Document aJpyEBeMzdqJ7RXybKmgJ8a7Y

To: From: Sent: Subject: Jackson, Ryan[jackson.ryan@epa.gov] Bloomberg BNA Mon 6/26/2017 12:09:09 PM June 26 - EHS Federal Regulatory Alert EHS Federal Regulatory Alert June 26, 2017-Number 121 You can create a report customized by topic, jurisdiction, and date range by using the Regulatory Summaries Report Tool. The report can be generated in Excel, Word, or PDF. Summaries AIR Indiana SIP/Incorporations by Reference AIR Direct final rule of the EPA amends regulations under 40 CFR 52.770 to approve a revision to the Indiana SIP. The revision reflects the incorporation by reference of the Code of Federal Regulations to the 2015 edition. The rule is effective Aug. 25, 2017, unless adverse comments are received by July 26, 2017. Contact: Charles Hatten; EPA Region 5, Air Programs Branch; 312-886 6031; hatten.charles@epa.gov 82 FR 28775 (06/26/2017) Regulatory Update AIR Indiana SIP/Incorporations by Reference AIR Proposed rule of the EPA amends regulations under 40 CFR 52.770 to approve a revision to the Indiana SIP. The revision reflects the incorporation by reference of the Code of Federal Regulations to the 2015 edition. A concurrent direct final rule adopts the provisions, effective Aug. 25, 2017. Comments are due July 26, 2017. Contact: Charles Hatten; EPA Region 5, Air Programs Branch; 312-886-6031; hatten.charles@epa.gov 82 FR 28801 (06/26/2017) Regulatory Update ENDANGERED SPECIES Arizona/Pima Pineapple Cactus Recovery Plan ENDANGERED SPECIES Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002699-00001 Notice of the U.S. Fish and Wildlife Service announces the availability of the draft recovery plan for the endangered Pima pineapple cactus, a species found in southern Arizona and in northern Sonora, Mexico. The draft recovery plan includes recovery objectives and criteria, including specific threat-, habitat-, and population-based objectives. Comments are due Aug. 25, 2017. Contact: Steve Spangle; USFWS, Arizona Ecological Services Field Office; 602-242-0210; Steve_S pa ng le@fws. gov 82 FR 28875 (06/26/2017) Regulatory Update ENDANGERED SPECIES Florida/Exemption from Threatened Species Permits ENDANGERED SPECIES Notice of the U.S. Fish and Wildlife Service announces the issuance of an exemption to threatened species permit requirements for beluga sturgeon (50 CFR 17.32 and 17.44). The exemption, which is for the Sturgeon AquaFarms aquaculture facility in Bascom, Fla., authorizes the facility to take sturgeon from its aquacultured stock for the purpose of harvesting meat and to engage in interstate commerce and export of beluga sturgeon meat. The exemption does not apply to beluga caviar or live beluga sturgeon. Contact: Rosemarie Gnam; USFWS; 703-358-1708; Rosemarie_Gnam@fws.gov 82 FR 28875 (06/26/2017) Regulatory Update ENDANGERED SPECIES Giant Clam Endangered/Threatened Sta ENDANGERED SPECIES :ition Notice of the National Oceanic and Atmospheric Administration, National Marine Fisheries Service, announces a 90-day finding on a petition to list 10 species of giant clam, including eight Tridacna species and two Hippopus species, as endangered or threatened under the Endangered Species Act. NMFS finds that the petition presents substantial scientific or commercial information indicating that listing may be warranted for seven of the species. The notice also announces the commencement of status review for those seven species. Comments are requested regarding historical and current distribution and abundance of the species; population trends; life history in marine environments; historical and current data on the commercial trade of giant clam products and on giant clam fisheries; current or planned activities that may adversely or positively impact the species; population structure information; and management, regulatory, and enforcement information. A finding as to whether listing the species as endangered or threatened is warranted will be made by Aug. 7, 2017. Comments are due Aug. 25, 2017. Contact: Lisa Manning; NMFS, Office of Protected Resources; 301-427-8403 82 FR 28946 (06/26/2017) Regulatory Update ENDANGERED SPECIES Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002699-00002 Taiwanese Humpback Dolphin Endangered Status ENDANGERED SPECIES Proposed rule of the National Oceanic and Atmospheric Administration, National Marine Fisheries Service, amends regulations under 50 CFR 224.101 to list as endangered the Taiwanese humpback dolphin, a subspecies of the Indo-Pacific humpback dolphin that occurs in a restricted area off the western coast of Taiwan. The agency seeks public comment on the range, distribution, and abundance of the subspecies; the genetics and population structure of the subspecies; habitat within the range that was present in the past but may have been lost over time; threats to the subspecies and protection efforts; current or planned activities within the range and their possible impact on the subspecies; and recent observations or sampling of the subspecies. Hearing requests are due Aug. 10, 2017. Comments are due Aug. 25, 2017. Contact: Chelsey Young; NMFS, Office of Protected Resources; 301-427-8403 82 FR 28802 (06/26/2017) Regulatory Update FOOD SAFETY Extralabel Drug Use in Animals FOOD SAFETY Notice announces the intention of the Food and Drug Administration to seek OMB approval of a continuing information collection request regarding extralabel drug use in animals (21 CFR 530.22(b)). The collection addresses the submission of analytical methods for the detection of residues of the drugs above established safe levels. Comments are due Aug. 25, 2017. Contact: Ila Mizrachi; FDA, Office of Operations; 301-796-7726; PRAStaff@fda.hhs.gov 83 FR 28858 (06/26/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Application to Export Electric Energy/M. M 1 ergy Solutions GENERAL ENVIRONMENT AND SAFETY Notice of the Department of Energy, Office of Electricity Delivery and Energy Reliability, announces the receipt of an application from MAG Energy Solutions Inc., of Montreal, for authority to transmit electric energy from the U.S. to Mexico as a power marketer for a five-year term using existing international transmission facilities. The energy proposed for export will be purchased from third parties and federal power marketing agencies under voluntary agreements. The agency will make a final decision after an environmental impact assessment and a determination that the action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system. Comments are due July 26, 2017. Contact: Angela Troy; DOE, Office of Electricity Delivery and Energy Reliability; 202-586-1411; Angela.Troy@hq.doe.gov 82 FR 28833 (06/26/2017) Regulatory Update Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002699-00003 GENERAL ENVIRONMENT AND SAFETY Application to Export Electric Energy/Rainbow Energy Marketing GENERAL ENVIRONMENT AND SAFETY Notice of the Department of Energy, Office of Electricity Delivery and Energy Reliability, announces the receipt of an application from Rainbow Energy Marketing Corp., of Bismarck, N.D., to renew its authority to transmit electric energy from the U.S. to Canada as a power marketer for a five-year term using existing international transmission facilities. The notice specifies that the energy proposed for export will be purchased from third parties and federal power marketing agencies under voluntary agreements. The notice also specifies that the agency will make a final decision after an environmental impact assessment and a determination that the action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system. Comments, protests, and motions to intervene are due July 26, 2017. Contact: Angela Troy; DOE, Office of Electricity Delivery and Energy Reliability; 202-586-1411; Angela.Troy@hq.doe.gov 82 FR 28834 (06/26/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Application to Export Electric Energy/Talen Energy Marketing LLC GENERAL ENVIRONMENT AND SAFETY Notice of the Department of Energy, Office of Electricity Delivery and Energy Reliability, announces the receipt of an application from Talen Energy Marketing LLC, of Allentown, Pa., to renew its authority to transmit electric energy from the U.S. to Canada as a power marketer for a five-year term using existing international transmission facilities. The notice specifies that the energy proposed for export will be purchased from third parties and federal power marketing agencies under voluntary agreements. The notice also specifies that the agency will make a final decision after an environmental impact assessment and a determination that the action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system. Comments are due July 26, 2017. Contact: Angela Troy; DOE, Office of Electricity Delivery and Energy Reliability; 202-586-1411; Angela.Troy@hq.doe.gov 82 FR 28833 (06/26/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Arthritis Advisory Committee Meeting GENERAL ENVIRONMENT AND SAFETY Notice of the Food and Drug Administration announces a meeting of the Arthritis Advisory Committee to address biologies drug application 761057 for sirukumab injection, submitted by Janssen Biotech Inc., of Horsham, Pa. The drug is used for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs. The meeting will include discussion of dose selection, efficacy, radiographic progression study, and safety. The meeting is scheduled for Aug. 2, 2017 in Silver Spring, Md. Comments are due Aug. 1, 2017. Contact: Philip Bautista; FDA, Center for Drug Evaluation and Research; 301-796-9001; AAC@fda.hhs.gov Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002699-00004 82 FR 28861 (06/26/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY California/West Santa Ana Branch f vsit Corridor Project GENERAL ENVIRONMENT AND SAFETY Notice announces the intention of the Federal Transit Administration, in cooperation with the Los Angeles County Metropolitan Transportation Authority, to prepare an environmental impact statement for the West Santa Ana Branch Transit Corridor Project in Los Angeles. The project involves the construction and operation of a 20-mile light rail transit line that would connect downtown Los Angeles to southeast Los Angeles County. The EIS will examine positive and negative environmental impacts of the project, which is expected to increase mobility and connectivity for historically underserved, transit-dependent, environmental justice communities. Comments are due Aug. 4, 2017. Contact: Candice Hughes; FTA; 213-629-8613; candice.hughes@dot.gov 82 FR 28932 (06/26/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Corrections and Removals of Medical Devices GENERAL ENVIRONMENT AND SAFETY Notice of the Food and Drug Administration announces the submission of a continuing information collection request to the OMB regarding reports of corrections and removals of medical devices. The collection addresses requirements for device manufacturers or importers to submit a written report to the FDA within 10 days of initiating any action to correct or remove devices to reduce health risks posed by the device or remedy a violation caused by the device (21 CFR 806.10). The collection also addresses requirements for device manufacturers or importers to maintain records of corrections or removals when such actions are initiated but not required to be reported to the FDA (21 CFR 806.20). Comments are due July 26, 2017. Contact: Amber Sanford; FDA, Office of Operations; 301-796-8867; PRAStaff@fda.hhs.gov. 82 FR 28857 (06/26/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Custom Devi' emption Annual Reports GENERAL ENVIRONMENT AND SAFETY Notice of the Food and Drug Administration announces the submission of a continuing information collection request to the OMB regarding custom device exemptions under Section 520(b) of the Federal Food, Drug, and Cosmetic Act. The collection addresses annual manufacturer report content and submission requirements for custom devices for which, due to the rarity of the patient's medical condition or the physician's special need, it would be impractical to comply with premarket review regulations and performance standards. Comments are due July 26, 2017. Contact: Amber Sanford; FDA, Office of Operations; 301-796-8867; Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002699-00005 PRAStaff@fda.h hs.gov 82 FR 28860 (06/26/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Environmental Settlement Funds-Classification GENERAL ENVIRONMENT AND SAFETY Notice announces the intention of the IRS to seek OMB approval for a continuing information collection request concerning environmental settlement funds-classifications. The collection addresses the requirement (26 CFR 301.7701-4) that the trustee of an environmental remediation trust must provide each grantor a statement showing all items of income, deduction, and credit of the trust for the taxable year attributable to the portion of the trust treated as owned by the grantor. This statement is provided for the purpose of computing the grantor's taxable income. Comments are due Aug. 25, 2017. Contact: Laurie Brimmer; IRS; 202-317-5756; Laurie.E.Brimmer@irs.gov 82 FR 28942 (06/26/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Oregon/Jordan Cove LNG Terminal, Pacific Connector Gas Pipeline GENERAL ENVIRONMENT AND SAFETY Notice announces the intention of the Federal Energy Regulatory Commission to prepare an environmental impact statement for the proposed Jordan Cove Liquefied Natural Gas (LNG) Terminal in Coos County and the Pacific Connector Gas Pipeline projects in Coos, Douglas, Jackson, and Klamath counties in Oregon. The terminal would be designed to liquefy approximately 1.04 billion cubic feet per day of LNG for export to Pacific Rim markets and include construction of a gas inlet facilities, a gas conditioning plant, ship loading facilities, and a new access channel. The pipeline would be approximately 235 miles long and be capable of transporting approximately 1.2 billion cubic feet of natural gas per day. FERC is the lead agency in preparing the draft EIS in cooperation with six federal agencies and seeks general comments on the project. The U.S. Forest Service seeks comments specific to the 2012 planning requirements under 36 CFR 219.8 through .11. Hearings are scheduled for June 27, 28, and 29, 2017, in Coos Bay, Roseburg, and Klamath Falls, respectively. Comments are due July 10, 2017. Contact: FERC, Office of External Affairs; 202-502-8258; FercOnlineSupport@ferc.gov 82 FR 28837 (06/26/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY R Jiatric Disease Product Priority Review Voucher GENERAL ENVIRONMENT AND SAFETY Notice of the Food and Drug Administration announces the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application for Brineuro (cerliponase alfa), Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002699-00006 manufactured by Biomarin Pharmaceuticals Inc., of Novato, Calif, The product is indicated to slow the progression of loss of ambulation in symptomatic pediatric patients three years of age or older with late infantile neuronal ceroid lipfuscinosis type 2, also known as tripeptidyl peptidase 1 deficiency. Contact: Althea Cuff; FDA, Center for Drug Evaluation and Research; 301 796-4061; althea.cuff@fda.hhs.gov 82 FR 28860 (06/26/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Wisconsin/Kaukauna City Pla ropower Project GENERAL ENVIRONMENT AND SAFETY Notice of the Federal Energy Regulatory Commission announces the filing of an application by Kaukauna Utilities, of Kaukauna, Wis., for a new major license for the Kaukauna City Plant Hydropower Project, on the Fox River in Outagamie County, Wis. The project consists of a 14foot-high dam that includes rubble masonry retaining wall sections, a concrete intake and powerhouse section, a gated spillway section with two spillway gates, and an overflow spillway section that includes a concrete ogee section. The project also consists of natural rock and concrete gravity sections, an impoundment, an intake structure with two head gates and two trashracks with clear-bar spacing, and a powerhouse containing two turbine-generator units. In addition, the project consists of an excavated tail race, two kilovolt generator leads that connect the turbine-generator units to the regional distribution line, and appurtenant facilities with an annual average generation of approximately 29,704 megawatt-hours. The commission seeks comments concerning Scoping Document 1 that includes the information to be addressed in the environmental assessment. Comments are due Aug. 21, 2017. Contact: Erin Kimsey; FERC; erin.kimsey@ferc.gov 82 FR 28846 (06/26/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Applications for Special Permits HAZARDOUS MATERIALS TRANSPORTATION Notice of the Pipeline and Hazardous Materials Safety Administration announces the receipt of 15 applications for new special permits and eight applications for modifications of special permits related to specified hazardous materials transportation regulations under 49 CFR 171 through 180 (nonconsecutive). Comments are due July 26, 2017. Contact: Ryan Paquet; PHMSA, Office of Hazardous Materials Approvals and Permits; 202-366-4535 82 FR 28935 (06/26/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Applications for Special Permits HAZARDOUS MATERIALS TRANSPORTATION Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002699-00007 Notice of the Pipeline and Hazardous Materials Safety Administration announces the receipt of six applications for new special permits related to specified hazardous materials transportation regulations under 49 CFR 172,173, and 175. Comments are due July 26, 2017. Contact: Ryan Paquet; PHMSA, Office of Hazardous Materials Approvals and Permits; 202-366-4535 82 FR 28937 (06/26/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Applications for Special Permits HAZARDOUS MATERIALS TRANSPORTATION Notice of the Pipeline and Hazardous Materials Safety Administration announces the receipt of six applications modifications of special permits related to specified hazardous materials transportation regulations under 49 CFR 171,173,177, and 180. Comments are due July 11, 2017. Contact: Ryan Paquet; PHMSA, Office of Hazardous Materials Approvals and Permits; 202-366 4535 82 FR 28935 (06/26/2017) Regulatory Update OCCUPA TIONAL SAFETY AND HEALTH Logging Operations Standard OCCUPATIONAL SAFETY AND HEALTH Notice of OSHA announces the submission of a continuing information collection request to the OMB regarding the logging operations standard (29 CFR 1910.266), The collection addresses the requirement for employers to make machine and vehicle operating instructions available on the device or in the operations area. The collection also addresses related certification of training requirements. Comments are due July 31,2017. Contact: Michel Smyth; Department of Labor; 202 693-4129; DOL_PRA_PUBLIC@dol.gov 82 FR 28908 (06/26/2017) Regulatory Update OCCUPA TIONAL SAFETY AND HEALTH Personnel Hoisting Equipment in Mines OCCUPATIONAL SAFETY AND HEALTH Notice of the Mine Safety and Health Administration announces the submission of a continuing information collection request to the OMB regarding personnel hoisting equipment (30 CFR 56, 57, 75, and 77). The collection addresses recordkeeping requirements for mine operators when examining hoists and appurtenances, including wire rope, for work in coal, metal and nonmetal surface, and underground mines. Comments are due July 26, 2017. Contact: Michel Smyth; Department of Labor; 202-693-4129; DOL_PRA_PUBLIC@dol.gov 82 FR 28907 (06/26/2017) Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002699-00008 Regulatory Update RADIATION International Atomic Energy Agency Safeguards Agreement RADIATION Notice of the Nuclear Regulatory Commission announces the submission of a continuing information collection request to the OMB regarding U.S, responsibilities as a participant in the U.S./lnternational Atomic Energy Agency (IAEA) Safeguards Agreement. The collection addresses the mandatory submission to the IAEA of a design information questionnaire and associated forms issued to licensees of facilities that appear on the U.S. eligible list and have been notified in writing by the NRC. Comments are due July 26, 2017. Contact: David Cullison; NRC; 301-415 2084; lnfocollects.Resource@nrc.gov 82 FR 28911 (06/26/2017) Regulatory Update WATER Delaware River Temporary Safety Zones WATER Proposed rule of the U.S. Coast Guard adopts regulations under 13 CFR 165.T05-0400 to establish temporary safety zones, from July 29 to Oct. 31,2017, in portions of Billingsport Range on the Delaware River, to aid in the removal of existing pipelines along the Federal Navigation Channel river bed. The rule requires vessels desiring to enter or navigate the safety zones to contact working vessels on very high-frequency FM marine band channel 13 or 16 at least one hour before arrival. Comments are due July 11, 2017. Contact: Amanda Boone; USCG, Sector Delaware Bay; 215-271-4889; Amanda.N.Boone@uscg.mil 82 FR 28796 (06/26/2017) Regulatory Update WATER Effluent Limitations and Standard1 WATER ,tal Facilities/Ci d ' << r tion Notice of the EPA announces a correction to a June 14, 2017, final rule (82 FR 27154) that adopted regulations under 40 CFR 441.10, 441.20, 441.30, 441.40, and 441.50 concerning the dental office point source category. The correction revises the definition of "new source" under 40 CFR 441.20 so that it means a dental discharger whose first discharge to a publicly owned treatment works occurs after July 14, 2027, instead of after June 14, 2017. 82 FR 28777 (06/26/2017) Regulatory Update WATER National Marine Monument and Sanctuary Designations Review Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002699-00009 WATER Notice of the National Oceanic and Atmospheric Administration announces the review of national marine sanctuaries and marine national monuments designated or expanded since April 28, 2007, as required by Executive Order 13795 (82 FR 20815; 05/03/2017). The notice specifies 11 designated areas subject to review and seeks comments concerning acreage and the budgetary impacts of management; the adequacy of required federal, state, and tribal consultations required prior to designation or expansion; and the opportunity costs associated with potential energy and mineral exploration and production from the Outer Continental Shelf and adjacent regions. NOAA will consider public comments submitted to the Department of the Interior for review of designations under the Antiquities Act (82 FR 22016; 05/11/2017), as required by Executive Order 13792 (82 FR 20429; 05/01/2017). Comments are due July 26, 2017. Contact: William Douros; NOAA; 831-647-1920 82 FR 28827 (06/26/2017) Regulatory Update Privacy Policy | Terms of Service | Manage Your Email | Contact Us 1801 South Bell Street, Arlington, VA 22202 Copyright 2017 The Bureau of National Affairs, Inc.. EHS Federal Regulatory Alert Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002699-00010