Document rBDn2kdNqQZJ2O6q5xjpwpRjr

To: From: Sent: Subject: Jackson, Ryan[jackson.ryan@epa.gov] Bloomberg BNA Tue 6/20/2017 12:03:20 PM June 20 - EHS Federal Regulatory Alert EHS Federal Regulatory Alert June 20, 2017 - Number 117 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 Gulf of Maine Distinct Popular h1 ,qment of Atlantic Salmon/Fi / 'C r Review ENDANGERED SPECIES Notice of the National Oceanic and Atmospheric Administration, National Marine Fisheries Service, announces the initiation of a five-year status review for the Gulf of Maine distinct population segment of Atlantic salmon to determine if the current endangered listing classification is still accurate. The agency is requesting information on the status, threats, and recovery of the species that has become available since the final listing decision in June 2009. Comments are due July 20, 2017. Contact: Dan Kircheis; NOAA; 207-866-7320; Dan.Kircheis@noaa.gov 82 FR 28049 (06/20/2017) Regulatory Update FOOD SAFETY Food Canning Mblishments/Acidified Foods and / FOOD SAFETY rr? ,Hy Processed Low-Acid Foods Notice announces the intention of the Food and Drug Administration to seek OMB approval for a continuing information collection request regarding food canning establishment registration, process filing, and recordkeeping for acidified foods and thermally processed low-acid foods in hermetically sealed containers (21 CFR 108.25 and 108.35). The collection addresses registration requirements (FDA 2541) for firms that manufacture, process, or pack the specified foods for introduction into interstate commerce. The collection also addresses data on food processing (FDA 2541a) and for aseptic processing of low-acid foods in hermetically sealed containers (FDA 2541c). Comments are due Aug. 21, 2017. Contact: JonnaLynn Capezzuto; FDA, Office of Operations; 301-796-3794; PRAStaff@fda.hhs.gov 82 FR 28069 (06/20/2017) Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002868-00001 Regulatory Update GENERAL ENVIRONMENT AND SAFETY ANDA Pre-Submission Facility Correspondence for Priority Submissions GENERAL ENVIRONMENT AND SAFETY Notice of the Food and Drug Administration announces the availability of a draft guidance for industry concerning abbreviated new drug application (ANDA) pre-submission facility correspondence (PFC) for priority submissions. The document describes the PFC content and format and addresses the agency's approach to assessment to allow the FDA to begin the facility assessment process in advance of a planned ANDA submission. Comments are due Sept. 18, 2017. Contact: Nikhil Thakur; FDA, Center for Drug Evaluation and Research; 301-796-5536 82 FR 28072 (06/20/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Drug Compounding Outsourcing Facilities GENERAL ENVIRONMENT AND SAFETY Notice announces the intention of the Food and Drug Administration to seek OMB approval for a continuing information collection request concerning registration of human drug compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act. The collection addresses annual registration information that is submitted electronically using the structured product label format for facilities that elect to register as outsourcing facilities. Comments are due Aug. 21, 2017. Contact: Domini Bean; FDA, Office of Operations; 301-796 5733; PRAStaff@fda.hhs.gov 82 FR 28076 (06/20/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY FDA Rapid Response Survey GENERAL ENVIRONMENT AND SAFETY Notice of the Food and Drug Administration announces the submission of a continuing generic information collection request to the OMB for use of rapid response surveys. The collection addresses the use of voluntary surveys by community-based health care professionals, general type medical facilities, specialized medical facilities, other health care professionals, patients, consumers, and risk managers working in medical facilities concerning vital information related to medical product risks and interventions to reduce risks. Comments are due July 20, 2017. Contact: Amber Sanford; FDA, Office of Operations; 301-796-8867; PRAStaff@fda.hhs.gov 82 FR 28074 (06/20/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002868-00002 Virginia/Municipal Hydroelectric Project GENERAL ENVIRONMENT AND SAFETY Notice of the Federal Energy Regulatory Commission announces the filing of a hydroelectric application by the City of Radford, Va., for a subsequent minor license for the Municipal Hydroelectric Project on the Little River in Montgomery and Pulaski counties in Virginia. The existing project consists of a reinforced concrete slab and buttress dam, an impoundment, an intake section, a penstock, a powerhouse with a 1,185 kilowatt turbine generator, transmission lines, and appurtenant facilities. The notice specifies that the applicant operates the project in both run-of-river and peaking modes with an annual average generation of approximately 4,550 megawatt-hours. The proposed revision would include transmission facilities composed of only three 4.16 kilovolt overhead conductors that transmit power to a switched disconnect/interconnection with the local distribution grid. The notice also specifies that a formerly licensed transmission line now serves to distribute power to other sources and is no longer part of the project. The notice includes a preliminary licensing procedural schedule. Study requests are due July 29, 2017. Contact: Allyson Conner; FERC; 202-502-6082; allyson.conner@ferc.gov 82 FR 28055 (06/20/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Underground Natural Gas Storage Facilities Safety Issues HAZARDOUS MATERIALS TRANSPORTATION Notice of the Pipeline and Hazardous Materials Safety Administration announces the receipt of a petition by the American Gas Association, the American Petroleum Institute (API), and the American Public Gas Association for reconsideration of a Dec. 19, 2016, interim final rule (81 FR 91860) that amended regulations under 49 CFR 191 and 192 regarding critical safety issues related to downhole facilities, including wells, wellbore tubing and casing, at underground natural gas storage facilities. The rule incorporated by reference two API recommended practices (API RP 1170 and 1171) as of Jan. 18, 2017. The petitioners seek reconsideration of the interim rule's mandatory application of nonmandatory sections of the RPs. PHMSA plans to issue a final rule by January 2018 to address the petition and comments received on the interim rule. For a period of at least one year following publication of the final rule, PHMSA will not issue any enforcement citations for noncompliance with any provisions that are nonmandatory in the RPs or for noncompliance with the requirement to justify and document deviations from the nonmandatory provisions. PHMSA will enforce other compliance deadlines in the interim rule, including the requirement that operators of existing underground gas storage facilities develop, by Jan. 18, 2018, policies and procedures to implement those sections of the RPs that are identified as mandatory in the actual RPs. Contact: Byron Coy; PHMSA; 609-771-7810; atbyron.coy@dot.gov 82 FR 28224 (06/20/2017) Regulatory Update HAZARDOUS WASTE CLEANUP Brownfields/AII Appropriate Inquiries HAZARDOUS WASTE CLEANUP Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002868-00003 Direct final rule of the EPA amends regulations under 40 CFR 312.11 to revise the standards and practices for conducting all appropriate inquiries under CERCLA. The rule incorporates by reference ASTM International Standard E2247-16 regarding the Phase I Environmental Site Assessment Process for Forestland or Rural Property. The rule is effective Sept. 18, 2017, unless adverse comments are received by July 20, 2017. Contact: Patricia Overmeyer; EPA, Office of Brownfields and Land Revitalization; 202-566-2774; overmeyer.patricia@epa.gov 82 FR 28009 (06/20/2017) Regulatory Update HAZARDOUS WASTE CLEANUP Brownfields/AII Appropriate Inquiries HAZARDOUS WASTE CLEANUP Proposed rule of the EPA amends regulations under 40 CFR 312.11 to revise the standards and practices for conducting all appropriate inquiries under CERCLA. The rule incorporates by reference ASTM International Standard E2247-16 regarding the Phase I Environmental Site Assessment Process for Forestland or Rural Property. A concurrent direct final rule adopts the changes, effective Sept. 18, 2017. Comments are due July 20, 2017. Contact: Patricia Overmeyer; EPA, Office of Brownfields and Land Revitalization; 202-566-2774; overmeyer.patricia@epa.gov 82 FR 28040 (06/20/2017) Regulatory Update OCCUPA TIONAL SAFETY AND HEALTH Miners Representative al Identity, Commencement of Operations and Closing of 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 miners representatives, notification of legal identity, and notification of commencement of operations and closing of mines. The collection addresses requirements for persons to file information to be identified as a representative of miners, to post a copy of the information upon receipt by the operator on the mine bulletin board and maintain in current status, and to file a statement with the MSHA district manager terminating their designation if the representative is not able to comply with such requirements (30 CFR 40). The collection also addresses requirements for mine operators to notify MSHA (Form 2000-7) of their legal identity and to request (Form 7000-51) a mine identification number for each mine (30 CFR 41). In addition, the collection addresses requirements for operators of metal and nonmetal mines to notify when operation of a mine will commence or close (30 CFR 56.1000 and 57.1000). Comments are due July 20, 2017. Contact: Michel Smyth; Department of Labor; 202-693-8064; DOL_PRA_PUBLIC@dol.gov 82 FR 28097 (06/20/2017) Regulatory Update OCCUPATIONAL SAFETY AND HEALTH Underground Construction Standard OCCUPATIONAL SAFETY AND HEALTH Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002868-00004 Notice announce the intention of OSHA to seek OMB approval for a continuing information collection regarding the underground construction standard (29 CFR 1926.800). The collection addresses requirements for employers to develop records for air quality tests; to post warning signs or notices during underground construction; and to inspect and load test hoists upon installation, repair, and after tripping a hoist safety device. The collection also addresses requirements for employers to prepare and maintain certification records of inspections and load tests. Comments are due Aug. 21, 2017. Contact: Theda Kenney; OSHA; Directorate of Standards and Guidance; 202-693-2222 82 FR 28098 (06/20/2017) Regulatory Update OIL AND GAS INDUSTRY Gas and Liquid Pipeline Advisory Committees OIL AND GAS INDUSTRY Notice of the Pipeline and Hazardous Materials Safety Administration announces a request for nominations for membership on the Gas Pipeline Advisory Committee (GPAC) and the Liquid Pipeline Advisory Committee (LPAC). The committees provide recommendations and advice on PHMSA's proposed safety standards for gas and hazardous liquid pipelines. The notice specifies that PHMSA is seeking nominations for one federal government and one industry member for the GPAC, and one federal government and three industry members for the LPAC. Nominations are due July 5, 2017. Contact: Cheryl Whetsei; PHMSA; 202-366-4431; cheryl.whetsel@dot.gov 82 FR 28223 (06/20/2017) Regulatory Update RADIATION Applications for Nuclear Power Plants RADIATION Notice of the Nuclear Regulatory Commission announces the issuance of a draft regulatory guide (DG-1325) regarding applications for nuclear power plants. The draft guide revises regulatory guide 1.206, Combined License Applications for Nuclear Power Plants, by updating the format and content of applications, including the review of nuclear power plant design certifications, early site permits, and combined license applications. The revision also removes detailed technical information on the format and content of a safety analysis report, which is proposed to be relocated to NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: Light-Water Reactor Edition, Comments are due Sept. 18, 2017. Contact: Mark Notich; NRC, Office of New Reactors; 301-415-3053; Mark.Notich@nrc.gov 82 FR 28101 (06/20/2017) Regulatory Update RADIATION Nuclear Energy Advisory Committee Meeting RADIATION Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002868-00005 Notice of the Department of Energy, Office of Nuclear Energy, announces the cancellation of a June 20, 2017, meeting of the Nuclear Energy Advisory Committee (82 101; 05/26/2017). The agenda would have included updates on activities of the Office of Nuclear Energy, presentations by Nuclear Energy Advisory Committee subcommittees, and a discussion/vote on the committee's acceptance of the International Subcommittee report. The notice specifies that the next regular meeting will be held on a future date. Contact: Rob Rova; DOE, Office of Energy Efficiency and Renewable Energy; 301-903-9096; robert.rova@nuclear.energy.gov 82 FR 28055 (06/20/2017) Regulatory Update RADIATION Nuclear Power Reactors/Loss-of-Coolant Accidents RADIATION Notice of the Nuclear Regulatory Commission announces the discontinuation of a proposed rulemaking and denial of the associated petition for rulemaking (PRM-50-77) to amend regulations under 10 CFR 50.46 regarding decoupling an assumed loss of off-site power from a loss of off-site power from a loss-of-coolant accident (LOOP/LOCA). The rule would have provided licensees an option to relax analysis requirements for considering a LOOP to occur along with a large-break LOCA. The action is in response to industry feedback that the proposal would be prohibitively expensive for the anticipated benefit. The action is effective June 20, 2017. Contact: Robert Beall; NRC, Office of Nuclear Reactor Regulation; 301-415-3874; Robert.Beall@nrc.gov 82 FR 28017 (06/20/2017) Regulatory Update WATER New Jersey, New York/Clean Water Act Consent Decree WATER Notice of the Department of Justice announces a proposed consent decree in United States v. NVR Inc. (Civil No. 2:17-cv-04346), lodged on June 15, 2017, with the U.S. District Court for the District of New Jersey. The consent decree resolves alleged Clean Water Act violations for discharges of pollutants into stormwater without a permit at various construction sites in New Jersey and New York. The consent decree requires the defendant to pay a civil penalty of $425,000 and implement a nationwide management, inspection, reporting, and training program to improve compliance with stormwater requirements at current and future construction sites. Comments are due July 20, 2017. Contact: Robert Maher; DOJ, Environment and Natural Resources Division; 202-514-2701 82 FR 28095 (06/20/2017) Regulatory Update Privacy Policy | Terms of Service | Manage Your Email | Contact Us Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00002868-00006 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_00002868-00007