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Jackson, Ryan[jackson.ryan@epa.gov] Bloomberg BNA Mon 10/2/2017 12:26:37 PM Oct. 02 - EHS Federal Regulatory Alert
EHS Federal Regulatory Alert
October 02, 2017 - Number 189
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Summaries
AIR 2008 Ozone NAAQS State Implementation Plans AIR
Notice of the EPA announces the submission of a continuing information collection request to the OMB regarding state implementation requirements of the 2008 ozone NAAQS adopted under a March 15, 2015, final rule (80 FR 12264). The collection addresses information from 17 states with 30 areas designated nonattainment for the 2008 eight-hour NAAQS, including state submissions of attainment demonstrations, request for proposal plans, and reasonably available control technology determinations. Comments are due Nov. 1, 2017. Contact: Lynn Dail; EPA, Air Quality Policy Division; 919-541-2363; dail.lynn@epa.gov. Citations 40 CFR 50, 51
82 FR 45843 (10/02/2017)
Regulatory Update
AIR Ambient Air Monitoring Reference and Equivalent Methods AIR
Notice of the EPA announces the designation of one new ambient air monitoring reference method for measuring concentrations of carbon monoxide (CO). The method is the Sabio Model 6050 Ambient CO Analyzer, an automated method utilizing a measurement principle based on nondispersive infrared analysis. The application was filed by the Sultron Corp., of Round Rock, Texas. Contact: Robert Vanderpool; EPA, National Exposure Research Laboratory; 919-541-7877; Vanderpool.Robert@epa.gov. Citations: 40 CFR 53, 58
82 FR 45842 (10/02/2017)
Regulatory Update
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AIR New Mexico SIP/Regional Haze Progress Report for Albuquerque and Bernalillo County AIR
Proposed rule of the EPA would approve portions of revisions to the New Mexico SIP for the city of Albuquerque and Bernalillo County. The rule would approve revisions concerning the city and county's regional haze five-year progress report as meeting applicable regional haze requirements and the determination that the current regional haze SIP is adequate to meet the state's 2018 reasonable progress goals. Comments are due Nov. 1,2017. Contact: James Grady; EPA Region 6; 214-665-6745; grady.james@epa.gov. Citations: 40 CFR 51.309, 52
82 FR 45762 (10/02/2017)
Regulatory Update
ENDANGERED SPECIES California/Naval Base Point Loma Pier Replacement Project ENDANGERED SPECIES
Notice of the National Marine Fisheries Service announces the issuance of an incidental harassment authorization request to the U.S. Navy to take nine species of marine mammals incidental to demolition and pile installation activities associated with a multiyear pier replacement project at Naval Base Point Loma in San Diego. The authorization allows take in the form of Level B harassment for one year. The authorization is effective Oct. 8, 2017, and expires Oct. 7, 2018. Contact: Laura McCue; NMFS, Office of Protected Resources; 301-427-8401; ITP.McCue@noaa.gov
82 FR 45811 (10/02/2017)
Regulatory Update
ENDANGERED SPECIES Connecticut/Marine Mammal Incidental Take ENDANGERED SPECIES
Notice of the National Marine Fisheries Service announces the receipt of a request from the U.S. Navy for authorization to take marine mammals incidental to noise exposure resulting from pier construction activities at the Navy Submarine Base New London in Groton, Conn. The authorization would allow the take of harbor and gray seals by Level A and B harassment during in-water construction and demolition over a five-year period beginning October 2018. Comments are due Nov. 1,2017. Contact: Shane Guan; NMFS, Office of Protected Resources; 301-427-8401
82 FR 45828 (10/02/2017)
Regulatory Update
ENDANGERED SPECIES Utah/Deseret Milkvetch Delisting ENDANGERED SPECIES
Proposed rule of the U.S. Fish and Wildlife Service would remove the Deseret milkvetch, found in
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Utah, from the list of endangered and threatened plants. The rule also includes the agency's 12month finding on a petition to delist the milkvetch. The agency requests information regarding reasons why the delisting should or should not occur; threats; efforts to protect or conserve the species; range, distribution, and population size; and post-delisting monitoring. Hearing requests are due Nov. 16, 2017. Comments are due Dec. 1,2017. Contact: Larry Crist; USFWS, Utah Ecological Services Field Office; 801-975-3330. Citations: 50 CFR 17.12
82 FR 45779 (10/02/2017)
Regulatory Update
FOOD SAFETY
Food Labeling/Nutrition and Supplement Facts Labels, Serving Size
FOOD SAFETY
'
Proposed rule of the FDA would extend the compliance dates for revised requirements for Nutrition Facts and Supplement Facts labels and require that all containers, including containers of products with large reference amounts customarily consumed (RACCs) containing less than 200 percent of the RACC be labeled as a single-serving container (81 FR 33742, 81 FR 34000; 05/27/2016). The current rule would extend the compliance date for manufacturers with $10 million or more in annual food sales to Jan. 1,2020, and the compliance date for manufacturers with less than $10 million in annual food sales to Jan. 1,2021. The extension is intended to ensure that manufacturers covered by the final rules have guidance from the FDA to address certain technical questions received after publication of the final rules and are able to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules. Comments are due Nov. 1,2017. Contact: Paula Trumbo; FDA, Center for Food Safety and Applied Nutrition; 240-402-2579. Citations: 21 CFR 101.9,101.12, 101.30,101.36
82 FR 45753 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Arizona/Apache-Sitgreaves National Forests Motorized Travel Management Plan GENERAL ENVIRONMENT AND SAFETY
Notice announces the intention of the U.S. Forest Service to prepare a revised draft environmental impact statement for the public motorized travel management plan for the Apache Sitgreaves National Forests in Apache, Coconino, Greenlee, and Navajo counties in Arizona. The plan will designate a system of roads, trails, and areas for motorized use as well as motorized access for dispersed camping and for big game retrieval. The revised EIS updates an Oct. 29, 2010 draft EIS (75 FR 66756) by addressing new information, including changed conditions due to the Wallow Fire of 2011, the 2015 land management plan for the Apache-Sitgreaves National Forests, and changes in aquatic and terrestrial species status. It also addresses more accurate road mapping based on light detection and ranging data and aerial photography, and USFS decisions made under the National Environmental Policy Act since the 2010 draft EIS. The revised draft EIS is expected to be available in the summer of 2018 and the final EIS is expected in the winter of 2019. Comments are due 45 days after the publication of the revised draft EIS in the Federal Register. Contact: Jennie O'Connor Card; USFS; 406-522-2537; jennieoconnorcard@fs.fed.us
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82 FR 45800 (10/02/2017) Regulatory Update
GENERAL ENVIRONMENT AND SAFETY California/Elk Creek Watershed Project GENERAL ENVIRONMENT AND SAFETY
Notice announces the intention of the U.S. Forest Service to prepare an environmental impact statement for the Elk Creek Watershed Project in the Klamath National Forest in California. The project is intended to address the need to manage forest stands to be more resilient to future disturbances, improve water quality to maintain and restore riparian and aquatic habitat, improve terrestrial habitat for northern spotted owl and Roosevelt elk, reduce fuel accumulations, and improve cultural resources. The project would include eight types of vegetation treatments and various recreation improvements. The draft EIS is expected to be available in June 2018 and the final EIS is expected to be available in February 2019. Comments are due Nov. 16, 2017. Contact: Dock Chastain; USFS; 530-493-1742; jchastain@fs.fed.us
82 FR 45797 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY California/Sites Reservoir Project GENERAL ENVIRONMENT AND SAFETY
Notice of the Bureau of Reclamation announces an extension of the comment period and rescheduling of meetings on a draft environmental impact report/environmental impact statement and draft feasibility report for the Sites Reservoir Project in Colusa and Glenn counties in California (82 FR 39454, 08/18/2017). The project would consist of a new offstream surface storage reservoir with two main dams, up to nine saddle dams, and up to three recreation areas. The reservoir would be filled via two Sacramento River diversions/canals and a new inlet/outlet structure and pipeline to allow for diversion of excess river flows. The project also would include modifications to an existing diversion facility at the Red Bluff Pumping Plant in Tehama County. Meetings now are scheduled for Dec. 5 and 7, 2017, in Sacramento and Maxwell, Calif., respectively. Comments noware due Jan. 15, 2018. Contact: Michael Dietl; Bureau of Reclamation; 916-978-5070; mdietl@usbr.gov
82 FR 45887 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Classification of the High Intensity Ultrasound System for Prost GENERAL ENVIRONMENT AND SAFETY
sue Ablation
Final rule of the FDA codifies a final order to classify the high intensity ultrasound system for prostate tissue ablation into class II (special controls). The order is issued in response to a de novo application submitted by SonaCare Medical LLC of Charlotte, N.C., regarding the Sonablate 450 device. The prescription device transmits high intensity therapeutic ultrasound energy into the prostate to thermally ablate a defined and targeted volume of tissue, performed
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under imaging guidance. The classification was applicable on Oct 9, 2015. The order is effective Oct, 2, 2017, Contact: John Baxley; FDA, Centers for Devices and Radiological Health; 301-796 6549; john.baxley@fda.hhs.gov. Citations: 21 CFR 876.4340
82 FR 45725 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Control of Yellow Toadflax GENERAL ENVIRONMENT AND SAFETY
Notice of the Animal and Plant Health Inspection Service announces the availability of a draft environmental assessment regarding control of yellow toadflax, an invasive plant in pastures and crops, particularly in the northern prairies of North America. The EA addresses the proposed issuance of permits for the field release of the stem gall weevil into the continental U.S. for classical biological control of yellow toadflax. Comments are due Nov. 1,2017. Contact: Colin Stewart; APHIS; 301-851-2327; Colin.Stewart@aphis.usda.gov
82 FR 45796 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Departm
isportation Regulatory Review
GENERAL ENVIRONMENT AND SAFETY
Notice of the Transportation Department announces a review of existing regulations and other agency actions, as required by the DOT'S regulatory policies and procedures, Section 610 of the Regulatory Flexibility Act, and multiple Executive Orders. The review is intended to ensure agency regulations continue to meet the needs for which they originally were designed, remain cost-effective and cost-justified, and promote clean and safe development of energy resources while avoiding regulatory burdens. The notice provides a list of economically significant rules issued between Oct. 16, 2008, and Dec. 8, 2016, and seeks public comment on burdens related to these rules or others. The list includes rules concerning motor vehicle safety standards, pipeline safety standards, greenhouse gas emissions and average fuel economy standards, air traffic control, positive train control systems, tank car standards for high-hazard flammable trains, and commercial drivers. A meeting may be announced at a later date. Comments are due Nov. 1, 2017. Contact: Jonathan Moss; DOT; 202-366-4723; jonathan.moss@dot.gov. Citations: 4 CFR Chapters I, II, III; 23 CFR Chapters I, II, III; 46 CFR Chapter II; 48 CFR Chapter 12; 49 CFR Chapters I, II, III, V, VI, VII, VIII, X, XI
82 FR 45750 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Displ
ices for Diagnostic Radiology
GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces the availability of a final guidance for industry regarding display
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devices for diagnostic radiology. The guidance addresses the types of information that should be provided in premarket notification submissions for display devices intended for diagnostic radiology with product code PGY. Such products are class II devices that are used in controlled viewing conditions for primary image interpretation. The guidance replaces a May 2008 guidance regarding display accessories for full-field digital mammography systems-premarket notification (501 (k)) submissions. Comments may be submitted at any time. Contact: Robert Ochs; FDA, Center for Devices and Radiological Health; 301-796-6661. Citations: 21 CFR 807, Subpart E; 892.2050
82 FR 45853 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Electronic Study Data Submission Standards GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces support for version 1.1 of the Clinical Data Interchange Standards Consortium Analysis Data Model Implementation Guide (ADaM IG V1.1), an update to the FDA Data Standards Catalog for electronic study data provided in new drug applications (NDAs), abbreviated NDAs, biologies license applications, and investigational NDAs. The FDA encourages sponsors and applicants to use ADaM IG V1.1 in investigational study data provided in regulatory submissions to the Center for Drug Evaluation and Research. The transition date for support of the new version is March 15, 2018, but it will be required in submissions for studies that start after March 15, 2019. Comments may be submitted at any time. Contact: Ron Fitzmartin; FDA, Center for Drug Evaluation and Research; 301-796-5333; CDERDataStandards@fda.hhs.gov
82 FR 45858 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Equivalence of Complex Products Workshop GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces a workshop concerning demonstration of equivalence of generic complex drug substances and formulations relating to advances in characterization and in vitro testing. The workshop is intended to address evaluation and characterization of critical quality attributes for complex drug substances and formulations and innovative approaches for development and review of equivalent products. The workshop also will serve to collect input from stakeholders on how to conduct and assess critical quality attribute measurements to demonstrate equivalence of complex drug products. The workshop is scheduled for Oct. 6, 2017, in Silver Spring, Md,, and via videocast. Comments are due Nov. 10, 2017. Contact: Xiaohui Jiang; FDA, Center for Drug Evaluation and Research; 240-402-4468; Xiaohui.Jiang@fda.hhs.gov
82 FR 45856 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY First Responder Network Authority/South Region
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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 south region of the proposed nationwide public safety broadband network. The PEIS addresses deployment and operation of the network in the south region consisting of Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, New Mexico, North Carolina, Oklahoma, South Carolina, Tennessee, and Texas. 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 45806 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Idaho/Lolo Insect and Disease Project GENERAL ENVIRONMENT AND SAFETY
Notice of the U.S. Forest Service announces a revised notice of intent to prepare an environmental impact statement for the Lolo Insect and Disease Project in the Nez PerceClearwater National Forests in Idaho. The project consists of forest management and watershed improvement activities within the Lolo Creek watershed near Kamiah to achieve a range of age and size classes with species diversity that is resistant and resilient to change agents such as insects, diseases, and wildfires. The notice reinitiates the NEPA process initiated under an April 25, 2013, notice of intent (78 FR 24718) by updating the purpose and need, proposed action, expected dates of the draft EIS (January 2018) and final EIS (August 2018), and contact and agency information. Comments are due Oct. 17, 2017. Contact: Sara Daugherty; USFS; 208-926 6404; sddaugherty@fs.fed.us
82 FR 45798 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Marketing Clearance of Diagnostic Ultrasound Systems a GENERAL ENVIRONMENT AND SAFETY
nsducers
Notice of the FDA announces the availability of a draft guidance for industry and agency staff regarding marketing clearance of diagnostic ultrasound systems and transducers. The guidance provides recommendations for manufacturers seeking such marketing clearance and is intended to supersede a 2008 FDA guidance on the subject. The guidance also addresses when a device modification to a diagnostic ultrasound device can be made without the need for submission of a premarket notification submission. Comments are due Jan. 2, 2018. Contact: Shahram Vaezy; FDA, Center for Devices and Radiological Health; 301-796-6242. Citations: 21 CFR 892.1550, 892.1560, 892.1570
82 FR 45854 (10/02/2017)
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Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Material Threat Medical Countermeasure Priority Review Voucher Fee GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces a user fee rate of approximately $2.8 million for material threat medical countermeasure (MCM) priority review vouchers for fiscal year 2018. The notice also describes the payment procedures for such fees, which apply to certain applications for review of human drug products that use a material threat MCM priority review voucher. The rate is effective Oct. 1, 2017, and expires Sept. 30, 2018. Contact: Robert Marcarelli; FDA, Office of Financial Management; 301-796-7223
82 FR 45859 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Quantitative Modeling and Simulations in Generic Drug Development Workshop GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces a workshop regarding the conduct of quantitative modeling and simulations in generic drug development. The workshop will address scientific approaches and applications and include discussions concerning opportunities and knowledge gaps to inform regulatory decision-making through the product lifecycle. The agency intends to utilize the information to support product-specific guidance development, improve preabbreviated new drug applications interactions with applicants, increase the quality and efficiency of regulatory reviews, and specify a next generation modeling and simulation toolset for complex and locally acting products. The workshop is scheduled for Oct. 2-3, 2017, in Silver Spring, Md. Comments are due Nov. 3, 2017. Contact: Lanyan Fang; FDA, Center for Drug Evaluation and Research; 301 796-5005; lanyan.fang@fda.hhs.gov
82 FR 45863 (10/02/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Wyoming/Kemmerer Grazing and Rangeland Vegetation Management Project GENERAL ENVIRONMENT AND SAFETY
Notice of the U.S. Forest Service announces revisions to a notice of intent (73 FR 67835; 11/17/2008) to prepare an environmental impact statement to analyze the effects of continued authorization for the Kemmerer Grazing and Rangeland Vegetation Management Project in the Bridger-Teton National Forest in Wyoming. The existing project consists of 181,227 acres of grazing on 17 sheep allotments. The EIS will update domestic sheep grazing and rangeland vegetation management plans and consider a no livestock grazing alternative. The revisions update and supplement the previous notice and add the Trespass Creek Allotment. The issuance of a draft EIS is scheduled for June 2018, and the issuance of a final EIS is scheduled for June 2019. Comments are due Nov. 1, 2017. Contact: Aaron Zobell; USFS, Kemmerer Ranger District; 307- 828-5100; richardazobell@fs.fed.us
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82 FR 45802 (10/02/2017) Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Wyoming/Rawli
sing Plant
GENERAL ENVIRONMENT AND SAFETY
Notice of FERC announces the filing of an application by Colorado Interstate Gas Co., of Colorado Springs, Colo,, for authorization to abandon certain facilities related to the Rawlins Processing Plant in Carbon County, Wyo. The facilities include the lean oil processing and fractionation plants, natural gas liquids truck off-loading facilities, and natural gas liquids interconnecting facilities that tie into the Overland Pass Pipeline of the Overland Pass Pipeline Co,, of Cheyenne, Wyo. The applicants also request authorization to abandon by sale natural gas liquids pipelines, associated natural gas liquids measurements facilities, and natural gas liquids rail loading facilities to Sinclair Wyoming Refining Co., of Sinclair, Wyo. The agency will complete an environmental assessment or issue a notice of schedule of environmental review by Dec. 26, 2017. Comments are due Oct. 17, 2017. Contact: FERC, Office of External Affairs; 866-208-3676; ferconlinesupport@ferc.gov
82 FR 45841 (10/02/2017)
Regulatory Update
HAZARDOUS MATERIALS TRANSPORTATION Underground Natural Gas Storage Facility Annual Report HAZARDOUS MATERIALS TRANSPORTATION
Notice of the PHMSA announces receipt of OMB approval to change the due date for the first annual report for underground natural gas storage facilities. The report addresses data that must be submitted by March 15 for the preceding calendar year from operators of underground natural gas storage facilities (Form 7100.4-1). An exception for the due date of the first annual report, which had been due by July 18, 2017, is extended to March 15, 2018, for reported information for calendar year 2017. Contact: Crystal Stewart; PHMSA, Office of Pipeline Safety Operations Systems Division; 202-366-1524; crystal.stewart@dot.gov. Citations: 49 CFR 191.17
82 FR 45946 (10/02/2017)
Regulatory Update
HAZARDOUS WASTE CLEANUP California/Casmalia Resources Site HAZARDOUS WASTE CLEANUP
Notice of the EPA announces a proposed administrative de minimis settlement with 57 settling parties regarding the Casmalia Resources Superfund Site in Santa Barbara County, Calif. The settlement requires the parties to pay approximately $590,772, to resolve liabilities for response costs and potential natural resource damages claims. Meeting requests are due Oct. 16, 2017. Comments are due Nov. 1, 2017. Contact: Russell Mechem; EPA Region 9; 415-972-3192; Mechem.russell@epa.gov.
Sierra Club v. EPA, 1:17-cv-01906
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82 FR 45846 (10/02/2017) Regulatory Update
HAZARDOUS WASTE CLEANUP Minnesota/St. Regis Paper Superfund Site HAZARDOUS WASTE CLEANUP
Notice of the Justice Department announces a proposed consent decree in United States v. City of Cass Lake (Civil Action No. 17-4367), lodged on Sept. 22, 2017, with the U.S. District Court for the District of Minnesota. The consent decree resolves claims under CERCLA concerning response costs and injunctive relief associated with the release and threatened release of hazardous substances from facilities at and near the St. Regis Paper Co. Superfund Site, in Cass Lake, Minn. The consent decree requires the defendant to pay $30,000 and to cooperate with the EPA and any other parties performing cleanup work at the site. It also requires the defendant to assist with implementing any necessary land use restrictions. Comments are due Nov. 1,2017. Contact: DOJ, Environment and Natural Resources Division; 202-514-2701
82 FR 45894 (10/02/2017)
Regulatory Update
HAZARDOUS WASTE CLEANUP Rhode Island/Great Lakes Container Corp. Superfund Site HAZARDOUS WASTE CLEANUP
Notice of the EPA announces a proposed first amendment to a 2010 settlement agreement (75 FR 34448; 06/17/2010) under CERCLA with Teknor Apex Co., of Pawtucket, R.I., and J P Hass and Sons and its affiliate Hass Brothers Inc. regarding the Great Lakes Container Corp. Superfund Site in Coventry, R.l. The amendment adds the settling parties as additional drum reconditioning customers and respondents and requires Teknor Apex and J P Hass and Sons to each pay $7,692 for past costs. Comments are due Nov. 1,2017. Contact: John Hultgren; EPA Region 1, Superfund Division; 617-918-1761; hultgren.john@epa.gov
82 FR 45842 (10/02/2017)
Regulatory Update
HAZARDOUS WASTE MANAGEMENT Texas/Samsung Austin Semiconductor Hazardous Waste Delisti HAZARDOUS WASTE MANAGEMENT
ition
Final rule of the EPA conditionally excludes the copper filter cake (F006) wastewater treatment sludge generated by Samsung Austin Semiconductor, of Austin, Texas, from the lists of hazardous waste under RCRA. Samsung will be permitted to generate the sludge, which is produced during the electroplating process, at a maximum rate of 750 cubic yards annually. The delisting is effective only in states subject to the federal RCRA delisting program. The rule also requires Samsung to perform specified analytical testing, to submit testing data, and to provide notification to the relevant state regulatory agency before transporting the delisted waste. The rule is effective Oct. 2, 2017. Contact: Michelle Peace; EPA Region 6; 214-665-7430; peace.michelle@epa.gov. Citations: 40 CFR 261.31, 261.32, Appendix IX
Sierra Club v. EPA, 1:17-cv-01906
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82 FR 45736 (10/02/2017)
Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH Advisory Board on Radiation and Worker Health/Procedures Review Subcommittee Meeting OCCUPATIONAL SAFETY AND HEALTH
Notice of the CDC announces a meeting of the Advisory Board on Radiation and Worker Health, Procedures Review Subcommittee, to discuss several dose reconstruction procedures, including OCAS Program Evaluation Report 59 (addressing dose reconstructions at the Norton Co. in Worcester, Mass.); DCAS Report 5: Alternative Dissolution Models for Insoluble Plutonium 238; Outstanding Findings of Prior Subcommittee Reviews; and DCAS Procedures Not Yet Reviewed. Agenda items are subject to change as priorities dictate. The meeting is scheduled for Nov. 20, 2017, via teleconference. Comments are due in advance of the meeting. Contact: Theodore Katz; CDC; 513-533-6800; ocas@cdc.gov
82 FR 45852 (10/02/2017)
Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH General Working Conditions in Shipyard Employment OCCUPATIONAL SAFETY AND HEALTH
Notice announces the intention of OSHA to seek OMB approval for a continuing information collection request concerning the general working conditions in shipyard employment standard. The collection addresses worker safety requirements related to housekeeping, lighting, utilities, working alone, vessel radar and communication systems, lifeboats, medical services and first aid, and sanitation. The collection also addresses safety requirements related to control of hazardous energy; safety color code for marking physical hazards; accident prevention signs and tags; retention of Transportation Department markings, placards, and labels; motor vehicle safety equipment operation and maintenance; and servicing multi-piece and single-piece rim wheels. Comments are due Dec. 1,2017. Contact: Todd Owen; OSHA, Directorate of Standards and Guidance; 202-693-2222. Citations: 29 CFR 1915, Subpart F
82 FR 45900 (10/02/2017)
Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH Nationally Recognized Testing Laboratories/IAPMO OCCUPATIONAL SAFETY AND HEALTH
Notice of OSHA announces a final decision to grant an application from International Association of Plumbing and Mechanical Officials EGS (IAPMO), of Ontario, Calif., for expansion of its recognition as a nationally recognized testing laboratory. The expansion involves the addition of four testing standards to its scope of recognition. The decision is effective Oct. 2, 2017. Contact: Kevin Robinson; OSHA, Directorate of Technical Support and Emergency Management; 202-693 2110; robinson.kevin@dol.gov. Citations: 29 CFR 1910.7
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82 FR 45899 (10/02/2017) Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH Nationally Recognized Testing Laboratories/TUVRNA OCCUPATIONAL SAFETY AND HEALTH
Notice of OSHA announces a final decision to grant an application from TUV Rheinland of North America Inc. (TUVRNA) Inc., of Newtown, Conn., for expansion of its recognition as a nationally recognized testing laboratory. The expansion involves the addition of the test standard for low voltage lighting systems to its scope of recognition. The decision is effective Oct. 2, 2017. Contact: Kevin Robinson; OSHA, Directorate of Technical Support and Emergency Management; 202-693-2110; robinson.kevin@dol.gov. Citations: 29 CFR 1910.7
82 FR 45898 (10/02/2017)
Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH Standard on Powered Platforms for Building Maintenance OCCUPATIONAL SAFETY AND HEALTH
Notice of OSHA announces the submission of a continuing information collection request to the OMB regarding the standard on powered platforms for building maintenance. The collection addresses the requirement for employers to develop and implement written emergency action plans for each type of powered platform operation. The plan must explain the emergency procedures that workers are to follow if they encounter a disruption of the power supply, an equipment failure, or other emergency. Comments are due Nov. 1,2017. Contact: Michel Smyth; Labor Department; 202-693-4129; DOL_PRA_PUBLIC@dol.gov. Citations: 29 CFR 1910.66
82 FR 45897 (10/02/2017)
Regulatory Update
OIL AND GAS INDUSTRY
Monthly Crude Oil and Lease Condensate, and Natural Gas Product
port
OIL AND GAS INDUSTRY
Notice of the Energy Information Administration announces the filing of a revised information collection request to the OMB concerning monthly crude oil and natural gas production. The collection addresses the use of Form EIA-914 by well operators to report monthly state level data on natural gas production, crude oil and lease condensate production, and crude oil and lease condensate sales by the API gravity category within the U.S. The revisions update the format and title of the form and provide for publication of separate estimates for the Alabama, Michigan, Mississippi, Virginia, and federal offshore Pacific categories. Comments are due Nov. 1, 2017. Contact: Jessica Biercevicz; EIA; 202-586-4299; jessica.biercevicz@eia.gov
82 FR 45834 (10/02/2017)
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Regulatory Update
PESTICIDES Pesticide Tolerances/Fluoxastrobin PESTICIDES
Final rule of the EPA establishes tolerances for residues of the fungicide fluoxastrobin and its Z isomer in or on avocado at 1.0 parts per million (ppm); barley, grain at 0,4 ppm; barley, hay at 15 ppm; barley, straw at 15 ppm; rapeseed subgroup 20A at 0.7 ppm; and dried shelled pea and bean (except soybean) subgroup 6C at 0.2 ppm. The approved tolerances differ slightly from the petitioned tolerances based on data submitted with the petition. The rule is issued in response to a petition filed by Arysta LifeScience North America LLC, of Cary, N.C. The rule is effective Oct. 2, 2017. Objections and hearing requests are due Dec. 1,2017. Contact: Michael Goodis; EPA, Office of Pesticide Programs; 703-305-7090; RDFRNotices@epa.gov. Citations: 40 CFR 180.609
82 FR 45730 (10/02/2017)
Regulatory Update
RADIATION Abnormal Occurrences Policy Statement RADIATION
Notice of the NRC announces the issuance of revisions to the policy statement on reporting abnormal occurrences (AOs) to Congress. AOs involve a major reduction in the degree of protection of public health or safety. The agency is required to provide the date, place, nature, and probable consequence of each AO; the cause or causes of each AO; and any actions taken to prevent recurrence in its report. The revisions clarify and restructure the criteria used by the NRC and agreement states for determining whether to consider an incident or event as an AO. The revisions also provide for consistency with current NRC guidance and requirements. The revisions are effective Oct. 2, 2017. Contact: Tanya Oxenberg; NRC, Office of Nuclear Regulatory Research; 301-415-2437; Tanya.Oxenberg@nrc.gov. Citations: 10 CFR 20 through 76 (nonconsecutive)
82 FR 45907 (10/02/2017)
Regulatory Update
RADIATION Laser Illuminated Projectors Guidance RADIATION
Notice of the FDA announces the availability of a draft guidance for industry and agency staff regarding classification of and requirements for laser illuminated projectors (LIPs) that project full-frame digital images. The guidance would clarify the application of certain aspects of the performance standard requirements in 21 CFR 1040.11(c). Specifically, the FDA does not intend to consider whether LIP manufacturers who conform to an alternative standard (IEC-624715:2015) under certain situations also comply with 21 CFR 1040.11(c). LIP manufacturers who choose not to conform to the alternative standards under the specified situations should evaluate these laser products in accordance with the FDA's guidance entitled Laser Products-Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50); Guidance for Industry
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and FDA Staff or continue to comply with 21 CFR 1040.10(c) and 21 CFR 1040.11(c), among other applicable requirements. When finalized, the guidance will supersede guidance issued in February 2015. Comments are due Dec. 1, 2017. Contact: Patrick Hintz; FDA, Center for Devices and Radiological Health; 301-796-6927. Citations: 21 CFR 1040.10,1040.11
82 FR 45861 (10/02/2017)
Regulatory Update
RADIATION Nuclear Reactors/Operator Simulator Training Data RADIATION
Notice of the NRC announces the submission of a new information collection request to the OMB concerning use by nuclear power stations with an onsite reactor simulator of Scenario Authoring, Characterization, and Debriefing Application software for operator simulator training. Use of the software is voluntary and free software licenses, training, and technical support will be provided by the NRC. The collection addresses data to be collected from users approximately six times during their training cycle. Comments are due Nov. 1, 2017. Contact: David Cullison; NRC, Office of the Chief Information Officer; 301-415-2084; INFOCOLLECTS.Resource@NRC.GOV. Citations: 10 CFR 50, 52
82 FR 45906 (10/02/2017)
Regulatory Update
WATER Arizona/Glen Canyon Dam Adaptive Management Work Group Charter Renewal WATER
Notice of the Bureau of Reclamation announces the renewal of the charter for the Glen Canyon Dam Adaptive Management Work Group. The group provides advice and recommendations to the secretary of the Interior concerning operation of the dam, near Page, Ariz. Contact: Linda Whetton; Bureau of Reclamation; 801-524-3880; lwhetton@usbr.gov
82 FR 45888 (10/02/2017)
Regulatory Update
WATER Colorado River Basin Salinity Control Advisory Council Meeting WATER
Notice of the Bureau of Reclamation announces a meeting of the Colorado River Basin Salinity Control Advisory Council. The agenda includes a briefing of the status of salinity control activities, discussion of the Basin States Program, input for drafting the council's annual report, and progress reports from federal agencies concerning salinity control in the Colorado River Basin. The meeting is scheduled for Oct. 25, 2017, in Sacramento, Calif. Comments are due Nov. 24, 2017. Contact: Kib Jacobson; Bureau of Reclamation, Upper Colorado Regional Office; 801 524-3753; kjacobson@usbr.gov
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82 FR 45888 (10/02/2017) Regulatory Update
WATER NPDES General Permit/Gulf of Mexico PCS Oil and Gas Extract! WATER
ilities
Notice of the EPA announces the reissuance of the NPDES general permit for the offshore subcategory of the oil and gas extraction category for the western portion of the Outer Continental Shelf (OCS) of the Gulf of Mexico (GMG290000). The general permit covers existing sources, new sources, and new dischargers located in and discharging to the OCS offshore of Louisiana and Texas and authorizes discharges of produced water. The final general permit includes specified significant changes to the draft permit issued on May 11,2017 (82 FR 21995). The permit is effective Oct. 1, 2017, and expires Sept. 30, 2022. Contact: Evelyn Rosborough; EPA Region 6; 214-665-7515; rosborough.evelyn@epa.gov. Citations: 40 CFR 435, Subpart A
82 FR 45845 (10/02/2017)
Regulatory Update
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EHS Federal Regulatory Alert
Sierra Club v. EPA, 1:17-cv-01906
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