for Humans have mined, refined, and mercury in mercury-added products fulfilling specific statutory provisions used mercury for a wide variety of sold in the United States in 2013. The and terms are set forth by topic as purposes over thousands of years. In the information collected by the Agency for follows. United States, mercury was mined until bulk elemental mercury manufactured 1991, but today is produced only as a and processed in the United States in A. Definition of Mercury byproduct of metals mining or by the same year was approximately 66 TSCA section 8(b)(10)(A) states recovering mercury from waste (Ref. 8). metric tons. In this instance, EPA ‘‘notwithstanding [TSCA] section In recent decades, mercury served as a determined that mercury may be used in 3(2)(B), the term ‘mercury’ means . . . catalyst in the chlor-alkali industry and manufacturing processes, including as a elemental mercury; and . . . a mercury in a variety of industrial, commercial, reactant or formulation component, compound’’ (15 U.S.C. 2607(b)(10)(A)). and consumer products (Ref. 8). Due to which may not be reflected in the As such, the definition for mercury at its toxicity and replacement by new amount of mercury reported as sold in TSCA section 8(b)(10)(A) supersedes the technologies, many uses of mercury products. An additional data gap exclusions for ‘‘chemical substances’’ have been discontinued in the United identified was the amount of mercury in described in TSCA section 3(2)(B) that States, and the overall quantity used has exported mercury-added products. The would otherwise apply to mercury, fallen dramatically in recent decades. Agency is also seeking to be able to mercury-added products, or otherwise For example, over the past three differentiate between the amount of intentional uses of mercury in decades there has been a strong mercury in imported mercury-added manufacturing processes. For example, downward trend of more than 97 products and the amount in mercury- any ‘‘drug, cosmetic, or device’’ as percent in the use of mercury in added products manufactured in the described in TSCA section 3(2)(B)(vi),
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should such items contain mercury, mercury and mercury compounds, or a mercury compound is reacted with would not be excluded from reporting elemental mercury be limited to another chemical substance. Examples under the proposed rule. elemental mercury (CASRN 7439–97–6) of mercury compounds from the TSCA For purposes of the proposed rule, the and mercury compounds be inclusive of Chemical Substance Inventory are listed Agency proposes that where EPA all instances where elemental mercury in Table 2. distinguishes between elemental
TABLE 2—LIST OF MERCURY COMPOUNDS
Chemical Abstracts Registry No. Mercury compound
10045–94–0 ...... Nitric acid, mercury(2+) salt (2:1). 100–57–2 ...... Mercury, hydroxyphenyl-. 10112–91–1 ...... Mercury chloride (Hg2Cl2). 10124–48–8 ...... Mercury amide chloride (Hg(NH2)Cl). 103–27–5 ...... Mercury, phenyl(propanoato-.kappa.O.)-. 10415–75–5 ...... Nitric acid, mercury(1+) salt (1:1). 104–60–9 ...... Mercury, (9-octadecenoato-.kappa.O)phenyl-. 1191–80–6 ...... 9-Octadecenoic acid (9Z)-, mercury(2+) salt (2:1). 12068–90–5 ...... Mercury telluride (HgTe). 13170–76–8 ...... Hexanoic acid, 2-ethyl-, mercury(2+) salt (2:1). 13302–00–6 ...... Mercury, (2-ethylhexanoato-.kappa.O)phenyl-. 1335–31–5 ...... Mercury cyanide oxide (Hg2(CN)2O). 1344–48–5 ...... Mercury sulfide (HgS). 1345–09–1 ...... Cadmium mercury sulfide. 13876–85–2 ...... Mercurate(2-), tetraiodo-, copper(1+) (1:2), (T–4)-. 138–85–2 ...... Mercurate(1-), (4-carboxylatophenyl)hydroxy-, sodium (1:1). 141–51–5 ...... Mercury, iodo(iodomethyl)-. 14783–59–6 ...... Mercury, bis[(2-phenyldiazenecarbothioic acid-.kappa.S) 2-phenylhydrazidato-.kappa.N2]-, (T–4)-. 15385–58–7 ...... Mercury, dibromodi-, (Hg-Hg). 15785–93–0 ...... Mercury, chloro[4-[(2,4-dinitrophenyl)amino]phenyl]-. 15829–53–5 ...... Mercury oxide (Hg2O). 1600–27–7 ...... Acetic acid, mercury(2+) salt (2:1). 1785–43–9 ...... Mercury, chloro(ethanethiolato)-. 19447–62–2 ...... Mercury, (acetato-.kappa.O)[4-[2-[4-(dimethylamino)phenyl]diazenyl]phenyl]-. 20582–71–2 ...... Mercurate(2-), tetrachloro-, potassium (1:2), (T–4)-. 20601–83–6 ...... Mercury selenide (HgSe). 21908–53–2 ...... Mercury oxide (HgO). 22450–90–4 ...... Mercury(1+), amminephenyl-, acetate (1:1). 24579–90–6 ...... Mercury, chloro(2-hydroxy-5-nitrophenyl)-. 24806–32–4 ...... Mercury, [.mu.-[2-dodecylbutanedioato(2-)-.kappa.O1:.kappa.O4]]diphenyldi-. 26545–49–3 ...... Mercury, (neodecanoato-.kappa.O)phenyl-. 27685–51–4 ...... Cobaltate(2-), tetrakis(thiocyanato-.kappa.N)-, mercury(2+) (1:1), (T–4)-. 29870–72–2 ...... Cadmium mercury telluride ((Cd,Hg)Te). 3294–57–3 ...... Mercury, phenyl(trichloromethyl)-. 33770–60–4 ...... Mercury, [3,6-dichloro-4,5-di(hydroxy-.kappa.O)-3,5-cyclohexadiene-1,2-dionato(2-)]-. 3570–80–7 ...... Mercury, bis(acetato-.kappa.O)[.mu.-(3’,6’-dihydroxy-3-oxospiro[isobenzofuran-1(3H),9’-[9H]xanthene]-2’,7’- diyl)]di-. 537–64–4 ...... Mercury, bis(4-methylphenyl)-. 539–43–5 ...... Mercury, chloro(4-methylphenyl)-. 54–64–8 ...... Mercurate(1-), ethyl[2-(mercapto-.kappa.S)benzoato(2-)-.kappa.O]-, sodium (1:1). 55–68–5 ...... Mercury, (nitrato-.kappa.O)phenyl-. 56724–82–4 ...... Mercury, phenyl[(2-phenyldiazenecarbothioic acid-.kappa.S) 2-phenylhydrazidato-.kappa.N2]-. 587–85–9 ...... Mercury, diphenyl-. 592–04–1 ...... Mercury cyanide (Hg(CN)2). 592–85–8 ...... Thiocyanic acid, mercury(2+) salt (2:1). 593–74–8 ...... Mercury, dimethyl-. 59–85–8 ...... Mercurate(1-), (4-carboxylatophenyl)chloro-, hydrogen. 623–07–4 ...... Mercury, chloro(4-hydroxyphenyl)-. 62–38–4 ...... Mercury, (acetato-.kappa.O)phenyl-. 62638–02–2 ...... Cyclohexanebutanoic acid, mercury(2+) salt (2:1). 627–44–1 ...... Mercury, diethyl-. 6283–24–5 ...... Mercury, (acetato-.kappa.O)(4-aminophenyl)-. 628–86–4 ...... Mercury, bis(fulminato-.kappa.C)-. 629–35–6 ...... Mercury, dibutyl-. 63325–16–6 ...... Mercurate(2-), tetraiodo-, (T–4)-, hydrogen, compd. with 5-iodo-2-pyridinamine (1:2:2). 63468–53–1 ...... Mercury, (acetato-.kappa.O)(2-hydroxy-5-nitrophenyl)-. 63549–47–3 ...... Mercury, bis(acetato-.kappa.O)(benzenamine)-. 68201–97–8 ...... Mercury, (acetato-.kappa.O)diamminephenyl-, (T–4)-. 72379–35–2 ...... Mercurate(1-), triiodo-, hydrogen, compd. with 3-methyl-2(3H)-benzothiazolimine (1:1:1). 7439–97–6 ...... Mercury. 7487–94–7 ...... Mercury chloride (HgCl2). 7546–30–7 ...... Mercury chloride (HgCl). 7616–83–3 ...... Perchloric acid, mercury(2+) salt (2:1). 7774–29–0 ...... Mercury iodide (HgI2). 7783–33–7 ...... Mercurate(2-), tetraiodo-, potassium (1:2), (T–4)-.
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TABLE 2—LIST OF MERCURY COMPOUNDS—Continued
Chemical Abstracts Registry No. Mercury compound
7783–35–9 ...... Sulfuric acid, mercury(2+) salt (1:1). 7783–39–3 ...... Mercury fluoride (HgF2). 7789–47–1 ...... Mercury bromide (HgBr2). 90–03–9 ...... Mercury, chloro(2-hydroxyphenyl)-. 94070–93–6 ...... Mercury, [.mu.-[(oxydi-2,1-ethanediyl 1,2-benzenedicarboxylato-.kappa.O2)(2-)]]diphenyldi-.
B. Explanation of Supply, Use, and manufacturing processes in which a baseline for comparison of the changes Trade mercury is used, and reporting. The in the amounts of other mercury United States is a Party to the Minamata compounds exported after the 2020 Pursuant to TSCA section 8(b)(10)(B), Convention, which is a multilateral effective date. The Agency also EPA interprets the scope of the mercury environmental agreement that addresses recognizes that the 2020 effective date of inventory to include activities within the supply, use, and trade in mercury 15 U.S.C. 2611(c)(7) is such that any the domestic and global commodity by, among other actions, not allowing reporting on those five compounds will mercury market that would fall under the introduction of new mercury mines not assist the Agency in recommending ‘‘supply, use, and trade of mercury in and the phasing out of existing ones, further actions to achieve further the United States.’’ An inventory that phasing out and phasing down the use reductions in mercury use because the adequately accounts for mercury in of mercury in a number of products and export ban will be in effect as of 2020. supply, use, and trade includes industrial processes, placing control Therefore, EPA requests public activities of persons who must report as measures on emissions to air and on comment on whether to require one- described in TSCA section 8(b)(10)(d)(i): releases to land and water, and taking time reporting for exports of the Manufacture, import, and otherwise action to reduce the use of mercury in mercury compounds prohibited from intentionally use mercury in a the informal sector of artisanal and export by 15 U.S.C. 2611(c)(7). It should manufacturing process. In addition, the small-scale gold mining. EPA seeks be noted that reporting for exports of Agency proposes that persons required comment on the proposed limited data mercury compounds that are not to report to the mercury inventory also collection requirements, such as the prohibited from export by 15 U.S.C. include information on distribution in identification of countries that 2611(c)(7), as well as products that commerce, storage, and export in order manufacture, import, or export mercury- contain intentionally-added elemental to provide for the requisite inventory of added products (i.e., countries of origin mercury and/or any mercury mercury supply, use, and trade in the and destination), as well as the compounds (including the compounds United States. EPA proposes that identification of purchasing or receiving prohibited from export) will be reporting to cover ‘‘supply’’ include industry sectors via NAICS codes, to required. manufacture and storage of mercury, inform activities under the Minamata In order to obtain information for the reporting to cover ‘‘use’’ include use of Convention. mercury inventory with the necessary mercury to manufacture a mercury- In regard to certain exports of level of detail, EPA is proposing to added product or otherwise intentional mercury, the Agency notes that the require reporting on activities that are use of mercury in a manufacturing export of elemental mercury has been subsets of defined terms. For example, process, and reporting to cover ‘‘trade’’ prohibited since January 1, 2013 (15 ‘‘manufacture’’ is defined in TSCA include import, export, and distribution U.S.C. 2611(c)(1)) and therefore the section 3(9) to mean: ‘‘import into the in commerce of mercury or mercury- Agency is not proposing to require customs territory of the United States added products. EPA proposes that reporting on the export of elemental (as defined in general note 2 of the obtaining information related to such mercury from the United States. TSCA, Harmonized Tariff Schedule of the activities, including reporting quantities as of January 1, 2020, will also prohibit United States), produce, or of mercury, as well as qualitative the export of certain mercury manufacture’’ (15 U.S.C. 2602(9)). While information related to supply, use, and compounds: Mercury (I) chloride or both manufacture and import are trade, is necessary to create the calomel; mercury (II) oxide; mercury (II) described in the statutory definition of inventory described at TSCA section sulfate; mercury (II) nitrate; and ‘‘manufacture,’’ the Agency proposes to 8(b)(10)(B). Examples of such qualitative cinnabar or mercury sulphide (the separate reporting for these activities of information include: Country of origin statute uses the term ‘‘mercury the mercury market in order to capture (for imports of mercury or mercury- sulphide’’ which is an alternative distinct actions by persons who handle added products), destination country spelling of ‘‘mercury sulfide’’ as found and trade mercury. As such, EPA is (for exported mercury-added products in the table above) (15 U.S.C. proposing that persons required to or certain mercury compounds), and 2611(c)(7)). EPA recognizes that a report specify distinct amounts, if any, identification of purchasing or receiving complete inventory would include at of imported or otherwise manufactured industry sectors via NAICS codes (for least one cycle of reporting prior to the mercury, as well as amounts of mercury mercury or mercury-added products effective date of the prohibition for in imported or otherwise manufactured distributed in domestic commerce). export of the five mercury compounds mercury-added products. In addition to using this information subject to 15 U.S.C. 2611(c)(7). As such, Conversely, the activity ‘‘otherwise for the mercury inventory, this the inventory would benefit from the intentionally uses mercury in a information would be used by the U.S. recent totals of at least one cycle of manufacturing process’’ is not defined Government to assist in its reporting prior to the effective date of under TSCA. The Agency considers this implementation of the Minamata the prohibition for export of mercury activity to be similar, but not identical Convention (Ref. 2), in particular with compounds subject to 15 U.S.C. to the definition for ‘‘process’’ at TSCA respect to mercury supply sources and 2611(c)(7) to (1) measure trends in section 3(13): ‘‘preparation of a trade, mercury-added products, supply, use, and trade; and (2) provide chemical substance or mixture, after its
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manufacture, for distribution in definition for ‘‘import for commercial mixture, or article; or to hold, or the commerce . . . in the same form or purposes’’ at 40 CFR 704.3, but finds it holding of, the substance, mixture, or physical state as, or in a different form to be substantially similar to germane article after its introduction into or physical state from, that in which it portions of ‘‘manufacture for commerce’’ (15 U.S.C. 2602(5)), are was received by the person so preparing commercial purposes.’’ adequate to describe both distribution in such substance or mixture, or . . . as EPA is proposing that the terms commerce and storage for the proposed part of an article containing the ‘‘manufacture,’’ ‘‘import,’’ and rule. In particular, the Agency is chemical substance or mixture’’ (15 ‘‘otherwise intentional use of mercury interested in quantities of mercury sold U.S.C. 2602(13)). EPA proposes to in a manufacturing process’’ be or transferred between facilities in the require reporting on both the otherwise interpreted for the purposes of mercury United States. As such, EPA is intentional use of mercury in a inventory reporting based on the proposing to incorporate the concept of manufacturing process, as well as aforementioned definitions in 40 CFR ‘‘domestic’’ as defined at 40 CFR 704.3 manufacture of mercury or a mercury- 704.3 and the statutory text at TSCA to activities considered to be added product, distinguished by section 8(f). In regard to the distribution in commerce, as opposed to focusing on how the mercury came to be manufacture (including import) of international import and export, which present in a final product. For mercury as a byproduct, impurity, or would be covered separately. Where ‘‘to manufacture of mercury or a mercury- similar occurrence, EPA considered hold’’ or ‘‘holding of’’ (i.e., storage) is added product, the Agency views such whether such chemical substances are concerned, EPA is proposing to require activities to be the intentional addition intentionally generated and whether reporting for quantities of mercury of mercury where mercury remains such substances are used for stored, if any, by persons who present in the final product for a commercial purposes. To synthesize manufacture (including import) particular purpose. For otherwise these concepts, EPA is proposing to mercury, as well as those who otherwise intentional use of mercury in a require reporting on mercury or intentionally use mercury in a manufacturing process, the Agency mercury-containing byproducts manufacturing process. Mercury stored views such activities to be the manufactured for commercial purposes. by persons who only produce mercury- intentional use of mercury, but where Mercury generated as a byproduct not added products would not be required no mercury remains or any mercury used for commercial purposes would to be reported. Moreover, the Agency is present in the final product exists only not be subject to the proposed rule. not proposing to require reporting for as an impurity. In addition, EPA is proposing that quantities of mercury within mercury- mercury that exists as an impurity added products that are stored after Finally, TSCA section 8(f) states ‘‘[f]or would not be subject to the proposed purposes of [TSCA section 8], the terms manufacture and prior to distribution in rule, except where such impurities are commerce. EPA assumes the quantity of ‘manufacture’ and ‘process’ mean present in a final product produced by mercury that manufacturers of mercury- manufacture or process for commercial persons who otherwise intentionally use added products store for later use or purposes’’ (15 U.S.C. 2607(f)). Under a mercury in a manufacturing process. keep within product inventories is TSCA section 8(a) reporting rule, EPA EPA is distinguishing between the likely to be too small to help explain the has previously defined ‘‘manufacture for manufacture of mercury-added products information gap between sold and used commercial purposes’’ for the purposes versus the final products containing mercury. The expected value of the of other information gathering rules to mercury that result from the intentional information is likely to be low include ‘‘import, produce, or use of mercury in a manufacturing considering the burden and cost on manufacture with the purpose of process. First, EPA considers the reporters. obtaining an immediate or eventual addition and presence of mercury in the commercial advantage for the final products of the former process to The Agency considered ‘‘export’’ in manufacturer’’ and ‘‘substances that are be intentional and, therefore, not an the context of ‘‘exporter’’ as defined in produced coincidentally during the impurity. Conversely, EPA considers the the TSCA section 12(b) export manufacture, processing, use, or presence of mercury in the final product notification rule at 40 CFR part 707 disposal of another substance or resulting from the intentional use of Subpart D: ‘‘determining and controlling mixture, including both byproducts that mercury during the manufacturing the sending of the chemical substance or are separated from that other substance processes identified in this proposed mixture to a destination out of the or mixture and impurities that remain in rule (see Unit III.D.5.) to be customs territory of the United States’’ that substance or mixture . . . [that] unintentional (i.e., present as an 40 CFR 707.63(b). For purposes of the may, or may not, in themselves have impurity). Second, the Agency has less proposed rule, however, the Agency commercial value’’ (40 CFR 704.3). In detailed institutional knowledge of this believes that it is necessary to collect the same rule, similarly, EPA has category of uses and is proposing to export data not only on certain mercury defined ‘‘process for commercial collect information on mercury that compounds, but also mercury-added purposes’’ as ‘‘the preparation of a exists as an unintended impurity in products that are exported from the chemical substance or mixture after its products in such cases to better identify United States. As such, EPA would manufacture for distribution in mercury use in manufacturing include articles in the reporting commerce with the purpose of obtaining processes, as directed in TSCA section required for export. an immediate or eventual commercial 8(b)(10)(C). Therefore, in summary, the Agency advantage for the processor. Processing EPA determined that actions proposes to require reporting for the of any amount of a chemical substance described in the definition of following activities: or mixture is included in this definition. ‘‘distribution in commerce’’ at TSCA • Import of mercury or a mercury- If a chemical substance or mixture section 3(5): ‘‘to sell, or the sale of, the added product with the purpose of containing impurities is processed for substance, mixture, or article in obtaining an immediate or eventual commercial purposes, then the commerce; to introduce or deliver for commercial advantage for the importer, impurities also are processed for introduction into commerce, or the except where such mercury is generated commercial purposes’’ (40 CFR 704.3). introduction or delivery for introduction as a byproduct not used for commercial EPA notes that there is a separate into commerce of, the substance, purposes or an impurity.
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• Manufacture (other than import) of reporting programs as much as possible. Specifically, those that report to IMERC mercury or a mercury-added product While developing this proposed rule, would not be required to report the with the purpose of obtaining an EPA reviewed four data collection amount of mercury distributed in immediate or eventual commercial systems applicable to supply, use, and commerce under this proposed rule advantage for the manufacturer, except trade of mercury (including mercury- because EPA believes that information where such mercury is generated as a added products and mercury used in is captured by IMERC as national sales byproduct not used for commercial manufacturing processes): IMERC, the data. However, those that report to purposes or an impurity. In this context, TSCA section 8(a) Chemical Data IMERC would still be required to EPA considers manufacture to be the Reporting rule, the Toxics Release provide qualitative data—NAICS codes intentional production of mercury, a Inventory (TRI) program, and the U.S. related to sales data—as part of the mercury compound, or a mercury-added International Trade Commission distribution in commerce reporting product, as opposed to the uses Interactive Trade DataWeb (USITC requirement (see Table 4—Information described for ‘‘otherwise intentionally DataWeb). to Report—Mercury-Added Products). uses mercury in a manufacturing 1. IMERC. IMERC is an online 2. TSCA Chemical Data Reporting process.’’ Incidental manufacture of reporting database managed by the Rule. EPA also sought to avoid mercury (e.g., burning of coal or similar) Northeast Waste Management Officials’ duplicating the mercury reporting would not be subject to the proposed Association (NEWMOA), which requirements of its own CDR rule (Ref. rule. provides publicly available, national 10) and reporting to the TRI program • Otherwise intentional use of data on mercury used in products. Laws (Ref. 11). The CDR rule collects mercury in a manufacturing process, in certain states (Connecticut, manufacturing, processing, and use other than the manufacture of a mercury Louisiana, Maine, Massachusetts, New information on certain chemical compound or a mercury-added product, Hampshire, New York, North Carolina, substances manufactured (including with the purpose of obtaining an Rhode Island, and Vermont—hereinafter imported) in the United States. Persons immediate or eventual commercial ‘‘IMERC Notification states’’) require required to report include those that advantage for the user, except where companies that manufacture, distribute, manufacture (including import) for such mercury is generated as a or import mercury-added products to commercial purposes in excess of 2,500 byproduct not used for commercial identify the mercury-added products lbs. for a specific reporting year for purposes. they sell and the volume of mercury in substances meeting certain criteria, • Distribution in commerce, them. The volume information is which include elemental mercury; or in including domestic sale or transfer, of reported at a national level, although excess of 25,000 lbs. for a specific mercury or a mercury-added product. only companies selling mercury reporting year for most other substances, • Storage of mercury after products within those states need to which include mercury compounds. manufacture (including import). report. The IMERC database houses the In general, CDR reporters do not • Export of mercury or a mercury- information that is reported to IMERC report information on chemical added product, including the Notification states on a triennial basis substances in articles, unless they first determining and controlling the sending and provides a detailed picture of some import or domestically manufacture the of mercury (unless specifically aspects of the mercury product market. chemical substance that they then prohibited) or a mercury-added product There are, however, some concerns incorporate into an article or product to a destination out of the customs about whether all nationwide sales are (Ref. 12). As discussed in regard to territory of the United States. captured (i.e., no reporting requirement coordinating with IMERC to avoid These proposed interpretations of for a company that sells mercury-added duplicative reporting, the Agency’s terms are intended to align with the products exclusively outside of IMERC intended design for the reporting structure and logical flow of reporting Notification states). Despite such application for the mercury inventory requirements described in Unit III.E. concerns and given the statutory would allow a CDR reporter to Nonetheless, EPA requests comment on direction to coordinate both programs, automatically skip certain reporting the proposed interpretations of activities EPA recognizes that the proposed rule requirement fields that would be to be considered as part of supply, use, and IMERC reporting requirements for considered duplicative. As an example, and trade of mercury in the United mercury-added products should be those that report to CDR would not be States. harmonized to the greatest extent required to provide the amount of mercury imported, however, they would C. Coordination With Existing Reporting practicable. While developing this proposed rule, be required to provide qualitative Programs the Agency coordinated with IMERC information—in this example the TSCA section 8(b)(10)(D)(ii) directs and NEWMOA to ensure that data country of origin—as part of the the Agency to ‘‘coordinate the reporting collected in accordance with the reporting requirement (see Table 3— . . . with the Interstate Mercury proposed reporting requirements and Information to Report—Mercury). Education and Reduction existing IMERC reporting requirements 3. Toxics Release Inventory. The TRI Clearinghouse’’ to avoid duplication (15 would not be duplicative and that program collects data on toxic chemical U.S.C. 2607(b)(10)(D)(ii)). Furthermore, information collected would be shared releases to air, water and land from TSCA section 8(a)(5)(a) states ‘‘[i]n to the greatest extent practicable. The industrial facilities and pollution carrying out [TSCA section 8], the Agency is designing the electronic prevention activities in the United Administrator shall, to the extent reporting application for the mercury States. The TRI program requires feasible . . . not require reporting inventory that would automatically skip reporting when covered facilities in which is unnecessary or duplicative’’ certain reporting requirement fields covered industrial sectors manufacture, (15 U.S.C. 2607(a)(5)(a)). The Agency when users indicate they report to the process, or otherwise use more than 10 seeks to avoid collecting data on IMERC Mercury-Added Products lbs. of elemental mercury and/or mercury that would duplicate Database. Such users would mercury compounds per year. However, information already reported to existing automatically bypass mercury inventory while the TRI program requires state and federal programs, and to reporting requirements that are reporters to specify whether mercury is coordinate with and complement those comparable to those reported to IMERC. manufactured, processed, or otherwise
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used in activities comparable to the products or otherwise intentionally use mercury in a manufacturing process. proposed rule (e.g., article component, mercury in a manufacturing process. As In that case, the facility would report formulation component, reactant, such, EPA determined that persons who the mercury it uses, but not the chemical processing aid, manufacturing merely trade (e.g., brokering, selling mercury in the products it discards aid), it does not require reporting of wholesale, shipping, warehousing, because the products and the mercury quantitative data on amounts of mercury repackaging, or retail sale), but do not within them are waste. used for such activities or the kind of manufacture or import mercury or • A person who uses a mercury- article involved. mercury-added products, should not be added product but does not 4. USITC DataWeb. Additionally, EPA subject to the proposed reporting manufacture mercury or mercury-added reviewed the USITC DataWeb, which requirements. Aside from its reading of products and does not intentionally use provides U.S. international trade TSCA section 8(b)(10)(D)(i), the Agency mercury in a manufacturing process. statistics and U.S. tariff data to the is concerned that requiring reporting • Hazardous waste treatment facilities public (Ref. 13). All trade data are from such entities risks: (1) Double- that recover elemental mercury from compiled from official data retrieved counting of mercury as it moves through mercury-containing waste and manage from the U.S. Bureau of the Census supply chains; and (2) undue burden or that elemental mercury as a waste. (Census). Data on U.S. exports of liability on entities that are not likely to There are currently two primary ways in merchandise from the United States to be aware if or how mercury is present which recovered elemental mercury can all countries, except Canada, are in products that they trade. be managed as a waste: Placed in long- compiled from the Electronic Export 1. Exemption for Persons Who term storage at a facility with a RCRA Information filed by the U.S. Principal Generate, Handle, or Manage Mercury- permit as allowed under Section 5(g) of Party in Interest or their agents through containing Waste. Persons ‘‘engaged in MEBA, or converted to mercury sulfide the Automated Export System. the generation, handling, or and exported for disposal. Published data on U.S. imports of management of mercury-containing • A generator producing mercury merchandise are compiled primarily waste, unless that person manufactures incidentally from the beneficiation or from automated data submitted through or recovers mercury in the management processing of ore or related pollution the Automated Commercial System of of that waste’’ are not required to report control activities, who accumulates this U.S. Customs and Border Protection to the mercury inventory (15 U.S.C. mercury on-site. (CBP). Data are also compiled from 2607(b)(10)(D)(iii)). There are generally • A generator who temporarily stores import entry summary forms, four sources of mercury-containing waste elemental mercury for up to 90 or warehouse withdrawal forms and waste: (1) Industrial processes, which Foreign Trade Zone documents as 180 days pending shipment for long- often generate a mixture of elemental term storage or for treatment and required by law to be filed with CBP. mercury or mercury compounds After reviewing these reporting disposal. The elemental mercury in all combined with other substances; (2) the programs, EPA has sought to design the of these cases is not subject to the discard of mercury-added products such proposed reporting requirements to be proposed rule. as fluorescent lamps; (3) the discard of least burdensome for reporters already EPA seeks comments on the examples elemental mercury (e.g. surplus familiar with IMERC, CDR, TRI, and provided and requests input on other commodity mercury); and (4) mercury- USITC DataWeb protocol. Therefore, the relevant examples that may be useful. contaminated environmental media that Agency is proposing to incorporate The exemption at 15 U.S.C. are excavated as part of a contaminated comparable reporting concepts and tools 2607(b)(10)(D)(iii) does not apply to site clean-up. Mercury-containing waste from each program, as well as propose persons who manufacture or recover that is hazardous is regulated by the some exemptions, in an attempt to elemental mercury in the management increase the efficacy of while decreasing Resource Conservation and Recovery of mercury-containing waste with the the burden to the greatest extent Act (RCRA). intent to use it or store it for use. For practicable for reporting to a national EPA considers the following examples example, if a waste treatment facility mercury inventory. EPA is seeking of persons and waste types to be exempt retorts or distills mercury-containing from reporting to the proposed rule: waste to recover elemental mercury and comment on the incorporation of the • reporting concepts and tools from each Hazardous waste treatment facilities then sells or stores the mercury for later program, as well as the proposed that stabilize and landfill low- sale, that person is considered to be a exemptions. concentration mercury-containing manufacturer of mercury and must waste. report to the proposed rule for the D. Persons Who Must Report • Manufacturing facilities that: amount of elemental mercury it sells or TSCA section 8(b)(10)(D)(i) states —Generate a mercury-containing waste stores. If any manufacturer covered by ‘‘any person who manufactures mercury and send it to a waste management the proposed rule decides at any time to or mercury-added products or otherwise facility. manage the elemental mercury as a intentionally uses mercury in a —Use mercury to manufacture products waste, that mercury is subject to the manufacturing process shall make or otherwise intentionally use RCRA, but not to the proposed rule. periodic reports to the Administrator’’ mercury in a manufacturing process, Elemental mercury that is stored under (15 U.S.C. 2607(b)(10)(D)(i)). As and also generate a mercury- MEBA or converted to a mercury explained in Unit III.B., EPA interprets containing waste from that use or compound and disposed of remains a the statutory text at TSCA sections another process. The exemption waste, that is, its status cannot change 8(b)(10)(B), 8(b)(10)(D)(i), and applies to the mercury in the facility’s from waste to commodity mercury. 8(b)(10)(D)(iii) as applying to intentional waste but not to the quantity it uses. 2. Reporting Threshold. As discussed acts that introduce mercury into supply, Under the proposed rule, the facility in Unit III.C., the Agency compared use, and trade in the United States. would report on the quantity it uses. existing state and federal reporting Furthermore, EPA reads TSCA section —Discard mercury-added products, databases applicable to the supply, use, 8(b)(10)(D)(i) to narrow potential such as fluorescent light bulbs, and trade of mercury. EPA conducted reporters to persons who first switches, and thermometers, unless this review in an attempt not only to manufacture mercury or mercury-added the facility also intentionally uses eliminate duplicative reporting
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requirements, but also to incorporate intentional use of mercury in a • Generating or isolating mercury applicable features of such programs, manufacturing process, EPA determined during ore, petroleum, or natural gas including the consideration of that all quantities of mercury used in refining; respective reporting thresholds. both activities should be reported • Retorting, recovering, or recycling The statutory text at TSCA section without a reporting threshold. EPA (including purifying) mercury from 8(b)(10) is silent on a reporting seeks comment on this approach. waste streams; threshold; however, TSCA section By comparison, the CDR rule contains • Chemical manufacturing of 8(b)(10)(C) directs the Agency to reporting thresholds for chemical mercury; ‘‘identify any manufacturing processes substances, including elemental • Importing mercury; or or products that intentionally add mercury and mercury compounds. EPA • Capturing mercury using methods mercury’’ (15 U.S.C. 2607(10)(b)(C)). interprets the mandate in TSCA section to reduce emissions of hazardous air The Agency interprets the direction to 8(b)(10)(B) to call for a comprehensive pollutants, unless the captured mercury ‘‘identify any’’ to apply to any amount inventory such that existing data gaps is generated, handled, or managed as a of mercury in a manufacturing process would be eliminated, where feasible. waste or is identified as an impurity. or product. When considered in light of The Agency also seeks as much as As described in Unit III.C., the the statutory text at TSCA section possible to complement amounts of Agency is seeking to decrease the 8(b)(10)(C), as well as concerns related quantitative mercury data already burden of reporting to the greatest to the potential adverse effects on collected by, but without overlapping extent practicable by, among other human health and the environment with, reporting requirements of the CDR things, complementing without resulting from releases of mercury, the rule. In general, the Agency seeks to overlapping existing reporting Agency finds that it would be require reporting for persons who requirements related to mercury and inappropriate to propose a threshold manufacture (including import) mercury mercury-added products. As such, EPA under which reporting would not be in quantities less than the CDR proposes that persons who manufacture required. Therefore, EPA proposes to thresholds for elemental mercury (2,500 (including import) for commercial apply the proposed reporting lbs.) and mercury compounds (25,000 purposes in excess of 2,500 lbs. for requirements to any person who lbs.). The coordination between elemental mercury or in excess of manufactures (including imports) additional, proposed reporting 25,000 lbs. for mercury compounds for mercury, mercury-added products or requirements and the CDR rule are a specific reporting year would not be otherwise intentionally uses mercury in discussed in ‘‘Persons Who Manufacture required to report amounts a manufacturing process regardless of (Including Import) Mercury.’’ manufactured (including imported) or the amount of mercury at issue. EPA 3. Persons Who Manufacture exported that are already reported per seeks comment on this approach. (Including Import) Mercury. As the CDR rule. Such persons would, The absence of a reporting threshold described in Unit III.B., manufacture however, be required to provide is consistent with IMERC reporting and import for the purpose of the quantitative data on storage and requirements, which apply to the proposed rule would include the distribution in commerce, as well as intentional addition of mercury to a manufacture (including import) of qualitative and contextual information product, including where ‘‘mercury is mercury. Although not exhaustive, related to all applicable data elements intentionally added for any reason or persons who engage in the following under the proposed rule. In further that incorporates a component to which activities would be required to report efforts to decrease reporting burdens, mercury was intentionally added’’ (Ref. under the proposed rule (see Table 3. the Agency intends to provide pre- 14). Because of the similarities in the Information to Report—Mercury): selected lists of mercury compounds to intentional addition of mercury to • Mining (including extraction and streamline reporting requirements as manufacture a product and otherwise beneficiation processes) mercury; much as possible.
TABLE 3—INFORMATION TO REPORT—MERCURY
Persons who must report Potential reporting requirements
Persons who manufacture (including import) mercury in amounts great- —Country(ies) of origin for imported mercury. er than or equal to 2,500 lbs. for elemental mercury or greater than —Country(ies) of destination for exported mercury. or equal to 25,000 lbs. for mercury compounds for a specific report- —Amount of mercury stored (lbs.). ing year (i.e., current CDR reporters). —Amount of mercury distributed in commerce (lbs.). —NAICS code(s) for mercury distributed in commerce. —As applicable, specific mercury compound(s) from pre-selected list. All other persons who manufacture (including import) mercury ...... —Amount of mercury manufactured (lbs.). —Amount of mercury imported (lbs.). —Country(ies) of origin for imported mercury. —Amount of mercury exported (lbs.), except mercury prohibited from export at 15 U.S.C. 2611(c)(1) and (7). —Country(ies) of destination for exported mercury. —Amount of mercury stored (lbs.). —Amount of mercury distributed in commerce (lbs.). —NAICS code(s) for mercury distributed in commerce. —As applicable, specific mercury compound(s) from pre-selected list.
4. Persons Who Manufacture or manufacture (including import) added product. The Agency proposes Import Mercury-added Products. As mercury-added products, except import that a person who imports a product described in Unit III.B., EPA is of a product that contains mercury that contains a component that is a proposing to require reporting for solely as a component that is a mercury- mercury-added product (e.g., toy or
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novelty item containing a mercury- hemorrhoid ointments, lotions, contact- • Manufacturers of concrete made added battery) would not be required to lens solutions, and nasal sprays) and from coal ash that contains mercury, but report under the proposed rule. EPA medical devices (e.g., thermometers and where such mercury originated from determined that this distinction was blood pressure devices) from foreign coal burned as a fuel source (i.e., appropriate after reviewing the data vendors. These parcels typically enter mercury was not intentionally added to reported to the IMERC Mercury-Added the United States via international mail the coal ash or the concrete); Products Database and comparing the and are processed at international mail • Fuel blenders who combine companies that reported national sales facilities by the U.S. Postal Service, U.S. materials that might contain mercury, data for individual mercury-added Customs and Border Protection, or the but are not chosen for blending because products (including components), as U.S. Food and Drug Administration. they contain mercury; well as items that would be considered The addressee on the parcel is • Consumers who purchase and to contain a component that is a considered to be the importer of record. import mercury-added products for mercury-added product (Ref. 15). For If an express courier is used, the express personal use from a foreign vendor; or, example, companies that report to courier may assume the role of the • Persons engaged in the delivery of IMERC for sales of appliances and importer of record. In the case where an mercury-added products to an vehicles list lamps as a mercury-added individual consumer is purchasing and individual consumer, unless the component. The Agency is interested in importing a mercury-added product for delivery service intentionally collecting data on original personal use, the Agency believes that specializes in part or whole in the manufacturers (including importers) the proposed rule does not apply to import and distribution in commerce of and users of mercury and believes that such persons. Furthermore, the mercury-added products. requiring certain contextual data (e.g., proposed rule would not apply to NAICS codes) would sufficiently persons engaged in the delivery of such For mercury-added products, the describe the use of mercury-added mercury-added products to an Agency seeks not only to balance efforts components by companies who do not individual consumer, even if the to increase the efficacy of reporting first manufacture, import, or otherwise delivery service constitutes import and while decreasing the burden to the intentionally use mercury. Based on its distribution in commerce. In both greatest extent practicable, but also to review of the companies who report to scenarios, the persons who are fully describe applicable sectors of the IMERC and the types of mercury-added importing the mercury-added product mercury market. As described in Unit products reported, the Agency is are not doing so ‘‘with the purpose of III.C., persons who report to IMERC concerned that requiring reporting for obtaining an immediate or eventual identify the amount of mercury sold in products where mercury is present commercial advantage for the importer.’’ mercury-added products that may be solely within a previously manufactured However, if a delivery service manufactured, distributed, or imported. component poses risks of double- intentionally specialized in part or The Agency considers the amount of counting and thereby could negatively whole in the import and distribution in mercury reported to IMERC as sold to be affect the reliability of future mercury commerce of mercury-added products, comparable to the amount of mercury to inventory updates. then that person (or company) would be be reported under the proposed rule as EPA also is concerned that requiring required to report to the mercury distributed in commerce. As such, EPA reporting for a product that contains a inventory. proposes that persons reporting to mercury-added component could create Although not exhaustive, persons IMERC would not need to report undue burden for certain importers. For who engage in the following activities amounts of mercury distributed in example, the Agency concluded that it would be required to report under the commerce under the proposed rule. is more likely that an importer of proposed rule (see Table 4. Information However, those persons would need to batteries would know if the specific to Report—Mercury-Added Products): report quantitative and qualitative kind of battery contained mercury, as • Importing mercury-added products information for other applicable data opposed to an importer of toys that may (except the import of a product that elements. Under the proposed rule, such or may not contain a mercury-added contains a component that is a mercury- persons also would be required to report battery. However, EPA requests added product); or contextual information applicable to comment on whether persons who • Producing mercury-added products amounts, if any, of mercury manufacture (including import) items (e.g., inserting mercury into a switch or manufactured, imported, distributed in that contain components that are battery, or mixing a mercury compound commerce, or exported. In further efforts mercury-added products should also with other substances to formulate a to decrease reporting burdens, the report under the proposed rule. topical antiseptic). Agency intends to provide pre-selected In addition, the Agency is aware of Examples of persons who would not lists of mercury-added product transactions where a consumer directly be required to report to this proposed categories to streamline reporting orders mercury-added drugs (e.g., rule include: requirements as much as possible.
TABLE 4—INFORMATION TO REPORT—MERCURY-ADDED PRODUCTS
Persons who must report Potential reporting requirements
Persons who manufacture (including import) mercury-added products, —Amount of mercury in manufactured products (lbs.). except a product that contains a component that is a mercury-added —Amount of mercury in imported products (lbs.). product, who currently report to IMERC. —Country(ies) of origin for imported products. —Amount of mercury in exported products (lbs.). —Country(ies) of destination for exported products. —NAICS code(s) for products distributed in commerce. —As applicable, specific product category(ies) and subcategory(ies) from pre-selected list.
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TABLE 4—INFORMATION TO REPORT—MERCURY-ADDED PRODUCTS—Continued
Persons who must report Potential reporting requirements
All other persons who manufacture (including import) mercury-added —Amount of mercury in manufactured products (lbs.). products, except a product that contains a component that is a mer- —Amount of mercury in imported products (lbs.). cury-added product. —Country(ies) of origin for imported products. —Amount of mercury in exported products (lbs.). —Country(ies) of destination for exported products. —Amount of mercury in products distributed in commerce (lbs.). —NAICS code(s) for products distributed in commerce. —As applicable, specific product category(ies) and subcategory(ies) from pre-selected list.
5. Persons Who Otherwise • Producers of chlorine (e.g., programs cover only some of the data Intentionally Use Mercury in a mercury-cell chlor-alkali process); elements that would be required of EPA Manufacturing Process. As described in • Producers of polyurethane for the mercury inventory. As such, the Unit III.B., TSCA section 8(b)(10)(d)(i) elastomer; or general, specific, and contextual includes persons who intentionally use • Producers of other commercial reporting requirements proposed by mercury in a manufacturing process chemicals (except mercury compounds). EPA are intended to provide a complete amongst those who must report. Unlike manufacturers (including picture of uses for which little Examples of persons who otherwise importers) of mercury and mercury- information is currently available. In intentionally use mercury in a added products, the Agency believes further efforts to decrease reporting manufacturing process that would be that persons who otherwise burdens, the Agency intends to provide required to report under the proposed intentionally use mercury in a pre-selected lists of manufacturing rule include, but are not limited to (see manufacturing process may currently processes and attendant uses of mercury Table 5. Information to Report— report to existing data collection Otherwise Intentional Use of Mercury in programs in the United States; however, to streamline reporting requirements as a Manufacturing Process): the reporting requirements for those much as possible.
TABLE 5—INFORMATION TO REPORT—OTHERWISE INTENTIONAL USE OF MERCURY IN A MANUFACTURING PROCESS
Persons who must report Potential reporting requirements
Persons who otherwise intentionally use mercury in a manufacturing —Amount of mercury intentionally used (lbs.) in pre-selected list of process, other than the manufacture of a mercury compound or a manufacturing processes. mercury-added product. —Amount of mercury stored (lbs.). —Amount of mercury in exported final product(s) (lbs.). —Country(ies) of destination for exported final product(s). —Amount of mercury in final product(s) distributed in commerce (lbs.). —NAICS code(s) for mercury in final product(s) distributed in com- merce. —As applicable, specific manufacturing process from pre-selected list. —As applicable, specific use of mercury in manufacturing process from pre-selected list.
To the extent that the proposed requirements associated with TSCA reporting database, explain persons who must report and section 8(b) are applicable to all affected requirements, and offer Q&A and other descriptions and examples of the kinds entities. EPA is striving to minimize the support. Under TSCA section 26(d), of information to be reported can be burden on all respondents, including EPA also provides specialized clarified, the Agency welcomes small entities, as much as possible by assistance to respondents, particularly comment on the aforementioned developing the reporting application to small entities, including technical discussion and tables. In addition, the and database to be user-friendly and and other non-financial assistance to Agency requests comment on whether dynamic, consisting of straightforward manufacturers and processors of other persons should be required to questions that are to include fill-in-the- chemical substances. EPA’s TSCA report or, in the alternative, if any of the blank (numbers) fields, check boxes, Hotline assists small businesses proposed persons should not report. and drop down menus. complying with TSCA rules and 6. Consideration of Small Entities. In addition, the Agency is considering provides various materials such as Based on EPA’s economic assessment of the development of compliance guides copies of Federal Register notices, the proposed rule (Ref. 3), tailored to small entities that will be advisories, and other information upon approximately 40 percent of the required to comply with the reporting request. Contact information for the respondents will be small entities. requirements. EPA requests public TSCA Hotline is listed under FOR However, small businesses are not comment on what kinds of information FURTHER INFORMATION CONTACT. exempt from reporting requirements would be particularly important to E. Reporting Requirements because, unlike the exemption for small address for small entities in such manufacturers and processors provided compliance guides. EPA expects to TSCA section 8(b)(10)(B) sets the under TSCA 8(a)(1)(A) and (B), conduct outreach and webinars for general scope of the inventory as the reporting and recordkeeping small businesses to introduce the ‘‘mercury supply, use, and trade in the
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United States’’ (15 U.S.C. distributed in commerce per year (lbs.); report would provide the total amount 2607(b)(10)(B)). EPA interprets the core Amount of mercury in exported of mercury used during the reporting elements to be covered in the mercury products per year (lbs.). year in pounds for general reporting inventory to be the amount of mercury e. Persons who intentionally use activities associated with supply, use, used in the activities within the mercury in manufacturing processes, and trade, rather than per category and mercury market described in Unit III.B. other than the manufacture of a subcategory. EPA based this decision on (i.e., manufacture, import, export, mercury compound or a mercury-added issues concerning burden and storage, distribution in commerce, and product: Amount of mercury used in a confidential business information that otherwise intentional use of mercury in manufacturing process per year (lbs.); could be created by reporting a manufacturing process). EPA also Amount of mercury stored per year quantitative information for increasingly determined that, for certain elements, (lbs.); Amount of mercury distributed in specific categories and subcategories. requiring reporting of more specific commerce in final product(s) of Nonetheless, EPA requests comment on information would help to better manufacturing process per year (lbs.); whether quantitative information contextualize reported quantities of Amount of mercury exported in final should be required for such specific mercury used in domestic and, where product(s) of manufacturing process per reporting categories and subcategories, appropriate, global supply, use, and year (lbs.). as well as on the reporting categories trade. The proposed general, specific, EPA understands that certain persons and subcategories. and contextual reporting requirements may report for multiple activities a. Mercury-added products. Based on are described in this section. associated with supply, use, and trade the current knowledge of mercury- 1. General Reporting Requirements. of mercury. For example, a person may added products available in the EPA considers ‘‘supply’’ to include import mercury and manufacture marketplace, including skin products manufacture and storage, ‘‘use’’ to mercury-added products. As such, the manufactured abroad and sold illegally include otherwise intentional use of Agency attempted to design the in the United States (Ref. 16), EPA mercury in a manufacturing process, proposed quantitative data elements for proposes the following list of categories and ‘‘trade’’ to include import, export, reporting requirements such that a and subcategories of mercury-added and distribution in commerce. The person could report both as an products: ‘‘importer of mercury’’ and Agency is proposing that accounting for • Batteries: Button cell, silver; Button ‘‘manufacturer of mercury-added such activities is necessary to fulfill cell, zinc-air; Button cell, alkaline; products,’’ but only report for the statutory mandates at TSCA sections Stacked button cell batteries; Manganese specific activity in which they engage. 8(b)(10)(B) and (C). Therefore, for oxide; Silver oxide; Mercuric oxide, The Agency expects there may be persons required to report (as described non-button cell; Button cell, mercuric certain persons engaged in the supply, in Unit III.D.), EPA proposes reporting oxide; Button cell, zinc carbon; Other use, and trade of mercury who might quantitative data for mercury, mercury- (specify). added products, and otherwise not be accounted for in the inventory, • Dental amalgam. intentional use of mercury in a but EPA views this omission of • Formulated products (includes uses manufacturing process (as qualified prospective reporters as an opportunity in cosmetics, pesticides, and laboratory from existing terms as discussed in Unit to limit undue burden and avoid chemicals): Skin-lightening creams; III.B.) as follows: double-counting. Thus, the Agency is a. Importers of mercury: Amount of proposing to limit the persons who must Lotions; Soaps and sanitizers; Topical mercury imported per year (lbs.); report at TSCA section 8(b)(10)(D)(i) to antiseptics; Bath oils and salts; Amount of mercury stored per year only those persons described in Unit Preservatives (e.g., for use in vaccines (lbs.); Amount of mercury distributed in III.D. However, EPA requests comment and eye-area cosmetics when no commerce per year (lbs.); Amount of on whether the proposed reporting preservative alternatives are available); mercury exported per year (lbs.). requirements should apply to persons Pharmaceuticals (including prescription b. Manufacturers (other than who do not manufacture or import and over-the-counter drug products); importers) of mercury: Amount of mercury or mercury-added products, or Cleaning products (not registered as mercury manufactured (other than otherwise intentionally use mercury in pesticides under the Federal Insecticide, imported) per year (lbs.); Amount of a manufacturing process, but engage in Fungicide, and Rodenticide Act); mercury stored per year (lbs.); Amount the supply, use, and trade of mercury in Pesticides; Paints; Dyes; Reagents (e.g., of mercury distributed in commerce per the United States. catalysts, buffers, fixatives); Other year (lbs.). 2. Specific Reporting Requirements. (specify). c. Importers of any mercury-added To better understand the categories of • Lighting, lamps, bulbs: Linear product other than a product that mercury-added products and otherwise fluorescent; Compact fluorescent; U- contains a component that is a mercury- intentional use of mercury in a tube and circular fluorescent; Cold added product (NOTE—see Unit III.D.): manufacturing process, the Agency also cathode fluorescent; External electrode Amount of mercury in imported proposes to require reporters to identify fluorescent; Mercury vapor; Metal products per year (lbs.); Amount of the specific categories and subcategories halide; High pressure sodium; Mercury mercury in products distributed in of products and functional uses for short arc; Neon; Other (specify). domestic commerce per year (lbs.); which quantitative data is reported. The • Measuring instruments: Barometer; Amount of mercury in exported Agency believes this is an appropriate Fever thermometer; Flow meter; products per year (lbs.). interpretation of the direction to Hydrometer; Hygrometer/psychrometer; d. Manufacturers (other than ‘‘identify any manufacturing processes Manometer; Non-fever thermometer; importers) of any mercury-added or products that intentionally add Pyrometer; Sphygmomanometer; Other product other than a product that mercury,’’ which, in turn, could inform (specify). contains a component that is a mercury- how to ‘‘recommend actions, including • Pump seals. added product (NOTE—see Unit III.D.): proposed revisions of Federal law or • Switches, relays, sensors, valves: Amount of mercury in manufactured regulations, to achieve further Tilt switch; Vibration switch; Float (other than imported) products per year reductions in mercury use’’ (15 U.S.C. switch; Pressure switch; Temperature (lbs.); Amount of mercury in products 2607(b)(10)(C)). Persons required to switch; Displacement relay; Wetted reed
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relay; Contact relay; Flame sensor; much as possible, the Agency would publication deadline (April 1). The Thermostat; Other (specify). design all requirements to be answered Agency then considered whether it was • Miscellaneous mercury-added only where a reporter engages in the feasible to select a date and reporting products: Wheel weights; Wheel specific activity from the inclusive list frequency that would coincide with the rotation balancers/stabilizers; Firearm of options. In fact, EPA believes that it IMERC, CDR rule, and TRI program recoil suppressors; Carburetor is unlikely that the typical reporter reporting deadlines, so as not to impose synchronizers; Joint support/shock would be engaged in and, as a result, be an additional date for those that might absorption bands; Other (specify). required to answer all, or even many, of be required to report to multiple b. Intentional mercury use in the proposed reporting requirements. systems. Due to the incongruities of manufacturing processes. Based on the Nonetheless, to the extent that the frequency of collection among the current knowledge of manufacturing proposed reporting process can be proposed rule (triennial cycle— processes involving the otherwise streamlined, the Agency welcomes publication date of April 1), IMERC intentional use of mercury, EPA comment on the proposed general, (triennial cycle—reporting deadline of proposes the following manufacturing specific, and contextual reporting April 1), the CDR rule (quadrennial processes for which mercury may be requirements. In addition, the Agency cycle—reporting deadline of September intentionally used: Chlorine production requests comment on whether such 30), and TRI program (annual cycle— (e.g., mercury-cell chlor-alkali process); reporting requirements should be added reporting deadline of July 1), the Agency Acetaldehyde production; Vinyl or eliminated. determined that attempting to chloride monomer production; Sodium/ coordinate with each program would be F. Frequency of Inventory Publication potassium methylate/ethylate more confusing for reporters, would not production; Polyurethane/plastic TSCA section 8(b)(10)(B) sets the date allow for ample time to review and production; Other (specify). for publication of initial and coordinate similar data (e.g., EPA proposes the following list of subsequent, triennial iterations of the mismatched dates for reporting deadline uses of mercury in the aforementioned mercury inventory to commence on and inventory publication between CDR manufacturing processes: Catalyst; April 1, 2017 (15 U.S.C. 8(b)(10)(B)). rule and the proposed rule), and could Reactant; Reagent; Other (specify). Therefore, EPA expects to publish the result in gaps of up to several years 3. Contextual Reporting first mercury inventory supported by between the availability of most Requirements. Within certain sectors of the proposed reporting requirements by applicable information (e.g., principal the mercury market, the Agency April 1, 2020 and every three years reporting year data for the CDR rule). determined that additional data thereafter. Based on such considerations, the requirements are important to provide G. Frequency of Data Collection and Agency determined that coinciding with context to the quantitative data Reporting Deadline the triennial IMERC frequency of reported. While the individual collection is appropriate given the quantities and overarching, categorical TSCA section 8(b)(10)(D) provides the mercury inventory publication schedule sums can help to fulfill the statutory authority to promulgate the rule being is also triennial. In addition, the Agency mandate to identify manufacturing proposed here to assist in the is proposing to set the mercury processes or products that intentionally preparation of the triennial inventory inventory reporting deadline to coincide add mercury, EPA seeks to collect publication (15 U.S.C. 8(b)(10)(D)), but with the TRI program deadline in an information to more thoroughly describe TSCA offers no guidance on the effort to align with a date with which such activities and enhance efforts to frequency of collection or reporting certain, potential reporters might recommend actions to achieve further deadline. To attempt to minimize already be familiar. Therefore, EPA reductions in mercury use, as mandated reporting obligations, the Agency proposes to establish a July 1st reporting in TSCA section 8(b)(10)(C). Examples compared the respective collection deadline for 2019 and every three years of such data requirements include frequencies and reporting deadlines for thereafter. Data submitted should cover descriptions of countries of origin or IMERC, the CDR rule, and the TRI only the calendar year preceding the destination for reported import and program to when EPA is required to year in which the reporting deadline export quantities, as well as NAICS publish the mercury inventory. TSCA occurs (e.g., data for calendar year codes for purchasing or receiving section 8(b)(10)(B), (15 U.S.C. January 1 to December 31, 2018 reported industries for mercury or mercury- 8(b)(10)(B)), sets a publication date for on or before July 1, 2019). The Agency added products distributed in the mercury inventory that falls on the notes that IMERC ‘‘Product commerce. In order to fully understand reporting deadline for IMERC: April 1 in Notification’’ requirements are intended the supply, use, and trade or mercury in a triennial cycle starting in April 2017. to inform consumers, recyclers, policy the United States, EPA proposes the Data collected under the CDR rule is makers, and others about the total following reporting requirements: submitted to the Agency on a amount of mercury in the specific a. For imports of mercury or mercury- quadrennial cycle; the next reporting products that were sold in the United added products: Country of origin. cycle will occur in 2020, with a States in a given year. EPA seeks b. For mercury or mercury-added reporting deadline of September 2020. comment on the proposed timelines and products distributed in commerce: The TRI program collects and publishes reporting deadlines proposed. Identify the applicable purchasing or data on an annual cycle with a reporting EPA notes that there would be some receiving industry sectors via NAICS deadline of July 1 of each year. discrepancies between the proposed codes. EPA recognizes that the mercury rule and IMERC deadlines (e.g., the c. For exported mercury or mercury- inventory reporting deadline would Agency’s inventory publishing deadline added products: Destination country. need to allow for an appropriate amount is the same day as IMERC reporting The Agency determined that the of time for quality control and assurance deadline). However, the Agency would combination of general, specific, and to be performed by EPA staff before the look to statutory provisions calling for contextual reporting requirements inventory is published. As such, the coordination with IMERC to reconcile provides for the body of information Agency concluded that the proposed such concerns. In addition, the Agency’s required to fulfill statutory mandates of reporting deadline would need to occur intent to avoid duplicative reporting of TSCA sections 8(b)(10)(B) and (C). As at least several months in advance of the quantitative data could result in reliance
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on information reported to other data Guide.pdf. The registrant would also Geneva, Switzerland. vi + 263 pp. collection systems in differing reporting select a role and complete an electronic Available at http://apps.unep.org/piwik/ years (i.e., current reporters to IMERC signature agreement either through download.php?file=/publications/ and the CDR rule). For the reasons electronic validation using the pmtdocuments/-Technical%20 described above, EPA believes the LexisNexis services or through wet ink background%20report%20for proposed reporting parameters would signature. Once registration and the %20the%20global%20mercury%20 provide for the most convenience and electronic signature agreement are assessment%20-2013TechBackRep least burden to potential reporters and complete, the user would prepare a GMA2013.pdf. the Agency. Nonetheless, EPA requests submission. EPA is proposing 6. EPA. Basic Information about Mercury. comment on the proposed frequency of mandatory electronic reporting because (No date). Available at https:// data collection, reporting deadline, and such a requirement would streamline www.epa.gov/mercury/basic- timeline. the reporting process and reduce the information-about-mercury. [Accessed August 4, 2017]. H. Recordkeeping administrative costs associated with information submission and 7. EPA. Health Effects of Exposures to Consistent with the proposed recordkeeping. The effort to eliminate Mercury. (No date). Available at https:// triennial reporting and publication cycle paper-based submissions in favor of www.epa.gov/mercury/health-effects- for the mercury inventory, EPA CDX reporting is part of broader exposures-mercury. [Accessed August 4, proposes that each person who is government efforts to move to modern, 2017]. subject to the reporting requirements electronic methods of information 8. EPA. EPA’s Roadmap for Mercury, EPA– must retain records that document any gathering. Electronic reporting allows 747R–06–001. July 2006. Available at http://www.epa.gov/hg/roadmap.htm. information reported to EPA. Records for more efficient data transmittal and a 9. EPA. Subpoena and Information Request. relevant to reporting during a reduction in errors with the built-in March 20, 2015. Available at https:// submission period must be retained for validation procedures. EPA determined www.epa.gov/mercury/2015-subpoena- a period of 3 years beginning on the last the adoption of electronic reporting and-information-request-epa-mercury- day of the submission period. reduces the reporting burden for Submitters are encouraged to retain recyclers. submitters by reducing the cost and 10. EPA. Chemical Data Reporting under the their records longer than 3 years to time required to review. Nonetheless, ensure that past records are available as Toxic Substances Control Act. (No date). the Agency requests comment on its Available at https://www.epa.gov/ a reference when new submissions are proposal to require mandatory being generated. chemical-data-reporting. [Accessed electronic reporting. August 4, 2017]. I. Reporting Requirements and IV. Request for Comment 11. EPA. Toxics Release Inventory (TRI) Confidential Business Information Program. (No date). Available at https:// In addition to the areas where EPA www.epa.gov/toxics-release-inventory- Reporters to the information has specifically requested comment, collection of the proposed rule may tri-program. [Accessed August 4, 2017]. EPA requests comment on all other 12. EPA. TSCA Chemical Data Reporting Fact claim that their submitted information aspects of this proposed rule. is CBI. The statutory provisions for CBI Sheet: Articles. 2012. Available at under TSCA are at Section 14 of the law V. References https://www.epa.gov/sites/production/ files/documents/articlesfactsheetforcdr_ (15 U.S.C. 2613). The following is a listing of the reporting_080312.pdf. J. Electronic Reporting documents that are specifically 13. USITC. Guide to Foreign Trade referenced in this document. The docket EPA is proposing to require electronic Statistics—Description of the Foreign includes these documents and other Trade Statistical Program. (No date). reporting of the mercury inventory data, information considered by EPA, using an Agency-provided, web-based Available at https://www.census.gov/ including documents that are referenced foreign-trade/guide/sec2.html. [Accessed reporting software to submit mercury within the documents that are included inventory reports through the Internet to August 4, 2017]. in the docket, even if the referenced 14. NEWMOA. Instructions—Mercury-added EPA’s Central Data Exchange (CDX). document is not physically located in CDX provides the capability for Product Notification Form, Version for the docket. For assistance in locating Use by a Single Manufacturer, submitters to access their data through these other documents, please consult the use of web services. For more Distributor/Wholesaler, or Importer. the technical person listed under FOR information about CDX, go to http:// August 2011. Available at FURTHER INFORMATION CONTACT. epa.gov/cdx. www.newmoa.org/prevention/mercury/ Should EPA adopt a mandatory 1. EPA. Mercury; Initial Inventory Report of imerc/InstructionsMultiple.doc. electronic reporting requirement, Supply, Use, and Trade. (82 FR. 15522; 15. NEWMOA. Mercury-Added Products submitters would be required to register March 29, 2017). Database. (No date). Available at http:// 2. UNEP. Minamata Convention on Mercury. with EPA’s CDX, complete an electronic www.newmoa.org/prevention/mercury/ (No date). Available at http:// imerc/notification/. [Accessed August 4, signature agreement, and to prepare a www.mercuryconvention.org. [Accessed data file for submission. To submit 2017]. August 4, 2017]. 16. U.S. Food and Drug Administration. electronically to EPA via CDX, 3. EPA. Economic Analysis for the Proposed Mercury Poisoning Linked to Skin individuals must first register with that Reporting Requirements for the TSCA Products. (July 26, 2016). Available at system at http://cdx.epa.gov/epa_ Mercury Inventory. August 2, 2017. https://www.fda.gov/forconsumers/ home.asp. To register in CDX, the CDX 4. EPA. TSCA Chemical Substance Inventory. consumerupdates/ucm294849.htm. registrant agrees to the Terms and (No date). Available at https:// [Accessed October 3, 2017]. Conditions, provides information about www.epa.gov/tsca-inventory. [Accessed August 4, 2017]. 17. EPA. Collection of Information for the submitter and organization, selects a 5. AMAP/UNEP. Technical Background Mercury Inventory Reporting Rule; EPA user name and password, and follows Report for the Global Mercury ICR No. 2567.01; OMB Control No.: the procedures outlined in the guidance Assessment 2013. 2013. Arctic 2070–NEW. [Month DD], 2017. document for CDX available at https:// Monitoring and Assessment Programme, cdx.epa.gov/TSCA/eTSCA-Registration Oslo, Norway/UNEP Chemicals Branch,
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VI. Statutory and Executive Order States. Respondents may claim some of number of small entities under the RFA. Reviews the information reported to EPA under The small entities subject to the the proposed rule as CBI under TSCA A. Executive Order 12866: Regulatory requirements of this action include section 14. TSCA section 14(c) requires Planning and Review and Executive those that manufactures, including a supporting statement and certification Order 13563: Improving Regulation and imports, mercury or mercury-added Regulatory Review for confidentiality claims asserted after products (manufacturers), or otherwise June 22, 2016. intentionally uses mercury in a This action is a significant regulatory EPA estimated total burden and costs manufacturing process (processors). To action that was submitted to the Office to industry associated with the identify the number of firms that are of Management and Budget (OMB) for proposed rule over the first three years subject to the rule and considered small review under Executive Orders 12866 of its promulgation (Ref. 3). For the 750 under SBA size standards, EPA (58 FR 51735, October 4, 1993) and companies anticipated to be subject to compared the appropriate SBA size 13563 (76 FR 3821, January 21, 2011). the proposed reporting requirements, definition to the company’s revenue or Any changes made in response to OMB the average per respondent burden recommendations have been number of employees, as identified hours for Year 1 (of a triennial cycle for using Dun and Bradstreet or other documented in the docket for this submitting information) was estimated action. market research Web sites. Of the 506 to be 98.94 hours (Ref. 3). Years 2 and parent companies that are subject to the B. Executive Order 13771: Reducing 3 are not data collection years, so there rule, 211 companies (42 percent) meet Regulations and Controlling Regulatory is no cost associated with the proposed the SBA small business definitions for Costs rule during these years (Ref. 3). their respective NAICS classifications. Therefore, the average for total burden This action is expected to be subject hours per the three-year reporting cycle The small entity analysis estimated to the requirements for regulatory is 32.94 hours per year (Ref. 3). that 1 parent company (0.46 percent of actions specified in Executive Order Respondents/affected entities: total entities) would incur an impact of 13771 (82 FR 9339, February 3, 2017). Manufacturers, importers, and 3 percent or greater, and 3 parent EPA prepared an analysis of the processors of mercury. companies (1.39 percent of total estimated costs and benefits associated Respondent’s obligation to respond: entities) would incur an impact of 1 to with this action. This analysis, Mandatory (15 U.S.C. 2607(b)(10)(D)). 3 percent. Details of this analysis are ‘‘Economic Analysis for the Proposed Estimated number of respondents: included in the accompanying Reporting Requirements for the TSCA 750. Economic Analysis for this Rule (Ref. 3). Mercury Inventory’’ (Economic Frequency of response: Triennially. Analysis, Ref. 3) is available in the Total estimated annual burden: E. Unfunded Mandates Reform Act docket and is summarized in Unit I.E. 24,734 hours (averaged over 3 years). (UMRA) C. Paperwork Reduction Act (PRA) Burden is defined at 5 CFR 1320.3(b). Total estimated annual cost: This action does not contain an The information collection activities $1,985,446 (averaged over 3 years), unfunded mandate of $100 million or in this proposed rule have been includes $0 annualized capital or more as described in UMRA, 2 U.S.C. submitted for approval to the Office of operation and maintenance costs. 1531 through 1538, and does not Management and Budget (OMB) under An agency may not conduct or significantly or uniquely affect small the PRA, 44 U.S.C. 3501 et seq. The sponsor, and a person is not required to governments. As such, the requirements Information Collection Request (ICR) respond to, a collection of information of sections 202, 203, 204, or 205 of document that the EPA prepared has unless it displays a currently valid OMB UMRA do not apply to this action. been assigned EPA ICR number 2567.01 control number. The OMB control F. Executive Order 13132: Federalism (Ref. 17). You can find a copy of the ICR numbers for the EPA’s regulations in 40 in the docket for this rule, and it is CFR are listed in 40 CFR part 9. This action does not have federalism briefly summarized here. Submit your comments on the implications, as specified in Executive The reporting requirements identified Agency’s need for this information, the Order 13132 (64 FR 43255, August 10, in the proposed rule would provide EPA accuracy of the provided burden 1999). It will not have substantial direct with information necessary to prepare estimates and any suggested methods effects on the States, on the relationship and periodically update an inventory of for minimizing respondent burden to between the national government and mercury supply, use, and trade in the the EPA using the docket identified at the States, or on the distribution of United States, as required by TSCA the beginning of this rule. You may also power and responsibilities among the section 8(b)(10)(D). These proposed send your ICR-related comments to various levels of government. reporting requirements would help the OMB’s Office of Information and Agency to prepare subsequent, triennial Regulatory Affairs via email to oira_ G. Executive Order 13175: Consultation publications of the inventory, as well as [email protected], Attention: and Coordination With Indian Tribal to carry out the requirement of TSCA Desk Officer for the EPA. Since OMB is Governments section 8(b)(10)(C) to identify any required to make a decision concerning manufacturing processes or products the ICR between 30 and 60 days after This action does not have tribal that intentionally add mercury and receipt, OMB must receive comments no implications as specified in Executive recommend actions, including proposed later than November 27, 2017. The EPA Order 13175 (65 FR 67249, November 9, revisions of Federal law or regulations, will respond to any ICR-related 2000). It will not have any effect on to achieve further reductions in mercury comments in the final rule. tribal governments, on the relationship use. EPA intends to use information between the Federal government and collected under the rule to assist in D. Regulatory Flexibility Act (RFA) the Indian tribes, or on the distribution efforts to reduce the use of mercury in Pursuant to section 605(b) of the RFA, of power and responsibilities between products and processes and to facilitate 5 U.S.C. 601 et seq., I certify that this the Federal government and Indian reporting on implementation of the action will not have a significant tribes, as specified in the Order. Thus, Minamata Convention by the United economic impact on a substantial EO 13175 does not apply to this action.
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H. Executive Order 13045: Protection of PART 713—REPORTING obtaining an immediate or eventual Children From Environmental Health REQUIREMENTS FOR THE TSCA commercial advantage for the importer, Risks and Safety Risks INVENTORY OF MERCURY SUPPLY, except: USE, AND TRADE (A) Mercury generated as a byproduct EPA interprets Executive Order 13045 not used for commercial purposes or an (62 FR 19885, April 23, 1997) as Sec. impurity; or applying only to those regulatory 713.1 Purpose, scope, and compliance. (B) A product that contains a actions that concern environmental 713.5 Mercury for which information must component that is a mercury-added health or safety risks that EPA has be reported. product. reason to believe may 713.7 Mercury for which reporting is not (2) Manufacture (other than import) of required. mercury or a mercury-added product disproportionately affect children, per 713.9 General requirements for which the definition of ‘‘covered regulatory information must be reported. with the purpose of obtaining an action’’ in section 2–202 of the 713.11 Specific requirements for which immediate or eventual commercial Executive Order. This action is not information must be reported. advantage for the manufacturer, except subject to Executive Order 13045 713.13 Contextual requirements for which a product that contains a component information must be reported. because it does not concern an that is a mercury-added product. 713.15 Persons who must report. (3) Intentional use of mercury in a environmental health risk or safety risk, 713.17 Persons not subject to this part. manufacturing process, other than the nor is this action economically 713.19 Reporting information to EPA. manufacture of a mercury compound or 713.21 When to report. significant as the impact of this action a mercury-added product, with the will be less than $100 million. 713.23 Recordkeeping requirements. 713.25 Electronic filing. purpose of obtaining an immediate or I. Executive Order 13211: Actions eventual commercial advantage for the Concerning Regulations That Authority: 15 U.S.C. 2607(b)(10)(D). processor, except mercury generated as a byproduct not used for commercial Significantly Affect Energy Supply, § 713.1 Purpose, scope, and compliance. Distribution, or Use purposes. (a) This part specifies reporting and (4) Distribution in commerce, This proposed rule is not subject to recordkeeping procedures under section including domestic sale or transfer, of Executive Order 13211 (66 FR 28355, 8(b)(10) of the Toxic Substances Control mercury or a mercury-added product. Act (TSCA) (15 U.S.C. 2607(b)(10)) for May 22, 2001) because it is not expected (5) Storage of mercury after certain manufacturers (including to affect energy supply, distribution, or manufacture (including import). importers) and processers of mercury as use. (6) Export of mercury or a mercury- defined in section 8(b)(10)(A) to include added product, including the J. National Technology Transfer and elemental mercury and mercury determining and controlling the sending Advancement Act (NTTAA) compounds. Section 8(b)(10)(D) of of mercury (unless specifically TSCA authorizes the EPA Administrator prohibited) or a mercury-added product Since this action does not involve any to require reporting from any person to a destination out of the customs technical standards, section 12(d) of who manufactures mercury or mercury- territory of the United States. NTTAA, 15 U.S.C. 272 note, does not added products or otherwise (d) Section 15(3) of TSCA makes it apply to this section. intentionally uses mercury in a unlawful for any person to fail or refuse manufacturing process to carry out and to submit information required under K. Executive Order 12898: Federal publish in the Federal Register an Actions To Address Environmental this part. In addition, TSCA section inventory of mercury supply, use, and 15(3) makes it unlawful for any person Justice in Minority Populations and trade in the United States. In to fail to keep, and permit access to, Low-Income Populations administering this mercury inventory, records required by this part. Section 16 This action is not subject to Executive EPA will identify any manufacturing of TSCA provides that any person who processes or products that intentionally Order 12898 (59 FR 7629, February 16, violates a provision of TSCA section 15 add mercury and recommend actions, 1994) because it does not establish an is liable to the United States for a civil including proposed revisions of Federal environmental health or safety standard. penalty and may be criminally law or regulations, to achieve further prosecuted. Pursuant to TSCA section This action establishes an information reductions in mercury use. EPA intends requirement and does not affect the 17, the Federal Government may seek to use the collected information to judicial relief to compel submission of level of protection provided to human implement TSCA and shape the TSCA section 8 information and to health or the environment. Agency’s efforts to recommend actions, otherwise restrain any violation of List of Subjects in 40 CFR Part 713 both voluntary and regulatory, to reduce TSCA section 15. the use of mercury in commerce. In so (e) Each person who reports under Environmental protection, Mercury, doing, the Agency will conduct timely this part must certify the accuracy of its Elemental mercury, Mercury evaluation and refinement of these information and maintain records that compounds, Inventory, Supply, Use, reporting requirements so that they are document information reported under Trade, Manufacture, Import, Export. efficient and non-duplicative for this part and, in accordance with TSCA, reporters. Dated: October 19, 2017. permit access to, and the copying of, (b) This part applies to the activities such records by EPA officials. E. Scott Pruitt, associated with the periodic publication Administrator. of information on mercury supply, use, § 713.5 Mercury for which information must be reported. Therefore, it is proposed that 40 CFR and trade in the United States. (c) For purposes of this part, the (a) Elemental mercury (Chemical chapter I, subchapter R, be amended by reporting for mercury supply, use, and Abstracts Registry Number 7439–97–6); adding a new part 713 to read as trade includes the following activities: or follows: (1) Import of mercury or a mercury- (b) A mercury compound, including added product with the purpose of but not limited to the mercury
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compounds listed in Table 1 of this part by Chemical Abstracts Registry Number:
TABLE 1—MERCURY COMPOUNDS
Chemical abstracts registry No. Mercury compound
10045–94–0 ...... Nitric acid, mercury(2+) salt (2:1). 100–57–2 ...... Mercury, hydroxyphenyl-. 10112–91–1 ...... Mercury chloride (Hg2Cl2). 10124–48–8 ...... Mercury amide chloride (Hg(NH2)Cl). 103–27–5 ...... Mercury, phenyl(propanoato-.kappa.O)-. 10415–75–5 ...... Nitric acid, mercury(1+) salt (1:1). 104–60–9 ...... Mercury, (9-octadecenoato-.kappa.O)phenyl-. 1191–80–6 ...... 9-Octadecenoic acid (9Z)-, mercury(2+) salt (2:1). 12068–90–5 ...... Mercury telluride (HgTe). 13170–76–8 ...... Hexanoic acid, 2-ethyl-, mercury(2+) salt (2:1). 13302–00–6 ...... Mercury, (2-ethylhexanoato-.kappa.O)phenyl-. 1335–31–5 ...... Mercury cyanide oxide (Hg2(CN)2O). 1344–48–5 ...... Mercury sulfide (HgS). 1345–09–1 ...... Cadmium mercury sulfide. 13876–85–2 ...... Mercurate(2-), tetraiodo-, copper(1+) (1:2), (T–4)-. 138–85–2 ...... Mercurate(1-), (4-carboxylatophenyl)hydroxy-, sodium (1:1). 141–51–5 ...... Mercury, iodo(iodomethyl)-. 14783–59–6 ...... Mercury, bis[(2-phenyldiazenecarbothioic acid-.kappa.S) 2-phenylhydrazidato-.kappa.N2]-, (T–4)-. 15385–58–7 ...... Mercury, dibromodi-, (Hg-Hg). 15785–93–0 ...... Mercury, chloro[4-[(2,4-dinitrophenyl)amino]phenyl]-. 15829–53–5 ...... Mercury oxide (Hg2O). 1600–27–7 ...... Acetic acid, mercury(2+) salt (2:1). 1785–43–9 ...... Mercury, chloro(ethanethiolato)-. 19447–62–2 ...... Mercury, (acetato-.kappa.O)[4-[2-[4-(dimethylamino)phenyl]diazenyl]phenyl]-. 20582–71–2 ...... Mercurate(2-), tetrachloro-, potassium (1:2), (T–4)-. 20601–83–6 ...... Mercury selenide (HgSe). 21908–53–2 ...... Mercury oxide (HgO). 22450–90–4 ...... Mercury(1+), amminephenyl-, acetate (1:1). 24579–90–6 ...... Mercury, chloro(2-hydroxy-5-nitrophenyl)-. 24806–32–4 ...... Mercury, [.mu.-[2-dodecylbutanedioato(2-)-.kappa.O1:.kappa.O4]]diphenyldi-. 26545–49–3 ...... Mercury, (neodecanoato-.kappa.O)phenyl-. 27685–51–4 ...... Cobaltate(2-), tetrakis(thiocyanato-.kappa.N)-, mercury(2+) (1:1), (T–4)-. 29870–72–2 ...... Cadmium mercury telluride ((Cd,Hg)Te). 3294–57–3 ...... Mercury, phenyl(trichloromethyl)-. 33770–60–4 ...... Mercury, [3,6-dichloro-4,5-di(hydroxy-.kappa.O)-3,5-cyclohexadiene-1,2-dionato(2-)]-. 3570–80–7 ...... Mercury, bis(acetato-.kappa.O)[.mu.-(3′,6′-dihydroxy-3-oxospiro[isobenzofuran-1(3H),9′-[9H]xanthene]-2′,7′- diyl)]di-. 537–64–4 ...... Mercury, bis(4-methylphenyl)-. 539–43–5 ...... Mercury, chloro(4-methylphenyl)-. 54–64–8 ...... Mercurate(1-), ethyl[2-(mercapto-.kappa.S)benzoato(2-)-.kappa.O]-, sodium (1:1). 55–68–5 ...... Mercury, (nitrato-.kappa.O)phenyl-. 56724–82–4 ...... Mercury, phenyl[(2-phenyldiazenecarbothioic acid-.kappa.S) 2-phenylhydrazidato-.kappa.N2]-. 587–85–9 ...... Mercury, diphenyl-. 592–04–1 ...... Mercury cyanide (Hg(CN)2). 592–85–8 ...... Thiocyanic acid, mercury(2+) salt (2:1). 593–74–8 ...... Mercury, dimethyl-. 59–85–8 ...... Mercurate(1-), (4-carboxylatophenyl)chloro-, hydrogen. 623–07–4 ...... Mercury, chloro(4-hydroxyphenyl)-. 62–38–4 ...... Mercury, (acetato-.kappa.O)phenyl-. 62638–02–2 ...... Cyclohexanebutanoic acid, mercury(2+) salt (2:1). 627–44–1 ...... Mercury, diethyl-. 6283–24–5 ...... Mercury, (acetato-.kappa.O)(4-aminophenyl)-. 628–86–4 ...... Mercury, bis(fulminato-.kappa.C)-. 629–35–6 ...... Mercury, dibutyl-. 63325–16–6 ...... Mercurate(2-), tetraiodo-, (T–4)-, hydrogen, compd. with 5-iodo-2-pyridinamine (1:2:2). 63468–53–1 ...... Mercury, (acetato-.kappa.O)(2-hydroxy-5-nitrophenyl)-. 63549–47–3 ...... Mercury, bis(acetato-.kappa.O)(benzenamine)-. 68201–97–8 ...... Mercury, (acetato-.kappa.O)diamminephenyl-, (T–4)-. 72379–35–2 ...... Mercurate(1-), triiodo-, hydrogen, compd. with 3-methyl-2(3H)-benzothiazolimine (1:1:1). 7439–97–6 ...... Mercury. 7487–94–7 ...... Mercury chloride (HgCl2). 7546–30–7 ...... Mercury chloride (HgCl). 7616–83–3 ...... Perchloric acid, mercury(2+) salt (2:1). 7774–29–0 ...... Mercury iodide (HgI2). 7783–33–7 ...... Mercurate(2-), tetraiodo-, potassium (1:2), (T–4)-. 7783–35–9 ...... Sulfuric acid, mercury(2+) salt (1:1). 7783–39–3 ...... Mercury fluoride (HgF2). 7789–47–1 ...... Mercury bromide (HgBr2).
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TABLE 1—MERCURY COMPOUNDS—Continued
Chemical abstracts registry No. Mercury compound
90–03–9 ...... Mercury, chloro(2-hydroxyphenyl)-. 94070–93–6 ...... Mercury, [.mu.-[(oxydi-2,1-ethanediyl 1,2-benzenedicarboxylato-.kappa.O2)(2-)]]diphenyldi-.
§ 713.7 Mercury for which reporting is not (5) Amount of mercury distributed in manufacture of a mercury compound or required. commerce (lbs.). a mercury-added product, shall report, (a) Mercury that is generated as a (c) Persons who sell mercury-added as applicable: byproduct not used for commercial products, except a product that contains (1) Amount of mercury otherwise purposes; or a component that is a mercury-added intentionally used (lbs.) in a (b) Mercury-containing waste. product, in IMERC Notification states manufacturing process; shall report, as applicable: § 713.9 General requirements for which (1) Amount of mercury in (2) Amount of mercury stored (lbs.); information must be reported. manufactured (other than imported) (3) Amount of mercury in exported (a) Persons who manufacture products (lbs.); final product(s) (lbs.); or (including import) mercury in amounts (2) Amount of mercury in imported (4) Amount of mercury in final greater than or equal to 2,500 pounds products (lbs.); or product(s) distributed in commerce (lbs.) for elemental mercury or greater (3) Amount of mercury in exported (lbs.). than or equal to 25,000 lbs. for mercury products (lbs.). compounds for a specific reporting year (d) All other persons who § 713.11 Specific requirements for which shall report, as applicable: manufacture (including import) information must be reported. (1) Amount of mercury stored (lbs.); mercury-added products, except a (a) Any person who manufactures or product that contains a component that (including imports) mercury shall (2) Amount of mercury distributed in is a mercury-added product, shall specify, as applicable, the specific commerce (lbs.) report, as applicable: mercury compound(s) from a pre- (b) All other persons who (1) Amount of mercury in manufacture (including import) mercury selected list (as listed in Table 1 of this manufactured (other than imported) part). shall report, as applicable: products (lbs.); (1) Amount of mercury manufactured (2) Amount of mercury in imported (b) Any person who manufactures (other than imported) (lbs.); products (lbs.); (including imports) a mercury-added (2) Amount of mercury imported (3) Amount of mercury in exported product, except manufacture (including (lbs.); products (lbs.); import) of a product that contains a (3) Amount of mercury exported (4) Amount of mercury in products component that is a mercury-added (lbs.), except mercury prohibited from distributed in commerce (lbs.); or product, shall specify as applicable, the export at 15 U.S.C. 2611(c)(1) and (7); (e) Persons who otherwise specific category(ies) and (4) Amount of mercury stored (lbs.); intentionally use mercury in a subcategory(ies) from a pre-selected list, or manufacturing process, other than the as listed in Table 2 of this part:
TABLE 2—CATEGORIES AND SUBCATEGORIES OF MERCURY-ADDED PRODUCTS
Category Subcategory
Batteries ...... —Button cell, silver. —Button cell, zinc-air. —Button cell, alkaline. —Stacked button cell batteries. —Manganese oxide. —Silver oxide. —Mercuric oxide, non-button cell. —Button cell, mercuric oxide. —Button cell, zinc carbon. —Other (specify). Dental amalgam ...... [No subcategories]. Formulated products (includes uses in cosmetics, pesticides, and lab- —Skin-lightening creams. oratory chemicals). —Lotions. —Soaps and sanitizers. —Bath oils and salts. —Topical antiseptics. —Preservatives (e.g., for use in vaccines and eye-area cosmetics when no preservative alternatives are available). —Pharmaceuticals (including prescription and over-the-counter drug products). —Cleaning products (not registered as pesticides under the Federal In- secticide, Fungicide, and Rodenticide Act). —Pesticides. —Paints. —Dyes. —Reagents (e.g., catalysts, buffers, fixatives).
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TABLE 2—CATEGORIES AND SUBCATEGORIES OF MERCURY-ADDED PRODUCTS—Continued
Category Subcategory
—Other (specify). Lighting, lamps, bulbs ...... —Linear fluorescent. —Compact fluorescent. —U-tube and circular fluorescent. —Cold cathode fluorescent. —External electrode fluorescent. —Mercury vapor. —Metal halide. —High pressure sodium. —Mercury short arc. —Neon. —Other (specify). Measuring instruments ...... —Barometer. —Fever thermometer. —Flow meter. —Hydrometer. —Hygrometer/psychrometer. —Manometer. —Non-fever thermometer. —Pyrometer. —Sphygmomanometer. —Other (specify). Pump seals ...... [No subcategories]. Switches, relays, sensors, valves ...... —Tilt switch. —Vibration switch. —Float switch. —Pressure switch. —Temperature switch. —Displacement relay. —Wetted reed relay. —Contact relay. —Flame sensor. —Thermostat. —Other (specify). Miscellaneous/novelty mercury-added products ...... —Wheel weights. —Wheel rotation balancers/stabilizers. —Firearm recoil suppressors. —Carburetor synchronizers. —Joint support/shock absorption bands. —Other (specify).
(c) Any person who otherwise selected list, as listed in Table 4 of this (b) All other persons who intentionally uses mercury in a part: manufacture (including import) mercury manufacturing process, other than the shall report, as applicable: manufacture of a mercury compound or TABLE 4—SPECIFIC USE OF MERCURY (1) Country(ies) of origin for imported a mercury-added product, shall specify, IN A MANUFACTURING PROCESS mercury; as applicable: (2) Country(ies) of destination for (1) The specific manufacturing Catalyst. exported mercury; process for which mercury is otherwise Reactant. (3) NAICS code(s) for mercury intentionally added from a pre-selected Reagent. distributed in commerce. Other (specify). list, as listed in Table 3 of this part: (c) Persons who sell mercury-added products, except a product that contains TABLE 3—MANUFACTURING PROCESS § 713.13 Contextual requirements for a component that is a mercury-added which information must be reported. FOR WHICH MERCURY IS OTHER- product, in IMERC Notification states (a) Persons who manufacture shall report, as applicable: WISE INTENTIONALLY ADDED (including import) mercury in amounts (1) Country(ies) of origin for imported Chlorine production (e.g., mercury-cell chlor- greater than or equal to 2,500 lbs. for products; alkali process). elemental mercury or greater than or (2) Country(ies) of destination for Acetaldehyde production. equal to 25,000 lbs. for mercury exported products; or Vinyl chloride monomer production. compounds for a specific reporting year (3) NAICS code(s) for products Sodium/potassium methylate/ethylate produc- shall report, as applicable: distributed in commerce. tion. (1) Country(ies) of origin for imported (d) All other persons who Polyurethane/plastic production. mercury; manufacture (including import) Other (specify). (2) Country(ies) of destination for mercury-added products, except a exported mercury; product that contains a component that (2) The specific use of mercury in a (3) NAICS code(s) for mercury is a mercury-added product, shall manufacturing process from a pre- distributed in commerce. report, as applicable:
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(1) Country(ies) of origin for imported shipping, warehousing, repackaging, or 2019. Subsequent recurring submission products; retail sale), but does not first deadlines are from July 1, in 3-year (2) Country(ies) of destination for manufacture (including import) mercury intervals, beginning in 2022. exported products; or or mercury-added products or otherwise (3) NAICS code(s) for products intentionally use mercury in a § 713.23 Recordkeeping requirements. distributed in commerce. manufacturing process. Each person who is subject to the (e) Persons who otherwise reporting requirements of this part must § 713.19 Reporting information to EPA. intentionally use mercury in a retain records that document any manufacturing process, other than the Any person who must report under information reported to EPA. Records manufacture of a mercury compound or this part shall report for the submission relevant to a reporting year must be a mercury-added product, shall report, period described at § 713.21: retained for a period of 3 years as applicable: (a) Quantities of mercury in pounds beginning on the last day of the (1) Country(ies) of destination for per applicable activity listed under the reporting year. Submitters are exported final product(s); or general requirements for which encouraged to retain their records longer (2) NAICS code(s) for mercury in final information must be reported described product(s) distributed in commerce. than 3 years to ensure that past records at § 713.9; are available as a reference when new § 713.15 Persons who must report. (b) Specific requirements for which submissions are being generated. (a) Any person who manufactures information must be reported described § 713.25 Electronic filing. (including imports) mercury; at § 713.11; (b) Any person who manufactures (c) Contextual requirements for which (a) You must use [xxx name of (including imports) a mercury-added information must be reported described application xxx] to complete and submit product, except a product that contains at § 713.13; and [xxx form? xxx]. Submissions may only a component that is a mercury-added (d) According to the procedures be made as set forth in this section. described at § 713.25. product; or (b) Submissions must be sent (c) Any person who otherwise § 713.21 When to report. electronically to EPA via CDX. intentionally uses mercury in a manufacturing process, other than the (a) Any person who must report under (c) Access [xxx name of application manufacture of a mercury compound or this part shall report for the reporting xxx] and instructions, as follows: a mercury-added product. year described as follows. The 2020 (1) By Web site. Go to the EPA [xxx reporting year is from January 1 to name of application xxx] homepage at § 713.17 Persons not subject to this part. December 31, 2018. Subsequent http://www.epa.gov/[xxxURLxxx] and (a) Any person engaged in the recurring reporting years are from follow the appropriate links. generation, handling, or management of January 1 to December 31 at 3-year mercury-containing waste, unless that intervals, beginning in 2021. (2) By phone or email. Contact the person manufactures or recovers (b) All information reported for an EPA TSCA Hotline at (202) 554–1404 or mercury in the management of that applicable reporting year must be [email protected] for a CD–ROM waste. submitted on or before the first day of containing the instructions. (b) Any person who engaged in trade July following the reporting year. The [FR Doc. 2017–23225 Filed 10–25–17; 8:45 am] (e.g., brokering, selling wholesale, 2020 submission deadline is July 1, BILLING CODE 6560–50–P
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Notices Federal Register Vol. 82, No. 206
Thursday, October 26, 2017
This section of the FEDERAL REGISTER 2017, the Access Board will consider DEPARTMENT OF COMMERCE contains documents other than rules or the following agenda items: proposed rules that are applicable to the • Approval of draft meeting minutes Foreign-Trade Zones Board public. Notices of hearings and investigations, committee meetings, agency decisions and (vote): March 15, 2017; July 12, 2017; [S–164–2017] September 13, 2017 rulings, delegations of authority, filing of • petitions and applications and agency Ad Hoc Committee Reports: Design Foreign-Trade Zone 295—Central statements of organization and functions are Guidance; Frontier Issues Pennsylvania; Application for examples of documents appearing in this • Technical Programs Committee Subzone; North American Ho¨ gana¨s section. • Budget Committee Company; Johnstown, Hollsopple and • Planning and Evaluation Committee St, Mary’s, Pennsylvania • Election Assistance Commission An application has been submitted to ARCHITECTURAL AND Report the Foreign-Trade Zones (FTZ) Board by TRANSPORTATION BARRIERS • Executive Director’s Report the Pennsylvania Foreign Trade Zone COMPLIANCE BOARD • Public Comment (final 15 minutes of Corporation, grantee of FTZ 295, the meeting) Meetings requesting subzone status for the Members of the public can provide facilities of North American Ho¨gana¨s AGENCY: Architectural and comments either in-person or over the Company (Ho¨gana¨s), located in Transportation Barriers Compliance telephone during the final 15 minutes of Johnstown, Hollsopple and St. Mary’s, Board. the Board meeting on Wednesday, Pennsylvania. The application was ACTION: Notice of meetings. November 15, 2017. Any individual submitted pursuant to the provisions of interested in providing comment is the Foreign-Trade Zones Act, as SUMMARY: The Architectural and asked to pre-register by sending an amended (19 U.S.C. 81a–81u), and the Transportation Barriers Compliance email to [email protected] with regulations of the FTZ Board (15 CFR Board (Access Board) plans to hold its the subject line ‘‘Access Board part 400). It was formally docketed on regular committee and Board meetings meeting—Public Comment’’ with your October 19, 2017. in Washington, DC, Monday through name, organization, state, and topic of The proposed subzone would consist Wednesday, November 13–15, 2017 at comment included in the body of your of the following sites: Site 1 (9.38 acres) the times and location listed below. email. All emails to register for public 101 Bridge Street, Johnstown, Cambria DATES: The schedule of events is as comment must be received by County; Site 2 (98.98 acres) 111 Ho¨gana¨s follows: Wednesday, November 8, 2017. Way, Hollsopple, Somerset County; and, Commenters will be provided with a Site 3 (3.42 acres) 210 Ceramic Street, Monday, November 13, 2017 call-in number and passcode before the St. Mary’s, Elk County. No authorization 9:30 a.m.–4:00 p.m. Achieving Access meeting. Commenters will be called on for production activity has been for People with Disabilities in the in the order by which they are pre- requested at this time. The proposed Built Environment; an International registered. Due to time constraints, each subzone would be subject to the existing Comparison commenter is limited to two minutes. activation limit of FTZ 295. In accordance with the FTZ Board’s Tuesday, November 14, 2017 Commenters on the telephone will be in a listen-only capacity until they are regulations, Elizabeth Whiteman of the 9:30 a.m.–10:30 a.m. Technical called on. FTZ Staff is designated examiner to Programs All meetings are accessible to persons review the application and make 10:30 a.m.–11:30 a.m. Ad Hoc with disabilities. An assistive listening recommendations to the Executive Committee on Frontier Issues system, Communication Access Secretary. 11:30 a.m.–Noon Budget Realtime Translation (CART), and sign Public comment is invited from Wednesday, November 15, 2017 language interpreters will be available at interested parties. Submissions shall be the Board meeting and committee addressed to the FTZ Board’s Executive 10:00 a.m.–10:30 a.m. Ad Hoc meetings. Secretary at the address below. The Committee on Design Guidance closing period for their receipt is 10:30 a.m.–Noon Planning and Persons attending Board meetings are requested to refrain from using perfume, December 5, 2017. Rebuttal comments Evaluation in response to material submitted 1:30 p.m.–3:00 p.m. Board Meeting cologne, and other fragrances for the comfort of other participants (see during the foregoing period may be ADDRESSES: Meetings will be held at the www.access-board.gov/the-board/ submitted during the subsequent 15-day Access Board Conference Room, 1331 F policies/fragrance-free-environment for period to December 20, 2017. Street NW., Suite 800, Washington, DC more information). A copy of the application will be 20004. You may view the Wednesday, available for public inspection at the FOR FURTHER INFORMATION CONTACT: For November 15, 2017 meeting through a Office of the Executive Secretary, further information regarding the live webcast from 1:30 p.m. to 3:00 p.m. Foreign-Trade Zones Board, Room meetings, please contact David Capozzi, at: www.access-board.gov/webcast. 21013, U.S. Department of Commerce, Executive Director, (202) 272–0010 1401 Constitution Avenue NW., (voice); (202) 272–0054 (TTY). David M. Capozzi, Washington, DC 20230–0002, and in the SUPPLEMENTARY INFORMATION: At the Executive Director. ‘‘Reading Room’’ section of the FTZ Board meeting scheduled on the [FR Doc. 2017–23323 Filed 10–25–17; 8:45 am] Board’s Web site, which is accessible afternoon of Wednesday, November 15, BILLING CODE 8150–01–P via www.trade.gov/ftz.
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For further information, contact petitioner filed responses to these and the PRC. For a full description of Elizabeth Whiteman at requests on October 4, 2017, and the scope of these investigations, see the [email protected] or (202) October 5, 2017.4 In addition, the ‘‘Scope of the Investigations,’’ in the 482–0473. petitioner filed revised scope language Appendix to this notice. 5 Dated: October 20, 2017. on October 13, 2017. In accordance with section 732(b) of Comments on Scope of the Andrew McGilvray, the Tariff Act of 1930, as amended (the Investigations Executive Secretary. Act), the petitioner alleges that imports During our review of the Petitions, the [FR Doc. 2017–23309 Filed 10–25–17; 8:45 am] of PTFE resin from India and the PRC petitioner submitted a revised proposed BILLING CODE 3510–DS–P are being, or are likely to be, sold in the scope to ensure that the scope language United States at less than fair value in the Petitions would be an accurate within the meaning of section 731 of the reflection of the products for which the DEPARTMENT OF COMMERCE Act, and that such imports are domestic industry is seeking relief.7 materially injuring, or threatening As discussed in the preamble to the International Trade Administration material injury to, the domestic industry Department’s regulations, we are setting [A–533–879, A–570–066] producing PTFE resin in the United aside a period for interested parties to States. Also, consistent with section raise issues regarding product coverage Polytetrafluoroethylene Resin From 732(b)(1) of the Act, the Petitions are (scope).8 The Department will consider India and the People’s Republic of accompanied by information reasonably all comments received from interested China: Initiation of Less-Than-Fair- available to the petitioner supporting its parties and, if necessary, will consult Value Investigations allegations. with interested parties prior to the The Department finds that the issuance of the preliminary AGENCY: Enforcement and Compliance, petitioner is an interested party as determinations. If scope comments International Trade Administration, defined in section 771(9)(C) of the Act include factual information,9 all such Department of Commerce. and that the petitioner filed these factual information should be limited to DATES: Applicable October 18, 2017. Petitions on behalf of the domestic public information. To facilitate FOR FURTHER INFORMATION CONTACT: industry and demonstrated sufficient preparation of its questionnaires, the Mark Kennedy at (202) 482–7883 industry support with respect to the Department requests all interested (India), and Catherine Cartsos (the initiation of the AD investigations that parties to submit such comments by People’s Republic of China (PRC)) at the petitioner is requesting.6 5:00 p.m. Eastern Time (ET) on (202) 482–1757, AD/CVD Operations, Tuesday, November 7, 2017, which is 20 Periods of Investigation Enforcement and Compliance, calendar days from the signature date of International Trade Administration, Because the Petitions were filed on this notice. Any rebuttal comments, U.S. Department of Commerce, 1401 September 28, 2017, the period of which may include factual information, Constitution Avenue NW., Washington, investigation (POI) for India is July 1, must be filed by 5:00 p.m. ET on Friday, DC 20230. 2016, through June 30, 2017. Because November 17, 2017, which is 10 the PRC is a non-market economy SUPPLEMENTARY INFORMATION: calendar days from the initial comments (NME) country, the POI for the PRC is deadline.10 The Petitions January 1, 2017, through June 30, 2017. The Department requests that any On September 28, 2017, the U.S. Scope of the Investigations factual information the parties consider Department of Commerce (the relevant to the scope of the The product covered by these investigations be submitted during this Department) received antidumping duty investigations is PTFE resin from India (AD) Petitions concerning imports of time period. However, if a party polytetrafluoroethylene resin (PTFE subsequently finds that additional Polytetrafluoroethylene Resin from the People’s factual information pertaining to the resin) from India and the PRC, filed in Republic of China: Supplemental Questions,’’ dated proper form on behalf of The Chemours October 2, 2017 (PRC AD Supplemental scope of the investigations may be Company FC LLC (the petitioner).1 The Questionnaire); Letter from the Department, relevant, the party may contact the AD Petitions were accompanied by a ‘‘Petition for the Imposition of Antidumping Duties Department and request permission to on Imports of Polytetrafluoroethylene Resin from submit the additional information. All countervailing duty (CVD) Petition India: Supplemental Questions,’’ dated October 3, concerning imports of PTFE resin from 2017 (India AD Supplemental Questionnaire). such comments must be filed on the India. The petitioner is a domestic 4 See Letter from the petitioner, records of each of the concurrent AD 2 ‘‘Polytetrafluoroethylene (PTFE) Resin from the and CVD investigations. producer of PTFE resin. People’s Republic of China and India: Responses to On October 2, 2017, and October 3, Supplemental Questions Regarding the Filing Requirements Antidumping and Countervailing Duty Petitions’’ 2017, the Department requested All submissions to the Department supplemental information pertaining to (October 4, 2017) (General Issues and AD 3 Supplement); see also Letter from the petitioner, must be filed electronically using certain areas of the Petitions. The ‘‘Polytetrafluoroethylene (PTFE) Resin from the Enforcement and Compliance’s People’s Republic of China and India: Additional Antidumping Duty and Countervailing 1 See Letter to the Secretary of Commerce re: Responses to Supplemental Questions Regarding ‘‘Polytetrafluoroethylene (PTFE) Resin from the the Antidumping and Countervailing Duty People’s Republic of China and India: Antidumping Petitions’’ (October 5, 2017); Letter from the 7 See Letter from the petitioner, and Countervailing Duty Petitions,’’ dated petitioner, ‘‘Polytetrafluoroethylene (PTFE) Resin ‘‘Polytetrafluoroethylene (PTFE) Resin from the September 28, 2017 (the Petitions). from India: Exhibit III–12’’ (October 5, 2017). People’s Republic of China and India: Amendment 2 See the Petitions at 2. 5 See Letter from the petitioner, to the Suggested Scope of the Antidumping and 3 See Letter from the Department, ‘‘Petitions for ‘‘Polytetrafluoroethylene (PTFE) Resin from the Countervailing Duty Petitions’’ (October 13, 2017). the Imposition of Antidumping and Countervailing People’s Republic of China and India: Amendment See also Memorandum to the File, dated October Duties on Imports of Polytetrafluoroethylene Resin to the Suggested Scope of the Antidumping and 11, 2017. from India and the People’s Republic of China: Countervailing Duty Petitions’’ (October 13, 2017). 8 See Antidumping Duties; Countervailing Duties, Supplemental Questions,’’ dated October 2, 2017 See also Memorandum to the File, dated October Final Rule, 62 FR 27296, 27323 (May 19, 1997). (General Issues Questionnaire); see also Letter from 11, 2017. 9 See 19 CFR 351.102(b)(21) (defining ‘‘factual the Department, ‘‘Petition for the Imposition of 6 See the ‘‘Determination of Industry Support for information’’). Antidumping Duties on Imports of the Petitions’’ section, below. 10 See 19 CFR 351.303(b).
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Duty Centralized Electronic Service and the least important characteristics may result in different definitions of the System (ACCESS).11 An electronically last. like product, such differences do not filed document must be received In order to consider the suggestions of render the decision of either agency successfully in its entirety by the time interested parties in developing and contrary to law.13 and date it is due. Documents exempted issuing the AD questionnaires, all Section 771(10) of the Act defines the from the electronic submission product characteristics comments must domestic like product as ‘‘a product requirements must be filed manually be filed by 5:00 p.m. ET on November which is like, or in the absence of like, (i.e., in paper form) with Enforcement 7, 2017. Any rebuttal comments must be most similar in characteristics and uses and Compliance’s APO/Dockets Unit, filed by 5:00 p.m. ET on November 17, with, the article subject to an Room 18022, U.S. Department of 2017. All comments and submissions to investigation under this title.’’ Thus, the Commerce, 1401 Constitution Avenue the Department must be filed reference point from which the NW., Washington, DC 20230, and electronically using ACCESS, as domestic like product analysis begins is stamped with the date and time of explained above, on the records of both ‘‘the article subject to an investigation’’ receipt by the applicable deadlines. the India and the PRC less-than-fair- (i.e., the class or kind of merchandise to value investigations. be investigated, which normally will be Comments on Product Characteristics the scope as defined in the petition). for AD Questionnaires Determination of Industry Support for With regard to the domestic like the Petitions The Department will provide product, the petitioner does not offer a interested parties an opportunity to Section 732(b)(1) of the Act requires definition of the domestic like product comment on the appropriate physical that a petition be filed on behalf of the distinct from the scope of the characteristics of PTFE resin to be domestic industry. Section 732(c)(4)(A) investigations. Based on our analysis of reported in response to the of the Act provides that a petition meets the information submitted on the Department’s AD questionnaires. This this requirement if the domestic record, we have determined that PTFE information will be used to identify the producers or workers who support the resin, as defined in the scope, key physical characteristics of the petition account for: (i) At least 25 constitutes a single domestic like merchandise under consideration in percent of the total production of the product and we have analyzed industry order to report the relevant costs of domestic like product; and (ii) more support in terms of that domestic like production accurately as well as to than 50 percent of the production of the product.14 develop appropriate product- domestic like product produced by that In determining whether the petitioner comparison criteria. portion of the industry expressing has standing under section 732(c)(4)(A) Interested parties may provide any support for, or opposition to, the of the Act, we considered the industry information or comments that they feel petition. Moreover, section 732(c)(4)(D) support data contained in the Petitions are relevant to the development of an of the Act provides that, if the petition with reference to the domestic like accurate list of physical characteristics. does not establish support of domestic product as defined in the ‘‘Scope of the Specifically, they may provide producers or workers accounting for Investigations,’’ in Appendix I of this comments as to which characteristics more than 50 percent of the total notice. The petitioner provided its own are appropriate to use as: (1) General production of the domestic like product, production of the domestic like product product characteristics and (2) product- the Department shall: (i) Poll the in 2016, as well as estimated 2016 comparison criteria. We note that it is industry or rely on other information in production data of the domestic like not always appropriate to use all order to determine if there is support for product by the entire U.S. industry.15 To product characteristics as product- the petition, as required by establish industry support, the comparison criteria. We base product- subparagraph (A); or (ii) determine petitioner compared its production to comparison criteria on meaningful industry support using a statistically the total 2016 production of the commercial differences among products. valid sampling method to poll the domestic like product for the entire 16 In other words, although there may be ‘‘industry.’’ domestic industry. We relied on the some physical product characteristics Section 771(4)(A) of the Act defines data the petitioner provided for utilized by manufacturers to describe the ‘‘industry’’ as the producers as a PTFE resin, it may be that only a select whole of a domestic like product. Thus, 13 See USEC, Inc. v. United States, 132 F. Supp. 2d 1, 8 (CIT 2001) (citing Algoma Steel Corp., Ltd. few product characteristics take into to determine whether a petition has the requisite industry support, the statute v. United States, 688 F. Supp. 639, 644 (CIT 1988), account commercially meaningful aff’d 865 F.2d 240 (Fed. Cir. 1989)). physical characteristics. In addition, directs the Department to look to 14 For a discussion of the domestic like product interested parties may comment on the producers and workers who produce the analysis in this case, see Antidumping Duty Investigation Initiation Checklist: order in which the physical domestic like product. The International Trade Commission (ITC), which is Polytetrafluoroethylene (PTFE) Resin from the characteristics should be used in People’s Republic of China (PRC AD Initiation matching products. Generally, the responsible for determining whether Checklist), at Attachment II, Analysis of Industry Department attempts to list the most ‘‘the domestic industry’’ has been Support for the Antidumping and Countervailing Duty Petitions Covering Polytetrafluoroethylene important physical characteristics first injured, must also determine what constitutes a domestic like product in (PTFE) Resin from the People’s Republic of China and India (Attachment II); and Antidumping Duty 11 See Antidumping and Countervailing Duty order to define the industry. While both Investigation Initiation Checklist: Proceedings: Electronic Filing Procedures; the Department and the ITC must apply Polytetrafluoroethylene (PTFE) Resin from India Administrative Protective Order Procedures, 76 FR the same statutory definition regarding (India AD Initiation Checklist), at Attachment II. 39263 (July 6, 2011); see also Enforcement and the domestic like product,12 they do so These checklists are dated concurrently with, and Compliance; Change of Electronic Filing System hereby adopted by, this notice and on file Name, 79 FR 69046 (November 20, 2014) for details for different purposes and pursuant to a electronically via ACCESS. Access to documents of the Department’s electronic filing requirements, separate and distinct authority. In filed via ACCESS is also available in the Central which went into effect on August 5, 2011. addition, the Department’s Records Unit, Room B8024 of the main Department Information on help using ACCESS can be found at determination is subject to limitations of of Commerce building. https://access.trade.gov/help.aspx and a handbook 15 See the Petitions, at 2–4 and Exhibit I–2; see can be found at https://access.trade.gov/help/ time and information. Although this also General Issues and AD Supplement, at 3–4. Handbook%20on%20Electronic%20Filling 16 See the Petitions, at Exhibit I–2; see also %20Procedures.pdf. 12 See section 771(10) of the Act. General Issues and AD Supplement, at 3–4.
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purposes of measuring industry alleges that subject imports exceed the for sale were made through a U.S. support.17 negligibility threshold provided for affiliate, the petitioner also based the Our review of the data provided in the under section 771(24)(A) of the Act.23 U.S. price on constructed export price Petitions and other information readily The petitioner contends that the (CEP) using price quotes for sales and available to the Department indicates industry’s injured condition is prices of actual sales of PTFE resin that the petitioner has established illustrated by a significant volume of produced in, and exported from, India industry support.18 First, the Petitions subject imports; an increase in the and offered for sale in the United established support from domestic volume of subject imports relative to States.29 Where applicable, the producers (or workers) accounting for U.S. consumption and production; petitioner made deductions from U.S. more than 50 percent of the total reduced market share; underselling and price for movement and other expenses, production of the domestic like product price suppression or depression; lost consistent with the terms of sale.30 and, as such, the Department is not sales and revenues; a negative impact on Normal Value required to take further action in order the domestic industry’s capacity, to evaluate industry support (e.g., capacity utilization, and employment; For India, the petitioner provided polling).19 Second, the domestic and a negative impact on revenues and home market price information for PTFE producers (or workers) have met the operating profits.24 We have assessed resin produced and offered for sale in statutory criteria for industry support the allegations and supporting evidence India that was obtained through market 31 under section 732(c)(4)(A)(i) of the Act regarding material injury, threat of research. For India, the petitioner because the domestic producers (or material injury, and causation, and we provided a declaration from a market workers) who support the Petitions have determined that these allegations researcher to support the price 32 account for at least 25 percent of the are properly supported by adequate information. total production of the domestic like evidence, and meet the statutory With respect to the PRC, the product.20 Finally, the domestic requirements for initiation.25 petitioner stated that the Department producers (or workers) have met the has found it to be a NME country in statutory criteria for industry support Allegations of Sales at Less Than Fair prior administrative proceedings in under section 732(c)(4)(A)(ii) of the Act Value which they were involved.33 In because the domestic producers (or The following is a description of the accordance with section 771(18)(C)(i) of workers) who support the Petitions allegations of sales at less than fair value the Act, the presumption of NME status account for more than 50 percent of the upon which the Department based its remains in effect until revoked by the production of the domestic like product decision to initiate AD investigations of Department. The presumption of NME produced by that portion of the industry imports of PTFE resin from India and status for the PRC has not been revoked expressing support for, or opposition to, the PRC. The sources of data for the by the Department and, therefore, the Petitions.21 Accordingly, the deductions and adjustments relating to remains in effect for purposes of the Department determines that the U.S. price and NV are discussed in initiation of this investigation. Petitions were filed on behalf of the greater detail in the country-specific Accordingly, NV in the PRC is domestic industry within the meaning initiation checklists. appropriately based on factors of of section 732(b)(1) of the Act. production (FOPs) valued in a surrogate The Department finds that the Export Price market economy country, in accordance 34 petitioner filed the Petitions on behalf of For the PRC, the petitioner based the with section 773(c) of the Act. In the the domestic industry because it is an U.S. price on export price (EP) using course of this investigation, all parties, interested party as defined in section average unit values (AUVs) of publicly and the public, will have the 771(9)(C) of the Act and it has available import data and price quotes opportunity to provide relevant demonstrated sufficient industry for sales of PTFE resin produced in, and information related to the granting of support with respect to the AD exported from, the PRC and offered for separate rates to individual exporters. investigations that it is requesting that sale in the United States.26 For India, The petitioner claims that Mexico is the Department initiate.22 the petitioner based U.S. price on EP an appropriate surrogate country for the using AUVs of publicly available import PRC because it is a market economy Allegations and Evidence of Material country that is at a level of economic data.27 Where applicable, the petitioner Injury and Causation development comparable to that of the made deductions from U.S. price for PRC, it is a significant producer of The petitioner alleges that the U.S. movement and other expenses, comparable merchandise, and public industry producing the domestic like consistent with the terms of sale.28 product is being materially injured, or is information from Mexico is available to threatened with material injury, by Constructed Export Price value all material input factors.35 Based reason of the imports of the subject For India, because the petitioner had on the information provided by the merchandise sold at less than normal reason to believe that the prices/offers petitioner, we determine that it is value (NV). In addition, the petitioner appropriate to use Mexico as a surrogate 23 See the Petitions, at 21 and Exhibit I–14. country for initiation purposes. 17 Id. For further discussion, see PRC AD 24 Id. at 24–34, Exhibit I–8, and Exhibits I–14, I– Interested parties will have the Initiation Checklist, at Attachment II; and India AD 16, and I–17. opportunity to submit comments Initiation Checklist, at Attachment II. 25 See PRC AD Initiation Checklist, at Attachment regarding surrogate country selection 18 See PRC AD Initiation Checklist, at Attachment III, Analysis of Allegations and Evidence of Material and, pursuant to 19 CFR II; and India AD Initiation Checklist, at Attachment Injury and Causation for the Antidumping and II. Countervailing Duty Petitions Covering 29 19 See section 732(c)(4)(D) of the Act; see also Polytetrafluoroethylene Resin (PTFE Resin) from See India AD Initiation Checklist. PRC AD Initiation Checklist, at Attachment II; and India and the People’s Republic of China (the PRC) 30 Id. India AD Initiation Checklist, at Attachment II. (Attachment III); see also India AD Initiation 31 Id. 20 See PRC AD Initiation Checklist, at Attachment Checklist, at Attachment III. 32 Id. II; and India AD Initiation Checklist, at Attachment 26 See PRC AD Initiation Checklist. 33 See the Petitions, at 38. II. 27 See India AD Initiation Checklist. 34 See PRC AD Initiation Checklist. 21 Id. 28 See India AD Initiation Checklist and PRC AD 35 See Petitions, at 39–42 and Exhibits I–1, II–2, 22 Id. Initiation Checklist. II–3.
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351.301(c)(3)(i), will be provided an material injury by the ITC.41 The parties and our analysis of the record opportunity to submit publicly available amendments to sections 771(15), 773, information. information to value FOPs within 30 776, and 782 of the Act are applicable With respect to the PRC, the days before the scheduled date of the to all determinations made on or after petitioner named 49 companies in the preliminary determination. August 6, 2015, and, therefore, apply to PRC as producers/exporters of PTFE these AD investigations.42 resin.44 In accordance with our standard Factors of Production practice for respondent selection in AD Because information regarding the Respondent Selection cases involving NME countries, we volume of inputs consumed by the PRC The petitioner named seven intend to issue quantity and value producers/exporters is not available, the companies in India as producers/ (Q&V) questionnaires to producers/ petitioner relied on its own production exporters of PTFE resin.43 For India, exporters of merchandise subject to this experience as an estimate of Chinese following standard practice in AD NME investigation and, in the event the 36 manufacturers’ FOPs. The petitioner investigations involving market Department determines that the number valued the estimated FOPs using economy countries, in the event the of producers/exporters involved in the surrogate values from Mexico and used Department determines that the number investigation is large, base respondent the average POI exchange rate to convert of producers/exporters involved in the selection on the responses received. For 37 the data to U.S. dollars. investigation is large, the Department this NME investigation, the Department Fair Value Comparisons intends to review U.S. Customs and will request Q&V information from known exporters and producers Based on the data provided by the Border Protection (CBP) data for U.S. imports of PTFE resin during the POI identified, with complete contact petitioner, there is reason to believe that information, in the Petitions. In imports of PTFE resin from India and under the appropriate Harmonized Tariff Schedule of the United States addition, the Department will post the the PRC are being, or are likely to be, Q&V questionnaire along with filing sold in the United States at less than fair subheadings, and if it determines that it cannot individually examine each instructions on Enforcement and value. Based on comparisons of EP and Compliance’s Web site at http:// CEP to NV for India and EP to NV for company based upon the Department’s resources, then the Department will www.trade.gov/enforcement/news.asp. the PRC in accordance with sections 772 Producers/exporters of PTFE resin and 773 of the Act, the estimated select respondents based on that data. We intend to release CBP data under from the PRC that do not receive Q&V dumping margins for PTFE resin for questionnaires by mail may still submit Administrative Protective Order (APO) each of the countries covered by this a response to the Q&V questionnaire to all parties with access to information initiation are as follows: (1) PRC—23.4 and can obtain a copy of the Q&V 38 protected by APO within five business to 408.9 percent, and (2) India—15.8 questionnaire from Enforcement & 39 days of the announcement of the to 128.1 percent. Compliance’s Web site. The Q&V initiation of this investigation. response must be submitted by the Initiation of Less-Than-Fair-Value Interested parties must submit relevant PRC exporters/producers no Investigations applications for disclosure under APO later than 5:00 p.m. ET on November 2, in accordance with 19 CFR 351.305(b). Based upon the examination of the 2017. All Q&V responses must be filed Instructions for filing such applications AD Petitions, we find that the Petitions electronically via ACCESS. meet the requirements of section 732 of may be found on the Department’s Web the Act. Therefore, we are initiating AD site at http://enforcement.trade.gov/apo. Separate Rates investigations to determine whether Interested parties may submit In order to obtain separate-rate status imports of PTFE resin from India and comments regarding the CBP data and in an NME investigation, exporters and the PRC are being, or are likely to be, respondent selection by 5:00 p.m. ET producers must submit a separate-rate sold in the United States at less than fair seven calendar days after the placement application.45 The specific requirements value. In accordance with section of the CBP data on the record of this for submitting a separate-rate 733(b)(1)(A) of the Act and 19 CFR investigation. Interested parties wishing application in the PRC investigation are 351.205(b)(1), unless postponed, we to submit rebuttal comments should outlined in detail in the application intend to make our preliminary submit those comments five calendar itself, which is available on the determinations no later than 140 days days after the deadline for initial Department’s Web site at http:// after the date of this initiation. comments. enforcement.trade.gov/nme/nme-sep- Under the Trade Preferences Comments must be filed rate.html. The separate-rate application Extension Act of 2015, numerous electronically using ACCESS. An will be due 30 days after publication of amendments to the AD and CVD law electronically-filed document must be this initiation notice.46 Exporters and were made.40 The 2015 law does not received successfully, in its entirety, by producers who submit a separate-rate specify dates of application for those ACCESS no later than 5:00 p.m. ET on application and have been selected as amendments. On August 6, 2015, the the date noted above. If respondent mandatory respondents will be eligible Department published an interpretative selection is necessary, within 20 days of for consideration for separate-rate status rule, in which it announced the publication of this notice, we intend to only if they respond to all parts of the applicability dates for each amendment make our decisions regarding to the Act, except for amendments respondent selection based upon 44 See the Petitions at Exhibit I–13. contained in section 771(7) of the Act, comments received from interested 45 See Policy Bulletin 05.1: Separate-Rates which relate to determinations of Practice and Application of Combination Rates in Antidumping Investigation involving Non-Market 41 See Dates of Application of Amendments to the Economy Countries (April 5, 2005), available at 36 See the Petitions, at 43 and Exhibit II–5. Antidumping and Countervailing Duty Laws Made http://enforcement.trade.gov/policy/bull05-1.pdf 37 See the Petitions, at 43–46 and Exhibits II–6, by the Trade Preferences Extension Act of 2015, 80 (Policy Bulletin 05.1). II–7, II–8, II–9, II–10, II–11, II–12, II–13, and II–14. FR 46793 (August 6, 2015). 46 Although in past investigations this deadline 38 See PRC AD Initiation Checklist. 42 Id. at 46794–95. The 2015 amendments may be was 60 days, consistent with 19 CFR 351.301(a), 39 See India AD Initiation Checklist. found at https://www.congress.gov/bill/114th- which states that ‘‘the Secretary may request any 40 See Trade Preferences Extension Act of 2015, congress/house-bill/1295/text/pl. person to submit factual information at any time PubLIC LAW 114–27, 129 Stat. 362 (2015). 43 See the Petitions, at Exhibit I–13. during a proceeding,’’ this deadline is now 30 days.
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Department’s AD questionnaire as negative ITC determination for either separate, stand-alone submission; under mandatory respondents. The country will result in the investigation limited circumstances we will grant Department requires that companies being terminated with respect to that untimely-filed requests for the extension from the PRC submit a response to both country.49 Otherwise, these of time limits. Parties should review the Q&V questionnaire and the separate- investigations will proceed according to Extension of Time Limits; Final Rule, 78 rate application by the respective statutory and regulatory time limits. FR 57790 (September 20, 2013), deadlines in order to receive Submission of Information available at http://www.gpo.gov/fdsys/ consideration for separate-rate status. pkg/FR-2013-09-20/html/2013- Companies not filing a timely Q&V Factual information is defined in 19 22853.htm, prior to submitting factual response will not receive separate-rate CFR 351.102(b)(21) as: (i) Evidence information in these investigations. consideration. submitted in response to questionnaires; (ii) evidence submitted in support of Certification Requirements Use of Combination Rates allegations; (iii) publicly available Any party submitting factual The Department will calculate information to value factors under 19 information in an AD or CVD combination rates for certain CFR 351.408(c) or to measure the proceeding must certify to the accuracy respondents that are eligible for a adequacy of remuneration under 19 CFR and completeness of that information.52 separate rate in an NME investigation. 351.511(a)(2); (iv) evidence placed on Parties must use the certifications The Separate Rates and Combination the record by the Department; and (v) formats provided in 19 CFR Rates Bulletin states: evidence other than factual information 351.303(g).53 The Department intends to described in (i)–(iv). 19 CFR 351.301(b) {w}hile continuing the practice of assigning reject factual submissions if the separate rates only to exporters, all separate requires any party, when submitting submitting party does not comply with rates that the Department will now assign in factual information, to specify under applicable certification requirements. its NME Investigation will be specific to which subsection of 19 CFR those producers that supplied the exporter 351.102(b)(21) the information is being Notification to Interested Parties during the period of investigation. Note, submitted 50 and, if the information is Interested parties must submit however, that one rate is calculated for the submitted to rebut, clarify, or correct applications for disclosure under APO exporter and all of the producers which factual information already on the in accordance with 19 CFR 351.305. On supplied subject merchandise to it during the record, to provide an explanation January 22, 2008, the Department period of investigation. This practice applies identifying the information already on published Antidumping and both to mandatory respondents receiving an individually calculated separate rate as well the record that the factual information Countervailing Duty Proceedings: 51 as the pool of non-investigated firms seeks to rebut, clarify, or correct. Time Documents Submission Procedures; receiving the weighted-average of the limits for the submission of factual APO Procedures, 73 FR 3634 (January individually calculated rates. This practice is information are addressed in 19 CFR 22, 2008). Parties wishing to participate referred to as the application of ‘‘combination 351.301, which provides specific time in these investigations should ensure rates’’ because such rates apply to specific limits based on the type of factual that they meet the requirements of these combinations of exporters and one or more information being submitted. Interested procedures (e.g., the filing of letters of producers. The cash-deposit rate assigned to parties should review the regulations appearance as discussed in 19 CFR an exporter will apply only to merchandise prior to submitting factual information 351.103(d)). both exported by the firm in question and This notice is issued and published produced by a firm that supplied the exporter in these investigations. during the period of investigation.47 pursuant to sections 732(c)(2) and 777(i) Extensions of Time Limits of the Act, and 19 CFR 351.203(c). Distribution of Copies of the Petitions Parties may request an extension of Dated: October 18, 2017. time limits before the expiration of a In accordance with section Gary Taverman, 732(b)(3)(A)(i) of the Act and 19 CFR time limit established under 19 CFR 351.301, or as otherwise specified by the Deputy Assistant Secretary for Antidumping 351.202(f), copies of the public version and Countervailing Duty Operations of the Petitions have been provided to Secretary. In general, an extension performing the non-exclusive functions and the governments of India and the PRC request will be considered untimely if it duties of the Assistant Secretary for via ACCESS. To the extent practicable, is filed after the expiration of the time Enforcement and Compliance. limit established under 19 CFR 351.301. we will attempt to provide a copy of the Appendix public version of the Petitions to each For submissions that are due from exporter named in the Petitions, as multiple parties simultaneously, an Scope of the Investigations provided under 19 CFR 351.203(c)(2). extension request will be considered The product covered by these untimely if it is filed after 10:00 a.m. ET investigations is polytetrafluoroethylene ITC Notification on the due date. Under certain (PTFE) resin, including but not limited to We will notify the ITC of our circumstances, we may elect to specify granular, dispersion, or coagulated initiation, as required by section 732(d) a different time limit by which dispersion (also known as fine powder). of the Act. extension requests will be considered PTFE is covered by the scope of these untimely for submissions which are due investigations whether filled or unfilled, Preliminary Determinations by the ITC whether or not modified, and whether or not from multiple parties simultaneously. In containing co-polymer additives, pigments, The ITC will preliminarily determine, such a case, we will inform parties in or other materials. Also included is PTFE wet within 45 days after the date on which the letter or memorandum setting forth raw polymer. The chemical formula for PTFE the Petitions were filed, whether there the deadline (including a specified time) is a reasonable indication that imports by which extension requests must be 52 See section 782(b) of the Act. of PTFE resin from India and/or the PRC filed to be considered timely. An 53 See Certification of Factual Information to are materially injuring or threatening extension request must be made in a Import Administration during Antidumping and material injury to a U.S. industry.48 A Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (Final Rule); see also frequently asked 49 Id. questions regarding the Final Rule, available at 47 See Policy Bulletin 05.1 at 6 (emphasis added). 50 See 19 CFR 351.301(b). http://enforcement.trade.gov/tlei/notices/factual_ 48 See section 733(a) of the Act. 51 See 19 CFR 351.301(b)(2). info_final_rule_FAQ_07172013.pdf.
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is C2F4, and the Chemical Abstracts Service to this request on October 6, 2017.4 In As discussed in the preamble to the Registry number is 9002–84–0. addition, the petitioner filed revised Department’s regulations, we are setting PTFE further processed into micropowder, scope language on October 13, 2017.5 aside a period for interested parties to having particle size typically ranging from 1 In accordance with section 702(b)(1) raise issues regarding product coverage to 25 microns, and a melt-flow rate no less 8 than 0.1 gram/10 minutes, is excluded from of the Tariff Act of 1930, as amended (scope). The Department will consider the scope of these investigations. (the Act), the petitioner alleges that the all comments received from interested PTFE is classified in the Harmonized Tariff Government of India is providing parties and, if necessary, will consult Schedule of the United States (HTSUS) under countervailable subsidies, within the with the interested parties prior to the subheadings 3904.61.0010 and 3904.61.0090. meaning of sections 701 and 771(5) of issuance of the preliminary Subject merchandise may also be classified the Act, to imports of PTFE resin from determinations. If scope comments under HTSUS subheading 3904.69.5000. India and that such imports are include factual information,9 all such Although the HTSUS subheadings and CAS factual information should be limited to Number are provided for convenience and materially injuring, or threatening Customs purposes, the written description of material injury to, the domestic industry public information. To facilitate the scope is dispositive. producing PTFE resin in the United preparation of its questionnaires, the Department requests all interested [FR Doc. 2017–23307 Filed 10–25–17; 8:45 am] States. Also, consistent with section parties to submit such comments by BILLING CODE 3510–DS–P 702(b)(1) of the Act, for those alleged programs on which we are initiating a 5:00 p.m. Eastern Time (ET) on CVD investigation, the Petition is Tuesday, November 7, 2017, which is 20 DEPARTMENT OF COMMERCE accompanied by information reasonably calendar days from the signature date of available to the petitioner supporting its this notice. Any rebuttal comments, International Trade Administration allegations. which may include factual information, must be filed by 5:00 p.m. ET on Friday, [C–533–880] The Department finds that the petitioner is an interested party as November 17, 2017, which is 10 Polytetrafluoroethylene Resin From defined in section 771(9)(C) of the Act calendar days from the initial comments India: Initiation of Countervailing Duty and that the petitioner filed this Petition deadline. Investigation on behalf of the domestic industry and The Department requests that any demonstrated sufficient industry factual information the parties consider AGENCY: Enforcement and Compliance, support with respect to the initiation of relevant to the scope of the investigation International Trade Administration, the CVD investigation that the petitioner be submitted during this time period. Department of Commerce. is requesting.6 However, if a party subsequently finds DATES: Applicable October 18, 2017. that additional factual information Period of Investigation FOR FURTHER INFORMATION CONTACT: pertaining to the scope of the Toby Vandall at (202) 482–1664 or Because the Petition was filed on investigation may be relevant, the party Aimee Phelan at (202) 482–0697, September 28, 2017, the period of may contact the Department and request AD/CVD Operations, Enforcement and investigation (POI) is January 1, 2016, permission to submit the additional Compliance, International Trade through December 31, 2016. information. All such comments must Administration, U.S. Department of be filed on the records of each of the Scope of the Investigation Commerce, 1401 Constitution Avenue concurrent AD and CVD investigations. NW., Washington, DC 20230. The product covered by this Filing Requirements investigation is PTFE resin from India. SUPPLEMENTARY INFORMATION: All submissions to the Department For a full description of the scope of this must be filed electronically using The Petition investigation, see the ‘‘Scope of the Enforcement and Compliance’s On September 28, 2017, the U.S. Investigation,’’ in the Appendix to this Antidumping Duty and Countervailing Department of Commerce (the notice. Department) received a countervailing Duty Centralized Electronic Service 10 duty (CVD) Petition concerning imports Comments on Scope of the Investigation System (ACCESS). An electronically of polytetrafluoroethylene (PTFE) resin During our review of the Petition, the filed document must be received from India, filed in proper form on Department issued questions to, and successfully in its entirety by the time behalf of the Chemours Company FC received a response from, the petitioner and date it is due. Documents exempted LLC (the petitioner).1 The CVD Petition pertaining to the proposed scope to from the electronic submission was accompanied by antidumping duty ensure that the scope language in the requirements must be filed manually (AD) Petitions concerning imports of Petition would be an accurate reflection (i.e., in paper form) with Enforcement PTFE resin from India and the People’s of the products for which the domestic 7 See also Memorandum to the File (October 11, Republic of China. The petitioner is a industry is seeking relief. 2017). 2 domestic producer of PTFE resin. 8 See Antidumping Duties; Countervailing Duties; On October 3, 2017, the Department 4 See Letter from the petitioner, Final Rule, 62 FR 27296, 27323 (May 19, 1997). requested supplemental information ‘‘Polytetrafluoroethylene (PTFE) Resin from India: 9 See 19 CFR 351.102(b)(21) (defining ‘‘factual pertaining to certain areas of the Responses to Supplemental Questions Regarding information’’). the Countervailing Duty Petition’’ (October 6, 2017). Petition.3 The petitioner filed a response 10 See Antidumping and Countervailing Duty 5 See Letter from the petitioner, Proceedings: Electronic Filing Procedures; ‘‘Polytetrafluoroethylene (PTFE) Resin from the Administrative Protective Order Procedures, 76 FR 1 See Letter from the petitioner, ‘‘Re: People’s Republic of China and India: Amendment 39263 (July 6, 2011), see also Enforcement and Polytetrafluoroethylene (PTFE) Resin from the to the Suggested Scope of the Antidumping and Compliance: Change of Electronic Filing System People’s Republic of China and India: Antidumping Countervailing Duty Petitions’’ (October 13, 2017). Name, 79 FR 69046 (November 20, 2014) for details and Countervailing Duty Petitions’’ (September 28, 6 See ‘‘Determination of Industry Support for the of the Department’s electronic filing requirements, 2017) (the Petition). Petition’’ section, below. which went into effect on August 5, 2011. 2 Id. at 2. 7 See Letter from the petitioner, Information on help using ACCESS can be found at 3 See Letter from the Department, ‘‘Petition for the ‘‘Polytetrafluoroethylene (PTFE) Resin from the https://access.trade.gov/help.aspx, and a handbook Imposition of Countervailing Duties on Imports of People’s Republic of China and India: Amendment can be found at https://access.trade.gov/help/ Polytetrafluoroethylene Resin from India: to the Suggested Scope of the Antidumping and Handbook%20on%20Electronic Supplemental Questions’’ (October 3, 2017). Countervailing Duty Petitions’’ (October 13, 2017). %20Filling%20Procedures.pdf.
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and Compliance’s APO/Dockets Unit, constitutes a domestic like product in petitioner compared its production to Room 18022, U.S. Department of order to define the industry. While both the total 2016 production of the Commerce, 1401 Constitution Avenue the Department and the ITC must apply domestic like product for the entire NW., Washington, DC 20230, and the same statutory definition regarding domestic industry.17 We relied on the stamped with the date and time of the domestic like product,13 they do so data the petitioner provided for receipt by the applicable deadlines. for different purposes and pursuant to a purposes of measuring industry separate and distinct authority. In support.18 Consultations addition, the Department’s Our review of the data provided in the Pursuant to sections 702(b)(4)(A)(i) determination is subject to limitations of Petition and other information readily and (ii) of the Act, the Department time and information. Although this available to the Department indicates notified representatives of the may result in different definitions of the that the petitioner has established Government of India of the receipt of like product, such differences do not industry support.19 First, the Petition the Petition, and provided them the render the decision of either agency established support from domestic opportunity for consultations with contrary to law.14 producers (or workers) accounting for respect to the CVD Petition.11 Section 771(10) of the Act defines the more than 50 percent of the total Consultations with the GOI were held at domestic like product as ‘‘a product production of the domestic like product the Department of Commerce on which is like, or in the absence of like, and, as such, the Department is not October 18, 2017.12 most similar in characteristics and uses required to take further action in order with, the article subject to an Determination of Industry Support for to evaluate industry support (e.g., investigation under this title.’’ Thus, the 20 the Petition polling). Second, the domestic reference point from which the producers (or workers) have met the Section 702(b)(1) of the Act requires domestic like product analysis begins is statutory criteria for industry support that a petition be filed on behalf of the ‘‘the article subject to an investigation’’ under section 702(c)(4)(A)(i) of the Act domestic industry. Section 702(c)(4)(A) (i.e., the class or kind of merchandise to because the domestic producers (or of the Act provides that a petition meets be investigated, which normally will be workers) who support the Petition this requirement if the domestic the scope as defined in the petition). account for at least 25 percent of the producers or workers who support the With regard to the domestic like total production of the domestic like petition account for: (i) At least 25 product, the petitioner does not offer a product.21 Finally, the domestic percent of the total production of the definition of the domestic like product producers (or workers) have met the domestic like product; and (ii) more distinct from the scope of this statutory criteria for industry support than 50 percent of the production of the investigation. Based on our analysis of under section 702(c)(4)(A)(ii) of the Act domestic like product produced by that the information submitted on the because the domestic producers (or record, we have determined that PTFE portion of the industry expressing workers) who support the Petition resin, as defined in the scope, support for, or opposition to, the account for more than 50 percent of the constitutes a single domestic like petition. Moreover, section 702(c)(4)(D) production of the domestic like product product and we have analyzed industry of the Act provides that, if the petition produced by that portion of the industry support in terms of that domestic like does not establish support of domestic expressing support for, or opposition to, product.15 producers or workers accounting for the Petition.22 Accordingly, the more than 50 percent of the total In determining whether the petitioner has standing under section 702(c)(4)(A) Department determines that the Petition production of the domestic like product, was filed on behalf of the domestic the Department shall: (i) Poll the of the Act, we considered the industry support data contained in the Petition industry within the meaning of section industry or rely on other information in 702(b)(1) of the Act. order to determine if there is support for with reference to the domestic like product as defined in the ‘‘Scope of the The Department finds that the the petition, as required by petitioner filed the Petition on behalf of subparagraph (A); or (ii) determine Investigation,’’ in the Appendix to this notice. The petitioner provided its own the domestic industry because it is an industry support using a statistically production of the domestic like product interested party as defined in section valid sampling method to poll the in 2016, as well as estimated 2016 771(9)(C) of the Act and it has ‘‘industry.’’ production data of the domestic like demonstrated sufficient industry Section 771(4)(A) of the Act defines product by the entire U.S. industry.16 To support with respect to the CVD the ‘‘industry’’ as the producers as a establish industry support, the investigation that it is requesting the whole of a domestic like product. Thus, Department initiate.23 to determine whether a petition has the 13 See section 771(10) of the Act. Injury Test requisite industry support, the statute 14 See USEC, Inc. v. United States, 132 F. Supp. directs the Department to look to 2d 1, 8 (CIT 2001) (citing Algoma Steel Corp., Ltd. Because India is a ‘‘Subsidies producers and workers who produce the v. United States, 688 F. Supp. 639, 644 (CIT 1988), Agreement Country’’ within the domestic like product. The International aff’d 865 F.2d 240 (Fed. Cir. 1989)). meaning of section 701(b) of the Act, 15 For a discussion of the domestic like product Trade Commission (ITC), which is analysis in this case, see Countervailing Duty section 701(a)(2) of the Act applies to responsible for determining whether Investigation Initiation Checklist ‘‘the domestic industry’’ has been Polytetrafluoroethylene (PTFE) Resin from India 17 See Petition at Exhibit I–2; see also General injured, must also determine what (India CVD Initiation Checklist), at Attachment II, Issues and AD Supplement at 3–4. Analysis of Industry Support for the Antidumping 18 Id. For further discussion, see India CVD and Countervailing Duty Petitions Covering Initiation Checklist at Attachment II. 11 See Letter to the Embassy of India, Polytetrafluoroethylene (PTFE) Resin from the 19 See India CVD Initiation Checklist at ‘‘Countervailing Duty Petition on People’s Republic of China and India (Attachment Attachment II. Polytetrafluoroethylene Resin from India’’ II). This checklist is dated concurrently with this 20 (September 28, 2017). notice and on file electronically via ACCESS. See section 702(c)(4)(D) of the Act; see also 12 See Memorandum, ‘‘Consultations with Access to documents filed via ACCESS is also India CVD Initiation Checklist at Attachment II. Officials from the Government of India Regarding available in the Central Records Unit, Room B8024 21 See India CVD Initiation Checklist at the Countervailing Duty Petition on of the main Department of Commerce building. Attachment II. Polytetrafluoroethylene (PTFE) Resin from India’’ 16 See Petition at 2–4 and Exhibit I–2; see also 22 Id. (October 18, 2017). General Issues and AD Supplement at 3–4. 23 Id.
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this investigation. Accordingly, the ITC from countervailable subsidies Department’s resources, then the must determine whether imports of the conferred by the government of this Department will select respondents subject merchandise from India country. In accordance with section based on that data. materially injure, or threaten material 703(b)(1) of the Act and 19 CFR On October 12, 2017, the Department injury to, a U.S. industry. 351.205(b)(1), unless postponed, we released CBP data under the intend to make our preliminary Administrative Protective Order (APO) Allegations and Evidence of Material determination no later than 65 days to all parties with access to information Injury and Causation after the date of this initiation. protected by APO and indicated that The petitioner alleges that the U.S. Under the Trade Preferences interested parties wishing to comment industry producing the domestic like Extension Act of 2015, numerous regarding the CBP data and respondent product is being materially injured, or is amendments to the AD and CVD laws selection must do so within three threatened with material injury, by were made.28 The 2015 law does not business days of the publication date of reason of the imports of the subject specify dates of application for those the notice of initiation of this CVD merchandise, which are benefitting from amendments. On August 6, 2015, the investigation.32 Interested parties must countervailable subsidies. In addition, Department published an interpretative submit applications for disclosure under the petitioner alleges that subject rule, in which it announced the APO in accordance with 19 CFR imports exceed the negligibility applicability dates for each amendment 351.505(b). Instructions for filing such threshold provided for under section to the Act, except for amendments applications may be found on the 771(24)(A) of the Act.24 In CVD contained in section 771(7) of the Act, Department’s Web site at http:// petitions, section 771(24)(B) of the Act which relate to determinations of enforcement.trade.gov/apo. The provides that imports of subject material injury by the ITC.29 The Department will not accept rebuttal merchandise from developing and least amendments to sections 776 and 782 of comments regarding the CBP data or developed countries must exceed the the Act are applicable to all respondent selection. negligibility threshold of four percent. determinations made on or after August Comments must be filed The petitioner also demonstrates that 6, 2015, and, therefore, apply to this electronically using ACCESS. An subject imports from India, which has CVD investigation.30 electronically filed document must be been designated as a least developed Based on our review of the Petition, received successfully, in its entirety, by country under section 771(36)(B) of the we find that there is sufficient ACCESS no later than 5:00 p.m. ET on Act, exceed the negligibility threshold information to initiate a CVD the date noted above. If respondent of four percent.25 investigation on 18 of the 22 alleged selection is necessary, within 20 days of The petitioner contends that the programs in India. For a full discussion publication of this notice, we intend to industry’s injured condition is of the basis for our decision on whether make our decision regarding respondent illustrated by a significant volume of to initiate on each program, see the selection based upon comments subject imports; an increase in the India CVD Initiation Checklist. A public received from interested parties and our volume of subject imports relative to version of the initiation checklist for analysis of the record information. U.S. consumption and production; this investigation is available on reduced market share; underselling and ACCESS. Distribution of Copies of the Petition price suppression or depression; lost In accordance with section 703(b)(1) In accordance with section sales and revenues; a negative impact on of the Act and 19 CFR 351.205(b)(1), 702(b)(4)(A)(i) of the Act and 19 CFR the domestic industry’s capacity, unless postponed, we will make our 351.202(f), a copy of the public version capacity utilization, and employment; preliminary determination no later than of the Petition has been provided to the and a negative impact on revenues and 65 days after the date of this initiation. Government of India via ACCESS. To operating profits.26 We have assessed Respondent Selection the extent practicable, we will attempt the allegations and supporting evidence to provide a copy of the public version regarding material injury, threat of The petitioner named seven of the Petition to each exporter named material injury, and causation, and we companies in India as producers/ in the Petition, as provided under 19 have determined that these allegations exporters of PTFE resin.31 For India, CFR 351.203(c)(2). are properly supported by adequate following standard practice in CVD evidence, and meet the statutory investigations, in the event the ITC Notification requirements for initiation.27 Department determines that the number We will notify the ITC of our of producers/exporters is large, the initiation, as required by section 702(d) Initiation of CVD Investigation Department intends to review U.S. of the Act. Based on the examination of the CVD Customs and Border Protection (CBP) Petition, we find that the Petition meets data for U.S. imports of PTFE resin Preliminary Determination by the ITC the requirements of section 702 of the during the POI under the appropriate The ITC will preliminarily determine, Act. Therefore, we are initiating a CVD Harmonized Tariff Schedule of the within 45 days after the date on which investigation to determine whether United States subheadings, and if it the Petition were filed, whether there is imports of PTFE resin from India benefit determines it cannot individually a reasonable indication that imports of examine each company based upon the PTFE resin from India is materially 24 See Volume I of the Petitions at 21 and Exhibit injuring, or threatening material injury I–14. 28 See Trade Preferences Extension Act of 2015, to, a U.S. industry.33 A negative ITC 25 Id. Public Law 114–27, 129 Stat. 362 (2015). determination will result in the 29 26 Id. at 24–34, Exhibit I–8, and Exhibits I–14, I– See Dates of Application of Amendments to the investigation being terminated.34 16, and I–17. Antidumping and Countervailing Duty Laws Made 27 See India CVD Initiation Checklist at by the Trade Preferences Extension Act of 2015, 80 Attachment III, Analysis of Allegations and FR 46793 (August 6, 2015) (Applicability Notice). 32 See Memorandum, ‘‘Polytetrafluoroethylene Evidence of Material Injury and Causation for the The 2015 amendments may be found at https:// (PTFE) Resin from India Countervailing Duty Antidumping and Countervailing Duty Petitions www.congress.gov/bill/114th-congress/house-bill/ Petition: Release of U.S. Customs and Border Covering Polytetrafluoroethylene Resin (PTFE 1295/text/pl. Protection Data’’ (October 12, 2017). Resin) from India and the People’s Republic of 30 See Applicability Notice, 80 FR at 46794–95. 33 See section 703(a)(2) of the Act. China (the PRC) (Attachment III). 31 See Petition at Exhibit I–13. 34 See section 703(a)(1) of the Act.
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Otherwise, this investigation will of Time Limits; Final Rule, 78 FR 57790 to 25 microns, and a melt-flow rate no less proceed according to statutory and (September 20, 2013), available at than 0.1 gram/10 minutes, is excluded from regulatory time limits. http://www.gpo.gov/fdsys/pkg/FR-2013- the scope of this investigation. 09-20/html/2013-22853.htm, prior to PTFE is classified in the Harmonized Tariff Submission of Factual Information submitting factual information in this Schedule of the United States (HTSUS) under subheadings 3904.61.0010 and 3904.61.0090. Factual information is defined in 19 investigation. CFR 351.102(b)(21) as: (i) Evidence Subject merchandise may also be classified Certification Requirements under HTSUS subheading 3904.69.5000. submitted in response to questionnaires; Although the HTSUS subheadings and CAS (ii) evidence submitted in support of Any party submitting factual Number are provided for convenience and allegations; (iii) publicly available information in an AD or CVD Customs purposes, the written description of information to value factors under 19 proceeding must certify to the accuracy the scope is dispositive. 37 CFR 351.408(c) or to measure the and completeness of that information. [FR Doc. 2017–23308 Filed 10–25–17; 8:45 am] adequacy of remuneration under 19 CFR Parties must use the certification BILLING CODE 3510–DS–P 351.511(a)(2); (iv) evidence placed on formats provided in 19 CFR the record by the Department; and (v) 351.303(g).38 The Department intends to evidence other than factual information reject factual submissions if the DEPARTMENT OF COMMERCE described in (i)–(iv). 19 CFR 351.301(b) submitting party does not comply with requires any party, when submitting the applicable revised certification National Institute of Standards and factual information, to specify under requirements. Technology which subsection of 19 CFR Notification to Interested Parties 351.102(b)(21) the information is being Judges Panel of the Malcolm Baldrige submitted 35 and, if the information is Interested parties must submit National Quality Award submitted to rebut, clarify, or correct applications for disclosure under APO AGENCY: National Institute of Standards factual information already on the in accordance with 19 CFR 351.305. On and Technology, Department of record, to provide an explanation January 22, 2008, the Department Commerce. identifying the information already on published Antidumping and the record that the factual information Countervailing Duty Proceedings: ACTION: Notice of closed meeting. seeks to rebut, clarify, or correct.36 Time Documents Submission Procedures; APO Procedures, 73 FR 3634 (January SUMMARY: The Judges Panel of the limits for the submission of factual Malcolm Baldrige National Quality information are addressed in 19 CFR 22, 2008). Parties wishing to participate in this investigation should ensure that Award (Judges Panel) will meet in 351.301, which provides specific time closed session Sunday, November 5, limits based on the type of factual they meet the requirements of these procedures (e.g., the filing of letters of 2017 through Thursday, November 9, information being submitted. Interested 2017 from 8:30 a.m. until 5:30 p.m. parties should review the regulations appearance as discussed at 19 CFR 351.103(d)). Eastern Time each day. The purpose of prior to submitting factual information this meeting is to review in this investigation. This notice is issued and published pursuant to sections 702 and 777(i) of recommendations from site visits, and Extensions of Time Limits the Act. recommend 2017 Malcolm Baldrige National Quality Award recipients. The Parties may request an extension of Dated: October 18, 2017. meeting is closed to the public in order time limits before the expiration of a Gary Taverman, time limit established under 19 CFR to protect the proprietary data to be Deputy Assistant Secretary for Antidumping examined and discussed at the meeting. 351.301, or as otherwise specified by the and Countervailing Duty Operations Secretary. In general, an extension performing the non-exclusive functions and DATES: The meeting will be held request will be considered untimely if it duties of the Assistant Secretary for Sunday, November 5, 2017 through is filed after the time limit established Enforcement and Compliance. Thursday, November 9, 2017, from 8:30 a.m. until 5:30 p.m. Eastern Time each under 19 CFR 351.301 expires. For Appendix submissions that are due from multiple day. The entire meeting will be closed parties simultaneously, an extension Scope of the Investigation to the public. request will be considered untimely if it The product covered by this investigation ADDRESSES: The meeting will be held at is filed after 10:00 a.m. ET on the due is polytetrafluoroethylene (PTFE) resin, the National Institute of Standards and date. Under certain circumstances, we including but not limited to granular, Technology, 100 Bureau Drive, may elect to specify a different time dispersion, or coagulated dispersion (also known as fine powder). PTFE is covered by Gaithersburg, MD 20899. limit by which extension requests will the scope of this investigation whether filled FOR FURTHER INFORMATION CONTACT: be considered untimely for submissions or unfilled, whether or not modified, and Robert Fangmeyer, Director, Baldrige which are due from multiple parties whether or not containing co-polymer Performance Excellence Program, simultaneously. In such a case, we will additives, pigments, or other materials. Also National Institute of Standards and inform parties in the letter or included is PTFE wet raw polymer. The Technology, 100 Bureau Drive, Mail chemical formula for PTFE is C2F4, and the memorandum setting forth the deadline Stop 1020, Gaithersburg, MD 20899– (including a specified time) by which Chemical Abstracts Service Registry number is 9002–84–0. 1020, telephone number (301) 975– extension requests must be filed to be PTFE further processed into micropowder, 2360, email [email protected]. considered timely. An extension request having particle size typically ranging from 1 SUPPLEMENTARY INFORMATION: must be made in a separate, stand-alone Authority: 15 U.S.C. 3711a(d)(1) and the submission; under limited 37 See section 782(b) of the Act. Federal Advisory Committee Act, as circumstances we will grant untimely- 38 See also Certification of Factual Information to amended, 5 U.S.C. App. filed requests for the extension of time Import Administration During Antidumping and limits. Parties should review Extension Countervailing Duty Proceedings, 78 FR 42678 (July Pursuant to 41 CFR 102–3.150(b), this 17, 2013) (‘‘Final Rule’’). Answers to frequently asked questions regarding the Final Rule are Federal Register notice for this meeting 35 See 19 CFR 351.301(b). available at http://enforcement.trade.gov/tlei/ is being published fewer than 15 36 See 19 CFR 351.301(b)(2). notices/factual_info_final_rule_FAQ_07172013.pdf. calendar days prior to the meeting as
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exceptional circumstances exist. It is DEPARTMENT OF COMMERCE minimum sizes) may otherwise prohibit imperative that the Judges Panel will the collection of live animals and/or meet on Sunday, November 5, 2017 National Oceanic and Atmospheric biological samples for data collection through Thursday, November 9, 2017, Administration and public display purposes or may from 8:30 a.m. until 5:30 p.m. Eastern RIN 0648–XF750 otherwise prohibit certain fishing Time each day to accommodate the activity. Pursuant to 50 CFR 600 and scheduling priorities of the key Atlantic Highly Migratory Species; 635, a NMFS Regional Administrator or participants, who must maintain a strict Exempted Fishing, Scientific Research, Director may authorize, for limited schedule to review recommendations Display, and Shark Research Fishery; testing, public display, data collection, from site visits, and recommend 2017 Letters of Acknowledgment exploratory fishing, compensation Malcolm Baldrige National Quality fishing, conservation engineering, Award recipients. The Judges Panel is AGENCY: National Marine Fisheries health and safety surveys, composed of twelve members, Service (NMFS), National Oceanic and environmental cleanup, and/or hazard appointed by the Secretary of Atmospheric Administration (NOAA), removal purposes, the target or Commerce, with balanced Commerce. incidental harvest of species managed representation from U.S. service, ACTION: Notice of intent; request for under an FMP or fishery regulations that manufacturing, nonprofit, education, comments. would otherwise be prohibited. These and health care industries. Members are permits exempt permit holders from the SUMMARY: selected for their familiarity with NMFS announces its intent to specific portions of the regulations (e.g., quality improvement operations and issue exempted fishing permits (EFPs), fishing seasons, prohibited species, competitiveness issues of manufacturing scientific research permits (SRPs), authorized gear, closed areas, and companies, service companies, small display permits, letters of minimum sizes) that may otherwise businesses, health care providers, and acknowledgment (LOAs), and shark prohibit the collection of HMS for educational institutions. Members are research fishery permits for Atlantic public education, public display, or also chosen who have broad experience highly migratory species (HMS) in 2018. scientific research. Permit holders are in for-profit and nonprofit areas. The EFPs and related permits would not exempted from the regulations in purpose of this meeting is to review authorize collection of a limited number entirety. Collection of HMS under EFPs, recommendations from site visits and of tunas, swordfish, billfishes, and SRPs, LOAs, display, and shark research recommend 2017 Malcolm Baldrige sharks (collectively known as HMS) fishery permits represents a small National Quality Award (Award) from Federal waters in the Atlantic portion of the overall fishing mortality recipients. The meeting is closed to the Ocean, Caribbean Sea, and Gulf of for HMS, and this mortality is counted public in order to protect the Mexico for the purposes of scientific against the quota of the species proprietary data to be examined and data collection, bycatch research, public harvested, as appropriate and discussed at the meeting. display, and to evaluate the efficacy of applicable. The terms and conditions of environmental clean-up efforts, among individual permits are unique; however, The Chief Financial Officer and other things. Letters of Assistant Secretary for Administration, all permits will include reporting acknowledgement acknowledge that requirements, limit the number and/or with the concurrence of the Assistant scientific research activity aboard a General Counsel for Administration and species of HMS to be collected, and only scientific research vessel is being authorize collection in Federal waters of Transactions, formally determined on conducted. Generally, EFPs and related March 21, 2017, pursuant to Section the Atlantic Ocean, Gulf of Mexico, and permits would be valid from the date of Caribbean Sea. 10(d) of the Federal Advisory issuance through December 31, 2018, Committee Act, in accordance with unless otherwise specified, subject to EFPs and related permits are issued Section 5(c) of the Government in the terms and conditions of individual under the authority of the Magnuson- Sunshine Act, Public Law 94–409, that permits. Stevens Fishery Conservation and the meeting of the Judges Panel may be Management Reauthorization Act DATES: Written comments on these (Magnuson-Stevens Act) (16 U.S.C. 1801 closed to the public in accordance with activities received in response to this 5 U.S.C. 552b(c)(4), because the meeting et seq.) and/or the Atlantic Tunas notice will be considered by NMFS Convention Act (ATCA) (16 U.S.C. 971 is likely to disclose trade secrets and when issuing EFPs and related permits commercial or financial information et seq.). Regulations at 50 CFR 600.745 and must be received on or before and 635.32 govern scientific research obtained from a person which is November 27, 2017. privileged or confidential; and 5 U.S.C. activity, exempted fishing, and 552b(c)(9)(B) because the meeting is ADDRESSES: Comments may be exempted public display and likely to disclose information the submitted by any of the following educational activities with respect to methods: Atlantic HMS. Before issuing LOAs, premature disclosure of which would, • in the case of any agency, be likely to Email: nmfs.hms.efp2018@ EFPs, or SRPs, NMFS requests, among significantly frustrate implementation of noaa.gov. Include in the subject line the other things, copies of scientific a proposed agency action. The meeting, following identifier: 0648–XF750 research plans. Because the Magnuson- • Mail: Craig Cockrell, Highly which involves examination of current Stevens Act states that scientific Migratory Species Management Division Award applicant data from U.S. research activity which is conducted on (F/SF1), NMFS, 1315 East-West organizations and a discussion of these a scientific research vessel is not Highway, Silver Spring, MD 20910. data as compared to the Award criteria fishing, NMFS issues LOAs and not in order to recommend Award FOR FURTHER INFORMATION CONTACT: EFPs for bona fide research activities recipients, will be closed to the public. Craig Cockrell, phone: (301) 427–8503 (e.g., scientific research being conducted SUPPLEMENTARY INFORMATION: Issuance from a research vessel and not a Kevin Kimball, of EFPs and related permits are commercial or recreational fishing NIST Chief of Staff. necessary because HMS regulations vessel) involving species that are only [FR Doc. 2017–23273 Filed 10–25–17; 8:45 am] (e.g., fishing seasons, prohibited species, regulated under the Magnuson-Stevens BILLING CODE 3510–13–P authorized gear, closed areas, and Act (e.g., most species of sharks) and not
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under ATCA. NMFS generally does not tiger sharks), and collection of fish Some of the comments also stated that consider recreational or commercial below the regulatory minimum size. NMFS should approve EFP applications vessels to be bona fide research vessels. Under Amendment 2 to the 2006 for white shark research on a case-by- However, if the vessels have been Consolidated Atlantic HMS Fishery case basis or that NMFS should stop contracted only to conduct research and Management Plan, NMFS determined issuing EFPs or related permits for not participate in any commercial or that dusky sharks cannot be collected research on sharks. After reviewing recreational fishing activities during for public display. these comments, NMFS decided to issue that research, NMFS may consider those The majority of EFPs and related EFPs and related permits for white vessels as bona fide research platforms permits described in this annual notice shark research as appropriate in 2017. while conducting the specified research. relate to scientific sampling and tagging During 2018, NMFS anticipates permits For example, in the past, NMFS has of Atlantic HMS within existing quotas for white shark research would be determined that commercial pelagic and the impacts of the activities have undertaken with substantially the same longline vessels assisting with been previously analyzed in various terms and conditions and scope as last population surveys for sharks may be environmental assessments and year, with no additional anticipated considered ‘‘bona fide research vessels’’ environmental impact statements for effects. Comments are invited while engaged only in the specified Atlantic HMS. NMFS intends to issue specifically on these issues related to research. NMFS acknowledges that the these permits without additional issuance of white shark permits this proposed activity meets the definition of opportunity for public comment beyond year. scientific research under the Magnuson- what is provided in this notice. In addition, Amendment 2 to the 2006 Occasionally, NMFS receives Stevens Act and not ATCA by issuing Consolidated HMS Fishery Management applications for research activities that an LOA to researchers. Examples of Plan (FMP) implemented a shark were not anticipated, or for research that research conducted under LOAs include research fishery. This research fishery is is outside the scope of general scientific tagging and releasing of sharks during conducted under the auspices of the sampling and tagging of Atlantic HMS, bottom longline surveys to understand exempted fishing permit program. Shark or rarely, for research that is particularly the distribution and seasonal abundance research fishery permit holders assist controversial. Should NMFS receive of different shark species, and collecting NMFS in collecting valuable shark life and sampling sharks caught during such applications, NMFS will provide history and other scientific data trawl surveys for life history and additional opportunity for public required in shark stock assessments. bycatch studies. comment, consistent with the While scientific research is exempt regulations at 50 CFR part 600.745. Since the shark research fishery was under MSA, scientific research is not During the comment period for the established in 2008, the research fishery exempt from regulation under ATCA. November 2016 notice of intent to issue has allowed for: The collection of Therefore, NMFS issues SRPs that EFPs (81 FR 80646), NMFS received fishery dependent data for current and authorize researchers to collect HMS numerous comments regarding previous future stock assessments; the operation from bona fide research vessels for years’ white shark research in Federal of cooperative research to meet NMFS’ collection of species managed under waters, focusing primarily on concerns ongoing research objectives; the this statute (e.g., tunas, swordfish, about the need for coordination among collection of updated life-history billfish, and some species of sharks). researchers regarding the potential information used in the sandbar shark One example of research conducted effects of one project on another. The (and other species) stock assessment; under SRPs consists of scientific volume of these comments indicated the collection of data on habitat surveys of HMS conducted from NOAA that any EFPs or SRP applications preferences that might help reduce research vessels. involving white sharks in 2017 should fishery interactions through bycatch EFPs are issued to researchers be considered ‘‘controversial’’ and mitigation; the evaluation of the utility collecting ATCA and Magnuson-Stevens warranted additional opportunity for of the mid-Atlantic closed area on the Act-managed species while conducting public comment. Subsequently, NMFS recovery of dusky sharks; and the research from commercial or published a notice in the Federal collection of hook-timer and pop-up recreational fishing vessels. Examples of Register (March 1, 2017, 82 FR 12340) satellite archival tag information to research conducted under EFPs include requesting public comment on determine at-vessel and post-release collection of young-of-the-year bluefin applications for exempted fishing mortality of dusky sharks. Fishermen tuna for genetic research; conducting permits and related permits for white who wish to participate must fill out an billfish larval tows from private vessels shark research, particularly on two application for a shark research permit to determine billfish habitat use, life applications involving white shark under the exempted fishing program. history, and population structure; research that had been received at that Shark research fishery participants are determining catch rates and gear time. subject to 100-percent observer characteristics of the swordfish buoy During the comment period, NMFS coverage. All non-prohibited shark gear fishery and the green-stick tuna received 722 comments related to white species brought back to the vessel dead fishery; and tagging sharks caught on shark research and the applications must be retained and will count against commercial or recreational fishing gear described in the notice. The majority of the appropriate quotas of the shark to determining post-release mortality the comments were in support of research fishery participant. During the rates. continuing white shark research. Other 2017 shark research fishery, all NMFS is also seeking public comment comments that were received participants were limited to a very small on its intent to issue display permits for commented on a range of issues related number of dusky shark mortalities on a the collection of sharks and other HMS to white shark research including regional basis. Once the number of for public display in 2017. Collection of concern regarding the proper handling mortalities occurs in a specific region all sharks and other HMS sought for public of white sharks and the type of gear shark research fishery activities must display in aquaria often involves being used for research and concern stop within that region. Also, collection when the commercial fishing regarding tagging operations on charter participants are limited to two sets per seasons are closed, collection of and private vessels due to long fight trip with, one set limited to 150 hooks otherwise prohibited species (e.g., sand times on light tackle rods and reels. and the second set limited to 300 hooks.
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All participants are also limited to a The authorized number of species for In all cases, mortality associated with maximum of 500 hooks onboard the 2017, as well as the number of an EFPs, SRPs, or display permits vessel with on a shark research fishery specimens collected in 2016, is (except for larvae) is counted against the trip. A Federal Register notice summarized in Table 1. The number of appropriate quota. NMFS issued a total describing the specific objectives for the specimens collected in 2017 will be of 39 EFPs, SRPs, display permits, and shark research fishery in 2018 and available when all 2017 interim and LOAs in 2016 for the collection of HMS requesting applications from interested annual reports are submitted to NMFS. and a total of 5 shark research fishery and eligible shark fishermen is expected In 2016, the number of specimens permits. As of October 3, 2017, NMFS to publish in the near future. NMFS collected was less than the number of has issued a total of 33 EFPs, SRPs, requests public comment regarding authorized specimens for all permit display permits, and LOAs and a total NMFS’ intent to issue shark research types, other than SRPs issued for shark of 5 shark research fishery permits. fishery permits in 2018 during the research. comment period of this notice.
TABLE 1—SUMMARY OF HMS EXEMPTED FISHING PERMITS ISSUED IN 2016 AND 2017, OTHER THAN SHARK RESEARCH FISHERY PERMITS [‘‘HMS’’ refers to multiple species being collected under a given permit type.]
2016 2017
Permit type Permits Authorized fish Authorized Fish kept/dis- Larvae kept Permits Authorized fish issued** (num) larvae carded dead (num) issued** (Num)** (num) (num)
EFP HMS ...... 4 247 0 17 0 4 357 Shark ...... 12 721 0 85 0 4 57 Tuna ...... 4 530 0 0 0 2 350 SRP HMS ...... 1 42 0 0 0 3 260 Shark ...... 5 1,165 0 310 0 1 720 Tuna ...... 1 60 0 0 0 0 0 Display HMS ...... 0 0 0 0 0 2 88 Shark ...... 3 109 0 26 0 5 109
Total ...... 30 2,874 0 0 21 1,941 LOA* Shark ...... 9 2,906 0 618 0 12 2,275 *LOAs are issued for bona fide scientific research activities involving non-ATCA managed species (e.g., most species of sharks). Collections made under an LOA are not authorized; rather this estimated harvest for research is acknowledged by NMFS. Permittees are encouraged to re- port all fishing activities in a timely manner. **Atlantic HMS larvae were authorized for collection but no limit on the number of larvae were set.
Final decisions on the issuance of any Authority: 16 U.S.C. 971 et seq. and 16 DATES: These appointments are effective EFPs, SRPs, display permits, and shark U.S.C. 1801 et seq. as of November 13, 2017. research fishery permits will depend on Dated: October 23, 2017. SUPPLEMENTARY INFORMATION: Pursuant the submission of all required Emily H. Menashes, to 5 U.S.C. 4314(c) (1–5), the information about the proposed Acting Director, Office of Sustainable Department of the Air Force (AF) activities, NMFS’ review of public Fisheries, National Marine Fisheries Service. announces the appointment of members comments received on this notice, an [FR Doc. 2017–23312 Filed 10–25–17; 8:45 am] to the AF’s Senior Executive Service applicant’s reporting history on past BILLING CODE 3510–22–P (SES) Performance Review Board (PRB). permits, if vessels or applicants were Appointments are made by the issued any prior violations of marine authorizing official. Each board member resource laws administered by NOAA, shall review and evaluate performance DEPARTMENT OF DEFENSE consistency with relevant NEPA scores provided by the SES’ immediate documents, and any consultations with Department of the Air Force supervisor. Performance standards must appropriate Regional Fishery be applied consistently across the AF. Management Councils, states, or Federal Names of Members of the Performance The board will make final agencies. NMFS does not anticipate any Review Board for the Department of recommendations to the authorizing significant environmental impacts from the Air Force official relative to the performance of the issuance of these EFPs as assessed the executive. AGENCY: Department of the Air Force, in the 1999 FMP, the 2006 Consolidated The members of the 2017 Performance DOD. HMS FMP and its amendments, the Review Board for the Air Force are: ACTION: Notice. Environmental Assessment for the 2012 1. Board President—Gen Ellen M. Swordfish Specifications, and the SUMMARY: Notice is given of the names Pawlikowski, Commander, Air Environmental Assessment for the 2015 of members of the 2017 Performance Force Material Command Final Bluefin Tuna Quota and Atlantic Review Board for the Department of the 2. Honorable Matthew P. Donovan, Tuna Fisheries Management Measures. Air Force. Under Secretary of the Air Force
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3. General Stephen W. Wilson, Vice DEPARTMENT OF DEFENSE ID number and title for this Federal Chief of Staff of the Air Force Register document. The general policy 4. Lt Gen Stayce D. Harris, Assistant Office of the Secretary for comments and other submissions Vice Chief of Staff and Director [Docket ID DOD–2017–OS–0035] from members of the public is to make these submissions available for public 5. Lt Gen Gina M. Grosso, Deputy Chief viewing on the Internet at http:// of Staff, Manpower, Personnel and Submission for OMB Review; www.regulations.gov as they are Services Comment Request received without change, including any 6. Lt Gen John F. Thompson, AGENCY: Office of the Under Secretary of personal identifiers or contact Commander, Space and Missile Defense for Acquisition, Technology information. Systems Center and Logistics, DoD. DOD Clearance Officer: Mr. Frederick 7. Lt Gen Bradford J. Shwedo, Chief, ACTION: 30-Day information collection Licari. Information Dominance and Chief notice. Written requests for copies of the Information Officer information collection proposal should SUMMARY: The Department of Defense 8. Lt Gen Jerry D. Harris, Deputy Chief be sent to Mr. Licari at WHS/ESD has submitted to OMB for clearance, the Directives Division, 4800 Mark Center of Staff, Strategic Plans and following proposal for collection of Requirements Drive, East Tower, Suite 03F09, information under the provisions of the Alexandria, VA 22350–3100. 9. Dr. Todd A. Fore, Assistant Deputy Paperwork Reduction Act. Dated: October 20, 2017. Chief of Staff, Manpower, Personnel DATES: Consideration will be given to all Aaron Siegel, and Services comments received by November 27, 10. Ms. Patricia M. Young, Air Force 2017. Alternate OSD Federal Register Liaison Material Command Executive Officer, Department of Defense. ADDRESSES: Comments and Director [FR Doc. 2017–23258 Filed 10–25–17; 8:45 am] recommendations on the proposed BILLING CODE 5001–06–P 11. Mr. Richard K. Hartley, Principle information collection should be Deputy Assistant Secretary, emailed to Ms. Jasmeet Seehra, DoD Installations and Environment Desk Officer, at Oira_submission@ DEPARTMENT OF DEFENSE 12. Mr. Jeffery R. Shelton, Deputy omb.eop.gov. Please identify the Administrative Assistant for the proposed information collection by DoD Office of the Secretary Secretary of the Air Force Desk Officer and the Docket ID number [Docket ID: DOD–2017–OS–0061] 13. Mr. Daniel R. Sitterly, Principal and title of the information collection. Deputy Assistant Secretary, FOR FURTHER INFORMATION CONTACT: Fred Submission for OMB Review; Manpower and Reserve Affairs Licari, 571–372–0493, or whs.mc- Comment Request alex.esd.mbx.dd-dod-information- 14. Mr. Joseph M. McDade, Principal AGENCY: Office of the Under Secretary of [email protected]. Deputy General Counsel Defense for Acquisition, Technology 15. Mr. John B. Salvatori, Director, SUPPLEMENTARY INFORMATION: and Logistics, DOD. Title, Associated Form and OMB Capabilities Management Office ACTION: 30-day information collection Number: Pre-embarkation Certificate of 16. Ms. Pamela C. Schwenke, Deputy notice. Disinsection, DD Form 3044; OMB Assistant Secretary, Cost and Control Number 0704–XXXX. Economics SUMMARY: The Department of Defense Type of Request: New. has submitted to OMB for clearance, the 17. Mr. James J. Brooks, Air National Number of Respondents: 1,000. following proposal for collection of Guard, Executive Director Responses per Respondent: 1. information under the provisions of the 18. Mr. Craig A. Smith, Deputy General Annual Responses: 1,000. Paperwork Reduction Act. Counsel, Intelligence, International Average Burden per Response: 10 DATES: Consideration will be given to all and Military Affairs minutes. comments received by November 27, Annual Burden Hours: 166.67 hours. Additionally, all career status Air 2017. Needs and Uses: The information Force Tier 3 SES members not included collection requirement is necessary to ADDRESSES: Comments and in the above list are eligible to serve on provide proof of aircraft disinsection to recommendations on the proposed the 2017 Performance Review Board and foreign countries that require it, before information collection should be are hereby nominated for inclusion on cargo and aircrew will be allowed to emailed to Ms. Jasmeet Seehra, DoD an ad hoc basis in the event of _ dis-embark in those countries. Desk Officer, at Oira submission@ absence(s). Affected Public: Individuals or omb.eop.gov. Please identify the proposed information collection by DoD FOR FURTHER INFORMATION CONTACT: households. Desk Officer and the Docket ID number Please direct any written comments or Frequency: On Occasion. and title of the information collection. requests for information to Ms. Lorna Respondent’s Obligation: Mandatory. Fermanis, Senior Executive OMB Desk Officer: Ms. Jasmeet FOR FURTHER INFORMATION CONTACT: Fred Management, AF/DPS, 1040 Air Force Seehra. Licari, 571–372–0493, or whs.mc- Pentagon, Washington, DC 20330–1040 You may also submit comments and alex.esd.mbx.dd-dod-information- (PH: 703–697–0897; or via email at recommendations, identified by Docket [email protected]. [email protected]) ID number and title, by the following SUPPLEMENTARY INFORMATION: method: Title, Associated Form and OMB Henry Williams, • Federal eRulemaking Portal: http:// Number: Assessing and Strengthening Acting Air Force Federal Register Liaison www.regulations.gov. Follow the the Manufacturing and Defense Officer. instructions for submitting comments. Industrial Base Supply Chain Resiliency [FR Doc. 2017–23327 Filed 10–25–17; 8:45 am] Instructions: All submissions received of the United States; OMB Control BILLING CODE 5001–10–P must include the agency name, Docket Number 0704–XXXX.
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Type of Request: Emergency. DEPARTMENT OF DEFENSE commenter’s physical mailing address Number of Respondents: 300. and the project title in the subject line. Department of the Army, Corps of Please ensure that your comments are Responses per Respondent: 1. Engineers submitted within the specified comment Annual Responses: 300. period. Comments received after the Environmental Impact Statement closing date will be marked ‘‘late,’’ and Average Burden Per Response: 60 Withdrawal and Availability of an minutes. may only be considered if time permits. Environmental Assessment for the Please note that comments may be part Annual Burden Hours: 300. Souris River Basin Flood Risk of the public record. Needs and Uses: The information Management Feasibility Study, Ward FOR FURTHER INFORMATION CONTACT: collection requirement is being County, North Dakota Questions regarding this action can be submitted as an emergency. The AGENCY: U.S. Army Corps of Engineers, addressed to Mr. David F. Potter, information collection requirement is DoD. Regional Planning & Environment necessary to obtain information in ACTION: Notice of withdrawal of an Division North, by phone: (651) 290– support of Executive Order 13806: environmental impact statement; notice 5713, by fax: (651) 290–5805, by email: Assessing and Strengthening the United of availability of an environmental [email protected], or by States Manufacturing and Defense assessment. mail: Regional Planning and Industrial Base and Supply Chain Environment Division North, U.S. Army Resiliency. The questionnaire is used to SUMMARY: In accordance with the Corps of Engineers, 180 Fifth Street identify, assess, and make National Environmental Policy Act East, Suite 700, St. Paul, MN 55101– recommendations in support of a more (NEPA), on September 18, 2016, the St. 1678. robust industrial base. Paul District, U.S. Army Corps of SUPPLEMENTARY INFORMATION: The Engineers (Corps) initiated the Souris River Basin Flood Risk Affected Public: Businesses or other Environmental Impact Statement (EIS) Management Feasibility Study for-profit. process to identify and analyze potential (Feasibility Study) is being developed Frequency: One Time. impacts associated with flood risk by the Corps in partnership with the Respondent’s Obligation: Voluntary. management measures evaluated within Souris River Joint Water Resources a Federal feasibility study for the Souris Board (SRJB). The purpose of this study OMB Desk Officer: Ms. Jasmeet River Basin within the continental is to collect and evaluate pertinent Seehra. United States. Currently, the Corps has engineering, economic, social, and You may also submit comments and identified a Tentatively Selected Plan environmental information in order to recommendations, identified by Docket (TSP) that includes a high-flow assess the potential for a federal flood ID number and title, by the following diversion and a 1200-ft long levee. risk management project within the method: However, preliminary analysis of the basin. The study objective is to define TSP indicate no significant impacts are • Federal eRulemaking Portal: http:// a feasible and implementable project to expected, therefore the Corps is www.regulations.gov. Follow the reduce flood risk which is relatively terminating the EIS process and is instructions for submitting comments. high within the basin. Due to the withdrawing the Notice of Intent potentially significant environmental Instructions: All submissions received published in the Thursday, September effects associated with the project, the must include the agency name, Docket 18, 2016 issue of the Federal Register. Corps issued a Notice of Intent to ID number and title for this Federal In its place, a draft integrated Feasibility Prepare an EIS (76 FR 336) on Register document. The general policy Report and Environmental Assessment September 18, 2016. for comments and other submissions (FR/EA) will be available for a 30-day The Feasibility Study is from members of the public is to make public comment period beginning complementary to the SRJB’s local plan, these submissions available for public October 30, 2017. the Mouse River Enhanced Flood viewing on the Internet at http:// DATES: Comments on the draft FR/EA Protection Plan (MREFPP). Because of www.regulations.gov as they are may be submitted starting October 30, its influence on an existing federal flood received without change, including any 2017 through November 30, 2017. If project, this non-federal effort has personal identifiers or contact comments are provided by mail, they requested permission from the Corps of information. must be received at the address below Engineers to pursue actions under 33 no later than November 30, 2017. U.S.C. 408 (frequently referred to as DOD Clearance Officer: Mr. Frederick Section 408). A separate Notice of Intent Licari. ADDRESSES: The draft FR/EA can be viewed online starting October 30, 2017 was published (FR Doc. 2015–17670 Written requests for copies of the at http://www.mvp.usace.army.mil/ Filed July 16, 2015) for an EIS information collection proposal should Home/Public-Notices/. associated with the Corps of Engineers’ be sent to Mr. Licari at WHS/ESD Comments may be submitted on the decision on the Section 408 request. Directives Division, 4800 Mark Center draft FR/EA using any of the following Additional details on the local, non- Drive, East Tower, Suite 03F09, methods: federal flood MREFPP can be found at Alexandria, VA 22350–3100. • Mail: Attn: David F. Potter, mouseriverplan.com. During this Feasibility Study, many of the initial Dated: October 20, 2017. Regional Planning and Environment Division North, U.S. Army Corps of flood risk management measures were Aaron Siegel, Engineers, 180 Fifth Street East, Suite screened out from further consideration. Alternate OSD Federal Register, Liaison 700, St. Paul, MN 55101–1678. Major features of the TSP include a Officer, Department of Defense. • Email: david.f.potter@ high-flow diversion and a 1200-ft long [FR Doc. 2017–23262 Filed 10–25–17; 8:45 am] usace.army.mil. levee. Preliminary analysis indicate that BILLING CODE 5001–06–P Instructions: Direct your comments to the environmental effects of the TSP are Corps of Engineers St. Paul District. less than significant. For this reason, an Comment letters should include the EIS is no longer being pursued in favor
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of an EA in accordance with Corps • Mail: U.S. Army Corps of Engineers, EIS/EIR for the Pajaro River Flood Risk regulations at 33 CFR part 230, San Francisco District, ATTN: CESPN– Management Study. Since publication Appendix C(2). ET–PB-Pajaro River, 1455 Market Street, of the NOI, USACE and Monterey and We are advising the public that a draft San Francisco, CA 94103–1398. Santa Cruz Counties have worked with integrated FR/EA for the Feasibility • Email: CESPN-ET-PB@ stakeholders to identify and incorporate Study has been prepared and is usace.army.mil. measures to avoid, minimize, and • available for public review and Comment letters should include the compensate for adverse environmental comment. The FR/EA considers the commenter’s physical mailing address effects. As a result, the environmental effects of, and alternatives to, the TSP. and include ‘‘Pajaro River’’ in the review conducted as part of this study subject line. Dated: October 12, 2017. has initially concluded that, with FOR FURTHER INFORMATION CONTACT: Terry J. Birkenstock, Mr. mitigation, the proposed alternatives Christopher Eng, U.S. Army Corps of Deputy Chief, Regional Planning and would not result in any significant Engineers, San Francisco District, 1455 Environment Division North. environmental effects. Therefore, an EA Market Street, San Francisco, CA [FR Doc. 2017–23318 Filed 10–25–17; 8:45 am] has been prepared instead of an EIS. 94103–1398. Telephone: (415) 503– BILLING CODE 3720–58–P Also, USACE now requires water 6868. Email: CESPN-ET-PB@ usace.army.mil. resources planning and NEPA documents to be integrated into a single DEPARTMENT OF DEFENSE SUPPLEMENTARY INFORMATION: document, in this case, an integrated 1. Proposed Action. USACE and the GRR/EA. The California Environmental Department of the Army, Corps of non-Federal study partners, Monterey Quality Act (CEQA) document for the Engineers and Santa Cruz Counties, propose to study is being prepared separately by reduce flood risk to the City of Santa Cruz and Monterey Counties as Notice of Availability of a Draft Watsonville and the town of Pajaro by Integrated General Reevaluation implementing a combination of the CEQA lead agencies. Report and Environmental Assessment structural measures along the lower c. USACE is consulting with the State and Draft Finding of No Significant Pajaro River, Salsipuedes Creek, and Historic Preservation Officer and with Impact for the Proposed Lower Pajaro Corralitos Creek. These measures Native American Tribes to comply with River Flood Risk Management Project, include: Improving existing levees; the National Historic Preservation Act, Monterey and Santa Cruz Counties, CA constructing new levees, including and with the U.S. Fish and Wildlife setback levees; and constructing new AGENCY: Department of the Army, U.S. Service and National Marine Fisheries Army Corps of Engineers, DoD. floodwalls. The draft GRR/EA presents Service to comply with the Endangered the draft findings of the General Species Act. USACE is also coordinating ACTION: Notice of availability. Reevaluation Study and identifies and with the U.S. Fish and Wildlife Service describes the benefits, costs, and SUMMARY: The U.S. Army Corps of to comply with the Fish and Wildlife Engineers (USACE), San Francisco environmental effects of alternatives Coordination Act. plans to reduce flood risk to the city of District, announces the availability for 4. Availability of the Draft EA. The review and comment of the draft Watsonville, town of Pajaro, and surrounding area. Based on the draft GRR/EA and draft FONSI are integrated General Reevaluation Report available for public review and and Environmental Assessment (GRR/ evaluation, USACE has identified a Federal interest in at least one comment 30 days beginning October 31, EA) and the draft Finding of No 2017 and ending November 30, 2017. Significant Impact (FONSI) for the alternative plan, the Tentatively proposed Pajaro River Flood Risk Selected Plan (TSP), to reduce the risk 5. A public meeting to discuss the Management Project, Monterey and of flooding while minimizing adverse status of the study, present the draft Santa Cruz Counties, CA., USACE environmental effects. The TSP is the results of the GRR/EA, and receive Procedures for Implementing [the National Economic Development Plan questions and comments will be held on National Environmental Policy Act] (NED). The environmental review November 8, 2017, from 6:00 p.m. to NEPA, notice of the availability of this conducted as part of this study has 8:00 p.m. at the Watsonville Civic Plaza draft GRR/EA and draft FONSI for initially concluded that, with Community Room, 275 Main Street, 4th review and comment is being provided mitigation, the proposed alternatives Floor, Watsonville, California 95076– to agencies, organizations, and the would not result in any significant 5133. interested public. environmental effects. This review and its findings are documented in the draft Dated: October 18, 2017. DATES: Comments on the draft GRR/EA GRR/EA. Travis J. Rayfield, and draft FONSI may be submitted 2. Alternatives. Ten project Lieutenant Colonel, U.S. Army, District starting October 31, 2017, through alternatives, including the no action Commander. November 30, 2017. If comments are alternative, have been evaluated in [FR Doc. 2017–23276 Filed 10–25–17; 8:45 am] provided by mail, they must be received detail in the draft GRR/EA in BILLING CODE 3720–58–P at the address below no later than accordance with NEPA (33 CFR part 230 November 30, 2017. (USACE NEPA Regulations) and 33 CFR ADDRESSES: The draft GRR/EA can be part 325, Appendix B (NEPA viewed online starting October 31, 2017, Implementation Procedures for USACE at: http://www.spn.usace.army.mil/ Regulatory Projects). Missions/Projects-and-Programs/ 3. Changes Since Publication of the Projects-by-Category/Projects-for-Flood- Notice of Intent (NOI). An NOI was Risk-Management/Pajaro-River- published in the Federal Register on Watsonville/. Comments may be June 8, 2001, (66 FR 30894) to advise submitted on the draft GRR/EA using the interested public and agencies that any of the following methods: USACE planned to prepare a combined
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DEPARTMENT OF EDUCATION Education is especially interested in Applicants: South Central MCN LLC. public comment addressing the Description: Response to Deficiency [Docket No.: ED–2017–ICCD–0130] following issues: (1) Is this collection Letter and Update to June 1, 2017 Agency Information Collection necessary to the proper functions of the Application of South Central MCN LLC Activities; Comment Request; State Department; (2) will this information be for Authorization to Acquire Educational Agency and Local processed and used in a timely manner; Transmission Facilities. Educational Agency—School Data (3) is the estimate of burden accurate; Filed Date: 10/19/17. Collection and Reporting Under ESEA, (4) how might the Department enhance Accession Number: 20171019–5135. Title I, Part A the quality, utility, and clarity of the Comments Due: 5 p.m. ET 11/9/17. information to be collected; and (5) how Take notice that the Commission AGENCY: Office of Elementary and might the Department minimize the received the following electric rate Secondary Education (OESE), burden of this collection on the filings: Department of Education (ED). respondents, including through the use Docket Numbers: ER17–1769–001. ACTION: Notice. of information technology. Please note Applicants: Solar Star Oregon II, LLC. that written comments received in Description: Notice of Change in SUMMARY: In accordance with the response to this notice will be Paperwork Reduction Act of 1995, ED is Status of Solar Star Oregon II, LLC. considered public records. Filed Date: 10/20/17. proposing an extension of an existing Title of Collection: State Educational information collection. Accession Number: 20171020–5107. Agency and Local Educational Comments Due: 5 p.m. ET 11/13/17. DATES: Interested persons are invited to Agency—School Data Collection and submit comments on or before Reporting under ESEA, Title I, Part A. Docket Numbers: ER17–399–002. December 26, 2017. OMB Control Number: 1810–0622. Applicants: Midcontinent Independent System Operator, Inc., ADDRESSES: To access and review all the Type of Review: An extension of an Duke Energy Indiana, LLC. documents related to the information existing information collection. Description: Compliance filing: 2017– collection listed in this notice, please Respondents/Affected Public: State, 10–20_SA 2285 Duke Energy-AEP WDS use http://www.regulations.gov by Local, and Tribal Governments. (Hagerstown) to be effective 3/1/2017. searching the Docket ID number ED– Total Estimated Number of Annual Filed Date: 10/20/17. 2017–ICCD–0130. Comments submitted Responses: 52. Accession Number: 20171020–5075. in response to this notice should be Total Estimated Number of Annual Comments Due: 5 p.m. ET 11/13/17. submitted electronically through the Burden Hours: 2,080. Abstract: Although the U.S. Federal eRulemaking Portal at http:// Docket Numbers: ER17–772–003. Department of Education (ED) www.regulations.gov by selecting the Applicants: Southwest Power Pool, determines Title I, Part A allocations for Docket ID number or via postal mail, Inc. Local Educational Agencies (LEAs), commercial delivery, or hand delivery. Description: Compliance filing: State Educational Agencies (SEAs) must Please note that comments submitted by Compliance Filing in ER17–772—Order adjust ED-determined Title I, Part A fax or email and those submitted after No. 825 Compliance Filing to be LEA allocations to account for newly the comment period will not be effective 5/11/2017. created LEAs and LEA boundary accepted. Written requests for Filed Date: 10/20/17. changes, to redistribute Title I, Part A information or comments submitted by Accession Number: 20171020–5088. funds to small LEAs (under 20,000 total postal mail or delivery should be Comments Due: 5 p.m. ET 11/17/17. population) using alternative poverty addressed to the Director of the Docket Numbers: ER18–112–000. data, and to reserve funds for school Information Collection Clearance Applicants: Southwestern Public improvement, State administration, and Division, U.S. Department of Education, Service Company. the State academic achievement awards 400 Maryland Avenue SW., LBJ, Room Description: § 205(d) Rate Filing: program. This control number covers 216–44, Washington, DC 20202–4537. SPS–GSEC–DSEC-Intecon Agrmt-Sub only the burden associated with the 25–692–0.0.0 to be effective 10/21/2017. FOR FURTHER INFORMATION CONTACT: For actual procedures an SEA must follow specific questions related to collection Filed Date: 10/20/17. when adjusting ED-determined LEA Accession Number: 20171020–5071. activities, please contact Hannah Hodel, allocations. 202–453–6448. Comments Due: 5 p.m. ET 11/13/17. Dated: October 20, 2017. SUPPLEMENTARY INFORMATION: The Docket Numbers: ER18–113–000. Department of Education (ED), in Tomakie Washington, Applicants: Northern States Power accordance with the Paperwork Acting Director, Information Collection Company, a Minnesota corporation. Reduction Act of 1995 (PRA) (44 U.S.C. Clearance Division, Office of the Chief Privacy Description: § 205(d) Rate Filing: Officer, Office of Management. 3506(c)(2)(A)), provides the general 2017–10–20 CAPX-Big Stone-So Brkngs- public and Federal agencies with an [FR Doc. 2017–23222 Filed 10–25–17; 8:45 am] CMA–594–0.1.0–NOC to be effective 12/ opportunity to comment on proposed, BILLING CODE 4000–01–P 20/2017. revised, and continuing collections of Filed Date: 10/20/17. information. This helps the Department Accession Number: 20171020–5080. assess the impact of its information DEPARTMENT OF ENERGY Comments Due: 5 p.m. ET 11/13/17. collection requirements and minimize Docket Numbers: ER18–114–000. Federal Energy Regulatory the public’s reporting burden. It also Applicants: PJM Interconnection, Commission helps the public understand the L.L.C. Department’s information collection Combined Notice of Filings #1 Description: § 205(d) Rate Filing: requirements and provide the requested Wholesale Market Participation data in the desired format. ED is Take notice that the Commission Agreement No. 4820; Queue AC1–016 to soliciting comments on the proposed received the following electric corporate be effective 10/12/2017. information collection request (ICR) that filings: Filed Date: 10/20/17. is described below. The Department of Docket Numbers: EC17–126–000. Accession Number: 20171020–5084.
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Comments Due: 5 p.m. ET 11/13/17. Docket Numbers: ER18–122–000. and 214 of the Commission’s Docket Numbers: ER18–115–000. Applicants: New England Power Pool Regulations (18 CFR 385.211 and Applicants: PJM Interconnection, Participants Committee, ISO New 385.214) on or before 5:00 p.m. Eastern L.L.C. England Inc. time on the specified comment date. Description: § 205(d) Rate Filing: Description: § 205(d) Rate Filing: Protests may be considered, but Wholesale Market Participation Revisions Regarding Modeling Options intervention is necessary to become a Agreement No. 4821; Queue AC1–017 to for Small Generators to be effective 12/ party to the proceeding. be effective 10/12/2017. 20/2017. eFiling is encouraged. More detailed Filed Date: 10/20/17. Filed Date: 10/20/17. information relating to filing Accession Number: 20171020–5085. Accession Number: 20171020–5149. requirements, interventions, protests, Comments Due: 5 p.m. ET 11/13/17. Comments Due: 5 p.m. ET 11/13/17. service, and qualifying facilities filings Docket Numbers: ER18–116–000. Docket Numbers: ER18–123–000. can be found at: http://www.ferc.gov/ Applicants: PJM Interconnection, Applicants: PJM Interconnection, docs-filing/efiling/filing-req.pdf. For L.L.C. L.L.C. other information, call (866) 208–3676 Description: § 205(d) Rate Filing: Description: § 205(d) Rate Filing: (toll free). For TTY, call (202) 502–8659. Wholesale Market Participation Amendment to Wholesale Market Dated: October 20, 2017. Agreement No. 4822; Queue AC1–019 to Participation Agreement No. 3499, Nathaniel J. Davis, Sr., be effective 10/12/2017. Queue No. Y1–063 to be effective 1/30/ Deputy Secretary. 2013. Filed Date: 10/20/17. [FR Doc. 2017–23291 Filed 10–25–17; 8:45 am] Accession Number: 20171020–5086. Filed Date: 10/20/17. BILLING CODE 6717–01–P Comments Due: 5 p.m. ET 11/13/17. Accession Number: 20171020–5160. Docket Numbers: ER18–117–000. Comments Due: 5 p.m. ET 11/13/17. Applicants: Solar Star Oregon II, LLC. Docket Numbers: ER18–124–000. DEPARTMENT OF ENERGY Description: § 205(d) Rate Filing: Applicants: Midcontinent Normal filing 1017 to be effective 10/21/ Independent System Operator, Inc., Federal Energy Regulatory 2017. Northern States Power Company, a Commission Filed Date: 10/20/17. Minnesota corporation, Great River [Docket No. EL18–18–000] Accession Number: 20171020–5087. Energy. Comments Due: 5 p.m. ET 11/13/17. Description: § 205(d) Rate Filing: Midcontinent Independent System Docket Numbers: ER18–118–000. 2017–10–20_SA 3060 NSP–GRE T–T Operator, Inc.; Notice of Institution of Applicants: Public Service Company Pomerleau Lake to be effective 11/1/ Section 206 Proceeding and Refund of New Mexico. 2017. Effective Date Description: Notice of Cancellation of Filed Date: 10/20/17. Interconnection Agreement (Rate Accession Number: 20171020–5171. On October 19, 2017, the Commission Schedule No. 95) of Public Service Comments Due: 5 p.m. ET 11/13/17. issued an order in Docket No. EL18–18– Company of New Mexico. Take notice that the Commission 000, Midcontinent Indep. Sys. Operator, Filed Date: 10/20/17. received the following electric securities Inc., 161 FERC 61,057 (2017) (October Accession Number: 20171020–5106. filings: 2017 Order), pursuant to section 206 of Comments Due: 5 p.m. ET 11/13/17. the Federal Power Act (FPA), 16 U.S.C. Docket Numbers: ES17–64–000. 824e (2012), instituting an investigation Docket Numbers: ER18–119–000. Applicants: Monongahela Power to examine the Midcontinent Applicants: Pacific Gas and Electric Company. Independent System Operator, Inc. Company. Description: Amendment to (MISO) Transmission Owners Description: § 205(d) Rate Filing: September 29, 2017 Application for Agreement and any other Commission- CDWR Work Performance Agreement Authorization Under Section 204(a) of jurisdictional MISO documents that for Wind Gap Pumping Plant #2 to be the Federal Power Act to Issue Short- must be revised to fully implement the effective 10/23/2017. Term Debt Securities of Monongahela refund commitment concerns identified Filed Date: 10/20/17. Power Company. in the Commission’s July 21, 2016 order Accession Number: 20171020–5110. Filed Date: 10/20/17. in Docket No. EL16–99–000 in Ark. Comments Due: 5 p.m. ET 11/13/17. Accession Number: 20171020–5135. Elec. Coop. Corp. v. ALLETE, Inc., 156 Docket Numbers: ER18–120–000. Comments Due: 5 p.m. ET 11/13/17. FERC 61,061 (2016). The October 2017 Applicants: Arizona Public Service Docket Numbers: ES18–4–000. Order also consolidated Docket Nos. Company. Applicants: Monongahela Power EL16–99–000 and EL18–18–000. Description: § 205(d) Rate Filing: Company. The refund effective date in Docket OATT Attachment G Revision to be Description: Application Of No. EL18–18–000, established pursuant effective 12/20/2017. Monongahela Power Company For to section 206(b) of the FPA, will be the Filed Date: 10/20/17. Authorization under Section 204(A) of date of publication of this notice in the Accession Number: 20171020–5115. the FPA. Federal Register. Comments Due: 5 p.m. ET 11/13/17. Filed Date: 10/20/17. Any interested person desiring to be Docket Numbers: ER18–121–000. Accession Number: 20171020–5105. heard in Docket No. EL18–18–000 must Applicants: Alabama Power Comments Due: 5 p.m. ET 11/13/17. file a notice of intervention or motion to Company. The filings are accessible in the intervene, as appropriate, with the Description: § 205(d) Rate Filing: Core Commission’s eLibrary system by Federal Energy Regulatory Commission, Solar SPV XX LGIA Filing to be clicking on the links or querying the 888 First Street NE., Washington, DC effective 10/10/2017. docket number. 20426, in accordance with Rule 214 of Filed Date: 10/20/17. Any person desiring to intervene or the Commission’s Rules of Practice and Accession Number: 20171020–5136. protest in any of the above proceedings Procedure, 18 CFR 385.214, within 21 Comments Due: 5 p.m. ET 11/13/17. must file in accordance with Rules 211 days of the date of issuance of the order.
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Dated: October 19, 2017. Accession Number: 20171017–5178. 000, pursuant to section 206 of the Nathaniel J. Davis, Sr., Comments Due: 5 p.m. ET 10/30/17. Federal Power Act (FPA), 16 U.S.C. Deputy Secretary. Docket Numbers: RP18–37–000. 824e (2012), instituting an investigation [FR Doc. 2017–23296 Filed 10–25–17; 8:45 am] Applicants: Equitrans, L.P. into whether the formula rate protocols Description: Compliance filing Notice BILLING CODE 6717–01–P of Transource Kansas, LLC may be Regarding Non-Jurisdictional Gathering unjust, unreasonable, unduly Facilities (F–1006 F–1008 F–1009). discriminatory or preferential. DEPARTMENT OF ENERGY Filed Date: 10/17/17. Transource Kansas, LLC, 161 FERC Accession Number: 20171017–5127. 61,050 (2017). Federal Energy Regulatory Comments Due: 5 p.m. ET 10/30/17. The refund effective date in Docket Commission Docket Numbers: RP18–38–000. No. EL18–13–000, established pursuant Applicants: Great Lakes Gas [Docket No. EL18–12–000] to section 206(b) of the FPA, will be the Transmission Limited Partnership. date of publication of this notice in the Description: § 4(d) Rate Filing: ATX Southwest, LLC; Notice of Federal Register. Language Revision and Updates to be Institution of Section 206 Proceeding Any interested person desiring to be effective 11/18/2017. and Refund Effective Date heard in Docket No. EL18–13–000 must Filed Date: 10/17/17. file a notice of intervention or motion to On October 19, 2017, the Commission Accession Number: 20171017–5139. Comments Due: 5 p.m. ET 10/30/17. intervene, as appropriate, with the issued an order in Docket No. EL18–12– Federal Energy Regulatory Commission, Docket Numbers: RP18–39–000. 000, pursuant to section 206 of the 888 First Street NE., Washington, DC Federal Power Act (FPA), 16 U.S.C. Applicants: Natural Gas Pipeline Company of America LLC. 20426, in accordance with Rule 214 of 824e (2012), instituting an investigation the Commission’s Rules of Practice and into whether the formula rate protocols Description: § 4(d) Rate Filing: Shell Energy North America-NRA Filing to be Procedure, 18 CFR 385.214, within 21 of ATX Southwest, LLC may be unjust, days of the date of issuance of the order. unreasonable, unduly discriminatory or effective 10/18/2017. Filed Date: 10/17/17. Dated: October 19, 2017. preferential. ATX Southwest, LLC, 161 Accession Number: 20171017–5163. Nathaniel J. Davis, Sr., FERC 61,049 (2017). Comments Due: 5 p.m. ET 10/30/17. The refund effective date in Docket Deputy Secretary. The filings are accessible in the No. EL18–12–000, established pursuant [FR Doc. 2017–23292 Filed 10–25–17; 8:45 am] Commission’s eLibrary system by to section 206(b) of the FPA, will be the BILLING CODE 6717–01–P date of publication of this notice in the clicking on the links or querying the Federal Register. docket number. Any person desiring to intervene or Any interested person desiring to be DEPARTMENT OF ENERGY protest in any of the above proceedings heard in Docket No. EL18–12–000 must must file in accordance with Rules 211 file a notice of intervention or motion to Federal Energy Regulatory and 214 of the Commission’s intervene, as appropriate, with the Commission Regulations (18 CFR 385.211 and Federal Energy Regulatory Commission, § 385.214) on or before 5:00 p.m. Eastern Combined Notice of Filings #2 888 First Street, NE., Washington, DC time on the specified comment date. 20426, in accordance with Rule 214 of Take notice that the Commission Protests may be considered, but the Commission’s Rules of Practice and received the following exempt intervention is necessary to become a Procedure, 18 CFR 385.214, within 21 wholesale generator filings: party to the proceeding. days of the date of issuance of the order. eFiling is encouraged. More detailed Docket Numbers: EG18–8–000. Dated: October 19, 2017. information relating to filing Applicants: 54KR 8ME LLC. Nathaniel J. Davis, Sr., requirements, interventions, protests, Description: Notice of Self- Deputy Secretary. service, and qualifying facilities filings Certification of Exempt Wholesale Generator Status of 54KR 8me LLC. [FR Doc. 2017–23288 Filed 10–25–17; 8:45 am] can be found at: http://www.ferc.gov/ Filed Date: 10/19/17. BILLING CODE 6717–01–P docs-filing/efiling/filing-req.pdf. For other information, call (866) 208–3676 Accession Number: 20171019–5108. (toll free). For TTY, call (202) 502–8659. Comments Due: 5 p.m. ET 11/9/17. Take notice that the Commission DEPARTMENT OF ENERGY Dated: October 18, 2017. received the following electric rate Federal Energy Regulatory Nathaniel J. Davis, Sr., filings: Deputy Secretary. Commission Docket Numbers: ER18–7–001. [FR Doc. 2017–23283 Filed 10–25–17; 8:45 am] Applicants: Lamarr Energy, LLC. Combined Notice of Filings BILLING CODE 6717–01–P Description: Tariff Amendment: Take notice that the Commission has Market Based Rate Tariff to be effective 12/1/2017. received the following Natural Gas DEPARTMENT OF ENERGY Pipeline Rate and Refund Report filings: Filed Date: 10/19/17. Federal Energy Regulatory Accession Number: 20171019–5079. Filings Instituting Proceedings Commission Comments Due: 5 p.m. ET 11/9/17. Docket Numbers: RP17–1103–001. Docket Numbers: ER18–7–002. Applicants: Transcontinental Gas [Docket No. EL18–13–000] Applicants: Lamarr Energy, LLC. Pipe Line Company, LLC. Transource Kansas, LLC; Notice of Description: Tariff Amendment: Description: Tariff Amendment: Institution of Section 206 Proceeding Market Based Rate Tariff to be effective Virginia Southside Expansion Project II and Refund Effective Date 12/1/2017. Initial Rates Amended to be effective Filed Date: 10/19/17. 12/1/2017. On October 19, 2017, the Commission Accession Number: 20171019–5099. Filed Date: 10/17/17. issued an order in Docket No. EL18–13– Comments Due: 5 p.m. ET 11/9/17.
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Docket Numbers: ER18–103–000. Description: § 205(d) Rate Filing: authorization, under 18 CFR part 34, of Applicants: 67RK 8me LLC. Pootatuck Ring Bus Expansion future issuances of securities and Description: § 205(d) Rate Filing: SFA Agreement to be effective 10/20/2017. assumptions of liability, is November 8, to be effective 10/20/2017. Filed Date: 10/19/17. 2017. Filed Date: 10/19/17. Accession Number: 20171019–5111. The Commission encourages Accession Number: 20171019–5034. Comments Due: 5 p.m. ET 11/9/17. electronic submission of protests and Comments Due: 5 p.m. ET 11/9/17. The filings are accessible in the interventions in lieu of paper, using the Docket Numbers: ER18–104–000. Commission’s eLibrary system by FERC Online links at http:// Applicants: 67RK 8me LLC. clicking on the links or querying the www.ferc.gov. To facilitate electronic Description: § 205(d) Rate Filing: Co- docket number. service, persons with Internet access Tenancy Agreement to be effective 10/ Any person desiring to intervene or who will eFile a document and/or be 20/2017. protest in any of the above proceedings listed as a contact for an intervenor Filed Date: 10/19/17. must file in accordance with Rules 211 must create and validate an Accession Number: 20171019–5035. and 214 of the Commission’s eRegistration account using the Comments Due: 5 p.m. ET 11/9/17. Regulations (18 CFR 385.211 and eRegistration link. Select the eFiling Docket Numbers: ER18–105–000. 385.214) on or before 5:00 p.m. Eastern link to log on and submit the Applicants: 65HK 8me LLC. time on the specified comment date. intervention or protests. Description: § 205(d) Rate Filing: Protests may be considered, but Persons unable to file electronically 65HK 8me LLC Hayworth SFA to be intervention is necessary to become a should submit an original and 5 copies effective 10/20/2017. party to the proceeding. of the intervention or protest to the Filed Date: 10/19/17. eFiling is encouraged. More detailed Federal Energy Regulatory Commission, Accession Number: 20171019–5036. information relating to filing 888 First Street NE., Washington, DC Comments Due: 5 p.m. ET 11/9/17. requirements, interventions, protests, 20426. Docket Numbers: ER18–106–000. service, and qualifying facilities filings The filings in the above-referenced Applicants: 87RL 8me LLC. can be found at: http://www.ferc.gov/ proceeding are accessible in the Description: § 205(d) Rate Filing: docs-filing/efiling/filing-req.pdf. For Commission’s eLibrary system by 87RL 8me LLC Woodmere SFA to be other information, call (866) 208–3676 clicking on the appropriate link in the effective 10/20/2017. (toll free). For TTY, call (202) 502–8659. above list. They are also available for Filed Date: 10/19/17. Dated: October 19, 2017. electronic review in the Commission’s Accession Number: 20171019–5037. Nathaniel J. Davis, Sr., Public Reference Room in Washington, Comments Due: 5 p.m. ET 11/9/17. Deputy Secretary. DC. There is an eSubscription link on Docket Numbers: ER18–107–000. the Web site that enables subscribers to [FR Doc. 2017–23285 Filed 10–25–17; 8:45 am] receive email notification when a Applicants: 65HK 8me LLC. BILLING CODE 6717–01–P Description: § 205(d) Rate Filing: document is added to a subscribed 65HK 8me LLC Hayworth Co-Tenancy docket(s). For assistance with any FERC Agreement to be effective 10/20/2017. DEPARTMENT OF ENERGY Online service, please email Filed Date: 10/19/17. [email protected]. or call Accession Number: 20171019–5038. Federal Energy Regulatory (866) 208–3676 (toll free). For TTY, call Comments Due: 5 p.m. ET 11/9/17. Commission (202) 502–8659. Docket Numbers: ER18–108–000. [Docket No. ER18–97–000] Dated: October 19, 2017. Applicants: 87RL 8me LLC. Nathaniel J. Davis, Sr., Description: § 205(d) Rate Filing: MS Solar 3, LLC; Supplemental Notice Deputy Secretary. 87RL 8me LLC Woodmere Co-Tenancy That Initial Market-Based Rate Filing [FR Doc. 2017–23297 Filed 10–25–17; 8:45 am] Agreement to be effective 10/20/2017. Includes Request for Blanket Section BILLING CODE 6717–01–P Filed Date: 10/19/17. 204 Authorization Accession Number: 20171019–5039. Comments Due: 5 p.m. ET 11/9/17. This is a supplemental notice in the DEPARTMENT OF ENERGY above-referenced proceeding MS Solar Docket Numbers: ER18–109–000. 3, LLC‘s application for market-based Applicants: Nevada Power Company. Federal Energy Regulatory rate authority, with an accompanying Commission Description: Tariff Cancellation: Rate rate tariff, noting that such application Schedule No. 153 NPC/Aha Macav includes a request for blanket [Docket No. EL18–14–000] Termination to be effective 10/20/2017. authorization, under 18 CFR part 34, of Filed Date: 10/19/17. future issuances of securities and Midwest Power Transmission Accession Number: 20171019–5083. assumptions of liability. Comments Due: 5 p.m. ET 11/9/17. Arkansas, LLC; Notice of Institution of Any person desiring to intervene or to Section 206 Proceeding and Refund Docket Numbers: ER18–110–000. protest should file with the Federal Effective Date Applicants: Duke Energy Progress, Energy Regulatory Commission, 888 LLC. First Street NE., Washington, DC 20426, On October 19, 2017, the Commission Description: § 205(d) Rate Filing: DEP in accordance with Rules 211 and 214 issued an order in Docket No. EL18–14– Five Towns Pro Forma NITSA Filing to of the Commission’s Rules of Practice 000, pursuant to section 206 of the be effective 1/1/2018. and Procedure (18 CFR 385.211 and Federal Power Act (FPA), 16 U.S.C. Filed Date: 10/19/17. 385.214). Anyone filing a motion to 824e (2012), instituting an investigation Accession Number: 20171019–5098. intervene or protest must serve a copy into whether the formula rate protocols Comments Due: 5 p.m. ET 11/9/17. of that document on the Applicant. of Midwest Power Transmission Docket Numbers: ER18–111–000. Notice is hereby given that the Arkansas, LLC may be unjust, Applicants: The United Illuminating deadline for filing protests with regard unreasonable, unduly discriminatory or Company. to the applicant’s request for blanket preferential. Midwest Power
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Transmission Arkansas, LLC, 161 FERC DEPARTMENT OF ENERGY Filed Date: 10/18/17. 61,051 (201X). Accession Number: 20171018–5173. The refund effective date in Docket Federal Energy Regulatory Comments Due: 5 p.m. ET 11/8/17. No. EL18–14–000, established pursuant Commission Docket Numbers: ER18–101–000. to section 206(b) of the FPA, will be the Applicants: Wisconsin Power and date of publication of this notice in the Combined Notice of Filings #1 Light Company. Federal Register. Take notice that the Commission Description: § 205(d) Rate Filing: Any interested person desiring to be received the following electric corporate WPL—CWEC Wholesale Power heard in Docket No. EL18–14–000 must filings: Agreement to be effective 6/1/2020. file a notice of intervention or motion to Filed Date: 10/18/17. intervene, as appropriate, with the Docket Numbers: EC18–6–000. Applicants: V3 Commodities Group, Accession Number: 20171018–5174. Federal Energy Regulatory Commission, LLC. Comments Due: 5 p.m. ET 11/8/17. 888 First Street NE., Washington, DC Description: Application for Docket Numbers: ER18–102–000. 20426, in accordance with Rule 214 of Authorization under Section 203 of the Applicants: Wisconsin Power and the Commission’s Rules of Practice and Federal Power Act, and Requests for Light Company. Procedure, 18 CFR 385.214, within 21 Waivers of Filing Requirements, Description: § 205(d) Rate Filing: days of the date of issuance of the order. Expedited Review and Confidential WPL—REC Wholesale Power Agreement Dated: October 19, 2017. Treatment of V3 Commodities Group, to be effective 6/1/2020. Nathaniel J. Davis, Sr., LLC. Filed Date: 10/18/17. Deputy Secretary. Filed Date: 10/18/17. Accession Number: 20171018–5175. [FR Doc. 2017–23293 Filed 10–25–17; 8:45 am] Accession Number: 20171018–5191. Comments Due: 5 p.m. ET 11/8/17. Comments Due: 5 p.m. ET 11/8/17. BILLING CODE 6717–01–P The filings are accessible in the Take notice that the Commission Commission’s eLibrary system by received the following electric rate clicking on the links or querying the DEPARTMENT OF ENERGY filings: docket number. Docket Numbers: ER13–343–008; Any person desiring to intervene or Federal Energy Regulatory ER13–342–012; ER16–700–001; ER16– protest in any of the above proceedings Commission 701–001. must file in accordance with Rules 211 [Docket No. EL18–17–000] Applicants: CPV Shore, LLC, CPV and 214 of the Commission’s Maryland, LLC, CPV Towantic, LLC, Regulations (18 CFR 385.211 and Midcontinent Independent System CPV Valley, LLC. 385.214) on or before 5:00 p.m. Eastern Operator, Inc.; Notice of Institution of Description: Supplement to June 30, time on the specified comment date. Section 206 Proceeding and Refund 2017 Market Power Update of CPV Protests may be considered, but Effective Date Maryland, LLC, et. al. intervention is necessary to become a Filed Date: 10/18/17. party to the proceeding. On October 19, 2017, the Commission Accession Number: 20171018–5183. eFiling is encouraged. More detailed issued an order in Docket No. EL18–17– Comments Due: 5 p.m. ET 11/1/17. information relating to filing 000, pursuant to section 206 of the Docket Numbers: ER15–2735–001. requirements, interventions, protests, Federal Power Act (FPA), 16 U.S.C. Applicants: Garrison Energy Center service, and qualifying facilities filings 824e (2012), instituting an investigation LLC. can be found at: http://www.ferc.gov/ into whether the Open Access Description: Report Filing: Refund docs-filing/efiling/filing-req.pdf. For Transmission, Energy and Operating Report—Informational Filing to be other information, call (866) 208–3676 Reserve Markets Tariff of Midcontinent effective N/A. (toll free). For TTY, call (202) 502–8659. Independent System Operator, Inc. may Filed Date: 10/18/17. be unjust, unreasonable, unduly Accession Number: 20171018–5145. Dated: October 19, 2017. discriminatory or preferential. Comments Due: 5 p.m. ET 11/8/17. Nathaniel J. Davis, Sr., Midcontinent Indep. Sys. Operator, Inc., Docket Numbers: ER17–2210–000. Deputy Secretary. 161 FERC 61,076 (2017). Applicants: Duke Energy Carolinas, [FR Doc. 2017–23284 Filed 10–25–17; 8:45 am] The refund effective date in Docket LLC. BILLING CODE 6717–01–P No. EL18–17–000, established pursuant Description: Report Filing: DEC–SCEG to section 206(b) of the FPA, will be the Refund Report to be effective N/A. date of publication of this notice in the Filed Date: 10/18/17. DEPARTMENT OF ENERGY Federal Register. Accession Number: 20171018–5158. Any interested person desiring to be Comments Due: 5 p.m. ET 11/8/17. Federal Energy Regulatory heard in Docket No. EL18–17–000 must Docket Numbers: ER18–99–000. Commission file a notice of intervention or motion to Applicants: Southwest Power Pool, [Docket No. ER18–95–000] intervene, as appropriate, with the Inc. Federal Energy Regulatory Commission, Description: § 205(d) Rate Filing: Buchanan Energy Services Company, 888 First Street NE., Washington, DC South Central MCN LLC Formula Rate LLC; Supplemental Notice That Initial 20426, in accordance with Rule 214 of to be effective 12/31/9998. Market-Based Rate Filing Includes the Commission’s Rules of Practice and Filed Date: 10/18/17. Request for Blanket Section 204 Procedure, 18 CFR 385.214, within 21 Accession Number: 20171018–5171. Authorization days of the date of issuance of the order. Comments Due: 5 p.m. ET 11/8/17. Docket Numbers: ER18–100–000. This is a supplemental notice in the Dated: October 19, 2017. Applicants: Wisconsin Power and above-referenced proceeding Buchanan Nathaniel J. Davis, Sr., Light Company. Energy Services Company, LLC’s Deputy Secretary. Description: § 205(d) Rate Filing: application for market-based rate [FR Doc. 2017–23295 Filed 10–25–17; 8:45 am] WPL—ACEC Wholesale Power authority, with an accompanying rate BILLING CODE 6717–01–P Agreement to be effective 6/1/2020. tariff, noting that such application
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includes a request for blanket DEPARTMENT OF ENERGY Any interested person desiring to be authorization, under 18 CFR part 34, of heard in Docket No. EL18–16–000 must future issuances of securities and Federal Energy Regulatory file a notice of intervention or motion to assumptions of liability. Commission intervene, as appropriate, with the Any person desiring to intervene or to [Docket No. EL18–15–000] Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC protest should file with the Federal Kanstar Transmission, LLC; Notice of 20426, in accordance with Rule 214 of Energy Regulatory Commission, 888 Institution of Section 206 Proceeding the Commission’s Rules of Practice and First Street, NE., Washington, DC 20426, and Refund Effective Date Procedure, 18 CFR 385.214, within 21 in accordance with Rules 211 and 214 days of the date of issuance of the order. of the Commission’s Rules of Practice On October 19, 2017, the Commission and Procedure (18 CFR 385.211 and issued an order in Docket No. EL18–15– Dated: October 19, 2017. 385.214). Anyone filing a motion to 000, pursuant to section 206 of the Nathaniel J. Davis, Sr., intervene or protest must serve a copy Federal Power Act (FPA), 16 U.S.C. Deputy Secretary. of that document on the Applicant. 824e (2012), instituting an investigation [FR Doc. 2017–23294 Filed 10–25–17; 8:45 am] into whether the formula rate protocols BILLING CODE 6717–01–P Notice is hereby given that the of Kanstar Transmission, LLC may be deadline for filing protests with regard unjust, unreasonable, unduly to the applicant’s request for blanket discriminatory or preferential. Kanstar ENVIRONMENTAL PROTECTION authorization, under 18 CFR part 34, of Transmission, LLC, 161 FERC 61,052 AGENCY future issuances of securities and (2017). assumptions of liability, is November 8, The refund effective date in Docket [FRL–9969–90–Region 1] 2017. No. EL18–15–000, established pursuant 2017 Fall Joint Meeting of the Ozone The Commission encourages to section 206(b) of the FPA, will be the date of publication of this notice in the Transport Commission and the Mid- electronic submission of protests and Atlantic Northeast Visibility Union interventions in lieu of paper, using the Federal Register. Any interested person desiring to be FERC Online links at http:// AGENCY: Environmental Protection heard in Docket No. EL18–15–000 must www.ferc.gov. To facilitate electronic Agency. file a notice of intervention or motion to ACTION: Notice of meeting. service, persons with Internet access intervene, as appropriate, with the who will eFile a document and/or be Federal Energy Regulatory Commission, SUMMARY: The United States listed as a contact for an intervenor 888 First Street NE., Washington, DC Environmental Protection Agency is must create and validate an 20426, in accordance with Rule 214 of announcing the joint 2017 Fall Meeting eRegistration account using the the Commission’s Rules of Practice and of the Ozone Transport Commission eRegistration link. Select the eFiling Procedure, 18 CFR 385.214, within 21 (OTC) and the Mid-Atlantic Northeast link to log on and submit the days of the date of issuance of the order. Visibility Union (MANE–VU). The intervention or protests. Dated: October 19, 2017. meeting agenda will include topics Persons unable to file electronically Nathaniel J. Davis, Sr., regarding reducing ground-level ozone should submit an original and 5 copies Deputy Secretary. precursors and matters relative to of the intervention or protest to the [FR Doc. 2017–23289 Filed 10–25–17; 8:45 am] Regional Haze and visibility improvement in Federal Class I areas in Federal Energy Regulatory Commission, BILLING CODE 6717–01–P 888 First Street, NE., Washington, DC a multi-pollutant context. 20426. DATES: The meeting will be held on The filings in the above-referenced DEPARTMENT OF ENERGY November 15, 2017 starting at 9:15 a.m. proceeding are accessible in the and ending at 4:00 p.m. Federal Energy Regulatory ADDRESSES: Location: Melrose Commission’s eLibrary system by Commission clicking on the appropriate link in the Georgetown Hotel, 2430 Pennsylvania above list. They are also available for [Docket No. EL18–16–000] Avenue NW., Washington, DC 20037, electronic review in the Commission’s 202–955–6400. South Central MCN LLC; Notice of Public Reference Room in Washington, FOR FURTHER INFORMATION CONTACT: For Institution of Section 206 Proceeding documents and press inquiries contact: DC. There is an eSubscription link on and Refund Effective Date the Web site that enables subscribers to Ozone Transport Commission, 444 receive email notification when a On October 19, 2017, the Commission North Capitol Street NW., Suite 322, document is added to a subscribed issued an order in Docket No. EL18–16– Washington, DC 20001; (202) 508–3840; docket(s). For assistance with any FERC 000, pursuant to section 206 of the email: [email protected]; Web site: http://www.otcair.org. Online service, please email Federal Power Act (FPA), 16 U.S.C. [email protected]. or call 824e (2012), instituting an investigation SUPPLEMENTARY INFORMATION: The Clean (866) 208–3676 (toll free). For TTY, call into whether the formula rate protocols Air Act Amendments of 1990 contain at (202) 502–8659. of South Central MCN LLC may be Section 184 provisions for the Control of unjust, unreasonable, unduly Interstate Ozone Air Pollution. Section Dated: October 19, 2017. discriminatory or preferential. South 184(a) establishes an Ozone Transport Nathaniel J. Davis, Sr., Central MCN LLC, 161 FERC 61,053 Region (OTR) comprised of the States of Deputy Secretary. (2017). Connecticut, Delaware, Maine, [FR Doc. 2017–23290 Filed 10–25–17; 8:45 am] The refund effective date in Docket Maryland, Massachusetts, New No. EL18–16–000, established pursuant Hampshire, New Jersey, New York, BILLING CODE 6717–01–P to section 206(b) of the FPA, will be the Pennsylvania, Rhode Island, Vermont, date of publication of this notice in the parts of Virginia and the District of Federal Register. Columbia. The purpose of the OTC is to
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deal with ground-level ozone formation, collection of information unless it requirement and third-party disclosure transport, and control within the OTR. displays a currently valid control requirement. The Mid-Atlantic/Northeast Visibility number. No person shall be subject to Obligation to Respond: Required to Union (MANE–VU) was formed at in any penalty for failing to comply with obtain or retain benefits. Statutory 2001, in response to EPA’s issuance of a collection of information subject to the authority for this information collection the Regional Haze rule. MANE–VU’s PRA that does not display a valid Office is contained in 47 U.S.C. 201 and 251 members include: Connecticut, of Management and Budget (OMB) of the Communications Act of 1934, as Delaware, the District of Columbia, control number. amended. Maine, Maryland, Massachusetts, New DATES: Written PRA comments should Total Annual Burden: 32,845 hours. Hampshire, New Jersey, New York, be submitted on or before December 26, Total Annual Cost: No cost. Pennsylvania, Rhode Island, Vermont, 2017. If you anticipate that you will be Privacy Act Impact Assessment: No the Penobscot Indian Nation, the St. submitting comments, but find it impact(s). Regis Mohawk Tribe along with EPA difficult to do so within the period of Nature and Extent of Confidentiality: and Federal Land Managers. time allowed by this notice, you should The Commission is not requesting Type of Meeting: Open. advise the contact listed below as soon respondents to submit confidential Agenda: Copies of the final agenda as possible. information. Any respondent that will be available from the OTC office ADDRESSES: Direct all PRA comments to submits information to the Commission (202) 508–3840; by email: ozone@ Nicole Ongele, FCC, via email PRA@ that they believe is confidential may otcair.org or via the OTC Web site at fcc.gov and to [email protected]. request confidential treatment of such http://www.otcair.org. information under 47 CFR 0.459 of the FOR FURTHER INFORMATION CONTACT: For Dated: October 4, 2017. additional information about the Commission’s rules. Deborah Szaro, information collection, contact Nicole Needs and Uses: The information Acting Regional Administrator, Region I. Ongele at (202) 418–2991. collection requirements implement sections 201 and 251 of the [FR Doc. 2017–23242 Filed 10–25–17; 8:45 am] SUPPLEMENTARY INFORMATION: As part of Communications Act of 1934, as BILLING CODE 6560–50–P its continuing effort to reduce amended, to provide for physical paperwork burdens, and as required by collocation on rates, terms and the Paperwork Reduction Act (PRA) of conditions that are just, reasonable and 1995 (44 U.S.C. 3501–3520), the Federal FEDERAL COMMUNICATIONS nondiscriminatory, and to promote Communications Commission (FCC or COMMISSION deployment of advanced Commission) invites the general public [OMB 3060–0848] telecommunications services without and other Federal agencies to take this significantly degrading the performance opportunity to comment on the Information Collection Being Reviewed of other services. All of the following information collections. by the Federal Communications requirements will be used by the Comments are requested concerning: Commission Commission and competitive local whether the proposed collection of exchange carriers (LECs) to facilitate the AGENCY: Federal Communications information is necessary for the proper deployment of telecommunications Commission. performance of the functions of the services, including advanced ACTION: Commission, including whether the Notice and request for telecommunications services. comments. information shall have practical utility; the accuracy of the Commission’s Federal Communications Commission. SUMMARY: As part of its continuing effort burden estimate; ways to enhance the Katura Jackson, to reduce paperwork burdens, and as quality, utility, and clarity of the Federal Register Liaison Officer, Office of the required by the Paperwork Reduction information collected; ways to minimize Secretary. Act (PRA) of 1995, the Federal the burden of the collection of [FR Doc. 2017–23216 Filed 10–25–17; 8:45 am] Communications Commission (FCC or information on the respondents, BILLING CODE 6712–01–P the Commission) invites the general including the use of automated public and other Federal agencies to collection techniques or other forms of take this opportunity to comment on the information technology; and ways to FEDERAL RESERVE SYSTEM following information collection. further reduce the information Comments are requested concerning: collection burden on small business Proposed Agency Information Whether the proposed collection of concerns with fewer than 25 employees. Collection Activities; Comment information is necessary for the proper OMB Control Number: 3060–0848. Request performance of the functions of the Title: Deployment of Wireline Commission, including whether the Services Offering Advanced AGENCY: Board of Governors of the information shall have practical utility; Telecommunications Capability, CC Federal Reserve System. the accuracy of the Commission’s Docket No. 98–147. ACTION: Revision to proposal. burden estimate; ways to enhance the Form Number: N/A. quality, utility, and clarity of the Type of Review: Extension of a SUMMARY: The Board of Governors of the information collected; ways to minimize currently approved collection. Federal Reserve System (Board or the burden of the collection of Respondents: Business or other for- Federal Reserve) is modifying its information on the respondents, profit. proposal to extend for three years, with including the use of automated Number of Respondents and revision, the Banking Organization collection techniques or other forms of Responses: 750 respondents; 9,270 Systemic Risk Report (FR Y–15; OMB information technology; and ways to responses. No. 7100–0352). The Board is extending further reduce the information Estimated Time per Response: 3.54 the proposed implementation date for collection burden on small business hours (average burden per response). the proposed revisions to the FR Y–15 concerns with fewer than 25 employees. Frequency of Response: On occasion from December 31, 2017, to March 31, The FCC may not conduct or sponsor a reporting requirement, recordkeeping 2018. The Board is also reopening the
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public comment period for the proposal This notice also amends the proposed SUPPLEMENTARY INFORMATION: by 30 days, so that the comment period implementation date of the FR Y–15 Purpose: This Council advises and ends on November 23, 2017. proposal such that the proposed makes recommendations to the DATES: The proposed collection of changes would be effective for reports Secretary of Health and Human information is amended effective reflecting the March 31, 2018, as-of date. Services, the Assistant Secretary for October 18, 2017 and the public This revision would provide Health, and the Director, CDC, regarding comment period shall terminate on respondents with an additional 90 days the elimination of tuberculosis. November 23, 2017. to prepare their systems to reflect any Specifically, the Council makes FOR FURTHER INFORMATION CONTACT: A changes to the FR Y–15 that the Board recommendations regarding policies, copy of the PRA OMB submission, may adopt after reviewing the strategies, objectives, and priorities; including the proposed reporting form comments received. addresses the development and and instructions, supporting statement, Board of Governors of the Federal Reserve application of new technologies; and and other documentation will be placed System, October 23, 2017. reviews the extent to which progress has into OMB’s public docket files, once Ann E. Misback, been made toward eliminating tuberculosis. approved. These documents will also be Secretary of the Board. made available on the Board’s public Matters To Be Considered: The agenda [FR Doc. 2017–23271 Filed 10–25–17; 8:45 am] will include discussions on (1) Update Web site at: http:// BILLING CODE 6210–01–P www.federalreserve.gov/apps/ on preliminary tuberculosis funding reportforms/review.aspx or may be formula; (2) Update on whole genome requested from the agency clearance sequencing data sharing plan; (3) DEPARTMENT OF HEALTH AND Update on three-month Isoniazid/ officer, whose name appears below. HUMAN SERVICES Federal Reserve Board Clearance Rifapentine Regimen (3HP) guidelines; Officer—Nuha Elmaghrabi—Office of and (4) Updates from ACET Centers for Disease Control and workgroups. Agenda items are subject to the Chief Data Officer, Board of Prevention Governors of the Federal Reserve change as priorities dictate. System, Washington, DC 20551, (202) Advisory Council for the Elimination of The Director, Management Analysis 452–3829. Telecommunications Device Tuberculosis Meeting and Services Office, has been delegated for the Deaf (TDD) users may contact the authority to sign Federal Register (202) 263–4869, Board of Governors of AGENCY: Centers for Disease Control and notices pertaining to announcements of the Federal Reserve System, Prevention (CDC), Department of Health meetings and other committee Washington, DC 20551. and Human Services (HHS). management activities, for both the ACTION: Notice of meeting. Centers for Disease Control and SUPPLEMENTARY INFORMATION: On August Prevention and the Agency for Toxic 24, 2017, the Board invited public SUMMARY: In accordance with the Substances and Disease Registry. comment on a proposal that would Federal Advisory Committee Act, the extend for three years the FR Y–15 and Centers for Disease Control and Claudette Grant, make certain revisions to the report (FR Prevention (CDC) announces the Acting Director, Management Analysis and Y–15 proposal). As revised, the report following meeting of the Advisory Services Office, Centers for Disease Control would include Mexican pesos in total Council for the Elimination of and Prevention. payments activity rather than as a Tuberculosis (ACET). This meeting is [FR Doc. 2017–23335 Filed 10–25–17; 8:45 am] memorandum item; add securities open to the public, limited only by 100 BILLING CODE 4163–18–P brokers to the definition of financial room seating and 100 ports for audio institutions; expressly include phone lines. Time will be available for derivative transactions where a clearing public comment. Comments should be DEPARTMENT OF HEALTH AND member bank guarantees the submitted in writing by email to the HUMAN SERVICES performance of a client to a central contact person listed below. The counterparty; and, specify how certain Centers for Disease Control and deadline for receipt is Monday, Prevention cleared derivatives transactions are December 4, 2017. Persons who desire reported.1 As initially proposed, these to make an oral statement, may request Board of Scientific Counselors, Office revisions to the FR Y–15 would have it at the time of the public comment of Infectious Diseases (BSC, OID) been effective for reports reflecting a period on December 12, 2017 at 11:40 December 31, 2017, as-of date. The a.m. EST. This meeting is also AGENCY: Centers for Disease Control and comment period for the FR Y–15 accessible by teleconference: 1–877– Prevention (CDC), Department of Health proposal was previously scheduled to 927–1433 and participant passcode: and Human Services (HHS). end on October 23, 2017. 12016435. ACTION: Notice of meeting. The Board has received feedback that additional time may be required for DATES: The meeting will be held on SUMMARY: In accordance with the affected banking organizations to December 11, 2017, 8:30 a.m. to 4:30 Federal Advisory Committee Act, the analyze the impact of, and to provide p.m., EST and December 12, 2017, 8:30 Centers for Disease Control and comments on, the FR Y–15 changes a.m. to 12:00 p.m., EST. Prevention (CDC), announces the being proposed. ADDRESSES: CDC Corporate Square following meeting for the Board of In response to the feedback, this Campus, 8 Corporate Square Boulevard, Scientific Counselors, Office of notice hereby reopens the public Atlanta, Georgia 30329. Infectious Diseases (BSC, OID). This comment period for the FR Y–15 FOR FURTHER INFORMATION CONTACT: meeting is open to the public, limited proposal by 30 days, with comments Margie Scott-Cseh, Committee only by the space available; the meeting due November 23, 2017, to provide Management Specialist, CDC, 1600 room will accommodate up to 100 additional time for comment. Clifton Road NE., Mailstop: E–07, people. The public is also welcome to Atlanta, Georgia 30329, telephone (404) listen to the meeting by telephone, 1 See 82 FR 40154 (August 24, 2017). 639–8317; [email protected]. limited only by the number of ports
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available (50); the toll-free dial-in DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: number is 1–877–951–7311, with a pass HUMAN SERVICES Background: The Advisory Board was code of 2208740. established under the Energy Employees Centers for Disease Control and Occupational Illness Compensation DATES: The meeting will be held on Prevention Program Act of 2000 to advise the December 6, 2017, 8:30 a.m. to 5:00 President on a variety of policy and p.m., EST, and December 7, 2017, 8:30 Advisory Board on Radiation and technical functions required to a.m. to 12:00 p.m., EST. Worker Health (ABRWH or the implement and effectively manage the Advisory Board), National Institute for new compensation program. Key ADDRESSES: CDC, Global Occupational Safety and Health Communications Center, 1600 Clifton functions of the Advisory Board include (NIOSH); Meeting providing advice on the development of Road NE., Building 19, Auditorium B3, AGENCY: Centers for Disease Control and probability of causation guidelines Atlanta, Georgia 30329; also 1–877– which have been promulgated by the 951–7311, with a pass code of 2208740. Prevention (CDC), Department of Health and Human Services (HHS). Department of Health and Human Services (HHS) as a final rule, advice on FOR FURTHER INFORMATION CONTACT: ACTION: Notice of meeting. Robin Moseley, MAT, Designated methods of dose reconstruction which Federal Officer, OID, CDC, 1600 Clifton SUMMARY: In accordance with section have also been promulgated by HHS as Road NE., Mailstop D10, Atlanta, 10(a)(2) of the Federal Advisory a final rule, advice on the scientific Georgia 30329, Telephone (404) 639– Committee Act, the Centers for Disease validity and quality of dose estimation 4461; [email protected]. Control and Prevention (CDC), and reconstruction efforts being announces the following meeting of the performed for purposes of the SUPPLEMENTARY INFORMATION: Advisory Board on Radiation and compensation program, and advice on Purpose: The BSC, OID, provides Worker Health (ABRWH). This meeting petitions to add classes of workers to the advice and guidance to the Secretary, is open to the public, limited only by Special Exposure Cohort (SEC). In Department of Health and Human the space available. The meeting space December 2000, the President delegated Services; the Director, CDC; the accommodates approximately 150 responsibility for funding, staffing, and operating the Advisory Board to HHS, Director, OID; and the Directors of the people. The public is welcome to which subsequently delegated this National Center for Immunization and submit written comments in advance of the meeting, to the contact person authority to the CDC. NIOSH Respiratory Diseases, the National below. Written comments received in implements this responsibility for CDC. Center for Emerging and Zoonotic advance of the meeting will be included The charter was issued on August 3, Infectious Diseases, and the National in the official record of the meeting. The 2001, renewed at appropriate intervals, Center for HIV/AIDS, Viral Hepatitis, public is also welcome to listen to the rechartered on March 22, 2016 pursuant STD, and TB Prevention, CDC, in the meeting by joining the teleconference at to Executive Order 13708, and will following areas: Strategies, goals, and the USA toll-free, dial-in number at 1– expire on September 30, 2019. priorities for programs; research within 866–659–0537; the pass code is Purpose: This Advisory Board is the national centers; and overall 9933701. The conference line has 150 charged with (a) providing advice to the strategic direction and focus of OID and ports for callers. The Web conference by Secretary, HHS, on the development of the national centers. which the public can view presentations guidelines under Executive Order Matters To Be Considered: The agenda as they are presented is https:// 13179; (b) providing advice to the Secretary, HHS, on the scientific will include discussions on priority webconf.cdc.gov/zab6/yzdq02pl?sl=1. validity and quality of dose issues for the national centers, including DATES: The meeting will be held on reconstruction efforts performed for this foodborne infections, advanced December 13 from 8:15 to 6:00 p.m. Mountain Time and December 14, 2017, program; and (c) upon request by the molecular detection, antimicrobial Secretary, HHS, advising the Secretary resistance, sexually transmitted 8:15 a.m. to 11:00 a.m. Mountain Time. A public comment session will begin on on whether there is a class of employees diseases, and vaccination coverage. A at any Department of Energy facility report back from the Board’s Food December 13 at 6:00 p.m. Mountain Time and conclude at 7:00 p.m. or who were exposed to radiation but for Safety Modernization Act Surveillance following the final call for public whom it is not feasible to estimate their Working Group will also be given. comment, whichever comes first. radiation dose, and on whether there is Agenda items are subject to change as reasonable likelihood that such ADDRESSES: Doubletree by Hilton priorities dictate. radiation doses may have endangered Albuquerque, 201 Marquette Avenue the health of members of this class. The Director, Management Analysis Northwest, Albuquerque, New Mexico and Services Office, has been delegated Matters to be Considered: The agenda 87102; Phone: (505) 247–7057, Fax: will include discussions on: NIOSH the authority to sign Federal Register (505) 247–7017. Audio conference call Program Update; Department of Labor notices pertaining to announcements of via FTS Conferencing. The USA toll-free Program Update; Department of Energy meetings and other committee dial-in number is 1–866–659–0537; the Program Update; SEC Petitions Update; management activities, for both the pass code is 9933701. Web conference dose reconstruction review methods; Centers for Disease Control and by Skype: Meeting CONNECTION: review of methods for estimating co- Prevention and the Agency for Toxic https://webconf.cdc.gov/zab6/ worker radiation doses; possible Substances and Disease Registry. yzdq02pl?sl=1. discussions of Site Profile reviews for Claudette Grant FOR FURTHER INFORMATION CONTACT: Weldon Spring Plant (Weldon Spring, Theodore Katz, MPA, Designated Missouri) and Pacific Proving Grounds Acting Director, Management Analysis and Federal Officer, NIOSH, CDC, 1600 (Marshall Islands); the SEC petition for Services Office, Centers for Disease Control and Prevention . Clifton Road, Mailstop E–20, Atlanta, Savannah River Site (1973–2007; Aiken, Georgia 30333, Telephone (513) 533– South Carolina), and possibly one or [FR Doc. 2017–23336 Filed 10–25–17; 8:45 am] 6800, Toll Free 1 (800) CDC–INFO, more of the following SEC petitions: BILLING CODE 4163–19–P Email [email protected]. Idaho National Laboratory (1963–1970;
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Scoville, Idaho), Area IV of Santa Purpose: The Subcommittee will collection for the proper performance of Susanna Field Laboratory (1991–1993; provide counsel to the ACD, CDC on the agency’s functions, the accuracy of Ventura County, California), Ames strategies, future needs, and challenges the estimated burden, ways to enhance Laboratory (1971—undetermined faced by State, Tribal, Local and the quality, utility, and clarity of the ending date; Ames, Iowa); and Board Territorial health agencies, and will information to be collected; and the use Work Sessions. Agenda items are provide guidance on opportunities for of automated collection techniques or subject to change as priorities dictate. CDC through the ACD. other forms of information technology to The Director, Management Analysis Matters To Be Considered: The agenda minimize the information collection and Services Office, has been delegated will include discussions on burden. the authority to sign Federal Register implementation of ACD-adopted DATES: notices pertaining to announcements of recommendations related to the health Comments on the collection(s) of meetings and other committee department of the future, additional information must be received by the management activities, for both the developments that may expand these OMB desk officer by November 27, Centers for Disease Control and recommendations, and how CDC can 2017. Prevention and the Agency for Toxic best support STLT health departments. ADDRESSES: When commenting on the Substances and Disease Registry. Agenda items are subject to change as proposed information collections, priorities dictate. please reference the document identifier Claudette Grant, The Director, Management Analysis or OMB control number. To be assured Acting Director, Management Analysis and and Services Office, has been delegated consideration, comments and Services Office, Centers for Disease Control and Prevention. the authority to sign Federal Register recommendations must be received by notices pertaining to announcements of the OMB desk officer via one of the [FR Doc. 2017–23333 Filed 10–25–17; 8:45 am] meetings and other committee following transmissions: OMB, Office of BILLING CODE 4163–19–P management activities, for both the Information and Regulatory Affairs, Centers for Disease Control and Attention: CMS Desk Officer, Fax DEPARTMENT OF HEALTH AND Prevention and the Agency for Toxic Number: (202) 395–5806 OR, Email: _ HUMAN SERVICES Substances and Disease Registry. OIRA [email protected]. Claudette Grant, To obtain copies of a supporting statement and any related forms for the Centers for Disease Control and Acting Director, Management Analysis and Prevention Services Office, Centers for Disease Control proposed collection(s) summarized in and Prevention. this notice, you may make your request Advisory Committee to the Director [FR Doc. 2017–23334 Filed 10–25–17; 8:45 am] using one of following: (ACD), Centers for Disease Control and 1. Access CMS’ Web site address at BILLING CODE 4163–18–P Prevention (CDC)—State, Tribal, Local Web site address at https:// and Territorial (STLT) Subcommittee www.cms.gov/Regulations-and- AGENCY: Centers for Disease Control and DEPARTMENT OF HEALTH AND Guidance/Legislation/Paperwork Prevention (CDC), Department of Health HUMAN SERVICES ReductionActof1995/PRA-Listing.html. and Human Services (HHS). 2. Email your request, including your Centers for Medicare & Medicaid address, phone number, OMB number, ACTION: Notice of meeting. Services and CMS document identifier, to SUMMARY [email protected]. : In accordance with the [Document Identifiers: CMS–10114 and Federal Advisory Committee Act, the CMS–417] 3. Call the Reports Clearance Office at Centers for Disease Control and (410) 786–1326. Prevention (CDC), announces the Agency Information Collection FOR FURTHER INFORMATION CONTACT: following meeting for the State, Tribal, Activities: Submission for OMB William Parham at (410) 786–4669. Local and Territorial Subcommittee, Review; Comment Request SUPPLEMENTARY INFORMATION: Under the Centers for Disease Control and AGENCY: Centers for Medicare & Paperwork Reduction Act of 1995 (PRA) Prevention (STLT, CDC). This meeting (44 U.S.C. 3501–3520), federal agencies is open to the public, limited only by Medicaid Services, HHS. ACTION: Notice. must obtain approval from the Office of 100 ports for audio phone lines access Management and Budget (OMB) for each available. The public is also welcome to SUMMARY: The Centers for Medicare & collection of information they conduct listen to the meeting by (866) 917–2712, Medicaid Services (CMS) is announcing or sponsor. The term ‘‘collection of passcode 9418625. The public comment an opportunity for the public to information’’ is defined in 44 U.S.C. period is from 03:50 p.m.–03:55 p.m. comment on CMS’ intention to collect 3502(3) and 5 CFR 1320.3(c) and EST. Please register for public comment information from the public. Under the includes agency requests or by December 8, 2017 via email to Paperwork Reduction Act of 1995 requirements that members of the public [email protected]. (PRA), federal agencies are required to submit reports, keep records, or provide DATES: The meeting will be held on publish notice in the Federal Register information to a third party. Section December 18, 2017, 2:30 p.m. to 4:00 concerning each proposed collection of 3506(c)(2)(A) of the PRA (44 U.S.C. p.m., EST. information, including each proposed 3506(c)(2)(A)) requires federal agencies ADDRESSES: Audio Line Access Only extension or reinstatement of an existing to publish a 30-day notice in the (866) 917–2712, passcode 9418625. collection of information, and to allow Federal Register concerning each FOR FURTHER INFORMATION CONTACT: Jose a second opportunity for public proposed collection of information, Montero, MD, MPH, Director, Office for comment on the notice. Interested including each proposed extension or State, Tribal, Local and Territorial persons are invited to send comments reinstatement of an existing collection Support, CDC, 4770 Buford Highway, regarding the burden estimate or any of information, before submitting the Mailstop E70, Atlanta, Georgia 30341, other aspect of this collection of collection to OMB for approval. To (404) 498–0300, [email protected]. information, including the necessity and comply with this requirement, CMS is SUPPLEMENTARY INFORMATION: utility of the proposed information publishing this notice that summarizes
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the following proposed collection(s) of Dated: October 23, 2017. of Counterterrorism and Emerging information for public comment: William N. Parham, III, Threats, Food and Drug Administration, 1. Type of Information Collection Director, Paperwork Reduction Staff, Office 10903 New Hampshire Ave., Bldg. 1, Request: Extension of a currently of Strategic Operations and Regulatory Rm. 4338, Silver Spring, MD 20993– Affairs. approved collection; 0002. Send one self-addressed adhesive [FR Doc. 2017–23341 Filed 10–25–17; 8:45 am] label to assist that office in processing Title of Information Collection: BILLING CODE 4120–01–P your request or include a fax number to National Provider Identifier (NPI) which the Authorizations may be sent. Application and Update Form and See the SUPPLEMENTARY INFORMATION Supporting Regulations in 45 CFR DEPARTMENT OF HEALTH AND section for electronic access to the 142.408, 45 CFR 162.406, 45 CFR HUMAN SERVICES Authorizations. 162.408; Use: The National Provider FOR FURTHER INFORMATION CONTACT: Identifier Application and Update Form Food and Drug Administration Carmen Maher, Office of is used by health care providers to apply [Docket No. FDA–2016–N–1486] Counterterrorism and Emerging Threats, for NPIs and furnish updates to the Food and Drug Administration, 10903 information they supplied on their Authorizations of Emergency Use of In New Hampshire Ave., Bldg. 1, Rm. initial applications. The form is also Vitro Diagnostic Devices for Detection 4347, Silver Spring, MD 20993–0002, used to deactivate their NPIs if of Zika Virus; Availability 301–796–8510 (this is not a toll free necessary. The original application form AGENCY: Food and Drug Administration, number). was approved in February 2005 and has HHS. been in use since May 23, 2005. The SUPPLEMENTARY INFORMATION: ACTION: Notice. form is available on paper or can be I. Background completed via a web-based process. SUMMARY: The Food and Drug Section 564 of the FD&C Act (21 Health care providers can mail a paper Administration (FDA) is announcing the U.S.C. 360bbb–3) as amended by the application, complete the application issuance of two Emergency Use Project BioShield Act of 2004 (Pub. L. via the web-based process via the Authorizations (EUAs) (the 108–276) and the Pandemic and All- National Plan and Provider Authorizations) for in vitro diagnostic Hazards Preparedness Reauthorization Enumeration System (NPPES), or have a devices for detection of the Zika virus Act of 2013 (Pub. L. 113–5) allows FDA trusted organization submit the in response to the Zika virus outbreak to strengthen the public health application on their behalf via the in the Americas. FDA issued these protections against biological, chemical, Electronic File Interchange (EFI) Authorizations under the Federal Food, nuclear, and radiological agents. Among process. The Enumerator uses the Drug, and Cosmetic Act (the FD&C Act), other things, section 564 of the FD&C NPPES to process the application and as requested by Thermo Fisher Act allows FDA to authorize the use of generate the NPI. NPPES is the Medicare Scientific and The Center for Infection an unapproved medical product or an contractor tasked with issuing NPIs, and and Immunity, Columbia University. unapproved use of an approved medical maintaining and storing NPI data. Form The Authorizations contain, among product in certain situations. With this Number: CMS–10114 (OMB control other things, conditions on the EUA authority, FDA can help assure number: 0938–0931); Frequency: On emergency use of the authorized in vitro that medical countermeasures may be occasion; Affected Public: Business or diagnostic devices. The Authorizations used in emergencies to diagnose, treat, other for-profit, Not-for-profit follow the February 26, 2016, or prevent serious or life-threatening institutions, and Federal government; determination by the Secretary of Health diseases or conditions caused by Number of Respondents: 1,473,185; and Human Services (HHS) that there is biological, chemical, nuclear, or Total Annual Responses: 1,473,185; a significant potential for a public radiological agents when there are no Total Annual Hours: 250,442. (For health emergency that has a significant adequate, approved, and available policy questions regarding this potential to affect national security or alternatives. collection contact Kimberly McPhillips the health and security of U.S. citizens Section 564(b)(1) of the FD&C Act at 410–786–5374). living abroad and that involves Zika provides that, before an EUA may be 2. Type of Information Collection virus. On the basis of such issued, the Secretary of HHS must Request: Reinstatement without change determination, the Secretary of HHS declare that circumstances exist of a previously approved collection; declared on February 26, 2016, that justifying the authorization based on Title of Information Collection: Hospice circumstances exist justifying the one of the following grounds: (1) A Request for Certification and Supporting authorization of emergency use of in determination by the Secretary of Regulations; Use: The Hospice Request vitro diagnostic tests for detection of Homeland Security that there is a for Certification Form is the Zika virus and/or diagnosis of Zika domestic emergency, or a significant identification and screening form used virus infection, subject to the terms of potential for a domestic emergency, to initiate the certification process and any authorization issued under the involving a heightened risk of attack to determine if the provider has FD&C Act. The Authorizations, which with a biological, chemical, radiological, sufficient personnel to participate in the include an explanation of the reasons or nuclear agent or agents; (2) a Medicare program. Form Number: for issuance, are reprinted in this determination by the Secretary of CMS–417 (OMB Control number: 0938– document. Defense that there is a military 0313); Frequency: Annually; Affected DATES: The Authorization for Thermo emergency, or a significant potential for Public: Private Sector—Business or Fisher Scientific is applicable as of a military emergency, involving a other for-profits; Number of August 2, 2017; the Authorization for heightened risk to U.S. military forces of Respondents: 851; Total Annual The Center for Infection and Immunity, attack with a biological, chemical, Responses: 851; Total Annual Hours: Columbia University is effective as of radiological, or nuclear agent or agents; 213. (For policy questions regarding this August 11, 2017. (3) a determination by the Secretary of collection contact Thomas Pryor at 410– ADDRESSES: Submit written requests for HHS that there is a public health 786–1332.) single copies of the EUAs to the Office emergency, or a significant potential for
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a public health emergency, that affects, FDA 1 concludes: (1) That an agent potential to affect national security or or has a significant potential to affect, referred to in a declaration of emergency the health and security of U.S. citizens national security or the health and or threat can cause a serious or life- living abroad and that involves Zika security of U.S. citizens living abroad, threatening disease or condition; (2) virus. On February 26, 2016, under and that involves a biological, chemical, that, based on the totality of scientific section 564(b)(1) of the FD&C Act, and radiological, or nuclear agent or agents, evidence available to FDA, including on the basis of such determination, the or a disease or condition that may be data from adequate and well-controlled Secretary of HHS declared that attributable to such agent or agents; or clinical trials, if available, it is circumstances exist justifying the (4) the identification of a material threat reasonable to believe that: (A) The authorization of emergency use of in by the Secretary of Homeland Security product may be effective in diagnosing, vitro diagnostic tests for detection of under section 319F–2 of the Public treating, or preventing (i) such disease Zika virus and/or diagnosis of Zika Health Service (PHS) Act (42 U.S.C. or condition; or (ii) a serious or life- virus infection, subject to the terms of 247d–6b) sufficient to affect national threatening disease or condition caused any authorization issued under section security or the health and security of by a product authorized under section 564 of the FD&C Act. Notice of the U.S. citizens living abroad. 564, approved or cleared under the determination and declaration of the FD&C Act, or licensed under section 351 Secretary was published in the Federal Once the Secretary of HHS has of the PHS Act, for diagnosing, treating, Register on March 2, 2016 (81 FR declared that circumstances exist or preventing such a disease or 10878). On June 5, 2017, Thermo Fisher justifying an authorization under condition caused by such an agent; and Scientific requested, and on August 2, section 564 of the FD&C Act, FDA may (B) the known and potential benefits of 2017, FDA issued, an EUA for the authorize the emergency use of a drug, the product, when used to diagnose, TaqPath Zika Virus Kit (ZIKV), subject device, or biological product if the prevent, or treat such disease or to the terms of the Authorization. On Agency concludes that the statutory condition, outweigh the known and July 31, 2017, The Center for Infection criteria are satisfied. Under section potential risks of the product, taking and Immunity, Columbia University 564(h)(1) of the FD&C Act, FDA is into consideration the material threat requested, and on August 11, 2017, FDA required to publish in the Federal posed by the agent or agents identified issued, an EUA for the CII-ArboViroPlex Register a notice of each authorization, in a declaration under section rRT-PCR assay, subject to the terms of and each termination or revocation of an 564(b)(1)(D) of the FD&C Act, if the Authorization. authorization, and an explanation of the applicable; (3) that there is no adequate, reasons for the action. Section 564 of the approved, and available alternative to III. Electronic Access FD&C Act permits FDA to authorize the the product for diagnosing, preventing, introduction into interstate commerce of or treating such disease or condition; An electronic version of this a drug, device, or biological product and (4) that such other criteria as may document and the full text of the intended for use when the Secretary of be prescribed by regulation are satisfied. Authorizations are available on the HHS has declared that circumstances No other criteria for issuance have internet at https://www.regulations.gov. exist justifying the authorization of been prescribed by regulation under IV. The Authorizations emergency use. Products appropriate for section 564(c)(4) of the FD&C Act. emergency use may include products Because the statute is self-executing, Having concluded that the criteria for and uses that are not approved, cleared, regulations or guidance are not required issuance of the Authorizations under or licensed under sections 505, 510(k), for FDA to implement the EUA section 564(c) of the FD&C Act are met, or 515 of the FD&C Act (21 U.S.C. 355, authority. FDA has authorized the emergency use 360(k), and 360(e) or section 351 of the of two in vitro diagnostic devices for II. EUA Requests for In Vitro Diagnostic PHS Act (42 U.S.C. 262). FDA may issue detection of Zika virus subject to the Devices for Detection of the Zika Virus an EUA only if, after consultation with terms of the Authorizations. The the HHS Assistant Secretary for On February 26, 2016, the Secretary of Authorizations in their entirety (not Preparedness and Response, the HHS determined that there is a including the authorized versions of the Director of the National Institutes of significant potential for a public health fact sheets and other written materials) Health, and the Director of the Centers emergency that has a significant follows and provides an explanation of for Disease Control and Prevention (to the reasons for issuance, as required by the extent feasible and appropriate 1 The Secretary of HHS has delegated the section 564(h)(1) of the FD&C Act. authority to issue an EUA under section 564 of the given the applicable circumstances), FD&C Act to the Commissioner of Food and Drugs. BILLING CODE 4164–01–P
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1ssua1~ce of Authorization
L
of Authorization
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•
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Ill.
Conditions of Authorization
of the the
Thenno
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Promotion
•
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Page 2-Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University
of such determination, the Secretary of HHS then declared that circumstances exist justifYing the authorization of the 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 21 U.S.C. § 360bbb-3(a).4
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(c)) are met, I am authorizing the emergency use of the CII ArboViroPlex rRT-PCR assay (as described in the Scope of Authorization section ofthis letter {Section II)) in individuals meeting CDC Zika virus clinical criteria (e.g., clinical and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria {e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated) {as described in the Scope of Authorization section ofthis letter (Section II)) for the detection of Zika virus infection by authorized laboratories, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the Cli-ArboViroPlex rRT-PCR assay for the detection of Zika virus and diagnosis of Zika virus infection in the specified population meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
l. The Zika virus can cause Zika virus infection, a serious or life-threatening disease or condition to humans infected with the virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the CII-ArboViroPlex rRT-PCR assay, when used with the specified instrument(s) and in accordance with the Scope of Authorization, may be effective in detecting Zika virus and diagnosing Zika virus infection, and that the known and potential benefits of the CII-ArboViroPlex rRT-PCR assay for detecting Zika virus and diagnosing Zika virus infection outweigh the known and potential risks of such product; and
3. There is no adequate, approved, and available alternative to the emergency use of the CII-Arbo ViroPlex rRT -PCR assay for detecting Zika virus and diagnosing Zika virus infection. s
II. Seope of Authorization
I have concluded, pursuant to section 564( d)(l) of the Act, that the scope of this authorization is limited to the use of the authorized CH-ArboViroPlex rRT-PCR assay by authorized laboratories for the qualitative detection and differentiation of RNA from Zika virus, dengue virus,
564(b ){I )(C) of lhe Act, the Secretary may make a determination of a public health emergency, or of a significant f?tential for a public health emergency. HHS. Determination and Declaration Regarding Emergency Use of in Vitro Diagnostic Tests far Detection afZika Virus and/or DiagnosisofZika Virus Infection. 81 Fed. Reg. 10878 (Maroh2, 2016). 5 No other criteria of issuance have been prescribed by regulation under section .564(c )( 4) of the Act.
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Page 3-Dr. W. Ian Lipkin, The Center for Infection and Immunity, Colwnbia University
chikungunya virus, and West Nile virus in serwn, and for the qualitative detection of Zika virus RNA in urine (collected alongside a patient-matched serwn specimen) in individuals meeting CDC Zika virus clinical criteria (e.g., clinical and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).
The Authorized CII-ArboViroPiex rRT-PCR assay
The CII-ArboViroPlex rRT-PCR assay is a multiplex one-step real-time reverse transcription polymerase chain reaction (rRT-PCR) assay for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, chikungunya virus, and West Nile virus in serum, and other authorized specimen types. The CII-ArboViroPiex rRT-PCR assay can also be used for the qualitative detection of Zika virus RNA in urine when collected alongside a patient-matched serum specimen and other authorized whole blood derived specimen types.
To perfonn the CII-ArboViroPlex rRT-PCR assay, the RNA is first extracted and purified from the patient specimen. The RNA is then reverse transcribed into eDNA which is amplified using the primer set and detected using the specific probe. The rRT-PCR is performed on the CFX96 Real-Time PCR Detection System (Bio-Rad), or other authorized instruments.
The CII-ArboViroPlex rRT-PCR assay includes the following materials or other authorized materials: • ZIKV-MIX, DENV-MIX, CHIKV-MIX, WNV-MIX and RP-MIX vials containing primers and probes for the assay targets and internal contrul • ZPC, DPC, CP, WPC, HSC, eHSC, NTC vials containing the positive and negative controls used in the assay • Diluent vial used to reconstitute dried vials The CII-ArboViroPlex rRT-PCR assay also requires the use of additional materials and ancillary reagents that are not included with the test but are commonly used in clinical laboratories and are described in the authorized CII-ArboViroPlex rRT-PCR assay Instructions for Use.
The CII-ArboViroPiex rRT-PCR assay requires the following contrul materials, or other authorized control materials; all controls listed below must generate expected results in order for a test to be considered valid, as outlined in the CII-ArboViroPlex rRT-PCR assay Instructions for Use: • Human Specimen Control: A hwnan cell culture preparation used as an extraction control and positive control for the RNase P primer and probe set that is extracted and tested concurrently with the test specimens. • Extracted Hwnan Specimen Control (eHSC): Extracted total nucleic acid from a hwnan cell culture preparation known to contain RNase P (eHSC), but negative for viral targets, is used as a control for perfonnance ofRNase P primer/probe set and PCR reagent function. • Positive Controls for viruses: Run with each batch of patient specimens. Monitors for failures ofrRT-PCR reagents and reaction conditions. o ZIKV Positive Control (ZPC), synthetic in vitro transcribed RNA
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II
.. ..
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Page 5-Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University
Arbo ViroPlex rRT-PCR assay, when used for detection of Zika virus and to diagnose Zika virus infection in the specified population (as described in the Scope of Authorization of this letter (Section II)}, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized CII-ArboViroPlex rRT-PCR assay under this EUA must be consistent with, and may not exceed, the terms of this letter, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section IV). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination described above and the Secretary of HHS' s corresponding declaration under section 564(b )(1 ), the CII-ArboViroPlex rRT-PCR assay described above is authorized to detect Zika virus and diagnose Zika virus infection in individuals meeting CDC Zika virus clinical criteria (e.g,., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika virus transmissions at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).
This EUA will cease to be effective when the HHS declaration that circumstances exist to justizy the EUA is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
10. Waiver of Certain Requirements
I am waiving the following requirements for the CII-ArboViroPlex rRT-PCR assay during the duration of this EUA:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution oftheCII-ArboViroPlex rRT-PCR assay.
• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under21 CFR 809.10 and 21 CFR 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate directions for use (21 U.S.C. 352(:1)), (21 CFR 809JO(b)(5), (7), and (8)}; any appropriate limitations on the use of the device including information required under 21 CFR 809.1 O(a)(4); and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
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Columbia
Columbia
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Page 7 Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University
Arbo ViroPlex rRT -PCR assay, including the name, address, and phone number of any authorized distributor( s).
J. Columbia University will provide its authorized distributor(s) with a copy of this and communicate to its authorized distributor(s) any subsequent amendments that might be made to this EUA and its authorized accompanying materials (e.g., Fact Sheets, Instructions for Use).
K. Columbia University may request changes to the authorized CII-Arbo ViroPlex rRT ~ PCR assay Fact Sheet for Healthcare Providers and the authorized CII-ArboViroPlex rRT-PCR assay Fact Sheet for Patients. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMD/OIRJCDRH.
L. Columbia University may request the addition of other instruments for use with the authorized CII-ArboViroPlex rRT-PCR assay. Such requests will be made Columbia University in consultation with, and require concurrence of, DMD/OIRICDRH.
M. Columbia University may request the addition of other extraction methods for use with the authorized CII-ArboViroPlex rRT-PCR assay. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMD/OIR/CDRH.
N. Columbia University may request the addition of other specimen types for use with the authorized CII·ArboViroPiex rRT-PCR assay. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMD/OIRJCDRH.
0. Columbia University may request the addition and/or substitution of other control materials for use with the authorized CII-Arbo ViroPlex. rRT-PCR assay. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMD/OIRJCDRH.
P. Columbia University may request the addition and/or substitution of other ancillary reagents and materials for use with the authorized CII-Arbo ViroPlex rRT -PCR assay. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMD/OIRJCDRH.
Q. Columbia University will assess traceability7 of the CII-ArboViroPlex rRT-PCR assay with FDA-recommended reference material(s). After submission to FDA and DMD/OIRICDRH's review of and concurrence with the data, Columbia University will update its labeling to reflect the additional testing.
R. Columbia University will track adverse events and to FDA under 21 CFR Part 803.
Authorized Laboratories
1 Traceability refers to tracing analytical sensitivity/reactivity back to a FDA-recommended reference material.
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Columbia and Authorized
Conditions
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9- Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University
authorized CII-ArboViroPlex rRT-PCR assay shall be consistent with the Fact Sheets and authorized labeling, !IS well as the terms set forth in this EUA and the 11pplicable requirements set forth in the Act and FDA regulations.
CC. All advertising and promotional descriptive printed matter relating to the use of the authorized CII-ArboViroPlex rRT-PCR assay shall clearly and conspicuously state that:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection and differentiation of RNA :from Zika virus, dengue virus, chik:ungunya virus, and West Nile virus, not for any other viruses or pathogens; and
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests fur detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(I) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.
No advertising or promotional descriptive printed matter relating to the nse of the authorized CII •Arbo ViroPlex rRT-PCR assay may represent or suggest that this test is safe or effective for the diagnosis ofZika virus infection.
The emergency use of the authorized CII-Arbo ViroPiex rRT -PCR assay as described in this letter of authorization must comply with the conditions and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests fur detection of Zika virus and/or diagnosis of Zika virus infection is terminated under section 564(b )(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Sincerely,
Enclosures
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Dated: October 20, 2017. November 17, 2017. Comments received the docket and, except for those Leslie Kux, by mail/hand delivery/courier (for submitted as ‘‘Confidential Associate Commissioner for Policy. written/paper submissions) will be Submissions,’’ publicly viewable at [FR Doc. 2017–23224 Filed 10–25–17; 8:45 am] considered timely if they are https://www.regulations.gov or at the BILLING CODE 4164–01–C postmarked or the delivery service Dockets Management Staff between 9 acceptance receipt is on or before that a.m. and 4 p.m., Monday through date. Friday. DEPARTMENT OF HEALTH AND Comments received on or before • Confidential Submissions—To HUMAN SERVICES November 3, 2017, will be provided to submit a comment with confidential the committee. Comments received after information that you do not wish to be Food and Drug Administration that date will be taken into made publicly available, submit your consideration by the Agency. comments only as a written/paper [Docket No. FDA–2017–N–5818] You may submit comments as submission. You should submit two Pharmacy Compounding Advisory follows: copies total. One copy will include the Committee; Notice of Meeting; Electronic Submissions information you claim to be confidential Establishment of a Public Docket; with a heading or cover note that states Submit electronic comments in the Request for Comments ‘‘THIS DOCUMENT CONTAINS following way: • CONFIDENTIAL INFORMATION.’’ The AGENCY: Food and Drug Administration, Federal eRulemaking Portal: Agency will review this copy, including HHS. https://www.regulations.gov. Follow the the claimed confidential information, in instructions for submitting comments. ACTION: Notice; establishment of a its consideration of comments. The Comments submitted electronically, public docket; request for comments. second copy, which will have the including attachments, to https:// claimed confidential information SUMMARY: The Food and Drug www.regulations.gov will be posted to redacted/blacked out, will be available Administration (FDA) announces a the docket unchanged. Because your for public viewing and posted on forthcoming public advisory committee comment will be made public, you are https://www.regulations.gov. Submit meeting of the Pharmacy Compounding solely responsible for ensuring that your both copies to the Dockets Management Advisory Committee (PCAC). The comment does not include any Staff. If you do not wish your name and general function of the committee is to confidential information that you or a contact information to be made publicly provide advice on scientific, technical, third party may not wish to be posted, available, you can provide this and medical issues concerning drug such as medical information, your or information on the cover sheet and not compounding under the Federal Food, anyone else’s Social Security number, or in the body of your comments and you Drug, and Cosmetic Act (the FD&C Act), confidential business information, such must identify this information as and, as required, any other product for as a manufacturing process. Please note ‘‘confidential.’’ Any information marked which FDA has regulatory that if you include your name, contact as ‘‘confidential’’ will not be disclosed responsibility, and to make appropriate information, or other information that except in accordance with 21 CFR 10.20 recommendations to the Agency. The identifies you in the body of your and other applicable disclosure law. For meeting will be open to the public. comments, that information will be more information about FDA’s posting DATES: The meeting will be held on posted on https://www.regulations.gov. of comments to public dockets, see 80 • If you want to submit a comment November 20, 2017, from 8:30 a.m. to 5 FR 56469, September 18, 2015, or access with confidential information that you p.m. and November 21, 2017, from 8:30 the information at: https://www.gpo.gov/ do not wish to be made available to the a.m. to 11:30 a.m. fdsys/pkg/FR-2015-09-18/pdf/2015- public, submit the comment as a 23389.pdf. ADDRESSES: FDA White Oak Campus, written/paper submission and in the 10903 New Hampshire Ave., Bldg. 31 Docket: For access to the docket to manner detailed (see ‘‘Written/Paper read background documents or the Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’). 1503), Silver Spring, MD 20993–0002. electronic and written/paper comments Answers to commonly asked questions, Written/Paper Submissions received, go to https:// including information regarding special Submit written/paper submissions as www.regulations.gov and insert the accommodations due to a disability, follows: docket number, found in brackets in the visitor parking, and transportation may • Mail/Hand delivery/Courier (for heading of this document, into the be accessed at: https://www.fda.gov/ written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts AdvisoryCommittees/ Management Staff (HFA–305), Food and and/or go to the Dockets Management AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. FDA is establishing a docket for • For written/paper comments FOR FURTHER INFORMATION CONTACT: public comment on this meeting. The submitted to the Dockets Management Cindy Chee, Center for Drug Evaluation docket number is FDA–2017–N–5818. Staff, FDA will post your comment, as and Research, Food and Drug The docket will close on November 17, well as any attachments, except for Administration, 10903 New Hampshire 2017. Submit either electronic or information submitted, marked and Ave., Bldg. 31, Rm. 2417, Silver Spring, written comments on this public identified, as confidential, if submitted MD 20993–0002, 301–796–9001, Fax: meeting by November 17, 2017. Please as detailed in ‘‘Instructions.’’ 301–847–8533, email: PCAC@ note that late, untimely filed comments Instructions: All submissions received fda.hhs.gov, or FDA Advisory will not be considered. Electronic must include the Docket No. FDA– Committee Information Line, 1–800– comments must be submitted on or 2017–N–5818 for ‘‘Pharmacy 741–8138 (301–443–0572 in the before November 17, 2017. The https:// Compounding Advisory Committee; Washington, DC area). A notice in the www.regulations.gov electronic filing Notice of Meeting; Establishment of a Federal Register about last minute system will accept comments until Public Docket; Request for Comments.’’ modifications that impact a previously midnight Eastern Time at the end of Received comments will be placed in announced advisory committee meeting
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cannot always be published quickly Section 502(f)(1) (concerning the A condition that must be satisfied to enough to provide timely notice. labeling of drugs with adequate qualify for the exemptions in section Therefore, you should always check the directions for use); (2) section 505 503B of the FD&C Act is that the Agency’s Web site at https:// (concerning the approval of human drug compounded drug is not identified www.fda.gov/AdvisoryCommittees/ products under NDAs or ANDAs); and (directly or as part of a category of default.htm and scroll down to the (3) section 582 (21 U.S.C. 360eee–1) drugs) on a list, published by the appropriate advisory committee meeting (concerning the drug supply chain Secretary by regulation, of drugs or link, or call the advisory committee security requirements). Outsourcing categories of drugs that present information line to learn about possible facilities are not exempt from CGMP demonstrable difficulties for modifications before coming to the requirements in section 501(a)(2)(B) of compounding that are reasonably likely meeting. the FD&C Act. to lead to an adverse effect on the safety SUPPLEMENTARY INFORMATION: One of the conditions that must be or effectiveness of the drug or category Background: Section 503A of the satisfied to qualify for the exemptions of drugs, taking into account the risks FD&C Act (21 U.S.C. 353a) describes the under section 503A of the FD&C Act is and benefits to patients, or the drug is conditions that must be satisfied for that a bulk drug substance (active compounded in accordance with all human drug products compounded by a pharmaceutical ingredient) used in a applicable conditions identified on the licensed pharmacist in a State licensed compounded drug product must meet list as conditions that are necessary to pharmacy or a Federal facility, or a one of the following criteria: (1) prevent the drug or category of drugs licensed physician, to be exempt from Complies with the standards of an from presenting such demonstrable the following three sections of the FD&C applicable United States Pharmacopoeia difficulties (see section 503B(a)(6)(A) Act: (1) Section 501(a)(2)(B) (21 U.S.C. (USP) or National Formulary (NF) and (B) of the FD&C Act). 351(a)(2)(B)) (concerning current good monograph, if a monograph exists, and FDA intends to discuss with the manufacturing practice (CGMP)); (2) the USP chapter on pharmacy committee bulk drug substances section 502(f)(1) (21 U.S.C. 352(f)(1)) compounding; (2) if an applicable nominated for inclusion on the 503A (concerning the labeling of drugs with monograph does not exist, is a Bulks List and drug products nominated adequate directions for use); and (3) component of a drug approved by the for inclusion on the list of drug products section 505 (21 U.S.C. 355) (concerning Secretary of Health and Human Services that present demonstrable difficulties the approval of human drug products (the Secretary); or (3) if such a for compounding under sections 503A under new drug applications (NDAs) or monograph does not exist and the drug and 503B (‘‘Difficult to Compound abbreviated new drug applications substance is not a component of a drug List’’). (ANDAs)). approved by the Secretary, appears on a Agenda: The committee intends to The Drug Quality and Security Act list developed by the Secretary through discuss six bulk drug substances added a new section 503B to the FD&C regulations issued by the Secretary (the nominated for inclusion on the section Act (21 U.S.C. 353b), which created a ‘‘503A Bulks List’’) (see section 503A Bulks List. FDA will discuss the new category of compounders termed 503A(b)(1)(A)(i) of the FD&C Act). following nominated bulk drug ‘‘outsourcing facilities.’’ Under section Another condition that must be substances: astragalus, L-citrulline, 503B of the FD&C Act, outsourcing satisfied to qualify for the exemptions pregnenolone, 7-keto facilities are defined, in part, as under section 503A of the FD&C Act is dehydroepiandrosterone (DHEA), facilities that meet certain conditions that the compounded drug product is epigallocatechin gallate (EGCg), and described in section 503B, including not a drug product identified by the resveratrol. The chart below identifies registration with FDA as an outsourcing Secretary by regulation as a drug the use(s) FDA reviewed for each of the facility. If these conditions are satisfied, product that presents demonstrable six bulk drug substances being a drug product compounded for human difficulties for compounding that discussed at this advisory committee use by or under the direct supervision reasonably demonstrate an adverse meeting. The nominators of these of a licensed pharmacist in an effect on the safety or effectiveness of substances will be invited to make a outsourcing facility is exempt from that drug product (see section short presentation supporting the three sections of the FD&C Act: (1) 503A(b)(3)(A) of the FD&C Act). nomination.
Drug Uses reviewed
Astragalus ...... Allergic rhinitis, asthma, diabetes, herpes simplex keratitis, wound healing. L-citrulline ...... Hyperammonaemia due to cycle disorders. Pregnenolone ...... Rheumatoid arthritis, hypercholesterolemia, manic and depressive symptoms of bipolar disorder and bipo- lar disorder with substance abuse (dual diagnosis), positive and negative symptoms of schizophrenia. 7-keto dehydroepiandrosterone ...... Weight loss, Raynaud’s phenomena. Epigallocatechin gallate ...... Treatment of obesity, wound healing, corneal neovascularization, non-alcoholic fatty liver disease, cardiac hypertrophy, diabetes (type 1 & 2), Parkinson’s disease. Resveratrol ...... Treatment of older adults with impaired glucose tolerance, pain.
The committee also intends to discuss List. The nominators will be invited to be made publicly available at the liposome drug products and drug make a short presentation supporting location of the advisory committee products produced using hot melt the nomination. meeting, and the background material extrusion technology for inclusion on FDA intends to make background will be posted on FDA’s Web site after the Difficult to Compound List. Drug material available to the public no later the meeting. Background material is products produced ‘‘by extrusion or than 2 business days before the meeting. available at https://www.fda.gov/ nanotechnology’’ were nominated for If FDA is unable to post the background AdvisoryCommittees/Calendar/ inclusion on the Difficult to Compound material on its Web site prior to the default.htm. Scroll down to the meeting, the background material will
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appropriate advisory committee meeting DEPARTMENT OF HEALTH AND Written/Paper Submissions link. HUMAN SERVICES Submit written/paper submissions as Procedure: Interested persons may follows: Food and Drug Administration present data, information, or views, • Mail/Hand delivery/Courier (for orally or in writing, on issues pending [Docket No. FDA–2013–N–0961] written/paper submissions): Dockets before the committee. All electronic and Management Staff (HFA–305), Food and written submissions submitted to the Matthew Schroeder; Denial of Hearing; Drug Administration, 5630 Fishers Docket (see the ADDRESSES section) on Final Debarment Order Lane, Rm. 1061, Rockville, MD 20852. or before November 3, 2017, will be • For a written/paper application provided to the committee. Oral AGENCY: Food and Drug Administration, HHS. submitted to the Dockets Management presentations from the public will be Staff, FDA will post your application, as ACTION: Notice. scheduled between approximately 9:35 well as any attachments, except for a.m. and 9:45 a.m., 10:55 a.m. and 11:05 SUMMARY: The Food and Drug information submitted, marked and a.m., 12 noon and 12:10 p.m., 2:05 p.m. Administration (FDA) is denying identified, as confidential, if submitted and 2:15 p.m., 3:25 p.m. and 3:35 p.m., Matthew Schroeder’s (Schroeder’s) as detailed in ‘‘Instructions.’’ and 4:30 p.m. and 4:40 p.m. on request for a hearing and is issuing an Instructions: Your application must November 20, 2017, and between order under the Federal Food, Drug, and include the Docket No. FDA–2013–N– approximately 9:40 a.m. and 9:50 a.m. Cosmetic Act (the FD&C Act) 0961. An application will be placed in and 11:10 a.m. and 11:20 a.m. on permanently debarring Schroeder from the docket and, unless submitted as November 21, 2017. Those individuals providing services in any capacity to a ‘‘Confidential Submissions,’’ publicly interested in making formal oral person that has an approved or pending viewable at https://www.regulations.gov presentations should notify the contact drug product application. FDA bases or at the Dockets Management Staff person and submit a brief statement of this order on a finding that Schroeder between 9 a.m. and 4 p.m., Monday the general nature of the evidence or was convicted of a felony under Federal through Friday. arguments they wish to present, the law for conduct relating to the • Confidential Submissions—To names and addresses of proposed regulation of a drug product under the submit an application with confidential participants, and an indication of the FD&C Act. Schroeder failed to file with information that you do not wish to be approximate time requested to make the Agency information and analyses made publicly available, submit your their presentation on or before October sufficient to create a basis for a hearing application only as a written/paper 26, 2017. Time allotted for each concerning this action. submission. You should submit two presentation may be limited. If the DATES: This order is applicable October copies total. One copy will include the number of registrants requesting to 26, 2017. information you claim to be confidential speak is greater than can be reasonably ADDRESSES: Any application by with a heading or cover note that states accommodated during the scheduled ‘‘THIS DOCUMENT CONTAINS open public hearing session, FDA may Schroeder for special termination of debarment under section 306(d) of the CONFIDENTIAL INFORMATION.’’ The conduct a lottery to determine the Agency will review this copy, including speakers for the scheduled open public FD&C Act (application) may be submitted as follows: the claimed confidential information, in hearing session. The contact person will its consideration of your application. notify interested persons regarding their Electronic Submissions The second copy, which will have the request to speak by October 27, 2017. • Federal eRulemaking Portal: claimed confidential information Persons attending FDA’s advisory https://www.regulations.gov. Follow the redacted/blacked out, will be available committee meetings are advised that the instructions for submitting comments. for public viewing and posted on Agency is not responsible for providing An application submitted electronically, https://www.regulations.gov. Submit access to electrical outlets. including attachments, to https:// both copies to the Dockets Management FDA welcomes the attendance of the www.regulations.gov will be posted to Staff. If you do not wish your name and public at its advisory committee the docket unchanged. Because your contact information to be made publicly meetings and will make every effort to application will be made public, you are available, you can provide this accommodate persons with disabilities. solely responsible for ensuring that your information on the cover sheet and not If you require accommodations due to a application does not include any in the body of your application and you disability, please contact Cindy Chee at confidential information that you or a must identify this information as least 7 days in advance of the meeting. FDA is committed to the orderly third party may not wish to be posted, ‘‘confidential.’’ Any information marked conduct of its advisory committee such as medical information, your or as ‘‘confidential’’ will not be disclosed meetings. Please visit our Web site at anyone else’s Social Security number, or except in accordance with 21 CFR 10.20 https://www.fda.gov/ confidential business information, such and other applicable disclosure law. For AdvisoryCommittees/ as a manufacturing process. Please note more information about FDA’s posting AboutAdvisoryCommittees/ that if you include your name, contact of comments to public dockets, see 80 ucm111462.htm for procedures on information, or other information that FR 56469, September 18, 2015, or access public conduct during advisory identifies you in the body of your the information at: https://www.gpo.gov/ committee meetings. application, that information will be fdsys/pkg/FR-2015-09-18/pdf/2015- posted on https://www.regulations.gov. 23389.pdf. Notice of this meeting is given under • the Federal Advisory Committee Act (5 If you want to submit an Docket: For access to the docket, go to U.S.C. app. 2). application with confidential https://www.regulations.gov and insert information that you do not wish to be the docket number, found in brackets in Dated: October 20, 2017. made available to the public, submit the the heading of this document, into the Leslie Kux, application as a written/paper ‘‘Search’’ box and follow the prompts Associate Commissioner for Policy. submission and in the manner detailed and/or go to the Dockets Management [FR Doc. 2017–23223 Filed 10–25–17; 8:45 am] (see ‘‘Written/Paper Submissions’’ and Staff, 5630 Fishers Lane, Rm. 1061, BILLING CODE 4164–01–P ‘‘Instructions’’). Rockville, MD 20852 between 9 a.m.
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and 4 p.m., Monday through Friday. denials, or general descriptions of Along with his request for a hearing, Publicly available submissions may be positions and contentions, or on data Schroeder also requested a special seen in the docket. and information insufficient to justify termination of debarment. Under FOR FURTHER INFORMATION CONTACT: Julie the factual determination urged (see 21 section 306(d), a debarred individual Finegan, Office of Scientific Integrity, CFR 21.24(b)). may apply for special termination of Food and Drug Administration, 10903 The Director of OSI considered debarment. While the debarment period New Hampshire Ave., Bldg. 1, Rm. Schroeder’s arguments and concludes can be limited to less than permanent, 4218, Silver Spring, Maryland 20993, that they are unpersuasive and fail to the individual must be debarred for at 301–796–8618. raise a genuine issue of fact requiring a least 1 year. Schroeder is not yet SUPPLEMENTARY INFORMATION: hearing. debarred, so his request for special termination of debarment is not I. Background II. Arguments appropriate for consideration at this On October 11, 2012, the U.S. District In his request for hearing, Schroeder time. Court for the Northern District of first argues that he took voluntary steps Georgia entered a criminal judgment to mitigate the dangers posed by the III. Findings and Order against Matthew Schroeder under his drugs by putting warnings against Therefore, the Director of OSI, under guilty plea. Schroeder pled guilty to a human consumption on the sales felony under the FD&C Act, namely packaging and Web site. Schroeder section 306(a)(2) of the FD&C Act and aiding and abetting, with the intent to states that he discontinued drug sales under the authority delegated to him, defraud or mislead, in the dispensing of after an FDA investigator contacted him finds that Matthew Schroeder has been phenazepam without a prescription, and that he fully disclosed all of his convicted of a felony under Federal law resulting in the phenazapam being wrongdoing. Schroeder next argues that for conduct relating to the regulation of misbranded while held for sale after he cooperated with investigations and a drug product under the FD&C Act. shipment in interstate commerce in provided testimony against the drug As a result of the foregoing findings, violation of sections 301(k), 503(b)(1), suppliers. Third, Schroeder argues that Matthew Schroeder is permanently 303(a)(2) of the FD&C Act (21 U.S.C. he ended all his activities concerning debarred from providing services in any 331(k), 353(b)(1) and 333(a)(2)) and 18 drug sales and has not violated the capacity to a person with an approved U.S.C. 2. Specifically, Schroeder, FD&C Act since September 2010. He or pending drug product application through his company, Novel Research also states that his phenazepam sales under section 505, 512, or 802 of the only spanned two months. Fourth, Supply, and eBay ID, FD&C Act (21 U.S.C. 355, 360b, or 382), Schroeder addresses Kevin Lewis’ death ‘‘finemineralsfossilssio2’’ sold or under section 351 of the Public and purchases. Schroeder states that in phenazepam and Health Service Act (42 U.S.C. 262), methylenedioxypyrovalerone. Both are the case against another drug supplier, effective (see DATES) (21 U.S.C. unapproved drugs and are used by drug the prosecutor determined that Kevin 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 users for recreational purposes. Lewis died from long-term IV drug use, U.S.C. 321(dd)). Any person with an According to FDA’s September 24, 2014, rather than the phenazepam purchased letter to Schroeder, in August 2010, from Schroeder’s eBay account. approved or pending drug product Kevin Lewis purchased phenazepam on Schroeder also clarifies that Kevin application who knowingly uses the eBay from ‘‘finemineralsfossilssio2’’ and Lewis purchased the phenazepam by services of Schroeder, in any capacity later died after ingesting phenazepam using his mother’s eBay account. during his period of debarment, will be through an injection. Finally, Schroeder alleges that he does subject to civil money penalties. See Schroeder is subject to debarment not pose a recidivism risk. section 307(a)(6) of the FD&C Act (21 based on a finding, under section Section 306(a)(2) of the FD&C Act U.S.C. 335b(a)(6)). If Schroeder, during 306(a)(2) of the FD&C Act (21 U.S.C. provides FDA with the authority to his period of debarment, provides 335a(a)(2)), that he was convicted of a debar an individual who has been services in any capacity to a person with felony under Federal law for conduct convicted of certain Federal felonies. an approved or pending drug product relating to the regulation of a drug The only relevant factual issue is application, he will be subject to civil product under the FD&C Act. By the whether Schroeder was actually money penalties. See section 307(a)(7) letter dated September 24, 2014, FDA convicted of a felony under Federal law of the FD&C Act (21 U.S.C. 335b(a)(7)). notified Schroeder of a proposal to for conduct relating to the development In addition, FDA will not accept or permanently debar him from providing or approval of a drug product or review any abbreviated new drug services in any capacity to a person otherwise relating to the regulation of a applications submitted by or with the having an approved or pending drug drug product under the FD&C Act. assistance of Schroeder during his product application. Schroeder Schroeder does not dispute that he pled period of debarment. requested a hearing on the proposal and guilty to a felony under the FD&C Act, special termination of debarment. specifically aiding and abetting, with Dated: October 20, 2017. Schroeder acknowledges his conviction the intent to defraud and mislead, in the G. Matthew Warren, under Federal law, but argues that dispensing of phenazepam without a Director, Office of Scientific Integrity. multiple mitigating factors merit a prescription, resulting in the [FR Doc. 2017–23275 Filed 10–25–17; 8:45 am] hearing or special termination of phenazepam being misbranded while BILLING CODE 4164–01–P debarment. held for sale after shipment in interstate Under the authority delegated to him commerce. Accordingly, Schroeder’s by the Commissioner of Food and arguments fail to raise a genuine and Drugs, the Director of the Office of substantial issue of fact as to whether he Scientific Integrity (OSI) has considered was convicted of a felony under Federal Schroeder’s request for a hearing. law for conduct relating to the Hearings will not be granted on issues regulation of a drug product under the of policy or law, on mere allegations, FD&C Act.
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DEPARTMENT OF HOMELAND on the affected public, an explanation of Summary: The information is needed SECURITY the necessity of the Collection, and to ensure compliance with our rules for other important information describing the design and operation of liquefied gas Coast Guard the Collection. There is one ICR for each carriers. [Docket No. USCG–2017–0953] Collection. Need: Title 46 U.S.C. 3703 and 9101 The Coast Guard invites comments on authorizes the Coast Guard to establish Information Collection Request to whether this ICR should be granted regulations to protect life, property, and Office of Management and Budget; based on the Collection being necessary the environment from the hazards OMB Control Number: 1625–0029 for the proper performance of associated with the carriage of Departmental functions. In particular, dangerous liquid cargo in bulk. Title 46 AGENCY: Coast Guard, DHS. the Coast Guard would appreciate CFR part 154 prescribes the rules for the ACTION: Sixty-day notice requesting comments addressing: (1) The practical carriage of liquefied gases in bulk on comments. utility of the Collection; (2) the accuracy self-propelled vessels by governing the of the estimated burden of the design, construction, equipment, and SUMMARY: In compliance with the Collection; (3) ways to enhance the operation of these vessels and the safety Paperwork Reduction Act of 1995, the quality, utility, and clarity of of personnel aboard them. U.S. Coast Guard intends to submit an information subject to the Collection; Forms: None. Information Collection Request (ICR) to and (4) ways to minimize the burden of Respondents: Owners and operators the Office of Management and Budget the Collection on respondents, of self-propelled vessels carrying (OMB), Office of Information and including the use of automated liquefied gas. Regulatory Affairs (OIRA), requesting an collection techniques or other forms of Frequency: On occasion. extension of its approval for the information technology. In response to Hour Burden Estimate: The estimated following collection of information: your comments, we may revise this ICR burden has increased from 7,890 hours 1625–0029, Self-propelled Liquefied or decide not to seek an extension of to 8,169 hours a year due to an increase Gas Vessels; without change. Our ICR approval for the Collection. We will in the estimated number of respondents. describes the information we seek to consider all comments and material Authority: The Paperwork Reduction Act collect from the public. Before received during the comment period. of 1995; 44 U.S.C. Chapter 35, as amended. submitting this ICR to OIRA, the Coast We encourage you to respond to this Dated: October 16, 2017. Guard is inviting comments as request by submitting comments and James D. Roppel, described below. related materials. Comments must U.S. Coast Guard, Acting Chief, Office of DATES: Comments must reach the Coast contain the OMB Control Number of the Information Management. Guard on or before December 26, 2017. ICR and the docket number of this [FR Doc. 2017–23302 Filed 10–25–17; 8:45 am] ADDRESSES: You may submit comments request, [USCG–2017–0953], and must BILLING CODE 9110–04–P identified by Coast Guard docket be received by December 26, 2017. number [USCG–2017–0953] to the Coast Submitting Comments Guard using the Federal eRulemaking DEPARTMENT OF HOMELAND Portal at http://www.regulations.gov. We encourage you to submit SECURITY See the ‘‘Public participation and comments through the Federal request for comments’’ portion of the eRulemaking Portal at http:// Coast Guard www.regulations.gov. If your material SUPPLEMENTARY INFORMATION section for [Docket No. USCG–2017–0902] further instructions on submitting cannot be submitted using http:// comments. www.regulations.gov, contact the person Information Collection Request to A copy of the ICR is available through in the FOR FURTHER INFORMATION Office of Management and Budget; the docket on the Internet at http:// CONTACT section of this document for OMB Control Number: 1625–0020 www.regulations.gov. Additionally, alternate instructions. Documents AGENCY: Coast Guard, DHS. copies are available from: Commandant mentioned in this notice, and all public ACTION: (CG–612), Attn: Paperwork Reduction comments, are in our online docket at Sixty-day notice requesting comments. Act Manager, U.S. Coast Guard, 2703 http://www.regulations.gov and can be viewed by following that Web site’s Martin Luther King, Jr. Ave. SE., STOP SUMMARY: In compliance with the 7710, Washington, DC 20593–7710. instructions. Additionally, if you go to the online docket and sign up for email Paperwork Reduction Act of 1995, the FOR FURTHER INFORMATION CONTACT: U.S. Coast Guard intends to submit an Mr. alerts, you will be notified when Information Collection Request (ICR) to Anthony Smith, Office of Information comments are posted. Management, telephone 202–475–3532, We accept anonymous comments. All the Office of Management and Budget or fax 202–372–8405, for questions on comments received will be posted (OMB), Office of Information and these documents. without change to http:// Regulatory Affairs (OIRA), requesting an SUPPLEMENTARY INFORMATION: www.regulations.gov and will include extension of its approval for the following collection of information: Public participation and Request for any personal information you have provided. For more about privacy and 1625–0020, Security Zones, Regulated Comments Navigation Areas, and Safety Zones; the docket, you may review a Privacy without change. Our ICR describes the This Notice relies on the authority of Act notice regarding the Federal Docket information we seek to collect from the the Paperwork Reduction Act of 1995; Management System in the March 24, public. Before submitting this ICR to 44 U.S.C. Chapter 35, as amended. An 2005, issue of the Federal Register (70 OIRA, the Coast Guard is inviting ICR is an application to OIRA seeking FR 15086). the approval, extension, or renewal of a comments as described below. Coast Guard collection of information Information Collection Request DATES: Comments must reach the Coast (Collection). The ICR contains Title: Self-propelled Liquefied Gas Guard on or before December 26, 2017. information describing the Collection’s Vessels. ADDRESSES: You may submit comments purpose, the Collection’s likely burden OMB Control Number: 1625–0029. identified by Coast Guard docket
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number [USCG–2017–0902] to the Coast Submitting Comments Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. Guard using the Federal eRulemaking We encourage you to submit Portal at http://www.regulations.gov. comments through the Federal Dated: October 16, 2017. See the ‘‘Public participation and eRulemaking Portal at http:// James D. Roppel, request for comments’’ portion of the www.regulations.gov. If your material Acting Chief, Office of Information SUPPLEMENTARY INFORMATION section for cannot be submitted using http:// Management, U.S. Coast Guard. further instructions on submitting www.regulations.gov, contact the person [FR Doc. 2017–23304 Filed 10–25–17; 8:45 am] comments. in the FOR FURTHER INFORMATION BILLING CODE 9110–04–P A copy of the ICR is available through CONTACT section of this document for the docket on the Internet at http:// alternate instructions. Documents www.regulations.gov. Additionally, mentioned in this notice, and all public DEPARTMENT OF HOMELAND copies are available from: Commandant comments, are in our online docket at SECURITY (CG–612), Attn: Paperwork Reduction http://www.regulations.gov and can be Act Manager, U.S. Coast Guard, 2703 viewed by following that Web site’s Coast Guard Martin Luther King Jr. Ave. SE., Stop instructions. Additionally, if you go to 7710, Washington, DC 20593–7710. the online docket and sign up for email [Docket No. USCG–2017–0904] FOR FURTHER INFORMATION CONTACT: Mr. alerts, you will be notified when Anthony Smith, Office of Information comments are posted. Information Collection Request to Management, telephone 202–475–3532, We accept anonymous comments. All Office of Management and Budget; or fax 202–372–8405, for questions on comments received will be posted OMB Control Number: 1625–0022 these documents. without change to http:// AGENCY: Coast Guard, DHS. SUPPLEMENTARY INFORMATION: www.regulations.gov and will include any personal information you have ACTION: Sixty-day notice requesting Public Participation and Request for provided. For more about privacy and comments. Comments the docket, you may review a Privacy SUMMARY: In compliance with the This Notice relies on the authority of Act notice regarding the Federal Docket Paperwork Reduction Act of 1995, the the Paperwork Reduction Act of 1995; Management System in the March 24, U.S. Coast Guard intends to submit an 44 U.S.C. Chapter 35, as amended. An 2005, issue of the Federal Register (70 Information Collection Request (ICR) to ICR is an application to OIRA seeking FR 15086). the approval, extension, or renewal of a the Office of Management and Budget Coast Guard collection of information Information Collection Request (OMB), Office of Information and (Collection). The ICR contains Title: Security Zones, Regulated Regulatory Affairs (OIRA), requesting an information describing the Collection’s Navigation Areas, and Safety Zones. extension of its approval for the purpose, the Collection’s likely burden OMB Control Number: 1625–0020. following collection of information: on the affected public, an explanation of Summary: The Coast Guard collects 1625–0022, Application for Tonnage the necessity of the Collection, and this information only when someone Measurement of Vessels; without other important information describing seeks a security zone, regulated change. Our ICR describes the the Collection. There is one ICR for each navigation area, or safety zone. It uses information we seek to collect from the Collection. the information to assess the need to public. Before submitting this ICR to The Coast Guard invites comments on establish one of these areas. OIRA, the Coast Guard is inviting whether this ICR should be granted Need: Section 1226 and 1231 of 33 comments as described below. based on the Collection being necessary U.S.C. and 50 U.S.C. 191 and 195, and DATES: Comments must reach the Coast for the proper performance of parts 6 and 165 of 33 CFR give the Coast Guard on or before December 26, 2017. Departmental functions. In particular, Guard Captain of the Port (COTP) the ADDRESSES: You may submit comments the Coast Guard would appreciate authority to designate security zones in identified by Coast Guard docket comments addressing: (1) The practical the U.S. for as long as the COTP deems number [USCG–2017–0904] to the Coast utility of the Collection; (2) the accuracy necessary to prevent damage or injury. Guard using the Federal eRulemaking of the estimated burden of the Section 1223 of 33 U.S.C. authorizes the Portal at http://www.regulations.gov. Collection; (3) ways to enhance the Coast Guard to prescribe rules to control See the ‘‘Public participation and quality, utility, and clarity of vessel traffic in areas he or she deems request for comments’’ portion of the information subject to the Collection; hazardous because of reduced visibility, SUPPLEMENTARY INFORMATION section for and (4) ways to minimize the burden of adverse weather, or vessel congestion. further instructions on submitting the Collection on respondents, Section 1225 of 33 U.S.C. authorizes the comments. including the use of automated Coast Guard to establish rules to allow A copy of the ICR is available through collection techniques or other forms of the designation of safety zones where the docket on the Internet at http:// information technology. In response to access is limited to authorized persons, www.regulations.gov. Additionally, your comments, we may revise this ICR vehicles, or vessels to protect the public copies are available from: Commandant or decide not to seek an extension of from hazardous situations. (CG–612), Attn: Paperwork Reduction approval for the Collection. We will Forms: Not applicable. Act Manager, U.S. Coast Guard, 2703 consider all comments and material Respondents: Federal, State, and local Martin Luther King Jr. Ave. SE., Stop received during the comment period. government agencies, owners and 7710, Washington, DC 20593–7710. We encourage you to respond to this operators of vessels and facilities. request by submitting comments and Frequency: On occasion. FOR FURTHER INFORMATION CONTACT: Mr. related materials. Comments must Hour Burden Estimate: The estimated Anthony Smith, Office of Information contain the OMB Control Number of the burden has decreased from 413 hours to Management, telephone 202–475–3532, ICR and the docket number of this 178 hours a year due to a decrease in the or fax 202–372–8405, for questions on request, [USCG–2017–0902], and must estimated annual number of these documents. be received by December 26, 2017. respondents. SUPPLEMENTARY INFORMATION:
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Public Participation and Request for any personal information you have the public. Before submitting this ICR to Comments provided. For more about privacy and OIRA, the Coast Guard is inviting This Notice relies on the authority of the docket, you may review a Privacy comments as described below. the Paperwork Reduction Act of 1995; Act notice regarding the Federal Docket DATES: Comments must reach the Coast 44 U.S.C. Chapter 35, as amended. An Management System in the March 24, Guard on or before December 26, 2017. ICR is an application to OIRA seeking 2005, issue of the Federal Register (70 ADDRESSES: You may submit comments the approval, extension, or renewal of a FR 15086). identified by Coast Guard docket Coast Guard collection of information Information Collection Request number [USCG–2017–0899] to the Coast (Collection). The ICR contains Guard using the Federal eRulemaking Title: Application for Tonnage information describing the Collection’s Portal at http://www.regulations.gov. Measurement of Vessels. purpose, the Collection’s likely burden See the ‘‘Public participation and OMB Control Number: 1625–0022. on the affected public, an explanation of request for comments’’ portion of the Summary: The information is used by the necessity of the Collection, and SUPPLEMENTARY INFORMATION section for the Coast Guard to determine a vessel’s other important information describing further instructions on submitting tonnage. Tonnage in turn helps to the Collection. There is one ICR for each comments. determine licensing, inspection, safety Collection. A copy of the ICR is available through requirements, and operating fees. The Coast Guard invites comments on the docket on the Internet at http:// Need: Under 46 U.S.C. 14104 certain whether this ICR should be granted www.regulations.gov. Additionally, vessels must be measured for tonnage. based on the Collection being necessary copies are available from: Commandant Coast Guard regulations for this for the proper performance of (CG–612), Attn: Paperwork Reduction measurement are contained in 46 CFR Departmental functions. In particular, Act Manager, U.S. Coast Guard, 2703 part 69. the Coast Guard would appreciate Martin Luther King Jr. Ave. SE., Stop Forms: CG–5397, Application for comments addressing: (1) The practical 7710, Washington, DC 20593–7710. Simplified Measurement. utility of the Collection; (2) the accuracy FOR FURTHER INFORMATION CONTACT: Mr. Respondents: Owners of vessels. of the estimated burden of the Anthony Smith, Office of Information Frequency: On occasion. Collection; (3) ways to enhance the Management, telephone 202–475–3532, Hour Burden Estimate: The estimated quality, utility, and clarity of or fax 202–372–8405, for questions on burden has increased from 14,610 hours information subject to the Collection; these documents. to 15,094 hours a year due to an and (4) ways to minimize the burden of SUPPLEMENTARY INFORMATION: increase in the estimated annual the Collection on respondents, number of responses. including the use of automated Public Participation and Request for collection techniques or other forms of Authority: The Paperwork Reduction Act Comments information technology. In response to of 1995; 44 U.S.C. Chapter 35, as amended. This Notice relies on the authority of your comments, we may revise this ICR Dated: October 16, 2017. the Paperwork Reduction Act of 1995; or decide not to seek an extension of James D. Roppel, 44 U.S.C. Chapter 35, as amended. An approval for the Collection. We will U.S. Coast Guard, Acting Chief, Office of ICR is an application to OIRA seeking consider all comments and material Information Management. the approval, extension, or renewal of a received during the comment period. [FR Doc. 2017–23298 Filed 10–25–17; 8:45 am] Coast Guard collection of information (Collection). The ICR contains We encourage you to respond to this BILLING CODE 9110–04–P request by submitting comments and information describing the Collection’s related materials. Comments must purpose, the Collection’s likely burden contain the OMB Control Number of the DEPARTMENT OF HOMELAND on the affected public, an explanation of ICR and the docket number of this SECURITY the necessity of the Collection, and request, [USCG–2017–0904], and must other important information describing be received by December 26, 2017. Coast Guard the Collection. There is one ICR for each Collection. Submitting Comments [Docket No. USCG–2017–0899] The Coast Guard invites comments on We encourage you to submit Information Collection Request to whether this ICR should be granted comments through the Federal Office of Management and Budget; based on the Collection being necessary eRulemaking Portal at http:// OMB Control Number: 1625–0058 for the proper performance of www.regulations.gov. If your material Departmental functions. In particular, cannot be submitted using http:// AGENCY: Coast Guard, DHS. the Coast Guard would appreciate www.regulations.gov, contact the person ACTION: Sixty-day notice requesting comments addressing: (1) The practical in the FOR FURTHER INFORMATION comments. utility of the Collection; (2) the accuracy CONTACT section of this document for of the estimated burden of the alternate instructions. Documents SUMMARY: In compliance with the Collection; (3) ways to enhance the mentioned in this notice, and all public Paperwork Reduction Act of 1995, the quality, utility, and clarity of comments, are in our online docket at U.S. Coast Guard intends to submit an information subject to the Collection; http://www.regulations.gov and can be Information Collection Request (ICR) to and (4) ways to minimize the burden of viewed by following that Web site’s the Office of Management and Budget the Collection on respondents, instructions. Additionally, if you go to (OMB), Office of Information and including the use of automated the online docket and sign up for email Regulatory Affairs (OIRA), requesting collection techniques or other forms of alerts, you will be notified when approval for reinstatement, without information technology. In response to comments are posted. change, of the following collection of your comments, we may revise this ICR We accept anonymous comments. All information: 1625–0058, Application for or decide not to seek reinstatement of comments received will be posted Permit to Transport Municipal and the Collection. We will consider all without change to http:// Commercial Waste. Our ICR describes comments and material received during www.regulations.gov and will include the information we seek to collect from the comment period.
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We encourage you to respond to this Dated: October 16, 2017. FOR FURTHER INFORMATION CONTACT: request by submitting comments and James D. Roppel, Contact Mr. Anthony Smith, Office of related materials. Comments must U.S. Coast Guard, Acting Chief, Office of Information Management, telephone contain the OMB Control Number of the Information Management. 202–475–3532, or fax 202–372–8405, for ICR and the docket number of this [FR Doc. 2017–23300 Filed 10–25–17; 8:45 am] questions on these documents. request, [USCG–2017–0899], and must BILLING CODE 9110–04–P SUPPLEMENTARY INFORMATION: be received by December 26, 2017. Public Participation and Request for Submitting Comments DEPARTMENT OF HOMELAND Comments We encourage you to submit SECURITY A sixty-day Notice was originally comments through the Federal published in the Federal Register on eRulemaking Portal at http:// Coast Guard October 15, 2017, and a thirty-day www.regulations.gov. If your material [Docket No. USCG–2015–0694] Notice published on February 17, 2017, cannot be submitted using http:// for this ICR. This ICR is being www.regulations.gov, contact the person Information Collection Request to resubmitted due to the length of time in the FOR FURTHER INFORMATION Office of Management and Budget; since publication of the thirty-day CONTACT section of this document for OMB Control Number: 1625–0040 notice and to provide the public with an opportunity to further comment on this alternate instructions. Documents AGENCY: Coast Guard, DHS. mentioned in this notice, and all public collection. We did receive one comment ACTION: Sixty-day notice requesting on this ICR during the prior submission comments, are in our online docket at comments. http://www.regulations.gov and can be and it is discussed below under the section, ‘‘Submitting comments.’’ viewed by following that Web site’s SUMMARY: In compliance with the This Notice relies on the authority of instructions. Additionally, if you go to Paperwork Reduction Act of 1995, the the Paperwork Reduction Act of 1995; the online docket and sign up for email U.S. Coast Guard intends to submit an 44 U.S.C. Chapter 35, as amended. An alerts, you will be notified when Information Collection Request (ICR) to ICR is an application to OIRA seeking comments are posted. the Office of Management and Budget the approval, extension, or renewal of a (OMB), Office of Information and We accept anonymous comments. All Coast Guard collection of information Regulatory Affairs (OIRA), requesting comments received will be posted (Collection). The ICR contains approval for reinstatement, without without change to http:// information describing the Collection’s change, of the following collection of www.regulations.gov and will include purpose, the Collection’s likely burden information: 1625–0040, Application for any personal information you have on the affected public, an explanation of Merchant Mariner Credential (MMC), provided. For more about privacy and the necessity of the Collection, and Application for Merchant Mariner the docket, you may review a Privacy other important information describing Medical Certificate, Applications for Act notice regarding the Federal Docket the Collection. There is one ICR for each Merchant Mariner Medical Certificate Management System in the March 24, Collection. 2005, issue of the Federal Register (70 for Entry Level Ratings, Small Vessel The Coast Guard invites comments on FR 15086). Sea Service Form, DOT/USCG Periodic whether this ICR should be granted Drug Testing Form, Disclosure Information Collection Request based on the Collection being necessary Statement for Narcotics, DWI/DUI, for the proper performance of Title: Application for Permit to and/or Other Convictions, Merchant Departmental functions. In particular, Transport Municipal and Commercial Mariner Medical Certificates, the Coast Guard would appreciate Waste. Recognition of Foreign Certificate. This comments addressing: (1) The practical is a resubmission of this ICR. Our ICR utility of the Collection; (2) the accuracy OMB Control Number: 1625–0058. describes the information we seek to Summary: This information collection of the estimated burden of the collect from the public. Before Collection; (3) ways to enhance the provides the basis for issuing or denying submitting this ICR to OIRA, the Coast a permit, required under 33 U.S.C. 2601 quality, utility, and clarity of Guard is inviting comments as information subject to the Collection; and 33 CFR 151.1009, for the described below. transportation of municipal or and (4) ways to minimize the burden of DATES: Comments must reach the Coast the Collection on respondents, commercial waste in the coastal waters Guard on or before December 26, 2017. of the United States. including the use of automated ADDRESSES: You may submit comments collection techniques or other forms of Need: In accordance with 33 U.S.C. identified by Coast Guard docket information technology. In response to 2601, the U.S. Coast Guard issued number USCG–2015–0694 to the Coast your comments, we may revise this ICR regulations requiring an owner or Guard using the Federal eRulemaking or decide not to seek reinstatement of operator of a vessel to apply for a permit Portal at http://www.regulations.gov. the Collection. We will consider all to transport municipal or commercial See the ‘‘Public participation and comments and material received during waste in the United States and to request for comments’’ portion of the the comment period. display an identification number or SUPPLEMENTARY INFORMATION section for We encourage you to respond to this other marking on their vessel. further instructions on submitting request by submitting comments and Forms: None. comments. related materials. Comments must Respondents: Owners and operators A copy of the ICR is available through contain the OMB Control Number of the of vessels. the docket on the Internet at http:// ICR and the docket number of this www.regulations.gov. Additionally, Frequency: Every 18 months. request, [USCG–2015–0694], and must copies are available from: Commandant be received by December 26, 2017. Hour Burden Estimate: The estimated (CG–612), Attn: Paperwork Reduction burden remains at 13 hours a year. Act Manager, U.S. Coast Guard, 2703 Submitting Comments Authority: The Paperwork Reduction Act Martin Luther King, Jr. Ave. SE., Stop We encourage you to submit of 1995; 44 U.S.C. Chapter 35, as amended. 7710, Washington, DC 20593–7710. comments through the Federal
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eRulemaking Portal at http:// for Entry Level Ratings, Small Vessel Hour Burden Estimate: The estimated www.regulations.gov. If your material Sea Service Form, DOT/USCG Periodic burden remains 47,444 hours a year cannot be submitted using http:// Drug Testing Form, Disclosure (CG–719B = 8,475 hours, CG–719K = www.regulations.gov, contact the person Statement for Narcotics, DWI/DUI, and/ 16,440 hours, CG–719K/E = 2,283 hours, in the FOR FURTHER INFORMATION or Other Convictions, contains the CG–719S = 14,125 hours, CG–719P = CONTACT section of this document for following information: Signature of 4,708 hours, and CG–719C = 1,413). alternate instructions. Documents applicant and supplementary material Authority: The Paperwork Reduction Act mentioned in this notice, and all public required to show that the mariner meets of 1995; 44 U.S.C. Chapter 35, as amended. comments, are in our online docket at the mandatory requirements for the Dated: October 17, 2017. http://www.regulations.gov and can be credential or medical certificate sought; viewed by following that Web site’s proof of applicant passing all applicable James D. Roppel, instructions. Additionally, if you go to vision, hearing, medical, and/or U.S. Coast Guard, Acting Chief, Office of the online docket and sign up for email physical exams; negative chemical test Information Management. alerts, you will be notified when for dangerous drugs; discharges or other [FR Doc. 2017–23218 Filed 10–25–17; 8:45 am] comments are posted. documentary evidence of sea service BILLING CODE 9110–04–P We accept anonymous comments. All indicating the name, tonnage, comments received will be posted propulsion mode and power of the without change to http:// vessels, dates of service, capacity in DEPARTMENT OF HOMELAND www.regulations.gov and will include which the applicant served, and on SECURITY any personal information you have what waters; and disclosure Coast Guard provided. For more about privacy and documentation for narcotics, DWI/DUI, the docket, you may review a Privacy and/or other convictions. [Docket No. USCG–2017–0901] Act notice regarding the Federal Docket Need: Title 46 United States Code Management System in the March 24, (U.S.C.) Subtitle II, Part E, Title 46 Code Information Collection Request to 2005, issue of the Federal Register (70 of Federal Regulation (CFR) Part 10, Office of Management and Budget; FR 15086). Subpart B, and International Convention OMB We did receive one comment on the on Standards of Training, Certification earlier submission of this ICR. The Control Number: 1625–0036 and Watchkeeping for Seafarers, 1978, AGENCY: Coast Guard, DHS. commenter requested that we provide as amended (STCW Convention) and the more detail on the progress of an ACTION: Sixty-day notice requesting STCW Code, including the STCW Final comments. application while it is being processed. Rule (Docket No. USCG–2004–17914) Although this is not a comment directed published on December 24, 2013, SUMMARY: In compliance with the at the collection, we do provide the requires MMC and Medical Certificate Paperwork Reduction Act of 1995, the following response. applicants to apply at one of the Coast U.S. Coast Guard intends to submit an The Coast Guard provides process Guard’s seventeen Regional Information Collection Request (ICR) to guides for the application of mariner Examination Centers located the Office of Management and Budget credentials that are available upon the nationwide. MMCs are established for (OMB), Office of Information and National Maritime Center (NMC) Web individuals who are required to hold a Regulatory Affairs (OIRA), requesting an site at [http://www.dco.uscg.mil/Our- credential under Subtitle II. The Coast extension of its approval for the Organization/Assistant-Commandant- Guard has the responsibility of issuing following collection of information: for-Prevention-Policy-CG–P/National- MMCs and Medical Certificates to 1625–0036, Plan Approval and Records Maritime-Center/] which detail the applicants found qualified as to age, for U.S. and Foreign Tank Vessels processes that are followed for the character, habits of life, experience, Carrying Oil in Bulk; without change. evaluation of merchant mariners. professional qualifications, and physical Our ICR describes the information we Furthermore, during the mariner fitness. The instruments contained seek to collect from the public. Before evaluation process, the applicants are within OMB Control No. 1625–0040 submitting this ICR to OIRA, the Coast provided email updates (if email serve as a means for the applicant to Guard is inviting comments as address is provided) detailing the status apply for a MMC and Medical described below. of their application(s). Certificate. DATES: Comments must reach the Coast Information Collection Request Forms: CG–719B, Application for Guard on or before December 26, 2017. Title: Application for Merchant Merchant Mariner Credential (MMC); ADDRESSES: You may submit comments Mariner Credential (MMC), Application CG–719C, Disclosure Statement for identified by Coast Guard docket for Merchant Mariner Medical Narcotics, DWI/DUI, and/or Other number [USCG–2017–0901] to the Coast Certificate, Application for Merchant Convictions; CG–719K, Application for Guard using the Federal eRulemaking Mariner Medical Certificate for Entry Merchant Mariner Medical Certificate; Portal at http://www.regulations.gov. Level Ratings, Small Vessel Sea Service CG–719K/E, Application for Merchant See the ‘‘Public participation and Form, DOT/USCG Periodic Drug Testing Mariner Medical Certificate for Entry request for comments’’ portion of the Form, Disclosure Statement for Level Ratings; CG–719S, Small Vessel SUPPLEMENTARY INFORMATION section for Narcotics, DWI/DUI, and/or Other Sea Service Form; CG–719P, DOT/USCG further instructions on submitting Convictions, Merchant Mariner Medical Periodic Drug Testing Form. comments. Certificate, Recognition of Foreign Respondents: Applicants for MMC, A copy of the ICR is available through Certificate. whether original, renewal, duplicate, the docket on the Internet at http:// OMB Control Number: 1625–0040. raise of grade, or a new endorsement on www.regulations.gov. Additionally, Summary: The Application for a previously issued MMC. Applicants copies are available from: Commandant Merchant Mariner Credential (MMC), for Medical Certificates to include (CG–612), Attn: Paperwork Reduction Application for Merchant Mariner National and STCW credentialed Act Manager, U.S. Coast Guard, 2703 Medical Certificate, Application for mariners, and first-class pilots. Martin Luther King Jr. Ave. SE., Stop Merchant Mariner Medical Certificate Frequency: On occasion. 7710, Washington, DC 20593–7710.
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FOR FURTHER INFORMATION CONTACT: Mr. alerts, you will be notified when ACTION: Sixty-day notice requesting Anthony Smith, Office of Information comments are posted. comments. Management, telephone 202–475–3532, We accept anonymous comments. All or fax 202–372–8405, for questions on comments received will be posted SUMMARY: In compliance with the these documents. without change to http:// Paperwork Reduction Act of 1995, the SUPPLEMENTARY INFORMATION: www.regulations.gov and will include U.S. Coast Guard intends to submit an any personal information you have Information Collection Request (ICR) to Public Participation and Request for provided. For more about privacy and the Office of Management and Budget Comments the docket, you may review a Privacy (OMB), Office of Information and This Notice relies on the authority of Act notice regarding the Federal Docket Regulatory Affairs (OIRA), requesting an the Paperwork Reduction Act of 1995; Management System in the March 24, extension of its approval for the 44 U.S.C. Chapter 35, as amended. An 2005, issue of the Federal Register (70 following collection of information: ICR is an application to OIRA seeking FR 15086). 1625–0109, Drawbridge Operation the approval, extension, or renewal of a Regulations; without change. Coast Guard collection of information Information Collection Request Our ICR describes the information we (Collection). The ICR contains Title: Plan Approval and Records for seek to collect from the public. Before information describing the Collection’s U.S. and Foreign Tank Vessels Carrying submitting this ICR to OIRA, the Coast purpose, the Collection’s likely burden Oil in Bulk. Guard is inviting comments as on the affected public, an explanation of OMB Control Number: 1625–0036. described below. the necessity of the Collection, and Summary: This information collection DATES: Comments must reach the Coast other important information describing aids the Coast Guard in determining if Guard on or before December 26, 2017. the Collection. There is one ICR for each a vessel complies with certain safety ADDRESSES: You may submit comments Collection. and environmental protection identified by Coast Guard docket The Coast Guard invites comments on standards. Plans, to include records, for number [USCG–2017–0951] to the Coast whether this ICR should be granted construction or modification of U.S. or Guard using the Federal eRulemaking based on the Collection being necessary foreign vessels submitted and Portal at http://www.regulations.gov. for the proper performance of maintained on board are required for See the ‘‘Public participation and Departmental functions. In particular, compliance with these standards. request for comments’’ portion of the the Coast Guard would appreciate Need: Title 46 U.S.C. 3703 provides SUPPLEMENTARY INFORMATION section for comments addressing: (1) the practical the Coast Guard with the authority to further instructions on submitting utility of the Collection; (2) the accuracy regulate design, construction, alteration, comments. of the estimated burden of the repair, maintenance, operation, A copy of the ICR is available through Collection; (3) ways to enhance the equipping, personnel qualification, and the docket on the Internet at http:// quality, utility, and clarity of manning of vessels carrying oil in bulk. www.regulations.gov. Additionally, information subject to the Collection; See e.g., 33 CFR part 157, Rules for the copies are available from: Commandant and (4) ways to minimize the burden of Protection of the Marine Environment (CG–612), Attn: Paperwork Reduction the Collection on respondents, Relating to Tank Vessels Carrying Oil in Act Manager, U.S. Coast Guard, 2703 including the use of automated Bulk, and 46 CFR chapter I, subchapter Martin Luther King, Jr. Ave. SE., Stop collection techniques or other forms of D, Tank Vessels. 7710, Washington, DC 20593–7710. information technology. In response to your comments, we may revise this ICR Forms: Not applicable. FOR FURTHER INFORMATION CONTACT: Mr. or decide not to seek an extension of Respondents: Owners and operators Anthony Smith, Office of Information approval for the Collection. We will of vessels. Management, telephone 202–475–3532, consider all comments and material Hour Burden Estimate: The estimated or fax 202–372–8405, for questions on received during the comment period. burden has increased from 2,033 hours these documents. We encourage you to respond to this to 2,106 hours a year due to an increase SUPPLEMENTARY INFORMATION: in the estimated number of respondents. request by submitting comments and Public Participation and Request for related materials. Comments must Authority: The Paperwork Reduction Act Comments contain the OMB Control Number of the of 1995; 44 U.S.C. Chapter 35, as amended. ICR and the docket number of this Dated: October 16, 2017. This Notice relies on the authority of the Paperwork Reduction Act of 1995; request, [USCG–2017–0901], and must James D. Roppel, be received by December 26, 2017. 44 U.S.C. Chapter 35, as amended. An U.S. Coast Guard, Acting Chief, Office of ICR is an application to OIRA seeking Information Management. Submitting Comments the approval, extension, or renewal of a We encourage you to submit [FR Doc. 2017–23303 Filed 10–25–17; 8:45 am] Coast Guard collection of information comments through the Federal BILLING CODE 9110–04–P (Collection). The ICR contains eRulemaking Portal at http:// information describing the Collection’s www.regulations.gov. If your material purpose, the Collection’s likely burden DEPARTMENT OF HOMELAND cannot be submitted using http:// on the affected public, an explanation of SECURITY www.regulations.gov, contact the person the necessity of the Collection, and in the FOR FURTHER INFORMATION Coast Guard other important information describing CONTACT section of this document for the Collection. There is one ICR for each alternate instructions. Documents Collection. mentioned in this notice, and all public [Docket No. USCG–2017–0951] The Coast Guard invites comments on comments, are in our online docket at Information Collection Request to whether this ICR should be granted http://www.regulations.gov and can be Office of Management and Budget; based on the Collection being necessary viewed by following that Web site’s OMB Control Number: 1625–0109 for the proper performance of instructions. Additionally, if you go to Departmental functions. In particular, the online docket and sign up for email AGENCY: Coast Guard, DHS. the Coast Guard would appreciate
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comments addressing: (1) The practical Need: 33 U.S.C. 499 authorizes the fax to (202) 325–4290. You must register utility of the Collection; (2) the accuracy Coast Guard to change the operating prior to the meeting in order to attend of the estimated burden of the schedules drawbridges that cross over the meeting in person. Collection; (3) ways to enhance the navigable waters of the United States. For members of the public who plan quality, utility, and clarity of Forms: None. to participate via webinar, please information subject to the Collection; Respondents: The public and private register online at https://apps.cbp.gov/ and (4) ways to minimize the burden of owners of bridges over navigable waters te_reg/index.asp?w=118 by 5:00 p.m. the Collection on respondents, of the United States. EST, November 13, 2017. including the use of automated Frequency: On occasion. Please feel free to share this collection techniques or other forms of Hour Burden Estimate: The estimated information with other interested information technology. In response to annual burden remains 150 hours. members of your organization or your comments, we may revise this ICR Authority: The Paperwork Reduction Act association. or decide not to seek an extension of of 1995; 44 U.S.C. Chapter 35, as amended. Members of the public who are pre- registered to attend and later need to approval for the Collection. We will Dated: October 16, 2017. consider all comments and material cancel, please do so by November 13, James D. Roppel, received during the comment period. 2017, utilizing the following links: We encourage you to respond to this U.S. Coast Guard, Acting Chief, Office of https://apps.cbp.gov/te_reg/ request by submitting comments and Information Management. cancel.asp?w=119 to cancel an in related materials. Comments must [FR Doc. 2017–23301 Filed 10–25–17; 8:45 am] person registration or https:// contain the OMB Control Number of the BILLING CODE 9110–04–P apps.cbp.gov/te_reg/cancel.asp?w=118 ICR and the docket number of this to cancel a webinar registration. request, [USCG–2017–0951], and must To facilitate public participation, we be received by December 26, 2017. DEPARTMENT OF HOMELAND are inviting public comment on the SECURITY issues the committee will consider prior Submitting Comments to the formulation of recommendations U.S. Customs and Border Protection We encourage you to submit as listed in the Agenda section below. comments through the Federal [Docket No. USCBP–2017–0044] Comments must be submitted in eRulemaking Portal at http:// writing no later than November 8, 2017, www.regulations.gov. If your material Commercial Customs Operations and must be identified by Docket No. cannot be submitted using http:// Advisory Committee (COAC) USCBP–2017–0044, and may be www.regulations.gov, contact the person submitted by one (1) of the following AGENCY: U.S. Customs and Border FOR FURTHER INFORMATION in the Protection (CBP), Department of methods: CONTACT • Federal eRulemaking Portal: http:// section of this document for Homeland Security (DHS). alternate instructions. Documents www.regulations.gov. Follow the ACTION: mentioned in this notice, and all public Committee management; Notice instructions for submitting comments. comments, are in our online docket at of Federal Advisory Committee Meeting. • Email: [email protected]. Include the docket number in the http://www.regulations.gov and can be SUMMARY: The Commercial Customs viewed by following that Web site’s Operations Advisory Committee (COAC) subject line of the message. • Fax: (202) 325–4290, Attention instructions. Additionally, if you go to will hold its quarterly meeting on Florence Constant-Gibson. the online docket and sign up for email Tuesday, November 14, 2017 in • Mail: Ms. Florence Constant- alerts, you will be notified when Washington, DC The meeting will be Gibson, Office of Trade Relations, U.S. comments are posted. open to the public. We accept anonymous comments. All Customs and Border Protection, 1300 DATES: The COAC will meet on comments received will be posted Pennsylvania Avenue NW., Room 3.5A, Tuesday, November 14, 2017, from 1:00 without change to http:// Washington, DC 20229. p.m. to 5:00 p.m. EST. Please note that www.regulations.gov and will include Instructions: All submissions received the meeting may close early if the any personal information you have must include the words ‘‘Department of committee has completed its business. provided. For more about privacy and Homeland Security’’ and the docket the docket, you may review a Privacy ADDRESSES: The meeting will be held at number (USCBP–2017–0044) for this Act notice regarding the Federal Docket U.S. Customs & Border Protection, 1717 action. Comments received will be Management System in the March 24, H Street NW., Room 700, Washington, posted without alteration at http:// 2005, issue of the Federal Register (70 DC 20006. For information on facilities www.regulations.gov. Please do not FR 15086). or services for individuals with submit personal information to this disabilities or to request special docket. Information Collection Request assistance at the meeting, contact Ms. Docket: For access to the docket or to Title: Drawbridge Operation Florence Constant-Gibson, Office of read background documents or Regulations. Trade Relations, U.S. Customs & Border comments, go to http:// OMB Control Number: 1625–0109. Protection, at (202) 344–1440 as soon as www.regulations.gov and search for Summary: The Bridge Program possible. Docket Number USCBP–2017–0044. To receives approximately 150 requests Pre-Registration: Meeting participants submit a comment, click the ‘‘Comment from bridge owners or the general may attend either in person or via Now!’’ button located on the top-right public per year to change the operating webinar after pre-registering using one hand side of the docket page. schedule of various drawbridges across of the methods indicated below: There will be multiple public the navigable water of the United States. For members of the public who plan comment periods held during the The information needed for the change to attend the meeting in person, please meeting on November 14, 2017. to the operating schedule can only be register by 5:00 p.m. EST by November Speakers are requested to limit their obtained from the bridge owner and is 13, 2017, either online at https:// comments to two (2) minutes or less to generally provided to the Coast Guard in apps.cbp.gov/te_reg/index.asp?w=119; facilitate greater participation. Contact a written format. by email to [email protected]; or by the individual listed below to register as
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a speaker. Please note that the public Working Group’s progress on the Federal Emergency Management Agency comment period for speakers may end implementation plan of the PDF (FEMA) has provided to the affected before the time indicated on the Proposal and will include steps to communities. The FIRM and FIS report schedule that is posted on the CBP Web initiate a proof of concept. The are the basis of the floodplain page, http://www.cbp.gov/trade/ subcommittee will also discuss the management measures that the stakeholder-engagement/coac. progress of the Manifest Working Group community is required either to adopt FOR FURTHER INFORMATION CONTACT: Ms. and progress on issues with the ongoing or to show evidence of having in effect Florence Constant-Gibson, Office of manifest pilots. The working group may in order to qualify or remain qualified Trade Relations, U.S. Customs and present recommendations in the area of for participation in the National Flood Border Protection, 1300 Pennsylvania manifest timelines during the November Insurance Program (NFIP). In addition, Avenue NW., Room 3.5A, Washington, meeting. the FIRM and FIS report, once effective, DC 20229; telephone (202) 344–1440; 5. The Trusted Trader Subcommittee will be used by insurance agents and facsimile (202) 325–4290; or Mr. will continue the discussion for an others to calculate appropriate flood Bradley Hayes, Executive Director and enhanced Trusted Trader program that insurance premium rates for new Designated Federal Officer, can be includes engagement with CBP to buildings and the contents of those reached at (202) 344–1440. include relevant partner government buildings. agencies with a potential for SUPPLEMENTARY INFORMATION: Notice of international interoperability. A review DATES: Comments are to be submitted this meeting is given under the Federal of the pilot program status and benefits on or before January 24, 2018. Advisory Committee Act, 5 U.S.C. will also be undertaken in parallel to ADDRESSES: The Preliminary FIRM, and Appendix. The Commercial Customs determine the optimum benefits that where applicable, the FIS report for Operations Advisory Committee (COAC) would be assigned to Trusted Trader each community are available for provides advice to the Secretary of participants. inspection at both the online location Homeland Security, the Secretary of the 6. The Trade Modernization and the respective Community Map Treasury, and the Commissioner of U.S. Subcommittee will discuss its plans for Repository address listed in the tables Customs and Border Protection (CBP) on the topics that will be addressed during below. Additionally, the current matters pertaining to the commercial the next quarter. effective FIRM and FIS report for each operations of CBP and related functions Meeting materials will be available by community are accessible online within the Department of Homeland November 10, 2017, at: http:// through the FEMA Map Service Center Security and the Department of the www.cbp.gov/trade/stakeholder- at www.msc.fema.gov for comparison. Treasury. engagement/coac/coac-public-meetings. You may submit comments, identified Agenda Dated: October 23, 2017. by Docket No. FEMA–B–1754, to Rick Bradley F. Hayes, Sacbibit, Chief, Engineering Services The COAC will hear from the Branch, Federal Insurance and Executive Director, Office of Trade Relations. following subcommittees on the topics Mitigation Administration, FEMA, 400 listed below and then will review, [FR Doc. 2017–23282 Filed 10–25–17; 8:45 am] C Street SW., Washington, DC 20472, deliberate, provide observations, and BILLING CODE 9111–14–P (202) 646–7659, or (email) formulate recommendations on how to [email protected]. proceed: FOR FURTHER INFORMATION CONTACT: 1. The Trade Enforcement & Revenue DEPARTMENT OF HOMELAND Rick Collection (TERC) Subcommittee will SECURITY Sacbibit, Chief, Engineering Services discuss new TERC recommendations Branch, Federal Insurance and and provide any necessary updates from Federal Emergency Management Mitigation Administration, FEMA, 400 the Anti-Dumping and Countervailing Agency C Street SW., Washington, DC 20472, (202) 646–7659, or (email) Duty, Bond, Forced Labor, and [Docket ID FEMA–2017–0002; Internal Intellectual Property Rights Working Agency Docket No. FEMA–B–1754] [email protected]; or visit Groups. the FEMA Map Information eXchange Proposed Flood Hazard (FMIX) online at 2. The Global Supply Chain _ Subcommittee will present the status of Determinations www.floodmaps.fema.gov/fhm/fmx main.html. a pilot that will test the utilization of AGENCY: Federal Emergency existing Automated Commercial Management Agency, DHS. SUPPLEMENTARY INFORMATION: FEMA Environment (ACE) automation in the ACTION: Notice. proposes to make flood hazard pipeline mode of transportation. The determinations for each community committee will also discuss the progress SUMMARY: Comments are requested on listed below, in accordance with section of the Global Supply Chain proposed flood hazard determinations, 110 of the Flood Disaster Protection Act Subcommittee’s new Emerging which may include additions or of 1973, 42 U.S.C. 4104, and 44 CFR Technologies Working Group. modifications of any Base Flood 67.4(a). 3. The One U.S. Government Elevation (BFE), base flood depth, These proposed flood hazard Subcommittee will continue discussions Special Flood Hazard Area (SFHA) determinations, together with the on the progress of the Fish & Wildlife boundary or zone designation, or floodplain management criteria required Service Working Group and will present regulatory floodway on the Flood by 44 CFR 60.3, are the minimum that the final white paper on the Insurance Rate Maps (FIRMs), and are required. They should not be Harmonized Tariff Schedule (HTS) where applicable, in the supporting construed to mean that the community project. The subcommittee will also Flood Insurance Study (FIS) reports for must change any existing ordinances discuss the progress of the newly the communities listed in the table that are more stringent in their created Technical and Operational below. The purpose of this notice is to floodplain management requirements. Outages Working Group. seek general information and comment The community may at any time enact 4. The Exports Subcommittee will regarding the preliminary FIRM, and stricter requirements of its own or discuss the Post Departure Filing (PDF) where applicable, the FIS report that the pursuant to policies established by other
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Federal, State, or regional entities. support of the appeal resolution respective Community Map Repository These flood hazard determinations are process. SRPs are independent panels of address listed in the tables. For used to meet the floodplain experts in hydrology, hydraulics, and communities with multiple ongoing management requirements of the NFIP other pertinent sciences established to Preliminary studies, the studies can be and also are used to calculate the review conflicting scientific and identified by the unique project number appropriate flood insurance premium technical data and provide and Preliminary FIRM date listed in the rates for new buildings built after the recommendations for resolution. Use of tables. Additionally, the current FIRM and FIS report become effective. the SRP only may be exercised after effective FIRM and FIS report for each The communities affected by the FEMA and local communities have been community are accessible online flood hazard determinations are engaged in a collaborative consultation through the FEMA Map Service Center provided in the tables below. Any process for at least 60 days without a at www.msc.fema.gov for comparison. request for reconsideration of the mutually acceptable resolution of an revised flood hazard information shown appeal. Additional information (Catalog of Federal Domestic Assistance No. on the Preliminary FIRM and FIS report regarding the SRP process can be found 97.022, ‘‘Flood Insurance.’’) _ that satisfies the data requirements online at http://floodsrp.org/pdfs/srp Dated: October 13, 2017. outlined in 44 CFR 67.6(b) is considered fact_sheet.pdf. Roy E. Wright, an appeal. Comments unrelated to the The watersheds and/or communities flood hazard determinations also will be affected are listed in the tables below. Deputy Associate Administrator for Insurance considered before the FIRM and FIS The Preliminary FIRM, and where and Mitigation, Department of Homeland report become effective. applicable, FIS report for each Security, Federal Emergency Management Agency. Use of a Scientific Resolution Panel community are available for inspection (SRP) is available to communities in at both the online location and the I. Non-watershed-based studies:
Community Community map repository address
Will County, Illinois and Incorporated Areas
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata
Project: 13–05–4873S Preliminary Date: February 1, 2017
City of Aurora ...... Engineering Department, City Hall, 44 East Downer Place, Aurora, IL 60507. City of Braidwood ...... City Hall, 141 West Main Street, Braidwood, IL 60408. City of Crest Hill ...... City Hall, 1610 Plainfield Road, Crest Hill, 60403. City of Joliet ...... City Hall, 150 West Jefferson Street, Joliet, IL 60432. City of Lockport ...... Public Works and Engineering, 17112 South Prime Boulevard, Lockport, IL 60441. City of Naperville ...... City Hall, 400 South Eagle Street, Naperville, IL 60540. City of Wilmington ...... City Hall, 1165 South Water Street, Wilmington, IL 60481. Unincorporated Areas of Will County ...... Land Use Department, 58 East Clinton Street, Suite 100, Joliet, IL 60432. Village of Beecher ...... Village Hall, 625 Dixie Highway, Beecher, IL 60401. Village of Bolingbrook ...... Village Hall, 375 West Briarcliff Road, Bolingbrook, IL 60440. Village of Channahon ...... Village Hall, 24555 South Navajo Drive, Channahon, IL 60410. Village of Coal City ...... Village Hall, 515 South Broadway Street, Coal City, IL 60416. Village of Crete ...... Village Hall, 524 West Exchange Street, Crete, IL 60417. Village of Diamond ...... Village Hall, 1750 East Division Street, Diamond, IL 60416. Village of Elwood ...... Village Hall, 401 East Mississippi Avenue, Elwood, IL 60421. Village of Frankfort ...... Village Hall, 432 West Nebraska Street, Frankfort, IL 60423. Village of Homer Glen ...... Village Hall, 14240 West 151st Street, Homer Glen, IL 60491. Village of Lemont ...... Village Hall, 418 Main Street, Lemont, IL 60439. Village of Manhattan ...... Village Hall, 260 Market Place, Manhattan, IL 60442. Village of Minooka ...... Village Hall, 121 East McEvilly Road, Minooka, IL 60447. Village of Mokena ...... Village Hall, 11004 Carpenter Street, Mokena, IL 60448. Village of Monee ...... Village Hall, 5130 West Court Street, Monee, IL 60449. Village of New Lenox ...... Village Hall, 1 Veterans Parkway, New Lenox, IL 60451. Village of Orland Park ...... Village Hall, 14700 South Ravinia Avenue, Orland Park, IL 60462. Village of Park Forest ...... Village Hall, 350 Victory Drive, Park Forest, IL 60466. Village of Peotone ...... Village Hall, 208 East Main Street, Peotone, IL 60468. Village of Plainfield ...... Village Hall, 24401 West Lockport Street, Plainfield, IL 60544. Village of Rockdale ...... Village Hall, 79 Moen Avenue, Rockdale, IL 60436. Village of Romeoville ...... Village Hall, 1050 West Romeo Road, Romeoville, IL 60446. Village of Shorewood ...... Village Hall, One Towne Center Boulevard, Shorewood, IL 60404. Village of Steger ...... Village Hall, 3320 Lewis Avenue, Steger, IL 60475. Village of Tinley Park ...... Village Hall, 16250 South Oak Park Avenue, Tinley Park, IL 60477. Village of University Park ...... Village Hall, 698 Burnham Drive, University Park, IL 60484. Village of Woodridge ...... Village Hall, 5 Plaza Drive, Woodridge, IL 60517.
[FR Doc. 2017–23253 Filed 10–25–17; 8:45 am] BILLING CODE 9110–12–P
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DEPARTMENT OF HOMELAND DEPARTMENT OF HOMELAND The Federal Emergency Management SECURITY SECURITY Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Federal Emergency Management Federal Emergency Management Administrator, Department of Homeland Agency Agency Security, under Executive Order 12148, as amended, William J. Doran III, of [Internal Agency Docket No. FEMA–3392– FEMA is appointed to act as the Federal [Internal Agency Docket No. FEMA–3384– EM; Docket ID FEMA–2017–0001] EM; Docket ID FEMA–2017–0001] Coordinating Officer for this declared Louisiana; Emergency and Related emergency. Puerto Rico; Amendment No. 2 to Determinations The following areas of the State of Notice of an Emergency Declaration Louisiana have been designated as AGENCY: Federal Emergency adversely affected by this declared AGENCY: Federal Emergency Management Agency, DHS. emergency: Management Agency, DHS. ACTION: Notice. The parishes of Assumption, Iberia, Jefferson, Lafourche, Livingston, Orleans, ACTION: Notice. SUMMARY: This is a notice of the Plaquemines, St. Bernard, St. Charles, St. Presidential declaration of an James, St. John the Baptist, St. Martin, St. SUMMARY: This notice amends the notice emergency for the State of Louisiana Mary, St. Tammany, Tangipahoa, of an emergency declaration for the (FEMA–3392–EM), dated October 6, Terrebonne, and Vermillion for emergency Commonwealth of Puerto Rico (FEMA– 2017, and related determinations. protective measures (Category B), including direct federal assistance, under the Public 3384–EM), dated September 5, 2017, DATES: The declaration was issued Assistance program. and related determinations. October 6, 2017. The following Catalog of Federal Domestic DATES: The change occurred on October FOR FURTHER INFORMATION CONTACT: Assistance Numbers (CFDA) are to be used 10, 2017. Dean Webster, Office of Response and for reporting and drawing funds: 97.030, Recovery, Federal Emergency Community Disaster Loans; 97.031, Cora FOR FURTHER INFORMATION CONTACT: Management Agency, 500 C Street SW., Brown Fund; 97.032, Crisis Counseling; Dean Webster, Office of Response and Washington, DC 20472, (202) 646–2833. 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); Recovery, Federal Emergency SUPPLEMENTARY INFORMATION: Notice is 97.046, Fire Management Assistance Grant; Management Agency, 500 C Street SW., hereby given that, in a letter dated Washington, DC 20472, (202) 646–2833. 97.048, Disaster Housing Assistance to October 6, 2017, the President issued an Individuals and Households in Presidentially SUPPLEMENTARY INFORMATION: The emergency declaration under the Declared Disaster Areas; 97.049, Federal Emergency Management Agency authority of the Robert T. Stafford Presidentially Declared Disaster Assistance— (FEMA) hereby gives notice that Disaster Relief and Emergency Disaster Housing Operations for Individuals pursuant to the authority vested in the Assistance Act, 42 U.S.C. 5121–5207 and Households; 97.050, Presidentially (the Stafford Act), as follows: Declared Disaster Assistance to Individuals Administrator, under Executive Order and Households—Other Needs; 97.036, 12148, as amended, Michael F. Byrne, of I have determined that the emergency Disaster Grants—Public Assistance FEMA is appointed to act as the Federal conditions in certain areas of the State of (Presidentially Declared Disasters); 97.039, Coordinating Officer for this emergency. Louisiana resulting from Tropical Storm Nate Hazard Mitigation Grant. beginning on October 5, 2017, and This action terminates the continuing, are of sufficient severity and Brock Long, appointment of Alejandro DeLaCampa magnitude to warrant an emergency Administrator, Federal Emergency as Federal Coordinating Officer for this declaration under the Robert T. Stafford Management Agency. Disaster Relief and Emergency Assistance emergency. [FR Doc. 2017–23240 Filed 10–25–17; 8:45 am] Act, 42 U.S.C. 5121 et seq. (‘‘the Stafford The following Catalog of Federal Domestic Act’’). Therefore, I declare that such an BILLING CODE 9111–23–P Assistance Numbers (CFDA) are to be used emergency exists in the State of Louisiana. for reporting and drawing funds: 97.030, You are authorized to provide appropriate Community Disaster Loans; 97.031, Cora assistance for required emergency measures, DEPARTMENT OF HOMELAND Brown Fund; 97.032, Crisis Counseling; authorized under Title V of the Stafford Act, SECURITY 97.033, Disaster Legal Services; 97.034, to save lives and to protect property and Disaster Unemployment Assistance (DUA); public health and safety, and to lessen or Federal Emergency Management 97.046, Fire Management Assistance Grant; avert the threat of a catastrophe in the Agency designated areas. Specifically, you are 97.048, Disaster Housing Assistance to authorized to provide assistance for [Internal Agency Docket No. FEMA–4339– Individuals and Households In Presidentially emergency protective measures (Category B), DR; Docket ID FEMA–2017–0001] Declared Disaster Areas; 97.049, including direct Federal assistance, under the Presidentially Declared Disaster Assistance— Public Assistance program. Puerto Rico; Amendment No. 3 to Disaster Housing Operations for Individuals Consistent with the requirement that Notice of a Major Disaster Declaration and Households; 97.050, Presidentially Federal assistance be supplemental, any Declared Disaster Assistance to Individuals Federal funds provided under the Stafford AGENCY: Federal Emergency and Households—Other Needs; 97.036, Act for Public Assistance will be limited to Management Agency, DHS. Disaster Grants—Public Assistance 75 percent of the total eligible costs. In order ACTION: Notice. (Presidentially Declared Disasters); 97.039, to provide Federal assistance, you are hereby Hazard Mitigation Grant. authorized to allocate from funds available SUMMARY: This notice amends the notice for these purposes such amounts as you find of a major disaster declaration for the Brock Long, necessary for Federal emergency assistance Commonwealth of Puerto Rico (FEMA– Administrator, Federal Emergency and administrative expenses. 4339–DR), dated September 20, 2017, Further, you are authorized to make Management Agency. changes to this declaration for the approved and related determinations. [FR Doc. 2017–23246 Filed 10–25–17; 8:45 am] assistance to the extent allowable under the DATES: The change occurred on October BILLING CODE 9111–23–P Stafford Act. 10, 2017.
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FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: The Program (NFIP). In addition, the FIRM Dean Webster, Office of Response and Federal Emergency Management Agency and FIS report are used by insurance Recovery, Federal Emergency (FEMA) hereby gives notice that agents and others to calculate Management Agency, 500 C Street SW., pursuant to the authority vested in the appropriate flood insurance premium Washington, DC 20472, (202) 646–2833. Administrator, under Executive Order rates for buildings and the contents of SUPPLEMENTARY INFORMATION: The 12148, as amended, Michael F. Byrne, of those buildings. Federal Emergency Management Agency FEMA is appointed to act as the Federal DATES: The date of January 5, 2018 has (FEMA) hereby gives notice that Coordinating Officer for this disaster. been established for the FIRM and, pursuant to the authority vested in the This action terminates the where applicable, the supporting FIS Administrator, under Executive Order appointment of Alejandro DeLaCampa report showing the new or modified 12148, as amended, Michael F. Byrne, of as Federal Coordinating Officer for this flood hazard information for each FEMA is appointed to act as the Federal disaster. community. Coordinating Officer for this disaster. The following Catalog of Federal Domestic This action terminates the Assistance Numbers (CFDA) are to be used ADDRESSES: The FIRM, and if appointment of Alejandro DeLaCampa for reporting and drawing funds: 97.030, applicable, the FIS report containing the as Federal Coordinating Officer for this Community Disaster Loans; 97.031, Cora final flood hazard information for each disaster. Brown Fund; 97.032, Crisis Counseling; community is available for inspection at 97.033, Disaster Legal Services; 97.034, the respective Community Map The following Catalog of Federal Domestic Disaster Unemployment Assistance (DUA); Repository address listed in the tables Assistance Numbers (CFDA) are to be used 97.046, Fire Management Assistance Grant; for reporting and drawing funds: 97.030, below and will be available online 97.048, Disaster Housing Assistance to through the FEMA Map Service Center Community Disaster Loans; 97.031, Cora Individuals and Households In Presidentially Brown Fund; 97.032, Crisis Counseling; Declared Disaster Areas; 97.049, at www.msc.fema.gov by the date 97.033, Disaster Legal Services; 97.034, Presidentially Declared Disaster Assistance— indicated above. Disaster Unemployment Assistance (DUA); Disaster Housing Operations for Individuals 97.046, Fire Management Assistance Grant; FOR FURTHER INFORMATION CONTACT: Rick and Households; 97.050, Presidentially 97.048, Disaster Housing Assistance to Sacbibit, Chief, Engineering Services Declared Disaster Assistance to Individuals Individuals and Households In Presidentially Branch, Federal Insurance and and Households—Other Needs; 97.036, Declared Disaster Areas; 97.049, Mitigation Administration, FEMA, 400 Disaster Grants—Public Assistance Presidentially Declared Disaster Assistance— (Presidentially Declared Disasters); 97.039, C Street SW., Washington, DC 20472, Disaster Housing Operations for Individuals Hazard Mitigation Grant. (202) 646–7659, or (email) and Households; 97.050, Presidentially [email protected]; or visit Declared Disaster Assistance to Individuals Brock Long, the FEMA Map Information eXchange and Households—Other Needs; 97.036, Administrator, Federal Emergency Disaster Grants—Public Assistance (FMIX) online at Management Agency. _ (Presidentially Declared Disasters); 97.039, www.floodmaps.fema.gov/fhm/fmx Hazard Mitigation Grant. [FR Doc. 2017–23243 Filed 10–25–17; 8:45 am] main.html. BILLING CODE 9111–23–P Brock Long, SUPPLEMENTARY INFORMATION: The Administrator, Federal Emergency Federal Emergency Management Agency Management Agency. DEPARTMENT OF HOMELAND (FEMA) makes the final determinations [FR Doc. 2017–23241 Filed 10–25–17; 8:45 am] SECURITY listed below for the new or modified BILLING CODE 9111–23–P flood hazard information for each Federal Emergency Management community listed. Notification of these Agency changes has been published in newspapers of local circulation and 90 DEPARTMENT OF HOMELAND [Docket ID FEMA–2017–0002] SECURITY days have elapsed since that Final Flood Hazard Determinations publication. The Deputy Associate Federal Emergency Management Administrator for Insurance and Agency AGENCY: Federal Emergency Mitigation has resolved any appeals Management Agency, DHS. [Internal Agency Docket No. FEMA–4336– resulting from this notification. DR; Docket ID FEMA–2017–0001] ACTION: Final Notice. This final notice is issued in accordance with section 110 of the SUMMARY: Flood hazard determinations, Puerto Rico; Amendment No. 5 to Flood Disaster Protection Act of 1973, which may include additions or Notice of a Major Disaster Declaration 42 U.S.C. 4104, and 44 CFR part 67. modifications of Base Flood Elevations FEMA has developed criteria for AGENCY: Federal Emergency (BFEs), base flood depths, Special Flood floodplain management in floodprone Management Agency, DHS. Hazard Area (SFHA) boundaries or zone areas in accordance with 44 CFR part ACTION: Notice. designations, or regulatory floodways on 60. the Flood Insurance Rate Maps (FIRMs) SUMMARY: This notice amends the notice and where applicable, in the supporting Interested lessees and owners of real of a major disaster declaration for the Flood Insurance Study (FIS) reports property are encouraged to review the Commonwealth of Puerto Rico (FEMA– have been made final for the new or revised FIRM and FIS report 4336–DR), dated September 10, 2017, communities listed in the table below. available at the address cited below for and related determinations. The FIRM and FIS report are the basis each community or online through the DATES: The change occurred on October of the floodplain management measures FEMA Map Service Center at 10, 2017. that a community is required either to www.msc.fema.gov. FOR FURTHER INFORMATION CONTACT: adopt or to show evidence of having in The flood hazard determinations are Dean Webster, Office of Response and effect in order to qualify or remain made final in the watersheds and/or Recovery, Federal Emergency qualified for participation in the Federal communities listed in the table below. Management Agency, 500 C Street SW., Emergency Management Agency’s (Catalog of Federal Domestic Assistance No. Washington, DC 20472, (202) 646–2833. (FEMA’s) National Flood Insurance 97.022, ‘‘Flood Insurance.’’)
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Dated: October 13, 2017. Roy E. Wright, Deputy Associate Administrator for Insurance and Mitigation, Department of Homeland Security, Federal Emergency Management Agency. I. Watershed-based studies:
Community Community map repository address
Upper Chattahoochee Watershed
Habersham County, Georgia and Incorporated Areas Docket No.: FEMA–B–1647
City of Baldwin ...... City Hall, 130 Airport Road, Baldwin, GA 30511. City of Clarkesville ...... City Hall, 123 North Laurel Drive, Clarkesville, GA 30523. City of Cornelia ...... City Hall, 181 Larkin Street, Cornelia, GA 30531. City of Demorest ...... City Hall, 546 Georgia Street, Demorest, GA 30535. Town of Alto ...... Town Hall, 162 South Grant Street, Alto, GA 30510. Unincorporated Areas of Habersham County ...... Habersham County Planning and Development Department, 555 Mon- roe Street, Suite 70, Clarkesville, GA 30523.
White County, Georgia and Incorporated Areas Docket No.: FEMA–B–1647
City of Cleveland ...... City Clerk’s Office, 85 South Main Street, Cleveland, GA 30528. City of Helen ...... City Hall, 25 Alpenrosen Strasse, Helen, GA 30545. Unincorporated Areas of White County ...... White County Planning Office, 1241 Helen Highway, Cleveland, GA 30528.
Lower Sabine Watershed
Beauregard Parish, Louisiana and Incorporated Areas Docket No.: FEMA–B–1644
Town of Merryville ...... Town Hall, 1009 State Highway 110 West, Merryville, LA 70653. Unincorporated Areas of Beauregard Parish ...... Beauregard Parish Department of Public Works, 201 West 2nd Street, DeRidder, LA 70634.
II. Non-watershed-based studies:
Community Community map repository address
Glynn County, Georgia and Incorporated Areas Docket No.: FEMA–B–1642
City of Brunswick ...... City Hall, 601 Gloucester Street, Brunswick, GA 31520. Jekyll Island State Park Authority ...... Fire and EMS Department, 200 Stable Road, Jekyll Island, GA 31527. Unincorporated Areas of Glynn County ...... Glynn County Offices, Harold Pate Building, 1725 Reynolds Street, 2nd Floor, Brunswick, GA 31520.
[FR Doc. 2017–23227 Filed 10–25–17; 8:45 am] SUMMARY: This notice lists communities determinations through issuance of a BILLING CODE 9110–12–P where the addition or modification of Letter of Map Revision (LOMR). The Base Flood Elevations (BFEs), base flood LOMR will be used by insurance agents depths, Special Flood Hazard Area and others to calculate appropriate flood DEPARTMENT OF HOMELAND (SFHA) boundaries or zone insurance premium rates for new SECURITY designations, or the regulatory floodway buildings and the contents of those (hereinafter referred to as flood hazard buildings. For rating purposes, the Federal Emergency Management determinations), as shown on the Flood currently effective community number Agency Insurance Rate Maps (FIRMs), and is shown in the table below and must be [Docket ID FEMA–2017–0002; Internal where applicable, in the supporting used for all new policies and renewals. Agency Docket No. FEMA–B–1756] Flood Insurance Study (FIS) reports, DATES: These flood hazard prepared by the Federal Emergency determinations will be finalized on the Changes in Flood Hazard Management Agency (FEMA) for each dates listed in the table below and Determinations community, is appropriate because of revise the FIRM panels and FIS report AGENCY: Federal Emergency new scientific or technical data. The in effect prior to this determination for Management Agency, DHS. FIRM, and where applicable, portions of the listed communities. the FIS report, have been revised to From the date of the second ACTION: Notice. reflect these flood hazard publication of notification of these
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changes in a newspaper of local (FMIX) online at 60.3, are the minimum that are required. circulation, any person has 90 days in www.floodmaps.fema.gov/fhm/fmx_ They should not be construed to mean which to request through the main.html. that the community must change any community that the Deputy Associate SUPPLEMENTARY INFORMATION: The existing ordinances that are more Administrator for Insurance and specific flood hazard determinations are stringent in their floodplain Mitigation reconsider the changes. The not described for each community in management requirements. The flood hazard determination information this notice. However, the online community may at any time enact may be changed during the 90-day location and local community map stricter requirements of its own or period. repository address where the flood pursuant to policies established by other Federal, State, or regional entities. The ADDRESSES: The affected communities hazard determination information is flood hazard determinations are in are listed in the table below. Revised available for inspection is provided. accordance with 44 CFR 65.4. flood hazard information for each Any request for reconsideration of community is available for inspection at flood hazard determinations must be The affected communities are listed in both the online location and the submitted to the Chief Executive Officer the following table. Flood hazard respective community map repository of the community as listed in the table determination information for each address listed in the table below. below. community is available for inspection at Additionally, the current effective FIRM The modifications are made pursuant both the online location and the to section 201 of the Flood Disaster and FIS report for each community are respective community map repository Protection Act of 1973, 42 U.S.C. 4105, accessible online through the FEMA address listed in the table below. and are in accordance with the National Map Service Center at Additionally, the current effective FIRM Flood Insurance Act of 1968, 42 U.S.C. www.msc.fema.gov for comparison. and FIS report for each community are 4001 et seq., and with 44 CFR part 65. accessible online through the FEMA Submit comments and/or appeals to The FIRM and FIS report are the basis the Chief Executive Officer of the Map Service Center at of the floodplain management measures www.msc.fema.gov for comparison. community as listed in the table below. that the community is required either to FOR FURTHER INFORMATION CONTACT: Rick adopt or to show evidence of having in (Catalog of Federal Domestic Assistance No. Sacbibit, Chief, Engineering Services effect in order to qualify or remain 97.022, ‘‘Flood Insurance.’’) Branch, Federal Insurance and qualified for participation in the Dated: October 13, 2017. Mitigation Administration, FEMA, 400 National Flood Insurance Program Roy E. Wright, C Street SW., Washington, DC 20472, (NFIP). Deputy Associate Administrator for Insurance (202) 646–7659, or (email) These flood hazard determinations, and Mitigation, Department of Homeland [email protected]; or visit together with the floodplain Security, Federal Emergency Management the FEMA Map Information eXchange management criteria required by 44 CFR Agency.
Location and Chief executive Community map Online location of letter Date of Community State and county case No. officer of community repository of map revision modification No.
Alaska: Anchorage Municipality of The Honorable Ethan City Hall, 632 West 6th http://www.msc.fema.gov/lomc Jan. 12, 2018 ..... 020005 Anchorage Berkowitz, Mayor, Mu- Avenue, Anchorage, AK (17–10– nicipality of Anchorage, 99501. 0709P). 632 West 6th Avenue, Suite 840, Anchorage, AK 99501. California: Riverside ...... City of Corona The Honorable Dick City Hall, 400 South http://www.msc.fema.gov/lomc Jan. 19, 2018 ..... 060250 (17–09– Haley, Mayor, City of Vicentia Avenue, Co- 0805P). Corona, 400 South rona, CA 92882. Vicentia Avenue, Co- rona, CA 92882. Riverside ...... Unincorporated The Honorable John F. Riverside County Flood http://www.msc.fema.gov/lomc Jan. 19, 2018 ..... 060245 Areas of River- Tavaglione, Chairman, and Water Conserva- side County Board of Supervisors, tion District, 1995 Mar- (17–09– Riverside County, 4080 ket Street, Riverside, 0805P). Lemon Street, 5th CA 92502. Floor, Riverside, CA 92501. Sacramento .... Unincorporated The Honorable Don Sacramento County, De- http://www.msc.fema.gov/lomc Jan. 10, 2018 ..... 060262 Areas of Sac- Nottoli, Chairman, partment of Water Re- ramento Coun- Board of Supervisors, sources, 827 7th Street, ty (16–09– Sacramento County, Suite 301, Sacramento, 2857P). 700 H Street, Suite CA 95814. 2450, Sacramento, CA 95814. San Benito ..... City of Hollister The Honorable Ignacio Planning Department, 420 http://www.msc.fema.gov/lomc Jan. 8, 2018 ...... 060268 (17–09– Velazquez, Mayor, City Hill Street, Building A, 1234P). of Hollister, 375 5th Hollister, CA 95023. Street, Hollister, CA 95023. San Benito ..... Unincorporated The Honorable Jaime De San Benito County De- http://www.msc.fema.gov/lomc Jan. 8, 2018 ...... 060267 Areas of San La Cruz, Chairman, partment of Public Benito County Board of Supervisors, Works, 3220 Southside (17–09– San Benito County, 481 Road, Hollister, CA 1234P). 4th Street, 1st Floor, 95023. Hollister, CA 95023.
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Location and Chief executive Community map Online location of letter Date of Community State and county case No. officer of community repository of map revision modification No.
San Luis Unincorporated The Honorable John San Luis Obispo County http://www.msc.fema.gov/lomc Jan. 11, 2018 ..... 060304 Obispo. Areas of San Peschong, Chairman, Public Works Depart- Luis Obispo Board of Supervisors, ment, 976 Osos Street, County (16– San Luis Obispo Coun- Room 207, San Luis 09–3181P). ty, 1055 Monterey Obispo, CA 93401. Street, Suite D430, San Luis Obispo, CA 93408. Santa Clara .... City of San Jose The Honorable Sam Department of Public http://www.msc.fema.gov/lomc Jan. 5, 2018 ...... 060349 (16–09– Liccardo, Mayor, City of Works, 200 East Santa 3074P). San Jose, 200 East Clara Street, 5th Floor, Santa Clara Street, San Jose, CA 95113. 18th Floor, San Jose, CA 95113. Florida: St. Johns .. Unincorporated The Honorable James K. St. Johns County Admin- http://www.msc.fema.gov/lomc Jan. 12, 2018 ..... 125147 Areas of St. Johns, Chairman, St. istration Building, 4020 Johns County Johns County Board of Lewis Speedway, St. (17–04– Commissioners, 500 Augustine, FL 32084. 4604P). San Sebastian View, St. Augustine, FL 32084. Idaho: Ada ...... City of Eagle The Honorable Stan City Hall, 660 East Civic http://www.msc.fema.gov/lomc Jan. 16, 2018 ..... 160003 (17–10– Ridgeway, Mayor, City Street, Eagle, ID 83616. 1535P). of Eagle, City Hall, 660 East Civic Lane, Eagle, ID 83616. Ada ...... Unincorporated The Honorable David L. Ada County Courthouse, http://www.msc.fema.gov/lomc Jan. 16, 2018 ..... 160001 Areas of Ada Case, Chairman, Ada 200 Front West Street, County (17– County Board of Com- Boise, ID 83702. 10–1535P). missioners, 200 West Front Street, 3rd Floor, Boise, ID 83702. Kansas: Johnson .. City of Overland The Honorable Carl Ger- City Hall, 8500 Santa Fe http://www.msc.fema.gov/lomc Jan. 5, 2018 ...... 200174 Park (17–07– lach, Mayor, City of Drive, Overland Park, 1247P). Overland Park, City KS 66212. Hall, 8500 Santa Fe Drive, Overland Park, KS 66212.
[FR Doc. 2017–23230 Filed 10–25–17; 8:45 am] where applicable, the FIS report that the preliminaryfloodhazarddata for BILLING CODE 9110–12–P Federal Emergency Management Agency comparison. (FEMA) has provided to the affected You may submit comments, identified communities. The FIRM and FIS report by Docket No. FEMA–B–1751, to Rick DEPARTMENT OF HOMELAND are the basis of the floodplain Sacbibit, Chief, Engineering Services SECURITY management measures that the Branch, Federal Insurance and community is required either to adopt Mitigation Administration, FEMA, 400 Federal Emergency Management C Street SW., Washington, DC 20472, Agency or to show evidence of having in effect in order to qualify or remain qualified (202) 646–7659, or (email) [Docket ID FEMA–2017–0002; Internal for participation in the National Flood [email protected]. Agency Docket No. FEMA–B–1751] Insurance Program (NFIP). In addition, FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering Services Proposed Flood Hazard the FIRM and FIS report, once effective, will be used by insurance agents and Branch, Federal Insurance and Determinations Mitigation Administration, FEMA, 400 others to calculate appropriate flood C Street SW., Washington, DC 20472, AGENCY: Federal Emergency insurance premium rates for new (202) 646–7659, or (email) Management Agency, DHS. buildings and the contents of those [email protected]; or visit ACTION: Notice. buildings. the FEMA Map Information eXchange SUMMARY: Comments are requested on DATES: (FMIX) online at Comments are to be submitted _ proposed flood hazard determinations, on or before January 24, 2018. www.floodmaps.fema.gov/fhm/fmx which may include additions or main.html. ADDRESSES: The Preliminary FIRM, and modifications of any Base Flood SUPPLEMENTARY INFORMATION: FEMA Elevation (BFE), base flood depth, where applicable, the FIS report for proposes to make flood hazard Special Flood Hazard Area (SFHA) each community are available for determinations for each community boundary or zone designation, or inspection at both the online location listed below, in accordance with section regulatory floodway on the Flood and the respective Community Map 110 of the Flood Disaster Protection Act Insurance Rate Maps (FIRMs), and Repository address listed in the tables of 1973, 42 U.S.C. 4104, and 44 CFR where applicable, in the supporting below. Additionally, the current 67.4(a). Flood Insurance Study (FIS) reports for effective FIRM and FIS report for each These proposed flood hazard the communities listed in the table community are accessible online determinations, together with the below. The purpose of this notice is to through the FEMA Map Service Center floodplain management criteria required seek general information and comment at www.msc.fema.gov or http:// by 44 CFR 60.3, are the minimum that regarding the preliminary FIRM, and www.fema.gov/ are required. They should not be
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construed to mean that the community flood hazard determinations also will be applicable, FIS report for each must change any existing ordinances considered before the FIRM and FIS community are available for inspection that are more stringent in their report become effective. at both the online location and the floodplain management requirements. Use of a Scientific Resolution Panel respective Community Map Repository The community may at any time enact (SRP) is available to communities in address listed in the tables. For stricter requirements of its own or support of the appeal resolution communities with multiple ongoing pursuant to policies established by other process. SRPs are independent panels of Preliminary studies, the studies can be Federal, State, or regional entities. experts in hydrology, hydraulics, and identified by the unique project number These flood hazard determinations are other pertinent sciences established to and Preliminary FIRM date listed in the review conflicting scientific and used to meet the floodplain tables. Additionally, the current management requirements of the NFIP technical data and provide effective FIRM and FIS report for each and also are used to calculate the recommendations for resolution. Use of community are accessible online appropriate flood insurance premium the SRP only may be exercised after rates for new buildings built after the FEMA and local communities have been through the FEMA Map Service Center FIRM and FIS report become effective. engaged in a collaborative consultation at www.msc.fema.gov for comparison. The communities affected by the process for at least 60 days without a (Catalog of Federal Domestic Assistance No. flood hazard determinations are mutually acceptable resolution of an 97.022, ‘‘Flood Insurance.’’) provided in the tables below. Any appeal. Additional information Dated: October 13, 2017. request for reconsideration of the regarding the SRP process can be found revised flood hazard information shown online at http://floodsrp.org/pdfs/srp_ Roy E. Wright, on the Preliminary FIRM and FIS report fact_sheet.pdf. Deputy Associate Administrator for Insurance that satisfies the data requirements The watersheds and/or communities and Mitigation, Department of Homeland outlined in 44 CFR 67.6(b) is considered affected are listed in the tables below. Security, Federal Emergency Management an appeal. Comments unrelated to the The Preliminary FIRM, and where Agency.
Community Community map repository address
Charleston County, South Carolina and Incorporated Areas
Project: 07–04–4771S Preliminary Date: September 9, 2016
City of Charleston ...... Engineering Department, 2 George Street, Suite 2100, Charleston, SC 29401. City of Folly Beach ...... City Hall, 21 Center Street, Folly Beach, SC 29439. City of Isle of Palms ...... City Hall, 1207 Palm Boulevard, Isle of Palms, SC 29451. City of North Charleston ...... City Hall, 2500 City Hall Lane, North Charleston, SC 29406. Town of Awendaw ...... Town Hall, 6971 Doar Road, Awendaw, SC 29429. Town of Hollywood ...... Town Hall, 6278 Highway 162, Hollywood, SC 29449. Town of James Island ...... Town Hall, 1238–B Camp Road, James Island, SC 29412. Town of Kiawah Island ...... Town Hall, 4475 Betsy Kerrison Parkway, Kiawah Island, SC 29455. Town of McClellanville ...... Town Hall, 405 Pinckney Street, McClellanville, SC 29458. Town of Meggett ...... Town Hall, 4776 Highway 165, Meggett, SC 29449. Town of Mount Pleasant ...... Municipal Complex, 100 Ann Edwards Lane, Mount Pleasant, SC 29464. Town of Ravenel ...... Town Hall, 5962 Highway 165, Suite 100, Ravenel, SC 29470. Town of Rockville ...... Rockville Presbyterian Church, 2479 Sea Island Yacht Club Road, Wadmalaw Island, SC 29487. Town of Seabrook Island ...... Town Hall, 2001 Seabrook Island Road, Seabrook Island, SC 29455. Town of Sullivan’s Island ...... Town Hall, 2056 Middle Street, Sullivan’s Island, SC 29482. Unincorporated Areas of Charleston County ...... Charleston County Lonnie Hamilton, III Public Services Building, 4045 Bridge View Drive, North Charleston, SC 29405.
Travis County, Texas and Incorporated Areas
Project: 13–06–0041S Preliminary Date: April 7, 2017
City of Austin ...... Watershed Engineering Division, 505 Barton Springs Road, 12th Floor, Austin, TX 78704. City of Bee Cave ...... City Hall, 4000 Galleria Parkway, Bee Cave, TX 78738. City of Jonestown ...... City Hall, 18649 FM 1431, Suite 4A, Jonestown, TX 78645. City of Lago Vista ...... City Hall, 5803 Thunderbird Street, Lago Vista, TX 78645. City of Lakeway ...... City Hall, 1102 Lohmans Crossing Road, Lakeway, TX 78734. City of Leander ...... City Hall, 200 West Willis Street, Leander, TX 78641. City of West Lake Hills ...... City Hall, 911 Westlake Drive, West Lake Hills, TX 78746. Unincorporated Areas of Travis County ...... Travis County Transportation and Natural Resources, 700 Lavaca Street, 5th Floor, Austin, TX 78701. Village of The Hills ...... Administrative Offices, 102 Trophy Drive, The Hills, TX 78738.
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[FR Doc. 2017–23228 Filed 10–25–17; 8:45 am] DEPARTMENT OF HOMELAND DEPARTMENT OF HOMELAND BILLING CODE 9110–12–P SECURITY SECURITY
Federal Emergency Management Federal Emergency Management DEPARTMENT OF HOMELAND Agency Agency SECURITY [Internal Agency Docket No. FEMA–4343– [Internal Agency Docket No. FEMA–4343– DR; Docket ID FEMA–2017–0001] Federal Emergency Management DR; Docket ID FEMA–2017–0001] Agency Wisconsin; Major Disaster and Related Wisconsin; Amendment No. 1 to Notice Determinations [Internal Agency Docket No. FEMA–3392– of a Major Disaster Declaration EM; Docket ID FEMA–2017–0001] AGENCY: Federal Emergency AGENCY: Federal Emergency Management Agency, DHS. Louisiana; Amendment No. 2 to Notice Management Agency, DHS. ACTION: Notice. of an Emergency Declaration ACTION: Notice. SUMMARY: This is a notice of the AGENCY: Federal Emergency Presidential declaration of a major SUMMARY: This notice amends the notice Management Agency, DHS. disaster for the State of Wisconsin of a major disaster declaration for the (FEMA–4343–DR), dated October 7, ACTION: Notice. State of Wisconsin (FEMA–4343–DR), 2017, and related determinations. dated October 7, 2017, and related DATES: The declaration was issued SUMMARY: This notice amends the notice determinations. October 7, 2017. of an emergency declaration for the DATES: The change occurred on October FOR FURTHER INFORMATION CONTACT: State of Louisiana (FEMA–3392–EM), 8, 2017. Dean Webster, Office of Response and dated October 6, 2017, and related Recovery, Federal Emergency determinations. FOR FURTHER INFORMATION CONTACT: Management Agency, 500 C Street SW., Dean Webster, Office of Response and Washington, DC 20472, (202) 646–2833. DATES: This amendment was issued Recovery, Federal Emergency SUPPLEMENTARY INFORMATION: October 13, 2017. Management Agency, 500 C Street SW., Notice is Washington, DC 20472, (202) 646–2833. hereby given that, in a letter dated FOR FURTHER INFORMATION CONTACT: October 7, 2017, the President issued a Dean Webster, Office of Response and SUPPLEMENTARY INFORMATION: The major disaster declaration under the Recovery, Federal Emergency Federal Emergency Management Agency authority of the Robert T. Stafford Management Agency, 500 C Street SW., (FEMA) hereby gives notice that Disaster Relief and Emergency Washington, DC 20472, (202) 646–2833. pursuant to the authority vested in the Assistance Act, 42 U.S.C. 5121 et seq. Administrator, under Executive Order (the ‘‘Stafford Act’’), as follows: SUPPLEMENTARY INFORMATION: Notice is 12148, as amended, Janet M. Odeshoo, I have determined that the damage in hereby given that the incident period for of FEMA is appointed to act as the this emergency is closed effective certain areas of the State of Wisconsin Federal Coordinating Officer for this resulting from severe storms, straight-line October 8, 2017. emergency. winds, flooding, landslides, and mudslides The following Catalog of Federal Domestic This action terminates the during the period of July 19–23, 2017, is of Assistance Numbers (CFDA) are to be used sufficient severity and magnitude to warrant appointment of Benigno Bern Ruiz as a major disaster declaration under the Robert for reporting and drawing funds: 97.030, Federal Coordinating Officer for this Community Disaster Loans; 97.031, Cora T. Stafford Disaster Relief and Emergency disaster. Assistance Act, 42 U.S.C. 5121 et seq. (the Brown Fund; 97.032, Crisis Counseling; The following Catalog of Federal Domestic ‘‘Stafford Act’’). Therefore, I declare that such 97.033, Disaster Legal Services; 97.034, a major disaster exists in the State of Disaster Unemployment Assistance (DUA); Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Wisconsin. 97.046, Fire Management Assistance Grant; In order to provide Federal assistance, you Community Disaster Loans; 97.031, Cora 97.048, Disaster Housing Assistance to are hereby authorized to allocate from funds Brown Fund; 97.032, Crisis Counseling; Individuals and Households In Presidentially available for these purposes such amounts as Declared Disaster Areas; 97.049, 97.033, Disaster Legal Services; 97.034, you find necessary for Federal disaster Disaster Unemployment Assistance (DUA); Presidentially Declared Disaster Assistance— assistance and administrative expenses. 97.046, Fire Management Assistance Grant; Disaster Housing Operations for Individuals You are authorized to provide Public 97.048, Disaster Housing Assistance to and Households; 97.050 Presidentially Assistance in the designated areas and Individuals and Households In Presidentially Declared Disaster Assistance to Individuals Hazard Mitigation throughout the State. Declared Disaster Areas; 97.049, Consistent with the requirement that Federal and Households—Other Needs; 97.036, Presidentially Declared Disaster Assistance— assistance be supplemental, any Federal Disaster Grants—Public Assistance Disaster Housing Operations for Individuals funds provided under the Stafford Act for (Presidentially Declared Disasters); 97.039, and Households; 97.050, Presidentially Hazard Mitigation will be limited to 75 Hazard Mitigation Grant. Declared Disaster Assistance to Individuals percent of the total eligible costs. Federal funds provided under the Stafford Act for Brock Long, and Households—Other Needs; 97.036, Disaster Grants—Public Assistance Public Assistance also will be limited to 75 Administrator, Federal Emergency (Presidentially Declared Disasters); 97.039, percent of the total eligible costs, with the Management Agency. exception of projects that meet the eligibility Hazard Mitigation Grant. [FR Doc. 2017–23238 Filed 10–25–17; 8:45 am] criteria for a higher Federal cost-sharing BILLING CODE 9111–23–P Brock Long, percentage under the Public Assistance Alternative Procedures Pilot Program for Administrator, Federal Emergency Debris Removal implemented pursuant to Management Agency. section 428 of the Stafford Act. [FR Doc. 2017–23249 Filed 10–25–17; 8:45 am] Further, you are authorized to make BILLING CODE 9111–23–P changes to this declaration for the approved
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assistance to the extent allowable under the Recovery, Federal Emergency at https://cyber.dhs.gov. Submit any Stafford Act. Management Agency, 500 C Street SW., inquiries about this notice of availability The Federal Emergency Management Washington, DC 20472, (202) 646–2833. to [email protected]. Agency (FEMA) hereby gives notice that SUPPLEMENTARY INFORMATION: The SUPPLEMENTARY INFORMATION: The pursuant to the authority vested in the Federal Emergency Management Agency Department of Homeland Security Administrator, under Executive Order (FEMA) hereby gives notice that (‘‘DHS’’ or ‘‘the Department’’) has the 12148, as amended, Benigno Bern Ruiz, pursuant to the authority vested in the of FEMA is appointed to act as the Administrator, under Executive Order statutory responsibility, in consultation Federal Coordinating Officer for this 12148, as amended, Michael F. Byrne, of with the Office of Management and major disaster. FEMA is appointed to act as the Federal Budget, to administer the The following areas of the State of Coordinating Officer for this emergency. implementation of agency information Wisconsin have been designated as This action terminates the security policies and practices for adversely affected by this major disaster: appointment of Alejandro DeLaCampa information systems, which includes Buffalo, Crawford, Grant, Iowa, Jackson, La as Federal Coordinating Officer for this assisting agencies and providing certain Crosse, Lafayette, Monroe, Richland, emergency. government-wide protections. 44 U.S.C. Trempealeau, and Vernon Counties for The following Catalog of Federal Domestic 3553(b). As part of that responsibility, Public Assistance. Assistance Numbers (CFDA) are to be used the Department is authorized to All areas within the State of Wisconsin are for reporting and drawing funds: 97.030, ‘‘develop[] and oversee[] the eligible for assistance under the Hazard Community Disaster Loans; 97.031, Cora implementation of binding operational Mitigation Grant Program. Brown Fund; 97.032, Crisis Counseling; directives to agencies to implement the The following Catalog of Federal Domestic 97.033, Disaster Legal Services; 97.034, policies, principles, standards, and Assistance Numbers (CFDA) are to be used Disaster Unemployment Assistance (DUA); for reporting and drawing funds: 97.030, 97.046, Fire Management Assistance Grant; guidance developed by the Director [of Community Disaster Loans; 97.031, Cora 97.048, Disaster Housing Assistance to the Office of Management and Budget] Brown Fund; 97.032, Crisis Counseling; Individuals and Households In Presidentially and [certain] requirements of [the 97.033, Disaster Legal Services; 97.034, Declared Disaster Areas; 97.049, Federal Information Security Disaster Unemployment Assistance (DUA); Presidentially Declared Disaster Assistance— Modernization Act of 2014.]’’ 44 U.S.C. 97.046, Fire Management Assistance Grant; Disaster Housing Operations for Individuals and Households; 97.050, Presidentially 3553(b)(2). A BOD is ‘‘a compulsory 97.048, Disaster Housing Assistance to direction to an agency that (A) is for Individuals and Households In Presidentially Declared Disaster Assistance to Individuals Declared Disaster Areas; 97.049, and Households—Other Needs; 97.036, purposes of safeguarding Federal Presidentially Declared Disaster Assistance— Disaster Grants—Public Assistance information and information systems Disaster Housing Operations for Individuals (Presidentially Declared Disasters); 97.039, from a known or reasonably suspected and Households; 97.050, Presidentially Hazard Mitigation Grant. information security threat, Declared Disaster Assistance to Individuals Brock Long, vulnerability, or risk; [and] (B) [is] in and Households—Other Needs; 97.036, accordance with policies, principles, Disaster Grants—Public Assistance Administrator, Federal Emergency (Presidentially Declared Disasters); 97.039, Management Agency. standards, and guidelines issued by the Hazard Mitigation Grant. [FR Doc. 2017–23245 Filed 10–25–17; 8:45 am] Director[.]’’ 44 U.S.C. 3552(b)(1). BILLING CODE 9111–23–P Agencies are required to comply with Brock Long, these directives. 44 U.S.C. Administrator, Federal Emergency 3554(a)(1)(B)(ii). Management Agency. DEPARTMENT OF HOMELAND [FR Doc. 2017–23251 Filed 10–25–17; 8:45 am] SECURITY Overview of BOD 18–01 BILLING CODE 9111–23–P National Protection and Programs In carrying out this statutory Directorate; Notification of Issuance of responsibility, the Department issued DEPARTMENT OF HOMELAND Binding Operational Directive 18–01 BOD 18–01, titled ‘‘Enhance Email and SECURITY Web Security.’’ For email security, the AGENCY: National Protection and BOD requires agencies to take specific Federal Emergency Management Programs Directorate, DHS. technical actions to ensure that agency Agency ACTION: Issuance of a binding email can be encrypted in transit and is operational directive; notice of [Internal Agency Docket No. FEMA–3391– more difficult to spoof. For web EM; Docket ID FEMA–2017–0001] availability. security, the BOD requires agencies to SUMMARY: To safeguard Federal take specific technical actions to ensure Puerto Rico; Amendment No. 1 to information and information systems, publicly accessible Federal Web sites Notice of an Emergency Declaration DHS has issued a binding operational and services are provided through AGENCY: Federal Emergency directive (BOD) to all Federal, executive secure connections. Across both topics, Management Agency, DHS. branch departments and agencies the BOD requires that agencies disable ACTION: Notice. relating to enhanced email and web and discontinue use of certain, security. The BOD requires agencies to vulnerable ciphers and Secure Socket SUMMARY: This notice amends the notice take specific actions on their Layer configurations. of an emergency declaration for the information systems to improve email Jeanette Manfra, Commonwealth of Puerto Rico (FEMA– and web security. DHS is publishing 3391–EM), dated September 18, 2017, this notice of availability to provide Assistant Secretary, Office of Cybersecurity and related determinations. awareness of the BOD. and Communications, Department of Homeland Security. DATES: The change occurred on October DATES: Binding Operational Directive 10, 2017. 18–01 was issued on October 16, 2017. [FR Doc. 2017–23317 Filed 10–25–17; 8:45 am] FOR FURTHER INFORMATION CONTACT: ADDRESSES: The text of Binding BILLING CODE 9110–9P–P Dean Webster, Office of Response and Operational Directive 18–01 is available
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DEPARTMENT OF HOUSING AND This Notice application to the bond-issuing agency, URBAN DEVELOPMENT This notice extends from 730 days to and (b) The submission is made before the 850 days the period for which the 2015 effective date of the subsequent lists, [Docket No. FR–5815–N–03] lists of QCTs and DDAs are effective for provided that both the issuance of the projects located in areas approved for bonds and the placement in service of Statutorily Mandated Designation of federal individual assistance under the the building occur after the application Difficult Development Areas and Robert T. Stafford Disaster Relief and is submitted. Qualified Census Tracts: Revision of Emergency Assistance Act (Stafford Act) Effective Date for 2015 Designations An application is deemed to be (42 U.S.C. 5170, et al.) due to a submitted on the date it is filed if the Presidentially-declared natural disaster AGENCY: Office of the Assistant application is determined to be in 2017 (hereafter, ‘‘declared counties’’) complete by the credit-allocating or Secretary for Policy Development and and were not in areas on subsequent Research, HUD. bond-issuing agency. A ‘‘complete lists of DDAs or QCTs but submitted application’’ means that no more than ACTION: Notice. applications while the area was a 2015 de minimis clarification of the QCT or DDA. DDAs and QCTs for 2016 application is required for the agency to SUMMARY: This document revises the were published on November 24, 2015 make a decision about the allocation of effective date for designations of at 80 FR 73201. DDAs and QCTs for tax credits or issuance of bonds ‘‘Difficult Development Areas’’ (DDAs) 2017 were published on October 17, requested in the application. and ‘‘Qualified Census Tracts’’ (QCTs) 2016 at 81 FR 71523. DDAs and QCTs In the case of a ‘‘multiphase project,’’ for purposes of the Low-Income for 2018 were published on September the DDA or QCT status of the site of the Housing Tax Credit (LIHTC) under 11, 2017 at 82 FR 42694. This applies project that applies for all phases of the Internal Revenue Code (IRC) Section 42 to declared counties in each of the 50 project is that which applied when the published on October 3, 2014 at 79 FR states, the District of Columbia, Puerto project received its first allocation of 59855 and amended December 17, 2015 Rico, American Samoa, Guam, the LIHTC. For purposes of IRC section at 80 FR 78749 in areas approved for Northern Mariana Islands, and the U.S. 42(h)(4), the DDA or QCT status of the Federal disaster-related individual Virgin Islands. The actual designations site of the project that applies for all assistance under the Stafford Act. This of 2015 QCTs and DDAs are not affected phases of the project is that which Notice extends from 730 days to 850 by this notice. HUD is revising the applied when the first of the following days the period for which the 2015 lists effective date of the 2015 QCTs and occurred: (a) The building(s) in the first of QCTs and DDAs are effective for DDAs in declared counties at this time phase were placed in service, or (b) the projects located in an area that was to aid the ability of areas affected by bonds were issued. approved for individual assistance natural disasters to place in service For purposes of this notice, a under the Stafford Act in 2017, not on affordable housing. ‘‘multiphase project’’ is defined as a set subsequent lists of DDAs or QCTs; and For LIHTC and bond-financed of buildings to be constructed or submitted applications while the area projects located in declared counties, rehabilitated under the rules of the was a 2015 QCT or DDA. the sections entitled ‘‘Effective Date’’ LIHTC and meeting the following and ‘‘Interpretive Examples of Effective criteria: FOR FURTHER INFORMATION CONTACT: For Date’’ of the 2015 DDA and QCT (1) The multiphase composition of the questions on how areas are designated designations as published October 3, project (i.e., total number of buildings and on geographic definitions, contact 2014 at 79 FR 59855 and December 17, and phases in project, with a Michael K. Hollar, Senior Economist, 2015 at 80 FR78749 are hereby revised description of how many buildings are Economic Development and Public to read as follows: to be built in each phase and when each Finance Division, Office of Policy Effective Date phase is to be completed, and any other Development and Research, Department information required by the agency) is of Housing and Urban Development, The 2015 lists of QCTs and DDAs are made known by the applicant in the 451 Seventh Street SW., Room 8234, effective: first application of credit for any Washington, DC 20410–6000; telephone (1) For allocations of credit after building in the project, and that number (202) 402–5878, or send an December 31, 2014; or applicant identifies the buildings in the email to [email protected]. For (2) For purposes of IRC section project for which credit is (or will be) specific legal questions, contact Branch 42(h)(4), if the bonds are issued and the sought; 5, Office of the Associate Chief Counsel, building is placed in service after (2) The aggregate amount of LIHTC Passthroughs and Special Industries, December 31, 2014. applied for on behalf of, or that would Internal Revenue Service, 1111 If an area is not on a subsequent list eventually be allocated to, the buildings Constitution Avenue NW., Washington, of DDAs, the 2015 lists are effective for on the site exceeds the one-year DC 20224; telephone number (202) 317– the area if: limitation on credits per applicant, as 4137, fax number (855) 591–7867. (1) The allocation of credit to an defined in the Qualified Allocation Plan (These are not toll-free telephone applicant is made no later than the end (QAP) of the LIHTC-allocating agency, numbers.) Additional copies of this of the 850-day period after the applicant or the annual per-capita credit authority notice are available through HUD User submits a complete application to the of the LIHTC allocating agency, and is at (800) 245–2691 for a small fee to LIHTC-allocating agency, and the the reason the applicant must request cover duplication and mailing costs. submission is made before the effective multiple allocations over two or more date of the subsequent lists; or COPIES AVAILABLE ELECTRONICALLY: This years; and (2) For purposes of IRC section notice and additional information about (3) All applications for LIHTC for 42(h)(4), if: DDAs and QCTs are available buildings on the site are made in (a) The bonds are issued or the electronically on the Internet at http:// immediately consecutive years. building is placed in service no later Members of the public are hereby www.huduser.org/datasets/qct.html. than the end of the 850-day period after reminded that the Secretary of Housing SUPPLEMENTARY INFORMATION: the applicant submits a complete and Urban Development, or the
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Secretary’s designee, has legal authority Project C was placed in service on consultation and funding requirements to designate DDAs and QCTs, in November 15, 2014. A complete of section 6 of the executive order. This accordance with 26 U.S.C. 42(d)(5), by application for tax-exempt bond notice merely designates DDAs as publishing lists of geographic entities as financing for Project C is filed with the required under IRC Section 42, as defined by, in the case of DDAs, the bond-issuing agency on January 15, amended, for the use by political Census Bureau, the several states and 2015. The bonds that will support the subdivisions of the states in allocating the governments of the insular areas of permanent financing of Project C are the LIHTC. As a result, this notice is not the United States and, in the case of issued on September 30, 2015. Project C subject to review under the order. QCTs, by the Census Bureau; and to is NOT eligible for the increase in basis Dated: October 19, 2017. establish the effective dates of such lists. otherwise accorded a project in a 2015 Kurt G. Usowski, The Secretary of the Treasury, through DDA, because the project was placed in the IRS thereof, has sole legal authority Deputy Assistant Secretary for Economic service BEFORE January 1, 2015. Affairs. to interpret, and to determine and (Case D) Project D is located in an area enforce compliance with the IRC and that is a DDA in 2015, but is NOT a DDA [FR Doc. 2017–23306 Filed 10–25–17; 8:45 am] associated regulations, including in 2016, 2017, or 2018 and is in a BILLING CODE 4210–67–P Federal Register notices published by declared county. A complete HUD for purposes of designating DDAs application for tax-exempt bond and QCTs. Representations made by any financing for Project D is filed with the DEPARTMENT OF THE INTERIOR other entity as to the content of HUD bond-issuing agency on October 30, Bureau of Indian Affairs notices designating DDAs and QCTs that 2015. Bonds are issued for Project D on do not precisely match the language January 30, 2018, but Project D is not [189A2100DD/AAKC001030/ published by HUD should not be relied placed in service until July 30, 2018. A0A501010.999900 253G] upon by taxpayers in determining what Project D is eligible for the increase in actions are necessary to comply with basis available to projects located in Indian Gaming; Tribal-State Class III HUD notices. 2015 DDAs because: (1) One of the two Gaming Compact Taking Effect in the State of New Mexico Interpretive Examples of Effective Date events necessary for triggering the effective date for buildings described in For the convenience of readers of this AGENCY: Bureau of Indian Affairs, Section 42(h)(4)(B) of the IRC (the two Interior. notice, interpretive examples are events being bonds issued and buildings ACTION: Notice. provided below to illustrate the placed in service) took place on January consequences of the effective date in 30, 2018, within the 850-day period SUMMARY: areas that gain or lose DDA status. The The notice announces that the after a complete application for tax- Tribal-State Class III Gaming Compact examples covering DDAs are equally exempt bond financing was filed, (2) the applicable to QCT designations. between the Pueblo of Pojoaque and application was filed during a time (Case A) Project A is located in a 2015 State of New Mexico is taking effect. when the location of Project D was in a DDA that is NOT a designated DDA in DATES: This notice is applicable as of 2016, 2017, or 2018 and is in a declared DDA, and (3) both the issuance of the October 26, 2017. bonds and placement in service of county. A complete application for tax FOR FURTHER INFORMATION CONTACT: Ms. Project D occurred after the application credits for Project A is filed with the Paula L. Hart, Director, Office of Indian was submitted. allocating agency on November 15, Gaming, Office of the Deputy Assistant 2015. Credits are allocated to Project A Findings and Certifications Secretary—Policy and Economic on January 30, 2018. Project A is eligible Development, Washington, DC 20240, A. Environmental Impact for the increase in basis accorded a (202) 219–4066. project in a 2015 DDA because the This notice involves the SUPPLEMENTARY INFORMATION: Under application was filed BEFORE January establishment of fiscal requirements or section 11 of the Indian Gaming 1, 2016 (the effective date for the 2016 procedures that are related to rate and Regulatory Act (IGRA) Public Law 100– DDA lists), and because tax credits were cost determinations and do not 497, 25 U.S.C. 2701 et seq., the allocated no later than the end of the constitute a development decision Secretary of the Interior shall publish in 850-day period after the filing of the affecting the physical condition of the Federal Register notice of approved complete application for an allocation of specific project areas or building sites. Tribal-State compacts for the purpose of tax credits. Accordingly, under 40 CFR 1508.4 of engaging in Class III gaming activities (Case B) Project B is located in a 2015 the regulations of the Council on on Indian lands. As required by IGRA DDA that is NOT a designated DDA in Environmental Quality and 24 CFR and 25 CFR 293.4, all compacts are 2016, 2017, or 2018 and is in a declared 50.19(c)(6) of HUD’s regulations, this subject to review and approval by the county. A complete application for tax notice is categorically excluded from Secretary. The Secretary took no action credits for Project B is filed with the environmental review under the on the compact between the Pueblo of allocating agency on December 1, 2015. National Environmental Policy Act of Pojoaque and the State of New Mexico Credits are allocated to Project B on 1969 (42 U.S.C. 4321). within 45 days of its submission. June 30, 2018. Project B is NOT eligible B. Federalism Impact Therefore, the Compact is considered to for the increase in basis accorded a have been approved, but only to the project in a 2015 DDA because, although Executive Order 13132 (entitled extent the Compact is consistent with the application for an allocation of tax ‘‘Federalism’’) prohibits an agency from IGRA. See 25 U.S.C. 2710(d)(8)(C). credits was filed BEFORE January 1, publishing any policy document that 2016 (the effective date of the 2016 DDA has federalism implications if the Dated: October 23, 2017. lists), the tax credits were allocated later document either imposes substantial Gavin Clarkson, than the end of the 850-day period after direct compliance costs on state and Deputy Assistant Secretary, Policy and the filing of the complete application. local governments and is not required Economic Development—Indian Affairs. (Case C) Project C is located in a 2015 by statute, or the document preempts [FR Doc. 2017–23343 Filed 10–25–17; 8:45 am] DDA that was not a DDA in 2014. state law, unless the agency meets the BILLING CODE 4337–15–P
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DEPARTMENT OF THE INTERIOR The opening and reading of the bids FOR FURTHER INFORMATION CONTACT: To for the 2017 lease sale will be available request additional information about Bureau of Land Management for online public viewing via video this ICR, contact Kristine Brunsman by livestreaming at http://www.blm.gov/ email at [email protected], or [17X.LLAK930000.L13100000.EI0000.241A] live. by telephone at (202) 354–2153. You The Detailed Statement of Sale will may also view the ICR at http:// Notice of National Petroleum Reserve include a description of the areas the www.reginfo.gov/public/do/PRAMain. in Alaska Oil and Gas Lease Sale 2017; BLM is offering for lease, as well as the SUPPLEMENTARY INFORMATION: Notice of Availability of the Detailed We, the lease terms, conditions, special National Park Service (NPS), in Statement of Sale for the NPR–A 2017 stipulations, required operating Oil and Gas Lease Sale accordance with the Paperwork procedures, and directions for how to Reduction Act of 1995, provide the AGENCY: Bureau of Land Management, submit bids. If you plan to submit a general public and other Federal Interior. bid(s), please note that all bids must be agencies with an opportunity to sealed in accordance with the ACTION: Notice. comment on proposed, revised, and provisions identified in the Detailed continuing collections of information. SUMMARY: The Bureau of Land Statement of Sale. The United States This helps us assess the impact of our Management’s (BLM) Alaska State reserves the right to withdraw any tract information collection requirements and Office will hold an oil and gas lease sale from this sale prior to issuance of a minimize the public’s reporting burden. bid opening for all available tracts in the written acceptance of a bid. It also helps the public understand our National Petroleum Reserve in Alaska Authority: 43 CFR 3131.4–1 and 42 U.S.C. information collection requirements and (NPR–A). 6506a. provide the requested data in the desired format. DATES: The oil and gas lease sale bid Karen Mouritsen, A Federal Register notice with a 60- opening will be at 1 p.m. (AKST) on Acting State Director, Alaska. Wednesday, December 6, 2017. The day public comment period soliciting [FR Doc. 2017–23281 Filed 10–25–17; 8:45 am] BLM must receive all sealed bids by 4 comments on this collection of p.m. (AKST), Monday, December 4, BILLING CODE 4310–JA–P information was published on July 26, 2017. The Detailed Statement of Sale for 2017 (82 FR 34688). No comments were received. the NPR–A Oil and Gas Lease Sale 2017 DEPARTMENT OF THE INTERIOR will be available to the public on We are again soliciting comments on October 26, 2017. National Park Service the proposed ICR that is described below. We are especially interested in ADDRESSES: Sealed bids must be [NPS–WASO–CR–4426; PPWOCRADP3, received at the BLM-Alaska State Office, public comment addressing the PCU00RP14.R50000; OMB Control Number following issues: (1) Is the collection ATTN: Carol Taylor (AK932); 222 West 1024–0038] 7th Avenue, #13; Anchorage, AK necessary to the proper functions of the 99513–7504. You may get the Detailed Agency Information Collection NPS; (2) will this information be Statement of Sale from the BLM Alaska Activities; Submission to the Office of processed and used in a timely manner; Web site at https://on.doi.gov/2fgHGRq, Management and Budget for Review (3) is the estimate of burden accurate; or request a copy from the Public and Approval; Procedures for State, (4) how might the NPS enhance the Information Center, BLM Alaska State Tribal, and Local Government Historic quality, utility, and clarity of the Office, 222 West 7th Avenue, #13; Preservation Programs information to be collected; and (5) how Anchorage, AK 99513–7504; 907–271– might the NPS minimize the burden of AGENCY: National Park Service, Interior. 5960. this collection on the respondents, ACTION: Notice of information collection; including through the use of FOR FURTHER INFORMATION CONTACT: request for comments. information technology. Robert Brumbaugh, 907–271–4429. Comments that you submit in People who use a telecommunications SUMMARY: In accordance with the response to this notice are a matter of device for the deaf (TDD) may call the Paperwork Reduction Act of 1995, the public record. Before including your Federal Relay Service (FRS) at 1–800– National Park Service is proposing to address, phone number, email address, 877–8339 to contact the above renew an information collection. or other personal identifying individual during normal business DATES: Interested persons are invited to information in your comment, you hours. The FRS is available 24 hours a submit comments on or before should be aware that your entire day, 7 days a week, to leave a message November 27, 2017. comment—including your personal or question with the above individual. ADDRESSES: Send written comments on identifying information—may be made You will receive a reply during normal this information collection request (ICR) publicly available at any time. While business hours. to the Office of Management and you can ask us in your comment to SUPPLEMENTARY INFORMATION: The Budget’s Desk Officer for the withhold your personal identifying December 2017 NPR–A Oil and Gas Department of the Interior by email at information from public review, we Lease Sale will include all 900 tracts [email protected]; or via cannot guarantee that we will be able to (approximately 10.3 million acres) that facsimile to (202) 395–5806. Please do so. are available for leasing under the NPR– provide a copy of your comments to An agency may not conduct or A Integrated Activity Plan/ Tim Goddard, Information Collection sponsor and a person is not required to Environmental Impact Statement Record Clearance Officer, National Park respond to a collection of information of Decision (ROD) that was finalized in Service, 12201 Sunrise Valley Drive, unless it displays a currently valid OMB February 2013. This is the first time that MS–242, Reston, VA 20192 (mail); or control number. all available tracts, as designated [email protected] (email). Please Title of Collection: Procedures for available for development in the 2013 reference OMB Control Number 1024– State, Tribal, and Local Government Record of Decision, will be offered for 0038 in the subject line of your Historic Preservation Programs. sale. comments. OMB Control Number: 1024–0038.
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Form Number: None. This request includes information and requirements for participation in Type of Review: Extension of a collections related to HPF grants to the National Historic Preservation currently approved collection. States and to THPOs. Section 101(b) of Program; and to meet program specific Respondents/Affected Public: State, the National Historic Preservation Act, requirements as well as government- tribal, and local governments. as amended, (54 U.S.C. 302301), wide requirements for Federal grant Total Estimated Number of Annual specifies the role of States in the NHPP programs. Responses: 43,108. Program. Section 101(c), section 103(c), The authorities for this action are the Total Estimated Number of Annual and section 301 of the Act (54 U.S.C. National Historic Preservation Act Burden Hours: 40,761. 302502, 54 U.S.C. 302902, and 54 U.S.C. (NHPA) (54 U.S.C. 300101 et seq.) and Total Estimated Number of Annual 300301), specify the role of local the Paperwork Reduction Act of 1995 Respondents: 2,229. governments in the NHPP program. (44 U.S.C. 3501 et seq.). Section 101(d) of the Act (54 U.S.C. Estimated Completion Time per Tim Goddard, Response: Varies from 15 minutes to 302701) specifies the role of tribes in the NHPP Program. Section 108 of the Act Information Collection Clearance Officer, 166 hours, depending on activity. National Park Service. Respondent’s Obligation: Required to (54 U.S.C. 303101) created the HPF to [FR Doc. 2017–23268 Filed 10–25–17; 8:45 am] Obtain or Retain a Benefit. support activities that carry out the Frequency of Collection: Annually or purposes of the Act. Section 101(e)(1) of BILLING CODE 4312–52–P on occasion. the Act (54 U.S.C. 302902) directs the Secretary of the Interior through the Total Estimated Annual Nonhour DEPARTMENT OF THE INTERIOR Burden Cost: $0.00. NPS to ‘‘administer a program of matching grants to the States for the Abstract: This set of information National Park Service collections has an impact on State, purposes of carrying out’’ the Act. Tribal, and local governments that wish Similarly, sections 101(d) and 101(e) of the Act direct the NPS to administer a [NPS–WASO–NRNHL–24228; to participate formally with the NPS in PPWOCRADI0, PCU00RP14.R50000] the National Historic Preservation program of grants to THPOs for carrying out their responsibilities under the Act. Partnership (NHPP) Program, and State National Register of Historic Places; Section 101j of the Act (54 U.S.C. and Tribal governments that wish to Notification of Pending Nominations 303903) directs the NPS to provide apply for Historic Preservation Fund and Related Actions historic preservation-related education (HPF) grants. The NPS uses the and training. AGENCY: National Park Service, Interior. information collections to ensure Each year Congress directs the NPS to ACTION: Notice. compliance with the National Historic use part of the annual appropriation Preservation Act, as amended (54 U.S.C. from the HPF for the State grant SUMMARY: The National Park Service is 300101, et seq.), as well as government- program and the Tribal grant programs. soliciting comments on the significance wide grant requirements OMB has The purpose of both the HPF State grant of properties nominated before issued and the Department of the program and the HPF THPO grant September 23, 2017, for listing or Interior implements through 43 CFR program is to assist States and Tribes in related actions in the National Register part 12. The information collections also carrying out their statutory role in the of Historic Places. produce performance data NPS uses to national historic preservation program. assess its progress in meeting its DATES: Comments should be submitted HPF grants to States and THPOs are by November 13, 2017. statutory mission goals pursuant to the program grants; i.e., each State/THPO ADDRESSES: Comments may be sent via 1993 Government Performance and selects its own HPF-eligible activities U.S. Postal Service and all other carriers Results Act, as amended. This request and projects. Each HPF grant to a State/ to the National Register of Historic for OMB approval includes local THPO has two years of fund availability. Places, National Park Service, 1849 C St. government burden for information At the end of the first year, the NPS NW., MS 7228, Washington, DC 20240. collections associated with various employs a ‘‘Use or Lose’’ policy to aspects of the Certified Local ensure efficient and effective use of the SUPPLEMENTARY INFORMATION: The Government (CLG) program; State grant funds. All 59 states, territories, properties listed in this notice are being government burden for information and the District of Columbia participate considered for listing or related actions collections related to the CLG program; in the NHPP Program. Almost 2,000 in the National Register of Historic the program-specific aspects of HPF local governments have become Places. Nominations for their grants to States, maintenance of a State Certified Local Governments (CLGs) in consideration were received by the inventory of historic and prehistoric order to participate in the NHPP National Park Service before September properties, tracking State Historic program. Approximately 30 local 23, 2017. Pursuant to section 60.13 of 36 Preservation Office historic preservation governments become CLGs each year. CFR part 60, written comments are consultation with Federal agencies, Almost 170 federally-recognized tribes being accepted concerning the developing the Statewide Historic have formally joined the NHPP Program significance of the nominated properties Preservation Plan, reporting on other and have established THPOs and tribal under the National Register criteria for State historic preservation historic preservation offices. Typically, evaluation. accomplishments, the State role in the each year six to nine tribes join the Before including your address, phone State program review process, and partnership. number, email address, or other evaluating NPS-provided program, The NPS developed the information personal identifying information in your grants management, and CLG training collections associated with 36 CFR part comment, you should be aware that for State officials; and Tribal 61 in consultation with State, Tribal, your entire comment—including your government burden for information and local government partners. The personal identifying information—may collections related to the program- obligation to respond is required to be made publicly available at any time. specific aspects of HPF grants to Tribal provide information to evaluate whether While you can ask us in your comment Historic Preservation Officers/Offices or not State, Tribal, and local to withhold your personal identifying (THPOs). governments meet minimum standards information from public review, we
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cannot guarantee that we will be able to DEPARTMENT OF THE INTERIOR IOWA do so. Polk County Nominations submitted by State National Park Service Historic Preservation Officers: I.O.O.F. (International Order of Odd Fellows) [NPS–WASO–NRNHL–24417; Valley Junction Lodge Hall No. 604, 216– NEW JERSEY PPWOCRADI0, PCU00RP14.R50000] 218 5th St., West Des Moines, SG100001793 Ocean County National Register of Historic Places; Hubbard, L. Ron, House, 666 East Ave., Bay Notification of Pending Nominations MARYLAND Head Borough, SG100001777 and Related Actions Montgomery County Sussex County AGENCY: National Park Service, Interior. Mesrobian, Mihran, House, 7410 Connecticut Erickson Lakeside Cabin, 103 Lakeside Dr., Ave., Chevy Chase, SG100001794 Lake Wallkill, SG100001778 ACTION: Notice. MICHIGAN RHODE ISLAND SUMMARY: The National Park Service is Isabella County Providence County soliciting comments on the significance of properties nominated before Mount Pleasant Indian Industrial Boarding Angell, Otis, Gristmill, 1 Governor Notte September 30, 2017, for listing or School, Bounded by Crawford, Pickard, Pkwy., North Providence, SG100001779 Bamber, River Rds., Mount Pleasant, related actions in the National Register SG100001795 Woonsocket Senior High and Junior High of Historic Places. Schools, 357 Park Place, Woonsocket, NEBRASKA SG100001780 DATES: Comments should be submitted by November 13, 2017. Antelope County SOUTH DAKOTA ADDRESSES: Comments may be sent via Downtown Neligh Historic District, Main St. Lawrence County U.S. Postal Service and all other carriers from 5th to 2nd Sts., Neligh, SG100001796 Spearfish Historic Commercial District to the National Register of Historic Buffalo County (Boundary Decrease), Various, Spearfish, Places, National Park Service, 1849 C St. BC100001782 Kearney Downtown Historic District, NW., MS 7228, Washington, DC 20240. Multiple, Kearney, SG100001797 WISCONSIN SUPPLEMENTARY INFORMATION: The Douglas County Dane County properties listed in this notice are being considered for listing or related actions Chiodo Apartments, (Apartments, Flats and Maple Bluff Boy Scout Cabin, 296 Woodland Tenements in Omaha, Nebraska from Cir., Maple Bluff, SG100001783 in the National Register of Historic Places. Nominations for their 1880–1962 MPS), 2556 Marcy St., Omaha, Jefferson County MP100001798 consideration were received by the Tong, On Leong, House, 1518 Cass St., Palmyra Boy Scout Cabin, 105 N. 1st St., National Park Service before September Omaha, SG100001799 Palmyra, SG100001784 30, 2017. Pursuant to section 60.13 of 36 Sheboygan County CFR part 60, written comments are Hall County Atlanta (steam screw) Shipwreck, 1.02 mi. being accepted concerning the Grand Island Historic District, Multiple, NNE. of Amsterdam Park boat launch in L. significance of the nominated properties Grand Island, SG100001800 Michigan, Cedar Grove vicinity, under the National Register criteria for NEW YORK SG100001785 evaluation. A request for removal has been made for Before including your address, phone Kings County the following resource(s): number, email address, or other Lefferts Manor Historic District (Boundary Increase), Fenimore, Maple & Midwood SOUTH DAKOTA personal identifying information in your comment, you should be aware that Sts., Lincoln & Rutland Rds., Bedford Ave., Brooklyn, BC100001801 Edmunds County your entire comment—including your Eisenbeis, John, House, (German-Russian personal identifying information—may New York County Folk Architecture TR), Address Restricted, be made publicly available at any time. Caffe Cino, 31 Cornelia St., New York, Bowdle vicinity, OT84003283 While you can ask us in your comment SG100001802 Nominations submitted by Federal Holy Cross African Orthodox Pro-Cathedral, Preservation Officers: to withhold your personal identifying 122 W. 129th St., New York, SG100001803 The State Historic Preservation Officer information from public review, we reviewed the following nomination and cannot guarantee that we will be able to Oneida County responded to the Federal Preservation Officer do so. Forest Hill Cemetery, 2201 Oneida St., Utica, within 45 days of receipt of the nomination Nominations submitted by State SG100001804 and supports listing the property in the Historic Preservation Officers: National Register of Historic Places. Ontario County ARIZONA ALASKA Warren—Benham House, 5680 Seneca Point Maricopa County Rd., Bristol Springs, SG100001805 Kenai Peninsula Borough Beadle House No. 11, 4323 E. McDonald Dr., Oswego County Tuxedni Bay Pictograph Site, Address Phoenix, SG100001786 Restricted, Port Alsworth vicinity, Oswego and Syracuse Railroad Freight SG100001776 COLORADO House, 20–24 W. Utica St., Oswego, SG100001806 Authority: 60.13 of 36 CFR part 60. Mesa County Dated: September 28, 2017. TBM Avenger Aircraft N53503, 780 Heritage Queens County J. Paul Loether, Way, Grand Junction Regional Airport, Spear and Company Factory, 94–15 100th St., Grand Junction vicinity, SG100001791 Ozone Park, SG100001807 Chief, National Register of Historic Places/ National Historic Landmarks Program and Montezuma County Suffolk County Keeper, National Register of Historic Places. Haynie Site, (Great Pueblo Period of the Bethel Christian Avenue Historic District, [FR Doc. 2017–23330 Filed 10–25–17; 8:45 am] McElmo Drainage Unit MPS), 29619 Cty. Roughly Christian Ave., Hill & Locust Sts., BILLING CODE 4312–52–P Rd. L, Mancos vicinity, MP100001792 Setauket, SG100001808
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Farnum, William A., Boathouse, 52 Actor’s ACTION: Notice. Gibson County Colony Rd., Sag Harbor, SG100001809 Mt. Zion Negro School, 30 Mt. Zion Rd., Old Bethel Cemetery, Christian & Woodfield SUMMARY: The National Park Service is Bradford vicinity, SG100001823 Aves., Stony Brook, SG100001810 soliciting comments on the significance Squires, Ellis Jr., House, 186 & 190 Greene County Squiretown Rd., Hampton Bays, of properties nominated before October SG100001811 7, 2017, for listing or related actions in Blue Springs Lutheran Church and Cemetery, the National Register of Historic Places. 920 Main St., Mosheim, SG100001824 Ulster County DATES: Comments should be submitted Lawrence County Saugerties and New York Steamboat Company Warehouse, 2 Ferry St., by November 13, 2017. Farmers and Merchants Bank, 213 Depot St., Saugerties, SG100001812 ADDRESSES: Comments may be sent via Ethridge, SG100001825 WISCONSIN U.S. Postal Service and all other carriers Maury County to the National Register of Historic Hardison Mill Farm, 4554 US 431, Columbia, Kenosha County Places, National Park Service, 1849 C St. SG100001826 Kenosha Elks Club, 5706 8th Ave., Kenosha, NW., MS 7228, Washington, DC 20240. SG100001815 Pottsville General Store, 4205 US 431, SUPPLEMENTARY INFORMATION: The Columbia vicinity, SG100001827 An owner objection received for the properties listed in this notice are being Scott County following resource: considered for listing or related actions NORTH DAKOTA in the National Register of Historic Black Creek Fire Lookout Tower, (Tennessee Division of Forestry Fire Lookout Towers Wells County Places. Nominations for their consideration were received by the MPS), Black Creek Rd., Robbins, Manfred Historic District, All of the original National Park Service before October 7, MP100001828 town of Manfred & the LeGrand’s Addition, A request for removal has been made for Manfred, SG100001813 2017. Pursuant to section 60.13 of 36 CFR part 60, written comments are the following resources: A request for removal has been made being accepted concerning the COLORADO for the following resources: significance of the nominated properties Fremont County COLORADO under the National Register criteria for evaluation. Rio Grande Railroad Viaduct, (Highway Eagle County Before including your address, phone Bridges in Colorado MPS), CO 120 at Dotsero Bridge, (Highway Bridges in number, email address, or other milepost 0.17, Florence vicinity, Colorado MPS), I–70 Service Rd. at personal identifying information in your OT02001148 milepost 133.51, Dotsero, OT02001155 Portland Bridge, (Vehicular Bridges in Eagle River Bridge, (Highway Bridges in comment, you should be aware that Colorado TR), SR 120, Portland, Colorado MPS), US 6 at milepost 150.24, your entire comment—including your Eagle vicinity, OT02001156 personal identifying information—may OT85000210 be made publicly available at any time. Additional documentation has been TENNESSEE While you can ask us in your comment received for the following resources: to withhold your personal identifying Williamson County ARIZONA information from public review, we Wilson, Joseph, House, (Williamson County Pima County cannot guarantee that we will be able to MRA), Clovercroft Rd. 2/10 mi. W of do so. Wilson Pike, Franklin vicinity, Barrio El Hoyo Historic District, 460 S. Otero OT88000372 Ave., Tucson, AD08000763 Nominations submitted by State Historic Preservation Officers: Nomination submitted by Federal COLORADO Preservation Officer: The State Historic HAWAII Denver County Preservation Officer reviewed the following Montview Boulevard Presbyterian Church, Honolulu County nomination and responded to the Federal 1980 Dahlia St., Denver, AD04000262 Smith, Francis J., Apartment Building, 2240 Preservation Officer within 45 days of receipt Waikolu Way, Honolulu, SG100001818 of the nomination and supports listing the Authority: 60.13 of 36 CFR part 60. property in the National Register of Historic Dated: October 6, 2017. IOWA Places. J. Paul Loether, Woodbury County UTAH Chief, National Register of Historic Places/ Belfrage, W.L. and Winnie (Woodfield), National Historic Landmarks Program and Farmstead Historic District, 2410 Port Neal San Juan County Keeper, National Register of Historic Places. Rd., Sergeant Bluff, SG100001819 Moon House Complex, Address Restricted, [FR Doc. 2017–23331 Filed 10–25–17; 8:45 am] TENNESSEE Blanding vicinity, SG100001830 BILLING CODE 4312–52–P Carroll County Authority: 60.13 of 36 CFR part 60. Leach Fire Lookout Tower, (Tennessee Dated: October 12, 2017. DEPARTMENT OF THE INTERIOR Division of Forestry Fire Lookout Towers J. Paul Loether, MPS), RT 1 Leach Rd., Cedar Grove, Chief, National Register of Historic Places/ National Park Service MP100001821 National Historic Landmarks Program and [NPS–WASO–NRNHL–24452; Coffee County Keeper, National Register of Historic Places. PPWOCRADI0, PCU00RP14.R50000] Wilson—Crouch House, (Tullahoma MPS), [FR Doc. 2017–23332 Filed 10–25–17; 8:45 am] 216 S. Jackson St., Tullahoma, BILLING CODE 4312–52–P National Register of Historic Places; MP100001820 Notification of Pending Nominations and Related Actions Davidson County Tennessee War Memorial, 301 6th Ave. N., AGENCY: National Park Service, Interior. Nashville, SG100001822
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DEPARTMENT OF THE INTERIOR INTERNATIONAL TRADE general application, consult the COMMISSION Commission’s Rules of Practice and Bureau of Ocean Energy Management Procedure, part 201, subparts A and B [Investigation Nos. 701–TA–442 and 731– (19 CFR part 201), and part 207, TA–1095–1096 (Second Review)] Notice of Availability of the Proposed subparts A, D, E, and F (19 CFR part Notice of Sale for Gulf of Mexico Outer Lined Paper School Supplies From 207). Continental Shelf Oil and Gas Region- China and India; Scheduling of an Staff report.—A staff report Wide Lease Sale 250; MMAA 104000 Expedited Five-Year Review containing information concerning the subject matter of the review will be AGENCY: Bureau of Ocean Energy AGENCY: United States International placed in the nonpublic record on Management, Interior. Trade Commission. October 31, 2017, and made available to ACTION: Notice of Availability of the ACTION: Notice. persons on the Administrative Proposed Notice of Sale for Gulf of Protective Order service list for this SUMMARY: The Commission hereby gives Mexico Outer Continental Shelf Oil and review. A public version will be issued notice of the scheduling of an expedited Gas Region-wide Lease Sale 250. thereafter, pursuant to section review pursuant to the Tariff Act of 207.62(d)(4) of the Commission’s rules. 1930 (‘‘the Act’’) to determine whether Written submissions.—As provided in SUMMARY: The Bureau of Ocean Energy revocation of the antidumping duty and section 207.62(d) of the Commission’s Management (BOEM) announces the countervailing duty orders on lined rules, interested parties that are parties availability of the Proposed Notice of paper school supplies from China and to the review and that have provided Sale (NOS) for the proposed Gulf of India would be likely to lead to individually adequate responses to the Mexico (GOM) Outer Continental Shelf continuation or recurrence of material notice of institution,2 and any party (OCS) Oil and Gas Lease Sale 250 (GOM injury within a reasonably foreseeable other than an interested party to the Region-wide Sale 250). This Notice is time. review may file written comments with published pursuant to 30 CFR DATES: October 6, 2017. the Secretary on what determination the 556.304(c). With regard to oil and gas Commission should reach in the review. leasing on the OCS, the Secretary of the FOR FURTHER INFORMATION CONTACT: Calvin Chang (202–205–3062), Office of Comments are due on or before Interior, pursuant to section 19 of the November 3, 2017 and may not contain Outer Continental Shelf Lands Act, Investigations, U.S. International Trade Commission, 500 E Street SW., new factual information. Any person provides affected states the opportunity that is neither a party to the five-year Washington, DC 20436. to review the Proposed NOS. The review nor an interested party may Hearing-impaired persons can obtain Proposed NOS sets forth the proposed submit a brief written statement (which information on this matter by contacting terms and conditions of the sale, shall not contain any new factual the Commission’s TDD terminal on including minimum bids, royalty rates, information) pertinent to the review by 202-205-1810. Persons with mobility and rental rates. November 3, 2017. However, should the impairments who will need special Department of Commerce extend the DATES: Affected states may comment on assistance in gaining access to the time limit for its completion of the final the size, timing, and location of Commission should contact the Office results of its review, the deadline for proposed GOM Region-wide Sale 250 of the Secretary at 202-205-2000. comments (which may not contain new within 60 days following their receipt of General information concerning the the Proposed NOS. The Final NOS will factual information) on Commerce’s Commission may also be obtained by final results is three business days after be published in the Federal Register at accessing its internet server (https:// least 30 days prior to the date of bid the issuance of Commerce’s results. If www.usitc.gov). The public record for comments contain business proprietary opening. Bid opening is currently this review may be viewed on the scheduled for March 21, 2018. information (BPI), they must conform Commission’s electronic docket (EDIS) with the requirements of sections 201.6, SUPPLEMENTARY INFORMATION: The at https://edis.usitc.gov. 207.3, and 207.7 of the Commission’s Proposed NOS for GOM Region-wide SUPPLEMENTARY INFORMATION: rules. The Commission’s rules with Sale 250 and Proposed NOS Package Background.—On October 6, 2017, respect to filing were revised effective containing information essential to the Commission determined that the July 25, 2014. See 79 Fed. Reg. 35920 potential bidders may be obtained from domestic interested party group (June 25, 2014), and the revised the Public Information Unit, Gulf of response to its notice of institution (82 Commission Handbook on E-filing, Mexico Region, Bureau of Ocean Energy FR 30902, July 3, 2017) of the subject available from the Commission’s Web Management, 1201 Elmwood Park five-year review was adequate and that site at https://edis.usitc.gov. Boulevard, New Orleans, Louisiana the respondent interested party group In accordance with sections 201.16(c) 70123–2394; telephone: (504) 736–2519. response was inadequate. The and 207.3 of the rules, each document The Proposed NOS and Proposed NOS Commission did not find any other filed by a party to the review must be Package also are available on BOEM’s circumstances that would warrant served on all other parties to the review Web site at http://www.boem.gov/Sale- conducting a full review.1 Accordingly, (as identified by either the public or BPI 250/. the Commission determined that it service list), and a certificate of service would conduct an expedited review AGENCY CONTACT: Dr. Andrew Krueger, must be timely filed. The Secretary will pursuant to section 751(c)(3) of the Chief, Sales Coordination Branch, 703– not accept a document for filing without Tariff Act of 1930 (19 U.S.C. 1675(c)(3)). 787–1554, [email protected]. a certificate of service. For further information concerning Authority: This review is being Dated: October 23, 2017. the conduct of this review and rules of conducted under authority of title VII of Walter D. Cruickshank, Acting Director, Bureau of Ocean Energy 1 A record of the Commissioners’ votes, the 2 The Commission has found the response Management. Commission’s statement on adequacy, and any submitted by the Association of American School individual Commissioner’s statements will be Paper Suppliers (‘‘AASPS’’) to be individually [FR Doc. 2017–23310 Filed 10–25–17; 8:45 am] available from the Office of the Secretary and at the adequate. Comments from other interested parties BILLING CODE 4310–MR–P Commission’s Web site. will not be accepted (see 19 CFR 207.62(d)(2)).
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the Tariff Act of 1930; this notice is Washington, DC 20436. Hearing- issued in the review, provided that the published pursuant to section 207.62 of impaired persons can obtain application is made by 45 days after the Commission’s rules. information on this matter by contacting publication of this notice. Authorized By order of the Commission. the Commission’s TDD terminal on 202– applicants must represent interested parties, as defined by 19 U.S.C. 1677(9), Issued: October 23, 2017. 205–1810. Persons with mobility impairments who will need special who are parties to the review. A party Lisa R. Barton, assistance in gaining access to the granted access to BPI following Secretary to the Commission. Commission should contact the Office publication of the Commission’s notice WORK SCHEDULE of the Secretary at 202–205–2000. of institution of the review need not General information concerning the reapply for such access. A separate Investigation Nos. 701–TA–442 and Commission may also be obtained by service list will be maintained by the 731–TA–1095–1096 (Second Review) accessing its internet server (https:// Secretary for those parties authorized to LINED PAPER SCHOOL SUPPLIES www.usitc.gov). The public record for receive BPI under the APO. FROM CHINA AND INDIA this review may be viewed on the Staff report.—The prehearing staff report in the review will be placed in Staff Assigned Commission’s electronic docket (EDIS) at https://edis.usitc.gov. the nonpublic record on February 7, Investigator ...... Calvin Chang ((202) 2018, and a public version will be 205–3062). SUPPLEMENTARY INFORMATION: Commodity-Industry Vincent Honnold ((202) Background.—On August 4, 2017, the issued thereafter, pursuant to section 207.64 of the Commission’s rules. Analyst. 205–3314). Commission determined that responses Attorney ...... Heng Loke ((202) 708– Hearing.—The Commission will hold to its notice of institution of the subject 1528). a hearing in connection with the review Supervisory Investigator Fred Ruggles ((202) five-year review were such that a full 205–3187). beginning at 9:30 a.m. on Thursday, review should proceed (82 FR 41053, February 22, 2018, at the U.S. August 29, 2017); accordingly, a full Date International Trade Commission review is being scheduled pursuant to Building. Requests to appear at the Institution ...... Monday, July 03, 2017. section 751(c)(5) of the Tariff Act of Report to the Commis- October 31. hearing should be filed in writing with 1930 (19 U.S.C. 1675(c)(5)). A record of the Secretary to the Commission on or sion and to Parties. the Commissioners’ votes, the Comments of Parties November 3. before February 16, 2018. A nonparty due 1. Commission’s statement on adequacy, who has testimony that may aid the Legal issues memo- November 13. and any individual Commissioner’s Commission’s deliberations may request randum to the Com- statements are available from the Office mission. permission to present a short statement Briefing and vote (sug- November 20. of the Secretary and at the at the hearing. All parties and gested date). Commission’s Web site. nonparties desiring to appear at the Determination and views Thursday, November 30, Participation in the review and public hearing and make oral presentations to Commerce. 2017. service list.—Persons, including should participate in a prehearing 1 If comments contain business proprietary infor- industrial users of the subject conference to be held on February 21, mation, a nonbusiness proprietary version is due the merchandise and, if the merchandise is following business day. 2018, at the U.S. International Trade sold at the retail level, representative Commission Building, if deemed [FR Doc. 2017–23315 Filed 10–25–17; 8:45 am] consumer organizations, wishing to necessary. Oral testimony and written BILLING CODE 7020–02–P participate in this review as parties materials to be submitted at the public must file an entry of appearance with hearing are governed by sections the Secretary to the Commission, as 201.6(b)(2), 201.13(f), 207.24, and INTERNATIONAL TRADE provided in section 201.11 of the COMMISSION 207.66 of the Commission’s rules. Commission’s rules, by 45 days after Parties must submit any request to [Investigation No. 731–TA–891 (Third publication of this notice. A party that present a portion of their hearing Review)] filed a notice of appearance following testimony in camera no later than 7 publication of the Commission’s notice business days prior to the date of the Foundry Coke From China; Scheduling of institution of the review need not file hearing. of a Full Five-Year Review an additional notice of appearance. The Written submissions.—Each party to Secretary will maintain a public service AGENCY: United States International the review may submit a prehearing Trade Commission. list containing the names and addresses brief to the Commission. Prehearing of all persons, or their representatives, briefs must conform with the provisions ACTION: Notice. who are parties to the review. of section 207.65 of the Commission’s SUMMARY: The Commission hereby gives For further information concerning rules; the deadline for filing is February notice of the scheduling of a full review the conduct of this review and rules of 14, 2018. Parties may also file written pursuant to the Tariff Act of 1930 (‘‘the general application, consult the testimony in connection with their Act’’) to determine whether revocation Commission’s Rules of Practice and presentation at the hearing, as provided of the antidumping duty order Procedure, part 201, subparts A and B in section 207.24 of the Commission’s countervailing duty order on foundry (19 CFR part 201), and part 207, rules, and posthearing briefs, which coke from China would be likely to lead subparts A, D, E, and F (19 CFR part must conform with the provisions of to continuation or recurrence of material 207). section 207.67 of the Commission’s injury within a reasonably foreseeable Limited disclosure of business rules. The deadline for filing time. proprietary information (BPI) under an posthearing briefs is March 1, 2018. In administrative protective order (APO) addition, any person who has not DATES: October 20, 2017. and BPI service list.—Pursuant to entered an appearance as a party to the FOR FURTHER INFORMATION CONTACT: section 207.7(a) of the Commission’s review may submit a written statement Ayanna Butler (202–708–2208), Office rules, the Secretary will make BPI of information pertinent to the subject of of Investigations, U.S. International gathered in this review available to the review on or before March 1, 2018. Trade Commission, 500 E Street SW., authorized applicants under the APO On March 23, 2018, the Commission
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will make available to parties all Act’’) to determine whether revocation Procedure, part 201, subparts A and B information on which they have not had of the antidumping duty order on tin- (19 CFR part 201), and part 207, an opportunity to comment. Parties may and chromium-coated steel sheet from subparts A, D, E, and F (19 CFR part submit final comments on this Japan would be likely to lead to 207). information on or before March 27, continuation or recurrence of material Limited disclosure of business 2018, but such final comments must not injury within a reasonably foreseeable proprietary information (BPI) under an contain new factual information and time. administrative protective order (APO) must otherwise comply with section DATES: October 20, 2017. and BPI service list.—Pursuant to section 207.7(a) of the Commission’s 207.68 of the Commission’s rules. All FOR FURTHER INFORMATION CONTACT: rules, the Secretary will make BPI written submissions must conform with Robert Casanova (202–708–2719), Office gathered in this review available to the provisions of section 201.8 of the of Investigations, U.S. International authorized applicants under the APO Commission’s rules; any submissions Trade Commission, 500 E Street SW., issued in the review, provided that the that contain BPI must also conform with Washington, DC 20436. Hearing- application is made by 45 days after the requirements of sections 201.6, impaired persons can obtain publication of this notice. Authorized 207.3, and 207.7 of the Commission’s information on this matter by contacting applicants must represent interested rules. The Commission’s Handbook on the Commission’s TDD terminal on 202– E-Filing, available on the Commission’s parties, as defined by 19 U.S.C. 1677(9), 205–1810. Persons with mobility who are parties to the review. A party Web site at https://edis.usitc.gov, impairments who will need special elaborates upon the Commission’s rules granted access to BPI following assistance in gaining access to the publication of the Commission’s notice with respect to electronic filing. Commission should contact the Office Additional written submissions to the of institution of the review need not of the Secretary at 202–205–2000. reapply for such access. A separate Commission, including requests General information concerning the pursuant to section 201.12 of the service list will be maintained by the Commission may also be obtained by Secretary for those parties authorized to Commission’s rules, shall not be accessing its internet server (https:// accepted unless good cause is shown for receive BPI under the APO. www.usitc.gov). The public record for Staff report.—The prehearing staff accepting such submissions, or unless this review may be viewed on the the submission is pursuant to a specific report in the review will be placed in Commission’s electronic docket (EDIS) the nonpublic record on February 9, request by a Commissioner or at https://edis.usitc.gov. Commission staff. 2018, and a public version will be SUPPLEMENTARY INFORMATION: issued thereafter, pursuant to section In accordance with sections 201.16(c) Background.—On August 4, 2017, the and 207.3 of the Commission’s rules, 207.64 of the Commission’s rules. Commission determined that responses Hearing.—The Commission will hold each document filed by a party to the to its notice of institution of the subject a hearing in connection with the review review must be served on all other five-year review were such that a full beginning at 9:30 a.m. on March 1, 2018, parties to the review (as identified by review should proceed (82 FR 40168, at the U.S. International Trade either the public or BPI service list), and August 24, 2017); accordingly, a full Commission Building. Requests to a certificate of service must be timely review is being scheduled pursuant to appear at the hearing should be filed in filed. The Secretary will not accept a section 751(c)(5) of the Tariff Act of writing with the Secretary to the document for filing without a certificate 1930 (19 U.S.C. 1675(c)(5)). A record of Commission on or before February 21, of service. the Commissioners’ votes, the 2018. A nonparty who has testimony Authority: This review is being Commission’s statement on adequacy, that may aid the Commission’s conducted under authority of title VII of and any individual Commissioner’s deliberations may request permission to the Tariff Act of 1930; this notice is statements are available from the Office present a short statement at the hearing. published pursuant to section 207.62 of of the Secretary and at the All parties and nonparties desiring to the Commission’s rules. Commission’s Web site. appear at the hearing and make oral By order of the Commission. Participation in the review and public presentations should participate in a Issued: October 23, 2017. service list.—Persons, including prehearing conference to be held on Lisa R. Barton, industrial users of the subject February 28, 2018, at the U.S. Secretary to the Commission. merchandise and, if the merchandise is International Trade Commission [FR Doc. 2017–23313 Filed 10–25–17; 8:45 am] sold at the retail level, representative Building, if deemed necessary. Oral consumer organizations, wishing to testimony and written materials to be BILLING CODE 7020–02–P participate in this review as parties submitted at the public hearing are must file an entry of appearance with governed by sections 201.6(b)(2), INTERNATIONAL TRADE the Secretary to the Commission, as 201.13(f), 207.24, and 207.66 of the COMMISSION provided in section 201.11 of the Commission’s rules. Parties must submit Commission’s rules, by 45 days after any request to present a portion of their [Investigation No. 731–TA–860 (Third publication of this notice. A party that hearing testimony in camera no later Review)] filed a notice of appearance following than 7 business days prior to the date of Tin- and Chromium-Coated Steel Sheet publication of the Commission’s notice the hearing. Written submissions.—Each party to From Japan; Scheduling of a Full Five- of institution of the review need not file the review may submit a prehearing Year Review an additional notice of appearance. The Secretary will maintain a public service brief to the Commission. Prehearing AGENCY: United States International list containing the names and addresses briefs must conform with the provisions Trade Commission. of all persons, or their representatives, of section 207.65 of the Commission’s ACTION: Notice. who are parties to the review. rules; the deadline for filing is February For further information concerning 20, 2018. Parties may also file written SUMMARY: The Commission hereby gives the conduct of this review and rules of testimony in connection with their notice of the scheduling of a full review general application, consult the presentation at the hearing, as provided pursuant to the Tariff Act of 1930 (‘‘the Commission’s Rules of Practice and in section 207.24 of the Commission’s
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rules, and posthearing briefs, which INTERNATIONAL TRADE Fields Co., Ltd of Bellingham, WA; and must conform with the provisions of COMMISSION Ningbo Green-Health Pharma-ceutical section 207.67 of the Commission’s Co., Ltd. a/k/a NB Green-Health rules. The deadline for filing Notice of Receipt of Complaint; Pharma-ceutical Co., Ltd. of China. The posthearing briefs is March 9, 2018. In Solicitation of Comments Relating to complainant requests that the addition, any person who has not the Public Interest Commission issue a limited exclusion order, cease and desist orders, and entered an appearance as a party to the AGENCY: U.S. International Trade review may submit a written statement Commission. impose a bond upon respondents’ alleged infringing articles during the 60- of information pertinent to the subject of ACTION: Notice. the review on or before March 9, 2018. day Presidential review period pursuant SUMMARY: Notice is hereby given that to 19 U.S.C. 1337(j). On April 3, 2018, the Commission will Proposed respondents, other make available to parties all information the U.S. International Trade Commission has received a complaint interested parties, and members of the on which they have not had an public are invited to file comments, not opportunity to comment. Parties may entitled Certain Glucosylated Steviol Glycosides, and Products Containing to exceed five (5) pages in length, submit final comments on this Same, DN 3266; the Commission is inclusive of attachments, on any public information on or before April 5, 2018, soliciting comments on any public interest issues raised by the complaint but such final comments must not interest issues raised by the complaint or § 210.8(b) filing. Comments should contain new factual information and or complainant’s filing pursuant to the address whether issuance of the relief must otherwise comply with section Commission’s Rules of Practice and specifically requested by the 207.68 of the Commission’s rules. All Procedure. complainant in this investigation would written submissions must conform with affect the public health and welfare in FOR FURTHER INFORMATION CONTACT: Lisa the provisions of section 201.8 of the the United States, competitive R. Barton, Secretary to the Commission, conditions in the United States Commission’s rules; any submissions U.S. International Trade Commission, economy, the production of like or that contain BPI must also conform with 500 E Street SW., Washington, DC directly competitive articles in the the requirements of sections 201.6, 20436, telephone (202) 205–2000. The 207.3, and 207.7 of the Commission’s public version of the complaint can be United States, or United States rules. The Commission’s Handbook on accessed on the Commission’s consumers. In particular, the Commission is E-Filing, available on the Commission’s Electronic Document Information Web site at https://edis.usitc.gov, interested in comments that: System (EDIS) at https://edis.usitc.gov, (i) Explain how the articles elaborates upon the Commission’s rules and will be available for inspection potentially subject to the requested with respect to electronic filing. during official business hours (8:45 a.m. remedial orders are used in the United to 5:15 p.m.) in the Office of the Additional written submissions to the States; Commission, including requests Secretary, U.S. International Trade (ii) identify any public health, safety, pursuant to section 201.12 of the Commission, 500 E Street SW., or welfare concerns in the United States Washington, DC 20436, telephone (202) Commission’s rules, shall not be relating to the requested remedial 205–2000. accepted unless good cause is shown for orders; General information concerning the (iii) identify like or directly accepting such submissions, or unless Commission may also be obtained by the submission is pursuant to a specific competitive articles that complainant, accessing its Internet server at United its licensees, or third parties make in the request by a Commissioner or States International Trade Commission Commission staff. United States which could replace the (USITC) at https://www.usitc.gov. The subject articles if they were to be In accordance with sections 201.16(c) public record for this investigation may excluded; and 207.3 of the Commission’s rules, be viewed on the Commission’s (iv) indicate whether complainant, each document filed by a party to the Electronic Document Information complainant’s licensees, and/or third review must be served on all other System (EDIS) at https://edis.usitc.gov. party suppliers have the capacity to parties to the review (as identified by Hearing-impaired persons are advised replace the volume of articles either the public or BPI service list), and that information on this matter can be potentially subject to the requested a certificate of service must be timely obtained by contacting the exclusion order and/or a cease and filed. The Secretary will not accept a Commission’s TDD terminal on (202) desist order within a commercially document for filing without a certificate 205–1810. reasonable time; and of service. SUPPLEMENTARY INFORMATION: The (v) explain how the requested Commission has received a complaint remedial orders would impact United Authority: This review is being and a submission pursuant to § 210.8(b) States consumers. conducted under authority of title VII of of the Commission’s Rules of Practice Written submissions must be filed no the Tariff Act of 1930; this notice is and Procedure filed on behalf of later than by close of business, eight published pursuant to section 207.62 of PureCircle USA Inc. and PureCircle Sdn calendar days after the date of the Commission’s rules. Bhd on October 20, 2017. The complaint publication of this notice in the Federal By order of the Commission. alleges violations of section 337 of the Register. There will be further Issued: October 23, 2017. Tariff Act of 1930 (19 U.S.C. 1337) in opportunities for comment on the the importation into the United States, public interest after the issuance of any Lisa R. Barton, the sale for importation, and the sale final initial determination in this Secretary to the Commission. within the United States after investigation. [FR Doc. 2017–23314 Filed 10–25–17; 8:45 am] importation of certain glucosylated Persons filing written submissions BILLING CODE 7020–02–P steviol glycosides, and products must file the original document containing same. The complaint names electronically on or before the deadlines as respondents Sweet Green Fields USA stated above and submit 8 true paper LLC of Bellingham, WA; Sweet Green copies to the Office of the Secretary by
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noon the next day pursuant to § 210.4(f) Issued: October 20, 2017. Research, Inc., #100 Carr 198, Industrial of the Commission’s Rules of Practice Lisa R. Barton, Park, Juncos, Puerto Rico 00777–3873 and Procedure (19 CFR 210.4(f)). Secretary to the Commission. applied to be registered as an importer Submissions should refer to the docket [FR Doc. 2017–23233 Filed 10–25–17; 8:45 am] of hydromorphone (9150), a basic class number (‘‘Docket No. 3266’’) in a BILLING CODE 7020–02–P of controlled substance in schedule II. prominent place on the cover page and/ The company plans to import the or the first page. (See Handbook for listed controlled substance in finished Electronic Filing Procedures, Electronic DEPARTMENT OF JUSTICE dosage form for clinical trials, research Filing Procedures 1). Persons with and analytical purposes. questions regarding filing should Drug Enforcement Administration The import of this class of controlled contact the Secretary (202–205–2000). substance will be granted only for [Docket No. DEA–392] analytical testing, research, and clinical Any person desiring to submit a trials. This authorization does not document to the Commission in Importer of Controlled Substances extend to the import of a finished FDA confidence must request confidential Application: Galephar Pharmaceutical Research, Inc. approved or non-approved dosage form treatment. All such requests should be for commercial sale. directed to the Secretary to the ACTION: Notice of application. Commission and must include a full Dated: October 18, 2017. Demetra Ashley, statement of the reasons why the DATES: Registered bulk manufacturers of Acting Assistant Administrator. Commission should grant such the affected basic classes, and treatment. See 19 CFR 201.6. Documents applicants therefore, may file written [FR Doc. 2017–23328 Filed 10–25–17; 8:45 am] for which confidential treatment by the comments on or objections to the BILLING CODE 4410–09–P Commission is properly sought will be issuance of the proposed registration on treated accordingly. All such requests or before November 27, 2017. Such DEPARTMENT OF JUSTICE should be directed to the Secretary to persons may also file a written request the Commission and must include a full for a hearing on the application on or Drug Enforcement Administration statement of the reasons why the before November 27, 2017. Commission should grant such ADDRESSES: Written comments should [Docket No. 17–28] treatment. See 19 CFR 201.6. Documents be sent to: Drug Enforcement for which confidential treatment by the Yoon H. Choi, M.D.; Decision and Administration, Attention: DEA Federal Order Commission is properly sought will be Register Representative/DRW, 8701 treated accordingly. All information, Morrissette Drive, Springfield, Virginia On April 4, 2017, the Assistant including confidential business 22152. All requests for hearing must be Administrator, Division of Diversion information and documents for which sent to: Drug Enforcement Control, issued an Order to Show Cause confidential treatment is properly Administration, Attn: Administrator, to Yoon H. Choi, M.D. (Respondent), of sought, submitted to the Commission for 8701 Morrissette Drive, Springfield, Brockton, Massachusetts. The Show purposes of this Investigation may be Virginia 22152. All requests for hearing Cause Order proposed the revocation of disclosed to and used: (i) By the should also be sent to: (1) Drug Respondent’s DEA Certificate of Commission, its employees and Offices, Enforcement Administration, Attn: Registration as a practitioner, on the and contract personnel (a) for Hearing Clerk/LJ, 8701 Morrissette ground that he does not have authority developing or maintaining the records Drive, Springfield, Virginia 22152; and to dispense controlled substances in of this or a related proceeding, or (b) in (2) Drug Enforcement Administration, Massachusetts, the State in which he is internal investigations, audits, reviews, Attn: DEA Federal Register registered with the Agency. Show Cause and evaluations relating to the Representative/DRW, 8701 Morrissette Order, at 1. programs, personnel, and operations of Drive, Springfield, Virginia 22152. As to the Agency’s jurisdiction, the the Commission including under 5 SUPPLEMENTARY INFORMATION: The Show Cause Order alleged that U.S.C. Appendix 3; or (ii) by U.S. Attorney General has delegated his Respondent holds DEA Certificate of government employees and contract authority under the Controlled Registration No. BC6966381, which personnel,2 solely for cybersecurity Substances Act to the Administrator of authorizes him to dispense controlled purposes. All nonconfidential written the Drug Enforcement Administration substances in schedules II through V as submissions will be available for public (DEA), 28 CFR 0.100(b). Authority to a practitioner, at the registered address inspection at the Office of the Secretary exercise all necessary functions with of Steward Medical Group, One Pearl and on EDIS.3 respect to the promulgation and Street, Suite 2200, Brockton, This action is taken under the implementation of 21 CFR part 1301, Massachusetts. Id. The Show Cause Order alleged that this registration does authority of section 337 of the Tariff Act incident to the registration of not expire until August 31, 2018. Id. of 1930, as amended (19 U.S.C. 1337), manufacturers, distributors, dispensers, As to the substantive ground for the and of §§ 201.10 and 210.8(c) of the importers, and exporters of controlled proceeding, the Show Cause Order Commission’s Rules of Practice and substances (other than final orders in connection with suspension, denial, or alleged that ‘‘[o]n January 5, 2017, the Procedure (19 CFR 201.10, 210.8(c)). revocation of registration) has been Commonwealth of Massachusetts Board By order of the Commission. redelegated to the Assistant of Registration in Medicine indefinitely Administrator of the DEA Diversion suspended [his] medical license’’ and 1 Handbook for Electronic Filing Procedures: Control Division (‘‘Assistant that ‘‘[t]his order remains in effect.’’ Id. https://www.usitc.gov/documents/handbook_on_ The Order thus alleged that Respondent _ Administrator’’) pursuant to section 7 of filing procedures.pdf. 28 CFR part 0, appendix to subpart R. is ‘‘without authority to handle 2 All contract personnel will sign appropriate nondisclosure agreements. In accordance with 21 CFR controlled substances in . . . 3 Electronic Document Information System 1301.34(a), this is notice that on August Massachusetts, the [S]tate in which [he (EDIS): https://edis.usitc.gov. 2, 2017, Galephar Pharmaceutical is] registered,’’ that he is ‘‘required to
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possess authority from a [S]tate in order Web site which it obtained on May 12, conclusion that he currently lacks to obtain or retain a DEA registration,’’ 2017 and which shows that authority to dispense controlled and that the Agency ‘‘must revoke [his Respondent’s medical license was still substances in Massachusetts and thus, registration] based upon [his] lack of suspended, as well as a copy of he ‘‘cannot maintain’’ his DEA authority to handle controlled Respondent’s Corrective Action Plan registration. I also adopt the ALJ’s substances in . . . Massachusetts in and his Certificate of Registration. recommended Order that I revoke his violation of 21 U.S.C. 823(f) and Respondent did not file any pleading registration. I make the following factual 824(a)(3).’’ 1 Id. at 1–2. in response to the Government’s motion. findings. The Show Cause Order also notified Order Granting Summary Disposition, at Respondent of his right to request a 2. Accordingly, on June 5, 2017, the ALJ Findings hearing on the allegations or to submit granted the Government’s motion, Respondent is the holder of DEA a written statement while waiving his finding it undisputed that Respondent’s Certificate of Registration No. right to a hearing, the procedure for state ‘‘medical license is currently BC6966381, pursuant to which he is electing either option, and the suspended’’ and that he ‘‘lacks state authorized to dispense controlled consequence for failing to elect either authorization to handle controlled substances in schedules II through V as option. Id. at 2. The Show Cause Order substances in Massachusetts,’’ the State a practitioner, at the registered address also notified Respondent of his right to in which he is registered. Id. at 5. of Steward Medical Group Brockton, submit a Corrective Action Plan under Because ‘‘DEA precedent requires that One Pearl Street Suite 2200, Brockton, 21 U.S.C. 824(c)(2)(C). Id. at 2–3. the Respondent cannot maintain a DEA MA 02301. GX 1. This registration does On May 8, 2017, Respondent, through registration for any location in that not expire until August 31, 2018. his counsel, timely requested a hearing.2 [S]tate,’’ the ALJ recommended that I Respondent is also the holder of Resp.’s Hearing Request, at 1. The revoke his registration. Id. at 5–6. Medical License No. 206555 issued by matter was placed on the docket of the Neither party filed exceptions to the the Commonwealth of Massachusetts Office of Administrative Law Judges and ALJ’s Order. Thereafter, on July 11, Board of Registration in Medicine. GX 2, assigned to ALJ Charles Wm. Dorman, 2017, the ALJ forwarded the record to at Attachment B. However, on January who issued a scheduling order the my Office for Final Agency Action. 5, 2017, the Board issued a Final following day. Order Granting Summary Upon review of the record, the former Decision and Order which ‘‘indefinitely Disposition, at 2. Under the ALJ’s order, Acting Administrator noted that while suspended’’ his medical license. GX 2, the Government was required to file any Respondent had filed a Corrective at Attachment A. According to the motion for summary disposition by May Action Plan the record contained no Board’s Physician Profile Web page of 16, 2017 and Respondent was required evidence as to the Assistant which I take Official Notice, see 5 U.S.C. to file its opposition to the motion by Administrator’s decision as to the 556(e),4 the suspension remains in effect ‘‘2:00 p.m. EDT on May 26, 2017.’’ Id. adequacy of Respondent’s Corrective as of the date of this Decision and On May 16, 2017, the Government Action Plan. Accordingly, on September Order.5 filed its motion for summary 22, 2017, the former Acting Discussion disposition. Therein, the Government Administrator issued an Order directing maintained that it is undisputed that the Government to notify my Office of Pursuant to 21 U.S.C. 824(a)(3), the Respondent lacks authority to dispense the status of Respondent’s Corrective Attorney General is authorized to controlled substances in Massachusetts, Action Plan, and in the event the suspend or revoke a registration issued the State in which he is registered, and Assistant Administrator had issued a under section 823, ‘‘upon a finding that that therefore, he ‘‘no longer meets the decision on review of the Plan, to the Registrant . . . has had his State statutory definition of a practitioner.’’ provide a copy of that decision. The license . . . suspended [or] revoked Mot. for Summ. Disp., at 3–4. As former Acting Administrator provided . . . by competent State authority and is support for the motion, the Government Respondent with the right to reply to no longer authorized by State law to engage in the . . . dispensing of attached a copy of the Final Decision the Government’s submission no later controlled substances.’’ Moreover, DEA and Order of the Commonwealth of than five business days from the date of has held repeatedly that the possession Massachusetts Board of Registration in receipt of the Government’s submission. Medicine, which indefinitely suspended On September 25, 2017, the of authority to dispense controlled Respondent’s medical license, effective Government submitted a copy of the substances under the laws of the State January 5, 2017. The Government also former Assistant Administrator’s letter in which a practitioner engages in attached a printout from the Board’s of June 12, 2017 rejecting Respondent’s professional practice is a fundamental condition for obtaining and maintaining Corrective Action Plan.3 The former 1 a practitioner’s registration. See, e.g., The Government’s allegation erroneously Assistant Administrator also explained suggests that Respondent’s mere holding of a James L. Hooper, 76 FR 71371 (2011), that ‘‘there [was] no potential registration when his state authority had been pet. for rev. denied, 481 Fed Appx. 826 suspended constitutes a violation of these modification of [Respondent’s Plan] that provisions. These provisions are, however, grants of (4th Cir. 2012). could or would alter my decision.’’ This rule derives from the text of two authority to the Attorney General to grant an Letter from Assistant Administrator, application or revoke an existing registration. While provisions of the CSA. First, Congress these provisions (along with 21 U.S.C. 802(21)) Diversion Control Division, to defined ‘‘the term ‘practitioner’ [to] manifest that a practitioner must hold state Respondent’s Counsel (June 12, 2017). mean[] a . . . physician . . . or other authority to obtain or maintain a registration, a Respondent did not file a response to practitioner does not violate the CSA simply by continuing to hold a registration after a State the Government’s submission. 4 Respondent may refute this finding by filing a suspends or revokes his medical license. If, Having considered the record in its properly supported motion for reconsideration with however, a practitioner prescribed controlled entirety, I adopt the ALJ’s factual the Office of the Administrator within 10 business substances without holding state authority, he finding that Respondent’s days of the date of this Decision and Order. would violate a DEA regulation. See 21 CFR Massachusetts medical license has been 5 While the Board’s Order provides that 1306.03(a)(1). ‘‘Respondent may petition to stay [the] suspension 2 In his hearing request, Respondent also noted suspended, as well as his legal upon successful completion of a clinical skills that he had filed a Corrective Action Plan with the assessment by a board-approved entity and entry Assistant Administrator, Diversion Control 3 A copy of this letter does not appear to have into a Probation Agreement,’’ the suspension Division. Hearing Request, at 1 n.1. been previously provided to the ALJ. remains in effect as of the date of this Order.
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person licensed, registered or otherwise in the Commonwealth of Massachusetts As the first substantive ground for the permitted, by . . . the jurisdiction in be denied. proceeding, the Show Cause Order which he practices . . . to distribute, alleged that Respondent is ‘‘currently Order dispense, [or] administer . . . a without authority to handle controlled controlled substance in the course of Pursuant to the authority vested in me substances in Arizona.’’ GX 4, at 1. It professional practice.’’ 21 U.S.C. by 21 U.S.C. 824(a), as well as 28 CFR alleged that, on December 21, 2016, 802(21). Second, in setting the 0.100(b), I order that DEA Certificate of Respondent ‘‘entered into an Interim requirements for obtaining a Registration No. BC6966381 issued to Consent Agreement for Practice practitioner’s registration, Congress Yoon Choi, M.D., be, and it hereby is, Restriction with the Arizona Medical directed that ‘‘[t]he Attorney General revoked. Pursuant to the authority Board’’ which ‘‘prohibited [Respondent] shall register practitioners . . . if the vested in me by 21 U.S.C. 823(f), I from engaging in the practice of applicant is authorized to dispense . . . further order that any application of medicine in the State of Arizona . . . controlled substances under the laws of Yoon Choi, M.D., to renew or modify until he applies to the Executive the State in which he practices.’’ 21 this registration, or for any other Director and receives permission to do U.S.C. 823(f). Because Congress has registration in the Commonwealth of so.’’ GX 4, at 1 and GX 3, at 5 (Interim clearly mandated that a physician Massachusetts, be, and it hereby is, Consent Agreement For Practice Restriction), respectively. The Show possess state authority in order to be denied. This Order is effective Cause Order alleged that Respondent deemed a practitioner under the Act, November 27, 2017. was ‘‘still currently prohibited from DEA has held that revocation of a Dated: October 17, 2017. practicing medicine in the state in practitioner’s registration is the Robert W. Patterson, which . . . [he is] registered with the appropriate sanction whenever he is no Acting Administrator. DEA . . . [and] therefore, the DEA must longer authorized to dispense controlled [FR Doc. 2017–23329 Filed 10–25–17; 8:45 am] revoke . . . [his] DEA . . . [registration] substances under the laws of the State BILLING CODE 4410–09–P based upon . . . [his] lack of authority in which he practices medicine. See, to handle controlled substances in the e.g., Calvin Ramsey, 76 FR 20034, 20036 State of Arizona.’’ GX 4, at 2 (citing 21 (2011); Sheran Arden Yeates, M.D., 71 DEPARTMENT OF JUSTICE U.S.C. 802(21), 823(f), and 824(a)(3)). FR 39130, 39131 (2006); Dominick A. As the second substantive ground for Ricci, 58 FR 51104, 51105 (1993); Bobby Drug Enforcement Administration the proceeding, the Show Cause Order Watts, 53 FR 11919, 11920 (1988); see alleged that the Arizona Attorney also Hooper v. Holder, 481 Fed. Appx. Harinder Takyar, M.D.; Decision and General’s Office and the Pinal County at 828. Order (Arizona) Task Force ‘‘initiated an As a consequence of the Board’s Final On January 24, 2017, the Assistant investigation of . . . [Respondent’s] Decision and Order, Respondent is not Administrator, Diversion Control medical practice after receiving currently authorized to dispense Division, Drug Enforcement information from a cooperating source controlled substances in Massachusetts, Administration (hereinafter, DEA or that . . . [he] routinely prescribed large the State in which he is registered. Government), issued an Order to Show quantities of oxycodone, a Schedule II controlled substance, without Because the CSA makes clear that the Cause to Harinder Takyar, M.D. performing an examination.’’ GX 4, at 2. possession of authority to dispense (hereinafter, Respondent) of Mesa, After summarizing two law enforcement controlled substances under the laws of Arizona. GX 4. The Show Cause Order officers’ undercover visits to the State in which a practitioner engages proposed the revocation of Respondent’s medical practice, the Respondent’s Certificate of Registration in professional practice is a Show Cause Order alleged that, on the grounds that Respondent does fundamental condition for both concerning the first undercover officer, ‘‘not have authority to handle controlled obtaining and maintaining a Respondent prescribed schedule II and substances in the State of Arizona,’’ the practitioner’s registration, it is of no IV controlled substances ‘‘after State in which he is registered, and that consequence that the Board’s Order conducting only a cursory medical provided that he may petition to stay Respondent’s ‘‘registration would be examination[, or no physical the suspension upon meeting certain inconsistent with the public interest.’’ examination but falsely documenting a conditions. Cf. Hooper v. Holder, 481 F. GX 4, at 1 (citing 21 U.S.C. 823(f), full physical exam] . . . without App’x at 828 (upholding revocation of a 824(a)(3) and (4)). inquiring about whether the agent physician’s registration as based on a As to the Agency’s jurisdiction, the experienced sleeplessness, anxiety, or reasonable interpretation of the CSA, Show Cause Order alleged that panic[, and without] . . . properly notwithstanding that the physician’s Respondent holds DEA Certificate of execut[ing] . . . a prescription . . . as medical license was subject to a Registration No. BT9321150 which required by 21 CFR 1306.05(a) by not suspension of known duration); see also authorizes him to dispense controlled listing the full address of the patient on James L. Hooper, 76 FR 71371, 71371– substances in schedules II through V as the face of the prescription . . . [or] 72 (2011).6 As of this date, Respondent a practitioner at the registered address maintain[ing] an adequate patient is not currently authorized to dispense of 9341 East McKellips Road, Mesa, chart.’’ GX 4, at 2–3. controlled substances in Massachusetts, Arizona 85207. GX 4, at 1. See also GX Concerning the second undercover and therefore, he is not entitled to 1 (Controlled Substance Registration officer, the Show Cause Order alleged maintain his registration in that State. Certificate) (including ‘‘Reform that Respondent prescribed a schedule Accordingly, I will order that his Physicians’’) and GX 2, at 1 II controlled substance the first time registration be revoked and that any (Certification of Registration History) ‘‘despite the agent informing . . . pending application to renew his (9341 E McKellips Road, Mesa, AZ [Respondent] that he felt no pain during registration, or for any other registration 85207–8520). The Show Cause Order . . . [Respondent’s] brief examination of alleged that this registration expires on him . . . [, and a second time without] 6 By contrast, Respondent’s suspension is of November 30, 2019. GX 4, at 1. See also conduct[ing] a physical exam . . . and unknown duration. GX 2, at 1. falsely documenting a full physical
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exam.’’ GX 4, at 4. The Show Cause Proceedings, finding that ‘‘no request for allegations that Respondent deviated Order concluded that Respondent a hearing was filed.’’ GX 8 (Order from the standard of care for another ‘‘unlawfully prescribed controlled Terminating Proceedings). patient ‘‘by failing to substantiate and substances to undercover law I find that the Government’s service of justify a reason for prescribing opioids enforcement officers for other than a the Show Cause Order on Respondent to . . . [her], failing to monitor his legitimate medical purpose and outside was legally sufficient, that the opioid prescribing, failing to access the the usual course of professional Respondent did not timely request a CSPMP, and failing to utilize urine drug practice’’ in violation of Federal and hearing, and that Respondent has screens.’’ GX 3, at 3. Those allegations State law, and violated Arizona medical waived his right to a hearing and his included that Respondent ‘‘failed to practice standards when he ‘‘failed to right to submit a written statement. 21 identify aberrant behavior including maintain appropriate patient records CFR 1301.43(d). I therefore issue this frequent ER visits, and claims of lost or that supported the prescribing of Decision and Order based on the record stolen medications and requests for controlled substances and . . . failed to submitted by the Government. 21 CFR early refills.’’ Id. According to the conduct an appropriate physical 1301.43(e). allegations, Respondent’s patient examination, or establish a . . . doctor- ‘‘experienced actual harm in that patient relationship before prescribing a Findings of Fact Respondent either created an addictive controlled substance.’’ GX 4, at 2 (citing Respondent’s DEA Registration state or contributed to a pre-existing 21 CFR 1306.04(a), Ariz. Rev. Stat. § 32– addictive state.’’ Id. Respondent currently holds DEA 1401.27(e), (j), (q), and (SS), and Ariz. The Interim Consent Agreement for practitioner registration BT9321150 Rev. Stat. § 32–901(15)). Practice Restriction contained The Show Cause Order notified authorizing him to dispense controlled allegations concerning a third patient of Respondent of his right to request a substances in schedules II through V at Respondent’s. Those allegations hearing on the allegations or to submit the address of Reform Physicians, 9341 included that ‘‘Respondent deviated a written statement while waiving his E McKellips Road, Mesa, AZ 85207– from the standard of care for . . . [the right to a hearing, the procedures for 8520. GX 1. This registration expires on patient] by failing to identify a source of electing each option, and the November 30, 2019. Id. pain for . . . [him], and failing to consequences for failing to elect either The Investigations of Respondent and demonstrate that the prescribing of option. GX 4, at 5 (citing 21 CFR the Status of Respondent’s State opioids met the goals of reduction of 1301.43). The Show Cause Order also Licenses pain and improvement of function.’’ Id. notified Respondent of the opportunity Additional allegations concerning the to submit a Corrective Action Plan. GX On December 21, 2016, Respondent third patient were that ‘‘Respondent 4, at 5 (citing 21 U.S.C. 824(c)(2)(C)). and the Executive Director of the failed to monitor his opioid prescribing, By letter dated February 22, 2017, Arizona Medical Board (hereinafter, failed to access the CSPMP and failed to Respondent, by his counsel, asked the ‘‘Board’’) signed an ‘‘Interim Consent utilize urine drug screens until April of Administrative Law Judge for ‘‘an Agreement for Practice Restriction.’’ GX 2016.’’ Id. According to the allegations, extension of 30 days within which to 3. Pursuant to the Interim Consent Respondent’s patient ‘‘experienced file a written request for hearing Agreement for Practice Restriction, actual harm in that Respondent ignored concerning the Order to Show Cause.’’ Respondent elected to relinquish all abnormal urine drug screens and GX 5. The letter alleged that ‘‘good rights to a hearing and to appeal, and aberrant behavior,’’ and faced the cause’’ supported the request because agreed not to dispute, but did not ‘‘potential for harm’’ due to Respondent’s counsel ‘‘has only concede, its allegations. GX 3, at 6, 4, ‘‘inappropriate medication prescribing, recently been retained,’’ the ‘‘discovery respectively. It contained the allegations including side effects such as sedation, concerning the listed allegations is that Respondent ‘‘deviated from the gastrointestinal dysfunction, cognitive voluminous,’’ and counsel ‘‘needed standard of care’’ for one patient by impairment, respiratory depression, [time] to gather necessary information ‘‘failing to substantiate and justify a insomnia and addiction.’’ GX 3, at 3–4. concerning the allegations . . . and reason for prescribing opioids to . . . The Interim Consent Agreement for more effectively complete the request her[,] to acknowledge and deal with Practice Restriction explicitly stated that for hearing letter.’’ Id. By Order dated aberrant behavior manifested by Respondent agreed not to dispute its March 1, 2017, the Chief Administrative frequent Emergency Room . . . visits allegations ‘‘[f]or the purposes of Law Judge, John J. Mulrooney, II, usually for overdoses and entering this Interim Consent granted an ‘‘enlargement of the time documentation [sic] cocaine use[,] . . . Agreement and for these purposes allotted to request a hearing . . . to the to utilize urine drug screens[,] . . . to only.’’ GX 3, at 4. It also stated that extent (but only to the extent) that, if the access [the patient’s] Controlled Respondent did ‘‘not concede these Respondent elects to request a hearing, Substance Prescription Monitoring allegations and this Interim Consent he must do so no later than March 17, Program (‘‘CSPMP’’) profile to monitor Agreement is not intended for use in 2017.’’ GX 6, at 2 (Order Granting in [the patient’s] prescription medication any subsequent proceeding, either civil Part the Respondent’s Request for an use[, and] . . . by performing trigger or criminal, as evidence of any kind.’’ Extension of the Time to File a Request point injections without identifying Id. for Hearing). physical trigger points on examination, The Interim Consent Agreement for By Motion dated March 27, 2017, the usually with a concomitant IM injection Practice Restriction’s Interim Order Government requested that further of Toradol.’’ GX 3, at 2. The Interim prohibited Respondent from engaging in proceedings be terminated because ‘‘[a]s Consent Agreement for Practice the practice of medicine in the State of of the date of this filing, Respondent has Restriction contained the allegation that Arizona ‘‘until he applies to the not notified this tribunal or Government this patient ‘‘experienced actual harm as Executive Director and receives counsel of any request for hearing.’’ GX Respondent caused or contributed to her permission to do so.’’ GX 3, at 5 (citing 7, at 2 (Government’s Motion for abuse and apparent addiction of A.R.S. § 32–1401(22)). The Interim Termination of Proceedings). By Order controlled substances.’’ Id. Order stated that Respondent may dated April 3, 2017, the Presiding Judge The Interim Consent Agreement for request release and/or modification of issued an Order Terminating Practice Restriction also contained the Interim Consent Agreement for
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Practice Restriction in writing substances.’’ With respect to a See also A.R.S. § 32–1401(21) (2017) (A accompanied by ‘‘information practitioner, the DEA has also long held ‘‘physician’’ is a ‘‘doctor of medicine demonstrating that he is safe to practice that the possession of authority to who is licensed pursuant to this medicine, including having successfully dispense controlled substances under chapter.’’) The ‘‘practice of medicine’’ completed a competency evaluation at a the laws of the State in which a means ‘‘the diagnosis, the treatment or facility approved by the Board or its practitioner engages in professional the correction of or the attempt or the staff.’’ GX 3, at 5. Among other things, practice is a fundamental condition for claim to be able to diagnose, treat or the Interim Order also stated that it is obtaining and maintaining a correct any and all human diseases . . . not a ‘‘final decision by the Board,’’ is practitioner’s registration. See, e.g., by any means, method, devices or ‘‘subject to further consideration,’’ and James L. Hooper, M.D., 76 FR 71,371 instrumentalities . . . .’’ A.R.S. § 32– ‘‘[o]nce the investigation is complete, it (2011), pet. for rev. denied, 481 Fed. 1401(22) (2017). ‘‘Medicine’’ means will be promptly provided to the Board Appx. 826 (4th Cir. 2012); Bourne ‘‘allopathic medicine as practiced by the for its review and appropriate action.’’ Pharmacy, Inc., 72 FR 18,273, 18,274 recipient of a degree of doctor of Id. The Interim Consent Agreement for (2007) (‘‘Under the Controlled medicine.’’ A.R.S. § 32–1401(19) (2017). Practice Restriction was ‘‘effective on Substances Act . . . , it is irrelevant that ‘‘Restrict’’ means ‘‘taking a disciplinary the date signed by the Board’s Executive Respondent’s state registration is being action that alters the physician’s Director,’’ December 21, 2016. GX 3, at held in escrow pending state practice or professional activities if the 5, 8–9. Respondent entered into the proceedings. Under the Act, a board determines that there is evidence Interim Consent Agreement for Practice practitioner must be currently that the physician is or may be Restriction voluntarily. GX 3, at 6. He authorized to handle controlled medically incompetent or guilty of understood that ‘‘any violation of this substances in ‘the jurisdiction in which unprofessional conduct.’’ A.R.S. § 32– Interim Consent Agreement constitutes [it] practices’ in order to maintain its 1401(23) (2017). Further, a physician unprofessional conduct under A.R.S. DEA registration.’’); Anne Lazar Thorn, who ‘‘wishes to dispense a controlled § 32–1401(27)(r).’’ GX 3, at 8. M.D., 62 FR 12,847, 12, 848 (1997) (The substance . . . shall be currently On May 9, 2017, the DEA Diversion ‘‘controlling question’’ is ‘‘whether the licensed to practice medicine in Investigator assigned to the Respondent is currently authorized to Arizona.’’ Arizona Medical Board investigation of Respondent’s medical handle controlled substances in the Licensure, R4–16–301 (2017). practice (hereinafter, DI) signed a state.’’); Frederick Marsh Blanton, M.D., ‘‘Dispense,’’ under Arizona law, means Declaration. GX 9. According to that 43 FR 27,616 (1978). ‘‘the delivery by a doctor of medicine of Declaration, the DI ‘‘confirmed’’ with This rule derives from the text of two a prescription drug or device to a the Senior Investigator for the Board provisions of the CSA. First, Congress patient . . . and includes the that ‘‘the current prohibition on . . . defined the term ‘‘practitioner’’ [to] prescribing, administering, packaging, [Respondent’s] practice of medicine also mean[ ] a . . . physician . . . or other labeling and security necessary to includes a prohibition on his person licensed, registered, or otherwise prepare and safeguard the drug or authorization to handle controlled permitted, by . . . the jurisdiction in device for delivery.’’ A.R.S. § 32– substances.’’ GX 9, at 2. Further, as of which he practices . . . , to distribute, 1401(9) (2017). April 24, 2017, the Declaration stated dispense, [or] administer . . . a In this case, the Arizona Medical that the Board’s Senior Investigator controlled substance in the course of Board and Respondent entered into an informed the DI that Respondent professional practice . . . .’’ 21 U.S.C. ‘‘Interim Consent Agreement for ‘‘remains prohibited from practicing 801(21). Second, in setting the Practice Restriction’’ which prohibits medicine in Arizona, pending requirements for obtaining a Respondent from engaging in the revocation proceedings currently before practitioner’s registration, Congress practice of medicine in the State of the Board.’’ Id. directed that ‘‘[t]he Attorney General Arizona ‘‘until he applies to the As found above, Respondent waived shall register practitioners . . . if the Executive Director and receives his right to a hearing and to submit a applicant is authorized to dispense . . . permission to do so.’’ GX 3, at 5 (citing written statement while waiving his controlled substances under the laws of A.R.S. § 32–1401(22)). Further, the right to a hearing concerning the Show the State in which he practices.’’ 21 unrefuted DI Declaration stated that Cause Order. Accordingly, there is no U.S.C. 823(f). Because Congress has ‘‘the current prohibition on . . . evidence to refute the allegations of the clearly mandated that a practitioner [Respondent’s] practice of medicine also Show Cause Order. I, therefore, find that possess State authority in order to be includes a prohibition on his Respondent currently is prohibited from deemed a practitioner under the CSA, authorization to handle controlled engaging in the practice of medicine, the DEA has held repeatedly that substances.’’ GX 9, at 2. Consequently, and currently is without authority to revocation of a practitioner’s registration Respondent is not currently authorized dispense controlled substances, in is the appropriate sanction whenever he to handle controlled substances in the Arizona, the State in which he is is no longer authorized to dispense State of Arizona, the State in which he registered. controlled substances under the laws of is registered and, therefore, he is not the State in which he practices. See, entitled to maintain his DEA Discussion e.g., Hooper, supra, 76 FR at 71,371–72; registration. Thorn, supra; Blanton, Pursuant to 21 U.S.C. 824(a)(3), the Sheran Arden Yeates, M.D., 71 FR supra. Accordingly, I will order that his Attorney General is authorized to 39,130, 39,131 (2006); Dominick A. registration be revoked and that any suspend or revoke a registration issued Ricci, M.D., 58 FR 51,104, 51,105 (1993); pending application for the renewal or under section 823 of the Controlled Bobby Watts, 53 FR 11,919, 11,920 modification of his registration be Substances Act (hereinafter, CSA), (1988); Thorn, supra, 62 FR at 12,848; denied. 21 U.S.C. 824(a)(3). ‘‘upon a finding that the registrant . . . Blanton, supra, 43 FR at 27,616. has had his State License or registration Under Arizona law, a ‘‘doctor of Order suspended [or] revoked by competent medicine’’ is a ‘‘natural person holding Pursuant to the authority vested in me State authority and is no longer a license, registration or permit to by 21 U.S.C. 824(a), as well as 28 CFR authorized by State law to engage in the practice medicine pursuant to this 0.100(b), I order that DEA Certificate of . . . dispensing of controlled chapter.’’ A.R.S. § 32–1401(10) (2017). Registration BT9321150 issued to
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Harinder Takyar, M.D., be, and it hereby appropriate. Exec. Order No. 13798 § 4, 2. The free exercise of religion includes is, revoked. I further order that any 82 Fed. Reg. 21675 (May 4, 2017). the right to act or abstain from action pending application of Harinder Takyar, Consistent with that instruction, I am in accordance with one’s religious M.D., to renew or modify this issuing this memorandum and appendix beliefs. registration, as well as any other to guide all administrative agencies and The Free Exercise Clause protects not pending application by him for executive departments in the execution just the right to believe or the right to registration in the State of Arizona, be, of federal law. worship; it protects the right to perform and it hereby is, denied. This order is Principles of Religious Liberty or abstain from performing certain effective November 27, 2017. physical acts in accordance with one’s Dated: October 18, 2017. Religious liberty is a foundational beliefs. Federal statutes, including the Robert W. Patterson, principle of enduring importance in Religious Freedom Restoration Act of Acting Administrator. America, enshrined in our Constitution 1993 (‘‘RFRA’’), support that protection, [FR Doc. 2017–23338 Filed 10–25–17; 8:45 am] and other sources of federal law. As broadly defining the exercise of religion to encompass all aspects of observance BILLING CODE 4410–09–P James Madison explained in his Memorial and Remonstrance Against and practice, whether or not central to, Religious Assessments, the free exercise or required by, a particular religious DEPARTMENT OF JUSTICE of religion ‘‘is in its nature an faith. unalienable right’’ because the duty [OLP Docket No. 165] 3. The freedom of religion extends to owed to one’s Creator ‘‘is precedent, persons and organizations. Federal Law Protections for Religious both in order of time and in degree of obligation, to the claims of Civil The Free Exercise Clause protects not Liberty just persons, but persons collectively Society.’’ 1 Religious liberty is not exercising their religion through AGENCY: Department of Justice. merely a right to personal religious churches or other religious beliefs or even to worship in a sacred ACTION: Notice. denominations, religious organizations, place. It also encompasses religious schools, private associations, and even SUMMARY: This notice provides the text observance and practice. Except in the businesses. of the Attorney General’s Memorandum narrowest circumstances, no one should of October 6, 2017, for all executive be forced to choose between living out 4. Americans do not give up their departments and agencies entitled his or her faith and complying with the freedom of religion by participating in ‘‘Federal Law Protections for Religious law. Therefore, to the greatest extent the marketplace, partaking of the Liberty’’ and the appendix to this practicable and permitted by law, public square, or interacting with Memorandum. religious observance and practice government. DATES: This notice is applicable on should be reasonably accommodated in Constitutional protections for October 6, 2017. all government activity, including religious liberty are not conditioned employment, contracting, and FOR FURTHER INFORMATION CONTACT: upon the willingness of a religious programming. The following twenty Jennifer Dickey, Counsel, Office of Legal person or organization to remain principles should guide administrative Policy, U.S. Department of Justice, 950 separate from civil society. Although the agencies and executive departments in Pennsylvania Avenue NW., Washington, application of the relevant protections carrying out this task. These principles D.C. 20530, phone (202) 514–4601. may differ in different contexts, should be understood and interpreted in individuals and organizations do not SUPPLEMENTARY INFORMATION: The light of the legal analysis set forth in the give up their religious-liberty President instructed the Attorney appendix to this memorandum. protections by providing or receiving General to issue guidance interpreting 1. The freedom of religion is a social services, education, or healthcare; religious liberty protections in federal by seeking to earn or earning a living; law, as appropriate. Exec. Order 13798, fundamental right of paramount importance, expressly protected by by employing others to do the same; by § 4 (May 4, 2017). Pursuant to that receiving government grants or federal law. instruction and consistent with the contracts; or by otherwise interacting authority to provide advice and with federal, state, or local governments. opinions on questions of existing law to Religious liberty is enshrined in the the Executive Branch, the Attorney text of our Constitution and in 5. Government may not restrict acts or General issued the following numerous federal statutes. It abstentions because of the beliefs they memorandum to the heads of all encompasses the right of all Americans display. to exercise their religion freely, without executive departments and agencies on To avoid the very sort of religious October 6, 2017. being coerced to join an established church or to satisfy a religious test as a persecution and intolerance that led to Dated: October 20, 2017. qualification for public office. It also the founding of the United States, the Beth Ann Williams, encompasses the right of all Americans Free Exercise Clause of the Constitution protects against government actions that Assistant Attorney General, Office of Legal to express their religious beliefs, subject target religious conduct. Except in rare Policy. to the same narrow limits that apply to circumstances, government may not all forms of speech. In the United States, MEMORANDUM FOR ALL EXECUTIVE treat the same conduct as lawful when the free exercise of religion is not a mere DEPARTMENTS AND AGENCIES undertaken for secular reasons but policy preference to be traded against unlawful when undertaken for religious FROM: THE ATTORNEY GENERAL other policy preferences. It is a reasons. For example, government may fundamental right. SUBJECT: Federal Law Protections for not attempt to target religious persons or Religious Liberty conduct by allowing the distribution of 1 James Madison, Memorial and Remonstrance The President has instructed me to Against Religious Assessments (June 20, 1785), in political leaflets in a park but forbidding issue guidance interpreting religious 5 The Founders’ Constitution 82 (Philip B. Kurland the distribution of religious leaflets in liberty protections in federal law, as & Ralph Lerner eds., 1987). the same park.
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6. Government may not target religious cannot selectively impose regulatory of their religious beliefs, and individuals or entities for special burdens on some denominations but not government is not competent to assess disabilities based on their religion. others. It likewise cannot favor some the reasonableness of such lines drawn, Much as government may not restrict religious groups for participation in the nor would it be appropriate for government to do so. Thus, for example, actions only because of religious belief, Combined Federal Campaign over a government agency may not second- government may not target persons or others based on the groups’ religious guess the determination of a factory individuals because of their religion. beliefs. worker that, consistent with his Government may not exclude religious 9. Government may not interfere with religious precepts, he can work on a line organizations as such from secular aid the autonomy of a religious producing steel that might someday programs, at least when the aid is not organization. make its way into armaments but cannot being used for explicitly religious Together, the Free Exercise Clause work on a line producing the armaments activities such as worship or and the Establishment Clause also themselves. Nor may the Department of proselytization. For example, the restrict governmental interference in Health and Human Services second- Supreme Court has held that if intra-denominational disputes about guess the determination of a religious government provides reimbursement for doctrine, discipline, or qualifications for employer that providing contraceptive scrap tires to replace child playground ministry or membership. For example, coverage to its employees would make surfaces, it may not deny participation government may not impose its the employer complicit in wrongdoing in that program to religious schools. Nor nondiscrimination rules to require in violation of the organization’s may government deny religious Catholic seminaries or Orthodox Jewish religious precepts. schools—including schools whose yeshivas to accept female priests or 13. A governmental action substantially curricula and activities include religious rabbis. elements—the right to participate in a burdens an exercise of religion under voucher program, so long as the aid 10. The Religious Freedom Restoration RFRA if it bans an aspect of an reaches the schools through Act of 1993 prohibits the federal adherent’s religious observance or independent decisions of parents. government from substantially practice, compels an act inconsistent burdening any aspect of religious with that observance or practice, or 7. Government may not target religious observance or practice, unless substantially pressures the adherent to individuals or entities through imposition of that burden on a modify such observance or practice. discriminatory enforcement of neutral, particular religious adherent satisfies generally applicable laws. Because the government cannot strict scrutiny. second-guess the reasonableness of a Although government generally may RFRA prohibits the federal religious belief or the adherent’s subject religious persons and government from substantially assessment of the religious connection organizations to neutral, generally burdening a person’s exercise of between the government mandate and applicable laws—e.g., across-the-board religion, unless the federal government the underlying religious belief, the criminal prohibitions or certain time, demonstrates that application of such substantial burden test focuses on the place, and manner restrictions on burden to the religious adherent is the extent of governmental compulsion speech—government may not apply least restrictive means of achieving a involved. In general, a government such laws in a discriminatory way. For compelling governmental interest. action that bans an aspect of an instance, the Internal Revenue Service RFRA applies to all actions by federal adherent’s religious observance or may not enforce the Johnson administrative agencies, including practice, compels an act inconsistent Amendment—which prohibits 501(c)(3) rulemaking, adjudication or other with that observance or practice, or non-profit organizations from enforcement actions, and grant or substantially pressures the adherent to intervening in a political campaign on contract distribution and modify such observance or practice, will behalf of a candidate—against a administration. qualify as a substantial burden on the religious non-profit organization under exercise of religion. For example, a circumstances in which it would not 11. RFRA’s protection extends not just Bureau of Prisons regulation that bans a enforce the amendment against a secular to individuals, but also to devout Muslim from growing even a non-profit organization. Likewise, the organizations, associations, and at least half-inch beard in accordance with his National Park Service may not require some for-profit corporations. religious beliefs substantially burdens religious groups to obtain permits to RFRA protects the exercise of religion his religious practice. Likewise, a hand out fliers in a park if it does not by individuals and by corporations, Department of Health and Human require similarly situated secular groups companies, associations, firms, Services regulation requiring employers to do so, and no federal agency tasked partnerships, societies, and joint stock to provide insurance coverage for with issuing permits for land use may companies. For example, the Supreme contraceptive drugs in violation of their deny a permit to an Islamic Center Court has held that Hobby Lobby, a religious beliefs or face significant fines seeking to build a mosque when the closely held, for-profit corporation with substantially burdens their religious agency has granted, or would grant, a more than 500 stores and 13,000 practice, and a law that conditions permit to similarly situated secular employees, is protected by RFRA. receipt of significant government organizations or religious groups. benefits on willingness to work on 12. RFRA does not permit the federal Saturday substantially burdens the 8. Government may not officially favor government to second-guess the religious practice of those who, as a or disfavor particular religious groups. reasonableness of a religious belief. matter of religious observance or Together, the Free Exercise Clause RFRA applies to all sincerely held practice, do not work on that day. But and the Establishment Clause prohibit religious beliefs, whether or not central a law that infringes, even severely, an government from officially preferring to, or mandated by, a particular aspect of an adherent’s religious one religious group to another. This religious organization or tradition. observance or practice that the adherent principle of denominational neutrality Religious adherents will often be himself regards as unimportant or means, for example, that government required to draw lines in the application inconsequential imposes no substantial
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burden on that adherent. And a law that that would deprive or tend to deprive The Clinton Guidelines have the force of regulates only the government’s internal any individual of employment an Executive Order, and they also affairs and does not involve any opportunities because of the provide useful guidance to private governmental compulsion on the individual’s religion. This protection employers about ways in which religious adherent likewise imposes no applies regardless of whether the religious observance and practice can substantial burden. individual is a member of a religious reasonably be accommodated in the majority or minority. But the protection 14. The strict scrutiny standard workplace. does not apply in the same way to applicable to RFRA is exceptionally religious employers, who have certain 19. Religious employers are entitled to demanding. constitutional and statutory protections employ only persons whose beliefs and Once a religious adherent has for religious hiring decisions. conduct are consistent with the identified a substantial burden on his or employers’ religious precepts. her religious belief, the federal 17. Title VII’s protection extends to Constitutional and statutory government can impose that burden on discrimination on the basis of religious protections apply to certain religious the adherent only if it is the least observance or practice as well as belief, hiring decisions. Religious corporations, restrictive means of achieving a unless the employer cannot reasonably associations, educational institutions, accommodate such observance or compelling governmental interest. Only and societies—that is, entities that are practice without undue hardship on the those interests of the highest order can organized for religious purposes and business. outweigh legitimate claims to the free engage in activity consistent with, and exercise of religion, and such interests Title VII defines ‘‘religion’’ broadly to in furtherance of, such purposes—have must be evaluated not in broad include all aspects of religious an express statutory exemption from generalities but as applied to the observance or practice, except when an Title VII’s prohibition on religious particular adherent. Even if the federal employer can establish that a particular discrimination in employment. Under government could show the necessary aspect of such observance or practice that exemption, religious organizations interest, it would also have to show that cannot reasonably be accommodated may choose to employ only persons its chosen restriction on free exercise is without undue hardship to the business. whose beliefs and conduct are the least restrictive means of achieving For example, covered employers are consistent with the organizations’ that interest. That analysis requires the required to adjust employee work religious precepts. For example, a government to show that it cannot schedules for Sabbath observance, Lutheran secondary school may choose accommodate the religious adherent religious holidays, and other religious to employ only practicing Lutherans, while achieving its interest through a observances, unless doing so would only practicing Christians, or only those viable alternative, which may include, create an undue hardship, such as willing to adhere to a code of conduct in certain circumstances, expenditure of materially compromising operations or consistent with the precepts of the additional funds, modification of violating a collective bargaining Lutheran community sponsoring the existing exemptions, or creation of a agreement. Title VII might also require school. Indeed, even in the absence of new program. an employer to modify a no-head- the Title VII exemption, religious coverings policy to allow a Jewish employers might be able to claim a 15. RFRA applies even where a employee to wear a yarmulke or a religious adherent seeks an exemption similar right under RFRA or the Muslim employee to wear a headscarf. Religion Clauses of the Constitution. from a legal obligation requiring the An employer who contends that it adherent to confer benefits on third cannot reasonably accommodate a 20. As a general matter, the federal parties. religious observance or practice must government may not condition receipt Although burdens imposed on third establish undue hardship on its of a federal grant or contract on the parties are relevant to RFRA analysis, business with specificity; it cannot rely effective relinquishment of a religious the fact that an exemption would on assumptions about hardships that organization’s hiring exemptions or deprive a third party of a benefit does might result from an accommodation. attributes of its religious character. not categorically render an exemption 18. The Clinton Guidelines on Religious Religious organizations are entitled to unavailable. Once an adherent identifies Exercise and Religious Expression in compete on equal footing for federal a substantial burden on his or her the Federal Workplace provide useful financial assistance used to support religious exercise, RFRA requires the examples for private employers of government programs. Such federal government to establish that reasonable accommodations for organizations generally may not be denial of an accommodation or religious observance and practice in the required to alter their religious character exemption to that adherent is the least workplace. to participate in a government program, restrictive means of achieving a nor to cease engaging in explicitly compelling governmental interest. President Clinton issued Guidelines religious activities outside the program, on Religious Exercise and Religious nor effectively to relinquish their federal 16. Title VII of the Civil Rights Act of Expression in the Federal Workplace 1964, as amended, prohibits covered statutory protections for religious hiring (‘‘Clinton Guidelines’’) explaining that decisions. employers from discriminating against federal employees may keep religious individuals on the basis of their materials on their private desks and Guidance for Implementing Religious religion. read them during breaks; discuss their Liberty Principles Employers covered by Title VII may religious views with other employees, Agencies must pay keen attention, in not fail or refuse to hire, discharge, or subject to the same limitations as other everything they do, to the foregoing discriminate against any individual forms of employee expression; display principles of religious liberty. with respect to compensation, terms, religious messages on clothing or wear conditions, or privileges of employment religious medallions; and invite others Agencies as Employers because of that individual’s religion. to attend worship services at their Administrative agencies should Such employers also may not classify churches, except to the extent that such review their current policies and their employees or applicants in a way speech becomes excessive or harassing. practices to ensure that they comply
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with all applicable federal laws and appropriate. If, despite these internal Agencies Engaged in Contracting and policies regarding accommodation for reviews, a member of the public Distribution of Grants religious observance and practice in the identifies a significant concern about a federal workplace, and all agencies must prospective rule’s compliance with Agencies also must not discriminate observe such laws going forward. In federal protections governing religious against religious organizations in their particular, all agencies should review liberty during a period for public contracting or grant-making activities. the Guidelines on Religious Exercise comment on the rule, the agency should Religious organizations should be given and Religious Expression in the Federal carefully consider and respond to that the opportunity to compete for Workplace, which President Clinton request in its decision. See Perez v. government grants or contracts and issued on August 14, 1997, to ensure Mortgage Bankers Ass’n, 135 S. Ct. participate in government programs on that they are following those Guidelines. 1199, 1203 (2015). In appropriate an equal basis with nonreligious All agencies should also consider circumstances, an agency might explain organizations. Absent unusual practical steps to improve safeguards for that it will consider requests for circumstances, agencies should not religious liberty in the federal accommodations on a case-by-case basis condition receipt of a government workplace, including through subject- rather than in the rule itself, but the contract or grant on the effective matter experts who can answer agency should provide a reasoned basis relinquishment of a religious questions about religious for that approach. organization’s Section 702 exemption nondiscrimination rules, information Agencies Engaged in Enforcement for religious hiring practices, or any websites that employees may access to Actions other constitutional or statutory learn more about their religious protection for religious organizations. In accommodation rights, and training for Much like administrative agencies particular, agencies should not attempt all employees about federal protections engaged in rulemaking, agencies through conditions on grants or for religious observance and practice in considering potential enforcement contracts to meddle in the internal the workplace. actions should consider whether such actions are consistent with federal governance affairs of religious Agencies Engaged in Rulemaking protections for religious liberty. In organizations or to limit those In formulating rules, regulations, and particular, agencies should remember organizations’ otherwise protected policies, administrative agencies should that RFRA applies to agency activities. also proactively consider potential enforcement just as it applies to every * * * * * burdens on the exercise of religion and other governmental action. An agency Any questions about this memorandum possible accommodations of those should consider RFRA when setting or the appendix should be addressed to burdens. Agencies should consider agency-wide enforcement rules and the Office of Legal Policy, U.S. designating an officer to review priorities, as well as when making Department of Justice, 950 Pennsylvania proposed rules with religious decisions to pursue or continue any accommodation in mind or developing particular enforcement action, and Avenue NW., Washington, DC 20530, some other process to do so. In when formulating any generally phone (202) 514–4601. developing that process, agencies applicable rules announced in an APPENDIX should consider drawing upon the agency adjudication. expertise of the White House Office of Agencies should remember that Although not an exhaustive treatment Faith-Based and Neighborhood discriminatory enforcement of an of all federal protections for religious Partnerships to identify concerns about otherwise nondiscriminatory law can liberty, this appendix summarizes the the effect of potential agency action on also violate the Constitution. Thus, key constitutional and federal statutory religious exercise. Regardless of the agencies may not target or single out protections for religious liberty and sets process chosen, agencies should ensure religious organizations or religious forth the legal basis for the religious that they review all proposed rules, conduct for disadvantageous treatment liberty principles described in the regulations, and policies that have the in enforcement priorities or actions. The foregoing memorandum. potential to have an effect on religious President identified one area where this liberty for compliance with the could be a problem in Executive Order Constitutional Protections principles of religious liberty outlined 13798, when he directed the Secretary The people, acting through their in this memorandum and appendix of the Treasury, to the extent permitted Constitution, have singled out religious before finalizing those rules, by law, not to take any ‘‘adverse action liberty as deserving of unique regulations, or policies. The Office of against any individual, house of Legal Policy will also review any worship, or other religious organization protection. In the original version of the proposed agency or executive action on the basis that such individual or Constitution, the people agreed that ‘‘no upon which the Department’s organization speaks or has spoken about religious Test shall ever be required as comments, opinion, or concurrence are moral or political issues from a religious a Qualification to any Office or public sought, see, e.g., Exec. Order 12250 § 1– perspective, where speech of similar Trust under the United States.’’ U.S. 2, 45 Fed. Reg. 72995 (Nov. 2, 1980), to character’’ from a non-religious Const., art. VI, cl. 3. The people then ensure that such action complies with perspective has not been treated as amended the Constitution during the the principles of religious liberty participation or intervention in a First Congress to clarify that ‘‘Congress outlined in this memorandum and political campaign. Exec. Order No. shall make no law respecting an appendix. The Department will not 13798, § 2, 82 Fed. Reg. at 21675. But establishment of religion, or prohibiting concur in any proposed action that does the requirement of nondiscrimination the free exercise thereof.’’ U.S. Const. not comply with federal law protections toward religious organizations and amend. I, cl. 1. Those protections have for religious liberty as interpreted in this conduct applies across the enforcement been incorporated against the States. memorandum and appendix, and it will activities of the Executive Branch, Everson v. Bd. of Educ. of Ewing, 330 transmit any concerns it has about the including within the enforcement U.S. 1, 15 (1947) (Establishment Clause); proposed action to the agency or the components of the Department of Cantwell v. Connecticut, 310 U.S. 296, Office of Management and Budget as Justice. 303 (1940) (Free Exercise Clause).
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A. Free Exercise Clause merit First Amendment protection.’’ (internal quotation marks omitted). The The Free Exercise Clause recognizes Church of the Lukumi Babalu Aye v. Free Exercise Clause protects against and guarantees Americans the ‘‘right to Hialeah, 508 U.S. 520, 531 (1993) ‘‘indirect coercion or penalties on the believe and profess whatever religious (internal quotation marks omitted). free exercise of religion’’ just as surely doctrine [they] desire [ ].’’ Empl’t Div. v. They must merely be ‘‘sincerely held.’’ as it protects against ‘‘outright Frazee, 489 U.S. at 834. prohibitions’’ on religious exercise. Smith, 494 U.S. 872, 877 (1990). ___ Government may not attempt to regulate Importantly, the protection of the Free Trinity Lutheran, 582 U.S. at ( (slip religious beliefs, compel religious Exercise Clause also extends to acts op. at 11) (internal quotation marks beliefs, or punish religious beliefs. See undertaken in accordance with such omitted). ‘‘It is too late in the day to id.; see also Sherbert v. Verner, 374 U.S. sincerely-held beliefs. That conclusion doubt that the liberties of religion and flows from the plain text of the First 398, 402 (1963); Torcaso v. Watkins, 367 expression may be infringed by the Amendment, which guarantees the U.S. 488, 492–93, 495 (1961); United denial of or placing of conditions upon freedom to ‘‘exercise’’ religion, not just States v. Ballard, 322 U.S. 78, 86 (1944). a benefit or privilege.’’ Id. (quoting the freedom to ‘‘believe’’ in religion. See It may not lend its power to one side in Sherbert, 374 U.S. at 404). Smith, 494 U.S. at 877; see also Thomas, Because a law cannot have as its intra-denominational disputes about 450 U.S. at 716; Paty, 435 U.S. at 627; official ‘‘object or purpose . . . the dogma, authority, discipline, or Sherbert, 374 U.S. at 403–04; Wisconsin suppression of religion or religious qualifications for ministry or v. Yoder, 406 U.S. 205, 219–20 (1972). conduct,’’ courts must ‘‘survey membership. Hosanna-Tabor Moreover, no other interpretation would meticulously’’ the text and operation of Evangelical Lutheran Church & Sch. v. actually guarantee the freedom of belief a law to ensure that it is actually neutral EEOC, 565 U.S. 171, 185 (2012); Smith, that Americans have so long regarded as and of general applicability. Church of 494 U.S. at 877; Serbian Eastern central to individual liberty. Many, if the Lukumi Babalu Aye, 508 U.S. at Orthodox Diocese v. Milivojevich, 426 not most, religious beliefs require 533–34 (internal quotation marks U.S. 696, 724–25 (1976); Presbyterian external observance and practice omitted). A law is not neutral if it Church v. Mary Elizabeth Blue Hull through physical acts or abstention from singles out particular religious conduct Mem’l Presbyterian Church, 393 U.S. acts. The tie between physical acts and for adverse treatment; treats the same 440, 451 (1969); Kedroff v. St. Nicholas religious beliefs may be readily apparent conduct as lawful when undertaken for Cathedral of the Russian Orthodox (e.g., attendance at a worship service) or secular reasons but unlawful when Church, 344 U.S. 94, 116, 120–21 not (e.g., service to one’s community at undertaken for religious reasons; visits (1952). It may not discriminate against a soup kitchen or a decision to close ‘‘gratuitous restrictions on religious or impose special burdens upon one’s business on a particular day of the conduct’’; or ‘‘accomplishes . . . a individuals because of their religious week). The ‘‘exercise of religion’’ ‘religious gerrymander,’ an beliefs or status. Smith, 494 U.S. at 877; encompasses all aspects of religious impermissible attempt to target [certain McDaniel v. Paty, 435 U.S. 618, 627 observance and practice. And because individuals] and their religious (1978). And with the exception of individuals may act collectively through practices.’’ Id. at 533–35, 538 (internal certain historical limits on the freedom associations and organizations, it quotation marks omitted). A law is not of speech, government may not punish encompasses the exercise of religion by generally applicable if ‘‘in a selective or otherwise harass churches, church such entities as well. See, e.g., Hosanna- manner [it] impose[s] burdens only on officials, or religious adherents for Tabor, 565 U.S. at 199; Church of the conduct motivated by religious belief,’’ speaking on religious topics or sharing Lukumi Babalu Aye, 508 U.S. at 525–26, id. at 543, including by ‘‘fail[ing] to their religious beliefs. See Widmar v. 547; see also Burwell v. Hobby Lobby prohibit nonreligious conduct that Vincent, 454 U.S. 263, 269 (1981); see Stores, Inc., 134 S. Ct. 2751, 2770, 2772– endangers [its] interests in a similar or also U.S. Const., amend. I, cl. 3. The 73 (2014) (even a closely held for-profit greater degree than . . . does’’ the Constitution’s protection against corporation may exercise religion if prohibited conduct, id., or enables, government regulation of religious belief operated in accordance with asserted expressly or de facto, ‘‘a system of is absolute; it is not subject to limitation religious principles). individualized exemptions,’’ as or balancing against the interests of the As with most constitutional discussed in Smith, 494 U.S. at 884; see government. Smith, 494 U.S. at 877; protections, however, the protection also Church of the Lukumi Babalu Aye, Sherbert, 374 U.S. at 402; see also West afforded to Americans by the Free 508 U.S. at 537. Virginia State Bd. of Educ. v. Barnette, Exercise Clause for physical acts is not ‘‘Neutrality and general applicability 319 U.S. 624, 642 (1943) (‘‘If there is any absolute, Smith, 491 U.S. at 878–79, and are interrelated, . . . [and] failure to fixed star in our constitutional the Supreme Court has identified satisfy one requirement is a likely constellation, it is that no official, high certain principles to guide the analysis indication that the other has not been or petty, can prescribe what shall be of the scope of that protection. First, satisfied.’’ Id. at 531. For example, a law orthodox in politics, nationalism, government may not restrict ‘‘acts or that disqualifies a religious person or religion, or other matters of opinion or abstentions only when they are engaged organization from a right to compete for force citizens to confess by word or act in for religious reasons, or only because a public benefit—including a grant or their faith therein.’’). of the religious belief that they display,’’ contract—because of the person’s The Free Exercise Clause protects id. at 877, nor ‘‘target the religious for religious character is neither neutral nor beliefs rooted in religion, even if such special disabilities based on their generally applicable. See Trinity beliefs are not mandated by a particular religious status,’’ Trinity Lutheran Lutheran, 582 U.S. at ___–___ (slip op. religious organization or shared among Church of Columbia, Inc. v. Comer, 582 at 9–11). Likewise, a law that selectively adherents of a particular religious U.S. ___, ___ (2017) (slip op. at 6) prohibits the killing of animals for tradition. Frazee v. Illinois Dept. of (internal quotation marks omitted), for it religious reasons and fails to prohibit Emp’t Sec., 489 U.S. 829, 833–34 (1989). was precisely such ‘‘historical instances the killing of animals for many As the Supreme Court has repeatedly of religious persecution and intolerance nonreligious reasons, or that selectively counseled, ‘‘religious beliefs need not be that gave concern to those who drafted prohibits a business from refusing to acceptable, logical, consistent, or the Free Exercise Clause.’’ Church of the stock a product for religious reasons but comprehensible to others in order to Lukumi Babalu Aye, 508 U.S. at 532 fails to prohibit such refusal for myriad
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commercial reasons, is neither neutral, speech, Reed v. Town of Gilbert, Ariz., 244–46 (1982). Indeed, ‘‘a significant nor generally applicable. See Church of 135 S. Ct. 2218, 2228 (2015). See Church factor in upholding governmental the Lukumi Babalu Aye, 508 U.S. at of the Lukumi Babalu Aye, 508 U.S. at programs in the face of Establishment 533–36, 542–45. Nonetheless, the 546–47. Under this level of scrutiny, Clause attack is their neutrality towards requirements of neutral and general government must establish that a religion.’’ Rosenberger, 515 U.S. at 839 applicability are separate, and any law challenged law ‘‘advance[s] interests of (emphasis added). That ‘‘guarantee of burdening religious practice that fails the highest order’’ and is ‘‘narrowly neutrality is respected, not offended, one or both must be subjected to strict tailored in pursuit of those interests.’’ when the government, following neutral scrutiny, id. at 546. Id. at 546 (internal quotation marks criteria and evenhanded policies, Second, even a neutral, generally omitted). ‘‘[O]nly in rare cases’’ will a extends benefits to recipients whose applicable law is subject to strict law survive this level of scrutiny. Id. ideologies and viewpoints, including scrutiny under this Clause if it restricts Of course, even when a law is neutral religious ones, are broad and diverse.’’ the free exercise of religion and another and generally applicable, government Id. Thus, religious adherents and constitutionally protected liberty, such may run afoul of the Free Exercise organizations may, like nonreligious as the freedom of speech or association, Clause if it interprets or applies the law adherents and organizations, receive or the right to control the upbringing of in a manner that discriminates against indirect financial aid through one’s children. See Smith, 494 U.S. at religious observance and practice. See, independent choice, or, in certain 881–82; Axson-Flynn v. Johnson, 356 e.g., Church of the Lukumi Babalu Aye, circumstances, direct financial aid F.3d 1277, 1295–97 (10th Cir. 2004). 508 U.S. at 537 (government through a secular-aid program. See, e.g., Many Free Exercise cases fall in this discriminatorily interpreted an Trinity Lutheran, 582 U.S. at ___ (slip. category. For example, a law that seeks ordinance prohibiting the unnecessary op. at 6) (scrap tire program); Zelman v. to compel a private person’s speech or killing of animals as prohibiting only Simmons-Harris, 536 U.S. 639, 652 expression contrary to his or her killing of animals for religious reasons); (2002) (voucher program). religious beliefs implicates both the Fowler v. Rhode Island, 345 U.S. 67, 69– freedoms of speech and free exercise. 70 (1953) (government discriminatorily C. Religious Test Clause See, e.g., Wooley v. Maynard, 430 U.S. enforced ordinance prohibiting Finally, the Religious Test Clause, 705, 707–08 (1977) (challenge by meetings in public parks against only though rarely invoked, provides a Jehovah’s Witnesses to requirement that certain religious groups). The Free critical guarantee to religious adherents state license plates display the motto Exercise Clause, much like the Free that they may serve in American public ‘‘Live Free or Die’’); Axson-Flynn, 356 Speech Clause, requires equal treatment life. The Clause reflects the judgment of F.3d at 1280 (challenge by Mormon of religious adherents. See Trinity the Framers that a diversity of religious student to University requirement that Lutheran, 582 U.S. at __ (slip op. at 6); viewpoints in government would student actors use profanity and take cf. Good News Club v. Milford Central enhance the liberty of all Americans. God’s name in vain during classroom Sch., 533 U.S. 98, 114 (2001) And after the Religion Clauses were acting exercises). A law taxing or (recognizing that Establishment Clause incorporated against the States, the prohibiting door-to-door solicitation, at does not justify discrimination against Supreme Court shared this view, least as applied to individuals religious clubs seeking use of public rejecting a Tennessee law that distributing religious literature and meeting spaces); Rosenberger v. Rector ‘‘establishe[d] as a condition of office seeking contributions, likewise & Visitors of Univ. of Va., 515 U.S. 819, the willingness to eschew certain implicates the freedoms of speech and 837, 841 (1995) (recognizing that protected religious practices.’’ Paty, 435 free exercise. Murdock v. Pennsylvania, Establishment Clause does not justify U.S. at 632 (Brennan, J., and Marshall, 319 U.S. 105, 108–09 (1943) (challenge discrimination against religious student J., concurring in judgment); see also id. by Jehovah’s Witnesses to tax on newspaper’s participation in neutral at 629 (plurality op.) (‘‘[T]he American canvassing or soliciting); Cantwell, 310 reimbursement program). That is true experience provides no persuasive U.S. at 307 (same). A law requiring regardless of whether the discriminatory support for the fear that clergymen in children to receive certain education, application is initiated by the public office will be less careful of anti- contrary to the religious beliefs of their government itself or by private requests establishment interests or less faithful to parents, implicates both the parents’ or complaints. See, e.g., Fowler, 345 their oaths of civil office than their right to the care, custody, and control of U.S. at 69; Niemotko v. Maryland, 340 unordained counterparts.’’). their children and to free exercise. U.S. 268, 272 (1951). Statutory Protections Yoder, 406 U.S. at 227–29 (challenge by B. Establishment Clause Amish parents to law requiring high Recognizing the centrality of religious school attendance). The Establishment Clause, too, liberty to our nation, Congress has Strict scrutiny is the ‘‘most rigorous’’ protects religious liberty. It prohibits buttressed these constitutional rights form of scrutiny identified by the government from establishing a religion with statutory protections for religious Supreme Court. Church of the Lukumi and coercing Americans to follow it. See observance and practice. These Babalu Aye, 508 U.S. at 546; see also Town of Greece, N.Y. v. Galloway, 134 protections can be found in, among City of Boerne v. Flores, 521 U.S. 507, S. Ct. 1811, 1819–20 (2014); Good News other statutes, the Religious Freedom 534 (1997) (‘‘Requiring a State to Club, 533 U.S. at 115. It restricts Restoration Act of 1993, 42 U.S.C. demonstrate a compelling interest and government from interfering in the 2000bb et seq.; the Religious Land Use show that it has adopted the least internal governance or ecclesiastical and Institutionalized Persons Act, 42 restrictive means of achieving that decisions of a religious organization. U.S.C. 2000cc et seq.; Title VII of the interest is the most demanding test Hosanna-Tabor, 565 U.S. at 188–89. Civil Rights Act of 1964, 42 U.S.C. known to constitutional law.’’). It is the And it prohibits government from 2000e et seq.; and the American Indian same standard applied to governmental officially favoring or disfavoring Religious Freedom Act, 42 U.S.C. 1996. classifications based on race, Parents particular religious groups as such or Such protections ensure not only that Involved in Cmty. Sch. v. Seattle Sch. officially advocating particular religious government tolerates religious Dist. No. 1, 551 U.S. 701, 720 (2007), points of view. See Galloway, 134 S. Ct. observance and practice, but that it and restrictions on the freedom of at 1824; Larson v. Valente, 456 U.S. 228, embraces religious adherents as full
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members of society, able to contribute substantial burden. See, e.g., Lyng v. provision of the coverage was morally through employment, use of public Nw. Indian Cemetery Protective Ass’n, wrong, and it was ‘‘not for us to say that accommodations, and participation in 485 U.S. 439, 448–49 (1988); Bowen v. their religious beliefs are mistaken or government programs. The considered Roy, 476 U.S. 693, 699–700 (1986). insubstantial.’’ Id. at 2779. judgment of the United States is that we As with claims under the Free Government bears a heavy burden to are stronger through accommodation of Exercise Clause, RFRA does not permit justify a substantial burden on the religion than segregation or isolation of a court to inquire into the exercise of religion. ‘‘[O]nly those it. reasonableness of a religious belief, interests of the highest order . . . can including into the adherent’s overbalance legitimate claims to the free A. Religious Freedom Restoration Act of exercise of religion.’’ Thomas, 450 U.S. 1993 (RFRA) assessment of the religious connection between a belief asserted and what the at 718 (quoting Yoder, 406 U.S. at 215). The Religious Freedom Restoration government forbids, requires, or Such interests include, for example, the Act of 1993 (RFRA), 42 U.S.C. 2000bb prevents. Hobby Lobby, 134 S. Ct. at ‘‘fundamental, overriding interest in et seq., prohibits the federal government 2778. If the proffered belief is sincere, eradicating racial discrimination in from ‘‘substantially burden[ing] a it is not the place of the government or education—discrimination that person’s exercise of religion’’ unless ‘‘it a court to second-guess it. Id. A good prevailed, with official approval, for the demonstrates that application of the illustration of the point is Thomas v. first 165 years of this Nation’s history,’’ burden to the person (1) is in Review Board of Indiana Employment Bob Jones Univ. v. United States, 461 furtherance of a compelling U.S. 574, 604 (1983), and the interest in Security Division—one of the Sherbert governmental interest; and (2) is the ensuring the ‘‘mandatory and line of cases, whose analytical test least restrictive means of furthering that continuous participation’’ that is Congress sought, through RFRA, to compelling governmental interest.’’ Id. ‘‘indispensable to the fiscal vitality of restore, 42 U.S.C. 2000bb. There, the § 2000bb–1(a), (b). The Act applies even the social security system,’’ United Supreme Court concluded that the where the burden arises out of a ‘‘rule States v. Lee, 455 U.S. 252, 258–59 denial of unemployment benefits was a of general applicability’’ passed without (1982). But ‘‘broadly formulated substantial burden on the sincerely held animus or discriminatory intent. See id. interests justifying the general religious beliefs of a Jehovah’s Witness § 2000bb-1(a). It applies to ‘‘any exercise applicability of government mandates’’ who had quit his job after he was of religion, whether or not compelled are insufficient. Gonzales v. O Centro by, or central to, a system of religious transferred from a department Espirita Beneficente Uniao do Vegetal, belief,’’ see §§ 2000bb–2(4), 2000cc– producing sheet steel that could be used 546 U.S. 418, 431 (2006). The 5(7), and covers ‘‘individuals’’ as well as for military armaments to a department government must establish a compelling ‘‘corporations, companies, associations, producing turrets for military tanks. interest to deny an accommodation to firms, partnerships, societies, and joint Thomas, 450 U.S. at 716–18. In doing the particular claimant. Id. at 430, 435– stock companies,’’ 1 U.S.C. 1, including so, the Court rejected the lower court’s 38. For example, the military may have for-profit, closely-held corporations like inquiry into ‘‘what [the claimant’s] a compelling interest in its uniform and those involved in Hobby Lobby, 134 S. belief was and what the religious basis grooming policy to ensure military Ct. at 2768. of his belief was,’’ noting that no one readiness and protect our national Subject to the exceptions identified had challenged the sincerity of the security, but it does not necessarily below, a law ‘‘substantially burden[s] a claimant’s religious beliefs and that follow that those interests would justify person’s exercise of religion,’’ 42 U.S.C. ‘‘[c]ourts should not undertake to denying a particular soldier’s request for 2000bb–1, if it bans an aspect of the dissect religious beliefs because the an accommodation from the uniform adherent’s religious observance or believer admits that he is struggling and grooming policy. See, e.g., Secretary practice, compels an act inconsistent with his position or because his beliefs of the Army, Army Directive 2017–03, with that observance or practice, or are not articulated with the clarity and Policy for Brigade-Level Approval of substantially pressures the adherent to precision that a more sophisticated Certain Requests for Religious modify such observance or practice, see person might employ.’’ Id. at 714–15 Accommodation (2017) (recognizing the Sherbert, 374 U.S. at 405–06. The (internal quotation marks omitted). The ‘‘successful examples of Soldiers ‘‘threat of criminal sanction’’ will satisfy Court likewise rejected the lower court’s currently serving with’’ an these principles, even when, as in comparison of the claimant’s views to accommodation for ‘‘the wear of a hijab; Yoder, the prospective punishment is a those of other Jehovah’s Witnesses, the wear of a beard; and the wear of a mere $5 fine. 406 U.S. at 208, 218. And noting that ‘‘[i]ntrafaith differences of turban or under-turban/patka, with the denial of, or condition on the receipt that kind are not uncommon among uncut beard and uncut hair’’ and of, government benefits may followers of a particular creed, and the providing for a reasonable substantially burden the exercise of judicial process is singularly ill accommodation of these practices in the religion under these principles. equipped to resolve such differences.’’ Army). The military would have to Sherbert, 374 U.S. at 405–06; see also Id. at 715. The Supreme Court show that it has a compelling interest in Hobbie v. Unemployment Appeals reinforced this reasoning in Hobby denying that particular accommodation. Comm’n of Fla., 480 U.S. 136, 141 Lobby, rejecting the argument that ‘‘the An asserted compelling interest in (1987); Thomas, 450 U.S. at 717–18. But connection between what the objecting denying an accommodation to a a law that infringes, even severely, an parties [were required to] do (provide particular claimant is undermined by aspect of an adherent’s religious health-insurance coverage for four evidence that exemptions or observance or practice that the adherent methods of contraception that may accommodations have been granted for himself regards as unimportant or operate after the fertilization of an egg) other interests. See O Centro, 546 U.S. inconsequential imposes no substantial and the end that they [found] to be at 433, 436–37; see also Hobby Lobby, burden on that adherent. And a law that morally wrong (destruction of an 134 S. Ct. at 2780. regulates only the government’s internal embryo) [wa]s simply too attenuated.’’ The compelling-interest requirement affairs and does not involve any 134 S. Ct. at 2777. The Court explained applies even where the accommodation governmental compulsion on the that the plaintiff corporations had a sought is ‘‘an exemption from a legal religious adherent likewise imposes no sincerely-held religious belief that obligation requiring [the claimant] to
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confer benefits on third parties.’’ Hobby commerce with foreign nations, among C. Other Civil Rights Laws Lobby, 134 S. Ct. at 2781 n.37. Although the several States, or with Indian ‘‘in applying RFRA ‘courts must take tribes.’’ 42 U.S.C. 2000cc(a)(2), 2000cc– To incorporate religious adherents adequate account of the burdens a 1(b). fully into society, Congress has requested accommodation may impose RLUIPA’s protections must ‘‘be recognized that it is not enough to limit on nonbeneficiaries,’ ’’ the Supreme construed in favor of a broad protection governmental action that substantially Court has explained that almost any of religious exercise, to the maximum burdens the exercise of religion. It must governmental regulation could be extent permitted by [RLUIPA] and the also root out public and private reframed as a legal obligation requiring Constitution.’’ Id. § 2000cc–3(g). discrimination based on religion. a claimant to confer benefits on third RLUIPA applies to ‘‘any exercise of Religious discrimination stood parties. Id. (quoting Cutter v. Wilkinson, religion, whether or not compelled by, alongside discrimination based on race, 544 U.S. 709, 720 (2005)). As nothing in or central to, a system of religious color, and national origin, as an evil to the text of RFRA admits of an exception belief,’’ id. § 2000cc–5(7)(A), and treats be addressed in the Civil Rights Act of for laws requiring a claimant to confer ‘‘[t]he use, building, or conversion of 1964, and Congress has continued to benefits on third parties, 42 U.S.C. real property for the purpose of religious legislate against such discrimination 2000bb–1, and such an exception would exercise’’ as the ‘‘religious exercise of over time. Today, the United States have the potential to swallow the rule, the person or entity that uses or intends Code includes specific prohibitions on the Supreme Court has rejected the to use the property for that purpose,’’ id. religious discrimination in places of proposition that RFRA accommodations § 2000cc–5(7)(B). Like RFRA, RLUIPA public accommodation, 42 U.S.C. 2000a; are categorically unavailable for laws prohibits government from substantially in public facilities, id. § 2000b; in public requiring claimants to confer benefits on burdening an exercise of religion unless education, id. § 2000c–6; in third parties. Hobby Lobby, 134 S. Ct. at imposition of the burden on the employment, id. §§ 2000e, 2000e–2, 2781 n.37. religious adherent is the least restrictive 2000e–16; in the sale or rental of Even if the government can identify a means of furthering a compelling housing, id. § 3604; in the provision of compelling interest, the government governmental interest. See id. § 2000cc– certain real-estate transaction or must also show that denial of an 1(a). That standard ‘‘may require a brokerage services, id. §§ 3605, 3606; in accommodation is the least restrictive government to incur expenses in its own federal jury service, 28 U.S.C. 1862; in means of serving that compelling operations to avoid imposing a access to limited open forums for governmental interest. This standard is substantial burden on religious speech, 20 U.S.C. 4071; and in ‘‘exceptionally demanding.’’ Hobby exercise.’’ Id. § 2000cc–3(c); cf. Holt v. participation in or receipt of benefits Lobby, 134 S. Ct. at 2780. It requires the Hobbs, 135 S. Ct. 853, 860, 864–65 from various federally-funded programs, government to show that it cannot (2015). 15 U.S.C. 3151; 20 U.S.C. 1066c(d), accommodate the religious adherent With respect to land use in particular, 1071(a)(2), 1087–4, 7231d(b)(2), 7914; while achieving its interest through a RLUIPA also requires that government 31 U.S.C. 6711(b)(3); 42 U.S.C. 290cc– viable alternative, which may include, not ‘‘treat[] a religious assembly or 33(a)(2), 300w–7(a)(2), 300x–57(a)(2), in certain circumstances, expenditure of institution on less than equal terms with 300x–65(f), 604a(g), 708(a)(2), 5057(c), additional funds, modification of a nonreligious assembly or institution,’’ 5151(a), 5309(a), 6727(a), 9858l(a)(2), existing exemptions, or creation of a 42 U.S.C. 2000cc(b)(1), ‘‘impose or 10406(2)(B), 10504(a), 10604(e), new program. Id. at 2781. Indeed, the implement a land use regulation that 12635(c)(1), 12832, 13791(g)(3), existence of exemptions for other discriminates against any assembly or 13925(b)(13)(A). individuals or entities that could be institution on the basis of religion or expanded to accommodate the claimant, religious denomination,’’ id. Invidious religious discrimination while still serving the government’s § 2000cc(b)(2), or ‘‘impose or implement may be directed at religion in general, stated interests, will generally defeat a a land use regulation that (A) totally at a particular religious belief, or at RFRA defense, as the government bears excludes religious assemblies from a particular aspects of religious the burden to establish that no jurisdiction; or (B) unreasonably limits observance and practice. See, e.g., accommodation is viable. See id. at religious assemblies, institutions, or Church of the Lukumi Babalu Aye, 508 2781–82. structures within a jurisdiction,’’ id. U.S. at 532–33. A law drawn to prohibit § 2000cc(b)(3). A claimant need not a specific religious practice may B. Religious Land Use and show a substantial burden on the discriminate just as severely against a Institutionalized Persons Act of 2000 exercise of religion to enforce these religious group as a law drawn to (RLUIPA) antidiscrimination and equal terms prohibit the religion itself. See id. No Although Congress’s leadership in provisions listed in § 2000cc(b). See id. one would doubt that a law prohibiting adopting RFRA led many States to pass § 2000cc(b); see also Lighthouse Inst. for the sale and consumption of Kosher analogous statutes, Congress recognized Evangelism, Inc. v. City of Long Branch, meat would discriminate against Jewish the unique threat to religious liberty 510 F.3d 253, 262–64 (3d Cir. 2007), people. True equality may also require, posed by certain categories of state cert. denied, 553 U.S. 1065 (2008). depending on the applicable statutes, an action and passed the Religious Land Although most RLUIPA cases involve awareness of, and willingness Use and Institutionalized Persons Act of places of worship like churches, reasonably to accommodate, religious 2000 (RLUIPA) to address them. mosques, synagogues, and temples, the observance and practice. Indeed, the RLUIPA extends a standard analogous law applies more broadly to religious denial of reasonable accommodations to RFRA to state and local government schools, religious camps, religious may be little more than cover for actions regulating land use and retreat centers, and religious social discrimination against a particular institutionalized persons where ‘‘the service facilities. Letter from U.S. Dep’t religious belief or religion in general substantial burden is imposed in a of Justice Civil Rights Division to State, and is counter to the general program or activity that receives Federal County, and Municipal Officials re: The determination of Congress that the financial assistance’’ or ‘‘the substantial Religious Land Use and United States is best served by the burden affects, or removal of that Institutionalized Persons Act (Dec. 15, participation of religious adherents in substantial burden would affect, 2016). society, not their withdrawal from it.
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1. Employment observance or practice, within the of the employer’s business.’’ Philbrook, i. Protections for Religious Employees ordinary meaning of that word. See U.S. 479 U.S. at 69 (internal quotations Airways, Inc. v. Barnett, 535 U.S. 391, omitted). Protections for religious individuals 400 (2002) (considering the ordinary The area of religious speech and in employment are the most obvious meaning in the context of an ADA expression is a useful example of example of Congress’s instruction that claim). Although there is no obligation reasonable accommodation. Where religious observance and practice be to provide an employee with his or her speech or expression is part of a reasonably accommodated, not preferred reasonable accommodation, person’s religious observance and marginalized. In Title VII of the Civil see Ansonia Bd. of Educ. v. Philbrook, practice, it falls within the scope of Title Rights Act, Congress declared it an 479 U.S. 60, 68 (1986), an employer may VII. See 42 U.S.C. 2000e, 2000e–2. unlawful employment practice for a justify a refusal to accommodate only by Speech or expression outside of the covered employer to (1) ‘‘fail or refuse showing that ‘‘an undue hardship [on its scope of an individual’s employment to hire or to discharge any individual, business] would in fact result from each can almost always be accommodated or otherwise . . . discriminate against available alternative method of without undue hardship to a business. any individual with respect to his accommodation.’’ 29 CFR § 1605.2(c)(1) Speech or expression within the scope compensation, terms, conditions, or (emphasis added). ‘‘A mere assumption of an individual’s employment, during privileges of employment, because of that many more people, with the same work hours, or in the workplace may, such individual’s . . . religion,’’ as well religious practices as the person being depending upon the facts and as (2) to ‘‘limit, segregate, or classify his accommodated, may also need circumstances, be reasonably employees or applicants for accommodation is not evidence of accommodated. Cf. Abercrombie, 135 S. employment in any way which would undue hardship.’’ Id. Likewise, the fact Ct. at 2032. deprive or tend to deprive any that an accommodation may grant the The federal government’s approach to individual of employment opportunities religious employee a preference is not free exercise in the federal workplace or otherwise adversely affect his status evidence of undue hardship as, ‘‘[b]y provides useful guidance on such as an employee, because of such definition, any special ‘accommodation’ reasonable accommodations. For individual’s . . . religion.’’ 42 U.S.C. requires the employer to treat an example, under the Guidelines issued 2000e–2(a); see also 42 U.S.C. 2000e– employee . . . differently, i.e., by President Clinton, the federal 16(a) (applying Title VII to certain preferentially.’’ U.S. Airways, 535 U.S. government permits a federal employee federal-sector employers); 3 U.S.C. at 397; see also E.E.O.C. v. Abercrombie to ‘‘keep a Bible or Koran on her private 411(a) (applying Title VII employment desk and read it during breaks’’; to in the Executive Office of the President). & Fitch Stores, Inc., 135 S. Ct. 2028, 2034 (2015) (‘‘Title VII does not demand discuss his religious views with other The protection applies ‘‘regardless of employees, subject ‘‘to the same rules of mere neutrality with regard to religious whether the discrimination is directed order as apply to other employee practices—that they may be treated no against [members of religious] majorities expression’’; to display religious worse than other practices. Rather, it or minorities.’’ Trans World Airlines, messages on clothing or wear religious gives them favored treatment.’’). Inc. v. Hardison, 432 U.S. 63, 71–72 medallions visible to others; and to (1977). Title VII does not, however, require hand out religious tracts to other After several courts had held that accommodation at all costs. As noted employees or invite them to attend employers did not violate Title VII above, an employer is not required to worship services at the employee’s when they discharged employees for accommodate a religious observance or church, except to the extent that such refusing to work on their Sabbath, practice if it would pose an undue speech becomes excessive or harassing. Congress amended Title VII to define hardship on its business. An Guidelines on Religious Exercise and ‘‘[r]eligion’’ broadly to include ‘‘all accommodation might pose an ‘‘undue Religious Expression in the Federal aspects of religious observance and hardship,’’ for example, if it would Workplace, § 1(A), Aug. 14, 1997 practice, as well as belief, unless an require the employer to breach an (hereinafter ‘‘Clinton Guidelines’’). The employer demonstrates that he is unable otherwise valid collective bargaining Clinton Guidelines have the force of an to reasonably accommodate to an agreement, see, e.g., Hardison, 432 U.S. Executive Order. See Legal Effectiveness employee’s or prospective employee’s at 79, or carve out a special exception of a Presidential Directive, as Compared religious observance or practice without to a seniority system, id. at 83; see also to an Executive Order, 24 Op. O.L.C. 29, undue hardship on the conduct of the U.S. Airways, 535 U.S. at 403. Likewise, 29 (2000) (‘‘[T]here is no substantive employer’s business.’’ 42 U.S.C. an accommodation might pose an difference in the legal effectiveness of 2000e(j); Hardison, 432 U.S. at 74 n.9. ‘‘undue hardship’’ if it would impose an executive order and a presidential Congress thus made clear that ‘‘more than a de minimis cost’’ on the directive that is styled other than as an discrimination on the basis of religion business, such as in the case of a executive order.’’); see also includes discrimination on the basis of company where weekend work is Memorandum from President William J. any aspect of an employee’s religious ‘‘essential to [the] business’’ and many Clinton to the Heads of Executive observance or practice, at least where employees have religious observances Departments and Agencies (Aug. 14, such observance or practice can be that would prohibit them from working 1997) (‘‘All civilian executive branch reasonably accommodated without on the weekends, so that agencies, officials, and employees must undue hardship. accommodations for all such employees follow these Guidelines carefully.’’). Title VII’s reasonable accommodation would result in significant overtime The successful experience of the federal requirement is meaningful. As an initial costs for the employer. Hardison, 432 government in applying the Clinton matter, it requires an employer to U.S. at 80, 84 & n.15. In general, though, Guidelines over the last twenty years is consider what adjustment or Title VII expects positive results for evidence that religious speech and modification to its policies would society from a cooperative process expression can be reasonably effectively address the employee’s between an employer and its employee accommodated in the workplace concern, for ‘‘[a]n ineffective ‘‘in the search for an acceptable without exposing an employer to modification or adjustment will not reconciliation of the needs of the liability under workplace harassment accommodate’’ a person’s religious employee’s religion and the exigencies laws.
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Time off for religious holidays is also particular business or enterprise,’’ houses of worship, but to religious often an area of concern. The employers may hire and employ colleges, charitable organizations like observance of religious holidays is an individuals based on their religion. 42 the Salvation Army and World Vision ‘‘aspect[ ] of religious observance and U.S.C. 2000e–2(e)(1). Likewise, where International, and many more. In that practice’’ and is therefore protected by educational institutions are ‘‘owned, way, it is consistent with other broad Title VII. 42 U.S.C. 2000e, 2000e–2. supported, controlled or managed, [in protections for religious entities in Examples of reasonable whole or in substantial part] by a federal law, including, for example, the accommodations for that practice could particular religion or by a particular exemption of religious entities from include a change of job assignments or religious corporation, association, or many of the requirements under the lateral transfer to a position whose society’’ or direct their curriculum Americans with Disabilities Act. See 28 schedule does not conflict with the ‘‘toward the propagation of a particular CFR app. C; 56 Fed. Reg. 35544, 35554 employee’s religious holidays, 29 CFR religion,’’ such institutions may hire (July 26, 1991) (explaining that ‘‘[t]he 1605.2(d)(1)(iii); a voluntary work and employ individuals of a particular ADA’s exemption of religious schedule swap with another employee, religion. Id. And ‘‘a religious organizations and religious entities id. § 1065.2(d)(1)(i); or a flexible corporation, association, educational controlled by religious organizations is scheduling scheme that allows institution, or society’’ may employ very broad, encompassing a wide employees to arrive or leave early, use ‘‘individuals of a particular religion to variety of situations’’). floating or optional holidays for perform work connected with the In addition to these explicit religious holidays, or make up time lost carrying on by such corporation, exemptions, religious organizations may on another day, id. § 1065.2(d)(1)(ii). association, educational institution, or be entitled to additional exemptions Again, the federal government has society of its activities.’’ Id. § 2000e– from discrimination laws. See, e.g., demonstrated reasonable 1(a); Corp. of Presiding Bishop of Hosanna-Tabor, 565 U.S. at 180, 188– accommodation through its own Church of Jesus Christ of Latter-Day 90. For example, a religious practice: Congress has created a flexible Saints v. Amos, 483 U.S. 327, 335–36 organization might conclude that it scheduling scheme for federal (1987). cannot employ an individual who fails employees, which allows employees to Because Title VII defines ‘‘religion’’ faithfully to adhere to the organization’s take compensatory time off for religious broadly to include ‘‘all aspects of religious tenets, either because doing so observances, 5 U.S.C. 5550a, and the religious observance and practice, as might itself inhibit the organization’s Clinton Guidelines make clear that ‘‘[a]n well as belief,’’ 42 U.S.C. 2000e(j), these exercise of religion or because it might agency must adjust work schedules to exemptions include decisions ‘‘to dilute an expressive message. Cf. Boy accommodate an employee’s religious employ only persons whose beliefs and Scouts of Am. v. Dale, 530 U.S. 640, observance—for example, Sabbath or conduct are consistent with the 649–55 (2000). Both constitutional and religious holiday observance—if an employer’s religious precepts.’’ Little v. statutory issues arise when governments adequate substitute is available, or if the Wuerl, 929 F.2d 944, 951 (3d Cir. 1991); seek to regulate such decisions. employee’s absence would not see also Killinger v. Samford Univ., 113 As a constitutional matter, religious otherwise impose an undue burden on F.3d 196, 198–200 (11th Cir. 1997). For organizations’ decisions are protected the agency,’’ Clinton Guidelines § 1(C). example, in Little, the Third Circuit held from governmental interference to the If an employer regularly permits that the exemption applied to a Catholic extent they relate to ecclesiastical or accommodation in work scheduling for school’s decision to fire a divorced internal governance matters. Hosanna- secular conflicts and denies such Protestant teacher who, though having Tabor, 565 U.S. at 180, 188–90. It is accommodation for religious conflicts, agreed to abide by a code of conduct beyond dispute that ‘‘it would violate ‘‘such an arrangement would display a shaped by the doctrines of the Catholic the First Amendment for courts to apply discrimination against religious Church, married a baptized Catholic [employment discrimination] laws to practices that is the antithesis of without first pursuing the official compel the ordination of women by the reasonableness.’’ Philbrook, 479 U.S. at annulment process of the Church. 929 Catholic Church or by an Orthodox 71. F.2d at 946, 951. Jewish seminary.’’ Id. at 188. The same Except for certain exceptions Section 702 broadly exempts from its is true for other employees who discussed in the next section, Title VII’s reach religious corporations, ‘‘minister to the faithful,’’ including protection against disparate treatment, associations, educational institutions, those who are not themselves the head 42 U.S.C. 2000e–2(a)(1), is implicated and societies. The statute’s terms do not of the religious congregation and who any time religious observance or limit this exemption to non-profit are not engaged solely in religious practice is a motivating factor in an organizations, to organizations that functions. Id. at 188, 190, 194–95; see employer’s covered decision. carry on only religious activities, or to also Br. of Amicus Curiae the U.S. Supp. Abercrombie, 135 S. Ct. at 2033. That is organizations established by a church or Appellee, Spencer v. World Vision, Inc., true even when an employer acts formally affiliated therewith. See Civil No. 08–35532 (9th Cir. 2008) (noting without actual knowledge of the need Rights Act of 1964, § 702(a), codified at that the First Amendment protects ‘‘the for an accommodation from a neutral 42 U.S.C. 2000e–1(a); see also Hobby right to employ staff who share the policy but with ‘‘an unsubstantiated Lobby, 134 S. Ct. at 2773–74; Corp. of religious organization’s religious suspicion’’ of the same. Id. at 2034. Presiding Bishop, 483 U.S. at 335–36. beliefs’’). The exemption applies whenever the Even if a particular associational ii. Protections for Religious Employers organization is ‘‘religious,’’ which decision could be construed to fall Congress has acknowledged, however, means that it is organized for religious outside this protection, the government that religion sometimes is an purposes and engages in activity would likely still have to show that any appropriate factor in employment consistent with, and in furtherance of, interference with the religious decisions, and it has limited Title VII’s such purposes. Br. of Amicus Curiae the organization’s associational rights is scope accordingly. Thus, for example, U.S. Supp. Appellee, Spencer v. World justified under strict scrutiny. See where religion ‘‘is a bona fide Vision, Inc., No. 08–35532 (9th Cir. Roberts v. U.S. Jaycees, 468 U.S. 609, occupational qualification reasonably 2008). Thus, the exemption applies not 623 (1984) (infringements on expressive necessary to the normal operation of [a] just to religious denominations and association are subject to strict
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scrutiny); Smith, 494 U.S. at 882 (‘‘[I]t 2. Government Programs or altering religious art, icons, is easy to envision a case in which a Protections for religious organizations scriptures, or other symbols from these challenge on freedom of association likewise exist in government contracts, facilities,’’ and they may continue to grounds would likewise be reinforced grants, and other programs. Recognizing ‘‘retain religious terms’’ in their names, by Free Exercise Clause concerns.’’). that religious organizations can make select ‘‘board members on a religious The government may be able to meet important contributions to government basis, and include religious references that standard with respect to race programs, see, e.g., 22 U.S.C. 7601(19), in . . . mission statements and other discrimination, see Bob Jones Univ., 461 Congress has expressly permitted chartering or governing documents.’’ Id. U.S. at 604, but may not be able to with religious organizations to participate in With respect to government contracts respect to other forms of discrimination. numerous such programs on an equal in particular, Executive Order 13279, 67 Fed. Reg. 77141 (Dec. 12, 2002), For example, at least one court has held basis with secular organizations, see, confirms that the independence and that forced inclusion of women into a e.g., 42 U.S.C. 290kk–1, 300x–65 604a, autonomy promised to religious mosque’s religious men’s meeting 629i. Where Congress has not expressly organizations include independence would violate the freedom of expressive so provided, the President has made and autonomy in religious hiring. association. Donaldson v. Farrakhan, clear that ‘‘[t]he Nation’s social service Specifically, it provides that the 762 N.E.2d 835, 840–41 (Mass. 2002). capacity will benefit if all eligible employment nondiscrimination organizations, including faith-based and The Supreme Court has also held that requirements in Section 202 of other neighborhood organizations, are the government’s interest in addressing Executive Order 11246, which normally able to compete on an equal footing for sexual-orientation discrimination is not apply to government contracts, do ‘‘not sufficiently compelling to justify an Federal financial assistance used to apply to a Government contractor or infringement on the expressive support social service programs.’’ Exec. subcontractor that is a religious association rights of a private Order No. 13559, § 1, 75 Fed. Reg. corporation, association, educational organization. Boy Scouts, 530 U.S. at 71319, 71319 (Nov. 17, 2010) (amending institution, or society, with respect to 659. Exec. Order No. 13279, 67 Fed. Reg. the employment of individuals of a 77141 (2002)). To that end, no As a statutory matter, RFRA too might particular religion to perform work organization may be ‘‘discriminated require an exemption or accommodation connected with the carrying on by such against on the basis of religion or for religious organizations from corporation, association, educational religious belief in the administration or antidiscrimination laws. For example, institution, or society of its activities.’’ distribution of Federal financial Exec. Order No. 13279, § 4, amending ‘‘prohibiting religious organizations assistance under social service from hiring only coreligionists can Exec. Order No. 11246, § 204(c), 30 Fed. programs.’’ Id. ‘‘Organizations that Reg. 12319, 12935 (Sept. 24, 1965). ‘impose a significant burden on their engage in explicitly religious activities exercise of religion, even as applied to Because the religious hiring (including activities that involve overt protection in Executive Order 13279 employees in programs that must, by religious content such as worship, law, refrain from specifically religious parallels the Section 702 exemption in religious instruction, or Title VII, it should be interpreted to activities.’’’ Application of the Religious proselytization)’’ are eligible to Freedom Restoration Act to the Award protect the decision ‘‘to employ only participate in such programs, so long as persons whose beliefs and conduct are of a Grant Pursuant to the Juvenile they conduct such activities outside of Justice and Delinquency Prevention Act, consistent with the employer’s religious the programs directly funded by the precepts.’’ Little, 929 F.2d at 951. That 31 Op. O.L.C. 162, 172 (2007) (quoting federal government and at a separate parallel interpretation is consistent with Direct Aid to Faith-Based Organizations time and location. Id. the Supreme Court’s repeated counsel Under the Charitable Choice Provisions The President has assured religious that the decision to borrow statutory of the Community Solutions Act of organizations that they are ‘‘eligible to text in a new statute is ‘‘strong 2001, 25 Op. O.L.C. 129, 132 (2001)); see compete for Federal financial assistance indication that the two statutes should also Corp. of Presiding Bishop, 483 U.S. used to support social service programs be interpreted pari passu.’’ Northcross v. at 336 (noting that it would be ‘‘a and to participate fully in the social Bd. of Educ. of Memphis City Sch., 412 significant burden on a religious services programs supported with U.S. 427 (1973) (per curiam); see also organization to require it, on pain of Federal financial assistance without Jerman v. Carlisle, McNellie, Rini, substantial liability, to predict which of impairing their independence, Kramer & Ulrich L.P.A., 559 U.S. 573, its activities a secular court w[ould] autonomy, expression outside the 590 (2010). It is also consistent with the consider religious’’ in applying a programs in question, or religious Executive Order’s own usage of nondiscrimination provision that character.’’ See id.; see also 42 U.S.C. discrimination on the basis of ‘‘religion’’ applied only to secular, but not 290kk–1(e) (similar statutory assurance). as something distinct and more religious, activities). If an organization Religious organizations that apply for or expansive than discrimination on the establishes the existence of such a participate in such programs may basis of ‘‘religious belief.’’ See, e.g., burden, the government must establish continue to carry out their mission, Exec. Order No. 13279, § 2(c) (‘‘No that imposing such burden on the ‘‘including the definition, development, organization should be discriminated organization is the least restrictive practice, and expression of . . . against on the basis of religion or means of achieving a compelling religious beliefs,’’ so long as they do not religious belief . . . ’’ (emphasis governmental interest. That is a use any ‘‘direct Federal financial added)); id. § 2(d) (‘‘All organizations demanding standard and thus, even assistance’’ received ‘‘to support or that receive Federal financial assistance where Congress has not expressly engage in any explicitly religious under social services programs should exempted religious organizations from activities’’ such as worship, religious be prohibited from discriminating its antidiscrimination laws—as it has in instruction, or proselytization. Exec. against beneficiaries or potential other contexts, see, e.g., 42 U.S.C. 3607 Order No. 13559, § 1. They may also beneficiaries of the social services (Fair Housing Act), 12187 (Americans ‘‘use their facilities to provide social programs on the basis of religion or with Disabilities Act)—RFRA might services supported with Federal religious belief. Accordingly, require such an exemption. financial assistance, without removing organizations, in providing services
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supported in whole or in part with effectively to relinquish its Section 702 required to provide military recruiters Federal financial assistance, and in their exemption is the least restrictive means with access to student recruiting outreach activities related to such of achieving a compelling governmental information. 20 U.S.C. 7908. It has services, should not be allowed to interest. See 42 U.S.C. 2000bb–1. exempted federal employees and discriminate against current or The First Amendment also ‘‘supplies contractors with religious objections to prospective program beneficiaries on a limit on Congress’ ability to place the death penalty from being required to the basis of religion, a religious belief, conditions on the receipt of funds.’’ ‘‘be in attendance at or to participate in a refusal to hold a religious belief, or a Agency for Int’l Dev. v. All. for Open any prosecution or execution.’’ 18 refusal to actively participate in a Soc’y Int’l, Inc., 133 S. Ct. 2321, 2328 U.S.C. 3597(b). It has allowed religious practice.’’). Indeed, because (2013) (internal quotation marks individuals with religious objections to the Executive Order uses ‘‘on the basis omitted)). Although Congress may certain forms of medical treatment to of religion or religious belief’’ in both specify the activities that it wants to opt out of such treatment. See, e.g., 33 the provision prohibiting discrimination subsidize, it may not ‘‘seek to leverage U.S.C. 907(k); 42 U.S.C. 290bb–36(f). It against religious organizations and the funding’’ to regulate constitutionally has created tax accommodations for provision prohibiting discrimination protected conduct ‘‘outside the contours members of religious faiths ‘‘against beneficiaries or potential of the program itself.’’ See id. Thus, if conscientiously opposed to acceptance beneficiaries,’’ a narrow interpretation a condition on participation in a of the benefits of any private or public of the protection for religious government program—including insurance, see, e.g., 26 U.S.C. 1402(g), organizations’ hiring decisions would eligibility for receipt of federally backed 3127, and for members of religious lead to a narrow protection for student loans—would interfere with a orders required to take a vow of poverty, beneficiaries of programs served by such religious organization’s constitutionally see, e.g., 26 U.S.C. 3121(r). protected rights, see, e.g., Hosanna- organizations. See id. §§ 2(c), (d). It Congress has taken special care with Tabor, 565 U.S. at 188–89, that would also lead to inconsistencies in respect to programs touching on condition could raise concerns under the treatment of religious hiring across abortion, sterilization, and other the ‘‘unconstitutional conditions’’ government programs, as some program- procedures that may raise religious doctrine, see All. for Open Soc’y Int’l, specific statutes and regulations conscience objections. For example, it expressly confirm that ‘‘[a] religious Inc., 133 S. Ct. at 2328. Finally, Congress has provided an has prohibited entities receiving certain organization’s exemption provided federal funds for health service under section 2000e–1 of this title additional statutory protection for educational institutions controlled by programs or research activities from regarding employment practices shall requiring individuals to participate in not be affected by its participation, or religious organizations who provide education programs or activities such program or activity contrary to receipt of funds from, a designated receiving federal financial assistance. their religious beliefs. 42 U.S.C. 300a– program.’’ 42 U.S.C. 290kk–1(e); see Such institutions are exempt from Title 7(d), (e). It has prohibited also 6 CFR § 19.9 (same). IX’s prohibition on sex discrimination discrimination against health care Even absent the Executive Order, in those programs and activities where professionals and entities that refuse to however, RFRA would limit the extent that prohibition ‘‘would not be undergo, require, or provide training in to which the government could consistent with the religious tenets of the performance of induced abortions; condition participation in a federal such organization[s].’’ 20 U.S.C. to provide such abortions; or to refer for grant or contract program on a religious 1681(a)(3). Although eligible such abortions, and it will deem organization’s effective relinquishment institutions may ‘‘claim the exemption’’ accredited any health care professional of its Section 702 exemption. RFRA in advance by ‘‘submitting in writing to or entity denied accreditation based on applies to all government conduct, not the Assistant Secretary a statement by such actions. Id. § 238n(a), (b). It has just to legislation or regulation, see 42 the highest ranking official of the also made clear that receipt of certain U.S.C. 2000bb–1, and the Office of Legal institution, identifying the provisions federal funds does not require an Counsel has determined that application . . . [that] conflict with a specific tenet individual ‘‘to perform or assist in the of a religious nondiscrimination law to of the religious organization,’’ 34 CFR performance of any sterilization the hiring decisions of a religious § 106.12(b), they are not required to do procedure or abortion if [doing so] organization can impose a substantial so to have the benefit of it, see 20 U.S.C. would be contrary to his religious burden on the exercise of religion. 1681. beliefs or moral convictions’’ nor an Application of the Religious Freedom entity to ‘‘make its facilities available for Restoration Act to the Award of a Grant, 3. Government Mandates the performance of’’ those procedures if 31 Op. O.L.C. at 172; Direct Aid to Congress has undertaken many such performance ‘‘is prohibited by the Faith-Based Organizations, 25 Op. similar efforts to accommodate religious entity on the basis of religious beliefs or O.L.C. at 132. Given Congress’s adherents in diverse areas of federal moral convictions,’’ nor an entity to ‘‘recognition that religious law. For example, it has exempted ‘‘provide any personnel for the discrimination in employment is individuals who, ‘‘by reason of religious performance or assistance in the permissible in some circumstances,’’ the training and belief,’’ are conscientiously performance of’’ such procedures if government will not ordinarily be able opposed to war from training and such performance or assistance ‘‘would to assert a compelling interest in service in the armed forces of the United be contrary to the religious beliefs or prohibiting that conduct as a general States. 50 U.S.C. 3806(j). It has moral convictions of such personnel.’’ condition of a religious organization’s exempted ‘‘ritual slaughter and the Id. § 300a–7(b). Finally, no ‘‘qualified receipt of any particular government handling or other preparation of health plan[s] offered through an grant or contract. Application of the livestock for ritual slaughter’’ from Exchange’’ may discriminate against any Religious Freedom Restoration Act to federal regulations governing methods health care professional or entity that the Award of a Grant, 31 Op. of O.L.C. of animal slaughter. 7 U.S.C. 1906. It has refuses to ‘‘provide, pay for, provide at 186. The government will also bear a exempted ‘‘private secondary school[s] coverage of, or refer for abortions,’’ heavy burden to establish that requiring that maintain [ ] a religious objection to § 18023(b)(4); see also Consolidated a particular contractor or grantee service in the Armed Forces’’ from being Appropriations Act, 2016, Public Law
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114–113, div. H, § 507(d), 129 Stat. DEPARTMENT OF JUSTICE To submit Send them to: 2242, 2649 (Dec. 18, 2015). comments: Notice of Lodging of Proposed Congress has also been particularly By email ...... pubcomment-ees.enrd@ solicitous of the religious freedom of Consent Decree Under the Oil Pollution Act usdoj.gov. American Indians. In 1978, Congress By mail ...... Assistant Attorney General, declared it the ‘‘policy of the United U.S. DOJ—ENRD, P.O. On October 19, 2017, the Department States to protect and preserve for Box 7611, Washington, DC of Justice lodged a proposed Consent 20044–7611. American Indians their inherent right of Decree (‘‘Consent Decree’’) with the freedom to believe, express, and United States District Court for the During the public comment period, exercise the traditional religions of the District of Massachusetts in the lawsuit the proposed Consent Decree may be American Indian, Eskimo, Aleut, and entitled United States, et al. v. examined and downloaded at this Native Hawaiians, including but not Bouchard Transportation Company, Justice Department Web site: https:// limited to access to sites, use and Inc., et al., Civil Action No. 1:17–cv– www.justice.gov/enrd/consent-decrees. possession of sacred objects, and the 12046–NMG. We will provide a paper copy of the freedom to worship through The proposed Consent Decree will proposed Consent Decree upon written ceremonials and traditional rites.’’ 42 settle claims of the United States (on request and payment of reproduction U.S.C. 1996. Consistent with that policy, behalf of the Department of Commerce/ costs. Please mail your request and it has passed numerous statutes to National Oceanic and Atmospheric payment to: Consent Decree Library, protect American Indians’ right of Administration and the Department of U.S. DOJ—ENRD, P.O. Box 7611, access for religious purposes to national the Interior/Fish and Wildlife Service), Washington, DC 20044–7611. park lands, Scenic Area lands, and the Commonwealth of Massachusetts, Please enclose a check or money order lands held in trust by the United States. and the State of Rhode Island for for $22.75 (25 cents per page See, e.g., 16 U.S.C. 228i(b), 410aaa– injuries to birds (other than piping reproduction cost), payable to the 75(a), 460uu–47, 543f, 698v–11(b)(11). It plover) under the Oil Pollution Act, 33 United States Treasury. has specifically sought to preserve lands U.S.C. 2701, et seq., (‘‘Trustees’’) against Robert E. Maher, Jr., of religious significance and has Bouchard Transportation Company, Assistant Section Chief, Environmental required notification to American Inc., and related companies Enforcement Section, Environment and Indians of any possible harm to or (‘‘Defendants’’), caused by an oil spill Natural Resources Division. destruction of such lands. Id. § 470cc. from the tank barge Bouchard No. 120 [FR Doc. 2017–23259 Filed 10–25–17; 8:45 am] Finally, it has provided statutory which occurred in April 2003 in BILLING CODE 4410–15–P exemptions for American Indians’ use of Buzzards Bay. Under the proposed otherwise regulated articles such as bald Consent Decree, the Defendants will pay eagle feathers and peyote as part of $13,300,000 to the Trustees as damages DEPARTMENT OF JUSTICE traditional religious practice. Id. for injuries to wildlife resources, as §§ 668a, 4305(d); 42 U.S.C. 1996a. defined in the Consent Decree. The Office of Justice Programs The depth and breadth of payment will be used to plan for and [OMB Number 1121–0197] constitutional and statutory protections implement the restoration, for religious observance and practice in rehabilitation, replacement, or acquisition of the equivalent of the Agency Information Collection America confirm the enduring damaged resources. In addition, the Activities; Proposed eCollection importance of religious freedom to the Defendants acknowledge payment of eComments Requested; Extension of United States. They also provide clear Currently Approved Collection almost $3,500,000 to the Trustees for guidance for all those charged with reimbursement of their assessment AGENCY: Office of Justice Programs, enforcing federal law: The free exercise costs. The proposed Consent Decree is of religion is not limited to a right to Department of Justice. the second settlement between the ACTION: 60 day notice. hold personal religious beliefs or even Trustees and the Defendants for injuries to worship in a sacred place. It to natural resources caused by the oil SUMMARY: The Department of Justice, encompasses all aspects of religious spill. Under the first settlement, entered Bureau of Justice Assistance, is observance and practice. To the greatest by the District Court in 2011, the submitting the following information extent practicable and permitted by law, Defendants paid the Trustees $6,076,393 collection request to the Office of such religious observance and practice for injuries to other natural resources Management and Budget (OMB) for should be reasonably accommodated in caused by the oil spill. review and approval in accordance with all government activity, including The publication of this notice opens the Paperwork Reduction Act of 1995. employment, contracting, and a period for public comment on the DATES: The Department of Justice programming. See Zorach v. Clauson, proposed Consent Decree. Comments encourages public comment and will 343 U.S. 306, 314 (1952) should be addressed to the Assistant accept input until December 26, 2017. (‘‘[Government] follows the best of our Attorney General, Environment and FOR FURTHER INFORMATION CONTACT: If traditions . . . [when it] respects the Natural Resources Division, and should you have additional comments religious nature of our people and refer to United States, et al. v. Bouchard especially on the estimated public accommodates the public service to Transportation Company, Inc., et al., burden or associated response time, their spiritual needs.’’). D.J. Ref. No. 90–5–1–1–08159/1. All suggestions, or need a copy of the [FR Doc. 2017–23269 Filed 10–25–17; 8:45 am] comments must be submitted no later proposed information collection BILLING CODE 4410–13–P; 4410–BB–P than thirty (30) days after the instrument with instructions or publication date of this notice. additional information, please contact Comments may be submitted either by Michelle Martin, Senior Management email or by mail: Analyst, Bureau of Justice Assistance,
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810 Seventh Street NW., Washington, payments to States and localities that DEPARTMENT OF LABOR DC 20531 (phone: 202 514–9354). incurred correctional officer salary costs SUPPLEMENTARY INFORMATION: Written for incarcerating undocumented Employment and Training comments and suggestions from the criminal aliens with at least one felony Administration or two misdemeanor convictions for public and affected agencies concerning Notice of the Task Force on the proposed collection of information violations of state or local law, and who Apprenticeship Expansion Charter are encouraged. Your comments should are incarcerated for at least 4 Establishment and Public Meeting address one or more of the following consecutive days during the designated four points: reporting period and for the following AGENCY: Employment and Training —Evaluate whether the proposed correctional purposes: Administration (ETA), Labor. collection of information is necessary ACTION: Notice. Salaries for corrections officers for the proper performance of the SUMMARY: The Department of Labor is functions of the Bureau of Justice Overtime costs publishing this notice to announce the Assistance, including whether the Performance based bonuses establishment of a Charter for the Task information will have practical utility; Corrections work force recruitment and —Evaluate the accuracy of the agency’s Force on Apprenticeship Expansion retention estimate of the burden of the (hereinafter ‘‘the Task Force’’ or ‘‘the proposed collection of information, Construction of corrections facilities panel’’), a non-discretionary federal advisory committee authorized pursuant including the validity of the Training/education for offenders methodology and assumptions used; to section 8 of Executive Order 13801, Training for corrections officers related —Evaluate whether and if so how the entitled ‘‘Expanding Apprenticeships in to offender population management quality, utility, and clarity of the America’’ (hereinafter ‘‘the Executive information to be collected can be Consultants involved with offender Order’’), which was issued on June 15, enhanced; and population 2017 (82 FR 28229) and which directed the Secretary of Labor to establish and —Minimize the burden of the collection Medical and mental health services of information on those who are to chair such a panel in the Department of Vehicle rental/purchase for transport of respond, including through the use of Labor and to provide notice, pursuant to appropriate automated, electronic, offenders section 10 of the Federal Advisory mechanical, or other technological Prison Industries Committee Act (FACA), of the initial public meeting of the Task Force to be collection techniques or other forms Pre-release/reentry programs of information technology, e.g., held on November 13, 2017. Technology involving offender permitting electronic submission of DATES: The initial public meeting of the responses. management/inter agency information Task Force will begin at approximately sharing 3:00 p.m. Eastern Standard Time on Overview of This Information Disaster preparedness continuity of November 13, 2017. Collection operations for corrections facilities ADDRESSES: The meeting will be held at 1. Type of Information Collection: the U.S. Department of Labor, Frances Extension of currently approved 5. An estimate of the total number of Perkins Building, 200 Constitution collection. respondents and the amount of time Avenue NW., Washington, DC 20210. 2. The Title of the Form/Collection: estimated for an average respondent to The Department will post any updates State Criminal Alien Assistance respond: It is estimated that no more regarding the agenda and meeting Program. than 800 respondents will apply. Each logistics to the Task Force Web site: 3. The agency form number, if any, application takes approximately 120 https://www.dol.gov/apprenticeship/ and the applicable component of the minutes to complete and is submitted task-force.htm. Department sponsoring the collection: once per year (annually). FOR FURTHER INFORMATION CONTACT: Mr. Bureau of Justice Assistance, Office of 6. An estimate of the total public John V. Ladd, Administrator, Office of Justice Programs, United States burden (in hours) associated with the Apprenticeship, Employment and Department of Justice. collection: The total hour burden to Training Administration, U.S. 4. Affected public who will be asked complete the applications is 1,600 Department of Labor, 200 Constitution or required to respond, as well as a brief hours. 800 × 120 minutes = 96,000/60 Avenue NW., Washington, DC 20210, abstract: minutes per hour = 1,600 burden hours Telephone: (202) 693–2796 (this is not Primary: States and local units of a toll-free number). If additional information is required general government including the 50 SUPPLEMENTARY INFORMATION: state governments, the District of contact: Melody Braswell, Department Columbia, Guam, Puerto Rico, the U.S. Clearance Officer, United States I. Task Force Charter Virgin Islands, and the more than 3,000 Department of Justice, Justice The Task Force has been established counties and cities with correctional Management Division, Policy and in accordance with the provisions of facilities. Planning Staff, Two Constitution FACA, as amended, 5 U.S.C. App. 2, Other: None. Square, 145 N Street NE., 3E.405A, and its implementing regulations (41 Abstract: In response to the Violent Washington, DC 20530. CFR 101–6 and 102–3). Interested Crime Control and Law Enforcement Dated: October 23, 2017. parties can obtain the Task Force’s Act of 1994 Section 130002(b) as charter on the Task Force Web site: amended in 1996, BJA administers the Melody Braswell, https://www.dol.gov/apprenticeship/ State Criminal Alien Assistance Department Clearance Officer for PRA, U.S. task-force.htm. The Task Force is Program (SCAAP) with the Bureau of Department of Justice. charged with the mission of identifying Immigration and Customs Enforcement [FR Doc. 2017–23279 Filed 10–25–17; 8:45 am] strategies and proposals to promote (ICE), and the Department of Homeland BILLING CODE 4410–18–P apprenticeships, especially in sectors Security (DHS). SCAAP provides federal where apprenticeship programs are
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insufficient. Upon completion of this designate a senior member of his or her meeting by Tuesday, November 7, 2017, assignment, the Task Force shall submit organization to attend any Task Force via the public registration Web site to the President of the United States a meeting. Members of the Task Force using the following link: https:// final report detailing these strategies shall serve without compensation for secure.thegateam.com/dol-aetf-reg/. and proposals. Pursuant to the their work on the Task Force, but shall Additionally, if individuals have special Executive Order and the charter, the be allowed travel expenses, including needs and/or disabilities that will report must specifically address the per diem in lieu of subsistence, to the require special accommodations, please following four topics: extent permitted by law for persons send an email to • Federal initiatives to promote serving intermittently in the [email protected], apprenticeships; Government service (5 U.S.C. 5701— subject line ‘‘Special Accommodations • Administrative and legislative 5707), consistent with the availability of for the November 2017 Task Force reforms that would facilitate the funds. Each member of the Task Force Meeting’’ no later than Tuesday, formation and success of apprenticeship shall serve at the pleasure of the November 7, 2017. programs; The tentative agenda for this meeting • Secretary of Labor for a term that will The most effective strategies for cease 30 days after the delivery of the includes the following: creating industry-recognized panel’s final report to the President, at • Strategies and proposals to promote apprenticeships; and • which time the Task Force will be apprenticeships The most effective strategies for disbanded officially. • amplifying and encouraging private- Federal initiatives to promote sector initiatives to promote II. Initial Public Meeting of the Task apprenticeships • Administrative and legal reforms apprenticeships. Force • Effective strategies for creating The Task Force is solely advisory in In order to promote openness, and nature, and will consider testimony, industry-recognized apprenticeships increase public participation, a viewing • Effective strategies for amplifying and reports, comments, research, evidence, room will be made available for and existing practices as appropriate to encouraging private-sector initiatives members of the public to observe the • Adjourn develop recommendations for inclusion meeting proceedings. Registration is in its final report to the President. While Any member of the public who required. Instructions on how to register wishes to provide a written statement the Executive Order did not set forth a are listed below and will be posted definite time by which the panel must should send an email to prominently on the Task Force Web site: complete its development of [email protected], https://www.dol.gov/apprenticeship/ apprenticeship-related strategies and subject line ‘‘Public Comment task-force.htm. Members of the public proposals and submit its final report to November 2017 Task Force Meeting.’’ that will view the meeting in-person, the President, it is important to note that The agenda and meeting logistics may from the viewing room, are encouraged the Task Force will not be continuing in be updated between the time of this to arrive early to allow for security nature. Additionally, given the nature publication and the scheduled date of clearance into the U.S. Department of and mission of the Task Force, some of the Task Force meeting. All meeting Labor, Frances Perkins Building. the meeting proceedings could be updates will be posted to the Task Force included in a regulatory docket for an Security and Transportation Web site: https://www.dol.gov/ apprenticeship rulemaking, or other Instructions for Frances Perkins apprenticeship/task-force.htm. collection of documents made available Building Nancy M. Rooney, by the agency for public viewing. Meeting participants should use the Deputy Assistant Secretary for the Pursuant to both the Executive Order visitor’s entrance to access the Frances Employment and Training Administration. and the Charter, the Task Force shall Perkins Building, one block north of [FR Doc. 2017–23305 Filed 10–25–17; 8:45 am] terminate 30 days after it submits its Constitution Avenue on 3rd and C BILLING CODE 4510–FR–P final report to the President. Streets NW. For security purposes: Under both the Executive Order and 1. Visitors must present valid photo the Charter, the Secretary of Labor shall identification (ID) to receive a visitor DEPARTMENT OF LABOR serve as the Chair of the Task Force. The badge. Secretaries of Education and Commerce 2. Visitors must know the name of the Occupational Safety and Health shall serve as Vice-Chairs of the Task event you are attending: the meeting Administration Force. The Secretary of Labor has event is the Task Force on [Docket No. OSHA–2016–0005] appointed the representative members Apprenticeship Expansion meeting. of the Task Force, which consists of 3. Visitor badges are issued by the Preparations for the 34th Session of twenty (20) individuals who work for or security officer at the Visitor Entrance the UN Sub-Committee of Experts on represent the perspectives of trade and located at 3rd and C Streets NW., as the Globally Harmonized System of industry groups, companies, workforce described above. Classification and Labelling of advocacy organizations, unions, joint 4. Laptops and other electronic Chemicals (UNSCEGHS) labor-management organizations, devices may be inspected and logged for educational institutions, state or local identification purposes. AGENCY: Occupational Safety and Health governments, and such other persons as 5. Due to limited parking options, Administration, Department of Labor. the Secretary of Labor may from time to Metro rail is the easiest way to travel to ACTION: Notice of public meeting. time designate. These members include the Frances Perkins Building. For distinguished citizens from outside of individuals wishing to take metro rail, SUMMARY: This notice is to advise the Federal Government with relevant the closest metro stop to the building is interested persons that on Tuesday, experience concerning the development Judiciary Square on the Red Line. November 14, 2017, from 1 p.m. to 4 of a skilled workforce through quality p.m., OSHA will conduct a public apprenticeship programs. Pursuant to Notice of Intent To Attend the Meeting: meeting to discuss proposals in the Executive Order and the charter, a All members of the public are being preparation for the 34th session of the member of the Task Force may asked to register for the Task Force United Nations Sub-Committee of
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Experts on the Globally Harmonized hazmat/regs/international, under meeting will be available upon System of Classification and Labelling Upcoming Events. This information will publication at: http:// of Chemicals (UNSCEGHS) to be held also be posted on OSHA’s Hazard www.regulations.gov (Docket No. December 6 through December 8, 2017, Communication Web site on the PHMSA–2017–0037, Notice No. 2017– in Geneva, Switzerland. OSHA, along international tab at: https:// 06), and on the PHMSA Web site at: with the U.S. Interagency GHS (Globally www.osha.gov/dsg/hazcom/hazcom_ http://www.phmsa.dot.gov/hazmat/ Harmonized System of Classification international.html#meeting-notice. regs/international. and Labelling of Chemicals) FOR FURTHER INFORMATION CONTACT: PHMSA will host the meeting to gain Coordinating Group, plans to consider At the Department of Transportation, input from the public concerning the comments and information gathered please contact: Mr. Steven Webb or Mr. proposals submitted to the UNSCE TDG at this public meeting when developing Aaron Wiener, Office of Hazardous for the 21st Revised Edition of the the U.S. Government positions for the Materials Safety, Department of United Nations Recommendations on UNSCEGHS meeting. OSHA also will Transportation, Washington, DC 20590, the Transport of Dangerous Goods give an update on the Regulatory telephone: (202) 366–8553. Model Regulations, which may be Cooperation Council (RCC). At the Department of Labor, please implemented into relevant domestic, On Tuesday, November 14, 2017, contact: Ms. Maureen Ruskin, OSHA regional, and international regulations from 9:00 a.m. to 12:00 p.m., the Directorate of Standards and Guidance, beginning January 1, 2021. During this Department of Transportation (DOT), Department of Labor, Washington, DC meeting, PHMSA is also soliciting input Pipeline and Hazardous Materials Safety 20210, telephone: (202) 693–1950, relative to preparing for the 52nd Administration (PHMSA) will conduct a email: [email protected]. session of the UNSCE TDG as well as public meeting (See Docket No. SUPPLEMENTARY INFORMATION: potential new work items that may be PHMSA–2017–0037 Notice No. 2017– The OSHA Meeting: OSHA is hosting considered for inclusion in its 06) to discuss proposals in preparation an open informal public meeting of the international agenda. for the 52nd session of the United U.S. Interagency GHS Coordinating Copies of working documents, Nations Sub-Committee of Experts on Group to provide interested groups and informal documents, and the meeting the Transport of Dangerous Goods individuals with an update on GHS- agenda may be obtained from the United (UNSCE TDG) to be held November 27 related issues and an opportunity to Nations Transport Division’s Web site to December 6, 2017, in Geneva, express their views orally and in writing at: http://www.unece.org/trans/danger/ Switzerland. During this meeting, for consideration in developing U.S. danger.html. PHMSA is also requesting comments Government positions for the upcoming Authority and Signature relative to potential new work items that UNSCEGHS meeting. may be considered for inclusion in its General topics on the agenda include: This document was prepared under international agenda. PHMSA will also • Review of Working/Informal papers the direction of Loren Sweatt, Acting provide an update on recent actions to • Correspondence Group updates Deputy Assistant Secretary of Labor for enhance transparency and stakeholder • Regulatory Cooperation Council (RCC) Occupational Safety and Health, U.S. interaction through improvements to the Update Department of Labor, pursuant to international standards portion of its Information on the work of the sections 4, 6, and 8 of the Occupational Web site. UNSCEGHS, including meeting Safety and Health Act of 1970 (29 U.S.C. DATES: Tuesday, November 14, 2017. agendas, reports, and documents from 653, 655, 657), and Secretary’s Order 1– ADDRESSES: Both meetings will be held previous sessions, can be found on the 2012 (77 FR 3912), (Jan. 25, 2012). at the DOT Headquarters Conference United Nations Economic Commission Signed at Washington, DC, on October 16, Center, West Building, Oklahoma City for Europe (UNECE) Transport Division 2017. Conference Room, 1200 New Jersey Web site located at the following Web Loren Sweatt, Avenue SE., Washington, DC 20590. address: http://www.unece.org/trans/ Deputy Assistant Secretary of Labor for Times and Locations: PHMSA public danger/publi/ghs/ghs_welcome_e.html. Occupational Safety and Health. meeting: 9:00 a.m. to 12:00 p.m. EDT, The UNSCEGHS bases its decisions [FR Doc. 2017–23261 Filed 10–25–17; 8:45 am] Oklahoma City Conference Room, on Working Papers. The Working Papers BILLING CODE 4510–26–P OSHA public meeting: 1:00 p.m. to 4:00 for the 34th session of the UNSCEGHS p.m. EDT, Oklahoma City Conference are located at: https://www.unece.org/ Room trans/main/dgdb/dgsubc4/c42017.html. DEPARTMENT OF LABOR Advanced Meeting Registration: The Informal Papers submitted to the DOT requests that attendees pre-register UNSCEGHS provide information for the Mine Safety and Health Administration for these meetings by completing the Sub-committee and are used either as a form at: https:// mechanism to provide information to Petitions for Modification of www.surveymonkey.com/r/GHSZ2Q9 . the Sub-committee or as the basis for Application of Existing Mandatory Attendees may use the same form to future Working Papers. Safety Standards pre-register for both meetings. Failure to In addition to participating at the AGENCY: pre-register may delay your access into Public meeting, interested parties may Mine Safety and Health the DOT Headquarters building. submit comments on the Working and Administration, Labor. Additionally, if you are attending in- Informal Papers for the 34th session of ACTION: Notice. person, arrive early to allow time for the UNSCEGHS to the docket security checks necessary to access the established for International/Globally SUMMARY: This notice is a summary of building. Harmonized System (GHS) efforts at petitions for modification submitted to Conference call-in and ‘‘Skype http://www.regulations.gov, Docket No. the Mine Safety and Health meeting’’ capability will be provided for OSHA–2016–0005. Administration (MSHA) by the parties both meetings. Specific information on The PHMSA Meeting: The Federal listed below. such access will be posted when Register notice and additional detailed DATES: All comments on the petitions available at: http://www.phmsa.dot.gov/ information relating to PHMSA’s public must be received by MSHA’s Office of
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Standards, Regulations, and Variances Petitioner: Revelation Energy, LLC, handrails will be utilized to provide safe on or before November 27, 2017. P.O. Box 249, Stanville, Kentucky access for travel across a pool of water. ADDRESSES: You may submit your 41659. (b) Each end of the bridge across the comments, identified by ‘‘docket Mine: D–1A Garmeada Mine, MSHA entry will be blocked with danger signs, number’’ on the subject line, by any of I.D. No. 15–19791, located in Bell flagging, and/or fencing to warn miners the following methods: County, Kentucky. of the potential hazard and that travel 1. Electronic Mail: zzMSHA- Regulation Affected: 30 CFR through this area is only permitted [email protected]. Include the docket 75.364(b)(2) (Weekly examination). across the bridge. number of the petition in the subject Modification Request: The petitioner (c) A pump will be maintained in the line of the message. requests a modification of the existing pool to maintain the water level. 2. Facsimile: 202–693–9441. standard in reference to weekly (d) Life vests will be provided and 3. Regular Mail or Hand Delivery: examinations in its entirety for the worn while traveling across the bridge. MSHA, Office of Standards, hazardous condition of return air (e) All miners at the D–1A Garmeada Regulations, and Variances, 201 12th course. The petitioner states that: mine will be given notice of this request Street South, Suite 4E401, Arlington, (1) As a result of a dip with a steep for modification during safety meetings. Within 60 days after approval of this Virginia 22202–5452, Attention: Sheila incline on the end, a large pool of water petition and the order becoming final, McConnell, Director, Office of has developed at the outby end of the the petitioner will submit proposed Standards, Regulations, and Variances. Northwest Mains and extending inby revisions to the Part 48 training plan to Persons delivering documents are approximately 1200 feet in the right- the District Manager. These revisions required to check in at the receptionist’s side return, in the No. 5 entry. This will apply to initial and refresher desk in Suite 4E401. Individuals may mine utilizes split air and there are two training. inspect copies of the petition and returns. There is a return entry in the The petitioner asserts that the comments during normal business No. 1 entry also. Currently, a 10-horse- proposed alternative method will at all hours at the address listed above. power pump with a 2-inch discharge times guarantee no less than the same MSHA will consider only comments line is installed in the pool of water. measure of protection afforded by the postmarked by the U.S. Postal Service or This is a low spot in the mine with existing standard. proof of delivery from another delivery elevations rising going in each direction. service such as UPS or Federal Express The mine height in this area is Docket Number: M–2017–019–C. on or before the deadline for comments. approximately 12 feet. The water level Petitioner: Marfork Coal Company, Inc., 500 Lee Street, East, Suite 701 is currently 41⁄2 feet deep. The water has FOR FURTHER INFORMATION CONTACT: (25301), Post Office Box 2548, Barbara Barron, Office of Standards, been pumped down to current levels, reducing the affected area to Charleston, WV 25329. Regulations, and Variances at 202–693– Mine: Slip Ridge Cedar Grove Mine, approximately 70 feet in length. It is 9447 (Voice), [email protected] MSHA I.D. No. 46–09048, located in proposed to utilize a metal catwalk (Email), or 202–693–9441 (Facsimile). Raleigh County, West Virginia. [These are not toll-free numbers.] bridge, with handrails to provide safe Regulation Affected: 30 CFR 75.360 SUPPLEMENTARY INFORMATION: Section travel through this area for the weekly (Preshift examination at fixed intervals). 101(c) of the Federal Mine Safety and examinations. The bridge would Modification Request: The petitioner Health Act of 1977 and Title 30 of the provide safer travel through the area, as requests a modification of the existing Code of Federal Regulations Part 44 the bridge is level. If the water is standard as it pertains to preshift govern the application, processing, and completely pumped out, it would result examinations that are only required on disposition of petitions for modification. in a steep, slippery slope that would be a side of the mine that is active (i.e. both treacherous to travel and could sides of the mine only have to be fully I. Background contribute to slip, trip, and fall hazards. examined when both sides are active). Section 101(c) of the Federal Mine It would be difficult to establish and The petitioner states that: Safety and Health Act of 1977 (Mine maintain safe travel in this portion of (1) The Slip Ridge mine is a large Act) allows the mine operator or the right return, No. 5 entry. underground coal mine that has been representative of miners to file a (2) The remaining life of the reserve permanently divided into three separate petition to modify the application of any is approximately 10 years. Access to this areas via the installation of MSHA- mandatory safety standard to a coal or reserve is only possible through the approved 120 PSI mine seals. other mine if the Secretary of Labor existing mine drifts, as all other (2) On the East end of the mine is the determines that: approaches are blocked by abandoned Ellis Creek Side and this is the active 1. An alternative method of achieving mines. The procedures listed in this mining side with two continuous miner the result of such standard exists which petition will provide a level of safety no sections producing 5 to 6 days a week. will at all times guarantee no less than less than equivalent to that afforded by (3) The West end of the mine is called the same measure of protection afforded 30 CFR 75.364(b)(2) for the remaining the Slip Ridge Transfer and this end of the miners of such mine by such life of the mine. the mine serves only as a belt through standard; or (3) Therefore, the petitioner proposes (i.e. transfer) for coal from two other 2. That the application of such an alternate plan to provide safe access Marfork mines (Horse Creek and Allen standard to such mine will result in a over pooled water in the right return, Powellton) on its way to the Marfork diminution of safety to the miners in No. 5 entry for approximately 70 feet at Plant. such mine. the outby end of the Northwest Mains. (4) The East and West ends of the In addition, the regulations at 30 CFR The petitioner states that use of the mine are separated by approximately 44.10 and 44.11 establish the bridge as described below will keep 3.66 miles of old mine works that were requirements and procedures for filing employees from being exposed to sealed on each end with MSHA- petitions for modification. hazardous travel in order to meet the approved 120 PSI seals. requirements of the applicable standard: (5) The East and West ends of the II. Petitions for Modification (a) A metal catwalk bridge mine are ventilated by separate mine Docket Number: M–2017–018–C. approximately 75 feet long with fans.
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(6) The East and West ends of the status of each fan can be monitored from (d) From the end of the common mine are monitored by separate CO both sides of the mine. horizontal bore, several interconnected systems. (g) In the event of a fan stoppage on horizontal bores, ranging from 5 to 6.5 (7) The East and West ends of the one side of the mine, both sides will inches in diameter are drilled mine have their own dispatcher. withdraw personnel. horizontally through the coalbed for (8) Other than being on the opposite (h) In the event of a fan stoppage on distances up to 3500 feet; ends of a common sealed area, the East an idle side of the mine, the active side (e) A second vertical wellbore and West ends of the mine are would be alerted via an alarm and (production hole) is drilled to intersect effectively separate and independent personnel will be withdrawn from the the common horizontal bore. The underground coal mines. active side. production hole is commonly cased (9) Currently, if the East side of the The petitioner asserts that the with 7-inch O.D. casing to a point 100 mine is scheduled to produce coal, the proposed alternative method will at all feet more or less above the coal seam. regulations require preshift times guarantee no less than the same The production hole is drilled 50 to 100 examinations in accordance with 30 measure of protection afforded by the feet below the coal seam to provide a CFR 75.360 be completed on both sides existing standard by ensuring that the ‘‘rat-hole’’ for pumping liquid from the of the mine, regardless of their examinations are performed on the well; and autonomy. active side of the mine while (f) Coal bed methane gas entering the (10) Application of the existing continually monitoring the fan and CO horizontal wellbores travels through the standard may result in a diminution of systems on the idle side of the mine. common horizontal bore to the safety to the miners as it currently Docket Number: M–2017–020–C. production hole and then to the surface. requires that preshift examination on Petitioner: Spartan Mining Company, (3) The Road Fork #52 Mine will both the East and West ends of the mine 500 Lee Street, East, Suite 701 (25301), employ the continuous mining room be performed on any day that either end Post Office Box 2548, Charleston, WV and pillar method of mining. It is of the mine will be active (i.e. the West 25329. anticipated that each lateral wellbore end has to be fully examined preshift Mine: Road Fork #52 Mine, MSHA will be mined through at least once. every day that the East end wants to I.D. No. 46–09522, located in Wyoming (4) Prior to mining within 50 feet (+1- produce coal even if the West end is County, West Virginia. degree accuracy factor) of a horizontal idle). Preshift examination of the idle Regulation Affected: 30 CFR 75.1700 wellbore, the petitioner proposes to side of the Slip Ridge Mine does not (Oil and gas wells). verify that the following procedures advance safety for the miners working Modification Request: The petitioner have been performed on the well: on the active side of the mine and can requests a modification of the existing (a) The well will be vented to outside expose examiners on the idle side to standard in the following three atmosphere pressure for at least 8 hours; additional time and hazards situations: (1) When mining within 50 (b) A volume of fresh water sufficient underground. feet (+1-degree accuracy factor) of a to fill the horizontal (lateral) wellbores The petitioner proposes the following horizontal wellbore; (2) when initially will be injected into the well with alternative method of compliance to the mining through a horizontal wellbore; sufficient pressure to attain a existing standard: bottomhole pressure of approximately (a) Since the East and West side are and (3) when subsequently mining 500 pounds per square inch (PSI); separated by two sets of 120 PSI seals, through horizontal wellbores as (c) The liquid will be bailed from the ventilated with their own mine fans and addressed in this petition. The production hole, using normal bailing monitored by independent CO systems, petitioner states that: equipment, to a point just above the each end of the mine should be treated (1) Potential in-seam methane in the level of the coal seam; separately for purposes of 30 CFR majority of the Road Fork #52 Mine 75.360. reserve area has been reduced and/or (d) A volume of gel, made up of 2 to (b) On any active side of the Slip extracted by the drilling operation of 4 percent bentonite and fresh water, Ridge Mine, a preshift examination as horizontal coalbed methane wells by sufficient to fill the horizontal wellbores set forth in 30 CFR 75.360 will be CDX Gas, LLC (‘‘CDX’’). The first well plus 25 percent excess, will be injected performed. in the area was put into production in into the well with sufficient pressure to (b) No preshift examination under 30 January 2006 and the last in October attain a bottomhole pressure of CFR 75.360 will be required on an idle 2006. The location of these wells in approximately 500 PSI; and side of the mine. relation to the future mining for the (e) The wellbore will be filled to the (c) Preshift examinations of the idle Road Fork #52 Mine is shown on the surface with fresh water and allowed to side of the mine will be performed prior map attached to this petition as Exhibit stand for at least 72 hours, with the to work being performed underground A. (Road Fork #52 Mine will mine coal water level being supplemented as on the previously idle side of the mine. to the left of the mining shown on the required. In the alternative, water will (d) Marfork will update the CO map). be injected into the wellbore for 72 monitoring systems to allow either side (2) CDX will use the following hours at an average rate of 2 gallons per of the dispatcher to monitor the CO methodology to drill these wells: minute or more. systems for both sides of the mine. This (a) A vertical wellbore (access hole) is (5) Prior to mining through the first dual monitoring will allow the drilled and cased to a point 150 feet or lateral wellbore of a horizontal coalbed atmospheric conditions in the idle side more above the coal seal; methane well, the petitioner proposes to of the mine to be monitored by the (b) From the bottom of the casing in verify that the following procedures dispatcher on the active side of the the access hole, a curved hole is drilled have been performed on the well: mine. to intersect the coal seal at a tangent (a) The water will be bailed from the (e) If a CO event occurs that would point; vertical section of the wellbore, as close otherwise require evacuation, both sides (c) From the tangent point, a short to the coal seam elevation as practical will withdraw personnel. common horizontal bore is drilled using normal bailing equipment; (f) Marfork will set up dual horizontally through the coal seam for a (b) The surface wellhead will be monitoring of both mine fans so that the distance up to 500 feet; maintained open to bring the vertical
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section of the wellbore to outside to the coal seam elevation as practical measure of protection afforded by the atmospheric pressure; using normal bailing equipment; existing standard. (c) The petitioner further states that (b) The surface well head will be the MSHA District Manager and the Sheila McConnell, maintained open to bring the vertical appropriate West Virginia Office of Director, Office of Standards, Regulations, section of the wellbore to outside Miners’ Health Safety and Training and Variances. atmospheric pressure; representative will be notified at least [FR Doc. 2017–23263 Filed 10–25–17; 8:45 am] 48 hours prior to the anticipated mine- (c) Drivage sights will be installed BILLING CODE 4520–43–P through time; within 80 feet of the mine-through (d) Drivage sights will be installed point; within 80 feet of the mine-through (d) Firefighting equipment will be LEGAL SERVICES CORPORATION point; provided near the working face, (e) Firefighting equipment will be Notice of Intent To Award—Grant including two 10-pound fire provided near the working face, Awards for the Provision of Civil Legal extinguishers, 240 pounds of rock dust, including two 10-pound fire Services to Eligible Low-Income and fire hose of sufficient length to extinguishers, 240 pounds of rock dust, Clients Beginning January 1, 2018 and fire hose of sufficient length to reach the working face and capable of reach the working face and capable of delivering at least 50 gallons per minute AGENCY: Legal Services Corporation. delivering at least 50 gallons per minute of water at minimum pressure of 50 PSI; ACTION: Announcement of intention to of water at minimum pressure of 50 PSI; (e) At least 9,000 CFM of intake air at make FY 2018 Grant Awards. (f) At least 9,000 CFM of intake air at the face will be supplied, but no less SUMMARY: The Legal Services the face will be supplied, but no less than the amount in the approved Corporation (LSC) hereby announces its than the amount in the approved ventilation plan; intention to award grants to provide ventilation plan; (f) The continuous miner methane (g) The continuous miner methane economical and effective delivery of monitor will be calibrated on one of the monitor will be calibrated prior to use high quality civil legal services to five production shifts prior to the shift when the mine-through is anticipated or eligible low-income clients, beginning is occurring; during which the mine-through is January 1, 2018. (h) A test for methane will be anticipated; DATES: All comments and conducted with a hand-held methane (g) A test for methane will be recommendations must be received on detector at least every 10 minutes provided with a hand-held methane or before the close of business on during the time mining commences at detector at least every 10 minutes November 27, 2017. the minimum barrier distance line or during the time mining is conducted ADDRESSES: Legal Services within 30 feet of the wellbore, within 30 feet of the wellbore; Corporation—Grant Awards, Legal whichever is greater; (h) All equipment will be deenergized Services Corporation; 3333 K Street (i) All equipment will be deenergized and the area thoroughly examined when NW., Third Floor, Washington, DC and the area thoroughly examined when the wellbore is intersected; 20007. the wellbore is intersected; (j) Once the area has been determined (i) Once the area has been determined FOR FURTHER INFORMATION CONTACT: to be safe and mining has resumed, to be safe and mining has resumed, Reginald Haley, Office of Program hand-held methane detector tests will hand-held methane detector tests will Performance, at (202) 295–1545, or continue at least every 10 minutes continue at lease every 10 minutes [email protected]. during production shifts, until mining during production shifts, until mining SUPPLEMENTARY INFORMATION: Pursuant has progressed 20 feet past the initial has progressed 20 feet past the initial to LSC’s announcement of funding mine-through point; mine-through point; availability on March 22, 2017, 82 FR 14753, and Grant Renewal applications (k) No persons will be permitted in (j) No persons will be permitted in the the area of the mine-through operation due beginning June 5, 2017, LSC intends area of the mine-through operation except those persons actually engaged to award funds to provide civil legal except those persons actually engaged in the operation, including mine services in the indicated service areas. in the operation, including mine management, personnel from MSHA, Applicants for each service area are and personnel from the appropriate management, personnel from MSHA, listed below. The amounts below are State agency; and and personnel from the appropriate estimates based on the 2017 grant (l) A certified official will directly State agency; awards to each service area. The supervise the mine-through operation (k) A certified official will directly estimates incorporate the adjustments and only the certified official in charge supervise the mine-through operation for the agricultural worker population as will issue instructions concerning the and only the certified official in charge described at http://www.lsc.gov/ag- mine-through operation. will issue instructions concerning the worker-data. The funding estimates may (6) Prior to mining through a lateral mine-through operation; and change based on the final FY 2018 wellbore of a coalbed methane well appropriation. (l) The production hole will remain which has already at least one lateral LSC will post all updates and/or open and accessible until all mining wellbore mined through, the petitioner changes to this notice at http:// susceptible of intersecting horizontal proposes to verify the following www.grants.lsc.gov/grants-grantee- procedures have been performed on the wellbores has been completed. resources. Interested parties are asked to well: The petitioner asserts that the visit http://www.grants.lsc.gov/grants- (a) The water will be bailed from the proposed alternative method will at all grantee-resources regularly for updates vertical section of the wellbore, as close times guarantee no less than the same on the LSC grants process.
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Estimated Name of applicant organization State Service annualized area 2018 funding
Alaska Legal Services Corporation ...... AK AK–1 $741,073 Alaska Legal Services Corporation ...... AK NAK–1 556,121 Legal Services Alabama ...... AL AL–4 6,072,761 Legal Aid of Arkansas ...... AR AR–6 1,458,221 Center for Arkansas Legal Services ...... AR AR–7 2,121,222 American Samoa Legal Aid ...... AS AS–1 216,951 DNA-Peoples Legal Services ...... AZ AZ–2 423,371 Community Legal Services ...... AZ AZ–3 5,403,988 Southern Arizona Legal Aid ...... AZ AZ–5 2,145,113 Community Legal Services ...... AZ MAZ 205,629 DNA-Peoples Legal Services ...... AZ NAZ–5 2,683,310 Southern Arizona Legal Aid ...... AZ NAZ–6 655,456 California Indian Legal Services ...... CA CA–1 20,695 Inland Counties Legal Services ...... CA CA–12 5,227,831 Legal Aid Society of San Diego ...... CA CA–14 2,997,072 Legal Aid Society of Orange County ...... CA CA–19 3,861,757 Greater Bakersfield Legal Assistance ...... CA CA–2 1,135,641 Central California Legal Services ...... CA CA–26 3,226,959 Legal Services of Northern California ...... CA CA–27 3,878,184 Bay Area Legal Aid ...... CA CA–28 4,156,552 Legal Aid Foundation of Los Angeles ...... CA CA–29 6,247,806 Neighborhood Legal Services of Los Angeles County ...... CA CA–30 4,391,958 California Rural Legal Assistance ...... CA CA–31 5,019,889 California Rural Legal Assistance ...... CA MCA 2,525,354 California Indian Legal Services ...... CA NCA–1 908,493 Colorado Legal Services ...... CO CO–6 4,093,066 Colorado Legal Services ...... CO MCO 209,157 Colorado Legal Services ...... CO NCO–1 98,754 Statewide Legal Services of Connecticut ...... CT CT–1 2,499,625 Pine Tree Legal Assistance ...... CT NCT–1 16,099 Neighborhood Legal Services Program of DC ...... DC DC–1 754,782 Legal Services Corporation of Delaware ...... DE DE–1 761,226 Legal Aid Bureau ...... DE MDE 12,961 Legal Services of North Florida ...... FL FL–13 1,463,367 Three Rivers Legal Services ...... FL FL–14 2,163,335 Community Legal Services of Mid-Florida ...... FL FL–15 4,660,189 Bay Area Legal Services ...... FL FL–16 3,430,322 Florida Rural Legal Services ...... FL FL–17 3,918,976 Coast to Coast Legal Aid of South Florida ...... FL FL–18 2,104,893 Legal Services of Greater Miami ...... FL FL–5 3,623,941 Florida Rural Legal Services ...... FL MFL 539,561 Atlanta Legal Aid Society ...... GA GA–1 3,802,513 Georgia Legal Services Program ...... GA GA–2 8,192,300 Georgia Legal Services Program ...... GA MGA 268,109 Guam Legal Services Corporation ...... GU GU–1 244,499 Legal Aid Society of Hawaii ...... HI HI–1 1,284,668 Legal Aid Society of Hawaii ...... HI NHI–1 235,552 Iowa Legal Aid ...... IA IA–3 2,184,470 Iowa Legal Aid ...... IA MIA 324,185 Idaho Legal Aid Services ...... ID ID–1 1,374,816 Idaho Legal Aid Services ...... ID MID 248,309 Idaho Legal Aid Services ...... ID NID–1 66,807 Land of Lincoln Legal Assistance Foundation ...... IL IL–3 2,551,787 Legal Assistance Foundation ...... IL IL–6 5,874,008 Prairie State Legal Services ...... IL IL–7 3,632,099 Legal Assistance Foundation ...... IL MIL 249,804 Indiana Legal Services ...... IN IN–5 6,461,021 Indiana Legal Services ...... IN MIN 183,575 Kansas Legal Services ...... KS KS–1 2,610,245 Legal Aid of the Bluegrass ...... KY KY–10 1,439,798 Legal Aid Society ...... KY KY–2 1,254,797 Appalachian Research and Defense Fund of Kentucky ...... KY KY–5 1,593,861 Kentucky Legal Aid ...... KY KY–9 1,104,495 Acadiana Legal Service Corporation ...... LA LA–10 1,459,894 Acadiana Legal Service Corporation ...... LA LA–11 1,535,486 Southeast Louisiana Legal Services Corporation ...... LA LA–13 2,970,261 Community Legal Aid ...... MA MA–10 1,463,593 Volunteer Lawyers Project of the Boston Bar Assoc...... MA MA–11 2,005,092 South Coastal Counties Legal Services ...... MA MA–12 838,353 Northeast Legal Aid ...... MA MA–4 800,614 Legal Aid Bureau ...... MD MD–1 3,973,616 Legal Aid Bureau ...... MD MMD 49,208
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Estimated Name of applicant organization State Service annualized area 2018 funding
Pine Tree Legal Assistance ...... ME ME–1 1,168,230 Pine Tree Legal Assistance ...... ME MMX–1 253,514 Pine Tree Legal Assistance ...... ME NME–1 66,279 Michigan Advocacy Program ...... MI MI–12 1,532,726 Lakeshore Legal Aid ...... MI MI–13 4,265,840 Legal Services of Eastern Michigan ...... MI MI–14 1,579,715 Legal Aid of Western Michigan ...... MI MI–15 2,205,241 Legal Services of Northern Michigan ...... MI MI–9 799,487 Michigan Advocacy Program ...... MI MMI 317,148 Michigan Indian Legal Services ...... MI NMI–1 169,276 Southern Minnesota Regional Legal Services ...... MN MMN 280,032 Legal Aid Service of Northeastern Minnesota ...... MN MN–1 439,608 Legal Services of Northwest Minnesota Corporation ...... MN MN–4 319,678 Southern Minnesota Regional Legal Services ...... MN MN–5 1,525,475 Central Minnesota Legal Services ...... MN MN–6 1,604,909 Anishinabe Legal Services ...... MN NMN–1 245,745 Legal Aid of Western Missouri ...... MO MMO 193,905 Legal Aid of Western Missouri ...... MO MO–3 1,913,195 Legal Services of Eastern Missouri ...... MO MO–4 1,894,630 Mid-Missouri Legal Services Corporation ...... MO MO–5 443,463 Legal Services of Southern Missouri ...... MO MO–7 1,752,017 Micronesian Legal Services ...... MP MP–1 1,226,169 Mississippi Center for Legal Services ...... MS MS–10 2,525,075 North Mississippi Rural Legal Services ...... MS MS–9 1,591,595 Mississippi Center for Legal Services ...... MS NMS–1 85,478 Montana Legal Services Association ...... MT MMT 105,592 Montana Legal Services Association ...... MT MT–1 944,446 Montana Legal Services Association ...... MT NMT–1 163,734 Legal Aid of North Carolina ...... NC MNC 377,999 Legal Aid of North Carolina ...... NC NC–5 11,003,144 Legal Aid of North Carolina ...... NC NNC–1 224,422 Southern Minnesota Regional Legal Services ...... ND MND 118,792 Legal Services of North Dakota ...... ND ND–3 442,291 Legal Services of North Dakota ...... ND NND–3 276,997 Legal Aid of Nebraska ...... NE MNE 222,006 Legal Aid of Nebraska ...... NE NE–4 1,328,345 Legal Aid of Nebraska ...... NE NNE–1 33,990 Legal Advice & Referral Center ...... NH NH–1 780,387 South Jersey Legal Services ...... NJ MNJ 69,612 Legal Services of Northwest Jersey ...... NJ NJ–15 404,393 Central Jersey Legal Services ...... NJ NJ–17 1,140,290 Northeast New Jersey Legal Services Corporation ...... NJ NJ–18 1,896,940 South Jersey Legal Services ...... NJ NJ–20 2,241,706 Essex-Newark Legal Services Project ...... NJ NJ–8 882,685 New Mexico Legal Aid ...... NM MNM 95,692 DNA-Peoples Legal Services ...... NM NM–1 177,469 New Mexico Legal Aid ...... NM NM–5 2,701,602 DNA-Peoples Legal Services ...... NM NNM–2 23,363 New Mexico Legal Aid ...... NM NNM–4 477,790 Nevada Legal Services ...... NV NNV–1 136,737 Nevada Legal Services ...... NV NV–1 2,910,481 Legal Aid Society of Mid-New York ...... NY MNY 243,284 Legal Services of the Hudson Valley ...... NY NY–20 1,749,323 Legal Aid Society of Northeastern New York ...... NY NY–21 1,274,588 Legal Aid Society of Mid-New York ...... NY NY–22 1,641,366 Legal Assistance of Western New York ...... NY NY–23 1,666,745 Neighborhood Legal Services ...... NY NY–24 1,223,693 Nassau/Suffolk Law Services Committee ...... NY NY–7 1,319,382 Legal Services NYC ...... NY NY–9 11,772,176 Legal Aid of Western Ohio ...... OH MOH 224,663 Legal Aid Society of Greater Cincinnati ...... OH OH–18 1,620,098 Community Legal Aid Services ...... OH OH–20 1,780,903 The Legal Aid Society of Cleveland ...... OH OH–21 2,216,388 Legal Aid of Western Ohio ...... OH OH–23 2,978,972 Ohio State Legal Services ...... OH OH–24 3,358,791 Legal Aid Services of Oklahoma ...... OK MOK 138,399 Oklahoma Indian Legal Services ...... OK NOK–1 841,963 Legal Aid Services of Oklahoma ...... OK OK–3 4,116,455 Legal Aid Services of Oregon ...... OR MOR 443,163 Legal Aid Services of Oregon ...... OR NOR–1 189,825 Legal Aid Services of Oregon ...... OR OR–6 3,952,261 Philadelphia Legal Assistance Center ...... PA MPA 177,851
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Estimated Name of applicant organization State Service annualized area 2018 funding
Philadelphia Legal Assistance Center ...... PA PA–1 2,650,729 Southwestern Pennsylvania Legal Services ...... PA PA–11 416,614 Legal Aid of Southeastern Pennsylvania ...... PA PA–23 1,302,652 North Penn Legal Services ...... PA PA–24 1,877,867 MidPenn Legal Services ...... PA PA–25 2,429,480 Northwestern Legal Services ...... PA PA–26 652,434 Laurel Legal Services ...... PA PA–5 593,479 Neighborhood Legal Services Association ...... PA PA–8 1,372,284 Puerto Rico Legal Services ...... PR MPR 53,561 Puerto Rico Legal Services ...... PR PR–1 10,783,976 Community Law Office ...... PR PR–2 241,905 Rhode Island Legal Services ...... RI RI–1 986,794 South Carolina Legal Services ...... SC MSC 128,776 South Carolina Legal Services ...... SC SC–8 5,626,709 Dakota Plains Legal Services ...... SD NSD–1 960,128 East River Legal Services ...... SD SD–2 396,301 Dakota Plains Legal Services ...... SD SD–4 400,598 Legal Aid Society of Middle TN and the Cumberlands ...... TN TN–10 3,107,225 Memphis Area Legal Services ...... TN TN–4 1,553,797 West Tennessee Legal Services ...... TN TN–7 698,100 Legal Aid of East Tennessee ...... TN TN–9 2,497,599 Texas RioGrande Legal Aid ...... TX MSX–2 1,608,920 Texas RioGrande Legal Aid ...... TX NTX–1 32,183 Lone Star Legal Aid ...... TX TX–13 10,395,557 Legal Aid of NorthWest Texas ...... TX TX–14 9,004,475 Texas RioGrande Legal Aid ...... TX TX–15 10,707,097 Utah Legal Services ...... UT MUT 76,980 Utah Legal Services ...... UT NUT–1 84,598 Utah Legal Services ...... UT UT–1 2,241,282 Central Virginia Legal Aid Society ...... VA MVA 155,344 Southwest Virginia Legal Aid Society ...... VA VA–15 716,279 Legal Aid Society of Eastern Virginia ...... VA VA–16 1,296,346 Virginia Legal Aid Society ...... VA VA–17 897,396 Central Virginia Legal Aid Society ...... VA VA–18 1,185,499 Blue Ridge Legal Services ...... VA VA–19 790,876 Legal Services of Northern Virginia ...... VA VA–20 1,460,820 Legal Services of the Virgin Islands ...... VI VI–1 161,119 Legal Services Law Line of Vermont ...... VT VT–1 467,902 Northwest Justice Project ...... WA MWA 585,992 Northwest Justice Project ...... WA NWA–1 292,929 Northwest Justice Project ...... WA WA–1 5,645,286 Legal Action of Wisconsin ...... WI MWI 331,424 Wisconsin Judicare ...... WI NWI–1 159,512 Wisconsin Judicare ...... WI WI–2 897,777 Legal Action of Wisconsin ...... WI WI–5 3,806,115 Legal Aid of West Virginia ...... WV WV–5 2,235,497 Legal Aid of Wyoming ...... WY NWY–1 177,694 Legal Aid of Wyoming ...... WY WY–4 434,973
These grants will be awarded under Dated: October 23, 2017. a notice of permit applications received the authority conferred on LSC by Stefanie K. Davis, to conduct activities regulated under the section 1006(a)(1) of the Legal Services Assistant General Counsel. Antarctic Conservation Act of 1978. Corporation Act, 42 U.S.C. 2996e(a)(l). [FR Doc. 2017–23299 Filed 10–25–17; 8:45 am] NSF has published regulations under Awards will be made so that each BILLING CODE 7050–01–P the Antarctic Conservation Act in the service area is served, although no listed Code of Federal Regulations. This is the organization is guaranteed an award. required notice of permit applications received. Grants will become effective and grant NATIONAL SCIENCE FOUNDATION funds will be distributed on or about DATES: Interested parties are invited to January 1, 2018. Notice of Permit Applications Received submit written data, comments, or This notice is issued pursuant to 42 Under the Antarctic Conservation Act views with respect to this permit U.S.C. 2996f(f). Comments and of 1978 application by November 27, 2017. This application may be inspected by recommendations concerning potential AGENCY: National Science Foundation. grantees are invited, and should be interested parties at the Permit Office, ACTION: Notice of Permit Applications delivered to LSC within 30 days from address below. Received. the date of publication of this notice. ADDRESSES: Comments should be SUMMARY: The National Science addressed to Permit Office, Office of Foundation (NSF) is required to publish Polar Programs, National Science
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Foundation, 2415 Eisenhower Avenue, under the Antarctic Conservation Act of Dates of Permitted Activities: Alexandria, Virginia 22314. 1978. This is the required notice of a November 1, 2017–March 31, 2019. requested permit modification. FOR FURTHER INFORMATION CONTACT: Nadene G. Kennedy, Nature McGinn, ACA Permit Officer, at DATES: Interested parties are invited to Polar Coordination Specialist, Office of Polar the above address, 703–292–8030, or submit written data, comments, or Programs. [email protected]. views with respect to this permit [FR Doc. 2017–23316 Filed 10–25–17; 8:45 am] SUPPLEMENTARY INFORMATION: The application by November 27, 2017. BILLING CODE 7555–01–P National Science Foundation, as Permit applications may be inspected by directed by the Antarctic Conservation interested parties at the Permit Office, Act of 1978 (Pub. L. 95–541, 45 CFR address below. SECURITIES AND EXCHANGE 670), as amended by the Antarctic ADDRESSES: Comments should be COMMISSION Science, Tourism and Conservation Act addressed to Permit Office, Office of of 1996, has developed regulations for Polar Programs, National Science [Release No. 34–81914; File No. SR–NYSE– 2017–32] the establishment of a permit system for Foundation, 2415 Eisenhower Avenue, various activities in Antarctica and Alexandria, Virginia 22314. Self-Regulatory Organizations; New designation of certain animals and FOR FURTHER INFORMATION CONTACT: York Stock Exchange LLC; Notice of certain geographic areas a requiring Nature McGinn, ACA Permit Officer, at Designation of a Longer Period for special protection. The regulations the above address, 703–292–8030, or Commission Action on Proposed Rule establish such a permit system to [email protected]. Change To Amend Section 202.06 of designate Antarctic Specially Protected the NYSE Listed Company Manual To Areas. SUPPLEMENTARY INFORMATION: The National Science Foundation, as Prohibit Listed Companies From Application Details directed by the Antarctic Conservation Issuing Material News After the Official Closing Time for the Exchange’s Applicant Act of 1978 (Pub. L. 95–541), as amended by the Antarctic Science, Trading Session Until the Earlier of Permit Application: 2018–022 Tourism and Conservation Act of 1996, Publication of Such Company’s Official Jennifer Burns, National Science has developed regulations for the Closing Price on the Exchange or Five Foundation, 2415 Eisenhower Avenue, establishment of a permit system for Minutes After the Official Closing Time Alexandria, Virginia 22314. various activities in Antarctica and October 20, 2017. Activity for Which Permit is Requested designation of certain animals and On August 17, 2017, New York Stock certain geographic areas a requiring Harmful Interference. The applicant Exchange LLC (‘‘NYSE’’ or the special protection. The regulations ‘‘Exchange’’) filed with the Securities will be conducting programmatic establish such a permit system to oversight activities that may involve and Exchange Commission designate Antarctic Specially Protected (‘‘Commission’’), pursuant to Section approaching seabird colonies near Areas. Palmer Station in the Antarctic 19(b)(1) of the Securities Exchange Act Description of Permit Modification 1 Peninsula. The applicant is seeking a of 1934 (‘‘Act’’) and Rule 19b–4 Requested: The Foundation issued a 2 permit for harmful interference for thereunder, a proposed rule change to permit (ACA 2017–034) to David W. incidental disturbance of penguins or amend the NYSE Listed Company Johnston on January 6, 2017. The issued petrels during the conduct of the Manual (the ‘‘Manual’’) to prohibit permit allows the permit holder and his oversight activities. listed companies from issuing material agents to use unmanned aircraft systems news after the official closing time for Location (UAS) for photogrammetry and capture the Exchange’s trading session until the Torgersen Island; Humble Island; of behavior by video of whales and earlier of publication of such company’s Palmer Basin (ASMA 7). seabirds, including penguins. The UAS official closing price on the Exchange or is also used to conduct transect-type five minutes after the official closing Dates surveys of penguin and other seabird time. The proposed rule change was December 12–20, 2017. colonies, including colonies at Avian published for comment in the Federal Island, ASPA no. 117. Register on September 5, 2017.3 The Nadene G. Kennedy, Now the applicant proposes a Commission received one comment Polar Coordination Specialist, Office of Polar modification to his permit to use letter on the proposed rule change.4 Programs. unmanned aircraft systems (UAS) for Section 19(b)(2) of the Act 5 provides [FR Doc. 2017–23272 Filed 10–25–17; 8:45 am] photogrammetry and population that, within 45 days of the publication BILLING CODE 7555–01–P assessments by video of Antarctic seals. of notice of the filing of a proposed rule The permit holder plans overflights that change, or within such longer period up may result in the disturbance of to 90 days as the Commission may NATIONAL SCIENCE FOUNDATION Antarctic fur seals (n=6000/year), designate if it finds such longer period crabeater seals (n=6000/year), leopard Notice of Permit Modification Received to be appropriate and publishes its seals (n=2000/year), southern elephant Under the Antarctic Conservation Act reasons for so finding or as to which the seals (n=2000/year), and Weddell seals of 1978 self-regulatory organization consents, (n=2000/year). Authorization for the the Commission shall either approve the AGENCY: National Science Foundation. overflight of seals by UAS from the ACTION: Notice of permit modification National Marine Fisheries Service under 1 15 U.S.C. 78s(b)(1). 2 request. the authority of the Marine Mammal 17 CFR 240.19b–4. Protection Act of 1972, as amended (16 3 See Securities Exchange Act Release No. 81494 SUMMARY: The National Science U.S.C. 1361 et seq.) is pending. (August 29, 2017), 82 FR 42008. 4 See letter to Eduardo A. Aleman, Assistant Foundation (NSF) is required to publish Location: Antarctic Peninsula region; Secretary, Commission from John Dibacco Virtu a notice of requests to modify permits Torgersen Island; ASPA No. 117, Avian Financial LLC, dated September 20, 2017. issued to conduct activities regulated Island, Marguerite Bay. 5 15 U.S.C. 78s(b)(2).
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proposed rule change, disapprove the proposed rule change.4 The Commission SOCIAL SECURITY ADMINISTRATION proposed rule change, or institute has not received any comments on the [Docket No. SSA 2017–0044] proceedings to determine whether the proposed rule change. proposed rule change should be Section 19(b)(2) of the Act 5 provides Privacy Act of 1974; Matching Program disapproved. The 45th day for this filing that within 45 days of the publication of is October 20, 2017. AGENCY: Social Security Administration notice of the filing of a proposed rule The Commission is extending the 45- (SSA). change, or within such longer period up day time period for Commission action ACTION: Notice of a New Matching on the proposed rule change. The to 90 days as the Commission may Program. Commission finds that it is appropriate designate if it finds such longer period to designate a longer period within to be appropriate and publishes its SUMMARY: In accordance with the which to take action on the proposed reasons for so finding, or as to which the provisions of the Privacy Act, as rule change so that it has sufficient time self-regulatory organization consents, amended, this notice announces a new to consider the Exchange’s proposal, as the Commission shall either approve the computer matching program that we are described above. Accordingly, pursuant proposed rule change, disapprove the currently conducting with the Internal to Section 19(b)(2) of the Act,6 the proposed rule change, or institute Revenue Service (IRS). This computer matching agreement Commission designates December 4, proceedings to determine whether the sets forth the terms, conditions, and 2017, as the date by which the proposed rule change should be safeguards under which IRS will Commission shall either approve or approved or disapproved. The 45th day disclose to SSA certain return disapprove or institute proceedings to after publication of the notice for this information for the purpose of verifying determine whether to disapprove the proposed rule change is October 21, eligibility for the Prescription Drug proposed rule change (File No. SR– 2017. The Commission is extending this Subsidy Program (Subsidy) and or NYSE–2017–32). 45-day time period. determining the correct subsidy For the Commission, by the Division of The Commission finds it appropriate percentage of benefits provided under Trading and Markets, pursuant to delegated to designate a longer period within section 1860D–14 of the Social Security 7 authority. which to take action on the proposed Act (Act). Eduardo A. Aleman, rule change so that it has sufficient time DATES: The deadline to submit Assistant Secretary. to consider this proposed rule change, comments on the proposed matching [FR Doc. 2017–23264 Filed 10–25–17; 8:45 am] as modified by the recently filed program is 30 days from October 26, BILLING CODE 8011–01–P amendment. Accordingly, the 2017. The matching program will be Commission, pursuant to Section effective on November 11, 2017, or once 19(b)(2) of the Act,6 designates a minimum of 30 days after publication SECURITIES AND EXCHANGE December 5, 2017, as the date by which of this notice has elapsed, whichever is COMMISSION the Commission shall either approve or later. The matching program will expire on May 10, 2019. [Release No. 34–81915; File No. SR– disapprove, or institute proceedings to ADDRESSES: NYSEArca–2017–90] determine whether to disapprove, the Interested parties may proposed rule change (File No. SR– comment on this notice by either Self-Regulatory Organizations; NYSE NYSEArca–2017–90), as modified by telefaxing to (410) 966–0869, writing to Arca, Inc.; Notice of Designation of a Amendment No. 1. Mary Ann Zimmerman, Acting Longer Period for Commission Action Executive Director, Office of Privacy For the Commission, by the Division of on a Proposed Rule Change, as and Disclosure, Office of the General Trading and Markets, pursuant to delegated Counsel, Social Security Modified by Amendment No. 1 Thereto, authority.7 To List and Trade Shares of the Administration, 617 Altmeyer Building, Hartford Municipal Opportunities ETF Eduardo A. Aleman, 6401 Security Boulevard, Baltimore, MD Under NYSE Arca Rule 8.600–E Assistant Secretary. 21235–6401, or email at [FR Doc. 2017–23265 Filed 10–25–17; 8:45 am] [email protected]. All October 20, 2017. BILLING CODE 8011–01–P comments received will be available for On August 17, 2017, NYSE Arca, Inc. public inspection at this address. (‘‘Exchange’’) filed with the Securities 4 FOR FURTHER INFORMATION CONTACT: and Exchange Commission In Amendment No. 1, which amended and replaced the proposed rule change in its entirety, Interested parties may submit general (‘‘Commission’’), pursuant to Section the Exchange, among other things, clarified that: (i) questions about the matching program 19(b)(1) of the Securities Exchange Act The list of municipal securities included in the to Mary Ann Zimmerman, Acting of 1934 (‘‘Act’’) 1 and Rule 19b–4 section of the Notice entitled Hartford Municipal Executive Director, Office of Privacy thereunder,2 a proposed rule change to Opportunities ETF are the Municipal Securities in and Disclosure, Office of the General list and trade shares of the Hartford which the Fund may invest at least 80% of its net Counsel, by any of the means shown Municipal Opportunities ETF under assets; (ii) redemption orders are not subject to above. NYSE Arca Rule 8.600–E. The proposed acceptance by the distributor of the Fund; and (iii) the cut-off time for receipt of orders is 1 o’clock SUPPLEMENTARY INFORMATION: The rule change was published for comment p.m. Amendment No. 1 also made non-substantive, Computer Matching and Privacy in the Federal Register on September 6, technical amendments. Because Amendment No. 1 Protection Act of 1988 (Pub. L. 100– 2017.3 On October 17, 2017, the makes only clarifying and technical changes, and 503), amended the Privacy Act (5 U.S.C. Exchange filed Amendment No. 1 to the does not present unique or novel regulatory issues, 552a) by describing the conditions it is not subject to notice and comment. under which computer matching 6 Amendment No. 1 is available at: https:// 15 U.S.C. 78s(b)(2). involving the Federal government could 7 17 CFR 200.30–3(a)(31). www.sec.gov/comments/sr-nysearca-2017-90/ 1 15 U.S.C. 78s(b)(1). nysearca201790.htm. be performed and adding certain 5 2 17 CFR 240.19b–4. 15 U.S.C. 78s(b)(2). protections for persons applying for, 3 See Securities Exchange Act Release No. 81505 6 Id. and receiving, Federal benefits. Section (August 30, 2017), 82 FR 42147. 7 17 CFR 200.30–3(a)(31). 7201 of the Omnibus Budget
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Reconciliation Act of 1990 (Pub. L. 101– section 1860D–14 of the Act. (42 U.S.C. ACTION: Notice of a new matching 508) further amended the Privacy Act 1395w–114). This matching agreement program. regarding protections for such persons. between IRS and us is executed under The Privacy Act, as amended, the Privacy Act of 1974, (5 U.S.C. 552a), SUMMARY: In accordance with the regulates the use of computer matching as amended by the Computer Matching provisions of the Privacy Act, as by Federal agencies when records in a and Privacy Protection Act of 1988, and amended, this notice announces a new system of records are matched with the regulations and guidance computer matching program that we are other Federal, State, or local government promulgated thereunder. currently conducting with the Office of records. It requires Federal agencies Categories of Individuals: The Child Support Enforcement (OCSE). involved in computer matching individuals whose information is DATES: The deadline to submit programs to: involved in this matching program are comments on the proposed matching (1) Negotiate written agreements with beneficiaries who apply for Medicare program is 30 days from the date of the other agency or agencies prescription drug subsidy under section publication of this notice. The matching participating in the matching programs; 1860D–14 of the Act. They will self– (2) Obtain approval of the matching program will be effective on certificate on the application form the November 1, 2017, or once a minimum agreement by the Data Integrity Boards applicant’s income, resources, and of the participating Federal agencies; of 30 days after publication of this family size. We will verify each notice has elapsed, whichever is later. (3) Publish notice of the computer applicant’s self-certification information matching program in the Federal The matching program will expire on before making a subsidy determination. October 31, 2018. Register; When Medicare beneficiaries apply for (4) Furnish detailed reports about the subsidy, and we cannot otherwise ADDRESSES: Interested parties may matching programs to Congress and verify the income information provided comment on this notice by either OMB; on an application, SSA discloses to IRS telefaxing to (410) 966–0869, writing to (5) Notify applicants and beneficiaries the applicant’s name and Social Mary Ann Zimmerman, Acting that their records are subject to Security number. Executive Director, Office of Privacy matching; and Categories of Records: When and Disclosure, Office of the General (6) Verify match findings before beneficiaries apply for the Medicare Counsel, Social Security reducing, suspending, terminating, or prescription drug subsidy under section Administration, 617 Altmeyer Building, denying a person’s benefits or 1860D–14 of the Act, they must self- 6401 Security Boulevard, Baltimore, MD payments. certify on the application form the 21235–6401, or email at We have taken action to ensure that applicant’s income, resources, and [email protected]. All all of our computer matching programs family size. Once each year, we comments received will be available for comply with the requirements of the electronically transmit the identifying public inspection at this address. Privacy Act, as amended. information of each current subsidy FOR FURTHER INFORMATION CONTACT: Mary Ann Zimmerman, recipient to IRS. Interested parties may submit general Acting Executive Director, Office of Privacy When there is a match of individual questions about the matching program and Disclosure, Office of the General Counsel. identifier, IRS discloses to us: to Mary Ann Zimmerman, Acting a. Payee Account Number, Executive Director, Office of Privacy Participating Agencies: SSA and IRS. b. Payee Name and Mailing Address, Authority for Conducting the c. Payee Taxpayer Identification and Disclosure, Office of the General Matching Program: The legal authority Number (TIN), Counsel, by any of the means shown for Internal Revenue Code (IRC) section d. Payer Name and Address, above. 6103(1)(7) authorizes IRS to disclose e. Payer TIN, and SUPPLEMENTARY INFORMATION: The return information with respect to f. Income Type and Amount. Computer Matching and Privacy unearned income to Federal, state, and System(s) of Records: We will provide Protection Act of 1988 (Public Law local agencies administering certain IRS with identifying information with (Pub. L.) 100–503), amended the Privacy benefit programs under the Act. Section respect to applicants for, and recipients Act (5 U.S.C. 552a) by describing the 1860D–14 of the Act requires the of, the prescription drug subsidy from conditions under which computer Commissioner of Social Security to the existing Medicare Database (MDB matching involving the Federal determine the eligibility of applicants File) system of records, 60–0321 government could be performed and for the prescription drug subsidy who published at 71 FR 42159 (July 25, adding certain protections for persons self-certify their income, resources, and 2006). Unearned income information applying for, and receiving, Federal family size. Pursuant to section 1860D– provided by IRS is maintained in the benefits. Section 7201 of the Omnibus 14(a)(3) of the Act (42 U.S.C. 1395w– MDB File. IRS extracts return Budget Reconciliation Act of 1990 (Pub. 114(a)(3)), SSA must determine whether information with respect to unearned L. 101–508) further amended the a Social Security Part D eligible income from the IRMF, Treasury/IRS Privacy Act regarding protections for individual is a subsidy-eligible 22.061, as published at 77 FR 47946 such persons. individual, and whether the individual (August 10, 2012). is an individual as described in section The Privacy Act, as amended, [FR Doc. 2017–23280 Filed 10–25–17; 8:45 am] regulates the use of computer matching 1860D–14(a) of the Act. BILLING CODE 4191–02–P Purpose(s): The purpose of this by Federal agencies when records in a matching program is to sets forth the system of records are matched with terms, conditions, and safeguards under SOCIAL SECURITY ADMINISTRATION other Federal, State, or local government which IRS will disclose to us certain records. It requires Federal agencies return information for the purpose of [Docket No. SSA 2017–0022] involved in computer matching programs to: verifying eligibility for the Prescription Privacy Act of 1974; Matching Program Drug Subsidy Program (Subsidy) and or (1) Negotiate written agreements with determining the correct subsidy AGENCY: Social Security Administration the other agency or agencies percentage of benefits provided under (SSA). participating in the matching programs;
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(2) Obtain approval of the matching (OCSE) and the Social Security OCSE will provide electronically to agreement by the Data Integrity Boards Administration (SSA). The agreement SSA the following data elements from of the participating Federal agencies; covers information exchange operations the NDNH quarterly wage file: (3) Publish notice of the computer between OCSE and SSA that will • Quarterly wage record identifier matching program in the Federal provide SSA with quarterly wage and • For employees: Register; unemployment insurance information (1) Name (first, middle, last) (4) Furnish detailed reports about located in the National Directory of New (2) SSN matching programs to Congress and Hires (NDNH) to allow SSA to (3) Verification request code OMB; determine eligibility of applicants for (4) Processed date (5) Notify applicants and beneficiaries Extra Help (low-income subsidy (5) Non-verifiable indicator that their records are subject to assistance) under the Medicare (6) Wage amount matching; and Prescription Drug, Improvement, and (7) Reporting period (6) Verify match findings before Modernization Act of 2003 (Pub. L. 108– • For employers of individuals in the reducing, suspending, terminating, or 173) (Extra Help). This agreement also quarterly wage file of the NDNH: denying a person’s benefits or governs the use, treatment, and (1) Name payments. safeguarding of the information (2) Employer identification number We have taken action to ensure that exchanged. OCSE is the ‘‘source (3) Address(es) all of our computer matching programs agency’’ and SSA is the ‘‘recipient • Transmitter Agency Code comply with the requirements of the agency,’’ as defined by the Privacy Act. • Transmitter State Code Privacy Act, as amended. 5 U.S.C. 552a(a)(9) and (11). • State or Agency Name Mary Ann Zimmerman, This agreement assists SSA in (1) OCSE will provide electronically to Acting Executive Director, Office of Privacy determining eligibility of applicants for SSA the following data elements from and Disclosure, Office of the General Counsel. Extra Help; (2) redetermining eligibility the NDNH unemployment insurance Participating Agencies: SSA and of existing Extra Help beneficiaries file: during periodic screening; and (3) OCSE. • Unemployment insurance record Authority for Conducting the administering the Extra Help program. The Privacy Act provides that no identifier Matching Program: The legal authorities • Processed date for disclosures under this agreement are record contained in a system of record • (SOR) may be disclosed for use in a SSN the Social Security Act (Act) and the • Verification request code Privacy Act of 1974, as amended. computer matching program except • pursuant to a written agreement Name (first, middle, last) Subsection 453(j)(4) of the Act provides • Address that OCSE shall provide the containing specified provisions. 5 • U.S.C. 552a(o). SSA and OCSE are Unemployment insurance benefit Commissioner of SSA with all amount information in the NDNH. 42 U.S.C. executing this agreement to comply • with the Privacy Act of 1974, as Reporting period 653(j)(4). SSA has authority to use data • Transmitter Agency Code to determine entitlement to and amended, and the regulations and • guidance promulgated thereunder. Transmitter State Code eligibility for programs it administers • State or Agency Name pursuant to sections 453(j)(4), OCSE and SSA have been parties to Data Elements SSA updates in the 1631(e)(1)(B) and(f), and 1860D–14(a)(3) matching agreements and OCSEFITM table, if there is a match: of the Act. 42 U.S.C. 653(j)(4), recertifications for this purpose since April 1, 2005. Appendix A provides • QW record identifier 1383(e)(1)(B) and (f), and 1395w– • 114(a)(3). Disclosures under this background information about these For employees: agreement shall be made in accordance prior agreements. (1) Employee’s SSN with 5 U.S.C. 552a(b)(3), and in The SSA component responsible for (2) Employee’s wage amount this agreement and its contents is the (3) Reporting period compliance with the matching • procedures in 5 U.S.C. 552a(o), (p), and Office of Privacy and Disclosure. The For employers of individuals: (r). responsible component for OCSE is the (1) Employer identification number The Act provides that the Division of Federal Systems. (2) Employer’s name • determination of whether a Part D This agreement is applicable to UI identifier: eligible individual residing in a state is personnel, facilities, and information (1) Claimant SSN a subsidy-eligible individual shall be systems of SSA and OCSE involved in (2) Unemployment insurance benefit determined under the state plan for the processing and storage of NDNH amount medical assistance under section information. Personnel are defined as (3) Reporting period 1860D–14(a)(3)(B)(1) of the Act. 42 employees, contractors, or agents of (4) Transmitter State Name U.S.C. 1395w–114(a)(3)(B)(1). OCSE and SSA. System(s) of Records: SSA collects SSA has independent authority to This agreement includes a security and maintains this information in the collect this information regarding addendum and four appendices. Medicare Database (MDB) system of Medicare Parts A–D via sections 202– Categories of Individuals: The records, No. 60–0321, published at 69 205, 223, 226, 228, 1611, 1631, 1818, individuals whose information is FR 77816 (December 28, 2004) and 71 1836, 1839, 1840, and 1860D–1 to involved in this matching program are FR 42159–42164 (July 25, 2006). The 1860D–15 of the Act (42 U.S.C. 402– new hires, quarterly wage earners, and MDB contains information related to 405, 423, 426, 428, 1382, 1383, 1395i– recipients of unemployment insurance. Medicare Part A, Part B, Medicare 2, 1395o, 1395r, 1395s, and 1395w–101 Categories of Records: Advantage Part C, and Medicare Part D. to 1395w–115). SSA will provide OCSE the following OCSE will match SSA information in Purpose(s): This computer matching data elements electronically in the the MDB against the quarterly wage and agreement, hereinafter ‘‘agreement,’’ Finder File: unemployment insurance information governs a matching program between • COSSN (SSN) furnished by state and federal agencies the Office of Child Support Enforcement • Name maintained in its system of records
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‘‘OCSE National Directory of New estimate; the need for the information; collection instruments by writing to the Hires’’ (NDNH), No. 09–80–0381, its practical utility; ways to enhance its above email address. established by publication in the quality, utility, and clarity; and ways to 1. Request for Review of Hearing Federal Register on January 5, 2011 at minimize burden on respondents, Decision/Order—20 CFR 404.967– 76 FR 560. The disclosure of NDNH including the use of automated 404.981, 416.1467–416.1481—0960– information by OCSE to SSA constitutes collection techniques or other forms of 0277. Claimants have a statutory right a ‘‘routine use,’’ as defined by the information technology. Mail, email, or under the Social Security Act and Privacy Act. 5 U.S.C. 552a(b)(3). Routine fax your comments and current regulations to request review of use (#9) of the SOR authorizes recommendations on the information an administrative law judge’s (ALJ) disclosure of NDNH information to SSA, collection(s) to the OMB Desk Officer hearing decision or dismissal of a 76 FR 560, 562 (January 5, 2011). and SSA Reports Clearance Officer at hearing request on Title II and Title XVI [FR Doc. 2017–23326 Filed 10–25–17; 8:45 am] the following addresses or fax numbers. claims. Claimants may request Appeals BILLING CODE 4191–02–P (OMB), Office of Management and Council review by filing a written Budget, Attn: Desk Officer for SSA, request using paper Form HA–520, or Fax: 202–395–6974, Email address: the Internet application, i520. SSA uses SOCIAL SECURITY ADMINISTRATION [email protected] the information we collect to establish (SSA), Social Security Administration, the claimant filed the request for review [Docket No: SSA–2017–0056] OLCA, Attn: Reports Clearance within the prescribed time, and to Director, 3100 West High Rise, 6401 ensure the claimant completed the Agency Information Collection Security Blvd., Baltimore, MD 21235, requisite steps permitting the Appeals Activities: Proposed Request Fax: 410–966–2830, Email address: Council review. The Appeals Council The Social Security Administration [email protected] then uses the information to: (1) (SSA) publishes a list of information Or you may submit your comments Document the claimant’s reason(s) for collection packages requiring clearance online through www.regulations.gov, disagreeing with the ALJ’s decision or by the Office of Management and referencing Docket ID Number [SSA– dismissal; (2) determine whether the Budget (OMB) in compliance with 2017–0056]. claimant has additional evidence to Public Law 104–13, the Paperwork The information collections below are submit; and (3) determine whether the Reduction Act of 1995, effective October pending at SSA. SSA will submit them claimant has a representative or wants 1, 1995. This notice includes revisions to OMB within 60 days from the date of to appoint one. The respondents are of OMB-approved information this notice. To be sure we consider your claimants requesting review of an ALJ’s collections. comments, we must receive them no decision or dismissal of hearing. SSA is soliciting comments on the later than December 26, 2017. Type of Request: Revision of an OMB- accuracy of the agency’s burden Individuals can obtain copies of the approved information collection.
Average Estimated Number of Frequency of burden per total annual Modality of completion respondents response response burden (minutes) (hours)
HA–520—Paper ...... 105,000 1 10 17,500 i520—Internet ...... 70,000 1 15 17,500
Totals ...... 175,000 ...... 35,000
2. You Can Make Your Payment by provides a copy of the SSA–4588 when debtor contact representative completes Credit Card—0960–0462. SSA uses the we inform an individual that we the SSA–4589 electronic Intranet information we collect on Form SSA– detected an overpayment. Individuals application. Respondents are Old Age 4588, and its electronic application, may choose to make a one-time payment Survivors and Disability Insurance Form SSA–4589, to update individuals’ or recurring monthly payments when (OASDI) beneficiaries and Social Security records to reflect they complete and submit the SSA– Supplemental Security Income (SSI) payments made on their overpayments. 4588. When individuals choose to recipients who have outstanding In addition, SSA uses this information telephone the Program Service Centers overpayments. to process payments through the to make a one-time payment in lieu of Type of Request: Revision of an OMB- appropriate credit card company. SSA completing Form SSA–4588, an SSA approved information collection.
Average Estimated Number of Frequency of burden per total annual Modality of completion respondents response response burden (minutes) (hours)
SSA–4588 (Paper) ...... 16,500 1 10 2,750 SSA–4589 (Electronic intranet application) ...... 258,500 1 5 21,542
Totals ...... 275,000 ...... 24,292
3. Request to Show Cause for Failure When claimants who requested a reschedule the hearing if the claimants to Appear—20 CFR 404.938, hearing before an ALJ fail to appear at establish good cause for missing the 404.957(a)(ii), 416.1438—0960–0794. their scheduled hearing, the ALJ may hearings. To establish good cause,
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claimants must show one of the the HA–L90 for new cases, and the HA– established good cause for failure to following: (1) SSA did not properly L90–OP1 for redeterminations cases. We appear at the hearing, the ALJ will notify the claimant of the hearing, or (2) need two versions of the paper form, as schedule a supplemental hearing; if not, an unexpected event occurred without the ALJ follows different procedures the ALJ will make a claims eligibility sufficient time for the claimant to when determining the good cause on determination based on the claimants’ request a postponement. The claimants redetermination cases (cases that have a evidence of record. Respondents are can use paper Form HA–L90 or HA– prior decision and evidence on file), claimants, or their representatives, L90–OP1 to provide their reason for not than they do for new cases (where we seeking to establish good cause for appearing at their scheduled hearings; have no evidence on file). The ERE failure to appear at a scheduled hearing or the claimants’ representatives can use modality automatically adjusts for before an ALJ. Electronic Records Express (ERE), OMB redetermination cases, so we only need Control No. 0960–0753, Internet screens one version of the Internet screens. If Type of Request: Revision of an OMB- to submit the HA–L90 online. SSA uses the ALJ determines the claimants approved information collection.
Average Estimated Number of Frequency of burden per total annual Modality of completion responses response response burden (minutes) (hours)
HA–L90 ...... 39,500 1 10 6,583 HA–L90–OP1 ...... 500 1 10 83
Totals ...... 40,000 ...... 6,666 * We do not account for the ERE Internet screens here as we account for them under OMB Control No. 0960–0753.
Dated: October 23, 2017. By the Board, Scott M. Zimmerman, Acting Advisory Committee Act (Pub. L. 92– Naomi R. Sipple, Director, Office of Proceedings. 463, 5 U.S.C., App.), notice is hereby Reports Clearance Officer, Social Security Kenyatta Clay, given for a meeting of the Third RTCA Administration. Clearance Clerk. SC–236 joint Plenary with EUROCAE [FR Doc. 2017–23342 Filed 10–25–17; 8:45 am] [FR Doc. 2017–23325 Filed 10–25–17; 8:45 am] WG–96. The agenda will include the following: BILLING CODE 4191–02–P BILLING CODE 4915–01–P Tuesday, November 28, 2017—9:00AM– 5:00PM DEPARTMENT OF TRANSPORTATION 1. Welcome/Administrative Duties SURFACE TRANSPORTATION BOARD Federal Aviation Administration 2. IPR/Membership Call-Out and Introductions [Docket No. FD 36142 (Sub-No. 1)] Third RTCA SC–236 Joint Plenary With 3. Acceptance of Meeting Minutes for EUROCAE WG–96 the Second Joint Plenary of SC–236/ Savage Companies—Continuance in WG–96 Control Exemption—Savage Davenport AGENCY: Federal Aviation 4. Review Plenary Agenda and Sub- Railroad Company Administration (FAA), U.S. Department Working Group Schedule of Transportation (DOT). 5. Break Into Sub-Working Group AGENCY: Surface Transportation Board. ACTION: Third RTCA SC–236, Wireless Meetings When Plenary Business Airborne Intra Communications (WAIC), ACTION: Correction to notice of Complete joint Plenary with EUROCAE WG–96. exemption. 6. Reports of the Sub-Working Groups 7. Review of Special Committee SUMMARY: The FAA is issuing this notice Schedule On September 1, 2017, notice of the to advise the public of a meeting of 8. New Business Discussions above exemption was served and Third RTCA SC–236, Wireless Airborne 9. Review of Action Items published in the Federal Register (82 Intra Communications (WAIC), joint 10. Plan for Next Meeting FR 41,674). The exemption became Plenary with EUROCAE WG–96. 11. Adjourn effective on September 15, 2017. On DATES: The meeting will be held Wednesday, November 29, 2017— October 4, 2017, a correction was filed November 28–December 1, 2017 9:00 9:00AM–5:00PM with the Board advising that the parent a.m.–5:00 p.m. company, which was inadvertently ADDRESSES: The meeting will be held at: 12. Continue With Plenary or Sub- referred to in the continuance in control EASA Headquarters, Konrad-Adenauer- Working Group Meetings filing as ‘‘Savage Services Corporation’’ Ufer 3, D–50668 Cologne, Germany. Thursday, November 30, 2017— should have been referred to as ‘‘Savage FOR FURTHER INFORMATION CONTACT: 9:00AM–5:00PM Companies,’’ a privately held Utah Rebecca Morrison at [email protected] corporation. This notice corrects the 13. Continue With Plenary or Sub- or 202–330–0654, or The RTCA Working Group Meetings name of the parent company. All other Secretariat, 1150 18th Street NW., Suite information in the notice is correct. 910, Washington, DC 20036, or by Friday, December 1, 2017—9:00AM– Board decisions and notices are telephone at (202) 833–9339, fax at (202) 12:00PM available on our Web site at 833–9434, or Web site at http:// 14. Continue With Plenary or Sub- ‘‘WWW.STB.GOV.’’ www.rtca.org. Working Group Meetings Decided: October 23, 2017. SUPPLEMENTARY INFORMATION: Pursuant Registration is required for to section 10(a)(2) of the Federal attendance. Attendance is open to the
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interested public but limited to space submitting written views, data, or DEPARTMENT OF TRANSPORTATION availability. With the approval of the comments. FRA does not anticipate chairman, members of the public may scheduling a public hearing in Federal Railroad Administration present oral statements at the meeting. connection with these proceedings since Persons wishing to attend or to present the facts do not appear to warrant a [Docket Number FRA–2013–0019] statements or obtain information should hearing. If any interested parties desire Petition for Waiver of Compliance contact the person listed in the FOR an opportunity for oral comment and a FURTHER INFORMATION CONTACT section. public hearing, they should notify FRA, Under part 211 of Title 49 of the Code Members of the public may present a in writing, before the end of the of Federal Regulations (CFR), this written statement to the committee at comment period and specify the basis document provides the public notice any time. Issued in Washington, DC on for their request. that on August 15, 2017, Old Augusta Dated: October 23, 2017. Railroad (OAR) petitioned the Federal All communications concerning these Mohannad Dawoud, Railroad Administration (FRA) for a proceedings should identify the waiver of compliance from certain Management & Program Analyst, Partnership appropriate docket number and may be Contracts Branch, ANG–A17, NextGen, provisions of the hours of service laws Procurement Services Division, Federal submitted by any of the following contained at Title 49 United States Code Aviation Administration. methods: (U.S.C.) section 21103(a), in accordance [FR Doc. 2017–23278 Filed 10–25–17; 8:45 am] • Web site: http:// with the authority of section 21102(b). BILLING CODE 4910–13–P www.regulations.gov. Follow the online FRA assigned the petition docket instructions for submitting comments. number FRA–2013–0019. • Fax: 202–493–2251. OAR requested an extension of its DEPARTMENT OF TRANSPORTATION existing waiver of relief from the • Mail: Docket Operations Facility, provisions of 49 U.S.C. 21103(a), which Federal Railroad Administration U.S. Department of Transportation, 1200 prohibits a train employee from [Docket Number FRA–2017–0105] New Jersey Avenue SE., W12–140, remaining or going on duty for a period Washington, DC 20590. in excess of 12 consecutive hours. 49 Petition for Waiver of Compliance • Hand Delivery: 1200 New Jersey U.S.C. 21102(b) allows railroads with 15 or fewer employees to be exempted from Under part 211 of Title 49 Code of Avenue SE., Room W12–140, the restriction outlined at 49 U.S.C. Federal Regulations (CFR), this provides Washington, DC 20590, between 9 a.m. 21103(a)(4)(B). The existing waiver the public notice that on October 4, and 5 p.m., Monday through Friday, allows OAR employees to initiate an on- 2017, the Association of American except Federal Holidays. duty period each day for seven (7) Railroads (AAR) petitioned the Federal Communications received by consecutive days followed by 72 hours Railroad Administration (FRA) for a December 11, 2017 will be considered off duty. An employee may initiate an waiver of compliance from certain by FRA before final action is taken. on-duty period for an eighth provisions of the Federal Railroad safety Comments received after that date will consecutive day followed by 72 hours regulations contained at 49 CFR 229.23. be considered if practicable. FRA assigned the petition Docket off duty, if all eight assignments do not Number FRA–2017–0105. Anyone can search the electronic infringe upon the 10:00 p.m. to 5:00 Section 229.23(a) requires each form of any written communications a.m. time period. Employees’ schedules locomotive to be inspected on an and comments received into any of our may be extended no more than one time interval not to exceed 92 days; section dockets by the name of the individual within any 30-day period. An employee 229.23(b) allows a locomotive equipped submitting the comment (or signing the must agree to have his or her series of with advanced microprocessor-based document, if submitted on behalf of an consecutive days extended. If an on-board electronic condition association, business, labor union, etc.). employee’s series of consecutive days is monitoring controls to be inspected on Under 5 U.S.C. 553(c), DOT solicits extended and he or she subsequently feels fatigues, he or she may request up an interval not to exceed 184 days. AAR comments from the public to better to 24 hours of time off duty, which OAR states in its petition that it believes the inform its processes. DOT posts these shall allow the employee to receive. For approximately 422 locomotives comments, without edit, including any any employee whose series of equipped with 26–L brake systems and personal information the commenter microprocessor-based on-board consecutive days is extended subject to provides, to www.regulations.gov, as this waiver, the hours of service records pneumatic condition monitoring described in the system of records controls should fall within section for the relevant series of consecutive notice (DOT/ALL–14 FDMS), which can 229.23(b), and petitions for a two-year days must indicate that the limitation be reviewed at https:// test waiver to demonstrate the has been extended by waiver. appropriateness of that categorization. www.transportation.gov/privacy. See OAR states that its operation has not A copy of the petition, as well as any also https://www.regulations.gov/ had a single incident attributable to written communications concerning the privacyNotice for the privacy notice of fatigue during the effective period of the petition, is available for review online at regulations.gov. waiver. In addition, the relief has enabled the railroad to serve their www.regulations.gov and in person at Robert C. Lauby, the U.S. Department of Transportation’s customers safely and efficiently, (DOT) Docket Operations Facility, 1200 Associate Administrator for Railroad Safety, utilizing their own experienced Chief Safety Officer. New Jersey Avenue SE., W12–140, employees, and without having to rely Washington, DC 20590. The Docket [FR Doc. 2017–23237 Filed 10–25–17; 8:45 am] on less experienced personnel obtained Operations Facility is open from 9 a.m. BILLING CODE 4910–06–P from other areas or entities. OAR states to 5 p.m., Monday through Friday, that its employees have unanimously except Federal Holidays. consented to the waiver, and it has full Interested parties are invited to support from both management and participate in these proceedings by train service employees.
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A copy of the petition, as well as any privacyNotice for the privacy notice of working 6 consecutive days followed by written communications concerning the regulations.gov. 24 hours off duty. petition, is available for review online at Robert C. Lauby, A copy of the petition, as well as any www.regulations.gov and in person at Associate Administrator for Railroad Safety, written communications concerning the the Department of Transportation’s Chief Safety Officer. petition, is available for review online at Docket Operations Facility, 1200 New [FR Doc. 2017–23236 Filed 10–25–17; 8:45 am] www.regulations.gov and in person at Jersey Ave. SE., W12–140, Washington, the Department of Transportation’s BILLING CODE 4910–06–P DC 20590. The Docket Operations Docket Operations Facility, 1200 New Facility is open from 9 a.m. to 5 p.m., Jersey Ave. SE., W12–140, Washington, Monday through Friday, except Federal DEPARTMENT OF TRANSPORTATION DC 20590. The Docket Operations Holidays. Facility is open from 9 a.m. to 5 p.m., Interested parties are invited to Federal Railroad Administration Monday through Friday, except Federal participate in these proceedings by Holidays. submitting written views, data, or [Docket Number FRA–2009–0074] Interested parties are invited to comments. FRA does not anticipate participate in these proceedings by scheduling a public hearing in Petition for Waiver of Compliance submitting written views, data, or comments. FRA does not anticipate connection with these proceedings since Under part 211 of Title 49 of the Code the facts do not appear to warrant a scheduling a public hearing in of Federal Regulations (CFR), this connection with these proceedings since hearing. If any interested parties desire provides the public notice that on July an opportunity for oral comment, they the facts do not appear to warrant a 28, 2017, the Canadian National hearing. If any interested parties desire should notify FRA, in writing, before Railway Company (CN), the the end of the comment period and an opportunity for oral comment, they Transportation Division of the should notify FRA, in writing, before specify the basis for their request. International Association of Sheet the end of the comment period and All communications concerning these Metal, Air, Rail, and Transportation specify the basis for their request. proceedings should identify the Workers (TD–SMART) and the Brotherhood of Locomotive Engineers All communications concerning these appropriate docket number and may be proceedings should identify the submitted by any of the following and Trainmen (BLET) collectively petitioned the Federal Railroad appropriate docket number and may be methods: submitted by any of the following • Administration (FRA) for an extension Web site: http:// of CN’s existing waiver of compliance methods: www.regulations.gov. Follow the online from certain provisions of the hours of • Web site: http:// instructions for submitting comments. service laws contained at Title 49 www.regulations.gov. Follow the online • Fax: 202–493–2251. United States Code (U.S.C.) section instructions for submitting comments. • Mail: Docket Operations Facility, 21103(a)(4). FRA assigned the petition • Fax: 202–493–2251. U.S. Department of Transportation, 1200 Docket Number FRA–2009–0074. • Mail: Docket Operations Facility, New Jersey Avenue SE., W12–140, CN requested an extension of its U.S. Department of Transportation, 1200 Washington, DC 20590. existing waiver from the provisions of New Jersey Avenue SE., W12–140, 49 U.S.C. 21103(a), which prohibits a • Hand Delivery: 1200 New Jersey Washington, DC 20590. train employee from remaining or going • Avenue SE., Room W12–140, on duty after that employee has initiated Hand Delivery: 1200 New Jersey Washington, DC 20590, between 9 a.m. an on-duty period each day for six Avenue SE., Room W12–140, and 5 p.m., Monday through Friday, consecutive days, unless that employee Washington, DC 20590, between 9 a.m. except Federal Holidays. has had at least 48 consecutive hours off and 5 p.m., Monday through Friday, except Federal Holidays. Communications received December duty at the employee’s home terminal. 11, 2017 will be considered by FRA Specifically, CN, on behalf of its Communications received December before final action is taken. Comments railroad operating subsidiaries based in 11, 2017 will be considered by FRA received after that date will be the United States, and its unions, seeks before final action is taken. Comments considered if practicable. a waiver to allow train employees to received after that date will be initiate an on-duty period each day for considered if practicable. Anyone can search the electronic 6 consecutive days followed by 24 hours Anyone can search the electronic form of any written communications off duty. In support of the request, CN, form of any written communications and comments received into any of our BLET, and SMART explained that CN and comments received into any of our dockets by the name of the individual has operated these schedules of 6 dockets by the name of the individual submitting the comment (or signing the consecutive on-duty periods followed submitting the comment (or signing the document, if submitted on behalf of an by 24 hours off duty successfully since document, if submitted on behalf of an association, business, labor union, etc.). 2002. CN, BLET, and SMART indicate association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits that these schedules have not had an Under 5 U.S.C. 553(c), DOT solicits comments from the public to better adverse impact on safety. comments from the public to better inform its processes. DOT posts these CN also provided an analysis of the inform its processes. DOT posts these comments, without edit, including any most current 12-month period of train- comments, without edit, including any personal information the commenter employee on-duty human factor-related personal information the commenter provides, to www.regulations.gov, as accidents and injuries. CN indicates that provides, to www.regulations.gov, as described in the system of records its analyses revealed that of the 13 described in the system of records notice (DOT/ALL–14 FDMS), which can human factor-related accidents notice (DOT/ALL–14 FDMS), which can be reviewed at https:// involving CN employees in the be reviewed at https:// www.transportation.gov/privacy. See preceding 12 months, none involved www.transportation.gov/privacy. See also https://www.regulations.gov/ employees covered under the waiver also https://www.regulations.gov/
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privacyNotice for the privacy notice of scheduling a public hearing in ACTION: Notice. regulations.gov. connection with these proceedings since the facts do not appear to warrant a SUMMARY: The Department of the Robert C. Lauby, hearing. If any interested parties desire Treasury’s Office of Foreign Assets Associate Administrator for Railroad Safety, an opportunity for oral comment, they Control (OFAC) has removed from the Chief Safety Officer. should notify FRA, in writing, before Specially Designated Nationals and [FR Doc. 2017–23235 Filed 10–25–17; 8:45 am] the end of the comment period and Blocked Persons List (SDN List) the BILLING CODE 4910–06–P specify the basis for their request. names of persons whose property and All communications concerning these interests in property had been blocked proceedings should identify the pursuant to Sudan sanctions authorities. DEPARTMENT OF TRANSPORTATION appropriate docket number and may be DATES: OFAC’s action described in this notice was taken on October 12, 2017. Federal Railroad Administration submitted by any of the following methods: FOR FURTHER INFORMATION CONTACT: [Docket Number FRA–2003–15196] • Web site: http:// OFAC: Associate Director for Global www.regulations.gov. Follow the online Targeting, tel.: 202–622–2420; Assistant Petition for Waiver of Compliance instructions for submitting comments. Director for Sanctions Compliance & Under part 211 of Title 49 of the Code • Fax: 202–493–2251. Evaluation, tel.: 202–622–2490; of Federal Regulations (CFR), this • Mail: Docket Operations Facility, Assistant Director for Licensing, tel.: provides the public notice that on U.S. Department of Transportation, 1200 202–622–2480; or the Department of the September 27, 2017, New Jersey Transit New Jersey Avenue SE., W12–140, Treasury’s Office of the General (NJT) petitioned the Federal Railroad Washington, DC 20590. Counsel: Office of the Chief Counsel Administration (FRA) for an extension • Hand Delivery: 1200 New Jersey (Foreign Assets Control), tel.: 202–622– of a waiver of compliance from certain Avenue SE., Room W12–140, 2410. provisions of the Federal railroad safety Washington, DC 20590, between 9 a.m. SUPPLEMENTARY INFORMATION: regulations contained at 49 CFR part and 5 p.m., Monday through Friday, Electronic Availability 213, Track Safety Standards. The docket except Federal Holidays. The Specially Designated Nationals number associated with this petition is Communications received by and Blocked Persons List and additional FRA–2003–15196. December 11, 2017 will be considered information concerning OFAC sanctions NJT seeks an extension of its existing by FRA before final action is taken. programs are available on OFAC’s Web waiver from 49 CFR 213.233(c), relating Comments received after that date will site (www.treasury.gov/ofac). to the frequency of the required visual be considered if practicable. track inspections for FRA Class 3 and 4 Anyone can search the electronic Notice of OFAC Action(s) form of any written communications track carrying passenger traffic. FRA Effective October 12, 2017, sections 1 and comments received into any of our issued the initial waiver that granted and 2 of Executive Order (E.O.) 13067 dockets by the name of the individual NJT relief on August 25, 1999 (FRA of November 3, 1997, ‘‘Blocking submitting the comment (or signing the Docket No. RST–97–5), and FRA Sudanese Government Property and document, if submitted on behalf of an extended the waiver on April 28, 2003, Prohibiting Transactions With Sudan’’ association, business, labor union, etc.). May 1, 2008, and December 17, 2012 for and all of E.O. 13412 of October 13, Under 5 U.S.C. 553(c), DOT solicits three 5-year periods. 2006, ‘‘Blocking Property of and comments from the public to better NJT requests an extension of its Prohibiting Transactions With the inform its processes. DOT posts these waiver for reduced frequency of Government of Sudan’’ were revoked, comments, without edit, including any required visual track inspections pursuant to E.O. 13761 of January 13, personal information the commenter specifically for those tracks constructed 2017, ‘‘Recognizing Positive Actions by provides, to www.regulations.gov, as with continuous welded rail. NJT the Government of Sudan and Providing described in the system of records proposes to conduct one visual track for the Revocation of Certain Sudan- notice (DOT/ALL–14 FDMS), which can inspection per week, instead of the two Related Sanctions,’’ as amended by E.O. be reviewed at https:// inspections per week that are required 13804 of July 11, 2017, ‘‘Allowing www.transportation.gov/privacy. See in 49 CFR part 213, and to supplement Additional Time for Recognizing also https://www.regulations.gov/ its visual inspections with the operation Positive Actions by the Government of privacyNotice for the privacy notice of of an automated track geometry Sudan and Amending Executive Order regulations.gov. measuring vehicle over the affected 13761.’’ main tracks and sidings four times per Robert C. Lauby, Sections 1 and 2 of E.O. 13067 and year. Associate Administrator for Railroad Safety, E.O. 13412 blocked the property of the A copy of the petition, as well as any Chief Safety Officer. Government of Sudan and generally written communications concerning the [FR Doc. 2017–23234 Filed 10–25–17; 8:45 am] prohibited U.S. persons from engaging petition, is available for review online at BILLING CODE 4910–06–P in transactions with Sudan and the www.regulations.gov and in person at Government of Sudan. As a result of the the Department of Transportation’s revocation of these sanctions provisions, Docket Operations Facility, 1200 New effective October 12, 2017, the DEPARTMENT OF THE TREASURY Jersey Ave. SE., W12–140, Washington, individuals and entities listed below are DC 20590. The Docket Operations Office of Foreign Assets Control no longer subject to the blocking Facility is open from 9 a.m. to 5 p.m., provisions in E.O. 13067 and E.O. Monday through Friday, except Federal Sanctions Action Pursuant to 13412, and therefore were removed from Holidays. Executive Order 13067 and Executive the SDN List. Interested parties are invited to Order 13412 participate in these proceedings by Entities submitting written views, data, or AGENCY: Office of Foreign Assets 1. ACCOUNTS & ELECTRONICS comments. FRA does not anticipate Control, Treasury. EQUIPMENTS (a.k.a. ACCOUNTS AND
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ELECTRONICS EQUIPMENTS), P.O. Box 97, Sudan, Sudan; Wad Medani, Sudan; Wau, 40. GIAD MOTOR INDUSTRY COMPANY Khartoum, Sudan; c/o ENGINEERING Sudan [SUDAN]. LIMITED (a.k.a. GIAD MOTOR COMPANY), EQUIPMENT CORPORATION, undetermined 21. BASHAIER, Khartoum, Sudan Basheer Mohammad Saeed Building, Baladia [SUDAN]. [SUDAN]. Street, P.O. Box 13610, Khartoum, Sudan; 2. ADVANCED ENGINEERING WORKS, 22. BLUE NILE BREWERY, P.O. Box 1408, Web site www.giadmotors.com [SUDAN]. Street No. 53, P.O. Box 44690, Khartoum, Khartoum, Sudan [SUDAN]. 41. GINEID SUGAR FACTORY, P.O. Box 1, Sudan [SUDAN]. 23. BLUE NILE PACKING CORPORATION, Gineid, Sudan [SUDAN]. 3. ADVANCED MINING WORKS P.O. Box 385, Khartoum, Sudan [SUDAN]. 42. GREATER NILE PETROLEUM COMPANY LIMITED, Elmek Nimir Street, 24. BUILDING MATERIALS AND OPERATING COMPANY LIMITED (a.k.a. Khartoum Bahri/Industrial Area, P.O. Box REFRACTORIES CORPORATION, P.O. Box GNPOC), Hotel Palace, Room 420, El Nil 1034, Khartoum 11, Sudan; Email Address 2241, Khartoum, Sudan [SUDAN]. Avenue, Khartoum, Sudan; El Harr Oilfield, [email protected] [SUDAN]. 25. COPTRADE COMPANY LIMITED— Muglad Basin, Sudan; El Nar Oilfield, 4. ADVANCED PETROLEUM COMPANY PHARMACEUTICAL AND CHEMICAL Muglad Basin, Sudan; El Toor Oilfield, (a.k.a. APCO), House No. 10, Block 9, Street DIVISION, P.O. Box 246, Khartoum, Sudan; Muglad Basin, Sudan; Heglig Oilfield, 33, Amarat, P.O. Box 12811, Khartoum, Port Sudan, Sudan [SUDAN]. Muglad Basin, Sudan; Heglig Processing Sudan [SUDAN]. 26. COPTRADE ENG AND AUTOMOBILE Facility, Muglad Basin, Sudan; Kaikang 5. ADVANCED TRADING AND SERVICES CO LTD. (f.k.a. KORDOFAN Oilfield, Muglad Basin, Sudan; Toma South CHEMICAL WORKS COMPANY LIMITED AUTOMOBILE COMPANY), P.O. Box 97, Oilfield, Muglad Basin, Sudan; Unity (a.k.a. ADVANCED CHEMICAL WORKS; Khartoum, Sudan [SUDAN]. Oilfield, Muglad Basin, Sudan; Pipeline, a.k.a. ADVANCED COMMERCIAL AND 27. DUTY FREE SHOPS CORPORATION, Heglig via El-Obeid to Port Sudan, Sudan; CHEMICAL WORKS COMPANY LIMITED), P.O. Box 1789, Khartoum, Sudan [SUDAN]. Red Sea Export Terminal, Marsa al-Basha’ir, 19 Al Amarat Street, P.O. Box 44690, 28. EL GEZIRA AUTOMOBILE COMPANY Sudan [SUDAN]. Khartoum, Sudan; Email Address advance@ (a.k.a. GEZIRA AUTOMOBILE COMPANY), 43. GROUPED INDUSTRIES sudanmail.net; Email Address accw@htg- P.O. Box 232, Khartoum, Sudan [SUDAN]. CORPORATION, P.O. Box 2241, Khartoum, sdn.com [SUDAN]. 29. EL NILEIN BANK (n.k.a. EL NILEIN Sudan [SUDAN]. 6. AFRICAN DRILLING COMPANY, INDUSTRIAL DEVELOPMENT BANK 44. GUNEID SUGAR COMPANY LIMITED Khartoum, Sudan [SUDAN]. (SUDAN); n.k.a. EL NILEIN INDUSTRIAL (a.k.a. GUNEID SUGAR FACTORY), P.O. Box 7. AFRICAN OIL CORPORATION, P.O. DEVELOPMENT BANK GROUP; n.k.a. 511, Khartoum, Sudan [SUDAN]. Box 1, Khartoum North, Sudan [SUDAN]. NILEIN INDUSTRIAL DEVELOPMENT 45. HAGGAR ASSALAYA SUGAR 8. AGRICULTURAL BANK OF SUDAN, BANK (SUDAN)), Parliament Street, P.O. Box FACTORY, Haggar Assalaya, Sudan P.O. Box 1363, Khartoum, Sudan [SUDAN]. 466, Khartoum, Sudan; P.O. Box 6013, Abu [SUDAN]. 9. AL SUNUT DEVELOPMENT COMPANY Dhabi City, United Arab Emirates; P.O. Box 46. HI TECH GROUP (a.k.a. HIGH TECH (a.k.a. ALSUNUT DEVELOPMENT 466/1722, United Nations Square, Khartoum, GROUP; a.k.a. HIGHTECH GROUP; a.k.a. COMPANY), No. 1 Block 5 East, Khartoum 2, Sudan [SUDAN]. HITECH GROUP), Amarat Street No. 31, P.O. P.O. Box 1840, Khartoum, Sudan; Web site 30. EL TAKA AUTOMOBILE COMPANY Box 44690, Khartoum, Sudan; Web site www.alsunut.com; Email Address (a.k.a. TAKA AUTOMOBILE COMPANY), www.htg-sdn.com [SUDAN]. [email protected]; Email P.O. Box 221, Khartoum, Sudan [SUDAN]. 47. HICOM (a.k.a. HI–COM), Khartoum, Address [email protected] 31. EMIRATES AND SUDAN Sudan [SUDAN]. [SUDAN]. INVESTMENT COMPANY LIMITED, P.O. 48. HICONSULT (a.k.a. HI–CONSULT), 10. ALAKTAN COTTON TRADING Box 7036, Khartoum, Sudan; Port Sudan, Khartoum, Sudan [SUDAN]. COMPANY (a.k.a. ALAKTAN TRADING Sudan [SUDAN]. 49. HI–TECH CHEMICALS, Khartoum, COMPANY), P.O. Box 2067, Khartoum, 32. ENGINEERING EQUIPMENT Sudan [SUDAN]. Sudan [SUDAN]. COMPANY, P.O. Box 97, Khartoum, Sudan; 50. HI–TECH PETROLEUM GROUP, 11. ALFARACHEM COMPANY LIMITED c/o ENGINEERING EQUIPMENT Khartoum, Sudan [SUDAN]. (a.k.a. AL PHARAKIM; a.k.a. ALFARACHEM CORPORATION, undetermined [SUDAN]. 51. ICDB (a.k.a. ISLAMIC CO–OPERATIVE PHARMACEUTICALS INDUSTRIES 33. ENGINEERING EQUIPMENT DEVELOPMENT BANK), P.O. Box 62, LIMITED; a.k.a. ALFARAKIM), 27 Al Amarat CORPORATION, P.O. Box 97, Khartoum, Khartoum, Sudan [SUDAN]. Street, Khartoum, Sudan [SUDAN]. Sudan [SUDAN]. 52. INDUSTRIAL BANK COMPANY FOR 12. AMIN EL GEZAI COMPANY (a.k.a. EL 34. EXPLORATION AND PRODUCTION TRADE & DEVELOPMENT LIMITED (a.k.a. AMIN EL GEZAI COMPANY), Khartoum, AUTHORITY (SUDAN), Kuwait Building, INDUSTRIAL BANK COMPANY FOR Sudan [SUDAN]. Nile Avenue, Khartoum, Sudan; P.O. Box TRADE & DEVELOPMENT LIMITED), 13. ARAB CEMENT COMPANY, Durdeib, 2986, Khartoum, Sudan [SUDAN]. Khartoum, Sudan [SUDAN]. Sudan; P.O. Box 6180, Khartoum, Sudan 35. FOOD INDUSTRIES CORPORATION, 53. INDUSTRIAL BANK OF SUDAN (n.k.a. [SUDAN]. P.O. Box 2341, Khartoum, Sudan [SUDAN]. EL NILEIN INDUSTRIAL DEVELOPMENT 14. ARAB SUDANESE BLUE NILE 36. FRIENDSHIP SPINNING FACTORY, BANK GROUP), United Nations Square, P.O. AGRICULTURAL COMPANY, Khartoum, Hassaheisa, Sudan [SUDAN]. Box 1722, Khartoum, Sudan [SUDAN]. Sudan [SUDAN]. 37. GEZIRA TANNERY, Gezira, Sudan 54. INDUSTRIAL PRODUCTION 15. ARAB SUDANESE SEED COMPANY, [SUDAN]. CORPORATION, P.O. Box 1034, El Gamaa Khartoum, Sudan [SUDAN]. 38. GEZIRA TRADE & SERVICES Street, Khartoum, Sudan [SUDAN]. 16. ARAB SUDANESE VEGETABLE OIL COMPANY LIMITED (a.k.a. GEZIRA TRADE 55. INDUSTRIAL RESEARCH AND COMPANY, Khartoum, Sudan [SUDAN]. AND SERVICES COMPANY LIMITED), P.O. CONSULTANCY INSTITUTE, P.O. Box 268, 17. ASSALAYA SUGAR COMPANY Box 215, Khartoum, Sudan; P.O. Box 17, Port Khartoum, Sudan [SUDAN]. LIMITED, Eastern Bank of White Nile River, Sudan, Sudan; El Obeid, Sudan; Gedarit, 56. INGASSANA MINES HILLS near Rabak town (about 300 km from Sudan; Juba, Sudan; Kosti, Sudan; Sennar, CORPORATION (a.k.a. INGESSANA HILLS Khartoum, P.O. Box 511, Khartoum, Sudan Sudan; Wad Medani, Sudan [SUDAN]. MINES CORPORATION), P.O. Box 2241, [SUDAN]. 39. GIAD AUTOMOTIVE INDUSTRY Khartoum, Sudan; P.O. Box 1108, Khartoum, 18. AUTOMOBILE CORPORATION, COMPANY LIMITED (a.k.a. GIAD Sudan [SUDAN]. Khartoum, Sudan [SUDAN]. AUTOMOTIVE AND TRUCK; a.k.a. GIAD 57. JUBA DUTY FREE SHOP, Juba, Sudan 19. BABANOUSA MILK PRODUCTS AUTOMOTIVE COMPANY; a.k.a. GIAD [SUDAN]. FACTORY, P.O. Box 16, Babanousa, Sudan CARS & HEAVY TRUCKS COMPANY; a.k.a. 58. KARIMA DATE FACTORY, Karima, [SUDAN]. GIAD CARS AND HEAVY TRUCKS Sudan [SUDAN]. 20. BANK OF SUDAN, Sharia El Gamaa, COMPANY), Gazera State (40 km distance 59. KARIMA FRUIT AND VEGETABLE P.O. Box 313, Khartoum, Sudan; Atbara, from Khartoum), P.O. Box 444/13600, CANNING FACTORY, P.O. Box 54, Karima, Sudan; P.O. Box 27, El Obeid, Sudan; P.O. Khartoum 1111, Sudan; Web site Sudan [SUDAN]. Box 136, Juba, Sudan; P.O. Box 73, Kosti, www.giadmotors.com/giad_auto.html 60. KASSALA FRUIT PROCESSING Sudan; Nyala, Sudan; P.O. Box 34, Port [SUDAN]. COMPANY, Khartoum, Sudan [SUDAN].
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61. KASSALA ONION DEHYDRATION 88. PETROHELP PETROLEUM COMPANY 111. SHEREIK MICA MINES COMPANY FACTORY, P.O. Box 22, Kassala, Sudan LIMITED, Building No. 20, Street No. 42, Al (a.k.a. SHERIEK MICA PROJECT), P.O. Box [SUDAN]. Riyadh Area, P.O. Box 44690, Khartoum, 1034, Khartoum, Sudan; c/o SUDANESE 62. KENAF SOCKS FACTORY, Abu Sudan [SUDAN]. MINING CORPORATION, undetermined Naama, Sudan [SUDAN]. 89. PETROLEUM GENERAL [SUDAN]. 63. KHARTOUM CENTRAL FOUNDRY, ADMINISTRATION, P.O. Box 2649, 112. SILOS AND STORAGE Khartoum, Sudan [SUDAN]. Khartoum, Sudan [SUDAN]. CORPORATION, P.O. Box 1183, Khartoum, 64. KHARTOUM COMMERCIAL AND 90. PORT SUDAN COTTON AND TRADE Sudan [SUDAN]. SHIPPING COMPANY LIMITED, Kasr COMPANY (a.k.a. PORT SUDAN COTTON 113. SPINNING AND WEAVING Avenue, P.O. Box 221, Khartoum, Sudan COMPANY), P.O. Box 590, Khartoum, CORPORATION, P.O. Box 795, Khartoum, [SUDAN]. Sudan; P.O. Box 261, Port Sudan, Sudan Sudan [SUDAN]. 65. KHARTOUM TANNERY, P.O. Box 134, [SUDAN]. 114. SRC (a.k.a. SUDAN RAILWAYS Khartoum South, Sudan [SUDAN]. 91. PORT SUDAN DUTY FREE SHOP, Port CORPORATION), P.O. Box 43, Bara, Sudan; 66. KHOR OMER ENGINEERING Sudan, Sudan [SUDAN]. Babanousa, Sudan; Khartoum, Sudan; Kosti, COMPANY, P.O. Box 305, Khartoum, Sudan 92. PORT SUDAN EDIBLE OILS STORAGE Sudan; Port Sudan, Sudan [SUDAN]. [SUDAN]. CORPORATION, P.O. Box 429, Port Sudan, 115. SRDC (a.k.a. SUDAN RURAL 67. KORDOFAN COMPANY, Khartoum, Sudan [SUDAN]. DEVELOPMENT COMPANY LIMITED), P.O. Sudan [SUDAN]. 93. PORT SUDAN REFINERY LIMITED, Box 2190, Khartoum, Sudan [SUDAN]. 68. KRIKAH INDUSTRIES GROUP, P.O. P.O. Box 354, Port Sudan, Sudan [SUDAN]. 116. STATE CORPORATION FOR Box 755, Khartoum North, Sudan [SUDAN]. 94. PORT SUDAN SPINNING FACTORY, CINEMA, P.O. Box 6028, Khartoum, Sudan 69. LEATHER INDUSTRIES Port Sudan, Sudan [SUDAN]. [SUDAN]. CORPORATION (a.k.a. LEATHER 95. POSTS AND TELEGRAPHS PUBLIC 117. STATE TRADING COMPANY (a.k.a. INDUSTRIES TANNERIES), P.O. Box 1639, CORPORATION, Khartoum, Sudan STATE TRADING CORPORATION), P.O. Box Khartoum, Sudan [SUDAN]. [SUDAN]. 211, Khartoum, Sudan [SUDAN]. 70. MALUT SUGAR FACTORY, Malut, 96. PUBLIC CORPORATION FOR 118. SUDAN ADVANCED RAILWAYS, Sudan [SUDAN]. BUILDING AND CONSTRUCTION, P.O. Box Khartoum, Sudan [SUDAN]. 71. MANGALA SUGAR FACTORY, 2110, Khartoum, Sudan [SUDAN]. 119. SUDAN AIR (a.k.a. SUDAN Mangala, Sudan [SUDAN]. 97. PUBLIC CORPORATION FOR AIRWAYS), P.O. Box 253, Khartoum, Sudan; 72. MASPIO CEMENT CORPORATION, IRRIGATION AND EXCAVATION, P.O. Box Bahrain; Chad; Egypt; Ethiopia; Germany; P.O. Box 96, Atbara, Sudan [SUDAN]. 619, Khartoum, Sudan; P.O. Box 123, Wad Greece; Italy; Kenya; Kuwait; Nigeria; Saudi 73. MAY ENGINEERING COMPANY, P.O. Medani, Sudan [SUDAN]. Arabia; Uganda; United Arab Emirates; Box 97, Khartoum, Sudan; c/o 98. PUBLIC CORPORATION FOR OIL United Kingdom; 211 East 43rd Street, New ENGINEERING EQUIPMENT PRODUCTS AND PIPELINES, Khartoum, York, NY 10017, United States; 199 Atlantic CORPORATION, undetermined [SUDAN]. Sudan [SUDAN]. Avenue, Brooklyn, NY 11201–5606, United 74. MILITARY COMMERCIAL 99. PUBLIC ELECTRICITY AND WATER States [SUDAN]. CORPORATION, P.O. Box 221, Khartoum, CORPORATION (a.k.a. CENTRAL 120. SUDAN COTTON COMPANY, Sudan [SUDAN]. ELECTRICITY AND WATER Khartoum, Sudan [SUDAN]. 75. MODERN ELECTRONIC COMPANY, CORPORATION), P.O. Box 1380, Khartoum, 121. SUDAN COTTON COMPANY Khartoum, Sudan [SUDAN]. Sudan [SUDAN]. LIMITED, P.O. Box 1672, Khartoum, Sudan 76. MODERN LAUNDRY BLUE FACTORY 100. RABAK OIL MILL, P.O. Box 2105, [SUDAN]. (a.k.a. THE MODERN LAUNDRY BLUE Khartoum, Sudan [SUDAN]. 122. SUDAN DEVELOPMENT FACTORY), P.O. Box 2241, Khartoum, Sudan 101. RAINBOW FACTORIES, P.O. Box CORPORATION, Street 21, P.O. Box 710, [SUDAN]. 1768, Khartoum, Sudan [SUDAN]. Khartoum, Sudan [SUDAN]. 77. MODERN PLASTIC & CERAMICS 102. RAM ENERGY COMPANY LIMITED, 123. SUDAN EXHIBITION AND FAIRS INDUSTRIES COMPANY (a.k.a. MODERN Altiyadh Street 131/Almashtal Street, Block CORPORATION, P.O. Box 2366, Khartoum, PLASTIC AND CERAMICS INDUSTRIES 12, House No. 87, P.O. Box 802, Khartoum, Sudan [SUDAN]. COMPANY), Khartoum, Sudan [SUDAN]. Sudan [SUDAN]. 124. SUDAN GEZIRA BOARD (a.k.a. 78. NATIONAL CIGARETTES CO. LTD., 103. REA SWEET FACTORY, P.O. Box GEZIRA SCHEME), Khartum Gezira Scheme P.O. Box 2083, Khartoum, Sudan; and all 1027, Khartoum, Sudan [SUDAN]. Building, 39th Street, P.O. Box 884, other branches in Sudan [SUDAN]. 104. RED SEA HILLS MINERALS Khartoum, Sudan [SUDAN]. 79. NATIONAL COTTON AND TRADE COMPANY, P.O. Box 1034, Khartoum, 125. SUDAN MASTER TECHNOLOGY COMPANY, P.O. Box 1552, Khartoum, Sudan Sudan; c/o SUDANESE MINING (a.k.a. GIAD INDUSTRIAL CITY; a.k.a. GIAD [SUDAN]. CORPORATION, undetermined [SUDAN]. INDUSTRIAL GROUP; a.k.a. SUDAN 80. NATIONAL ELECTRICITY 105. RED SEA STEVEDORING, P.O. Box MASTER TECH), SMT Building, Gamhuria CORPORATION, P.O. Box 1380, Khartoum, 215, Khartoum, Sudan; P.O. Box 17, Port Street, GIAD Industrial Complex, P.O. Box Sudan [SUDAN]. Sudan, Sudan [SUDAN]. 10782, Khartoum, SU001, Sudan; Web site 81. NATIONAL REINSURANCE 106. REFRIGERATION AND www.sudanmaster.com; Email Address info@ COMPANY (SUDAN) LIMITED, P.O. Box ENGINEERING IMPORT COMPANY, P.O. sudanmaster.com [SUDAN]. 443, Khartoum, Sudan [SUDAN]. Box 1092, Khartoum, Sudan [SUDAN]. 126. SUDAN NATIONAL 82. NEW HAIFA SUGAR FACTORY, 107. ROADS AND BRIDGES PUBLIC BROADCASTING CORPORATION (a.k.a. Kashm el Girba, Sudan [SUDAN]. CORPORATION, P.O. Box 756, Khartoum, SUDAN RADIO & TV CORP.; a.k.a. SUDAN 83. NEW HALFA SUGAR FACTORY Sudan [SUDAN]. RADIO AND TV CORP.; a.k.a. SUDAN T.V. COMPANY LIMITED (a.k.a. NEW HALFA 108. SACKS FACTORY (a.k.a. PLASTIC CORPORATION), P.O. Box 1094, Omdurman, SUGAR COMPANY), El Gamaa Street SACKS FACTORY), P.O. Box 2328, Sudan [SUDAN]. (Aljama Street), New Halfa, P.O. Box 511/ Khartoum, Sudan [SUDAN]. 127. SUDAN OIL CORPORATION, P.O. 3047, Khartoum, Sudan; Email Address 109. SENNAR SUGAR COMPANY Box 2, Khartoum North, Sudan [SUDAN]. [email protected] [SUDAN]. LIMITED, P.O. Box 511, Khartoum, Sudan; 128. SUDAN OIL SEEDS COMPANY 84. NEW KHARTOUM TANNERY, P.O. Email Address [email protected] LIMITED, P.O. Box 167, Khartoum, Sudan; Box 17, Khartoum, Sudan [SUDAN]. [SUDAN]. Nyala, Sudan; Obied, Sudan; Port Sudan, 85. NORTHWEST SENNAR SUGAR 110. SHEIKAN INSURANCE AND Sudan; Tandalty, Sudan [SUDAN]. FACTORY, Northwest Sennar, Sudan REINSURANCE COMPANY LIMITED (a.k.a. 129. SUDAN SOAP CORPORATION, P.O. [SUDAN]. SHEIKAN INSURANCE COMPANY), Al Box 23, Khartoum North, Sudan [SUDAN]. 86. OIL CORPORATION, P.O. Box 64, Souq Al Arabi, Sheikan Building, Khartoum 130. SUDAN TEA COMPANY, LTD., P.O. Khartoum, Sudan [SUDAN]. SU001, P.O. Box 10037, Khartoum, Sudan; Box 1219, Khartoum, Sudan [SUDAN]. 87. OMDURMAN SHOE FACTORY, Email Address [email protected] 131. SUDAN TELECOMMUNICATIONS Omdurman, Sudan [SUDAN]. [SUDAN]. COMPANY LIMITED (a.k.a. SUDATEL), 9th
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Floor, Sudatel Tower, Nile Street, Khartoum, WAFRAPHARMA LABORATORIES), Main ADDRESSES: Send comments regarding Sudan; Sudatel Tower, Al Horriya Street, Street, P.O. Box 2032, Omdurman, Sudan; the burden estimate, or any other aspect P.O. Box 11155, Khartoum, Sudan; Web site Email Address [email protected] of the information collection, including www.sudatel.net/en; Email Address info@ [SUDAN]. suggestions for reducing the burden, to sudatel.net [SUDAN]. 151. WAU FRUIT AND VEGETABLE 132. SUDAN WAREHOUSING COMPANY, CANNING FACTORY, P.O. Box 110, Wau, (1) Office of Information and Regulatory P.O. Box 215, Khartoum, Sudan; P.O. Box 17, Sudan [SUDAN]. Affairs, Office of Management and Port Sudan, Sudan; El Obeid, Sudan; Gedarit, 152. WHITE NILE BATTERY COMPANY, Budget, Attention: Desk Officer for Sudan; Juba, Sudan; Kosti, Sudan; Sennar, Khartoum, Sudan [SUDAN]. Treasury, New Executive Office Sudan; Wad Medani, Sudan [SUDAN]. 153. WHITE NILE BREWERY, P.O. Box Building, Room 10235, Washington, DC 133. SUDANESE COMPANY FOR 1378, Khartoum, Sudan [SUDAN]. 20503, or email at OIRA_Submission@ BUILDING AND CONSTRUCTION LIMITED, 154. WHITE NILE TANNERY, P.O. Box OMB.EOP.gov and (2) Treasury PRA P.O. Box 2110, Khartoum, Sudan [SUDAN]. 4078, Khartoum, Sudan [SUDAN]. Clearance Officer, 1750 Pennsylvania 134. SUDANESE ESTATES BANK, Al- 155. NILE CEMENT COMPANY LIMITED, Ave. NW., Suite 8142, Washington, DC Baladiya Avenue, P.O. Box 309, Khartoum, P.O. Box 1502, Khartoum, Sudan; Factories at Sudan [SUDAN]. Rabak, St. 45–47, Khartoum Extension, 20220, or email at [email protected]. 135. SUDANESE FREE ZONES AND Sudan [SUDAN]. FOR FURTHER INFORMATION CONTACT: MARKETS COMPANY (a.k.a. SFZ), P.O. Box 156. NILE CEMENT FACTORY, Rabak, Copies of the submissions may be 1789, Khartoum, Sudan; Chad; Saudi Arabia; Sudan; P.O. Box 1502, Khartoum, Sudan obtained from Jennifer Leonard by Turkey; United Arab Emirates [SUDAN]. [SUDAN]. emailing [email protected], calling 136. SUDANESE INTERNATIONAL 157. FARMERS COMMERCIAL BANK TOURISM COMPANY, P.O. Box 7104, (202) 622–0489, or viewing the entire (f.k.a. FARMERS BANK FOR INVESTMENT information collection request at Khartoum, Sudan; c/o TOURISM AND & RURAL DEVELOPMENT; a.k.a. FARMERS HOTELS CORPORATION, undetermined BANK FOR INVESTMENT AND RURAL www.reginfo.gov. [SUDAN]. DEVELOPMENT; f.k.a. SUDAN SUPPLEMENTARY INFORMATION: 137. SUDANESE MINING CORPORATION, COMMERCIAL BANK), P.O. Box 1116, El P.O. Box 1034, Khartoum, Sudan [SUDAN]. Kasr Avenue, Khartoum, Sudan; P.O. Box 22, Alcohol and Tobacco Tax and Trade 138. SUDANESE PETROLEUM El Damazin, Sudan; El Fau, Sudan; P.O. Box Bureau (TTB) CORPORATION, 7th Floor, Al Kuwaitiah 182, El Gadaref, Sudan; P.O. Box 1, El Building, El Nile Street, Khartoum, Sudan Hawata, Sudan; P.O. Box 8, El Nuhud, Title: Schedule of Tobacco Products, [SUDAN]. Sudan; P.O. Box 412, El Obeid, Sudan; P.O. Cigarette Papers, or Tubes Withdrawn 139. SUDANESE REAL ESTATE SERVICES Box 45153, El Suk Elarabi, Sudan; P.O. Box from the Market. COMPANY, Khartoum, Sudan [SUDAN]. 1174, Gamhoria Avenue, Khartoum, Sudan; OMB Control Number: 1513–0034. 140. SUDANESE SAVINGS BANK, P.O. P.O. Box 1694, El Suk Elafrangi, Khartoum, Type of Review: Extension without Box 159, Wad Medani, Sudan [SUDAN]. Sudan; P.O. Box 384, Khartoum, Sudan; P.O. change of a currently approved 141. SUDANESE SUGAR PRODUCTION Box 86, Industrial Area, Khartoum, Sudan; collection. COMPANY LIMITED (a.k.a. SUDANESE P.O. Box 8127, Khartoum, Sudan; P.O. Box SUGAR COMPANY), El Gamaa Street 899, Omdurman, Sudan; Wad Madani, Abstract: As provided by the IRC at 26 (Aljama Street), Opposite the Authority of Sudan; P.O. Box 36, New Halfa, Sudan; P.O U.S.C. 5705, a manufacturer or importer Electricity Building, P.O. Box 511, Khartoum, Box 570, Port Sudan, Sudan [SUDAN]. is allowed credit or refund of the Sudan; P.O. Box 511, Building No. 3-Block Federal excise tax paid on tobacco No. 7, Alshatte Gharb-Gammaa Avenue, John E. Smith, products, cigarette papers, or cigarette Khartoum, Sudan; Email Address sukar@ Director, Office of Foreign Assets Control. tubes withdrawn from the market when sudanmail.net [SUDAN]. [FR Doc. 2017–23090 Filed 10–25–17; 8:45 am] satisfactory proof of the withdrawal is 142. SUDAPET LTD. (a.k.a. SUDAN PETROLEUM COMPANY LIMITED; a.k.a. BILLING CODE 4810–AL–P provided to the Secretary. Under this SUDAPET), El Nil Street, Khartoum, Sudan authority, the TTB regulations prescribe [SUDAN]. the use of TTB F 5200.7 by 143. SUGAR AND DISTILLING INDUSTRY DEPARTMENT OF THE TREASURY manufacturers or importers to identify CORPORATION (a.k.a. SUGAR AND tobacco products, cigarette papers, or DISTILLING CORPORATION), New Mustafa Agency Information Collection cigarette tubes to be withdrawn from the El Amin Building, Barlaman Avenue, P.O. Activities; Submission for OMB market and the location of those articles. Box 511, Khartoum, Sudan [SUDAN]. Review; Comment Request; Multiple The form also documents the taxpayer’s 144. TAHEER PERFUMERY Alcohol and Tobacco Tax and Trade planned disposition of the articles CORPORATION, P.O. Box 2241, Khartoum, Bureau Information Collection (destroyed, reduced to materials, or Sudan [SUDAN]. Requests 145. TAHREER PERFUMERY returned to bond), and TTB’s decision to CORPORATION, EL, Omdurman, Sudan AGENCY: Departmental Offices, U.S. witness or not witness that disposition. [SUDAN]. Department of the Treasury. Taxpayers file a completed TTB F 146. TEA PACKETING AND TRADING 5200.7 to support their subsequent ACTION: Notice. COMPANY, P.O. Box 369, Khartoum, Sudan claim for credit or refund of the excise [SUDAN]. SUMMARY: The Department of the taxes paid on the withdrawn articles. 147. TOURISM AND HOTELS Treasury will submit the following The information collected on the form is CORPORATION, P.O. Box 7104, Khartoum, necessary to protect the revenue; it Sudan; Ed Damer, Sudan; El Fasher, Sudan; information collection requests to the Khartoum Airport, Sudan; Port Sudan, Sudan Office of Management and Budget provides TTB with certain information [SUDAN]. (OMB) for review and clearance in needed to determine whether a claim is 148. WAD MADANI DUTY FREE SHOP, accordance with the Paperwork valid. Wad Madani, Sudan [SUDAN]. Reduction Act of 1995, on or after the Form: TTB F 5200.7. 149. WAFRA CHEMICALS & TECHNO– date of publication of this notice. The Affected Public: Businesses or other MEDICAL SERVICES LIMITED (a.k.a. public is invited to submit comments on for-profits. WAFRA CHEMICALS AND TECHNO– these requests. Estimated Total Annual Burden MEDICAL SERVICES LIMITED), Khartoum, Hours: 188. Sudan [SUDAN]. DATES: Comments should be received on 150. WAFRA PHARMA LABORATORIES or before November 27, 2017 to be Title: Tobacco Products (a.k.a. WAFRA PHARMACEUTICALS; a.k.a. assured of consideration. Manufacturers—Supporting Records for
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Removals for the Use of the United Form: None. Title: Labeling of Major Food States. Affected Public: Businesses or other Allergens and Petitions for Exemption. OMB Control Number: 1513–0069. for-profits. OMB Control Number: 1513–0121. Type of Review: Extension without Estimated Total Annual Burden Type of Review: Revision of a change of a currently approved Hours: 205. currently approved collection. collection. Abstract: The Federal Alcohol Abstract: Tobacco products and Title: Marks and Notices on Packages Administration Act (FAA Act) at 27 cigarette papers and tubes manufactured of Tobacco Products. U.S.C. 205(e) authorizes the Secretary to in or imported into the United States are OMB Control Number: 1513–0101. subject to a Federal excise tax under the Type of Review: Extension without issue regulations regarding the labeling IRC at 26 U.S.C. 5701. However, change of a currently approved of wine, distilled spirits, and malt pursuant to 26 U.S.C. 5704(b), collection. beverages in order to, among other manufacturers of tobacco products or Abstract: The IRC at 26 U.S.C. 5723(b) things, prohibit consumer deception cigarette papers and tubes may remove requires certain marks and notices be and ensure that labels provide such articles, without payment of tax, placed on packages of tobacco products consumers with adequate information as ‘‘for use of the United States’’ under and cigarette papers and tubes before to the identity and quality of such such regulations as the Secretary shall removal. Under this authority, the TTB products. Under this authority, the TTB prescribe. In addition, under 26 U.S.C. regulations require that packages of regulations allow for the voluntary 5741, all manufacturers and importers domestically manufactured or imported labeling of major food allergens (as of tobacco products or cigarette papers tobacco products bear certain marks to defined in the Food Allergen Labeling and tubes are required to keep such identify the product, its excise tax class, and Consumer Protection Act of 2004 records in such manner as the Secretary and the quantity or weight of the (118 Stat. 905)) used in the production of the Treasury prescribes by regulation. product, depending on the basis of the of alcohol beverages. The regulations Under these authorities, the TTB tax. The TTB regulations also require require that, if any one major food regulations require manufacturers to certain notices on packages of such allergen is voluntarily declared, all keep records related to the removals of articles intended for export or use of the major food allergens used in the product tobacco products or cigarette papers or United States. Tobacco products and must be declared, except when TTB has tubes for use of the United States, cigarette papers and tubes for export or approved a petition for exemption from including the date of removal, the name use of the United States are removed such labeling. This information and address of the Federal agency to without payment of tax (or are exported collection includes the labeling of which the products are shipped or after tax payment with benefit of allergens and petitions for exemption. delivered, the kind and quantity of drawback of the taxes paid), and the Form: None. products removed and, for large cigars, required notices on such packages (or Affected Public: Businesses or other the sale price. Records must also be kept shipping containers, under some for-profits. detailing any items removed for use of circumstances) are intended to ensure Estimated Total Annual Burden the United States and returned to the the product is readily identifiable in Hours: 527. manufacturer. The required records are order to prevent diversion of the Authority: 44 U.S.C. 3501 et seq. necessary to protect the revenue and products into the domestic market. prevent diversion of tobacco products Form: None. Dated: October 20, 2017. by ensuring that the tax exemption is Affected Public: Businesses or other Spencer W. Clark, applied only to products that are for-profits. Treasury PRA Clearance Officer. delivered to a Federal agency for Estimated Total Annual Burden [FR Doc. 2017–23221 Filed 10–25–17; 8:45 am] government use. Hours: 1. BILLING CODE 4810–31–P
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Part II
Department of Justice
Drug Enforcement Administration Lon F. Alexander, M.D.; Decision and Order; Notice
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DEPARTMENT OF JUSTICE The Show Cause Order also alleged documenting such in her file).’’ Id. that on various occasions from 2011 (citing same authorities as above). Drug Enforcement Administration through 2013, Respondent violated Finally, the Show Cause Order alleged federal and state law by issuing his wife that Respondent ‘‘engaged in conduct [Docket No. 16–17] prescriptions for hydrocodone, then a which may threaten public health and schedule III narcotic, as well as other safety . . . by attempting to mislead Lon F. Alexander, M.D.; Decision and controlled substances, which were also DEA investigators.’’ Id. (citing 21 U.S.C. Order nontherapeutic, for other than a 823(f)(5)). Specifically, the Government On February 4, 2016, the Deputy legitimate medical purpose, and were alleged that, ‘‘on February 2, 2016, Assistant Administrator, of the then outside the usual course of professional [Respondent] turned over to DEA in Office of Diversion Control, issued an practice. Id. at 2–3. Specifically, the response to an administrative subpoena Order to Show Cause to Lon F. Show Cause Order alleged that ‘‘[o]n at a record purporting to be the patient Alexander, M.D. (hereinafter, least one occasion in 2011,’’ Respondent file’’ of his wife. Id. The Order alleged Respondent), of Hattiesburg, issued prescriptions for hydrocodone that the file ‘‘contained false entries’’ in Mississippi. ALJ Ex. 1, at 1. The Show and diazepam ‘‘to [his] wife that it contained ‘‘repeated reference to Cause Order proposed the denial of concurrently with another prescription conversations with and attempts to Respondent’s application for a DEA [for clonazepam] issued by her . . . contact [his wife’s] treating psychiatrist’’ Certificate of Registration as a psychiatrist,’’ and that he did so and that ‘‘DEA’s investigation . . . practitioner, on the ground that his ‘‘without her psychiatrist’s knowledge indicate[s] that these statements and ‘‘registration is inconsistent with the or permission.’’ Id. at 2. The Order again others presented as part of the public interest.’’ Id. (citing 21 U.S.C. alleged that Respondent’s ‘‘actions purported patient file are false.’’ Id. Following service of the Show Cause 823(f)). dramatically increased the chances of Order, Respondent, through his counsel, As for the Agency’s jurisdiction, the [his] wife’s dependency, overdose, or requested a hearing on the allegations. Show Cause Order alleged that diversion of . . . controlled ALJ Ex. 2. The matter was placed on the Respondent had previously held a substance[s], while also potentially docket of the Office of Administrative registration which he surrendered for complicating her psychiatric Law Judges and assigned to ALJ Charles cause on January 16, 2014. Id. The condition.’’ Id. (citing same authorities Wm. Dorman. Following pre-hearing Order further alleged that on January 9, as above). procedures, the ALJ conducted an 2015, Respondent applied for a new Next, the Show Cause Order alleged evidentiary hearing in Jackson, registration as a practitioner in additional instances of non-therapeutic Mississippi on June 29–30, 2016, at schedules II through V, at the proposed prescribing by Respondent to his wife in which both parties elicited testimony registered address of 36 Bridgefield that, ‘‘[o]n at least four different from witnesses and submitted various Turn, Hattiesburg, Mississippi. Id. occasions in 2013,’’ he ‘‘repeatedly documents for the record. Following the As for the substantive grounds for the issued . . . prescriptions for hearing, both parties submitted briefs of proceeding, the Show Cause Order hydrocodone . . . zolpidem tartrate . . . their proposed findings of fact, raised multiple allegations to the effect and alprazolam . . . when she was conclusions of law, and argument. that, on numerous occasions in 2011 concurrently being issued other On September 20, 2016, the ALJ through 2013, Respondent violated controlled substances prescriptions for issued his Recommended Decision. federal and state law by issuing the same or similar drugs, as well as Therein, with respect to Factors Two controlled substance prescriptions to his amphetamines, by her . . . psychiatrist, (Respondent’s experience in dispensing wife ‘‘that were nontherapeutic, were which [he] did without his knowledge controlled substances) and Four for other than a legitimate medical or permission.’’ Id. at 2–3. As with the (compliance with applicable laws purpose, and were issued outside of the previous allegations, the Order alleged related to controlled substances), the usual course of [his] professional that Respondent’s ‘‘actions dramatically ALJ found that the Government had practice.’’ Id. at 1–3. The Show Cause increased the chances of her proved that Respondent violated 21 CFR Order alleged that Respondent dependency, overdose, or diversion of 1306.04, Mississippi Code Sec. 73–25– ‘‘repeatedly issued’’ prescriptions for those controlled substances, while also 29(3) and 73–25–29(13), as well as schedule IV controlled substances potentially complicating her psychiatric Mississippi Administrative Rules 1.7, which included zolpidem tartrate, condition.’’ Id. at 3 (citing same 1.10, and 1.16 when he issued alprazolam, and diazepam, ‘‘when she authorities as above). numerous controlled substance was concurrently being issued The Show Cause Order also alleged prescriptions to his wife. prescriptions for the same or similar that ‘‘[o]n at least fifteen different Specifically, the ALJ found that class of drugs by her own psychiatrist, occasions between 2011 and 2013, during 2011, Respondent issued nine which [he] did without [the] [Respondent] violated state and federal zolpidem, two alprazolam, seven psychiatrist’s knowledge or law by issuing’’ to his wife prescriptions hydrocodone, and one diazepam permission.’’ Id. The Order further for hydrocodone, and/or zolpidem, and/ prescription(s) in violation of these alleged that Respondent’s ‘‘actions or alprazolam, ‘‘without conducting any provisions. R.D. at 39–40. The ALJ also dramatically increased the chances of examination of [his] wife (or found that during 2012, Respondent [his] wife’s dependency, overdose, or documenting such in her file) or noting issued five alprazolam prescriptions, diversion of those controlled the . . . prescriptions in her patient and that during 2013, he issued 11 substances, while also potentially chart.’’ Id. (citing same authorities as alprazolam prescriptions in violation of complicating her psychiatric above). The Show Cause Order then these provisions. Id. at 41–43. The ALJ condition.’’ Id. (citing 21 CFR 1306.04; alleged that ‘‘[o]n at least nine occasions further found that in 2013, Respondent Miss. Admin. Code Part 2640, Ch. 1, r. between 2011 and 2013, [Respondent] issued five hydrocodone prescriptions 1.7, 1.10, and 1.16; Miss. Code Ann. violated state and federal law by and one zolpidem prescription in Sec. 73–25–29(3) & (13)).1 issuing’’ to his wife prescriptions for violation of these provisions. Id. at 44. these drugs, ‘‘without conducting In addition to the above, the ALJ 1 See also ALJ Ex. 1, at ¶¶ 5–6. sufficient examinations of [her] (or found that between 2011 and 2013,
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Respondent prescribed hydrocodone 11 respondent must express remorse for all a prescription is subsumed in his times, zolpidem 12 times, and acts of documented misconduct, and general acceptance of responsibility.’’ alprazolam five times without may be required to acknowledge the Id. documenting the prescriptions or a prior scope of his misconduct.’’ R.D. 52 While the ALJ acknowledged that examination in his wife’s patient file in (citations omitted); see also id. at 54. Respondent declined ‘‘to admit that he violation of various provisions of The ALJ also explained that violated federal laws because he did not Mississippi law and administrative ‘‘[a]cceptance of responsibility and want to speculate on what statutes he rules. Id. at 46. He also found that on remedial measures are assessed in the might have violated’’ and ‘‘testif[ied] nine occasions when Respondent did context of the egregiousness of the that he did not know whether the document a prescription in his wife’s violations and the [DEA’s] interest in prescriptions were outside the scope of file, he failed to include information deterring similar misconduct by [the] his professional practice as the DEA required by state rules such as a medical Respondent in the future as well as on defines those terms,’’ the ALJ reasoned history, examination results, or a the part of others.’’ Id. at 52 (internal that Respondent was not required to diagnosis. Id. at 47–48 (citing Miss. quotations and citations omitted). ‘‘identify the specific federal code Admin. Rule 1.4). The ALJ further The ALJ concluded that provisions he violated, or interpret concluded that ‘‘nothing in . . . ‘‘Respondent’s misconduct was federal laws and apply them to his Respondent’s file for his wife egregious’’ in that he ‘‘repeatedly and circumstances.’’ Id. at 56. The ALJ necessarily indicates that [he] ever wrongfully prescribed addictive, further explained that he found conducted any type of physical or dangerous, and potentially harmful Respondent’s remorse to be ‘‘sincere mental status examination of his wife controlled substances to his wife for and that his commitment to adhere to prior to prescribing controlled approximately three years,’’ which all regulations governing controlled substances to her.’’ Id. at 48. He thus ‘‘interfered with his wife’s treatment substances is genuine.’’ Id. at 56–57. found proved the ‘‘allegation that the and could have caused her to overdose, The ALJ further found that Respondent failed to conduct lose consciousness, or die.’’ Id. at 53. Respondent had undertaken ‘‘reasonable examinations and/or lacked adequate The ALJ nonetheless concluded that and appropriate’’ remedial measures. Id. documentation of examinations of his Respondent had accepted responsibility at 59. As for the Agency’s interest in wife’’ in violation of various provisions for his misconduct in prescribing specific deterrence, the ALJ suggested of Mississippi law and administrative outside the usual course of practice that it ‘‘might be negligible,’’ reasoning rules. Id. at 49. because, by ‘‘[s]imply acknowledging that Respondent ‘‘thoroughly Turning to Factor Five (such other that he failed to properly document his understands that if he engages in any conduct which may threaten public treatment of his wife, [he] admitted to further misconduct he will face health or safety), the ALJ rejected the practicing outside the usual scope of immediate sanctions from the’’ allegation that Respondent attempted to professional practice.’’ Id. at 54. Physicians Health Program and the State mislead DEA investigators by providing The ALJ also acknowledged Board ‘‘that will end his medical to them the patient file containing false Respondent’s testimony ‘‘that he did not career.’’ Id. at 59. And while the ALJ entries to the effect that he had made his think that his actions increased his noted that ‘‘Respondent’s conduct was wife’s psychiatrist aware of the wife’s chances of dependency, overdose, egregious,’’ he reasoned that the prescriptions. Id. at 49–52. The ALJ or diversion,’’ and that ‘‘[t]he circumstances were unique because reasoned that it appeared that Government’s argument that that ‘‘every allegation of misconduct . . . Respondent created the file ‘‘as he was Respondent did not accept involved . . . Respondent prescribing to treating his wife,’’ that he ‘‘did nothing responsibility for putting his wife at risk only his wife.’’ Id. at 60. The ALJ then more than turn over his file when is also understandable.’’ Id. The ALJ explained that Respondent’s testimony ordered to do so by the . . . subpoena,’’ reasoned, however, that ‘‘a respondent in a State Board proceeding to the effect and that there was ‘‘[n]o evidence . . . is not required to admit to every single that his prescribing ‘‘was not a matter of that, after the DEA subpoenaed the file, component of an allegation in order to judgment but a matter of the heart[] [he] created false entries or altered the accept responsibility.’’ Id. The ALJ then merits some consideration.’’ Id. The ALJ file he already maintained.’’ Id. at 51. noted that in a proceeding before the thus recommended that Respondent’s The ALJ nonetheless concluded that Mississippi Board, ‘‘Respondent application be granted subject to various ‘‘Factors Two and Four weigh acknowledged that his prescriptions conditions. Id. at 61–62. substantially in favor of denying . . . were probably hurting his wife and The Government filed Exceptions to Respondent’s application because he keeping her from getting appropriate the Recommended Decision. In its prescribed controlled substances to his treatment.’’ Id. Exceptions, the Government contended wife for illegitimate and nontherapeutic As for the Government’s contention that the ALJ committed error in purposes, outside the scope of that Respondent did not specifically concluding that Respondent has professional practice, and because he acknowledge his misconduct in ‘‘failing sufficiently accepted responsibility for did not appropriately document to conduct examinations and/or conduct his misconduct. Exceptions, at 3–15. examinations of, any prescriptions to, insufficient examinations prior to The Government also contended that his wife.’’ Id. at 52. The ALJ thus found issuing’’ the prescriptions, the ALJ the ALJ committed error in concluding ‘‘that the Government has made a prima noted that this ‘‘is technically correct.’’ that Respondent is entitled to a new facie case . . . that the Respondent’s Id. at 54–55. The ALJ, however, rejected registration notwithstanding the registration would be inconsistent with the Government’s contention, reasoning egregiousness of his misconduct. Id. at the public interest.’’ Id. that ‘‘the Government overlooks the 16–20. The Government thus argues that The ALJ acknowledged that ‘‘[t]o central concern of this case, which is I should deny Respondent’s application. rebut the Government’s prima facie that the Respondent wrote prescriptions Id. at 20. Respondent did not file a case, the Respondent must both accept for his wife when he should not have.’’ response to the Government’s responsibility for his actions and Id. at 55. The ALJ then explained that Exceptions. demonstrate that he will not engage in ‘‘[i]n his view, the Respondent’s Thereafter, the ALJ forwarded the future misconduct.’’ Id. (citation acceptance of responsibility for failing record to me for final agency action. omitted). The ALJ explained that a ‘‘[a] to examine his wife before writing her Having considered the record in its
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entirety including the Recommended In March 30, 2012, Respondent tested on behalf of Respondent. GE 14, at 23. Decision, the parties post-hearing briefs positive for Tramadol. He then returned Eight days later, the Board issued and the Government’s Exceptions, I to the Betty Ford Center for one month, Respondent an order of prohibition adopt the ALJ’s findings of fact (while after which he was discharged with a which barred him from practicing making several additional findings as to diagnosis of opioid dependence. GE 14, medicine until further notice. GE 13, at prescriptions) and legal conclusions at 14–16. The MPHP did not, however, 5. with respect to paragraphs two through withdraw its advocacy on his behalf, Thereafter, Respondent was charged ten of the Show Cause Order. I and on June 11, 2012, Respondent with two counts of violating the State’s entered into a new RCA which conclude, however, that the Medical Practice Act, including contained the same terms as the Government’s Exception to the ALJ’s violating an existing Board Order, previous RCA, including the prohibition legal conclusion that Respondent has Stipulation or Agreement, see Miss. on prescribing to family members. Id. at sufficiently accepted responsibility for Code Ann. Sec. 73–25–29(13), and 16–17. his misconduct is well taken. engaging in unprofessional conduct, by Accordingly, I deny his application. I On September 10, 2012, Respondent engaging in dishonorable or unethical make the following factual findings. met with the Mississippi Professionals Health Committee due to its concerns conduct. GE 14, at 5; see also Miss. Code Findings of Fact that he had ‘‘missed callings for random Ann. Sec. 73–25–29(8)(d) (unprofessional conduct includes Respondent’s Registration and drugs screens,’’ had failed to attend ‘‘[b]eing guilty of any dishonorable or Licensure Status Caduceus meetings, failed to continued his aftercare therapy, failed to pay his unethical conduct likely to deceive, Respondent is a neurosurgeon bill for the drug screen testing, and had defraud or harm the public’’). licensed by the Mississippi State Board ‘‘fail[ed] to turn in his support group of Medical Licensure. R.D. 3 (citing On January 16, 2014, the Board held attendance records.’’ Id. at 19–20. a hearing on the allegations at which Stipulation of Fact No. 4); Tr. 481–82. According to Dr. Hambleton’s testimony Respondent also previously held a DEA Respondent appeared. As the record of at the second State Board hearing, the the hearing shows, the allegations were Certificate of Registration, pursuant to committee ‘‘warned [Respondent] very which he was authorized to dispense based on Respondent’s violations of his carefully that any future noncompliance RCA, particularly in his prescribing of schedule II through V controlled would result in [the] potential loss of substances as a practitioner. GX 1, at 1. controlled substances to his wife. Also [the] MPHP[’s] advocacy’’ and ‘‘that this at issue was his lack of honesty in However, on January 17, 2014, was really his last chance to Respondent surrendered this failing to disclose his prescribing to his demonstrate that he could do what was treatment providers as well as the registration for cause. Id. According to necessary to prove that he’s safe.’’ Id. Respondent, he agreed to surrender his MPHP committee and the MPHP’s staff. While Respondent was compliant GE 14, at 21. registration at the time of the State with the issues raised by the committee, Board hearing that suspended his the committee was unaware that Following the hearing, the Board medical license. Tr. 485. On January 9, Respondent had been violating his RCA found Respondent guilty on both counts 2015, Respondent applied for a new by writing controlled substance and suspended his medical license for practitioner’s registration seeking prescriptions for his wife. Id. at 20–21. one year, after which he was entitled to authority to dispense controlled According to Dr. Hambleton, he did not petition the Board for reinstatement of substances in schedules II through V, at know that Respondent had been calling his license. Id. at 91. The Board ordered a registered address in Hattiesburg, in controlled substance prescriptions for that he ‘‘successfully complete Mississippi. R.D. 3 (citing Stipulation of his wife until the State Board informed multidisciplinary treatment at a Fact No. 1). him on October 7, 2013. Id. Dr. treatment facility approved in advance In 2008, Respondent referred himself Hambleton also testified in the State by the MPHP,’’ as well ‘‘establish a to the Betty Ford Center, ‘‘when [he] Board proceeding that Respondent did provisional contract [and] take those realized [he] had a problem with not disclose this information to his steps necessary to obtain affiliation and prescription medicines’’ and spent 90 ‘‘treatment providers at Betty Ford, to advocacy with the MPHP.’’ GE 13, at 7– days in treatment. Tr. 487. According to our committee, or [to] our staff at 8. Respondent, ‘‘[o]nce [he] went to the MPHP.’’ Id. On January 15, 2015, Respondent Betty Ford Center, [he] disclosed to the On October 15, 2013, the MPHP, appeared before the Board seeking MPHP [Mississippi Physician’s Health having concluded that Respondent’s reinstatement. At the hearing, Dr. Program] and ultimately the [B]oard of ‘‘continued practice of medicine Hambleton (the MPHP Medical Director) [M]edicine that [he] was now a represent[ed] a definite threat to the testified in support of Respondent’s participant.’’ Id. at 488. public health’’ withdrew its advocacy In May 2008, Respondent entered into petition, stating that he ‘‘complied with a Recovery Contract Agreement all of our requirements and he’s begun Director was, however, placed under oath in the the treatment process at Acumen.’’ Id. at (hereinafter, recovery contract, contract, State Board proceeding. GE 14, at 11. He also or RCA) with the MPHP. GE 14, at 13. testified in this proceeding and explained that with 13. Dr. Hambleton further expressed his The RCA’s terms included that he the exception of its duration, the terms of ‘‘belief . . . that he will comply with his Respondent’s current RCA (which ‘‘is his fourth completely abstain from mood-altering contract.’’ Id. At the conclusion of the contract’’) are the same as they were for his testimony, the Board reinstated addictive substances, that he not treat previous contracts. Tr. 452. Notably, his current himself or his family, that he undergo contract requires that, ‘‘[o]ther than cases of Respondent’s medical license. Id. at 15. random drug screens, and that he be medical emergencies, I agree to abstain from the use The DEA Investigation 2 of any mood-altering, addictive, or potentially honest. Id.; see also R.D. at 4. addictive prescription medication, including amphetamine preparations, without written At some point not clearly established 2 The ALJ noted that these facts, which are based permission from MPHP.’’ RX C, at 2. The RCA’s on the record, a DEA Diversion on the testimony of Dr. Hambleton, the Director of terms also state that ‘‘I agree not to prescribe, Investigator (DI) assigned to the Jackson, the MPHP, at Respondent’s January 15, 2015 Board dispense or administer to family members or myself Mississippi office opened an Hearing, are ‘‘not necessarily proven by a any drug having addiction-forming or addiction- preponderance of the evidence.’’ R.D. 4. The sustaining liability.’’ Id. investigation into Respondent’s
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prescribing practices.3 Tr. 31, 90. As the Thereafter, the DI visited Dr. Webb Restoril, and an anxiety medication DI explained, Respondent’s ‘‘history and ‘‘asked him if he was aware’’ that such as Xanax or Clonazepam. Id. at with the Medical Board . . . gave us Respondent’s wife was ‘‘receiving these 204. pause, so we began an investigation into prescriptions from’’ Respondent. Id. Dr. Dr. Webb testified that while he and . . . his prescribing habits.’’ Id. The DI Webb ‘‘said that he was not’’ and asked Respondent ‘‘talked a lot in the 90s and testified that he had access to the the DI to ‘‘look into it further.’’ Id. the early 2000s,’’ they have ‘‘talked less Board’s investigation, Tr. 22 & 32, and Following the visit, the DI served a and less over the last 10 years.’’ Id. at obtained reports from the State’s subpoena on Dr. Webb and obtained his 110. Dr. Webb testified that his records Prescription Monitoring Program patient file for Respondent’s wife. Id. at show that he had talked to Respondent showing Respondent’s controlled 35; GX 3, at 1–2. Dr. Webb’s file for ‘‘about four times’’ in the period from substance prescribing. Id. at 22–23. Respondent’s wife was entered into January 2011 to December 2013. Id. at Specifically, the DI obtained a evidence as GX 5. Tr. 68–75. 111; see also GX 7, at 1 (memo prepared ‘‘Prescriber Activity Report’’ showing The DI also obtained some of ‘‘the by Dr. Webb memorializing meeting Respondent’s prescriptions from hard copy prescriptions from several with DEA noting that he had talked with January 1, 2011 through December 31, different pharmacies throughout’’ the Respondent on Dec. 20, 2011, Feb. 20, 2013. Tr. 24; GX 10. The DI also State.6 Tr. 35–36. The DI presented the 2012, Sept. 4, 2012, and Aug. 5, 2013). obtained a PMP report using the various prescriptions to Dr. Webb and asked According to Dr. Webb, Respondent names of Respondent’s wife for the him: ‘‘were these authorized? Did you ‘‘would call me whenever he felt [his same period. Tr. 29; GX 11. Of note, know?’’ Id. at 36. Dr. Webb ‘‘again wife] was in a crisis . . . to give me that however, GX 10 contains a number of maintained that he did not’’ know about information and to . . . garner some prescriptions which Respondent issued the prescriptions. Id. help from me to her.’’ Tr. 110. Dr. Webb to his wife which are not listed on GX The DI also served a subpoena on testified that he never had a discussion 11.4 Respondent for ‘‘[a]ny and all charts, with Respondent about the latter’s In reviewing the PMP reports, the DI files and/or documents, written, typed prescribing controlled substances to his found it suspicious that Respondent was or computerized, relating to’’ his wife. wife. Id.; see also id. at 138. When then prescribing controlled substances to his GX 4, at 1. A ten-page exhibit of asked if Respondent had contacted him wife as ‘‘she was seeing a psychiatrist, Respondent’s Medical Progress Notes and told him that he had prescribed Dr. Mark Webb, during that timeframe.’’ for his wife was entered into evidence because his wife had ‘‘run out’’ and Tr. 30. The DI ‘‘noticed multiple as GX 6. Tr. 67. ‘‘need[ed] some’’ medication on a prescriptions’’ which Respondent temporary basis, Dr. Webb answered authorized for drugs that his wife ‘‘was Dr. Webb’s Testimony ‘‘no’’ and explained that ‘‘that would receiving’’ from Dr. Webb. Id. at 31. The The Government called Dr. Mark not make a lot of sense,’’ because he DI further explained that he was ‘‘aware Webb as a fact witness. Dr. Webb (Dr.Webb) ‘‘would be the person that [Respondent] was married to . . . testified that he has practiced psychiatry authorized that needed to call that in.’’ Ms. Alexander, so [I] knew there was a in Mississippi since 1990 and that Id. at 111. While Dr. Webb testified that pretty good assumption that he was Respondent’s wife has been his patient there was an instance during which he aware that she was receiving these since November 2000. Id. at 102, 105. ‘‘walked out to the car with medications, because she had seen Dr. Dr. Webb acknowledged that he [Respondent’s wife] . . . and Webb for such a long time.’’ Id. at 32. prescribes both controlled and non- [Respondent] was in the car with their According to the DI, during a phone controlled substances and that for most newborn son,’’ and they ‘‘chit-chatted conversation with Respondent’s wife of the patients who are treated with [for] two seconds,’’ there was no ‘‘[s]he advised that she needed the controlled substances, he prescribes discussion of Respondent’s prescribing medications’’ and that Respondent had only ‘‘two weeks’ worth of medications’’ of controlled substances to his wife. Id. written ‘‘her some prescriptions, but so that ‘‘it’s a tighter leash.’’ Id. at 111–12; see also R.D. 16 (ALJ Finding that she didn’t feel like that was a According to Dr. Webb, he has of Fact No. 28). Dr. Webb also testified problem.’’ Id. at 33. Respondent’s wife ‘‘known [Respondent] for a long time’’ that he did not have a conversation with also told the DI that ‘‘she didn’t know and the two ‘‘referred patients back and Respondent’s wife about Respondent’s if her husband had patient files . . . for forth in the 90s and the early 2000[s].’’ prescribing to her until either late in her [but] that he did prescribe some Id. at 110. Dr. Webb testified that he saw 2015 or 2016. Tr. 174–75. prescriptions to her.’’ 5 Id. at 34. Respondent’s wife at his request. Id. He Dr. Webb testified that DEA also testified that during the 2011 Investigators showed him the ten pages 3 Earlier in his testimony, the DI stated that the through 2013 period, his medication of notes Respondent created with investigation was prompted by Respondent’s 2015 regimen for Respondent’s wife was to respect to the prescriptions he issued for application. Tr. 31. Yet later in his testimony, the his wife and that he compared them DI stated that the case was opened earlier, after the prescribe ‘‘an anti-depressant,’’ an Board provided DEA ‘‘with documentation Attention Deficit Disorder (ADD) with the patient file he maintained on regarding his history with them.’’ Tr. 90. The DI medication such as Adderall XR, a Respondent’s wife. Id. at 116. However, explained that ‘‘[w]hen we obtain information from sleeping medication such as Ambien or ‘‘none of’’ the dates in the records the Medical Board, whether or not somebody’s created by Respondent ‘‘correspond[ed] applied for a DEA license or not, we have to document that information . . . the different surrender her DEA license because of that.’’ Tr. 33– to [Dr. Webb’s] treatment records.’’ Id. at allegations that the Board has made[,] or evidence 34. The DI testified that shortly after this 16 (quoting GX 9 (memo created by Dr. that they may have against a physician.’’ Id. at 90– conversation, he was contacted by Respondent’s Webb re: Feb. 25, 2016 meeting with 91. counsel, who advised that he was also representing DEA)). In his testimony, Dr. Webb 4 According to the DI, when calling in the Respondent’s wife and was told ‘‘not to contact her prescriptions, Respondent used ‘‘several different anymore unless there, you know.’’ Id. at 34. The DI adhered to his statement in the memo variations of’’ his wife’s name. Tr. 38. did not clarify what conditions Respondent’s that he ‘‘did not speak to [Respondent] 5 According to the DI, during this conversation, counsel asserted during this conversation. Id. The on these times in question and certainly he told Respondent’s wife (who holds a DEA DI did not subsequently speak to Respondent’s would not have authorized him to call registration as a Nurse Practitioner) that she wife. Id. appeared to be obtaining controlled substances 6 According to the DI, he provided the pharmacies in medication for my patient.’’ GX 9; Tr. ‘‘from multiple doctors, including her husband’’ with the prescription numbers, Respondent’s wife’s 117. As he testified, ‘‘[t]here’s no reason and that he ‘‘would potentially be asking her to name, and her date of birth. Tr. 38. for somebody else to call in the
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prescriptions. That’s my job.’’ Tr. 117. November 30, 2011. GE 11, 11. the prescription issued by Dr. Webb on Subsequently, Dr. Webb reiterated that Respondent did not document this February 3, 2011, and eventually he did not authorize Respondent to prescription in the patient file he refilled the prescription on July 7, 2011. issue any prescriptions to his wife maintained on his wife. See generally GE 11, at 12. Respondent did not during the relevant time frame. Id. at GE 6. He also did not disclose the document the prescription in the patient 119. prescription to Dr. Webb. file. See generally GE 6. Nor did he 4. March 30, 2011, 30 tablets of Respondent’s Prescriptions for His Wife disclose it to Dr. Webb. zolpidem tartrate (Ambien) 10 mg, with 9. July 15, 2011, prescription The evidence shows that between a dosing instruction of one tablet at (assigned RX # 4002009 by the January 1, 2011 and October 14, 2013 bedtime but ‘‘may repeat for early,’’ a pharmacy) for 28 tablets of (when his medical license was 15–30-day supply. GE 10, at 85; GE 11, hydrocodone-acetaminophen (Lorcet) suspended), Respondent issued the at 13; GE 30, at 1–2. Notably, the 10–650, a five-day supply. GE 10, at 64. following controlled substances zolpidem prescription which Dr. Webb This prescription also authorized a prescriptions for his wife.7 issued on February 3, 2011 (RX refill, which Respondent’s wife obtained 1. January 9, 2011, eight tablets of #949559) provided for multiple refills, on July 29, 2011. Id. As explained alprazolam (Xanax) 1 mg, one tablet to as it was refilled by Respondent’s wife above, other than in June/July 2013, Dr. be taken twice day, a four-day supply. on April 9, 2011, May 23, 2011, and July Webb did not prescribe this drug to GE 10, at 85; GE 11, at 14; GE 29, at 7, 2011. GE 11, at 13; Tr. 254–55. Respondent’s wife, and no other 1–2. The record does not establish when Respondent did not document the physician prescribed hydrocodone to Dr. Webb had last prescribed alprazolam prescription in the patient file he her until November 30, 2011. 8 to Respondent’s wife. Respondent did maintained on his wife. GE 6. Nor did Respondent did not document the not document the prescription in the he inform Dr. Webb that he issued the prescription in the patient file. GE 6. patient file he maintained for his wife. prescription. Nor did he disclose the prescription to See generally GE 6. Nor did he inform 5. April 8, 2011, 15 tablets of Dr. Webb. Dr. Webb that he had issued the hydrocodone/acetaminophen (Lorcet) 10. July 31, 2011, 12 tablets of prescription. 10–650, one tablet every six hours as zolpidem 10 mg, one tablet at bedtime, 2. January 31, 2011, 30 tablets of needed, a three-day supply. GE 10, at a 12-day supply, with one refill. GE 10, zolpidem tartrate (Ambien) 10 mg, a 15- 85; GE 11, at 13; GE 31, at 1–2. As at 84; GE 11, at 12; GE 33, at 1–2. As day supply. GE 10, at 19; GE 11, at 14. explained above, other than in June/July found above, on July 7, 2011, Notably, on January 8, 2011, 2013, Dr. Webb did not prescribe this Respondent’s wife obtained a refill of a Respondent’s wife had refilled a drug to Respondent’s wife, and no other prescription for 60 zolpidem issued by prescription issued by Dr. Webb on physician prescribed hydrocodone to Dr. Webb, which, if taken as directed, August 31, 2010 for 60 tablets, this her until November 30, 2011. should have lasted her until August 6, being a 30-day supply. GE 11, at 14. Respondent did not document the 2011 (this being in addition to the 30 Thus, if taken as directed, the refill of prescription in the patient file. GE 6. He zolpidem prescription Respondent Dr. Webb’s prescription should have last also did not disclose the prescription to issued on June 28, 2011). GE 11, at 12; Respondent’s wife until February 7, Dr. Webb. Tr. 251–53. Respondent did not 2011. On February 3, 2011 (only three 6. May 6, 2011, 30 tablets of zolpidem document the prescription in the patient days later), Dr. Webb prescribed 60 tartrate (Ambien) 10 mg, one tablet at file. See generally GE 6. Nor did he units of zolpidem 10 to Respondent’s bedtime but ‘‘may repeat,’’ a 30-day wife. GE 11, at 13. GE 5, at 112. disclose the prescription to Dr. Webb. supply. GE 10, at 85; GE 11, at 13; GE 11. August 13, 2011, 20 tablets of Respondent did not document the 32, at 1–2. As discussed above, alprazolam (Xanax) 1 mg, one-half to prescription in the patient file he Respondent’s wife still had refills one tablet, to be taken twice a day, a 10– maintained for his wife. GE 6. Nor did available for 60 dosage units based on 20-day supply. GE 22, at 1–2.9 Notably, he inform Dr. Webb that he issued the the prescription issued by Dr. Webb on prescription. on August 4, 2011, Respondent’s wife February 3, 2011, and eventually had refilled a prescription issued by Dr. 3. February 7, 2011, 20 tablets of refilled the prescription on May 23, hydrocodone/acetaminophen (Lorcet) Webb for 45 alprazolam 2 mg, a 15 day 2011. GE 11, at 13; Tr. 255. Respondent supply. GE 11, at 12. Thus, if taken as 7.5–650, a three-day supply. GE 10, at did not document the prescription in 23; GE 11, at 13; see generally Tr. 373– directed, this refill should have lasted the patient file. See generally GE 6. Nor Respondent’s wife until August 19, 74 (testifying that her husband did he disclose the prescription to Dr. prescribed hydrocodone for her once in 2011. Moreover, on August 16, 2011, Dr. Webb. Webb issued Respondent’s wife a new 2011). Other than on one occasion in 7. May 14, 2011, 14 tablets of prescription for 90 alprazolam 2mg, a June/July 2013, which is discussed hydrocodone/acetaminophen (Lorcet) 30-day supply. Id. Respondent did not below, Dr. Webb did not prescribe 10–650, a two-day supply. GE 10, at 19; document the prescription in his wife’s hydrocodone to Respondent’s wife. GE 11, at 13. As explained above, other patient file. See generally GE 6.10 Nor Moreover, the PMP report does not list than in June/July 2013, Dr. Webb did any hydrocodone prescriptions that not prescribe this drug to Respondent’s 9 Although this prescription was filled on August were issued by any other provider until wife, and no other physician prescribed 13, 2011, see GE–22, at 2, it does not appear on Mrs. hydrocodone to her until November 30, Alexander’s PMP. See GE–11, at 12. However, a 7 The ‘‘fill dates’’ are used to identify these 2011. Respondent did not document the copy of the prescription and the fill sticker is in the prescriptions because some of the prescriptions are prescription in the patient file. GE 6. record. GE 22. not dated or bear illegible dates. 10 The Respondent’s patient file for his wife 8 The ALJ found that this prescription overlapped Nor did he disclose the prescription to mentions a prescription for 20 tablets of Xanax, 2 with a 30-day prescription for zolpidem tartrate Dr. Webb. mg, dated July 13, 2011. See GE–6, at 1. The patient (Ambien) from Dr. Webb, which was filled on 8. June 28, 2011, 30 tablets of file says he prescribed Xanax because ‘‘Jill out of January 8, 2011. R.D. 16. Given that Dr. Webb zolpidem tartrate (Ambien) 10 mg, a 30- Xanax—in Philadelphia—Has had twitching— testified that he was prescribing both Xanax for [illegible] Dr. Webb has not called back.’’ GE–6, at anxiety and Ambien for sleep to Respondent’s wife day supply. GE 10, at 84; GE 11, at 12. 1. Dr. Webb, however, had no notes in his file about simultaneously, the record does not establish that Respondent’s wife still had a refill any attempt by the Respondent to contact him on these were overlapping prescriptions. available for 60 dosage units based on July 13, 2011. See Tr. 126. However, neither the
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did he disclose the prescription to Dr. generally GE 6. Nor did he disclose it to 21. December 5, 2011, 10 tablets of Webb. Dr. Webb. hydrocodone-acetaminophen (Lorcet) 12. August 28, 2011, 12 tablets of 16. October 20, 2011, 16 tablets of 10–650, a three-day supply. GE 10, at zolpidem tartrate (Ambien) 10 mg, a 12- hydrocodone-acetaminophen (Lorcet) 63. Respondent did not document the day supply. GE 10, at 19. Notably, on 10–650, a four-day supply, this being a prescription in the patient file. See August 16, 2011, Respondent’s wife had refill of the September 28, 2011 generally GE 6. Nor did he disclose it to obtained and filled a new prescription prescription. GE 10, at 64. As explained Dr. Webb. from Dr. Webb for 60 zolpidem, a 30- above, other than in June/July 2013, Dr. 22. December 27, 2011,12 30 tablets of day supply. GX 11, at 12. If taken as Webb did not prescribe this drug to zolpidem tartrate (Ambien) 10 mg, one directed, Dr. Webb’s prescription should Respondent’s wife, and no other tablet a day at bedtime, a 30-day supply. have lasted Respondent’s wife until physician prescribed hydrocodone to GE 10, at 80; GE 21, at 1–2. However, September 15, 2011. Moreover, as found her until November 30, 2011. As found on December 16, 2011, Respondent’s above, Respondent had also provided a above, Respondent did not document wife had obtained a refill of Dr. Webb’s refill when he issued the July 31, 2011 the prescription or the refill in the August 16, 2011 prescription for 60 prescription (RX# 443737), and this patient file. See GE 6. Nor did he dosage units, a 30-day supply. GE 11, at refill was still available to his wife on disclose the prescription to Dr. Webb. 11. Thus, if taken as directed, the August 28, 2011. GE 11, at 12. 17. November 13, 2011, 18 tablets of December 16 refill should have lasted Respondent did not document the clonazepam 2mg, a six-day supply. GE Respondent’s wife until January 15, prescription in the patient file. See 10, at 19. Notably, on November 3, 2011, 2012. In Respondent’s patient file for his generally GE 6. He also did not disclose Respondent’s wife had refilled a wife, he documented: ‘‘Jill not sleeping. the prescription to Dr. Webb. prescription issued by Dr. Webb on Holiday schedule at Mississippi Neuropsychiatric—stress of house 13. September 6, 2011, 12 tablets of October 19, 2011 for 45 dosage units, a repossession and moving in with zolpidem tartrate (Ambien) 10 mg, a 12- 15 day supply. GE 11, at 11. If taken as mother-in-law. Erratic. Bugs. Ambien 10 day supply, this being a refill authorized directed, the November 3 refill should mg #30 [one to two orally at bedtime]. by Respondent’s July 31, 2011 have lasted Respondent’s wife until No response on-call dr.’’ GE 6, at 1. prescription. GE 11, at 12. As discussed November 18, 2011. Moreover, on Respondent did not disclose the in the preceding paragraph, Dr. Webb’s November 15, 2011, only two days after prescription to Dr. Webb. August 16, 2011 prescription should filling the prescription she obtained from her husband, Respondent’s wife 23. January 7, 2012, 28 tablets of have lasted Respondent’s wife until zolpidem 10 mg, a 28-day supply. GE September 15, 2011. In addition, obtained a further refill of Dr. Webb’s prescription for 45 dosage units of 10, at 63. As found above, on December Respondent’s August 28, 2011 16, 2011, Respondent’s wife had prescriptions provided his wife with clonazepam. GE 11, at 11. Respondent did not document the prescription in obtained a refill of Dr. Webb’s additional medication in excess of what prescription and obtained medication Dr. Webb had prescribed. As found the patient file. See generally GE 6. Nor did he disclose it to Dr. Webb. that should have lasted her until above, Respondent did not document January 15, 2012. Moreover, on the original prescription in the patient 18. November 25, 2011, 10 tablets of clonazepam 2 mg, a three-day supply. December 27, 2011, she filled the file nor disclose it to Dr. Webb. See prescription Respondent wrote her for generally GE 6. GE 10, at 63. If taken as directed, by itself, the November 15, 2011 refill 30 more tablets. Respondent’s patient 14. September 28, 2011, 16 tablets of file for his wife does not document the hydrocodone/apap 10/650, a four-day should have lasted Respondent’s wife until November 30, 2011. Respondent issuance of a zolpidem prescription on supply with one refill. See GE 10, at 64. this date, but rather on January 10, 2012. As explained above, other than in June/ did not document the prescription in the patient file. GE 6. Nor did he See generally GE 6. That entry states: July 2013, Dr. Webb did not prescribe ‘‘Jill Philadephia at M-I-L house,’’ ‘‘Pills this drug to Respondent’s wife, and no disclose it to Dr. Webb. 19. November 29, 2011, four tablets of discarded—tension—No vehicles other physician prescribed hydrocodone (Bankruptcy).’’ GE 6, at 2. The entry to her until November 30, 2011. hydrocodone/acetaminophen (Lorcet) 10–650 mg, one tablet to be taken four then lists a prescription for 30 Ambien Respondent did not document the 10 mg, with a dosing instruction of one prescription in the patient file. See GE to six times a day, a one-day supply. GE 26. Respondent did not document the tablet by mouth per day. Id. Moreover, 6. Nor did he disclose the prescription Respondent did not disclose the to Dr. Webb. prescription in the patient file. GE 6. He also did not disclose the prescription to prescription to Dr. Webb. 15. October 11, 2011, 20 tablets of Dr. Webb. 24. January 16, 2012, 30 tablets of zolpidem tartrate (Ambien) 10 mg, one 20. Also on November 29, 2011, one alprazolam (Xanax) 2 mg, to be taken tablet at bedtime, a 20-day supply. GE 13 Diastat Acudial, 5–7.5–10 mg kit. GE 10, ‘‘as directed.’’ GE 23, at 1–2. However, 10, at 84; GE 11, at 11; GE 34, at 1–2; at 92; GE 11, at 11; GE 28, at 1. Diastat on January 5, 2012, Respondent’s wife Tr. 249. Of note, on September 19, 2011, Acudial is a rectal suppository of had refilled a prescription (Rx# 976879) Respondent’s wife had refilled Dr. diazepam, which is also a issued by Dr. Webb for 45 tablets, a 15- Webb’s August 16, 2011 prescription benzodiazepine and a schedule IV and obtained 60 tablets, a 30-day 12 The Government established that this was a controlled substance.11 Tr. 260–61; 21 supply. GE 11, at 12. If taken as Tuesday. Tr. 190. CFR 1308.14(c). Respondent did not 13 directed, the September 19 refill should While neither PMP report contains an entry for document the prescription in the patient an alprazolam prescription issued by Respondent have lasted Respondent’s wife until file. See GX 6. Nor did he disclose it to for his wife on this date, Government Exhibit 23 October 19. GE 11, at 12; Tr. 248–49. Dr. Webb. contains a copy of the prescription and the fill Respondent did not document the sticker showing that on January 16, 2012, prescription in the patient file. See Respondent issued, and his wife filled a 11 Dr. Chambers, the Government’s Expert prescription for 30 alprazolam 2 mg. testified that this prescription ‘‘is a bit puzzling Notwithstanding that the prescription appears to be PMP reports, nor the copies of the prescriptions, because it’s clear she’s taking oral meds and usually dated ‘‘1/16/11,’’ the fill sticker states that the support a finding that Respondent issued an that’s reserved for people who can’t take’’ the oral prescription was written on ‘‘01/16/12.’’ GX 23, at alprazolam prescription on or about this date. form of the drug. Tr. 259. 1–2.
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day supply, and that prescription had times a day.’’ GE 6, at 3. Respondent’s wife obtained 45 tablets (15 days) of an additional refill remaining which wife had available a refill of Dr. Webb’s alprazolam when she refilled Dr. Webb’s Respondent’s wife obtained on February February 23 prescription which she prescription. GE 11, at 9. In a note 14, 2012. GE 11, at 10. In his wife’s could have filled on this date (without (dated July 14, 2012) in his wife’s patient file, Respondent wrote: ‘‘Dr. being early) but which she did not fill patient file, Respondent wrote: ‘‘she had Webb wants Jill to come in. Difficult until March 19, 2012. GE 11, at 10. done very well without medicine—even [with] transportation—Will Rx 10 day Respondent did not disclose the though extremely stressful living supply til 1/26/12—Webb aware— prescription to Dr. Webb. conditions.... 4 month no meds— Xanax 2 mg #30 [two orally three times 28. March 12, 2012, 30 tablets of depressed, crying, jittery—Has been in a day].’’ GE 6, at 2. Dr. Webb testified, zolpidem 10 mg, 30-day supply. GE 10, contact [with] Dr. Webb.... She feels however, that neither Respondent nor at 80. As found above, on March 4, self harm—but no SI. Xanax 2 mg #20 Respondent’s wife ever told him about 2012, Respondent prescribed 30 6 day supply.’’ GE 6, at 4; Tr. 130. any prescription issued by zolpidem (a 30-day supply) for his wife Respondent did not disclose the Respondent.14 Tr. 115–17, 119, 138, which she filled the same day. GE 11, prescription to Dr. Webb, and Dr. Webb 174–75; see also R.D. 16 (Finding of Fact at 10. If taken as directed, Respondent’s did not talk to the Respondent’s wife on No. 28). March 4 prescription should have lasted July 14, 2012. See generally GE 5; Tr. 25. February 26, 2012, 20 tablets of until April 3, 2012. Also, Dr. Webb’s 131. Dr. Webb also testified that neither diazepam 5 mg, a six-day supply. GX Feb. 23, 2012 prescription (for 30 Respondent nor Respondent’s wife ever 11, at 10. Of note, on February 23, 2012, tablets) authorized multiple refills and told him about any prescription issued Respondent’s wife had obtained and Respondent’s wife obtained a refill on by Respondent. Tr. 115–17, 119, 138, filled a new prescription from Dr. Webb March 19, 2012. Id. Respondent did not 174–75; see also R.D. 16 (Finding of Fact for 45 alprazolam 2 mg, a 15-day document the prescription in his wife’s No. 28). supply; this prescription (Rx# 982872) patient file. See GE 6. Nor did he 33. August 13, 2012, 30 tablets of also authorized three refills. Id. at 10– disclose the prescription to Dr. Webb. hydrocodone/acetaminophen, 10–650, 11. Diazepam and alprazolam are both 29. April 1, 2012, 24 tablets of one tablet every four hours, a five-day zolpidem tartrate (Ambien) 10 mg, a 24- benzodiazepines and are used to treat supply. GE 10, at 80; GE 11, at 9; GE 16, day supply. GE 10, at 13; GE 11, at 10. anxiety. Tr. 259. Dr. Webb did not at 1. Respondent did not document the Putting aside that Respondent’s March 4 prescribe diazepam to Respondent’s prescription in his wife’s patient file. prescription should have lasted through wife. See generally GE 11; Tr. 204; GX See GE 6. Nor does the PMP report show April 3, 2012, as found above, 5. Respondent did not document the that any other doctor prescribed Respondent’s wife obtained 30 tablets prescriptions in his wife’s patient file. hydrocodone to Respondent’s wife on March 12 when she filled his See GE 6. Nor did he disclose the between December 22, 2011 and prescription to Dr. Webb. prescription and another 30 tablets on December 16, 2012. GE 11, at 8–10. 26. March 4, 2012, 30 tablets of March 19, when she refilled Dr. Webb’s Respondent did not disclose the zolpidem10 mg, a 30-day supply. GE 10, Feb. 2, 2012 prescription. GE 11, at 10. at 13; GE 11, at 10. Of note, on February Respondent did not document the prescription to Dr. Webb. 23, 2012, Respondent’s wife obtained prescription in his wife’s patient file. 34. October 5, 2012, 12 tablets of and filled a prescription from Dr. Webb See GE 6. Nor did he disclose the alprazolam (Xanax) 2 mg, a four-day for 30 zolpidem, a 15-day supply. GE prescription to Dr. Webb. supply. GE 10, at 22; GE 11, at 9. On 11, at 10. If taken as directed, Dr. 30. April 2, 2012, 120 units of September 24, 2012, Dr. Webb Webb’s prescription should have lasted hydrocodone-homatropine syrup prescribed and Respondent’s wife filled Respondent’s wife until March 9, 2012. (Hycodan), one teaspoon every four to a prescription for 45 alprazolam 2 mg, Moreover, Dr. Webb’s Feb. 23 six hours as needed. GE 19, at 1–2.15 a 15-day supply, which also provided prescription provided for two refills, the Respondent did not document the for two refills. GE 11, at 9. If taken as first of which Respondent’s wife prescription in his wife’s patient file. directed, Dr. Webb’s prescription should obtained on March 19, 2012, See GE 6. Nor did he disclose the have lasted until October 9, 2012. In his respectively. GE 11, at 10. Respondent prescription to Dr. Webb. wife’s patient file, Respondent wrote: did not document the prescription in 31. June 18, 2012, 20 tablets of ‘‘Dr. Webb Rx Xanax—She is out 2 days the patient file. See generally GE 6. Nor alprazolam (Xanax) 2 mg, one tablet to early—Laceration/cutting—severe did he disclose the prescription to Dr. be taken twice a day, a 10-day supply. anxiety & depression—arms excoriated Webb. GE 10, at 75; GE 11, at 9; GE 15, at 1– No return call from weekend MD—I 27. March 12, 2012, 12 tablets of 2; Tr. 262. Respondent’s wife still had have to leave to work out of town Xanax alprazolam (Xanax) 2 mg, one tablet to a refill remaining on Dr. Webb’s Feb. 23, 2 mg #12 Walgreens 3–4 day supply be taken three times a day, a four-day 2012 prescription for 45 alprazolam, through weekend.’’ GE 6, at 5. While the supply. GE 10, at 80; GE 20. As found which she filled on July 5, 2012. GE 11, note also appears to state ‘‘aware -,’’ Dr. above, on February 23, 2012, Dr. Webb at 9. Respondent did not document the Webb did not have any notes in his file issued a prescription for 45 tablets of prescriptions in his wife’s patient file. regarding any calls from Respondent on alprazolam 2 mg, a 15-day supply, See generally GE 6. Nor did he disclose October 5, 2012, Tr. 131, and I find that which authorized three refills. GE 11, at the prescription to Dr. Webb. Respondent did not disclose the 9–10. In the patient file, Respondent 32. July 17, 2012, 20 tablets of prescription to Dr. Webb. I also find that wrote: ‘‘Out of Xaax [sic] x 5 days— alprazolam (Xanax) 2 mg, one tablet Respondent’s wife did not disclose the Jerky & twitching—feels like Extreme twice a day, a 10-day supply. GE 10, at prescription. Tr. 174–75. anxiety—digging at arms [-] delusional 13; GE 11, at 9; see Tr. 262–63. As noted 35. December 22, 2012, 15 capsules of parasitosis? Will give 4 day supply— above, on July 5, 2012, Respondent’s Dextroamphetamine-Amphetamine ER [illegible] talk to Dr. Webb—Xaax [sic] 20 mg, a five-day supply. GE 11, at 8. 2 mg #12,’’ followed by the dosage 15 Although this prescription does not appear on While Dr. Webb had prescribed this either of the PMP reports, the Government instruction of one tablet by mouth, three produced both the prescription and the fill sticker drug to Respondent’s wife, see id., showing that the drug was dispensed on April 2, Respondent did not disclose the 14 January 16, 2012 was a Monday. Tr. 190. 2012. See GE 19, at 2. prescription to Dr. Webb. Nor did
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Respondent document the prescription 16, 2012 for 20 tablets for hydrocodone/ to fix—Out of Xanax early—rebound in his wife’s patient file. See GE 6. apap 7.5/500 (a two-day supply) and on anxieties—self-harm—Xanax #14—CVS 36. January 11, 2013, 10 tablets of December 18, 2012 for 20 tablets of Hardy St.’’ GE 6, at 7. The note also alprazolam (Xanax) 2 mg, a three-day hydrocodone/apap 10/500 (a five-day includes the following addendum: ‘‘Dr. supply. GE 10, at 21; GE 11, at 8. supply) from Dr. Pecunia. GE 11, at 8. Webb aware—he called in Restoril/ According to the PMP report, on January However, she was not regularly being Zoloft & the Xanax (3/30/13).’’ Id. Dr. 10, 2013, Respondent’s wife refilled a prescribed hydrocodone. See generally Webb, however, was not aware of this prescription issued by Dr. Webb 16 (Rx GE 11. Respondent did not document prescription. Tr. 132–33; 174–75. #996307) for 45 tablets of alprazolam 2 the prescription in his wife’s patient Further, Dr. Webb’s file contains no mg, a 15-day supply. Id. If taken as file. See GE 6. Nor did he disclose the documentation of any contact by directed, the January 10 refill provided prescription to Dr. Webb. Respondent around March 28 through enough medication to last Respondent’s 40. February 5, 2013, eight tablets of 30. Tr. 133; see generally GE 5; GE 7– wife until January 25. The PMP report alprazolam 2 mg, a two-day supply. GE 9. Notably, Respondent did not note also shows that on December 30, 2012, 10, at 86; GE 11, at 7; GE 40, at 2. In what dose of Xanax he prescribed or the Respondent’s wife had refilled a his wife’s patient file, Respondent dosing instructions. See GE 6, at 7; see different prescription issued by Dr. wrote: ‘‘Agitated—open sore on nose & Tr. 266, 287–88. Webb 17 (RX #2703928) for 45 tablets of hair line—Back from attempted trip— 43. May 10, 2013, 14 tablets of alprazolam 2 mg, a 15-day supply. Id. If weathered out—returned with tons of alprazolam (Xanax) 2 mg, one tablet to taken as directed, the December 30 refill anxiety—ran out of meds while be taken three times a day as needed, a provided enough medication to last OOT 19—Minneapolis.’’ GE 6, at 6. The four-day supply. GE 10, at 86; GE 11, at Respondent’s wife until January 14, note further states: ‘‘Xanax #8 CVS 7; GE 37, at 1–2. On April 30, 2013, 2013. Respondent did not document the Hattiesburg Zoloft #7’’ and ‘‘Filled Dr. Respondent’s wife obtained a refill of a prescription in his wife’s patient file. Webb in on Travel—Jill did.’’ GE 6, at prescription issued by Dr. Webb for 45 See generally GE 6. Nor did he disclose 6. Respondent did not, however, alprazolam 2 mg, a 15-day supply. GE the prescription to Dr. Webb. disclose the prescriptions to Dr. Webb. 11, at 7; Tr. 267. If taken as directed, the 37. January 11, 2013, six capsules of 41. February 27, 2013, 10 tablets of refill of Dr. Webb’s prescription should temazepam, a three-day supply. GE 11, alprazolam 2 mg, a three-day supply. GE have provided Respondent’s wife with at 8. According to the PMP report, on 6, at 6; GE 10, at 86; GE 11, at 7. On enough medication to last until May 15, January 10, 2013, Respondent’s wife February 19, 2013, Respondent’s wife 2013. Respondent did not document the refilled a prescription issued by Dr. filled a prescription written by Dr. Webb prescription in his wife’s patient file. GE Webb for 30 capsules of the drug, a 30- for 45 alprazolam 2 mg, a 15-day 6. Nor did he disclose the prescription day supply. Id. If taken as directed, the supply. GE 5, at 70; GE 11, at 7. If taken to Dr. Webb. January 10 refill provided enough as directed, Dr. Webb’s prescription 44. May 13, 2013, 12 tablets of medication to last Respondent’s wife should have provided Respondent’s alprazolam (Xanax) 2 mg, one tablet to until February 9, 2013. Respondent did wife with enough medication to last be taken three times a day, a four-day not document the prescription in his until March 6, 2013. In his wife’s supply. GE 10, at 21; GE 11, at 7; GE 41, wife’s patient file. See GE 6. Nor did he patient file, Respondent wrote: at 1–2. Respondent wrote in his wife’s disclose the prescription to Respondent. ‘‘Anxious about marital situation—sores patient file: ‘‘Out of Xanax 2 days 38. January 23, 2013, 15 tablets of on nose/forehead will not heal—No HI/ early—she says repeated [illegible] alprazolam 2 mg, to be taken ‘‘as SI—out of her meds early—Out of calls—no answer—No healing on face/ directed.’’ 18 GE 17; GE 10, at 79; GE 11, Xanax,’’ ‘‘Xanax #10 [one orally three arm—repeated re-openings. I am at 7. An entry in Respondent’s file times a day] CVS Hardy St (enough for scheduled OOT next 4 days—Xanax #12 (dated January 20, 2013) states ‘‘Jill has weekend) (Monday: Dr. Webb refilled [once orally three times a day].’’ GE 6, opened sore on nose,’’ ‘‘arms—del. for her).’’ GE 6, at 6. at 8. Respondent had already prescribed parastosis [sic]—arms,’’ ‘‘cutting— 42. March 27, 2013, 14 tablets of a four-day supply of Xanax to his wife Anxiety/depression,’’ ‘‘Out of her alprazolam (Xanax) 2 mg, one tablet to on May 10; additionally, Respondent’s Xanax—inconsolable,’’ ‘‘weekend—No be taken three times a day as needed, a wife still should have had two days’ five-day supply, which was filled the worth of Xanax left from Dr. Webb’s return from on-call,’’ ‘‘Xanax #15,’’ 20 ‘‘will contact Dr. Webb in Am,’’ ‘‘No HI/ next day. GE 36; GE 10, at 86; GE 11, April 30 refill. GE 11, at 7; Tr. 267. SI,’’ and a dosing instruction of ‘‘TID at 7. On March 19, 2013, Respondent’s Respondent did not disclose the prn.’’ GE 6, at 5. Dr. Webb’s patient file wife had refilled a prescription issued prescription to Dr. Webb. While the note for his wife does not document a call by Dr. Webb for 45 alprazolam 2 mg, a also states that Respondent prescribed 15-day supply. GE 11, at 7. If taken as from the Respondent on or near this ‘‘Ambien 10 for sleep,’’ GE 6, at 8, the directed, the refill of Dr. Webb’s date. See GE 5; Tr. 131–32. I therefore record does not contain a zolpidem prescription should have provided find that Respondent did not disclose prescription with this date. Respondent’s wife with enough 45. May 20, 2013, 20 tablets of the prescription to Dr. Webb. 39. January 23, 2013, 30 tablets of medication to last until April 3, 2013. A zolpidem 10 mg, one tablet at bedtime, hydrocodone/apap 10–650, a five-day note dated ‘‘3/28/13’’ in his wife’s a 20-day supply. GE 10, at 85; GE 11, at supply. GE 11, at 7. Respondent’s wife patient file, states: ‘‘Marital/physical/ 7; GE 38, at 1–2. Respondent’s patient had obtained prescriptions on December mental stress. Sky high Marriage file contains no note for a prescription Workshop in Montana just issued on this date. GE 6, at 8. On May accentuated—depilitating hairline— 16 The prescription was originally issued on July 23, 2013, Dr. Webb prescribed 30 du of 26, 2012 and provided five refills. GE 11, at 8. [illegible] meds needs plastic surg[ery] another sleep medication, Restoril 30 17 The prescription was originally issued on mg (temazepam), with five refills, to November 6, 2012. GE 11, at 8. 19 The ALJ presumed, with reason, that ‘‘OOT’’ is Respondent’s wife. GE 5, at 102; GE 11, 18 Both the prescription label and the PMP report an abbreviation for ‘‘out of town.’’ R.D. 22 n.32. at 6; Tr. 133–34. Moreover, the PMP list this as being a 30-day supply. See GE 17; GE 20 Although the PMP entry (as well as 10, at 79. However, according to Respondent’s note Respondent’s note) are dated March 28, 2013, the report shows that Dr. Webb had been in the file, the dosing instruction was take the drug prescription was written on March 27. See GE 36, prescribing temazepam with refills to three times a day as needed. at 1. Respondent’s wife beginning on July 26,
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2012 and had not issued a zolpidem See GE 6, at 9. Respondent did not this weekend—Rx: Xanax #12 [once prescription to her since February 23, disclose the prescription to Dr. Webb. orally three times a day]’’ and ‘‘[w]ill 2012, which she last refilled more than 49. July 25, 2013, 12 tablets of update Dr. Webb.’’ GE 6, at 10; Tr. 136– a year earlier on April 12, 2012. GE 11, hydrocodone/apap, 10–650, one tablet 37. However, there is nothing in Dr. at 7–10. Respondent did not discuss the every six hours as needed, a three-day Webb’s file for Respondent’s wife that prescription with Dr. Webb. Tr. 133. In supply. GE 10, at 21; GE 11, at 5; GE 42, indicates that he was contacted by the an entry dated ‘‘5/23,’’ Respondent at 1–2. Respondent did not document Respondent around August 22, 2013 wrote: ‘‘Dr Webb—started Zoloft & this prescription in his wife’s patient and Dr. Webb testified that Respondent Buspar—And [R]estoril[.] Ambien file. See generally GE 6. He also did not never disclosed any of the prescriptions. discarded—only Restoril.’’ GE 6, at 8. As disclose the prescription to Dr. Webb. See GE 5; Tr. 137. I find that also found above, Respondent had 50. July 29, 2013, eight tablets of Respondent did not disclose the previously prescribed temazepam for alprazolam 2 mg, one tablet to be taken prescription to Dr. Webb. his wife on January 11, 2013. GE 11, at three times a day as needed, a two-day 53. September 5, 2013, 24 tablets of 8. supply. GE 10, at 85; GE 11, at 5; GE 39, alprazolam (Xanax), 2 mg, an eight-day 46. July 1, 2013, 20 tablets of at 1–2. The PMP shows that on July 19, supply. GE 10, at 21; GE 11, at 5. The hydrocodone/acetaminophen (Lorcet), 2013, Respondent’s wife had obtained a Respondent recorded in his wife’s 10–650, a five-day supply.21 GE 10, at refill of a prescription issued by Dr. patient file: ‘‘Will not leave room— 93; GE 11, at 6; GE 27, at 1. In his wife’s Webb for 45 alprazolam 2 mg, a 15-day depressed—needs to get back with Dr. patient file, Respondent wrote: ‘‘Her supply. GE 11, at 6. If taken as directed, Webb—anorexic—very anxious/ mother in hospital in Jackson—dying— the refill should have provided depressed—Xanax #20 [once orally in ICU/hospice—she had seizure— Respondent’s wife with enough three times a day].’’ GE 6, at 10. injured shoulder/rib finger. Fractured medication to last until August 3, 2017. Respondent did not disclose the teeth. Would not go to ER—Lorcet 10/ In his wife’s patient file, Respondent prescription to Dr. Webb. 650 #20,’’ which was followed by wrote: ‘‘Out of Xanax—buried her Dr. Webb’s Testimony Regarding illegible handwriting. GE 6, at 9; Tr. mother—funeral—Dr. Webb back Respondent’s Prescriptions 134. Respondent did not discuss those Thursday. Xanax #8 [once orally three injuries with Dr. Webb at any point; times a day].’’ GE 6, at 9; Tr. 136. Dr. Asked if there were ‘‘any risks’’ in further, Respondent’s wife had an Webb testified that he did not receive Respondent’s wife ‘‘receiving appointment with Dr. Webb on July 1. any message or have any contact with prescriptions from someone other’’ than Tr. 134. While Dr. Webb did not Respondent on this day, Tr. 136, and himself, Dr. Webb testified that ‘‘this prescribe any medications to there is nothing in Dr. Webb’s file for particular patient . . . has some severe Respondent’s wife at this visit, she did Respondent’s wife that indicates that he problems[,] and takes a high dose of fill a prescription for 90 capsules of was contacted by Respondent around medication.... my concern is that I’m Adderall XR 20 (amphetamine), which July 29, 2013. See GE 5; GE 7–9. I find keeping a close tab on it, but if there’s Dr. Webb issued on June 28, 2013. GE that Respondent did not disclose the somebody out there writing that I don’t 11, at 6; Tr. 273. Also, on June 28, 2013, prescription to Dr. Webb. know about, that’s dangerous.’’ Id. at she had obtained from Dr. Webb and 51. August 15, 2013, 14 tablets of 120. Dr. Webb explained that filled new prescriptions for 45 hydrocodone/apap 10–650, one tablet Respondent’s prescribing was dangerous alprazolam 2 mg, a 15-day supply, and every four to six hours as needed, a two- because ‘‘you’re going above the 30 temazepam 30 mg, a 30-day supply. day supply. GE 10, at 21; GE 11, at 5; maximum dose that should be GE 11, at 6. GE 43, at 1–2. Respondent did not prescribed and more medicines can lead 47. July 7, 2013, 12 tablets of document the prescription in his wife’s to sedation, more sedation, difficulty, alprazolam (Xanax) 2 mg, one tablet to patient file. See generally GE 6. Nor did death, loss of balance, falls, poor be taken twice a day, a six-day supply. he disclose the prescription to Dr. judgment, things like that.’’ Id. at 121. GE 35, at 1–4; see GE 10, at 41; GE 11, Webb. Dr. Webb also explained that the at 6; Tr. 268–69. However, if taken as 52. August 22, 2013, 15 tablets of prescriptions ‘‘interfered with [my] directed, the June 28 alprazolam alprazolam (Xanax), 2 mg, one tablet to treatment for her, because I wasn’t prescription from Dr. Webb should have be taken three times a day, a five-day seeing the real patient, because there’s provided enough medication to last supply. GE 10, at 67; GE 11, at 5; GE 24, a ghost writer out there that I don’t Respondent’s wife until July 13, 2013. at 1–2. According to the PMP report, Dr. know about.’’ Id. Dr. Webb testified that In his wife’s patient file, Respondent Webb issued his last alprazolam ‘‘I have certain timed prescriptions and wrote: ‘‘She is out of her Xanax early. prescription to Respondent’s wife on if that timed prescription is getting Dr. Webb is aware of the tremendous July 31, 2013 for 45 tablets, a 15-day gapped . . . by another prescription, it’s stress of her mother’s illness. No return supply, and the PMP report contains no distracting me from my call on-call MS Neuro [illegible] Xanax entry for any refill of this prescription. decisionmaking.’’ Id. He also testified #12/Lorcet #12 Walgreens.’’ GE 6, at 9; GE 11, at 1–5. The PMP report further that this would ‘‘[m]ost definitely’’ Tr. 135. Dr. Webb’s file for Respondent’s shows that on August 5, 2013, Dr. Webb interfere with his decisionmaking, in wife does not document a call from had re-commenced prescribing that ‘‘[if] she was out of . . . my Respondent on this date. See generally clonazepam, a different benzodiazepine. medicines, then I would hear a GE 5; GE 7–9; Tr. 135. GE 11, at 5; see also GE 5, at 71. In an distressed phone call . . . and I would 48. July 7, 2013, 12 tablets of entry in his wife’s patient file dated ‘‘8/ need to reorient my treatment for her hydrocodone/apap 10–650 mg, one 24/13,’’ Respondent wrote: ‘‘Following [by] put[ting] her in the hospital.’’ Id. at tablet to be taken four to six times a day, [her mother’s] death, she has been very 122. a two-day supply. Respondent’s note in labile. Dr. Webb has tried multiple In a July 13, 2011 entry in his wife’s patient file does not discuss medications. Jill is very morose, often Respondent’s wife patient file, which his reason for prescribing hydrocodone. cannot stop crying. Denies SI/HI—No documents a prescription for 20 Xanax self-harm this month.’’ GE 6, at 10. 2mg, but for which there is no 21 See GE–14, at 59 (admitting to calling in a Continuing, the note states: ‘‘Multiple corresponding prescription in either the prescription for Lorcet in July). Rx & calls to Dr. Webb. Could not reach PMP reports or the other exhibits,
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Respondent wrote: ‘‘Dr. Webb has not [ ] po TID prn a prescription for eight Xanax 2 mg. GX called back.’’ GX 6, at 1. Regarding this GX 6, at 2, Tr. 126. Dr. Webb testified 11, at 5. The PMP report also shows, entry, Dr. Webb testified that there are that he was not sure if the prescription however, that Respondent’s wife refilled ‘‘five other [ ]’’ practitioners that work at referenced in the note was ‘‘attached to prescriptions for 45 Xanax (15 day his clinic and the phones are covered 24 the January 16 or January 26th note.’’ Tr. supply) issued by Dr. Webb on both July hours a day, seven days a week. Tr. 124. 127. He then testified that he had no 10 and 19, 2013. GX 11, at 6. Id. Dr. Moreover, his clinic has an answering contact with Respondent’s wife on Webb testified that he spoke with service for after office hours and January 16, 2012,23 but that on January Respondent’s wife on July 30, 2013, and weekends. Id. at 125. Dr. Webb testified 26, 2012, he called in a prescription for prescribed more Xanax to her and that Respondent’s note did not state 45 Xanax 2 mg, three tablets a day. Id. referred her to a psychologist. Tr. 136. what time the call to him had been at 127–28; see also GX 5, at 69. He also According to the PMP report, Dr. Webb placed and he maintained that he had no contact with Respondent on issued Respondent’s wife a prescription ‘‘always called patients back.’’ Id. at January 26, 2012.24 Tr. 128. for 45 Xanax on July 31, 2013. GX 11, 126. The Government also asked Dr. Webb at 5. Dr. Webb further testified that the file about an entry Respondent made on July Dr. Webb testified that in his view did not contain a note ‘‘from the 7, 2013, which states in part: ‘‘She’s out ‘‘gap filling . . . means that there’s a answering service or the secretary that of her Xanax early. Dr. Webb is aware prescription that is used to get [the on [this date] a message was left.’’ Id. of the tremendous stress of her mother’s patient] to the next authorized refill.’’ Dr. Webb then testified that his ‘‘file illness. No return on call.’’ GX 6, at 9; Tr. 138. Dr. Webb then cited stolen contains every telephone message see also Tr. 135. As found above, on this medication as an example of when a gap notation that is given to our office’’ and date, Respondent prescribed to his wife fill would be appropriate. Id. Dr. Webb that ‘‘the actual notes written by the 12 Xanax and 12 Lorcet. GX 6, at 9; GX also testified that if a doctor sets up a office staff are kept,’’ and that there are 11, at 6. Notably, the PMP report shows regimen of refills, the patient ‘‘needs to no notes for this date.22 Id. The closest that Respondent’s wife had refilled a follow that timeline. And so, if they’re phone message by date are two prescription issued by Dr. Webb on May short on set refills, that’s a problem.’’ Id. messages on July 21, 2011 from 23, 2013 for 45 Xanax (15 day supply) at 139. Respondent’s wife; the earlier message on June 21, 2013, and had obtained and On cross-examination, Respondent’s states ‘‘please call asap’’ and the later filled a new prescription for 45 Xanax counsel asked Dr. Webb about a message states ‘‘urgent out of med.’’ GE (15 day supply) on June 28, 2013.25 GX statement he wrote in a memo he 5, at 137. Notably, the PMP shows that 11, at 6. After again noting that there prepared following a January 11, 2016 on the same day, Dr. Webb issued to was no record of any call to the clinic meeting with DEA personnel in which Respondent’s wife a new prescription or its answering service by Respondent he noted that Respondent’s for 45 alprazolam 2 mg. GE 11, at 12. on this date, Dr. Webb testified that the ‘‘prescriptions consisted of large The Government also asked Dr. Webb fact that Respondent’s wife was out of quantities of controlled medications about Respondent’s note dated ‘‘1/16/ her Xanax early would concern him such as Xanax, [h]ydrocodone, [and] 12’’ (prescription No. 24). The note ‘‘[b]ecause it lets me know that she’s Ambien.’’ Tr. 151; see also GX 8. Asked appears as follows: using more than prescribed and would how he concluded that the prescriptions Dr. Webb wants Jill to come in . . . ha[ve] me wondering whether we were for large quantities, Dr. Webb Difficult s transportation need to put her in the hospital, to explained that ‘‘[t]hey appeared to be Will Rx 10 day supply til monitor her, or [if] there [are] other more than just a day or so’’ and that 1/26/12—Webb aware— issues going on.’’ Tr. 135–36. while ‘‘some were less than 10 . . . my Xanax 2 mg # 30 An entry in Respondent’s file dated recollection was that more, most of July 29, 2013 states: ‘‘Out of Xanax— them were more than 10’’ tablets. Tr. 22 On cross-examination, Dr. Webb acknowledged that the clinic’s answering service would not buried her mother—funeral—Dr Webb 151. necessarily page the on-call doctor just for a patient back Thursday Xanax #8’’ and includes Dr. Webb subsequently explained that ‘‘who needs a normal refill.’’ Tr. 156. However, Dr. dosing instructions of ‘‘po TID.’’ GX 6, he had Respondent’s wife ‘‘up to max Webb maintained that if a patient was out of at 9. As found above, the PMP report doses of all prescriptions . . . that I had medicine early and in distress, the answering service would pass this message on to the doctor. shows that Respondent issued his wife her on’’ and that ‘‘[a]nything over was Id. at 157, 182. He also testified that ‘‘[i]t’s our a potentially large impact.’’ Id. at 152. policy to call everybody back.’’ Id. at 183. 23 With respect to Respondent’s wife, Dr. Webb He added that ‘‘[m]aybe the number Dr. Webb further testified that to the best of his testified that early in his treatment of her, she lost isn’t large, but the potential impact is recollection, all of the phone call messages ‘‘should a bottle of Xanax which prompted him ‘‘to shorten be’’ in the patient file for Respondent’s wife. Id. at the leash and give smaller amounts.’’ Id. at 162. large.’’ Id. Asked by Respondent’s 159. Dr. Webb testified that he did not ‘‘find it odd’’ 24 Dr. Webb also identified other instances in counsel if he ‘‘agree[d] that compared to that there was ‘‘only [in the words of Respondent’s which Respondent made notes in his wife’s file [his] prescribing, the number of counsel] a handful of . . . call notes in her file.’’ documenting phone calls but Dr. Webb’s file controlled substances prescribed by Id. at 160. Putting aside that there are 48 such notes contained no record that the call was made to his in the patient file, Dr. Webb explained that office. See Tr. 129–33,137. These include notations [Respondent] was relatively small,’’ Dr. Respondent’s wife ‘‘typically kept pretty good for Feb. 18, 2012 (‘‘called answering service for Dr. Webb answered ‘‘correct,’’ but then contact. Knowing that I’d be in the daytime, she’s Webb No response—weekend Dr’’); Oct. 5, 2012 added that it was ‘‘[m]ore than I in the medical field, she knows night time phone (‘‘No return call from weekend doctor’’); Jan. 20, prescribe and moving into . . . above calls . . . aren’t very productive . . . [b]ecause 2013 (‘‘No return from on call’’ and ‘‘Will contact 26 you’re unlikely to have your doctor on call.’’ Id. He Dr. Webb in AM’’); Mar. 28, 2013 (‘‘Dr. Webb my max and serious harm.’’ Id. at 152– also testified that Respondent’s wife had not aware.’’); Aug. 24, 2013 (‘‘Will update Dr. Webb’’). 53. expressed any dissatisfaction with her being able to The record, however, does not establish whether reach him other than when he was not on call these notations were intended to document that 26 As found above, the evidence shows that during a weekend. Id. at 184. Respondent or his wife had placed the call and/or Respondent issued a number of prescriptions, Dr. Webb further testified that his practice has not notified, or intended to notify Dr. Webb. especially for zolpidem, that provided quantities received complaints about the clinic’s ‘‘on call 25 Respondent’s wife also obtained a refill of the that were for periods considerably longer than two service’’ and ‘‘the inability to connect with a June 28, 2013 prescription for 45 Xanax on July 10, to three days. Specifically, Respondent authorized doctor’’ or to ‘‘get a request fulfilled by a doctor.’’ 2013, and a refill of the May 23, 2011 prescription prescriptions on May 20, 2013, for 20 dosage units Id. at 161. The ALJ specifically found that Dr. (which also was for 45 Xanax) on July 19, 2013. GX (du) of zolpidem (a 20 day supply); on April 1, Webb’s testimony was credible. R.D. 8. 11, at 6; Tr. 144. Continued
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Dr. Webb testified that he had been Respondent’s wife ‘‘that were not and specific diagnosis. Id. at 188. As for ‘‘very careful in regimenting’’ the noted.’’ Id. at 203. whether the notes contained evidence of prescriptions he issued for Respondent’s Dr. Webb acknowledged that an examination, Dr. Webb explained wife based on his ‘‘years of working psychiatrists do not typically prescribe that, ‘‘other than the subjective notes with her’’ and her visit in either 2002 or opioids such as hydrocodone; he that are listed, no.’’ Id. 2009 (or both years) when ‘‘she went to testified that he had ‘‘written maybe less The Testimony of the Government’s Sierra Tucson’’ to be evaluated for than five [prescriptions] in my last 20 Expert Xanax abuse. Tr. 146–47. According to years.’’ Id. at 170–71. Asked why he Dr. Webb, Sierra Tucson did not issued the June 28, 2013 prescription for The Government called R. Andrew diagnose her as being addicted or 10 tablets of hydrocodone/ Chambers, M.D., to testify as an expert abusing controlled substances. Id. at acetaminophen 10/650 mg, see GX 11, at in psychiatry, the proper prescribing of 164. While he ‘‘was not aware’’ that she 6, Dr. Webb testified that the controlled substances and their effects was ‘‘overtly abusing,’’ Dr. Webb prescription was filled ‘‘at Beemon, so on patients, and on addiction; the ALJ testified that she ‘‘[s]he had been early potentially she had come up from accepted Dr. Chambers as an expert in . . . sometimes on her prescriptions.’’ Hattiesburg.’’ Tr. 171. Continuing, Dr. these areas. Tr. 246. Dr. Chambers Id. at 185. Dr. Webb also cited ‘‘the Webb testified: ‘‘[t]hat was right around obtained his B.S. degree in Chemical severity of her illness’’ as a reason for her mother’s death, mother’s sickness, Physics from Centre College, Danville, why he generally limited the and maybe she told me she was out of Kentucky in 1991 and his M.D. degree prescriptions to 15 days.27 Id. her medicine potentially. I’d want to see from the Duke University School of Dr. Webb subsequently testified that my note if I put it in there.’’ Id. Medicine in 1996. GX 12, at 1. ‘‘[s]ince I did not know about the other Subsequently, Dr. Webb added that Thereafter, he completed a residency in prescriptions out there, it did not appear Respondent’s wife had undergone a psychiatry at the Yale University School to be as big of an issue. She was early procedure by a different doctor and of Medicine in 2002 and a fellowship in a day or two here and there. But, yes, received hydrocodone about nine or ten addiction psychiatry at the Indiana substance dependence was on the days earlier, but he could not otherwise University (IU) School of Medicine in radar.’’ Id. at 194. On still further recall the circumstances. Id. at 172. Dr. 2012. Id. From 2002 through 2003, he questioning by the Government, Dr. Webb then admitted that this served as an Assistant Professor of Webb testified that if he had known prescription ‘‘certainly could’’ interfere Psychiatry, Division of Substance Abuse about Respondent’s prescriptions to his with the treatment being provided by at Yale; from 2003 through 2009, he wife during the 2011–2013 period, this the other doctor. Id. However, he served as an Assistant Professor of ‘‘would have’’ changed his opinion as to explained that Respondent’s wife ‘‘was Psychiatry at the Indiana University whether she was abusing controlled out of town from her treating . . . School of Medicine; and since 2010, he substances. Id. at 196–97. On physician, and out of her opiate for pain has been an Associate Professor of questioning by the ALJ, Dr. Webb relief.’’ Id. at 186. Moreover, this was Psychiatry with Tenure at the IU School testified that ‘‘[k]nowing what [he] the only instance in which he of Medicine. Id. Also since 2012, Dr. know[s] today . . . I would have prescribed hydrocodone or any other Chambers has been the Director of the suggested’’ that she undergo ‘‘in- opioid to her. Id. at 200–01. Fellowship Training Program in patient’’ treatment to address both ‘‘her Dr. Webb testified that he did not Addiction Psychiatry at the IU School of primary . . . and secondary have a conversation with Respondent’s Medicine. Id. problem[s].’’ Id. at 197. wife about Respondent’s prescribing Dr. Chambers has had appointments Asked about the notes he maintained controlled substances to her until either in the Department of Psychiatry at for his phone conversations with late 2015 or 2016, after he was contacted various hospitals including the West Respondent’s wife, which typically by the Diversion Investigator. Id. at 175. Haven (Connecticut) VA Hospital, Yale were no more than one or two lines, Dr. Dr. Webb testified that he ‘‘believe[d] at New-Haven Hospital, Connecticut Webb maintained that he and times’’ that Respondent was trying to Mental Health Center, and Indiana Respondent’s wife ‘‘always had in-depth help his wife and that ‘‘[t]hey have had University Health Hospitals. GX 12, at 2. conversations’’ and that ‘‘[t]hey were lots of difficulty.’’ Id. at 177. Based on He is board certified in general adult usually fairly long, like 20, 30, 45 the four phone calls he had with psychiatry and addiction psychiatry. Tr. minute phone conversations.’’ Id. at Respondent during the 2011 through 227–28. He has also been published in 169. He also testified that his notes met 2013 period and because Respondent the areas of psychiatry and addiction the standard for documentation. Dr. would ‘‘[t]ypically call if there would be ‘‘on the order of 50 times’’ in peer- Webb acknowledged, however, that he a crisis,’’ Dr. Webb acknowledged that reviewed journals, published in is ‘‘not perfect’’ and that there may have Respondent’s wife was often in crisis. multiple textbooks, and made a number been some phone calls that he had with Id. at 178. of presentations to professional On subsequent questioning, conferences. Id. at 229–30; GX 12, at 3– 2012, for 24 du of zolpidem (24 days); on March Respondent’s counsel suggested that 7, 11–18. 4, 2012, for 30 zolpidem (30 days); on October 11, just as the other doctors in his practice Dr. Chambers testified that treating 2011, for 20 du of zolpidem (20 days); on July 31, can appropriately prescribe gap fills to patients with mental illness and 2011, for 12 du (12 days) plus a refill; on June 28, 2011, for 30 du (30 days); on May 6, 2011, for 30 his patients because they can access the addiction is his ‘‘bread and butter du (30 days); on March 30, 2011, for 30 du (15 patient’s file and see ‘‘abuse issues in work.’’ Tr. 231. He testified that he is days), and on January 31, 2011, also for 30 du (15 the patient file . . . someone living with ‘‘familiar with and utilize[s] a broad days). GX 11, at 7, 10–14. He also authorized the patient can assess that person.’’ Id. range of pharmacotherapies for both prescriptions on July 7, 2013, for 12 du of alprazolam (6 day supply); on March 28, 2013, for at 196. Dr. Webb took issue with this mental illness and addiction, as well as 14 du of alprazolam (5 days); and on both July 17, suggestion, explaining that ‘‘the psychotherapies for both mental illness 2012 and June 18, 2012, for 20 du of alprazolam (10 difficulty with living with someone is and addiction’’ and that ‘‘the vast days). GX 11, at 6–7, 11. that you’re not potentially an expert.’’ majority of [his] patients have both 27 Dr. Webb testified that he ‘‘feel[s] that . . . she’s primarily a psychiatric disorder first, and then Id. mental illness and addiction.’’ Id. at medication difficulty second, rather than the other Dr. Webb testified that Respondent’s 231–32. He testified that he is familiar way around.’’ Id. at 165; id. at 194–95. notes did not contain a patient history with the prescribing of controlled
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substances to psychiatric patients, the patient was obtaining the drug ‘‘from a monthly, usually monthly allotments, risks of controlled substances, and the separate source.’’ Id. and then it starts over.’’ Id. Continuing, typical practices undertaken by According to Dr. Chambers, when a Dr. Chambers explained that ‘‘the psychiatrists to mitigate the risks or patient is obtaining a drug from other bottom line is that when the doctor dangers of the diversion of controlled sources, ‘‘it can create a great deal of writes the prescription and the substances. Id. He further testified that confusion on the part of the primary pharmacist records it . . . there’s a he is familiar with the standards for prescriber about the effects or side complete understanding of what’s prescribing controlled substances in effects of the drug and the mental status expected. There should be no haziness Mississippi, as well the circumstances of the patient.’’ Id. at 250–51. on the part of the doctor or the under which a doctor may fail to Continuing, Dr. Chambers testified that pharmacist or the patient . . . about the conduct himself in a manner that ‘‘there are also synergistic overdose expected rate of consumption . . . from comports with a legitimate medical risks of being on both doses at the same the start to finish, whether it be a 30-day purpose or is within the course of time.... It’s obviously not the dose supply or a 30-day supply with two proper professional practice. Id. at 233. that the primary prescriber wants refills.’’ Id. at 257–58. While Dr. Chambers had never because they would have prescribed Next, the Government questioned Dr. previously testified in a proceeding that dose if that’s what they wanted.’’ Chambers about the combination of based on the Mississippi law and the Id. at 251. Dr. Chambers then explained prescriptions/refills that Respondent’s State Board’s rules, id. at 240, he that ‘‘the same concerns’’ were raised by wife filled on November 28–29, 2011. testified that he had reviewed the State’s the zolpidem prescription Respondent Id. at 258–59. Specifically, on November laws and rules. Id. at 236. He further wrote on July 31, 2011 because the refill 28, 2011, she refilled a prescription testified that the Mississippi provisions his wife obtained on July 7, 2011 of Dr. issued by Dr. Webb for 45 clonazepam on prescribing controlled substances are Webb’s prescription for 30 days of (15 days) as well as filled a new ‘‘fairly universal.’’ Id. at 237. Dr. zolpidem should have lasted for another prescription issued by Webb for 90 Chambers explained ‘‘that the codes week. Id. at 252. capsules of Adderall. GX 11, at 11. The around the country are informed by the Dr. Chambers identified several next day, she filled prescriptions for a medical profession . . . and there are instances in which Dr. Webb’s one-day supply of Diastat Acudial (a universal, fairly universal ethical prescriptions ‘‘overlapped’’ with those rectal suppository of diazepam) and a standards, evidence-based standards of Respondent.28 These included the one-day supply (four tablets) of that are scientific that then inform the zolpidem prescription (for 30 tablets/30 hydrocodone/apap 10/650. Id. code.’’ Id. at 240. Dr. Chambers days) which Respondent issued on May Dr. Chambers noted that the Diastat subsequently cited the Patient Record 6, 2011 and the refills obtained on both prescription ‘‘is a bit puzzling because provisions of the State Board’s Rule 1.4 April 9, 2011 and May 23, 2011 by it’s clear [Respondent’s wife] is taking as one such standard that is accepted Respondent’s wife of Dr. Webb’s Feb. 3, oral meds and usually [Diastat] [is] across the medical profession. Id. at 244. 2011 prescription for 60 tablets (a 30- reserved for people who can’t take Turning to Respondent’s October 11, day supply). Tr. 255. Dr. Chambers [drugs] oral[ly].’’ Id. He then testified 2011 prescription for 20 zolpidem (No. testified that while ‘‘[t]he one before is that ‘‘it’s a very high risk and potentially 15 above), Dr. Chambers noted that the a relatively minor overlap[,] about one lethal combination one day after refill obtained by Respondent’s wife on or two days, which is fairly receiving a 15-day supply of’’ September 19 was for 30 days and insignificant, . . . the secondary overlap clonazepam and ‘‘also a stimulant’’ from should have lasted until October 19. Id. is more significant.’’ Id. The Dr. Webb. Id. Dr. Chambers then at 249. Dr. Chambers testified that prescriptions presented the same testified that ‘‘[t]he combination of an opioid and a benzodiazepine is causing Respondent’s October 11 prescription concerns of danger to the patient and was ‘‘a problem.’’ Id. As to why, Dr. an unprecedented epidemic of death in confusion for the doctor. Id. Chambers explained: ‘‘[t]his is a Dr. Chambers subsequently testified the United States . . . because when the prescription for a controlled substance that it does not matter whether Dr. two drugs are together they that is coming from a separate source Webb’s prescriptions were new synergistically suppress consciousness and breathing and the central nervous that’s occurring on top of a prescription prescriptions or refills because the from the primary psychiatrist, and the system.’’ Id. prescription ‘‘is essentially an combination of these kinds of controlled Addressing the prescriptions which instruction both to the pharmacist and substances could have serious Respondent issued on both June 18 and the patient for the daily dosing and the consequences.’’ Id. Dr. Chambers further July 17, 2012, for 20 du of alprazolam number of days that the patient should explained that ‘‘Ambien and other 2 mg (both being for a 10-day supply),29 follow that dosing.’’ Id. at 257. Dr. benzoate medications have central each of which was filled on the date of Chambers then testified that ‘‘[r]efills is nervous system effects that can cause issuance, as well as the refill she [sic] just a way to communicate to the oversedation, memory disturbances, obtained on July 5, 2012 of Dr. Webb’s patient and the pharmacist . . . that and, if taken in combination with other prescription for 45 du (15 days), Dr. you’re allotting the schedule out in drugs, especially opioids, death.’’ Id. at Chambers testified that the prescriptions 250. While Dr. Chambers testified that had different dosing instructions and 28 This particular overlap involved Respondent’s 10 milligrams (the dose prescribed by zolpidem prescription of March 30, 2011 for 30 overlapped. Id. at 262–63. Dr. Chambers Respondent) ‘‘is not the maximum dose tablets (a 15-day supply) (Rx No. 4 above) and an then testified that ‘‘we don’t know what of Ambien that can be prescribed,’’ a April 9 dispensing of a zolpidem prescription. Tr. she was actually taking, but if she was patient obtaining the drug from another 254–55. Dr. Chambers testified that ‘‘on April 9, actually taking the dose per both 2011, Dr. Webb issue[d] the same med for a 30-day source ‘‘would be of concern.’’ Id. Dr. supply. So now you have an example of Webb doctor’s directions, she would be taking Chambers explained that the concern unknowingly overlapping a controlled substance 10 milligrams of [alprazolam] a day . . . would be driven by the ‘‘the size of the with Dr. Alexander that happened on 3–30.’’ Id. at which would render me unconscious.’’ dose, the nature of the drug,’’ as well as 255. The PMP report shows, however, that the latter Id. at 263. As another example of event did not involve the issuance of a new ‘‘the fact the primary physician who is prescriptions but a refill of Dr. Webb’s February 3, Respondent’s issuance of an alprazolam prescribing the drug . . . would not 2011 prescription. See GE 11, at 13. Nonetheless, . . . necessarily [be] aware’’ that the Respondent’s prescription still created an overlap. 29 See prescription Nos.31 and 32 above.
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prescription which resulted in ‘‘nearly a prescription, Respondent had also patient file with the PMP data, ‘‘about week of overlap of the same dose by two issued her a prescription for 20 40 percent of the prescriptions’’ had ‘‘no different doctors’’ and raised ‘‘the same hydrocodone/apap 10/650, which she corresponding note at all. There’s no concern,’’ Dr. Chambers identified filled that day. Id. at 269–70. Dr. data. There’s no diagnosis, no detailing Respondent’s March 28, 2013 Chambers noted that this hydrocodone of what was prescribed.’’ Id. He also prescription for 14 dosage units (three prescription was ‘‘a higher dose than observed that ‘‘there are instances where tablets a day), which overlapped with a what Dr. Webb did.’’ Id. at 273. He the dosing or type of the drug is left out refill his wife obtained on March 19, explained that ‘‘there’s a combination of of the record.’’ Id. at 278. 2013 for 45 tablets (also three tablets a multiple overlaps of multiple classes of Dr. Chambers identified Respondent’s day).30 Id. at 266. addictive substances that can produce entry dated January 16, 2012 Addressing Respondent’s July 7, 2013 overdose and severe psychiatric (Prescription No. 24) as one such prescriptions (Nos. 46 and 47) for 12 du disturbances from two different example. Tr. 278. As found above, on of hydrocodone/apap 10/650 (two-day physicians who are apparently in no this date, Respondent prescribed 30 supply) and 12 alprazolam 2 mg (six- communication.’’ Id. Continuing, he alprazolam 2 mg ‘‘to be taken as day supply), Dr. Chambers characterized explained that ‘‘in [his] experience, directed’’ and wrote in the note: ‘‘Dr. the latter prescription as ‘‘remarkable,’’ when you see all three of those [classes Webb wants Jill to come in. Difficult explaining that ‘‘it’s prescribed at the of] drugs represented and you have [with] transportation—will Rx 10 day same time [Respondent] also prescribed multiple physicians contributing to it supply till 1/26/12—Webb aware— hydrocodone, an opioid medication, . . . that indicates a patient who is in Xanax 2 mg’’ with a dosing instruction also on the same day, again introducing serious trouble iatrogenically . . . of ‘‘po TID.’’ GE 6, at 2. the risk of a potentially lethal meaning harmed being caused through Dr. Chambers testified that ‘‘this note overdose.’’ Id. at 268–69. Dr. Chambers medical practice.’’ Id. at 274. does not have a diagnosis. It doesn’t noted that Respondent’s prescribing was Asked if he had ‘‘reach[ed] a have an examination to justify . . . why ‘‘also occurring in the context of’’ an conclusion’’ as to whether Respondent’s that prescription happened at that dose amphetamine (Adderall XR) prescriptions were issued ‘‘within the . . . was he aware of what the prescription for 30 days issued by Dr. usual course of professional conduct,’’ prescription was from another doctor? Webb ‘‘six days’’ earlier. Id. at 269. Dr. Dr. Chambers testified: Was he continuing? Was there any plan Chambers then testified that if I did. It is not [the] usual course of clinical to taper it?’’ Tr. 279. Dr. Chambers Respondent’s wife was ‘‘taking as conduct for someone with mental illness or added that ‘‘he’s kind of writing as if the prescribed, she’s doing what street someone without mental illness to be reason he’s doing it is because the people call a speedball, which is prescribed these combinations of drugs and patient can’t get to Dr. Webb, and he’s essentially an amphetamine/opioid to have these combinations being prescribed documenting that Webb is aware . . . combination with a . . . benzodiazepine by different individuals who—one of who— but in review of Webb’s chart, there no garnish.’’ Id. Dr. Chambers also noted where there’s not communication or awareness that it’s happening. So it’s not indication that Webb was ever aware that on July 1, 2013, the same day that only not usual clinical practice, but the that this kind of stuff was going on.’’ Id. 31 Respondent’s wife filled the Adderall reason it’s not usual is because it’s dangerous When then asked if a 10-day supply is for patients and harmful. So it’s actually not ‘‘unusual for . . . a gap fill,’’ Dr. 30 Other examples of overlapping prescriptions only is it not usual, it’s essentially Chambers answered: involved Respondent’s May 10 and May 13, 2013 malpractice. prescriptions (Nos. 43 and 44 above) for 14 and 12 . . . I think it’s unusual for one doctor to be dosage units of alprazolam 2 mg, which overlapped Id. at 275. On further questioning, Dr. gap filling another regardless of what the with the refill his wife obtained on April 30, 2013 Chambers testified that the duration is, especially when there’s no of Dr. Webb’s prescriptions for 45 du (15 days) of Respondent’s prescribing was not knowledge that that’s happening. So any alprazolam 2 mg. Tr. 267. According to Dr. ‘‘legitimate medical practice’’ and the duration is odd, I think. I guess the longer the Chambers, even Respondent’s May 10 and May 13 number of days the more concerning it is prescriptions overlapped, and that on May 13, prescriptions were ‘‘non-therapeutic.’’ ‘‘what you actually have here is a triple Id. Dr. Chambers further testified that because you’re dispensing bigger doses. I mean, she’s got 30 tabs. That’s quite a bit. compounding of the dosing based on the ‘‘[b]ased on the entirety of the evidence disposition dates and the way the drugs were Id. at 280. instructed to be taken.’’ Id. Dr. Chambers then [he] reviewed,’’ Respondent’s explained that ‘‘that is a very dangerous dose that prescribing did not comply with either Addressing Respondent’s note of would normally never be prescribed outside an the Controlled Substances Act or the February 18, 2012, Dr. Chambers intensive care unit.’’ Id. at 267–68. standards of the Mississippi acknowledged that it contained ‘‘a little Another such example is Respondent’s July 29, Administrative Code, including the bit more of what you could call a 2013 alprazolam prescription which provided eight clinical assessment’’ in that Respondent tablets (TID). Dr. Chambers testified that State’s requirements for patient records. Respondent’s prescription provided a dosing Id. at 276, 278. described his wife’s symptoms. Id. at instruction of eight milligrams a day, Tr. 271, which Addressing the patient file 281. Dr. Chambers observed, however, is supported by the PMP report which lists the Respondent maintained on his wife, Dr. that the note did not indicate ‘‘how prescription as providing a two-day supply. GE 11, many he prescribe[d].’’ Id. As for at 5. However, the dosing instruction on the actual Chambers testified that ‘‘there is a prescription was TID, or one tablet, three times a paucity of data to support the diagnosis Respondent’s statement that his wife day. GX 39, at 1–2. Nonetheless, the prescription or the prescription . . . that the note is was ‘‘[o]ut of her Xanax for . . . 10 overlapped with the refill Respondent’s wife built around. There’s a lack of physical days’’ and ‘‘[o]ut of her Ambien for a obtained on July 19, 2013 for Dr. Webb’s week,’’ GE 6, at 3, Dr. Chambers prescription for 45 tablets (15 days), and on July 31, or mental status exam that normally 2013, she obtained a new prescription from Dr. would be in a note like this to justify testified: Webb for 45 tablets (15 days). GE 11, at 5. However, and direct the use of controlled It’s not clear exactly what that means, but even if Respondent’s prescription only had a dosing substances.’’ Id. at 277. Dr. Chambers I take it to mean that he is prescribing instruction of 3 tablets a day, if she took the because she’s been out. And so, first of all, medications as prescribed by both Dr. Webb and further observed that in comparing the Respondent for the period in which the why is she out? Is it because she’s using it prescriptions overlapped, she would have taken six including attention deficit disorder [and] too rapidly? It’s just not clear. But he is tablets a day or 12 milligrams. Tr. 272. narcolepsy . . . [i]t also has significant street value’’ filling the gap with an unclear amount and 31 Dr. Chambers explained that while Adderall is and is ‘‘basically a cousin of methamphetamine.’’ then suggesting by my read . . . [that] he’s ‘‘used for a number of clinical indications, Tr. 270. documenting he’s contacting Dr. Webb,
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informing them of this gap fill, the best I a ‘‘potentially life threatening where’’ a primary care doctor is could tell. withdrawal,’’ Dr. Chambers testified that prescribing to a patient who is also But what’s beginning to emerge here in this Respondent’s ‘‘leaving for the weekend being treated by a psychiatrist. Id. at note and does come in later is that he is and leaving her with more medication 291. Dr. Chambers testified that in his becoming—Dr. Alexander is becoming aware unsupervised’’ is ‘‘of grave concern.’’ Id. that she’s running out and I assume ‘‘own practice,’’ if a new patient is prematurely because when you look at the Dr. Chambers offered similar receiving psychoactive medication from PDMP data from Dr. Webb, Dr. Webb is not testimony regarding Respondent’s May another physician, he ‘‘will call them to creating gaps.... He is not leaving her 13, 2012 note. See id. 288 (‘‘So again stop that because you can’t have two hanging with no medication a whole lot of he’s now creating a track record in his chefs in the kitchen.’’ Id. Dr. Chambers times. . . . notation that the patient is then explained: essentially out of control and abusing Id. at 281–82. If you have two chefs in the kitchen, this Xanax and injuring herself. His response Continuing on to the next note (March is the kind of stuff that can happen as you is to attempt to prescribe a combo of 12, 2012), Dr. Chambers testified that get chaos and harm and polypharmacy and Xanax and Ambien . . . .). no one understanding what is the illness this was ‘‘the first time I’ve seen a Respondent’s February 27, 2013 note diagnosis in the chart.’’ Id at 282. He versus what is [sic] the side effects of the states that his wife was ‘‘[a]nxious about medications, and it can lead to escalation of then explained that ‘‘delusional marital situation.’’ As to the note, Dr. mental illness, addiction, and even death. parasitosis is a non-specific psychotic Chambers testified that ‘‘it’s not Id. symptom,’’ and that while it can be considered a normal medical practice’’ Finally, on direct examination, Dr. caused by ‘‘a primary delusional illness to treat family members and ‘‘that when Chambers testified that ‘‘[a] competent . . . more commonly [it] is a sign of it comes to controlled substances it’s a psychiatrist would document [in the severe drug withdrawal’’ including whole different ball game’’ when the patient’s chart] if they knew that ‘‘benzodiazepine . . . or even opiate prescription is ‘‘for a family another doctor was prescribing withdrawal.’’ Id. at 282–83. Dr. member.’’ 33 Id. at 286–87. Chambers testified that the behavior Dr. Chambers offered similar controlled substances that were documented in the chart (jerking, testimony with respect to Respondent’s overlapping or representing a threat.’’ twitching, and delusional parasitosis) March 28, 2012 note, which states: Id. at 298. A competent psychiatrist ‘‘suggests extreme discomfort’’ and ‘‘Marital/physical/mental stress sky would also ‘‘take action to stop it or to ‘‘could suggest vital sign changes [and] high—Marriage workshop in Montana stop their practice.’’ Id. impending catastrophic just accentuated’’ and ‘‘Out of Xanax On cross-examination, Dr. Chambers 32 withdrawal.’’ Id. at 283. Dr. Chambers early—rebound anxiety—self harm.’’ GE agreed that ‘‘[i]n many cases,’’ observed, however, that Respondent did 6, at 7. Dr. Chambers testified that he Respondent prescribed the same drugs not obtain his wife’s blood pressure and found that entry was ‘‘interesting to his wife as were prescribed by Dr. pulse or perform a mental status exam. because the marital, physical and Webb. Id. at 307. Dr. Chambers also Id. at 284. mental stress . . . involves him, and acknowledged that he had not examined Respondent’s note of July 14, 2012 he’s prescribing this medication to Respondent’s wife and that ‘‘someone documents a prescription for 20 somebody who is in acute distress that’s who sees her in person’’ is in a better alprazolam 2 mg, a ‘‘6 day supply,’’ and ultimately related to the medication.’’ position to evaluate her than a person states, among other things, that his wife Tr. 287. Dr. Chambers also testified that who only reads her chart. Id. at 310. had been off medications for four Respondent’s notation of a prescription After accusing Dr. Chambers of making months and had been staying with her for ‘‘Xanax # 14’’ ‘‘is incomplete’’ a ‘‘serious allegation []’’ when he mother-in-law. GE 6, at 4. Regarding the because it does not state ‘‘the dose’’ or testified that Respondent’s ‘‘wife was note, Dr. Chambers testified that ‘‘I don’t the patient’s instructions. Id. going through withdrawal’’ and which know that she’s even around when this Subsequently, the Government asked ‘‘could be interpreted as she was prescription happens. It’s just not clear Dr. Chambers to address ‘‘the situation abusing controlled substances,’’ where . . . she [is]. There’s no evidence Respondent’s counsel asked Dr. that she’s even in front of him on July 33 Dr. Chambers also testified that there is a Chambers whether he or Dr. Webb was 14, and that’s also a concern.’’ Tr. 285. prohibition against a psychiatrist treating a spouse in a better position to make that Dr. Chambers observed that, in the for two reasons. Tr. 293. According to Dr. determination. Id. Dr. Chambers Chambers, the first reason is that the practice of answered that Dr. Webb was, but noted October 5, 2012 note (‘‘[s]he is out 2 psychiatry requires ‘‘getting inside the mind of the days early’’), Respondent documented patient’’ and ‘‘is a very invasive process’’ and that that he ‘‘was looking at data from’’ that his wife was ‘‘actually overusing ‘‘romantic and sexual . . . motives will Respondent and ‘‘had the ability to look the prescription that Dr. Webb ha[d] contaminate the clarity of the practitioner.... A at two charts.’’ Id. at 310–11; see also id. psychiatrist who is falling in love with his patient at 319 (Q. You don’t know if she was provided her. So he’s documenting will begin to take actions that benefit . . . him or evidence that she’s demonstrating abuse her rather than the patient.’’ Id. at 293–94. The exhibiting physical characteristics that of these drugs and then he . . . say[s], second reason is that ‘‘there is an implicit power correspond to drug addiction. A. I can ‘[s]he’s lacerating and cutting herself, differential’’ between ‘‘a psychiatrist and a patient’’ only go on what I’ve read.’’). and that ‘‘to exploit that power differential on a Asked by Respondent’s counsel if severe anxiety and depression, arms patient who’s vulnerable with mental illness excoriated. No return call from a through romantic or erotic counter-transference is ‘‘providing gap fills necessarily mean[s] weekend doctor. I have to leave to work regarded fairly much as a cardinal sin in there’s a drug abuse issue,’’ Dr. out of town.’’’ Id. After criticizing psychiatry.’’ Id. at 294. Continuing, Dr. Chambers Chambers answered that ‘‘[i]t can testified that in ‘‘many cases, these are patients who mean.’’ Id. at 311. After Respondent’s Respondent for ‘‘abandoning the have already suffered physical and sexual abuse patient,’’ who was self-mutilating and in previously’’ and are ‘‘susceptible’’ to more abuse counsel asserted that ‘‘[i]t can . . . it’s ‘‘later on.’’ Thus, if a ‘‘psychiatrist engages in a not definitive,’’ Dr. Chambers answered: 32 Dr. Chambers further criticized Respondent sexual relationship with a patient . . . the very real ‘‘I don’t see gap filling happen[ing] in because ‘‘the standard of care for the treatment of danger is [that] there could . . . be a revictimization this case. There is no gap filling going acute withdrawal’’ requires as part of ‘‘the basic . . . of the patient.’’ Id. at 295. response to get a blood pressure or a pulse,’’ and Dr. Chambers also testified, however, that ‘‘[t]his on. There’s overlaying.’’ Id. After ‘‘[i]f these measures aren’t taken, people die standard is actually not true for other branches of Respondent’s counsel asserted that Dr. routinely.’’ Id. at 284. medicine’’ such as family practice. Id. at 294. Webb ‘‘ha[d] categorized the same
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evidence . . . as gap filling,’’ Dr. 1500 doses of controlled substance in Dr. Chambers testified that he did not Chambers testified: ‘‘[i]t would surprise one year . . . be more responsible for see any notation in Dr. Webb’s patient me if he’s seen the same evidence . . . that versus the individual who file that he was aware that Respondent’s It would surprise me because that’s not prescribed 200 doses of controlled wife ‘‘was running out early and that what I see in the data.’’ 34 Id. substances a year?’’ Id. at 320. Dr. [Dr. Webb] was filling earlier.’’ Id. at Assuming facts not in evidence, Chambers answered: ‘‘but what we’re 328. Asked if he would be surprised that Respondent’s counsel then asked Dr. seeing here, that’s not what happened. Dr. Webb testified that he was aware Chambers if ‘‘somebody who sees [the We’re seeing two people prescribing [to] that Respondent’s wife was getting early patient] regularly five or six times a one person.’’ Id. Continuing, Dr. refills, Dr. Chambers answered that he week as a patient 35 or someone who’s Chambers explained that ‘‘it could be a ‘‘would be’’ and explained that PMP paid to review her patient file’’ is ‘‘in a totally different picture if . . . only Dr. ‘‘data doesn’t really reflect [that] there better position’’ to diagnose a patient as Webb’’ was prescribing but he had ‘‘no was a great deal of early refill activity a substance abuser. Id. While Dr. idea what that whole trajectory would going on from Webb by himself,’’ and Chambers agreed that a psychiatrist who look like’’ and whether ‘‘[s]he might be while ‘‘[t]here may be a few instances of saw the patient is in a better position to more stable.’’ Id. Dr. Chambers held to it, [it was] not very frequent.’’ Id. at 329. evaluate a patient, in response to the his earlier testimony that having two Dr. Chambers explained that Dr. Webb’s question of whether ‘‘it would not physicians prescribe to Respondent’s ‘‘prescribing shows a relative lack of surprise [him] that Dr. Webb concluded wife was ‘‘creating chaos that could overlap of his . . . prescriptions for that [Respondent’s wife] didn’t have a actually cause the treatment to get even controlled substances. And when I say substance abuse issue,’’ Dr. Chambers worse’’ and ‘‘to evolve in the wrong ‘relative lack,’ I mean maybe a day or explained that ‘‘[i]t wouldn’t’’ because direction.’’ Id. at 321. two,’’ which is ‘‘not really significant Dr. Webb is ‘‘not an addiction After Dr. Chambers acknowledged because people have got to go to the psychiatrist.’’ Id. at 312–13. When that ‘‘Dr. Webb prescribed a significant pharmacy.’’ Id. subsequently asked by Respondent’s amount of controlled substances, Respondent’s counsel then questioned counsel if he ‘‘disagree[d] . . . with the Respondent’s counsel asked him if he Dr. Chambers about the alprazolam doctor that’s seen her for 15 years five ‘‘was aware that in 2011 [Respondent] prescriptions which were issued by Dr. to six times a week with his diagnosis,’’ only prescribed 128 dosage units to Webb and filled by Respondent’s wife Dr. Chambers answered that he did.36 Id. her?’’ 37 Id. at 321. After answering on May 14, June 10, July 4, July 21, See also id. at 319 (Q. ‘‘So it’s better to ‘‘yes,’’ Dr, Chambers added that ‘‘Dr. August 4, and August 16, 2011, and leave it to the psychiatrist who sees her Alexander prescribed about 20 percent whether the overlap between the five to six times a week over a 15-year of the controlled prescriptions and Dr. prescriptions concerned him. Id. at 331. period to make that decision.’’ A. ‘‘Well, Webb about 70 percent on average over Dr. Chambers acknowledged that the not always. Not always, right.’’). three years. Id. June 10, 2011 filling created an overlap Dr. Chambers acknowledged that Following questions about the relative of three/four days and was ‘‘on the Respondent’s and Dr. Webb’s dosing of amounts of controlled substances margin’’ as did the August 16, 2011 alprazolam were ‘‘often in the same prescribed by Dr. Webb and filling. Id. at 331–32. Dr. Chambers also ballpark.’’ Id. at 317. However, Dr. Respondent, Respondent’s counsel acknowledged that the July 21 Chambers explained that, while ‘‘taken asked Dr. Chambers if Respondent’s prescription ‘‘would concern me.’’ Id. at separately both of the [doctors’] dose wife had ‘‘a substance abuse issue, . . . 332. Dr. Chambers offered similar ranges might be acceptable, . . . if isn’t it logical that Dr. Webb would have testimony with respect to several they’re . . . overlapping, that’s when as much, if not more, responsibility for alprazolam prescriptions that you get into the danger.’’ Id. Dr. that?’’ Id. at 322. Dr. Chambers Respondent’s wife filled on February 14 Chambers acknowledged, however, that disagreed, explaining: ‘‘not necessarily and 23, 2012, finding that the latter fill ‘‘[n]o one’’ knows how much of the drug because Dr. Webb is not aware that . . . was ‘‘five days early’’ and ‘‘[t]hat’s when Respondent’s wife was taking. Id. at two doctors [were] putting drugs into the red flag begins to go up.’’ Id. at 332– 318. one person.’’ Id. While Dr. Chambers 33. Of note, however, several of these Respondent’s counsel then asked Dr. acknowledged that there is evidence in fills were actually refills of prescriptions Chambers if ‘‘you’re saying that she was Dr. Webb’s chart ‘‘that he had written much earlier, see Tr. 333, and in addicted or . . . was abusing controlled discussions’’ with Respondent about his any event, to the extent that Dr. Webb substances . . . wouldn’t . . . the wife, he found ‘‘no evidence at all . . . should have been aware that a previous individual who prescribed her over that [Dr. Webb] knew that [Respondent] prescription he issued had provided was also prescribing controlled sufficient refills such that there was no 34 As found above, while Dr. Webb testified that substances.’’ Id. reason to issue a new prescription on a gap filling ‘‘means a prescription that is used to get particular date, Dr. Webb is not the you to the next authorized refill’’ and gave various respondent in this proceeding.38 examples, including ‘‘something that would speak 37 This, too, is a misstatement of the evidence. to a need for more medication,’’ his testimony was Rather, the evidence shows that during 2011, Likewise, while Respondent’s counsel clear that with the exception of a prescription Respondent issued prescriptions for 206 dosage raised a series of questions as to issued by ‘‘one of my on call doctors,’’ a gap fill units of zolpidem, 151 dosage units of whether the pharmacies that filled the by another provider was not appropriate. Tr. 138– hydrocodone, 28 dosage units of clonazepam, 28 prescriptions should not have dispensed 39, 192, 195–96. dosage units of alprazolam, and one kit of Diastat 35 Dr. Webb’s patient file contains progress notes acudial. various early refills, id. at 334–336, the for 10 visits by Respondent’s wife during the years Respondent’s counsel also misstated the evidence 2011 through 2013. GX 5, at 42–53. Thus, contrary when he asked Dr. Chambers if he was ‘‘aware [that] 38 Specifically, Dr. Webb’s February 3, 2011 to the premise of the question, there is no evidence in 2012 Dr. Webb prescribed approximately 1720 alprazolam prescription, which was for a 30-day that Dr. Webb saw Respondent’s wife ‘‘five or six dosage units of controlled substances versus the 132 supply, see GE 5, at 111, authorized five refills, and times a week as a patient.’’ Tr. 311. that [Respondent] prescribed] to’’ is wife. Tr. 321. Respondent’s wife obtained refills which were 36 While the ALJ admitted only Dr. Webb’s chart Rather, the evidence shows that Respondent authorized by this prescription on June 10 and July for Respondent’s wife during the years 2011 prescribed 112 du of zolpidem, 94 du of 4, 2011. See GE 11, at 12. However, on May 2, 2011, through 2013, Tr. 74, here again, there is no alprazolam, 20 du of diazepam, 30 du of Dr. Webb issued Respondent’s wife an additional evidence in the entire record that Dr. Webb saw hydrocodone, 15 du of Adderall, as well as prescription for 30 days of alprazolam. GE 11, at 13; Respondent’s wife five to six times a week. Hycodan cough syrup. GE 5, at 111.
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ALJ properly ruled that the conduct of like actively seizing and not conscious.’’ testified that ‘‘there was pain medicines the pharmacies is irrelevant. Id. at 336. Id. [sic] then,’’ he added that ‘‘in general, Respondent’s counsel subsequently the majority of the medicine were Respondent’s Testimony at the State asked Dr. Chambers if the hydrocodone Xanax, two milligrams, three days’ Board Hearing Regarding His Reasons supply were common.’’ Id. at 59–60. prescription which Dr. Webb issued on for Issuing the Prescriptions June 28, 2013 concerned him. Id. at 338. Respondent then maintained that his Dr. Chambers testified that he did ‘‘have At the January 2014 Board hearing wife ‘‘would get in with Dr. Webb the a concern in that [Dr. Webb] is which resulted in the suspension of his following Monday morning, and he will concurrently prescribing two other medical license, Respondent was asked refill everything.’’ Id. He further benzodiazepines at the same time,’’ to explain why he issued the testified that ‘‘I think the record reflects these being temazepam and alprazolam. prescriptions. GE 14, at 56. Respondent that I filled in in times where I just Id. at 338–39. Dr. Chambers also explained that his wife has a ‘‘fragile’’ didn’t think I had no other choice. I acknowledged that the Adderall psychiatric condition, which ‘‘became didn’t know what to do.’’ Id. prescription issued by Dr. Webb on this even more fragile’’ in ‘‘about November Continuing, Respondent testified that date created ‘‘a speedball.’’ Id. at 339. or December of last year.’’ Id. He ‘‘I have never denied that I called things Continuing, Dr. Chambers testified: testified that while ‘‘[t]here were times in for Jill . . . I always thought that if [that his wife] would run out of called to task for it, the context would So that is a concern. When you step back medicine and not decompensate . . . not speak for itself but would be from the record and you look at where—the there was never a decompensation opiate is the main threat actually, and when evidenced by number, etcetera.’’ Id. at you look at the predominance of opiate where she had her medicines.’’ Id. at 57. 61. Respondent then testified that he prescribing over three years, the majority of Respondent testified that ‘‘[w]ith [his] was monitored by the Board and that it came from Dr. Alexander. So the number history, there was no way to call anyone ‘‘[t]here’s not been any diversion. There of opiates that were prescribed were quite else’’ and ask them to prescribe Xanax has not been any suggestion of that and, rare. The incidents you’re putting in there— to his wife because anyone he knows fortunately, got a lot of urine tests that you’re pointing out is a concern, but . . . the would ‘‘be immediately suspicious that were negative. I only ever did what I did relative frequency of which Webb did that it was for me.’’ Id. at 58. According to when I perceived I had no other options was much, much, much lower than when Dr. Respondent, ‘‘as regards my wife Alexander [did] it, and that’s interesting having exhausted anything else that I herself, I would phone in usually a two- knew to do.’’ Id. because, as you pointed out, Dr. Webb is or three-day stop gap supply of prescribing . . . three or four times more Asked about the December 2012 number of prescriptions. So it’s a matter of medicines. And if you’ll look at the Adderall prescription, Respondent degree as well. numbers dispensed, it’s usually 12, stated that he did not ‘‘recall ever which would be a three-day supply for’’ writing’’ the prescription and that his Id. at 340. her. Id. wife ‘‘was in the hospital in Hattiesburg Asked if it is within the usual course Continuing, Respondent testified that at the time.’’ Id. at 62. Continuing, of professional practice for a ‘‘[w]e tried to . . . contact [Dr.] Webb, Respondent stated that ‘‘that one psychiatrist to prescribe an opiate, Dr. but . . . you can’t get him at night, on prescription doesn’t seem to fit for me. Chambers testified that a psychiatrist weekends, and I don’t blame him. And I don’t think that’s mine, but I would be ‘‘may treat pain on occasion.’’ Id. at 341. as he always tells [my wife], this is a glad if somebody had a copy of it to look While Dr. Chambers then testified that matter that she shouldn’t be running out at it.’’ Id. at 62–63. The prescription is, he was surprised that Dr. Webb had prematurely.’’ Id. Respondent however, in the record of this testified that that he had written the maintained that ‘‘[t]his happened . . . proceeding. GE 18, at 102. It shows June 28, 2013 hydrocodone prescription in December, in January, in February. I Respondent as the prescriber and knowing that another physician was don’t think it happened in April or Respondent offered no testimony in this prescribing the drug to Respondent’s May.’’ Id. He further asserted that ‘‘[i]t proceeding disputing that he issued it. wife and did so without consulting that was sporadic’’ and ‘‘was always for a Id. physician, when Respondent’s counsel confined number of pills, a small Respondent also told the Board that asked Dr. Chambers if this called into amount, that bridged her gap between his prescribing was ‘‘not a matter of question Dr. Webb’s treatment of her, obviously when she was in crisis and judgment’’ but ‘‘a matter of heart.’’ GE the ALJ properly sustained the didn’t have any medicine.’’ Id. 14, at 63. He further told the Board that: Government’s objection. Id. at 341–42. Respondent also testified that ‘‘we’ve Addressing the prescription for got a baby here,’’ ‘‘I may be working out I never did anything that I didn’t think at Diastat Acudial, a rectal suppository the moment . . . was necessary, and I think of town,’’ and ‘‘I’ve got to do something if you look at the record you can see that. form of diazepam, Dr. Chambers to calm this situation down.’’ Id. There can be no more. There can be no more. testified that while Dr. Webb’s file Respondent added that he ‘‘felt as if [he] You know, if I have to call 911 every time, shows that Respondent’s wife suffers was in an emergency situation.’’ Id. then I am Jill’s husband. I am not—I was from seizures, he did not see how Apparently referring to the never her doctor. I stopped gapped, but I administering Diastat would ‘‘be prescriptions he issued for can’t even do that anymore. I mean, I know consistent with treating someone who hydrocodone, Respondent testified that that is a matter of fact going forward. was having a seizure.’’ Id. at 345. While ‘‘[w]hen that changes—there were two Id. at 63–64. Dr. Chambers testified that Valium occasions in general’’ when he ‘‘called During cross-examination at the Board (diazepam) and benzodiazepines ‘‘can in.’’ Id. Respondent then related that a proceeding, Respondent admitted that be used to treat seizure disorder[s],’’ he plastic surgeon had drained an abscess he did not disclose that he had been added that these drugs ‘‘can also cause in his wife’s thigh and testified that he issuing the prescriptions until he was seizure disorders.’’ Id. at 346. Dr. ‘‘noticed that there was one prescription asked by the Board. Id. at 64–65. He Chambers subsequently testified that a for Lorcet then for a few, and it further asserted that he did not ‘‘come rectal suppository might be used ‘‘to happened again in July of last year’’ up with [his wife’s] regimen,’’ that he treat a seizure disorder if someone can’t when his wife’s mother died and his ‘‘didn’t change her regime,’’ and that he take [the drug] orally, meaning [the wife ‘‘had a seizure [and] fell,’’ suffering only ‘‘mirrored what her treating patient] would be in status epilepticus, various injuries. Id. While Respondent psychiatrist had done.’’ Id. at 65.
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However, after a Board member 81. Respondent subsequently testified Respondent’s wife testified that she is identified multiple hydrocodone and that ‘‘no, I didn’t do it every time. I have known by various names including Xanax prescriptions that he issued in had the discussion with him.’’ Id. at 81. Mona Jill Graham Alexander, Mona Jill July 2013 and asked if he thought Respondent testified that when he Graham, Mona Jill G. Alexander, and Jill ‘‘that’s wise,’’ Respondent stated that ‘‘I would call Dr. Webb’s answering Alexander. Tr. 357–58. She testified that have to alter what I said. She also has service, he would ‘‘ask [ ] for a call back she has been a patient of Dr. Webb for a treating neurologist’’ (Dr. Bell) who from Dr. Webb or the doctor on call.’’ Id. 16 years and she would usually see Dr. ‘‘also does musculoskeletal medicine’’ at 84. When asked if he Webb three times a year and speak on and that when his wife ‘‘had a seizure’’ ‘‘communicate[d] to the answering the phone two to three times a month she saw the neurologist. Id. at 66. service the gravity of the situation,’’ he for 30 minutes to one hour. Id. at 359. Respondent then explained that admitted that he did not. Id. at 85. He Respondent’s wife testified that ‘‘[w]hen I say psychiatrist, that’s what then explained that ‘‘I think I during the 2011 through 2013 time Dr. Bell had given her for pain, and she communicated that it was a medicine period, she ‘‘would tell’’ Dr. Webb that ran out, and she was sitting constantly shortfall and that we needed someone to Respondent was prescribing controlled in the . . . [h]ospital.’’ Id. Respondent remedy that.’’ Id. substances for her, ‘‘especially if I got out of medication.’’ Id. at 360. I do not asserted that ‘‘that was an isolated Respondent’s Case incident there.’’ Id. find this credible. Nor apparently did During the Board proceeding, Respondent’s first witness was his the ALJ. R.D. 16 (FoF #28: ‘‘Dr. Webb Respondent acknowledged that he had wife. Tr. 357–401. Of consequence, the did not know that the Respondent was violated his RCA and an agreement with ALJ found ‘‘that her testimony was not simultaneously prescribing controlled the Board. Id. at 68. He further asserted helpful in resolving the issues in this substances to Mrs. Alexander.’’) that he never issued the prescriptions case.’’ R.D. 9. Specifically, the ALJ (citations omitted). While Respondent’s ‘‘out of defiance[,] . . . self will, power, found that ‘‘her testimony was wife also testified that when she called or arrogance’’ and that ‘‘[i]t was always confusing, lacked specificity, and, at after hours, ‘‘[n]o one would ever . . . done in a short stop gap times [sic] times, was internally inconsistent’’ and call me back,’’ that this ‘‘was very when I believed again . . . that there that ‘‘she could not remember many frustrating’’ to her, and that she were no other options.’’ Id. at 69. details of the underlying events about expressed her frustration to Dr. Webb, Before the Board, Respondent further which she was testifying.’’ Id. (citing Tr. Tr. 360–61, the ALJ did not find this asserted that he did not notify Dr. Webb 373–74, 376–77, 382, 384, 391). The ALJ testimony credible. R.D. 15 n.21. about the prescriptions because his wife also ‘‘found her responses to some Indeed, the ALJ specifically found ‘‘assured [him] that [Webb] was questions to be evasive, and her credible Dr. Webb’s testimony that apprised of every situation.’’ Id. at 78. demeanor to be somewhat combative.’’ Respondent’s wife ‘‘never told [him] However, when a Board member noted Id. The ALJ also provided extensive that she was dissatisfied with her ability that ‘‘[c]ommon sense would dictate as reasons for why he gave ‘‘little credence to contact him or his office.’’ R.D. 15 a physician [that] the next morning you to her testimony, and where it [was] (FOF #23.). I agree with these findings. pick up the phone and call this contradicted by other evidence,’’ he did Respondent’s wife testified that ‘‘[t]he psychiatri[st] that’s taken care of [her] not find her testimony as credible. only conversation we [she and Dr. for 18 years and knows her probably These included: Webb] ever had about [her husband’s better than any healthcare professional’’ She could not recall the number of times prescribing] was to let me be the only and tell him ‘‘this is what happened last she had called Dr. Webb’s answering service one that prescribes you this medicine.’’ night, and this is what I did,’’ and had not received a return phone call. Tr. Tr. 363. She initially testified that this Respondent answered: ‘‘Not with every 360–62. She could not provide an adequate conversation ‘‘probably [occurred] time.’’ Id. at 79. Asked more specifically explanation of why she continued to be Dr. towards the end’’ of 2013, id. at 391, why he did not talk to Dr. Webb, Webb’s patient even though she was only to testify that the conversation Respondent maintained that his wife dissatisfied with his failure to return her occurred ‘‘after [she] got discharged phone calls. Tr. 361–62, 382, 391. In told him that ‘‘[w]ith your Betty Ford explaining her difficulty in recalling details from the hospital’’ in March 2016. Id. at attitude, he’s going to take me off my from 2011 to 2013, she said she could not 398–99. She also testified that during Xanax’’ and ‘‘I don’t want you to talk to recall because that was ‘‘seven years ago.’’ Tr. the 2011 through 2013 time period, she him.’’ Id. at 80. While Respondent 372. She testified that she did not have was hurting herself and that to the best testified that he should ‘‘have appointments with Dr. Webb between 2011 of her recollection, she shared this with overridden her concerns and intruded and 2013, yet Dr. Webb’s treatment notes Dr. Webb. Id. at 364. . . . upon her doctor/patient document several appointments during that Regarding the Diastat prescription, relationship,’’ he then added that ‘‘[i]n period. Compare GE 5, at 42–46, 49–53, with Respondent’s wife testified that she uses Tr. 386. She testified that she told Dr. Webb retrospect, I should have done that, that she would only get her prescriptions the drug because she has seizures and more than the few times that I did do from him, and that that had been her practice because ‘‘I’ve had seizures, I just always it. I certainly did it sometimes. I didn’t for the past three years, but later testified that try to travel with it and keep some on do it with every issuance herein.’’ Id. she had this discussion with Dr. Webb in me.’’ Id. at 366. Asked by the ALJ if she The same Board member noted that 2016. Tr. 363, 368, 398–99. She testified that was using this medication in the 2011– ‘‘there’s an insinuation that [Dr. Webb] she only used one pharmacy, but her PMP 2013 time period, Respondent’s wife knew something had happened and that report shows she filled prescriptions at answered: ‘‘I always keep it with me. It’s weekend or something had happened numerous pharmacies. GE 11; Tr. 369. She something that I’ll try not to ever run did not give a direct answer to the question and that emergency medicine had been of whether she had told Dr. Webb that the out.’’ Id. She also subsequently testified called in’’ and asked ‘‘is that correct?’’ Respondent had provided her with that the Diastat was not prescribed by Id. Respondent answered: ‘‘I certainly prescriptions, and when she provided an Dr. Webb but by her ‘‘neurologist.’’ Id at know that certain times he did. I don’t example of when she had passed that 393. know that at every time he did.’’ Id. information to Dr. Webb, the example was Respondent’s wife testified that she Respondent added that he was ‘‘certain outside of the time range of the Respondent’s believed her husband prescribed the that the answering service’s message alleged violations. Tr. 360–63, 398–99. controlled substances because he was was, ‘[c]all Dr. Alexander.’ ’’ Id. at 80– R.D. 9. trying to help her. Id. at 367. She further
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testified that her husband ‘‘never ‘‘usually [did] not’’ get a call back from Respondent subsequently underwent prescribed medicines that weren’t Respondent’s office when she would treatment, which included both a three- prescribed for [sic] Dr. Webb when I leave a message. Tr. 387. Not only did week inpatient and one-week follow-up got—until we could get in touch with the ALJ not find her testimony credible, visits at three and six months, him.’’ Id. See also id. at 383 (‘‘[B]ut he her medical file contains evidence of individual psychotherapy in his home never prescribed anything that I hadn’t only two phone calls she made during community, and a three-day wrap up already been prescribed by Dr. Webb.’’). this period in which Dr. Webb did not visit at the one-year mark. Id. at 421–22. She also testified that when her document that he called back or Dr. According to Dr. Graham, Respondent’s husband wrote a prescription for her, Webb did not issue a prescription either treatment team has determined that he she was in crisis, and that her husband the same day or the following day.39 can ‘‘return to supervised and had never provided her with a Respondent called as a witness Peter monitored practice.’’ Id. at 425. controlled substance prescription when Graham, Ph.D. Dr. Graham is a Respondent also called as a witness, she was not in crisis. Id. at 367–68, 376. psychologist who works with Acumen Scott Hambleton, M.D., the medical She further maintained that she ‘‘would Assessments, which provides clinical director of the MPHP. Id. at 435–37. Dr. try to get in touch with Dr. Webb, and evaluations of physicians who are Hambleton testified that ‘‘the heart of in the interim of a two- or three-day fill- referred to it by physician health [Respondent’s recovery] contract in, I did get medicine from’’ my programs and state boards, and the concerns abstinence from any mood- husband. Id. at 371. When later asked Acumen Institute, which provides altering or addictive substances, which why her husband would have to treatment, education and coaching to would increase the risk of a relapse to prescribe to her when she was in crisis, ‘‘licensed professionals who are in the substance use and active addition.’’ Id. she maintained that ‘‘[t]here would be process of being rehabilitated for one or at 443. He further testified that occasional times I might run out a day another professional reason.’’ Tr. 403– Respondent is subject to random testing early on a weekend . . . and he would 04. Dr. Graham testified that the main approximately 30 times a year for both see me very upset, crying, very focus of Acumen’s evaluations is not drug and alcohol use, that he is subject emotional, and I feel like his intent was whether a physician is competent to to a workplace monitor, and in the event never to harm me. He was just trying to practice medicine, but whether the he needs to take controlled substances, help me.’’ Id. at 379. See also id. at 381 physician’s ‘‘mental status, personality he ‘‘is required to use a medication (‘‘I don’t know if I told him I need more variables, [and] character traits . . . may monitor’’ and all such prescriptions or if he just knew that I just needed just impact on decision-making, ethical must be approved by the MPHP ‘‘in two, three, four to get back to Dr. Webb judgment, self-regulation, ability to advance.’’ Id. at 443–44. Dr. Hambleton because no one would call us back.’’). remain responsible and maintain the also testified that Respondent is However, when asked if Respondent duties of licensure.’’ Id. at 416–17. required to attend 12-step and Caduceus had ever given her a prescription for a Dr. Graham testified that Respondent meetings for physicians in recovery. Id. longer time period than two to four was referred to him ‘‘for evaluation of at 445. In addition, according to Dr. days, she answered: ‘‘Not to my his fitness secondary to having engaged Hambleton, a Board investigator visits knowledge. I do not remember.’’ Id. at in conduct that was contrary to his Respondent on a random basis at least 384. [recovery] contract,’’ that being writing once a quarter to witness a drug screen On cross-examination, she also the prescriptions for his wife. Id. at 417. and evaluate his appearance. Id. at 446– admitted that Respondent had written a According to Dr. Graham, the evaluation 47. Dr. Hambleton further stated that hydrocodone prescription for her but determined ‘‘that there was an Respondent’s contract will last for as maintained that he did so when her interaction between certain personality long as he has an active medical license. mother ‘‘was dying in the hospital’’ and factors that affected his judgment and Id. at 447. she developed back pain because she sat the way he was deciding to comply or As for how the MPHP monitors the at her ‘‘mother’s bedside waiting for her not with his contract, as well as anxiety provision in Respondent’s contract that to die.’’ Id. at 374. Respondent’s wife and situational stress related to’’ his prohibits prescribing to family members then maintained that she did not recall home life that ‘‘affect[ed] his mental and himself, Dr. Hambleton testified her husband as having written ‘‘[m]ore status.’’ Id. at 419. The evaluation that this is done by the Board’s than one’’ hydrocodone prescription. Id. recommended to the MPHP that However, as found above, Respondent investigators. Id. at 448. Dr. Hambleton Respondent ‘‘undergo treatment testified that if the MPHP found out that issued numerous hydrocodone designed for professionals who have prescriptions to her well before Dr. Respondent had prescribed controlled made ethical misjudgments or engaged Webb issued the single hydrocodone substances to himself or a family in some kind of misconduct . . . with prescription on June 28, 2013. Also, a member it ‘‘would withdraw advocacy a focus on examining his ethical substantial number of the prescriptions immediately.’’ Id. at 449. Dr. Hambleton decision-making’’ and how his (especially those for zolpidem) were for further testified that he had no ‘‘personality traits’’ affected his quantities that far exceeded the amount reservations about Respondent returning behavior. Id. at 420. necessary to provide medication until to the unrestricted practice of medicine. she was able to get a new prescription Id. at 450. The record does not establish, 39 The first of these was on August 25, 2011. GX however, what ‘‘the unrestricted from Dr. Webb. Moreover, in a number 5, at 140. Notably, Respondent’s wife had an office of instances, Respondent issued the visit with Dr. Webb on August 16, 2011, during practice of medicine’’ entails in light of prescription notwithstanding that his which he wrote her prescriptions for 30-day Respondent’s recovery contract. wife had either recently refilled a quantities of Adderall 20 mg, zolpidem 10 mg, and On cross-examination, Dr. Hambleton 90 alprazolam 2 mg. Id. at 49; GX 11, at 12. While prescription for the same drug or had acknowledged that Respondent had the phone messages states ‘‘Having problems,’’ GX violated his first two recovery refills outstanding which were 5, at 140, Respondent did not issue a prescription 40 authorized by an existing prescription until August 28, 2011, when he authorized 12 contracts. Id. at 452. He also issued by Dr. Webb. zolpidem. The second of these occurred on July 10, 2013. 40 Dr. Hambleton explained that Respondent had On questioning by the ALJ, GX 5, 133. However, the same day, Respondent’s been subject to a ‘‘provisional contract’’ during the Respondent’s wife maintained that wife refilled a prescription for 45 alprazolam 2 mg period of his license suspension ‘‘to establish a during the period of 2011 and 2013, she (15 days). GX 11, at 6. Continued
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acknowledged that at some point when asserted that ‘‘now it is part of their 494. After the ALJ overruled the Respondent had a job opportunity in policy to do regular PMP checks’’ on the objection of Respondent’s counsel that Tennessee, the MPHP had written to MPHP’s participants.’’ Id. at 477–78. the question was outside the scope of that State’s Board recommending The MPHP does not, however, have that direct examination, Respondent testified against granting a license to authority. Id. at 478. that he was ‘‘not certain that [he] Respondent. Id. at 475. Respondent also testified on his own understand[s] that fully.’’ Id. at 495. The Dr. Hambleton testified that he behalf. Id. at 481. After discussing his Government then asked Respondent if supported Respondent’s return to the background, training and current he understood that ‘‘DEA is asserting unrestricted practice of medicine employment, id. at 481–82, Respondent that with respect to the prescriptions because the Board’s suspension of his testified that he ‘‘[a]bsolutely’’ you issued for your wife that you license was ‘‘a profound experience, prescribed controlled substances to his violated Mississippi and federal law.’’ especially for a neurosurgeon, with that wife and did so when she was under the Id. Respondent answered: ‘‘I understand amount of training,’’ and ‘‘[t]hat type of care of another physician. Id. at 484. that you just asserted that, but my intervention has a powerful effect on the Asked if his prescribing of controlled understanding would only stop there.’’ recovery process.’’ Id. at 470. He also substances to his wife ‘‘violated his Id. testified that ‘‘Acumen has more obligations as a licensed doctor in . . . The Government followed-up by expertise in dealing with personality Mississippi,’’ Respondent answered: ‘‘I asking: ‘‘so . . . you are not admitting issues’’ and ‘‘[s]o that treatment in itself know it violated my contract with the that you violated either federal or state . . . represents a profound event that professionals healthcare program.’’ Id. law with respect to the prescriptions makes it possible to provide advocacy.’’ Asked if he believed that his prescribing you issued to your wife?’’ Id. Id. at 470–71. ‘‘in the manner that’’ he did ‘‘violated Respondent testified: ‘‘I think my Dr. Hambleton further testified that [his] obligations as a DEA registrant,’’ answer is I’m uncertain as to every Respondent’s ‘‘treatment has been Respondent testified: ‘‘I don’t know the component, specifically of the federal, effective’’ and that ‘‘[h]e’s gaining specific legalities of DEA registration, to be able to answer that as honestly as insight, sensitivity, demonstration of but I’m here to tell you what I did was I want to.’’ Id. more regard for others, responsibility, wrong, period, without any The Government asked Respondent if authenticity, the markers of recovery.’’ equivocation.’’ Id. he understood that what he had been Id. at 471. Respondent testified that when he charged with in the DEA proceeding However, on questioning by the ALJ, testified before the State Board, he ‘‘had nothing to do with’’ his recovery Dr. Hambleton testified that his accepted responsibility for prescribing contract. Id. at 497. Respondent ‘‘frequency of contact’’ with Respondent to his wife. Id. at 486. He then testified testified: ‘‘I understand that you just ‘‘is not what allows me to make that that he is under a lifetime monitoring represented half of what I understand’’ assessment of him.’’ Id. at 472. Rather, contract, and that he is monitored by and added that ‘‘I was found guilty of Dr. Hambleton explained that his both the MPHP and the Board. Id. two things one, violation of a previous assessment was based on reports he Asked why the Agency should entrust order . . . Number two, the unethical received from other participants in him with a DEA registration, behavior, which in my interpretation is Respondent’s Caduceus group, ‘‘from Respondent testified: subsumed by the number of things that another facilitator of the group,’’ his even . . . if I don’t know the letter or spirt you have cited as far as Mississippi cases manager’s reports, and ‘‘watching of any law that I transgressed, I do know that conduct, et cetera.’’ Id. him interact with other physicians becoming involved in a loved one’s care is After noting that Respondent was during’’ the MPHP’s ‘‘annual Caduceus foolish. There is no subjectivity there. I can only ‘‘admitting responsibility to what retreat.’’ Id. at 472. Dr. Hambleton then be Jill’s husband, but that’s all I can be to her, the Board found’’ and that was not what period. There can’t be any clinical judgment, DEA had charged him with, the acknowledged that when he ‘‘provides or any family member for that matter. advocacy, [his] interaction with As I testified in my [2014] board hearing Government explained that it was participants is very limited’’ and that he . . . , regardless of what it had come from, ‘‘trying to get a clarification as to what ‘‘provide[s] advocacy based on the I thought I’d hit a brick wall. And there are you’re accepting responsibility for?’’ Id. constellation of collateral sources of no other options for me. If I can’t practice at 497–98. Respondent testified: medicine, conforming to every jot, tittle, to information [and] their drug testing’’ . . . as I’ve said already . . . I wrote the letter of the law, I can’t practice results. Id. at 473. prescriptions. I shouldn’t have written medicine. There are no more get-out-of-jail Dr. Hambleton testified that ‘‘[i]n the prescriptions. It violated my contract. It cards for me. There aren’t. event that there is evidence of substance violated my duty to my wife. It violated—in abuse, we will withdraw advocacy Id. at 489–90. Continuing, Respondent this one instance, in all my years of practice, immediately, and it [will] be the end of testified: that’s the only time I’ve ever been called into question, but it violated as a layperson his medical career.’’ Id. at 477. He also I have tried to—perhaps I made enough everything I think I should have done, testified that ‘‘[i]n the event that he missteps, I can provide a beacon of some sort regardless of why I thought at the time it to younger physicians that might think it’s prescribes inappropriately . . . our might—erroneously thought it could be medical board investigators will okay to prescribe outside the bounds of normal patients. I don’t know what else I proper. monitor it closely’’ and the Board would As far as me as a physician testifying to ‘‘issue an immediate prohibition on possibly could do at this point to convince Your Honor what more I could do to be—that what statutes I may or may not have practice.’’ Id. Dr. Hambleton was ‘‘not I am worthy to be entrusted with a DEA transgressed, I can’t. That would be sure’’ as to how the Board found out registration. I will do it. If someone suggests speculative at least on some level for me. about Respondent’s prescribing to his something to me, I will gladly do it, but —. Id. wife, but based on ‘‘conversations’’ he Id. at 491. After the ALJ sustained Respondent’s has ‘‘had with investigators,’’ he On cross-examination, the objection to the Government’s attempt Government asked Respondent if he to question him about both his period of compliance and recovery.’’ Tr. 452. Respondent did not violate this contract, which understood that ‘‘DEA is alleging testimony before the State Board and the ended when he entered his current (fourth) something slightly different than patient file he maintained on his wife, contract. Id. at 453. prescribing outside the contract.’’ Id. at the Government asked Respondent if he
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‘‘accept[ed] that the prescriptions that acknowledged that ‘‘[i]t didn’t’’ and I was saying that I’m ignorant of the specifics you issued to your wife were outside the asserted ‘‘that’s why [he] was of a DEA charge. But if I meet the criteria and course of professional practice as confused.’’ Id. at 504. Noting that the I accept I did it, then I did it. From my defined by the DEA?’’ Id. at 501. hearing in January of 2014, I never said I allegations involved his prescribing to didn’t. I sat there and said, yes, this is what Respondent answered: his wife and his failure to make happened. There are some prescriptions I think I’ve answered that already. I don’t adequate notes in his wife’s record, the errors in that record, but in general, yes, this know precisely how the DEA defines it, and ALJ again expressed his puzzlement as is what happened. to be scrupulously honest, I can’t. I will once to what Respondent was ‘‘accepting Id. Respondent further testified on re- again accept the responsibility that what I responsibility for.’’ Id. at 504–05. did was wrong and I should not have done direct that he was, in the words of his Respondent replied that he knew counsel, ‘‘accepting responsibility for it. And I have done everything in my power ‘‘exactly what the State . . . said I did’’ to remediate that. But I do not know again inappropriate prescribing practices . . . the specifics of the—of what I’m being and ‘‘I think I believe that the DEA related to [his] wife.’’ Id. charged with by DEA now, three years after mimicked that . . . [or] paralleled that.’’ On re-cross, the Government asked I have assiduously striven to do everything Id. at 505. Continuing, Respondent Respondent ‘‘[w]hat portion of the I can to clean up and do everything right, and stated: ‘‘And if those two specifications prescribing to [his] wife [was] then you come along and ask me about new or charges are the same, then, yes, I do inappropriate?’’ Id. Respondent things. accept responsibility for what DEA answered: What hope is there for any other physician says.’’ Id. that follows me for redemption if we do The ALJ then explained that he was Through my education with Dr. Webb— everything we can.... What more, I mean, well, first of all, prescribing for family that’s—I’m sorry. I’m getting emotional. not sure what Respondent meant; members is a bad idea in general. I think the Respondent stated that it went to his Id. at 501. Then asked if he had been contract specifies it because commonly that ‘‘understanding of what I was charged means there’s diversion going on, and I’m treated unfairly by DEA, Respondent and found guilty with by the State,’’ prescribing for someone, and they’re kicking testified that ‘‘I’m not certain I have a which included violating his Recovery it back to me, but that’s not a question, and well-founded opinion of that. I know Contract and ‘‘basically unethical I think my urine tests show that didn’t that I have done everything I humanly behavior.’’ Id. Respondent added that he happen. I think that in general the objectivity can and will continue to do so and ‘‘assumed that that was also what DEA provide the DEA and every other required even in exigent circumstances must was doing here . . . [and] that I was be called into question when it’s a loved one. regulatory body with anything I can to being called to task for the same things.’’ ensure that I am safe for the public.’’ Id. Id. at 506. Id. at 508–09. Subsequently asked by the at 502. Thereafter, the ALJ stated to The Government then attempted to Government if ‘‘there [was] anything Respondent’s counsel that if he was ask Respondent if he accepted else wrong with your prescriptions to ‘‘getting into an area that you don’t want responsibility for failing maintain your wife, aside from the fact that she’s me to ask about, don’t hesitate to object patient files in compliance with a family member,’’ Respondent because I know I’m going beyond what Mississippi law. Id. at 502–03. The ALJ answered: disallowed the question, explaining that your direct examination was.’’ Id. The ALJ further stated that he ‘‘want[ed] to Let me think on that a minute. I’m a little Respondent’s ‘‘counsel has decided not almost frightened to answer because at no to ask him if he wants to accept respect the relationship between you and your client and your client’s rights time do I want anyone in this courtroom responsibility for that.’’ Id. thinking, exigent or not, that I’m saying it After both the Government and in this hearing,’’ and that if he asked a was right or that you’d have done it too if you Respondent’s counsel stated they had question that Respondent’s counsel were there. There’s not a complete patient ‘‘[n]othing further,’’ the ALJ observed ‘‘vigorously object[ed] to,’’ he expected file. I mean, is that what you’re asking me? that he was ‘‘was just a little bit puzzled Respondent’s counsel ‘‘to say so.’’ Id. Id. at 510. After the Government again as to [Respondent’s] answer about Respondent’s counsel then stated that asked Respondent what he thought he acceptance of responsibility.’’ Id. at 503. ‘‘[t]here are lines that I’m concerned ‘‘did wrong with respect to the While the ALJ stated that he found about here and based on the history here prescriptions,’’ Respondent answered: Respondent ‘‘generally very credible,’’ of whether or not a full-throated, yes, I ‘‘again, I shouldn’t have written. I he then explained that ‘‘[w]hat puzzles violated this statute was going to result violated the contract. Prompt me . . . me is how you could come to this in, you know additional action against’’ I’m not trying to minimize anything. I’m hearing without knowing what the Respondent. Id. The ALJ then offered blanking, frankly.’’ Id. charges against you by DEA are?’’ Id. Respondent’s counsel the opportunity to The Government then asked Respondent answered that he further question his client. Id. at 507. Respondent if he ‘‘admit[ted] that the ‘‘presumed . . . that they would parallel Respondent’s counsel resumed prescriptions you issued to your wife that which the state charged me with. I questioning Respondent and asked him were outside the usual course of mean, I knew we were having a to ‘‘clarify . . . what specific actions [he professional practice?’’ Id. at 511. hearing.’’ Id. Respondent then testified was] accepting responsibility for?’’ Id. Respondent answered: that when he ‘‘first applied for re- Respondent testified: ‘‘Violating the previous order, right? Writing As I understand that term of art . . . if the registration,’’ he was told by a DI that ‘‘it documentation is substandard, that that was all about my past history with prescriptions for my wife when I wasn’t renders it outside the course of professional addiction’’ but that when he ‘‘had the a treating physician, which I think is not practice, then I would accept that, if I’m— temerity to get an attorney, it morphed proper document, not fully proper any hesitancy previously has been based on into something else,’’ so he ‘‘wasn’t sure documentation of those things.’’ Id. that. I mean, you know, as a physician, I if’’ he was to talk about his ‘‘recovery or Respondent’s counsel then asked if ‘‘it don’t understand that term. When you say matter[ed] . . . what provisions that the outside the course of medical practice, it other things.’’ Id. at 503–04. makes me think that someone just gave rat After the ALJ asked if he had read the violations fall under?’’ Id. at 508. Respondent answered: poison or something absurd like that. But Show Cause Order and pointed out that when you lay the predicate about proper it ‘‘didn’t say anything about [his] . . . I have found me guilty, and so if documentation, for instance, then, yes, I failure in recovery,’’ Respondent someone shows me—and perhaps . . . what would have to accept that.
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Id. at 511–12. The Government manufacture, distribution, or dispensing of Respondent has failed to produce subsequently asked Respondent if he controlled substances. sufficient evidence to rebut the ‘‘believe[d] that [his] actions increased (4) Compliance with applicable State, Government’s prima facie case. Federal, or local laws relating to controlled the chances of [his] wife’s dependency, substances. overdose, or diversion of controlled (5) Such other conduct which may threaten substance prescribing authority under Mississippi substances?’’ Id. at 512. Respondent the public health and safety. law, Respondent satisfies the CSA’s prerequisite for answered ‘‘[n]o.’’ Id. obtaining a new practitioner’s registration. See 21 Id. U.S.C. 823(f)(1); see also id. 802(21). (defining ‘‘the On still a further round of re-direct, ‘‘[T]hese factors are . . . considered term ‘practitioner’ [to] mean[ ] a . . . physician . . . Respondent acknowledged that he is in the disjunctive.’’ Robert A. Leslie, or other person licensed, registered or otherwise ‘‘not a psychiatrist’’ and that ‘‘[t]hese M.D., 68 FR 15227, 15230 (2003). It is permitted, by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] medicines are . . . chiefly used in well settled that ‘‘I may rely on any one psychiatric conditions. Id. at 513. administer . . . a controlled substance in the course or a combination of factors, and may of professional practice’’). However, the restoration Respondent’s counsel further asked him give each factor the weight [I] deem [] of Respondent’s state authority is not dispositive of if he understood that the DEA had appropriate in determining whether the public interest inquiry. See Mortimer Levin, 57 alleged that he ‘‘prescrib[ed] controlled . . . an application for registration FR 8680, 8681 (1992) (‘‘[T]he Controlled Substances substances to someone who was under Act requires that the Administrator . . . make an [should be] denied.’’ Paul H. Volkman, independent determination [from that made by state the care of another physician for those 73 FR 30630, 30641 (2008) (citing id.), officials] as to whether the granting of controlled same ailments.’’ Id. Respondent testified pet. for rev. denied, Volkman v. DEA, substance privileges would be in the public that he understood that and ‘‘accept[ed] 567 F.3d 215, 222 (6th Cir. 2009); see interest.’’). that’’ it was wrong for him to do that. also MacKay v. DEA, 664 F.3d 808, 816 To be sure, the Agency’s case law contains some Id. at 513–14. older decisions which can be read as giving more (10th Cir. 2011); Hoxie v. DEA, 419 F.3d than nominal weight in the public interest Respondent’s counsel then asked if 477, 482 (6th Cir. 2005). Moreover, determination to a State Board’s decision (not could ‘‘be trusted to not engage in such while I am required to consider each of involving a recommendation to DEA) either prescribing in the future?’’ Id. at 514. the factors, I ‘‘need not make explicit restoring or maintaining a practitioner’s state Respondent testified: authority to dispense controlled substances. See, findings as to each one.’’ MacKay, 664 e.g., Gregory D. Owens, 67 FR 50461, 50463 (2002) I will first say strongly, absolutely. I have F.3d at 816 (quoting Volkman, 567 F.3d (expressing agreement with ALJ’s conclusion that spent the last three years trying to redeem at 222 (quoting Hoxie, 419 F.3d at the board’s placing dentist on probation instead of this situation, to show everyone exactly how 482)).41 suspending or limiting his controlled substance driven I am. And, Your Honor, I’m not trying authority ‘‘reflects favorably upon [his] retaining his The Government has the burden of . . . [r]egistration, and upon DEA’s granting of [his] to avoid anything. If someone shows me I’ve proving, by a preponderance of the pending renewal application’’); Vincent J. Scolaro, done something wrong, I will admit it. I’m evidence, that the requirements for 67 FR 42060, 42065 (2002) (concurring with ALJ’s not even bringing up the subtext. I did denial of an application pursuant to 21 ‘‘conclusion that’’ state board’s reinstatement of wrong. I throw myself upon the mercy of the U.S.C. 823(f) are met. 21 CFR medical license ‘‘with restrictions’’ established that process. I have done everything that I know ‘‘[b]oard implicitly agrees that the [r]espondent is to do to try to remedy this situation and I can 1301.44(d). However, once the ready to maintain a DEA registration upon the terms do no more than give my sworn oath that this Government has made a prima facie set forth in’’ its order). will not happen again. showing that issuing a new registration Of note, these cases cannot be squared with the Agency’s longstanding holding that ‘‘[t]he Id. to the applicant would be inconsistent with the public interest, an applicant Controlled Substances Act requires that the Respondent’s counsel concluded his Administrator . . . make an independent must then present sufficient mitigating examination by asking Respondent if his determination [from that made by state officials] as evidence to show why he can be to whether the granting of controlled substance acceptance of responsibility included entrusted with a new registration. privileges would be in the public interest.’’ Levin, his ‘‘prescribing to [his wife] while she 57 FR at 8681. Indeed, neither of these cases even Medicine Shoppe-Jonesborough, 73 FR was under the care of another doctor, acknowledged the existence of Levin, let alone 364, 387 (2008) (citing cases)); see also perhaps providing medications too soon attempted to reconcile the weight it gave the state MacKay, 664 F.3d at 817. board’s action with Levin. While in other cases, the in terms of early refills, providing gap Having considered all of the factors, I Agency has given some weight to a Board’s action fills, [and] not having an adequate in allowing a practitioner to retain his state find that the Government’s evidence authority even in the absence of an express medical file?’’ Id. at 515. Respondent with respect to Factors Two and Four answered ‘‘[y]es.’’ Id. recommendation, see Tyson Quy, 78 FR 47412, satisfies its prima facie burden of 47417 (2013), the Agency has repeatedly held that Discussion showing that granting Respondent’s a practitioner’s retention of his/her state authority application would be inconsistent with is not dispositive of the public interest inquiry. See, Section 303(f) of the Controlled e.g., Paul Weir Battershell, 76 FR 44359, 44366 the public interest.42 I further find that Substances Act (CSA) provides that (2011) (citing Edmund Chein, 72 FR 6580, 6590 (2007), pet. for rev. denied, Chein v. DEA, 533 F.3d ‘‘[t]he Attorney General may deny an 41 In short, this is not a contest in which score 828 (D.C. Cir. 2008)). application for [a practitioner’s] is kept; the Agency is not required to mechanically As to factor three, I acknowledge that there is no registration . . . if the Attorney General count up the factors and determine how many favor evidence that Respondent has been convicted of an determines that the issuance of such the Government and how many favor the registrant. offense under either federal or Mississippi law Rather, it is an inquiry which focuses on protecting ‘‘relating to the manufacture, distribution or registration . . . would be inconsistent the public interest; what matters is the seriousness dispensing of controlled substances.’’ 21 U.S.C. with the public interest.’’ 21 U.S.C. of the registrant’s misconduct. Jayam Krishna-Iyer, 823(f)(3). However, there are a number of reasons 823(f). With respect to a practitioner, the 74 FR 459, 462 (2009). Accordingly, as the Tenth why even a person who has engaged in criminal Act requires the consideration of the Circuit has recognized, findings under a single misconduct may never have been convicted of an factor can support the revocation of a registration offense under this factor, let alone prosecuted for following factors in making the public or the denial of an application. MacKay, 664 F.3d one. Dewey C. MacKay, 75 FR 49956, 49973 (2010), interest determination: at 821. pet. for rev. denied, MacKay v. DEA, 664 F.3d at (1) The recommendation of the appropriate 42 As to factor one, while the Mississippi Board 822. The Agency has therefore held that ‘‘the State licensing board or professional has taken disciplinary action against Respondent absence of such a conviction is of considerably less consequence in the public interest inquiry’’ and is disciplinary authority. based on his issuance of the prescriptions, the Board has not made a recommendation to the therefore not dispositive. Id. (2) The applicant’s experience in Agency with respect to whether his application As for factor five, because the Government did dispensing . . . controlled substances. should be granted. To be sure, as a result of the not file exceptions to the ALJ’s legal conclusions (3) The applicant’s conviction record under Board’s subsequent restoration of his medical with respect to this factor, I deem it unnecessary to Federal or State laws relating to the license without restriction of his controlled make any findings.
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Factors Two and Four—Respondent’s treatment.’’); Jack A. Danton, 76 FR history and physical examination consistent Experience in Dispensing Controlled 60900, 60904 (2011) (finding violations with the nature and complaint are necessary. Substances and Record of Compliance of 21 CFR 1306.04(a), in the absence of . . . The paramount importance of a With Applicable Controlled Substance expert testimony, ‘‘where a physician complete medical history in establishing a correct diagnosis is well established. Laws has utterly failed to comply with Standards of proper medical practice require Under a longstanding DEA regulation, multiple requirements of state law for that, upon any encounter with a patient, in a prescription for a controlled substance evaluating her patients and determining order to establish proper diagnosis and is not ‘‘effective’’ unless it is ‘‘issued for whether controlled substances are regimen of treatment, a physician must take a legitimate medical purpose by an medically indicated and thus has three steps: (a) take and record an individual practitioner acting in the ‘completely betrayed any semblance of appropriate medical history, (b) carry out an legitimate medical treatment’ ’’) (quoting appropriate physical examination, and (c) usual course of his professional record the results. The observance of these practice.’’ 21 CFR 1306.04(a). See also McKinney, 73 FR at 43266 (quoting 43 principles as a function of the ‘‘course of Miss. Code Ann. Sec. 41–29–137 (‘‘a Feingold, 454 F.3d at 1010)). Under the Mississippi Board’s Rule legitimate professional practice’’ is ‘valid prescription’ means a prescription particularly of importance in cases in which that is issued for a legitimate medical 1.4: controlled substances are to play a part in the purpose in the usual course of Patient Record. A physician who course of treatment. It is the responsibility of professional practice’’). prescribes, dispenses, or administers a the physician to dispense, prescribe or Under the CSA, it is fundamental that controlled substance shall maintain a administer such drugs with proper regard for a practitioner must establish a bonafide complete record of his or her examination, the actual and potential dangers. evaluation and treatment of the patient doctor-patient relationship in order to which must include documentation of the Id. act ‘‘in the usual course of . . . diagnosis and reasons for prescribing, Rule 1.4 further notes that ‘‘[a] professional practice’’ and to issue a dispensing or administering of any controlled determination of proper ‘medical prescription for a ‘‘legitimate medical substance; the name, dose, strength, quantity indication’[ ] also requires a careful purpose.’’ See United States v. Moore, of the controlled substance and the date that examination of the nature of the drug 423 U.S. 122, 142–43 (1975); United the controlled substance was prescribed, and all circumstances surrounding States v. Lovern, 590 F.3d 1095, 1100– dispensed or administered. The record dispensation.’’ Id. The Rule also required by this rule shall be maintained in specifically notes that ‘‘repeated refills 01 (10th Cir. 2009); United States v. the patient’s medical records, provided that Smith, 573 F.3d 639, 657 (8th Cir. 2009); such medical records are maintained at the over relatively short periods of time or see also 21 CFR 1306.04(a) (‘‘an order office of the physician .... the issuance of prescriptions at a time purporting to be a prescription issued No physician shall prescribe, administer or when the patient should not have not in the usual course of professional dispense any controlled substance or other finished taking the same medication treatment . . . is not a prescription drug having addiction-forming or addiction- from a prior prescription had the within the meaning and intent of [21 sustaining liability without a good faith prior prescription directions been properly U.S.C. 829] and . . . the person issuing examination and medical indication followed or the correct dosage taken’’ is it, shall be subject to the penalties therefore. a factor indicating a lack of good faith provided for violations of the provisions Miss. Admin. Code part 2640, Ch.1 r. 1.4. on the part of a physician. Id. Also, the Continuing, Rule 1.4 explains that: of law related to controlled Board’s Rule 1.16 specifically provides substances’’). As the Supreme Court has A determination as to whether a ‘‘good that ‘‘[t]he prescribing, administering or faith prior examination and medical explained, ‘‘the prescription indication therefore’’ exists depends upon dispensing of any controlled substance requirement . . . ensures patients use the facts and circumstances in each case. One in violation of the above rules shall controlled substances under the of the primary roles of a physician is to elicit constitute the administering, dispensing supervision of a doctor so as to prevent detailed information about the signs and or prescribing of any narcotic drug or addiction and recreational abuse. As a symptoms which a patient presents in order other drug having addiction-forming or corollary, [it] also bars doctors from that he or she may recommend a course of addiction-sustaining liability otherwise peddling to patients who crave the treatment to relieve the symptoms and cure than in the course of legitimate drugs for those prohibited uses.’’ the patient of his or her ailment or maintain professional practice, in violation of him or her in an apparent state of good Gonzales v. Oregon, 546 U.S. 243, 274 health. In order for a physician to achieve a Mississippi Code [ ] Section 73–25– (2006) (citing Moore, 423 U.S. 122, 135, proper diagnosis and treatment plan, a 29(3). ’’ Miss. Admin. Code part 2640, 143 (1975)). Ch. 1, r. 1.16). Both this Agency and the federal 43 However, as the Agency has held in multiple Here, the ALJ found that that courts have held that ‘‘establishing a cases, ‘‘the Agency’s authority to deny an Respondent acted outside of the usual violation of the prescription application [and] to revoke an existing registration course of professional practice and requirement ‘requires proof that the . . . is not limited to those instances in which a lacked a legitimate medical purpose practitioner intentionally diverts a controlled practitioner’s conduct went ‘‘beyond the substance.’’ Bienvenido Tan, 76 FR 17673, 17689 when he issued numerous prescriptions bounds of any legitimate medical (2011) (citing Paul J. Caragine, Jr., 63 FR 51592, for controlled substances included practice, including that which would 51601 (1998)); see also Dewey C. MacKay, 75 FR at alprazolam, diazepam, hydrocodone, constitute civil negligence.’’ ’ ’’ Laurence 49974. As Caragine explained: ‘‘[j]ust because zolpidem, and Adderall (amphetamine). misconduct is unintentional, innocent, or devoid of T. McKinney, 73 FR 43260, 43266 (2008) improper motive, [it] does not preclude revocation R.D. 39–44. I agree with the ALJ that (quoting United States v. McIver, 470 or denial. Careless or negligent handling of Respondent violated 21 CFR 1306.04(a) F.3d 550, 559 (4th Cir. 2006)). See also controlled substances creates the opportunity for in issuing the prescriptions. I further United States v. Feingold, 454 F.3d diversion and [can] justify’’ the revocation of an find that in issuing each of the existing registration or the denial of an application 1001, 1010 (9th Cir. 2006) (‘‘[T]he Moore for a registration. 63 FR at 51601. prescriptions enumerated above (Nos. 1 Court based its decision not merely on ‘‘Accordingly, under the public interest standard, through 53), Respondent acted outside the fact that the doctor had committed DEA has authority to consider those prescribing of the usual course of professional malpractice, or even intentional practices of a physician, which, while not rising to practice and lacked a legitimate medical the level of intentional or knowing misconduct, malpractice, but rather on the fact that nonetheless create a substantial risk of diversion.’’ purpose in doing so. his actions completely betrayed any MacKay, 75 FR at 49974; see also Patrick K. Chau, Dr. Chambers provided unrefuted semblance of legitimate medical 77 FR 36003, 36007 (2012). testimony that it is not within the usual
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course of professional practice to normally would be in a note like this to With respect to Respondent’s prescribe a controlled substance to a justify and direct the use of controlled prescribing of alprazolam, they include patient with mental illness when the substances.’’ Tr. 277. Dr. Chambers also prescription numbers 11 (20 du, a 10 to patient is being treated by a primary observed that ‘‘there are instances where 20-day supply), 34 (30 du, a 10-day prescriber and the second physician the dosing or type of the drug is left out supply 46), 53 (24 du, an eight-day does not communicate to the primary of the record.’’ Id. at 278. See also GE supply), 31, 32 (each for 20 du, each for physician that he has issued the 6, at 6 (entry for 2/5/13); id. at 7 (entry a 10-day supply), 38, 52 (15 du, a five- prescription. Tr. 275. Dr. Chambers for 3/28/13); id. at 8 (5/13/13 no dosing day supply) 42, 43 (14 du, a 4–5 day testified as to the serious risks created for Ambien); id. at 9 (entries for 7/1/13 supply), and 44, 47 (12 du, one a four- by such prescribing, including no dosing for Lorcet and 7/7/13 no day supply, the other a six-day supply). oversedation, memory disturbance, dosing for Lorcet and Xanax); id. at 10 Respondent also issued a prescription overdose and potentially death, (no drug strength for Xanax for 18 tablets of clonazepam (a six-day especially if the patient is also taking prescriptions of 8/24/13 and 9/5/13). supply), 15 capsules of opioids. Id. at 250; see also id. at 268– Before the State Board, Respondent Dextroamphetamine-Amphetamine 5 69. Dr. Chambers also explained that testified that his prescribing ‘‘was mg (a five-day supply), and 20 tablets of when a patient is obtaining drugs from sporadic’’ and ‘‘was always for a diazepam (a six-day supply). With other sources and the primary prescriber confined number of pills, a small respect to the diazepam prescription, is unaware, this ‘‘can create a great deal amount, that bridged her gap between Dr. Webb did not even prescribe this of confusion on the part of the primary obviously when she was in crisis and drug to Respondent’s wife. Of note, prescriber about the effects or side didn’t have any medicine.’’ GE 14, at 58. before the State Board, Respondent effects of the drug and the mental status He maintained that ‘‘the majority of the testified that he did not change his of the patient.’’ Id. at 251; see also id. medicine were Xanax, two milligrams, wife’s treatment regimen and only at 291 (‘‘If you have two chefs in the ‘‘mirrored what [Dr. Webb] had done.’’ [and that a] three day supply were [sic] kitchen, this is the kind of stuff that can GE 14, at 65. common.’’ Id. at 59–60. Also before the happen as you get chaos and harm and Likewise before the State Board, State Board, he maintained that ‘‘I think polypharmacy and no one Respondent initially offered testimony the record reflects that I filled in in understanding what is the illness versus regarding his prescribing of times where I just didn’t think I had no what is [sic] the side effects of the hydrocodone which addressed only the other choice.’’ Id. He further asserted medications, and it can lead to prescriptions he wrote after a plastic that his writing of the prescriptions escalation of mental illness, addiction, surgeon had drained an abscess in his ‘‘was always done in a short stop gap and even death.’’). wife’s thigh and when his wife had a Dr. Chambers also offered unrefuted times [sic] when I believed again . . . seizure and fell. Moreover, when on testimony that Respondent’s prescribing that there were no other options.’’ Id. at cross-examination a Board member resulted in ‘‘a combination of multiple 69. identified the multiple hydrocodone overlaps of multiple classes of addictive Although the Government introduced prescriptions Respondent issued in July substances that can produce overdose into evidence the transcript of the 2013, Respondent testified that ‘‘that and severe psychiatric disturbances.’’ January 2014 state board proceeding, it was an isolated incident there.’’ Id. at Id. at 273. And while Respondent is not did not submit the Board’s order 66. The evidence in this proceeding a psychiatrist, Dr. Chambers offered prohibiting him from practice and/or shows, however, that during 2011, unrefuted testimony that within the the charging document, any of the Respondent issued seven hydrocodone practice of psychiatry, there is a exhibits submitted in the Board prescriptions (Nos. 3, 5, 7, 9, 14, 16, 19) prohibition against treating a spouse. Id. proceeding which may have shown for his wife prior to any other doctor at 293. Dr. Chambers further offered what prescriptions were at issue in the prescribing the drug to her. See GE 11, unrefuted testimony that Respondent’s proceeding, or even the Board’s order at 11 (hydrocodone Rx written on Nov. prescribing was not for legitimate suspending his license after the January 30, 2011 by Dr. Bell, who Respondent medical practice and was non- 2014 proceeding. However, while it may identified as his wife’s neurologist). therapeutic. I thus find that Respondent have been the case that Respondent’s Respondent has offered no explanation violated 21 CFR 1306.04(a) with respect explanation as to his reasons for in either proceeding as to why he issued to each of the prescriptions set forth prescribing during the 2014 board these seven prescriptions, as well as the above. proceeding was consistent with the hydrocodone prescriptions he issued on Respondent’s failure to maintain evidence presented at that proceeding, it December 5, 2011 (No. 21), Aug. 13, adequate records to support the is not consistent with much of the 2012 (No. 33) and Jan. 23, 2013 (No. prescriptions provides additional evidence submitted in this proceeding. 39).47 support for this conclusion, as well as As found above, the record contains Also, in a number of instances, the conclusion that Respondent violated numerous prescriptions which are not Respondent issued prescriptions even Mississippi Board Rule 1.4’s provisions fairly characterized as two to three-day though his wife had refills available with respect to patient records.44 As gap fills. With respect to Respondent’s under prescriptions that were found above, there was no prescribing of zolpidem, they include previously issued by Dr. Webb. For documentation at all to support 36 of fourteen prescriptions which clearly example, on March 30, 2011, the prescriptions. Moreover, even with were not short-term gap fills. These Respondent issued a prescription for 30 respect to the entries Respondent did prescriptions include numbers 2, 4, 6, 8, zolpidem. (Rx No. 4). However, Dr. make, Dr. Chambers found that ‘‘there is 22, 26, 28 (each for 30 du 45), 23 (28 du), Webb’s February 3, 2011 zolpidem a paucity of data to support the 29 (24 du), 15, 45 (each for 20 du), and 46 diagnosis or the prescriptions . . . that 10, 12, 13 (each for 12 du). This is based on Respondent’s note for the the note is built around. There’s a lack prescription. 47 While Dr. Bell (his wife’s neurologist) issued of physical or mental status exam that 45 While some of Respondent’s prescriptions for hydrocodone prescriptions to Respondent’s wife on 30 du of zolpidem had a dosing instruction of two November 30, 2011 and June 19, 2013, 44 See supra findings for RXs No. 1–21, 25, 26, tablets, the dosing instructions generally provided Respondent’s testimony before the Board addressed 28–31, 33, 35–37, 39, 43, 45, 49, and 51. for one tablet. only his July 2013 prescriptions. GE 14, at 86.
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provided for multiple refills, which prescription was not a gap fill given that Sanction Respondent’s wife filled on April 9, Respondent issued the March 4, 2012 Where, as here, the Government has 2011, May 23, 2011, and July 7, 2011. prescription, which provided a 30-day met its prima facie burden of showing Moreover, Respondent issued new supply. Nor was the April 1, 2012 that issuing a new registration to the prescriptions for 30 zolpidem to his prescription a gap fill given applicant would be inconsistent with wife on May 6, 2011 and June 28, 2011 Respondent’s issuance of the March 12 the public interest, a respondent must (Rx No. 6 & 8). Respondent’s prescription and the refill she obtained come forward with ‘‘sufficient prescriptions of March 30, May 6, and on March 19, 2012 pursuant to Dr. mitigating evidence’’ to show why he June 28 were clearly not ‘‘gap fills.’’ Webb’s Feb. 23 prescription. can be entrusted with a new Moreover, when Respondent issued Similarly, the evidence shows that on registration. Medicine Shoppe- the July 31, 2011 prescription for 12 January 11, 2013, Respondent issued a Jonesborough, 73 FR 364, 387 (2008) zolpidem, he also authorized a refill, prescription for 10 du of alprazolam (see (quoting Samuel S. Jackson, 72 FR which was available to his wife on No. 36). While this prescription 23848, 23853 (2007) (quoting Leo R. August 28, 2011 (which she did not fill provided only a three-day supply, the Miller, 53 FR 21931, 21932 (1988))). until September 6, 2011), when evidence shows that Respondent’s wife ‘‘Moreover, because ‘past performance is Respondent issued her a new had refilled a prescription issued by Dr. prescription for 12 zolpidem. See Rx the best predictor of future Webb for 45 du of alprazolam the day No. 10 & 12. (Dr. Webb had also issued performance,’ ALRA Labs, Inc. v. DEA, before. GE 11, at 8. Thus, this was not a 60 du zolpidem prescription on 54 F.3d 450, 452 (7th Cir.1995), [DEA] a gap fill. Nor was Respondent’s January August 16, 2011 which provided has repeatedly held that where a 11, 2013 temazepam prescription (No. multiple refills.). Even ignoring the registrant has committed acts 37) a gap fill as the evidence shows that prescription she obtained from Dr. inconsistent with the public interest, the his wife had also refilled a prescription Webb, Respondent’s August 28, 2011 registrant must accept responsibility for for a 30-day supply of this drug the day prescription was not a gap fill given that [his] actions and demonstrate that [he] before. GE 11, at 8. she had a refill available on will not engage in future misconduct.’’ Respondent’s July 31, 2011 prescription. As one further example, on May 20, Medicine Shoppe, 73 FR at 387; see also So too, Respondent’s October 11, 2011 2013, Respondent issued a prescription Jackson, 72 FR at 23853; John H. prescription for 20 zolpidem, a 20-day for 20 tablets of zolpidem (No. 45). The Kennedy, 71 FR 35705, 35709 (2006); supply, (Rx No. 16) was issued evidence shows, however, that Dr. Webb Prince George Daniels, 60 FR 62884, notwithstanding that Dr. Webb’s August had not issued a zolpidem prescription 62887 (1995). See also MacKay v. DEA, 16, 2011 zolpidem prescription since February 23, 2012, which his wife 664 F.3d at 820; Hoxie v. DEA, 419 F.3d provided for five refills, one of which last refilled in April 2012. Here again, at 483 (‘‘admitting fault’’ is ‘‘properly his wife filled on October 19, 2011. See this was not a gap fill. consider[ed]’’ by DEA to be an GE 11, at 10–12. Even if Respondent’s Had Respondent’s prescribing been ‘‘important factor [ ]’’ in the public wife had run out of medication early limited to a few instances of small (two interest determination). Moreover, the egregiousness and because she failed to follow Dr. Webb’s to three day) gap fills, his conduct extent of a registrant’s misconduct are dosing instruction, she did not need this would be considerably less egregious significant factors in determining the quantity of drugs to last her to the day given the circumstances of his wife’s appropriate sanction. See Jacobo on which she could refill Dr. Webb’s illness. The evidence shows, however, Dreszer, 76 FR 19386, 19387–88 (2011) prescription. that his illicit prescribing went on for (explaining that a respondent can Another such example involves nearly three years. Even more disturbing ‘‘argue that even though the Respondent’s December 27, 2011 is that the evidence shows that many of Government has made out a prima facie prescription for 30 zolpidem and his the prescriptions were not for gap fills case, his conduct was not so egregious January 7, 2012 prescription for 28 at all, let alone for gap fills for two to as to warrant revocation’’); Paul H. zolpidem. (Nos. 22 & 23). Respondent’s three day periods as he testified before Volkman, 73 FR 30630, 30644 (2008); wife had obtained a refill of Dr. Webb’s the State Board. August 16, 2011 prescription for 60 du see also Paul Weir Battershell, 76 FR on December 16, 2011, only 11 days Notably, in this proceeding, 44359, 44369 (2011) (imposing six- earlier (Dec. 16). Thus, there was no gap Respondent has personally offered no month suspension, noting that the to fill. Nor was there a gap to fill on explanation as to why he issued the evidence was not limited to security and January 7, 2012, when he issued the prescriptions. Moreover, the only recordkeeping violations found at first prescription for an additional 28 dosage evidence he offered was the discredited inspection and ‘‘manifested a disturbing units given the quantity of drugs his testimony of his wife that there pattern of indifference on the part of wife had recently obtained. occasionally were times when she [r]espondent to his obligations as a Still more examples are provided by ‘‘might run out a day early on a registrant’’); Gregory D. Owens, 74 FR the zolpidem prescriptions Respondent weekend’’ and only needed a short term 36751, 36757 n.22 (2009). issued on March 4 and 12 (both for a 30- supply until Dr. Webb got back to her Finally, the Agency has also held that day supply), as well April 1, 2012 (for and that Respondent had never given ‘‘ ‘[n]either Jackson, nor any other a 24-day supply). During this period, her a prescription for a time period agency decision, holds . . . that the Respondent’s wife obtained a longer than two to four days. Tr. 379, Agency cannot consider the deterrent prescription for 30 du (a 15-day supply) 381, 384. value of a sanction in deciding whether on February 23, 2012, which provided I thus conclude that the Government’s a registration should be [suspended or] for two refills, the first of which she evidence with respect to Factors Two revoked’ ’’ or an application should be obtained on March 19, 2012. Here again, and Four makes out a prima facie case denied. Wesley Pope, 82 FR 14944, the only potential gap was likely created to deny Respondent’s application as 14985 (2017) (quoting Joseph Gaudio, by the failure of Respondent’s wife to ‘‘inconsistent with the public interest.’’ 74 FR 10083, 10094 (2009) (quoting follow Dr. Webb’s dosing instructions 21 U.S.C. 823(f). I further find that Southwood Pharmaceuticals, Inc., 72 FR on the February 23rd prescription. Respondent’s misconduct was 36487, 36504 (2007))). See also Robert Moreover, the March 12, 2012 egregious. Raymond Reppy, 76 FR 61154, 61158
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(2011); Michael S. Moore, 76 FR 45867, [r]espondent has not unequivocally I disagree with the ALJ’s conclusion 45868 (2011). This is so, both with acknowledged his misconduct’’ and that Respondent is entitled to a finding respect to the respondent in a particular holding that ‘‘[a] registrant’s acceptance that he has accepted responsibility for case and the community of registrants. of responsibility must be unequivocal’’); his misconduct. To the contrary, I find See Pope, 82 FR at 14985 (quoting Annicol Marrocco, 80 FR 28695, 28706 that his testimony was equivocal and Gaudio, 74 FR at 10095 (quoting (2015) (denying application, holding that he repeatedly attempted to Southwood, 71 FR at 36503)). Cf. that respondent’s ‘‘equivocal testimony minimize his misconduct. Indeed, even McCarthy v. SEC, 406 F.3d 179, 188–89 provided substantial evidence to after the ALJ granted Respondent a (2d Cir. 2005) (upholding SEC’s express support a finding that she does not second chance to explain what he was adoptions of ‘‘deterrence, both specific accept responsibility for her accepting responsibility for, he still did and general, as a component in misconduct’’); Arthur H. Bell, 80 FR not unequivocally acknowledge his analyzing the remedial efficacy of 50035, 50041 (2015) (denying misconduct. sanctions’’). application finding that physician’s In this matter, Respondent was The ALJ acknowledged that ‘‘to rebut ‘‘acceptance of responsibility is specifically charged with violating 21 the Government’s prima facie case, the equivocal at best’’ and ‘‘his failure to CFR 1306.04(a), the CSA’s prescription Respondent must both accept accept responsibility for [intentional] regulation which requires that a responsibility for his actions and misconduct is reason alone to conclude controlled substance prescription ‘‘be demonstrate that he will not engage in that he cannot be entrusted with a new issued for a legitimate medical purpose future misconduct.’’ R.D. at 52 (citing registration’’); Michael A. White, 79 FR by [a] practitioner acting in the usual Patrick W. Stodola, 74 FR 20727, 62957, 62598, 62967–68 (2014) course of professional practice.’’ ALJ Ex. 20734–35 (2009)). The ALJ then (revoking registration adopting ALJ’s 1, at 1–3 (¶¶ 3–9). Indeed, the explained that ‘‘[t]he Respondent may finding that physician did not accept Government specifically alleged that the accept responsibility by providing responsibility when his ‘‘acceptance of prescriptions ‘‘were nontherapeutic, evidence of his remorse, his efforts at responsibility was tenuous at best,’’ were for other than a legitimate medical rehabilitation, and his recognition of the ‘‘not once during the hearing did [he] purpose, and were outside the course of severity of his misconduct.’’ 48 Id. (citing unequivocally admit fault for his professional practice.’’ Id. The Robert A. Leslie, 68 FR 15227, 15228 improper . . . prescriptions,’’ and he Government also alleged that the (2003)). He also explained that ‘‘[t]o ‘‘minimized the severity of his prescriptions violated the counterpart accept responsibility, a respondent must misconduct’’); The Medicine Shoppe, 79 provision of State law. See id. (citing show ‘true remorse’ for wrongful FR 59504, 59510 (2014) (revoking Board Rule 1.16 and Miss. Code Sec. conduct,’’ which includes an registration where respondent ‘‘offered 73–25–29–(3)). The Government further ‘‘acknowledgment of wrongdoing.’’ Id. generalized acceptance of alleged that Respondent violated (citing Michael S. Moore, 76 FR 45867, responsibility’’ but then denied filling provisions of State regulations 45877 (2011) and Wesley G. Harline, 65 any unlawful prescriptions); Ronald prohibiting the prescribing of controlled FR 5665, 5671 (2000)). Lynch, 75 FR 78745, 78754 (2010) substances ‘‘without conducting any However, there are also numerous (revoking registration agreeing with examination of [his] wife (or cases, that were not discussed in the ALJ’s finding that respondent did not documenting such in her file) or noting Recommended Decision, which hold accept responsibility noting that he the . . . prescriptions in her patient that where the Government has proved ‘‘repeatedly attempted to minimize his chart,’’ as well as ‘‘without conducting that a respondent committed knowing [egregious] misconduct).49 sufficient examinations of [his] wife (or or intentional misconduct, he must documenting such in her file).’’ Id. at 3 unequivocally acknowledge his 49 More recently, in Roberto Zayas, 82 FR 21410, (citing, inter alia, Board Rules 1.4 and misconduct. See Daniel A. Glick, 80 FR 21429 (2017), I rejected the reasoning of Jeffrey 1.16, Miss. Code Ann. Sec. 73–25– Martin Ford, 68 FR 10750 (2003), which granted a 74800, 74800–01 (2015) (rejecting new registration to a respondent who had a history 29(3)). exception to ‘‘CALJ’s conclusion that of substance abuse and had been convicted of Notwithstanding that the Show Cause several drug felonies. In Zayas, I noted that the Ford Order clearly set forth these violations, 48 To the extent the ALJ’s statement suggests that ‘‘decision apparently excused the respondent’s and that Dr. Chambers offered unrefuted a respondent can satisfy his burden of production failure to unequivocally accept responsibility based on his having attended drug rehabilitation and testimony that Respondent’s prescribing on the issue of acceptance of responsibility by only was outside of the ‘‘usual course of producing evidence of efforts at rehabilitation, this remained sober for more than 10 years, as well [as] is not the Agency’s rule. Indeed, Leslie makes it having satisfied the conditions for reinstatement of clinical conduct,’’ ‘‘was dangerous and his state license.’’ 82 FR 21429. I also noted that clear that it was describing the total showing that harmful,’’ ‘‘non-therapeutic,’’ not for a ‘‘the decision [did] not even address whether [the is required to refute the Government’s prima facie respondent] accepted responsibility for his criminal ‘‘legitimate medical practice,’’ that there case. See Leslie, 68 FR at 15228 (discussing conduct.’’ Id. I further explained that I found ‘‘the was ‘‘a paucity of data to support the previous agency decision involving respondent and reasoning of this case unpersuasive, [and] were a stating that ‘‘[t]he agency also found that although diagnosis or the prescriptions’’ and case with similarly egregious misconduct presented there was ‘‘a lack of physical or mental he was free to offer evidence that he would never to me, I would not grant a registration absent a clear again engage in the sort of conduct that resulted in and unequivocal acceptance of responsibility for all status exam’’ documented in the noted his conviction, [r]espondent did not avail himself of the misconduct that was proven on the record.’’ to justify the prescriptions, Respondent of that opportunity and offered no evidence of Id. See also Jones Total Health Care, 81 FR 79188, repeatedly refused to acknowledge that remorse for his misconduct, efforts at rehabilitation, 79200–01 (2016) (‘‘[W]here the Government has he violated 21 CFR 1306.04(a). or recognition of the severity of his conduct’’). proved that a registrant has engaged in intentional The Agency has explained that where the or knowing misconduct, revocation is warranted in While Respondent testified that he Government has proved that a respondent has the absence of the registrant’s unequivocal violated his contract with the State PHP committed knowing or intentional misconduct, a acceptance of responsibility for its misconduct.’’); (which was not a charge in this respondent must fully acknowledge the misconduct Joe W. Morgan, 78 FR 61961, 61963 (2013) (‘‘Given proceeding), when asked by his counsel that has been proved on the record to be deemed [r]espondent’s multiple statements in which he to have accepted responsibility, and absent such a blamed others for his troubles, that he never once if he violated his obligations as a DEA showing, his evidence of remedial measures is acknowledged that he prescribed in violation of the registrant, he asserted that he did not irrelevant. See Hatem M. Ataya, 81 FR 8221, 8242– CSA and Florida law, and that he attempted ‘‘know the specific legalities of DEA 43 (2016) (‘‘the Agency has held that proof of unpersuasively to minimize his culpability, the registration’’ but was willing ‘‘to tell you remedial measures is rendered irrelevant where a overwhelming weight of the evidence fully supports respondent fails to accept responsibility for his the ALJ’s conclusion that [r]espondent is sorry only what I did was wrong,... without any knowing or intentional misconduct’’). because he was caught.’’). equivocation.’’ Tr. 484–85. While he
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also acknowledged that ‘‘becoming Notably, even after the ALJ repeatedly Respondent testified that it was wrong involved in a loved one’s care is expressed his puzzlement as to what for him to ‘‘prescribe controlled foolish,’’ he then stated that he did not Respondent was accepting substances to someone who was under ‘‘know the letter or spirit of any law that responsibility for, Respondent testified the care of another physician for those I transgressed.’’ Id. at 489. And when that he was accepting responsibility for same ailments,’’ this is not a full asked why the Agency should entrust what the State said he did and again acknowledgment of his illegal behavior. him with a new registration, he testified asserted that he thought the charges in Indeed, the mere fact that a physician that ‘‘[i]f I can’t practice medicine, the DEA proceeding were the same as prescribes controlled substances to conforming to every jot, tittle, to the the charges which he was found guilty someone who is under care of another letter of the law, I can’t practice of by the State Board. Tr. 503–05. While physician for the same ailments would medicine,’’ but he offered no the ALJ subsequently gave Respondent not necessarily give rise to liability explanation as to how he would several chances to answer this question, under 1306.04(a). Such prescribing conform ‘‘to the letter of the law’’ given his testimony continued to manifest would be entirely lawful under the CSA his acknowledgment that he does not equivocation, minimization and an in bona fide emergency situations ‘‘know the letter of or spirit of any law unwillingness to acknowledge that he provided the prescriptions were limited that [he] transgressed.’’ Id. at 489–90. violated the CSA’s prescription to what was medically necessary to treat Indeed, throughout his testimony, requirement. a patient before the primary physician Respondent asserted that he thought the For example, when asked to ‘‘clarify could resume care. charges in this proceeding simply . . . what specific actions [he was] Here, however, Respondent has accepting responsibility for,’’ involved the same charges that he was admitted to acting outside of the usual Respondent answered: ‘‘[v]iolating the found guilty of in the State Board course of professional practice only to previous order, right? Writing proceeding. He doggedly denied that he the extent he maintained ‘‘substandard prescriptions for my wife when I wasn’t violated the CSA’s prescription records.’’ Notwithstanding Dr. a treating physician, which I think is not requirement, asserting that that it Chambers’ testimony, Respondent has proper document, not fully proper ‘‘would be speculative . . . on some failed to acknowledge that his documentation of those things.’’ Tr. 507. level’’ for him to testify as ‘‘to what prescribing increased the risks of his He subsequently testified that ‘‘if statutes I may or may not have wife become dependent, overdosing, or someone shows me . . . what I was transgressed.’’ Id. at 498. And when diverting controlled substances, his saying that I’m ignorant of the specifics failure to conduct appropriate asked if he accepted that the of a DEA charge. But if I meet the prescriptions he issued to his wife examinations, as well as his failure to criteria and I accept I did it, then I did notify Dr. Webb that he had prescribed ‘‘were outside the course of professional it.’’ Id. at 508 (emphasis added). See practice,’’ he asserted that he did not the drugs. also id. at 514 (‘‘If someone shows me Moreover, before the State Board, know how DEA defined the term I’ve done something wrong, I will admit ‘‘outside the course of professional Respondent maintained that his it.’’) prescribing ‘‘was sporadic,’’ ‘‘was practice’’ and maintained that I ‘‘do not However, as found above, the know again . . . the specifics of . . . of always for a confined number of pills,’’ unrefuted evidence, including the that they were simply short gap fills what I’m being charged with by DEA testimony of Dr. Chambers, establishes now.’’ 50 Id. at 501. which ‘‘mirrored what [Dr. Webb] had that Respondent’s prescribing did ‘‘meet done.’’ However, as found above, many Given that the Show Cause Order the criteria’’ for a violation of 21 CFR of the prescriptions provided provided fair notice to Respondent that 1306.04(a). Yet even when confronted substantially more medication than was he was charged with violating 21 CFR with this evidence, Respondent still was necessary for a two to three-day period. 1306.04(a) and that he heard the unwilling to accept that he ‘‘did it.’’ Id. These include 14 zolpidem evidence against him and put up no On further cross-examination, prescriptions, each of which provided at defense, he was not required to Respondent was again asked what he least a 12-day supply (with 11 of the speculate as to ‘‘what statutes [he] may thought was ‘‘wrong with respect to the prescriptions providing 20 to 30 dosage or may not have transgressed.’’ prescriptions.’’ Id. at 510. While he units, most of which for a 20 to 30-day Moreover, the CSA’s requirement that answered that ‘‘I shouldn’t have supply) and five of the alprazolam ‘‘a prescription for a controlled written’’ and ‘‘I violated the contract,’’ prescriptions, four of which were for a substance . . . must be issued for a he then stated: ‘‘[p]rompt me. I’m not ten-day supply, the other being for an legitimate medical purposes by [a] trying to minimizing anything.’’ Id. eight-day supply. There were also the Minimizing is, however, exactly what practitioner acting in the usual course of seven hydrocodone prescriptions and a Respondent was engaged in. And when professional practice’’ is hardly a ‘‘jot’’ diazepam prescription, which although 51 the Government again asked or a ‘‘tittle’’ of the Act. To the they were for small amounts, did not Respondent if he was admitting that the contrary, the rule is one of the Act’s ‘‘mirror what [Dr. Webb or any other prescriptions were issued outside the fundamental features, as one of its doctor] had done,’’ and are unsupported usual course of professional practice, purposes is to ‘‘ensure [] patients use by the findings of an examination and Respondent maintained that ‘‘as a controlled substances under the a diagnosis. supervision of a doctor so as to prevent physician, I don’t understand that term’’ Respondent personally offered no addiction and recreational abuse.’’ and he was only willing to admit to explanation in this proceeding (or Gonzales, 546 U.S. at 274. acting outside of the usual course to the before the State Board) as to why he extent that his documentation was issued these prescriptions, which 50 Yet in his Pre-hearing Statement, Respondent ‘‘substandard.’’ Id. at 511. He then clearly provided more drugs than were stated that he ‘‘will acknowledge the allegations denied that his prescribing had medically necessary to address a two- to raised by DEA in the Order to Show Cause.’’ ALJ increased the chances of his wife’s three-day period.52 Indeed, while Ex. 5, at 3. becoming dependent, overdosing or 51 See Webster’s Third New International Dictionary, at 1221 (1976) (defining ‘‘jot’’ as ‘‘the diverting controlled substances. 52 In his Pre-hearing Statement, Respondent also least bit: IOTA’’); see also id. at 2401(defining While it is true that on a still further stated ‘‘he will discuss the circumstances in which ‘‘tittle,’’ in part, as ‘‘a very small part’’). round of re-direct examination, Continued
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Respondent maintained that he could ALJ’s assertion that ‘‘the central concern medical purpose. And he denied that ‘‘absolutely’’ be trusted to not engage in of this case . . . is that the Respondent his prescribing increased the risks of his such prescribing in the future, that he wrote prescriptions for his wife when he wife become dependent, overdosing, or was ‘‘not trying to avoid anything’’ and should not have,’’ the central concern of diverting controlled substances. that ‘‘I have done everything that I know this case is what the Government Respondent has therefore failed to to do to try to remedy this situation,’’ he alleged in the Show Cause Order and ‘‘express remorse to the full extent of has not been forthcoming in this matter. proved at the hearing.53 The proof fully [his] wrongful conduct.’’ 54 R.D. 56. Thus, I disagree with the ALJ that supported the allegations, which The ALJ further explained that he Respondent has ‘‘express[ed] remorse to included that he issued controlled found Respondent’s remorse to be the full extent of [his] wrongful substance prescriptions that ‘‘were sincere and that his acceptance of conduct.’’ R.D. at 56. nontherapeutic, were for other than a responsibility was ‘‘credible.’’ R.D. 56– The ALJ also gave weight to legitimate medical purpose, and were 57. This case, however, is less about Respondent’s testimony during the outside the usual course of professional Respondent’s credibility (although there second State Board hearing that he was practice,’’ that he issued the is ample reason to question it given his ‘‘committed to ‘absolute and complete prescriptions when his wife was ‘‘being testimony regarding what he thought he adherence’ to applicable rules and issued prescriptions for the same or had been charged with in this regulations,’’ id. at 55 (citing GE 13, at similar class of drugs by her . . . proceeding) 55 and more about the 9–10), and further asserted ‘‘that his psychiatrist, which [he] did without her weight to be given to his testimony. commitment to adhere to all regulations psychiatrist’s knowledge or Moreover, the ALJ failed to apply the governing controlled substances is permission,’’ and that his ‘‘actions Agency’s extensive case law which genuine.’’ Id. at 56–57. The ALJ did not dramatically increased the chances of requires that an acceptance of explain how Respondent would [his] wife’s dependency, overdose or responsibility be unequivocal, as well as accomplish this given his repeated diversion.’’ ALJ Ex. 1, at 1–3 (¶¶ 3–7). that which requires a full assertions in this proceeding that he did Moreover, the Government’s allegations acknowledgment of the proven not ‘‘know the specific legalities of DEA that Respondent violated state and misconduct. registration,’’ did not ‘‘know the letter or federal law by issuing controlled While I appreciate that the ALJ spirit of any law that [he] transgressed,’’ substance prescriptions ‘‘without closely examined Respondent’s that he does not ‘‘know precisely how conducting any examination,’’ Id. at 3 (¶ testimony both at this hearing and the DEA defines’’ the term ‘‘outside the 8), or ‘‘without conducting sufficient before the state board (as have I), I find course of professional practice,’’ and ‘‘as examinations,’’ id. (¶ 9), were not it particularly disturbing that a physician, [he does not] understand Respondent has never offered an simply additional factual allegations to 56 [the] term.’’ Tr. 511. support the charges in paragraphs three explanation in any proceeding for the The ALJ also rejected as only to seven of the Show Cause Order but ‘‘technically correct’’ the Government’s 54 Earlier in his Recommended Decision, the ALJ were stand-alone charges. asserted that my decision in Arvinder Singh, 81 FR argument that Respondent did not With respect to the proven 8247 (2016), ‘‘states only that a registrant may be accept responsibility for failing to misconduct, Respondent admitted that required to acknowledge the scope of his conduct examinations and/or he acted outside of the usual course of misconduct,’’ thus suggesting that a respondent’s conducting insufficient examinations acknowledgment of the scope of his misconduct is professional practice only to the extent optional and that he is not required to ‘‘accept prior to issuing the prescriptions. R.D. that he failed to maintain proper responsibility for the consequences of his acts.’’ 54–55. While the ALJ found that records. As for the ALJ’s further R.D. 54 (citing 81 FR at 8250–51). This is mistaken, Respondent did not ‘‘specifically assertion that his acceptance of as the case clearly stated that the respondent ‘‘was acknowledge that it was wrong of him required to acknowledge . . . the full scope of his responsibility for failing to conduct criminal behavior and the risk of diversion it to issue a prescription without first examinations was ‘‘subsumed in his created.’’ 81 FR at 8250. The risk of diversion was, conducting an examination,’’ the ALJ general acceptance of responsibility,’’ of course, a consequence of the respondent’s acts, faulted the Government for not asking the cited testimony does not support which involved pre-signing prescriptions for this question of Respondent. Id. at 55. controlled substances which were subsequently this, as the question, which was asked issued by nurses who were not lawfully authorized The ALJ further reasoned that the by his counsel, made no reference to his to prescribe controlled substances and the Government ‘‘overlook[ed] the central failing to conduct examinations. Tr. 515. respondent did not see the patients. Id. at 8248–49. concern of this case, which is that the The ALJ acknowledged that ‘‘[i]t is The ALJ also gave weight to Respondent’s having Respondent wrote prescriptions for his true . . . that Respondent did not ‘‘expressed remorse and accepted responsibility for wife when he should not have.’’ Id. In writing those prescriptions during the first three plainly and expressly accept weeks of his treatment at Acumen’’ as well as his the ALJ’s ‘‘view, the Respondent’s responsibility for violating specific testimony during the second Board hearing. R.D. 55. acceptance of responsibility for failing federal regulations.’’ R.D. 56. Indeed, at However, whether Respondent accepted to examine his wife before writing her no point did Respondent admit that he responsibility for writing the prescriptions during a prescription is subsumed in his his treatment at Acumen is wholly irrelevant. violated 21 CFR 1306.04(a) with respect Likewise, because the Agency was not a party in the general acceptance of responsibility.’’ to any of the prescriptions, including State Board’s proceedings, the weight to be given Id. (citing Tr. 515). those which clearly were not two to to Respondent’s testimony before the Board is I cannot agree with this reasoning. As three day ‘‘gap fills.’’ Nor did he ever substantially diminished. What matters is whether for the ALJ’s faulting of the Government admit that any of the prescriptions were he accepted responsibility for the misconduct for not asking Respondent if he accepted alleged and proved in this proceeding. non-therapeutic or lacked a legitimate 55 While Respondent professed that he did not responsibility for his failure to conduct understand what he was charged with in this examinations or conducting inadequate 53 Based on the Board’s order and his recovery proceeding, the Show Cause Order was clear on its examinations, Respondent, and not the contract, Respondent ‘‘should not have’’ written the face. Respondent was also represented and if he Government, had the burden of prescriptions. Yet, as the ALJ recognized when he truly did not understand the allegations, he should expressed his puzzlement (multiple times) at to have asked his counsel. production on this issue. As for the what Respondent was accepting responsibility for, 56 While I have noted Respondent’s testimony in the Government did not allege that Respondent the State Board proceeding as to why he issued the he prescribed controlled substances to his wife.’’ violated his recovery contract or a Board Order; it prescriptions, so that there is no lack of clarity for ALJ Ex. 5, at 3. Respondent, however, offered no alleged specific violations of federal and state laws future matters, a respondent is required to present such testimony. and regulations. his evidence in the Agency’s proceeding.
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many prescriptions he issued which responsibility for his misconduct. While 21 U.S.C. 823(f). Accordingly, I will clearly were not for short-term gap fills, there are cases in which the Agency has deny his application. an issue which is not even discussed in imposed a sanction less than denial or Order the Recommended Decision. Thus, I revocation where a respondent has conclude that Respondent does not failed to meet his burden on acceptance Pursuant to the authority vested in me recognize the full extent of his of responsibility, those cases have by 21 U.S.C. 823(f) and 28 CFR 0.100(b), misconduct. See MacKay v. DEA, 664 involved considerably less egregious I order that the application of Lon F. F.3d 808, 820 (10th Cir. 2011); see also misconduct than the knowing and Alexander, M.D., for a DEA Certificate Samuel Jackson, 72 FR 23848, 23852 intentional diversion of controlled of Registration as a practitioner, be, and (2007) (noting a respondent’s burden to substances which occurred here. it hereby is, denied. This Order is produce sufficient evidence to assure Because Respondent engaged in effective immediately. the Administrator that he/she can be egregious misconduct which he has entrusted with the responsibility carried failed to fully acknowledge, his Dated: October 17, 2017. by such a registration’’). evidence of remedial measures cannot Robert W. Patterson, I therefore find that Respondent has rebut the Government’s prima facie Acting Administrator. failed to produce sufficient evidence to showing that his registration ‘‘would be [FR Doc. 2017–23339 Filed 10–25–17; 8:45 am] support a finding that he accepts inconsistent with the public interest.’’ BILLING CODE 4410–09–P
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Part III
The President
Proclamation 9663—Minority Enterprise Development Week, 2017
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Federal Register Presidential Documents Vol. 82, No. 206
Thursday, October 26, 2017
Title 3— Proclamation 9663 of October 20, 2017
The President Minority Enterprise Development Week, 2017
By the President of the United States of America
A Proclamation Since our earliest days, hardworking entrepreneurs have driven our Nation’s prosperity. During Minority Enterprise Development Week, we recognize the contributions that minority-owned businesses make to our economy and our way of life, and we strive to ensure that small business owners have access to the resources they need to achieve the American Dream. The United States is entering upon a new period of economic revival. Unemployment is at a 16-year low, businesses are expanding, and wages are rising. Ensuring that minority-owned businesses remain strong and vi- brant is vital to the growth of our great Nation. Minority-owned firms employ eight million people and generate more than $1 trillion in annual economic output. They export their products at a greater rate than non-minority busi- nesses and provide a great boost to our global competitiveness. My Administration is committed to creating a business climate in which minority business enterprises can thrive and expand. The Unified Framework for Fixing Our Broken Tax Code, my Administration’s basic plan for tax cuts and tax reform, calls for a steep reduction to the corporate tax rate from 35 to 20 percent. This reform will lift up our entrepreneurs, our businesses, and our families. The Framework also caps the top tax rate for millions of family-owned and small- and mid-sized businesses at 25 percent—the lowest it has been in more than 80 years. We also want Ameri- cans to be able to invest in capital to build their businesses, so for 5 years, we will allow them to deduct 100 percent of their capital investments. By eliminating needless regulations, promoting fair and reciprocal trade relationships, lowering taxes, and increasing the flow of capital, the United States will further cement its status as a global economic powerhouse. During Minority Enterprise Development Week, we recommit to empowering every hardworking American to write our next great chapter. Let us work together to ensure that every American citizen can flourish and give back to our country and our communities. NOW, THEREFORE, I, DONALD J. TRUMP, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim October 22 through October 28, 2017, as National Minority Enterprise Development Week. I call upon all Americans to celebrate this week with programs, ceremonies, and activities to recognize the many contributions of American minority business enterprises.
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IN WITNESS WHEREOF, I have hereunto set my hand this twentieth day of October, in the year of our Lord two thousand seventeen, and of the Independence of the United States of America the two hundred and forty- second.
[FR Doc. 2017–23525 Filed 10–25–17; 11:15 am] Billing code 3295–F8–P
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Reader Aids Federal Register Vol. 82, No. 206 Thursday, October 26, 2017
CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING OCTOBER
Federal Register/Code of Federal Regulations At the end of each month the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. 839...... 49277 Presidential Documents 1 CFR 841...... 49277 Executive orders and proclamations 741–6000 601...... 48609 842...... 49277 The United States Government Manual 741–6000 603...... 48609 847...... 49277 Other Services 2 CFR 1201...... 47083 Electronic and on-line services (voice) 741–6020 Proposed Rules: 7 CFR Privacy Act Compilation 741–6050 1201...... 46716 15a...... 46655 Public Laws Update Service (numbers, dates, etc.) 741–6043 3 CFR 319...... 45955 983...... 49087 Proclamations: ELECTRONIC RESEARCH 996...... 48755 9646...... 46353 1217...... 49485 World Wide Web 9647...... 46355 3560...... 49282 9648...... 46357 Proposed Rules: 9649...... 46359 Full text of the daily Federal Register, CFR and other publications 33...... 46425 9650...... 46361 is located at: www.fdsys.gov. 35...... 46425 Federal Register information and research tools, including Public 9651...... 46653 Inspection List, indexes, and Code of Federal Regulations are 9652...... 47361 9 CFR 9653...... 47943 located at: www.ofr.gov. 201...... 48594 9654...... 47945 Proposed Rules: E-mail 9655...... 47947 9656...... 47949 1...... 48938 FEDREGTOC (Daily Federal Register Table of Contents Electronic 9657...... 47951 2...... 48938 Mailing List) is an open e-mail service that provides subscribers 9658...... 48191 201...... 48603 with a digital form of the Federal Register Table of Contents. The 9659...... 48383 10 CFR digital form of the Federal Register Table of Contents includes 9660...... 48749 HTML and PDF links to the full text of each document. 9661...... 48751 20...... 46666 To join or leave, go to https://public.govdelivery.com/accounts/ 9662...... 48753 Proposed Rules: USGPOOFR/subscriber/new, enter your email address, then 9663...... 49735 50...... 46717 follow the instructions to join, leave, or manage your Executive Orders: 11 CFR subscription. 13223 (Amended by Proposed Rules: PENS (Public Law Electronic Notification Service) is an e-mail EO 13814)...... 49273 110...... 46937 service that notifies subscribers of recently enacted laws. 13522 (Revoked by EO 13812)...... 46367 12 CFR To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 13708 (Superseded by and select Join or leave the list (or change settings); then follow EO 13811)...... 46363 34...... 49089 the instructions. 13805 (Revoked by 261...... 49286 FEDREGTOC and PENS are mailing lists only. We cannot EO 13811)...... 46363 271...... 45679 respond to specific inquiries. 13811...... 46363 Ch. II ...... 46668 225...... 49089 Reference questions. Send questions and comments about the 13812...... 46367 323...... 49089 Federal Register system to: [email protected] 13813...... 48385 13814...... 49273 Ch. V...... 47083 The Federal Register staff cannot interpret specific documents or Administrative Orders: 607...... 48758 regulations. Memorandums: 722...... 49089 CFR Checklist. Effective January 1, 2009, the CFR Checklist no Memorandum of 1002...... 45680 longer appears in the Federal Register. This information can be September 25, 1024...... 47953 found online at http://bookstore.gpo.gov/. 2017 ...... 46649 1101...... 45697 Notices: Proposed Rules: FEDERAL REGISTER PAGES AND DATE, OCTOBER Notice of October 16, 211...... 47164 2017 ...... 48607 238...... 47164 45679–45954...... 2 48609–48748...... 19 Notice of October 23, 740...... 46173 45955–46122...... 3 48749–48901...... 20 2017 ...... 49275 1026...... 48463 Presidential 46123–46368...... 4 48903–49086...... 23 13 CFR 46369–46654...... 5 49087–49274...... 24 Determinations: 102...... 46369 46655–46892...... 6 49275–49484...... 25 No. 2017–13 of September 29, 120...... 47958 46893–47082...... 10 49485–49736...... 26 2017 ...... 49083 126...... 48903 47083–47362...... 11 No. 2017–14 of 313...... 48760 47363–47610...... 12 September 30, Proposed Rules: 47611–47952...... 13 2017 ...... 49085 Ch. I ...... 47645 47953–48192...... 16 48193–48388...... 17 5 CFR 14 CFR 48389–48608...... 18 831...... 49277 25 ...... 48193, 48389, 48394,
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49492 40...... 49541 45986, 45988, 46132, 46901, Proposed Rules: 36...... 46123 801...... 47407 47113, 47374, 47616, 47618, 52 ...... 45762, 46010, 46433, 39 ...... 45697, 45701, 45703, 47620, 47623, 48420, 48422, 46434, 46444, 46450, 46453, 45705, 45710, 46379, 46382, 21 CFR 48931, 49106, 49110 46741, 46742, 46951, 47169, 46669, 47084, 47091, 47094, 862...... 48413 326...... 47623 47170, 47662, 48030, 48033, 47363, 47367, 47371, 48904, 866 ...... 47965, 47967, 48762, 334...... 49113 48034, 48035, 48472, 48473, 48906, 48910, 48912, 48915, 49098, 49100, 49102 Proposed Rules: 48474, 48475, 48780, 48942, 48917, 48919, 48921, 49091, 870...... 46900 110...... 46004 48944, 49166 49095, 49494, 49498 876...... 45725, 47969 117 ...... 46948, 48939, 48940, 60...... 48035 71 ...... 45713 45714, 45715, 882...... 47373 49153, 49550 62...... 47421, 49563 45716, 45717, 45719, 45720, 1308...... 47971, 49504 165...... 46007 70...... 46453 45957, 45958, 46893, 46894, Proposed Rules: 80...... 46174 46895, 46897, 47097, 47098, Ch. I ...... 49300 34 CFR 81...... 48474, 48475 47103, 47104, 47611, 47612, 101...... 45753 600...... 48424 180...... 47422 47959, 47960, 47961, 47962, 112...... 47656 668...... 48195, 49114 271...... 46454 48924 674...... 48195, 49114 711...... 47423 73 ...... 45721, 46898, 47964 23 CFR 682...... 48195, 49114 713...... 49564 91...... 46123 Proposed Rules: 685...... 48195, 49114 770...... 49302 97 ...... 46385, 46386, 48609, Ch. I ...... 45750 Proposed Rules: 48611, 48614, 48615 41 CFR Ch. II ...... 45750 668...... 49155 1264...... 48760 Ch. III ...... 45750 674...... 49155 Proposed Rules: 1271...... 48760 490...... 46427 682...... 49155 Ch. 301 ...... 47663 Proposed Rules: 685...... 49155 App. C...... 47663 Ch. I ...... 45750 25 CFR 304...... 47663 39 ...... 45743, 46719, 46722, Proposed Rules: 37 CFR 305...... 47663 46725, 46727, 46729, 46938, 517...... 48205 306...... 47663 47405, 48668, 48671, 49144, Proposed Rules: 49146, 49149, 49151 2...... 48469 42 CFR 26 CFR 201...... 47415, 49550 71 ...... 45747, 45749, 46426, 405...... 46138 1 ...... 46388, 46671, 46672, 202...... 47415 48010, 48011 409...... 46163 48618, 49508 97...... 46738 411...... 46163 54...... 47792, 47838 38 CFR Ch. II ...... 45750 412...... 46138 Ch. III ...... 45750 Proposed Rules: 3...... 49121 413...... 46138, 46163 1 ...... 47408, 48013, 48779, 8a...... 48630 414...... 46138 15 CFR 49549 Proposed Rules: 416...... 46138 730...... 45959 25...... 48779 17...... 45756, 48018 424...... 46163 732...... 45959 54...... 47656, 47658 486...... 46138 39 CFR 734...... 45959 301...... 48013 488...... 46138, 46163 736...... 45959 27 CFR 20...... 48933 489...... 46138 738...... 45959 111...... 47628, 49123 493...... 48770 740...... 45959 Proposed Rules: 266...... 47115 495...... 46138 742...... 45959 4...... 47164, 47165 3020...... 48632 Proposed Rules: 743...... 45959 24...... 47165, 47167 Proposed Rules: Ch. I ...... 49300 744...... 45959 20...... 49160 Ch. IV...... 49300 746...... 45959 29 CFR 111...... 46010, 47659 416...... 46181 748...... 45959, 48925 2590...... 47792, 47838 3050...... 46950, 47168 418...... 46181 750...... 45959 4022...... 47613 754...... 45959 424...... 46181 Proposed Rules: 40 CFR 482...... 46181 756...... 45959 2560...... 47409 758...... 45959 9...... 45990, 48637 483...... 46181 760...... 45959 30 CFR 52 ...... 45995, 45997, 46134, 485...... 46181 762...... 45959 46136, 46415, 46417, 46420, 511...... 46182 56...... 46411 46672, 46674, 46679, 46681, 764...... 45959 57...... 46411 43 CFR 766...... 45959 46682, 46903, 46915, 46917, 583...... 45962 768...... 45959 46919, 46921, 46923, 47122, Proposed Rules: 47145, 47147, 47149, 47154, 3160...... 46458 770...... 45959 31 CFR 772...... 45959 47376, 47378, 47380, 47383, 3170...... 46458 774...... 45959 0...... 47105 47385, 47393, 47396, 47397, 23...... 47107 45 CFR Proposed Rules: 47629, 47630, 47631, 47634, 47635, 47636, 47640, 47930, 147...... 47792, 47838 30...... 46739 32 CFR 47936, 47981, 47983, 47985, Proposed Rules: 16 CFR 706...... 48415, 48764 47988, 47992, 47993, 48324, Subtitle A ...... 49300 Proposed Rules: Proposed Rules: 48425, 48431, 48435, 48439, Subtitle B ...... 49300 Ch. II ...... 46740 Ch. I ...... 48939 48442, 48448, 48766, 48769, Ch. II ...... 49300 1250...... 47645 Ch. V...... 48939 49128 Ch. III ...... 49300 Ch. VI...... 48939 60...... 48202 Ch. IV...... 49300 17 CFR Ch. VII...... 48939 62...... 47398, 49511 Ch. X...... 49300 Ch. I ...... 48394 199...... 48938 63 ...... 47328, 48156, 49132, Ch. XIII...... 49300 227...... 45722 49513 160...... 46182 230...... 45722 33 CFR 70...... 46420 162...... 46182 100 ...... 45977, 45979, 46413, 81...... 48442, 48448 18 CFR 46672, 47615, 48417 97...... 48324 46 CFR 4...... 49501 117 ...... 45728, 45729, 45980, 180 ...... 45730, 46685, 46926, Proposed Rules: 5...... 49501 45981, 47112, 47615, 47974, 46929, 47996, 48000 Ch. II ...... 45750 16...... 49501 47975, 48419, 49104, 49510 261...... 45736, 49533 Proposed Rules: 155...... 47975 721...... 45990, 48637 47 CFR 35...... 46940, 48013 165 ...... 45729, 45981, 45984, 770...... 49287 1...... 46688, 48773
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2 ...... 46688, 47155, 48459 64...... 49303 Ch. III ...... 45750 47402, 47403, 48204,48460, 15...... 46688 74...... 47683 Ch. V...... 45750 48667, 49539 20...... 48773 76...... 47683 Ch. VI...... 45750 Proposed Rules: 27...... 47155 78...... 47683 Ch. VII...... 45750 17 ...... 45779, 46183, 46197, 36...... 48774 Ch. VIII...... 45750 46618, 46748 42...... 48774 48 CFR Ch. X...... 45750 20...... 46011 51...... 47161 Proposed Rules: 1102...... 45771 54...... 48774 Ch. 12 ...... 45750 Ch. XI...... 45750 36...... 45793 63...... 48774 222...... 48674 64...... 48203, 48774 49 CFR 50 CFR 223...... 48948 80...... 48459 Ch. X...... 49295 17...... 46691 229...... 47424 90 ...... 46688, 46690, 47400, 174...... 48006 622 ...... 46170, 47162, 47640, 300...... 46016 48005, 48459 191...... 48655 47641, 49142 622...... 46205, 49167 95...... 46688 192...... 48655 635...... 46000, 46934 635...... 49303 97...... 46688 593...... 49132 648 ...... 46002, 46936, 48007, 648 ...... 46749, 48781, 48967 831...... 47401 Proposed Rules: 48008, 48936, 49297 660...... 46209 1...... 46011 Proposed Rules: 660...... 48656 679...... 46016 20...... 46011, 47663 Ch. I ...... 45750 665...... 47642, 49143 52...... 47669 Ch. II ...... 45750 679 ...... 46171, 46422, 47162,
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in today’s List of Public enacted public laws. To Laws. subscribe, go to http:// LIST OF PUBLIC LAWS Public Laws Electronic listserv.gsa.gov/archives/ Last List October 24, 2017 Notification Service publaws-l.html (PENS) Note: No public bills which Note: This service is strictly have become law were for E-mail notification of new received by the Office of the PENS is a free electronic mail laws. The text of laws is not Federal Register for inclusion notification service of newly available through this service. PENS cannot respond to specific inquiries sent to this address.
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