Document JJN4v5JXLLdqY237K3LL0qLVK

To: From: Sent: Subject: Jackson, Ryan[jackson.ryan@epa.gov] Bloomberg BNA Fri 10/27/2017 12:00:24 PM Oct. 27 - EHS Federal Regulatory Alert EHS Federal Regulatory Alert October 27, 2017 - Number 207 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 ENDANGERED SPECIES Hawaii/Critical Habitat Boundaries for Certain Plants ENDANGERED SPECIES Final rule of the U.S. Fish and Wildlife Service removes textual descriptions of critical habitat boundaries for certain plants in Hawaii where it has been determined that maps are sufficient for such delineation. The rule applies to designations for plants on the islands of Hawaii, Kauai, and Niihau. The rule is effective Nov. 27, 2017. Contact: Carey Galst; USFWS; 703-358-1954. Citations: 50 CFR 17.94 82 FR 49751 (10/27/2017) Regulatory Update FOOD SAFETY Center for Veterinary Medicine Dispute Resolu FOOD SAFETY dures Guidance Notice announces the intention of the FDA to seek OMB approval for a continuing information collection request regarding the Center for Veterinary Medicine's guidance for industry (Guidance #79) concerning the dispute resolution procedures for science-based decisions on products regulated by the agency. The guidance addresses scientific controversies involving issues of technical expertise and outlines how the agency applies existing regulations to review such disputes. Comments are due Dec. 26, 2017. Contact: Ila Mizrachi; FDA, Office of Operations; 301 796-7726; PRAStaff@fda.hhs.gov. Citations: 21 CFR 10.75 82 FR 49836 (10/27/2017) Regulatory Update FOOD SAFETY Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00000693-00001 Genetically Engineered Cotton/Determination of Status FOOD SAFETY Notice of the Animal and Plant Health Inspection Service announces the receipt of a petition from Bayer CropScience LP, of Research Triangle Park, N.C., requesting a determination of nonregulated status of cotton designated as event GHB811, which has been genetically engineered for dual resistance to the herbicides glyphosate and isoxaflutole. Comments are due Dec. 26, 2017. Contact: John Turner; APHIS, Biotechnology Regulatory Services; 301-851-3954; john.t.turner@aphis.usda.gov. Citations: 7 CFR 340 82 FR 49782 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY California/Palen Solar Photovoltaic Project GENERAL ENVIRONMENT AND SAFETY Notice of the Bureau of Land Management, in cooperation with Riverside County, Calif., announces the availability of a draft supplemental environmental impact statement, environmental impact report, and draft land use plan amendment for the Palen Solar Photovoltaic Project, near Desert Center, Calif. The project, which now is proposed by EDF Renewable Energy, of San Diego, was abandoned by several previous applicants and involves the construction and operation of a 500-megawatt solar photovoltaic facility with a proposed project footprint of approximately 3,400 acres. The project also involves the construction of a 6.7-mile single circuit 230-kilovolt transmission line connecting it to the Southern California Edison Red Bluff Substation. The agency has identified the reduced footprint alternative as the preferred alternative. Comments are due Dec. 11, 2017. Contact: Mark DeMaio; BLM, Palm Springs-South Coast Field Office; 760-833-7124; mdemaio@blm.gov 82 FR 49846 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Determination Concerning Safety and Effectiveness/Cardene SR GENERAL ENVIRONMENT AND SAFETY Notice of the FDA announces a determination that Cardene SR (nicardipine HCI) extended-release capsules, 30 milligrams (mg), 45 mg, and 60mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the FDA to approve abbreviated new drug applications that refer to the product if relevant legal and regulatory requirements are met. Contact: Daniel Gottlieb; FDA, Center for Drug Evaluation and Research; 301-796-6650 82 FR 49840 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Development of Drugs t of Pediatric Gastroesophageal Reflux Disease GENERAL ENVIRONMENT AND SAFETY Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00000693-00002 Notice of the FDA announces the availability of a draft guidance for industry concerning development of drugs for treatment of pediatric gastroesophageal reflux disease. The guidance is intended to assist in clinical drug development and addresses clinical presentation by age and disease, study populations, endpoints, and pharmacometric issues affecting dosing. Comments are due Dec. 26, 2017. Contact: Stacy Barley; FDA, Center for Drug Evaluation and Research; 301 796-2137 82 FR 49837 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Environmental Impact Statements GENERAL ENVIRONMENT AND SAFETY Notice of the EPA announces the availability of environmental impact statements filed Oct. 16-20, 2017. Contact: Kelly Knight; EPA, Office of Federal Activities; 202-564-7146; knight.kelly@epa.gov. Citations: 40 CFR 1506.9 82 FR 49802 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY First Responder Network Authority/East Region GENERAL ENVIRONMENT AND SAFETY Notice of the National Telecommunications and Information Administration, First Responder Network Authority (FirstNet), announces the availability of the final programmatic environmental impact statement for the east region of the proposed nationwide public safety broadband network. The PEIS addresses deployment and operation of the proposed broadband network in the east region consisting of Connecticut, Delaware, the District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, and West Virginia. Once a record of decision is signed, the proposed FirstNet projects will submit site-specific environmental documentation to determine whether individual projects have been adequately evaluated in the PEIS or instead warrant a categorical exclusion, environmental assessment, or environmental impact statement. Contact: Amanda Pereira; NTIA, First Responder Network Authority, 571-665-6072 82 FR 49785 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Formal Dispute Resolution/lssues Related to Pharmaceutical Current Good Manufacturing Practice GENERAL ENVIRONMENT AND SAFETY Notice announces the intention of the FDA to seek OMB approval for a continuing information collection request concerning a guidance for industry on formal dispute resolution of scientific Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00000693-00003 and technical issues related to pharmaceutical current good manufacturing practice (CGMP). The guidance provides manufacturers of veterinary and human drugs, including human biological drug products, with information on how to resolve disputes about scientific and technical issues relating to CGMP that may arise during FDA inspections of pharmaceutical manufacturers or during the FDA's assessment of corrective actions. The guidance also describes procedures for raising disputes to the Office of Regulatory Affairs and center levels and for requesting review by the dispute resolution panel. Comments are due Dec. 26, 2017. Contact: Domini Bean; FDA, Office of Operations; 301-796-5733; PRAStaff@fda.hhs.gov 82 FR 49832 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Louisiana, Texas/East-West Project GENERAL ENVIRONMENT AND SAFETY Notice of FERC announces the availability of the environmental assessment for the East-West Project, proposed by Florida Gas Transmission Co. (FGT), of Houston. The project involves the construction and operation of approximately 25.22 miles of new lateral and connection pipeline and four new meter stations in Acadia and Calcasieu parishes in Louisiana and Jefferson, Matagorda, Orange, and Wharton counties in Texas for a new capacity of 275 million cubic feet per day on FGT's pipeline system. Comments are due Nov. 20, 2017. Contact: FERC, Office of External Affairs; 866-208-3676; FERCOnlinesupport@ferc.gov 82 FR 49800 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Oklahoma/Pensact roelectric Project GENERAL ENVIRONMENT AND SAFETY Notice of FERC announces meetings on the procedure for relicensing the Grand River Dam Authority's Pensacola Hydroelectric Project, located on the Grand River in Craig, Delaware, Mayes, and Ottawa counties in Oklahoma. The meetings will provide an overview of the integrated licensing process that will be used beginning in January 2018, the schedule for the project, and how FERC assesses information needs during the study planning process. The meetings are scheduled for Nov. 14, 2017, in Langley, Okla., and Nov. 15, 2017, in Langley and Grove, Okla. Contact: Rachel McNamara, FERC; 202-502-8340; rachel.mcnamara@ferc.gov 82 FR 49799 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Patient-Focused Drug Development GENERAL ENVIRONMENT AND SAFETY Notice of the FDA announces a workshop to discuss methodological approaches to collecting patient experience data for submission to the FDA to inform regulatory decision-making. The Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00000693-00004 workshop will be used to obtain feedback from stakeholders on considerations for standardized nomenclature and terminologies for patient-focused drug development, including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis. The workshop will inform the development of a patient-focused drug development guidance. A discussion document outlining the topic areas that will be addressed in the draft guidance will be published before the workshop. The workshop is scheduled for Dec. 18, 2017, in Silver Spring, Md. Comments are due Feb. 16, 2018. Contact: Meghana Chalasani; FDA, Center for Drug Evaluation and Research; 240-402-6525; Meghana.Chalasani@fda.hhs.gov 82 FR 49838 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Prohibition on Phthalates in Toys and Child Care Articles GENERAL ENVIRONMENT AND SAFETY Final rule of the Consumer Product Safety Commission prohibits children's toys or child care articles containing concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentylphthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP). The rule also restates the permanent prohibition on the manufacture for sale, offer for sale, distribution in commerce, or importation of children's toys or child care articles containing concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP). The rule is effective April 25, 2018. Contact: Carol Afflerbach; CPSC, Office of Compliance and Field Operations; 301 504-7529; cafflerbach@cpsc.gov. Citations: 16 CFR 1307.1,1307.2,1307.3 82 FR 49938 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Prohibition on Phthalates id Child Care Articles/Notice of Requirements GENERAL ENVIRONMENT AND SAFETY Proposed rule of the Consumer Product Safety Commission would update notice of requirements for prohibitions of children's toys and child care articles to reflect a concurrent final rule that prohibits children's toys or child care articles containing concentrations of more than 0.1 percent of specified phthalates. The rule also would implement a new test method to determine whether there are prohibited phthalates in children's toys or child care articles. The test method is substantially the same to the current test method except for revisions to reflect the updated list of phthalates in the concurrent rule. Comments are due Jan. 10, 2018. Contact: Scott Heh; CPSC, Directorate for Laboratory Sciences; 301-504-7646; sheh@cpsc.gov. Citation: 16 CFR 1112.15 82 FR 49767 (10/27/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY West Virqinia/Hawks Nest and GL o', Uy roelectric Projects Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00000693-00005 GENERAL ENVIRONMENT AND SAFETY Notice of FERC announces the availability of the final environmental assessment regarding an application by Hawks Nest Hydro LLC, of Gauley Bridge, W.Va., for the Hawks Nest and Glen Ferris hydroelectric projects on the New and Kanawha rivers in Fayette County, W.Va. The application addresses the continuation of a run-of-river operation and an increase in the minimum flow for the bypassed reach for the Hawks Nest project and the continuation of a run-ofriver operation for the Glen Ferris project. The final EA concludes that relicensing the projects, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment. Contact: Monir Chowdhury; FERC; 202-502-6736 82 FR 49799 (10/27/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Electronic Logging Device Exemption Request/Mc HAZARDOUS MATERIALS TRANSPORTATION cture Association of America Notice of the Federal Motor Carrier Safety Administration announces the receipt of an application from the Motion Picture Association of America for an exemption for commercial drivers providing transportation of property to or from a theatrical or television motion picture production site. The applicant requests an exemption from the electronic logging device requirements designed to record drivers' hours of service, allowing drivers instead to complete paper records of duty status. Comments are due Nov. 27, 2017. Contact: Tom Yager; FMCSA, Driver and Carrier Operations Division; 614-942-6477; MCPSD@dot.gov. Citations: 49 CFR 395 82 FR 49771 (10/27/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Electronic Logging Device Exemption Request/Pipe Line Contractors Association HAZARDOUS MATERIALS TRANSPORTATION Notice of the FMCSA announces the denial of an application (82 FR 31796; 07/10/2017) from the Pipe Line Contractors Association, of Dallas, for an exemption for pipeline contractor vehicle drivers. The applicant requested an exemption from the installation and driver use requirements for electronic logging devices designed to record driver hours-of-service for a period of five years. The agency has determined that the applicant would not achieve a level of safety that is equivalent to, or greater than, the level that would be achieved without such exemption. Contact: Tom Yager; FMCSA, Office of Carrier, Driverand Vehicle Safety Standards; 614-942-6477; MCPSD@dot.gov. Citations: 49 CFR 395 82 FR 49923 (10/27/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Electronic Logging Device Exemption Request/Western Equipment Dealers Association Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00000693-00006 HAZARDOUS MATERIALS TRANSPORTATION Notice of the Federal Motor Carrier Safety Administration announces the receipt of an application from the Western Equipment Dealers Association on behalf of several organizations for an exemption for farm, industrial, and outdoor power equipment dealers. The applicant requests an exemption from the electronic logging device requirements designed to record drivers' hours of service, allowing drivers instead to complete paper records of duty status. Comments are due Nov. 27, 2017. Contact: Tom Yager; FMCSA, Driver and Carrier Operations Division; 614-942 6477; MCPSD@dot.gov. Citations: 49 CFR 395 82 FR 49770 (10/27/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Sleeper Berth 1 ot Program HAZARDOUS MATERIALS TRANSPORTATION Notice of the Federal Motor Carrier Safety Administration announces the submission of a new information collection request to the OMB regarding a pilot program for temporary relief from sleeper berth requirements for licensed commercial drivers who regularly use a sleeper berth to accumulate their required hours of nonduty work status. The program would allow a limited number of commercial drivers to split the required 10 hours of nonduty work status. The agency is seeking to compile driver metrics and to assess safety performance and fatigue levels. The collection would include applications, questionnaires, daily field studies, weekly phone briefings, and use of instrumented vehicles concerning safety performance and fatigue levels. The agency also would compile electronic logging device data, onboard monitoring system data, roadside violation data, wrist actigraphy data, Psychomotor Vigilance Test data, subjective sleepiness ratings, and sleep logs data. Comments are due Nov. 27, 2017. Contact: Michel; FMCSA, Research Division; 202-366-4354; Nicole.michel@dot.gov. Citations: 49 CFR 395.1 82 FR 49924 (10/27/2017) Regulatory Update OIL AND GAS INDUSTRY Natural Gas Data Collection Program OIL AND GAS INDUSTRY Notice of the Department of Energy, Energy Information Administration, announces the submission of six revised information collection requests to the OMB regarding the Natural Gas Data Collection Program. The collections address the forms for the annual reporting of natural and supplemental gas supply and disposition (EIA-176), the monthly reporting of underground gas storage (EIA-191), the survey for natural gas processing plants (EIA-757), and the monthly reporting of natural gas purchases and deliveries to consumers (EIA-857). The collections also address the monthly natural gas marketer survey (EIA-910) and the weekly underground natural gas storage report (EIA-912). The revisions add questions, update response options, modify the data collected and survey schedules, and provide for respondent confidentiality. Comments are due Nov. 27, 2017. Contact: Michael Kopalek; EIA, Office of Petroleum and Biofuel Statistics; 202 586-4001; Michael.Kopalek@eia.gov 82 FR 49797 (10/27/2017) Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00000693-00007 Regulatory Update PESTICIDES Pesticide Product Registrations/New Uses PESTICIDES Notice of the EPA announces the receipt of four applications to register new uses for pesticide products containing currently registered active ingredients. The applications by various companies are for one fungicide, one herbicide, and two insecticides. Comments are due Nov. 27, 2017. Contact: Michael Goodis; EPA, Office of Pesticide Programs; 703-305-7090; RDFRNotices@epa.gov 82 FR 49801 (10/27/2017) Regulatory Update PESTICIDES Pesticide Tolerance Exemption/Bacillus Amyloliquefaciens Strain F727 PESTICIDES Final rule of the EPA establishes an exemption from the requirement of a tolerance for residues of Bacillus amyloliquefaciens strain F727 in or on all food commodities when used in accordance with label directions and good agricultural practices. The rule is issued in response to a petition filed by Marrone Bio Innovations, of Davis, Calif. The rule is effective Oct. 27, 2017. Objections and hearing requests are due Dec. 26, 2017. Contact: Robert McNally; EPA, Office of Pesticide Programs; 703-305-7090; BPPDFRNotices@epa.gov. Citations: 40 CFR 180.1347 82 FR 49745 (10/27/2017) Regulatory Update RADIATION ACRS Planning and Procedures Subcommittee Meeting RADIATION Notice of the NRC announces a meeting of the Advisory Committee on Reactor Safeguards Subcommittee on Planning and Procedures to discuss proposed ACRS activities and related matters. The meeting is scheduled for Nov. 1,2017, in Rockville, Md. Comments are due Nov. 1, 2017. Contact: Quynh Nguyen; NRC; 301-415-5844; Quynh.Nguyen@nrc.gov 82 FR 49859 (10/27/2017) Regulatory Update WATER Monohull Outboard Boats/Engine Weight and Flotation Standards WATER Final rule of the U.S. Coast Guard updates standards for outboard engine weights used in Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00000693-00008 calculating safe loading capacities and required amounts of flotation material for monohull outboard boats that are less than 20 feet in length. The rule replaces current standards with the American Boat and Yacht Council's S-30 Outboard Engines and Related Equipment Weights Standard to require additional flotation in new boats to support the weight of heavier engines. The rule is effective June 1, 2018. Contact: Jeffrey Ludwig; USCG; 202-372-1061; Jeffrey.A.Ludwig@uscg.mil. Citations: 33 CFR 183.41, 183.220, 813.320, Table 4 to 33 CFR 183, Subpart H 82 FR 49737 (10/27/2017) Regulatory Update WATER Susquehanna River Basin Commission/Projects Approved for Consumptive Water Uses WATER Notice of the Susquehanna River Basin Commission announces a list of projects approved for consumptive use of water in August 2017. The notice addresses 21 projects approved by rule for consumptive use, including uses related to unconventional natural gas and other hydrocarbon development. Contact: Jason Oyler; SRBC; 717-238-0423; joyler@srbc.net. Citations: 18 CFR 806.22 82 FR 49922 (10/27/2017) Regulatory Update WATER Susquehanna River Basin Commission/Projects Rescinded for Consumptive Uses of Water WATER Notice of the Susquehanna River Basin Commission lists the projects rescinded for the consumptive use of water during August 2017. The list includes two projects located in Lycoming County, Pa. Contact: Jason Oyler; SRBC; 717-238-0423; joyler@srbc.net. Citations: 18 CFR 806.22 82 FR 49923 (10/27/2017) Regulatory Update WATER Towing Safety Advisory Committee Meeting WATER Notice of the U.S. Coast Guard announces a meeting of the Towing Safety Advisory Committee. The agenda includes presentations and discussions concerning tasks of the current subcommittees, including tug and barge operations and manning, Subchapter M implementation, inland firefighting, towing liquefied natural gas barges, and regulatory reform. The agenda also includes consideration of a new subcommittee and task concerning load line exemption for river barges on lakes Erie and Ontario. The meeting is scheduled for Dec. 5-6, 2017, in New Orleans. Comments are due Nov. 21,2017. Contact: Jose Perez; USCG; 202-372-1410; jose.a.perez3@uscg.mil. Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00000693-00009 82 FR 49842 (10/27/2017) Regulatory Update Privacy Policy | Terms of Sen mage 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_00000693-00010