Document YjdMJZjEJ3yGM9756GLGMddyy

To: From: Sent: Subject: Jackson, Ryan[jackson.ryan@epa.gov] Bloomberg BNA Thur 9/14/2017 11:41:44 AM Sep. 14 - EHS Federal Regulatory Alert EHS Federal Regulatory Alert September 14, 2017 - Number 177 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 California SIP/Bay Area AQMD Emission Reduction Credit Banking AIR Proposed rule of the EPA would conditionally approve a revision to the Bay Area Air Quality Management District (AQMD) portion of the California SIP. The revision concerns the issuance and banking of emission reduction credits for use in the review and permitting of major sources and major modifications. The EPA determined that the Bay Area AQMD rule is deficient in three respects but that conditional approval of the revision would not interfere with the continued attainment of the NAAQS in the area. The approval is conditioned on the district submitting the required measures by Nov. 1, 2018. Comments are due Oct. 16, 2017. Contact: Laura Yannayon; EPA Region 9; 415-972-3534; yannayon.laura@epa.gov. Citations: 40 CFR 52.220, 52.232 82 FR 43202 (09/14/2017) Regulatory Update AIR California SIP/South Coast AQMD AIR Final rule of the EPA approves revisions to the South Coast Air Quality Management District portion of the California SIP regarding nitrogen oxide (NOx) and sulfur oxide (SOx) emissions from facilities that emit four or more tons per year of NOx or SOx. The rule approves revisions to the district's Regional Clean Air Incentives Market (RECLAIM) program that lower the NOx emission cap, allow electric generating facilities to exit RECLAIM, add provisions regarding facility shutdowns, and create a regional new source review holding account for existing electricity generating facilities constructed after 1993. The rule is effective Oct. 16, 2017. Contact: Nicole Law; EPA Region 9; 415-947-4126; law.nicole@epa.gov. Citations: 40 CFR 52.220 82 FR 43176 (09/14/2017) Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00003683-00001 Regulatory Update AIR Montana SIP/Missoula Carbon Monoxide Limited Maintenance Plan AIR Direct final rule of the EPA approves a revision to the Montana SIP. The revision consists of a second 10-year limited maintenance plan for the eight-hour carbon monoxide NAAQS for the Missoula area. The plan includes an emissions inventory for the base year 2010, an alternative monitoring strategy utilizing average daily traffic vehicle counts, and a contingency plan and demonstrates that the area will maintain the standards into the future. The rule is effective Nov. 13, 2017, unless adverse comments are received by Oct. 16, 2017. Contact: Adam Clark; EPA Region 8, Air Program; 303-312-7104; clark.adam@epa.gov. Citations: 40 CFR 52.1373 82 FR 43180 (09/14/2017) Regulatory Update AIR Montana SIP/Missoula Carbon Monoxide Limited Maintenance Plan AIR Proposed rule of the EPA would approve a revision to the Montana SIP. The revision consists of a second 10-year limited maintenance plan for the eight-hour carbon monoxide NAAQS for the Missoula area. The plan includes an emissions inventory for the base year 2010, an alternative monitoring strategy utilizing average daily traffic vehicle counts, and a contingency plan and demonstrates that the area will maintain the standards into the future. A concurrent direct final rule adopts the revisions, effective Nov. 13, 2017. Comments are due Oct. 16, 2017. Contact: Adam Clark; EPA Region 8, Air Program; 303-312-7104; clark.adam@epa.gov. Citations: 40 CFR 52.1373 82 FR 43208 (09/14/2017) Regulatory Update AIR New York SIP/2008 Eight-Hour Ozone NAAQS AIR Proposed rule of the EPA would conditionally approve revisions to the New York SIP regarding reasonably available control technology (RACT) requirements under the 2008 eight-hour ozone NAAQS. The conditional approval is contingent on the state submitting revised RACT control techniques guidelines (CTG) requirements for control of volatile organic compounds from industrial cleaning solvents within one year of the rule's effective date. The rule also fully approves revisions concerning RACT for non-CTG major sources and major sources of nitrogen oxides and the state's nonattainment new source review certification. Comments are due Oct. 16, 2017. Contact: Anthony Gardella; EPA Region 2; 212-637-3892; Gardella.Anthony@epa.gov. Citations: 40 CFR 52 82 FR 43209 (09/14/2017) Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00003683-00002 Regulatory Update AIR Utah SIP/Fine Particulate Matter and Fugitive Dust AIR Proposed rule of the EPA would approve portions of the Utah SIP regarding fine particulate matter (PM-2.5) and a related fugitive dust control rule. The rule also would approve an associated reasonable available control measures (RACM) determination. The agency is not proposing to determine that the state's PM-2.5 attainment plan has met all requirements regarding RACM. Comments are due Oct. 16, 2017. Contact: Crystal Ostigaard; EPA Region 8; 303-312-6602; ostigaard.crystal@epa.gov. Citations: 40 CFR 52 82 FR 43205 (09/14/2017) Regulatory Update ENDANGERED SPECIES Texas/lncidental Take Permit Application ENDANGERED SPECIES Notice of the National Marine Fisheries Service announces an incidental take permit application and the availability of a conservation plan for the green turtle and Kemp's ridley sea turtle. Barney M. Davis LP, of Corpus Christi, Texas, seeks a 10-year incidental take permit in association with the operation of their power station in Corpus Christi. The station, a natural gasfired electric power generating facility, monitors the intake canal on Laguna Madre in an effort to intercept sea turtles prior to their fatal contact with the facility's cooling water intake structure. The applicant coordinates with Texas Parks and Wildlife Department to collect and relocate the turtles. Comments are due Oct. 16, 2017. Contact: Ron Dean; NMFS, Office of Protected Resources; 301-427-8445 82 FR 43224 (09/14/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Biosimilar Biological Product User Fees GENERAL ENVIRONMENT AND SAFETY Notice of the FDA announces the rates for biosimilar user fees for fiscal year 2018. The fees concern certain activities in connection with biosimilar biological product development, review of certain applications for approval of biosimilar biological products, and each biosimilar biological product approved in a biosimilar biological product application. The fees are effective Oct. 1, 2017, and expire Sept. 30, 2018. Contact: David Haas; FDA, Office of Financial Management; 240 402-9845 82 FR 43241 (09/14/2017) Regulatory Update Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00003683-00003 GENERAL ENVIRONMENT AND SAFETY Environmental Review and Permitting of Infrastructure Projects/CEQ Initial List of Actions GENERAL ENVIRONMENT AND SAFETY Notice of the Council on Environmental Quality announces the availability of the initial list of actions it will take to enhance and modernize the federal environmental review and authorization process, as required under Executive Order 13807 (82 FR 40463; 08/24/2017). The CEQ proposes to develop a framework for the implementation of One Federal Decision for environmental review and refer state projects that qualify for high-priority designation to the Permitting Council, the Transportation Department, and U.S. Army Corps of Engineers, as appropriate. The CEQ also intends to revise its guidance on categorical exclusions under National Environmental Policy Act, preparation of environmental assessments, environmental rule procedures, and use of mitigation and monitoring. In addition, the CEQ intends to review its existing regulations and issue additional guidance to simplify and accelerate the NEPA process for infrastructure projects. Finally, the CEQ proposes to convene an interagency working group to review agency NEPA implementing regulations and other environmental review and authorization procedures and policies. Federal agencies involved in the working group would be required to develop action plans and timelines for completing identified actions and to establish procedures for a regular reviewand update of categorical exclusions. Contact: Ted Boling; CEQ; 202-395-5750; NEPA@ceq.eop.gov 82 FR 43226 (09/14/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY FDA-Regulated Product Focus Groups GENERAL ENVIRONMENT AND SAFETY Notice of the FDA announces the submission of a continuing information collection request to the OMB regarding FDA-regulated product focus groups. The collection addresses data gathered from patients and consumers through focus group interviews on regulated products, including drugs, biologies, devices, food, tobacco, and veterinary medicine. The collection also seeks to obtain patient and consumer information useful in developing variables and measures for quantitative studies, to develop a better understanding of patients' and consumers' attitudes and emotions in response to topics and concepts, and to further explore findings obtained from quantitative studies. Comments are due Oct. 16, 2017. Contact: Amber Sanford; FDA, Office of Operations; 301-796-8867; PRAStaff@fda.hhs.gov 82 FR 43243 (09/14/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Food Additive Petition/GLA Safflower Oil GENERAL ENVIRONMENT AND SAFETY Notice of the FDA announces the filing of a food additive petition by Arcadia Biosciences Inc., of Davis, Calif,, to provide for the safe use of gamma-linolenic acid (GLA) safflower oil as a nutritional source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage. If the FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. Contact: Carissa Doody; FDA, Center for Veterinary Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00003683-00004 Medicine; 240-402-6283; carissa.doody@fda.hhs.gov. Citations: 21 CFR 573 82 FR 43197 (09/14/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Prescription Drug User Fees GENERAL ENVIRONMENT AND SAFETY Notice of the FDA announces the rates for prescription drug user fees for fiscal year 2018. The fees concern certain applications for the review of human drug and biological products and prescription drug program fees for certain approved products. The fees are effective Oct. 1, 2017, and expire Sept. 30, 2018. Contact: Robert Marcarelli; FDA, Office of Financial Management; 301 796-7223 82 FR 43244 (09/14/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Applications for Special Permits HAZARDOUS MATERIALS TRANSPORTATION Notice of PHMSA announces the receipt of 19 new applications for special permits related to specified hazardous materials transportation regulations. Comments are due Oct. 16, 2017. Contact: Ryan Paquet; PHMSA, Office of Hazardous Materials Approvals and Permits; 202-366 4535. Citations: 49 CFR 105, 172,173,175,177, 178,180 82 FR 43285 (09/14/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Applications for Special Permits HAZARDOUS MATERIALS TRANSPORTATION Notice of PHMSA announces the receipt of 20 new applications and 14 modified applications for special permits related to specified hazardous materials transportation regulations. Comments are due Oct. 16, 2017. Contact: Ryan Paquet; PHMSA, Office of Hazardous Materials Approvals and Permits; 202-366-4535. Citations: 49 CFR 3,171 through 180 82 FR 43286 (09/14/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Electronic Logging Device Exemption/Power and Communicatic HAZARDOUS MATERIALS TRANSPORTATION ractors Association Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00003683-00005 Notice of the Federal Motor Carrier Safety Administration announces the receipt of an application from the Power and Communication Contractors Association for an exemption for all operators of commercial motor vehicles in the power and communications construction industry. The applicant requests an exemption from the installation and driver use requirements for electronic logging devices designed to record driver hours-of-service. Comments are due Oct. 16, 2017. Contact: Tom Yager; FMCSA, Driver and Carrier Operations Division; 614-942-6477; MCPSD@dot.gov 82 FR 43283 (09/14/2017) Regulatory Update HAZARDOUS WASTE MANAGEMENT Arkansas/Hazardous Waste Management Program HAZARDOUS WASTE MANAGEMENT Direct final rule of the EPA grants final authorization of revisions to the Arkansas hazardous waste program under RCRA. The revisions clarify federal standards related to generators of hazardous waste and owners and operators of hazardous waste treatment, storage, and disposal facilities. The rule is effective Nov. 13, 2017, unless adverse comments are received by Oct. 16, 2017, Contact: Alima Patterson; EPA Region 6, RCRA Permit Section; 214-665-8533; patterson.alima@epa.gov. Citations: 40 CFR 271,272.01,272 Appendix A 82 FR 43185 (09/14/2017) Regulatory Update HAZARDOUS WASTE MANAGEMENT Arkansas/Hazardous Waste Management Program HAZARDOUS WASTE MANAGEMENT Proposed rule of the EPA would grant final authorization of revisions to the Arkansas hazardous waste program under RCRA. The revisions clarify federal standards related to generators of hazardous waste and owners and operators of hazardous waste treatment, storage, and disposal facilities. A concurrent direct final rule adopts the revisions, effective Nov. 13, 2017. Comments are due Oct. 16, 2017. Contact: Alima Patterson; EPA Region 6, RCRA Permit Section; 214-665 8533; patterson.alima@epa.gov. Citations: 40 CFR 271,272.01,272 Appendix A 82 FR 43214 (09/14/2017) Regulatory Update OCCUPATIONAL SAFETY AND HEALTH Records and Reports of Job-Related Injuries and Illnesses OCCUPATIONAL SAFETY AND HEALTH Notice announces the intention of OSHA to seek OMB approval for a continuing information collection request regarding the maintenance of records and reports by employers of job-related injuries and illnesses. The records are needed to facilitate safe and healthful work environments and for the Bureau of Labor Statistics to report on the number and rate of occupational injuries Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00003683-00006 and illnesses in the U.S. The information also is needed to increase employer awareness of the types of injuries and illnesses occurring in the workplace and their related hazards. Comments are due Nov. 13, 2017. Contact: Dave Schmidt; OSHA, Office of Statistical Analysis; 202-693-1886; schmidt.dave@dol.gov. Citations: 29 CFR 1904 82 FR 43255 (09/14/2017) Regulatory Update WATER Waiver of Compliance with Navigation Laws/Hurricanes Harvey and Irma WATER Notice of the Department of Homeland Security announces an immediate seven-day waiver of provisions of the Jones Act, which requires certain vessels providing transportation of merchandise by water or by water and land between points in the U.S. to have a coastwise endorsement, or the vessel was built in and documented under U.S. laws and is wholly owned by U.S. citizens. The waiver is being provided due to severe disruptions in both the midstream and downstream sectors of the Gulf Cost oil supply system due to Hurricane Harvey and the potential imminent shortage of energy supply in areas affected by Hurricane Irma. The waiver is intended to facilitate movement of refined petroleum products, including gasoline, diesel, and jet fuel, to be shipped from Louisiana, New York, Pennsylvania, and Texas to Florida, Georgia, Puerto Rico, and South Carolina. The waiver is effective Sept. 8, 2017. Contact: DHS; 202-282-8010 82 FR 43248 (09/14/2017) 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_00003683-00007