Document 3L99dL10NzZGOVgMe4wQ3B7O

To: From: Sent: Subject: Jackson, Ryan[jackson.ryan@epa.gov] Bloomberg BNA Fri 7/28/2017 12:23:38 PM July 28 - EHS Federal Regulatory Alert EHS Federal Regulatory Alert July 28, 2017-Number 144 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/Antelope Valley AQMD AIR Proposed rule of the EPA approves and conditionally approves revisions to the Antelope Valley Air Quality Management District portion of the California SIP regarding reasonably available control technology (RACT) requirements for the 1997 8-hour ozone and the 2008 8-hour ozone NAAQS in the Antelope Valley nonattainment area. The rule withdraws and replaces a proposed rule (81 FR 90754; 12/15/2016) to partially approve and partially disapprove the 2006 and 2015 SIPs in which the agency determined that the district's rules did not implement RACT for all applicable sources. The district subsequently addressed the deficiencies identified by the EPA. The rule also approves the district's negative declarations into the SIP for the ozone standards. Comments are due Aug. 28, 2017. Contact: Nancy Levin; EPA Region 9; 415-942-3848; levin.nancy@epa.gov. Citations: 40 CFR 52 82 FR 35149 (07/28/2017) Regulatory Update AIR Clean Air Scientific Advis AIR nmittee Meeting Notice of the EPA Science Advisory Board Staff Office announces a meeting of the Clean Air Scientific Advisory Committee (CASAC) and the CASAC Secondary NAAQS Review Panel for Oxides of Nitrogen and Sulfur. The agenda includes discussion of the EPA's integrated science assessment for nitrogen oxides, sulfur oxides, and particulate matter-ecological criteria (first external review draft-February 2017). The meeting is scheduled for Aug. 31, 2017, via teleconference. Comments are due Aug. 24, 2017. Contact: Thomas Armitage; EPA, Science Advisory Board Staff Office; 202-564-2155; armitage.thomas@epa.gov 82 FR 35200 (07/28/2017) Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00001999-00001 Regulatory Update AIR Georgia SIP/Miscellaneous Revisions AIR Direct final rule of the EPA approves revisions to the Georgia SIP to clarify applicability requirements for certain volatile organic compound emission standards. The revisions also remove obsolete provisions regarding kraft pulp mill total reduced sulfur compliance schedules, conical burners for wood waste burning, cupola furnaces for metallurgical melting, and monitoring and reporting requirements for particular sources. In addition, the revisions correct a numbering error and remove various tables. The rule is effective Sept. 26, 2017, unless adverse comments are received by Aug. 28, 2017. Contact: Richard Wong; EPA Region 4, Air Planning and Implementation Branch; 404-562-8726; wong.richard@epa.gov. Citations: 40 CFR 52.570 82 FR 35106 (07/28/2017) Regulatory Update AIR Georgia SIP/Miscellaneous Revisions AIR Proposed rule of the EPA would approve revisions to the Georgia SIP to clarify applicability requirements for certain volatile organic compound emission standards. The revisions also remove obsolete provisions regarding kraft pulp mill total reduced sulfur compliance schedules, conical burners for wood waste burning, cupola furnaces for metallurgical melting, and monitoring and reporting requirements for particular sources. In addition, the revisions correct a numbering error and remove various tables. A concurrent direct final rule adopts the revisions, effective Sept. 26, 2017. Comments are due Aug. 28, 2017. Contact: Richard Wong; EPA Region 4, Air Planning and Implementation Branch; 404-562-8726; wong.richard@epa.gov. Citations: 40 CFR 52.570 82 FR 35149 (07/28/2017) Regulatory Update AIR Kentucky SIP/Louisville Metro Definitions AIR Direct final rule of the EPA approves a revision to the Kentucky SIP to change certain definitions for the Louisville Metro Air Pollution Control District, including the definition of "volatile organic compounds." The revision does not change the definition of "acute noncancer effect." The rule is effective Sept. 26, 2017, unless adverse comments are received by Aug. 28, 2017. Contact: Nacosta Ward; EPA Region 4, Pesticides and Toxics Management Division; 404-562-9140; ward.nacosta@epa.gov. Citations: 40 CFR 52.920 82 FR 35101 (07/28/2017) Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00001999-00002 Regulatory Update AIR Kentucky SIP/Louisville Metro Definitions AIR Proposed rule of the EPA would approve a revision to the Kentucky SIP to change certain definitions for the Louisville Metro Air Pollution Control District, including the definition of "volatile organic compounds." The revision does not change the definition of "acute noncancer effect," A concurrent direct final rule adopts the changes, effective Sept. 26, 2017. Comments are due Aug. 28, 2017. Contact: Nacosta Ward; EPA Region 4, Pesticides and Toxics Management Division; 404-562-9140; ward.nacosta@epa.gov. Citations: 40 CFR 52.920 82 FR 35148 (07/28/2017) Regulatory Update AIR Maryland SIP/Continuous Emission Monitoring AIR Final rule of the EPA approves revisions to the Maryland SIP that remove a Technical Memorandum 90-01 that has been superseded by a new continuous emission monitoring (CEM) regulation. The technical memorandum governed CEM requirements for fuel burning equipment. The rule is effective Aug. 28, 2017. Contact: Gavin Huang; EPA Region 3; 215-814-2042; huang.gavin@epa.gov. Citations: 40 CFR 52.1070 82 FR 35104 (07/28/2017) Regulatory Update AIR North Dakota SIP/Prevention of Significant Deterioration AIR Proposed rule of the EPA would approve revisions to the North Dakota SIP concerning prevention of significant deterioration under the new source review permitting program. The revisions incorporate EPA Reference Method 22 for determination of compliance with a visible emissions limit and add significance levels for fine particulate matter, modify the existing significance levels for nitrogen dioxide and sulfur dioxide, and remove the significance level for coarse particulate matter. Comments are due Aug. 28, 2017. Contact: Jaslyn Dobrahner; EPA Region 8, Air Program; 303-312-6252; dobrahner.jaslyn@epa.gov. Citations: 40 CFR 52 82 FR 35153 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Atlantic Coast Pipeline and Supply Header Projects GENERAL ENVIRONMENT AND SAFETY Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00001999-00003 Notice of FERC announces availability of the final environmental impact statement for the Atlantic Coast Pipeline and the Supply Header Project proposed by Atlantic Coast Pipeline LLC and Dominion Transmission Inc., respectively, both of Richmond, Va. The projects consist of a total of 642 miles of natural gas transmission pipeline, three new natural gas-fired compressor stations, and associated facilities and modification of four existing compressor stations in North Carolina, Pennsylvania, Virginia, and West Virginia. The projects would provide approximately 1.44 billion cubic feet per day of natural gas to electric generation, distribution, and end-use markets in Virginia and North Carolina. The final EIS, which was prepared in cooperation with the EPA, the U.S. Army Corps of Engineers, the U.S. Forest Service, and state relevant agencies concludes that the project would result in some adverse and significant environmental impacts that would be reduced to less than significant levels through the proposed mitigation measures. Contact: FERC, Office of External Affairs; 866-208-3676; FercOnlineSupport@ferc.gov 82 FR 35192 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Classification of Cranial Motion Measurement Device GENERAL ENVIRONMENT AND SAFETY Final rule of the FDA codifies a final order to classify the cranial motion measurement device into class II (special controls). The prescription device utilizes accelerometers to measure the motion or acceleration of the skull. The measurements are not to be used for diagnostic purposes. The classification was applicable Aug. 1, 2016. The order is effective July 28, 2017. Contact: Jay Gupta; FDA, Center for Devices and Radiological Health; 301-796-2795; jay.gupta@fda.hhs.gov. Citations: 21 CFR 882.1630 82 FR 35069 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Classification of Hysteroscopic Insufflator with Cutter-Coagulator GENERAL ENVIRONMENT AND SAFETY Final rule of the FDA codifies a final order to classify the closed loop hysteroscopic insufflator with cutter-coagulator into class II (special controls). The device is indicated for use to perform diagnostic and surgical procedures and contains a closed loop recirculating fluid management system for the controlled delivery of filtered distension fluid. The device also contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterine tissues. The classification was applicable March 28, 2014. The order is effective July 28, 2017. Contact: Veronica Price; FDA, Center for Devices and Radiological Health; 301-796 6538. Citations: 21 CFR 884.710 82 FR 35071 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00001999-00004 Classification of Oral Removable Palatal Space Occupying Device GENERAL ENVIRONMENT AND SAFETY Final rule of the FDA codifies a final order to classify the oral removable palatal space occupying device for weight management and/or weight loss into class II (special controls). The prescription device is worn during meals to limit bite size, thereby reducing the amount of food that is consumed. The device may contain recording sensors for monitoring patient use. The classification does not include devices that are intended to treat any dental diseases or conditions. The classification was applicable Sept. 26, 2016. The order is effective July 28, 2017. Contact: Mark Antonino; FDA, Center for Devices and Radiological Health; 240-402-9980; mark.antonino@fda.hhs.gov. Citations: 21 CFR 876.5981 82 FR 35067 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Classification of the Adjunctive Cardiovascular Status Indicator GENERAL ENVIRONMENT AND SAFETY Final rule of the FDA codifies a final order to classify the adjunctive cardiovascular status indicator into class II (special controls). The device is a prescription device based on sensor technology for the measurement of a physical parameter and is intended for adjunctive use with other physical vital sign parameters and patient information. It is not intended to independently direct therapy. The classification was applicable Dec. 21, 2016. The order is effective July 28, 2017. Contact: Nathalie Yarkony; FDA, Center for Devices and Radiological Health; 301-796-1235; nathalie.yarkony@fda.hhs.gov. Citations: 21 CFR 870.2200 82 FR 35065 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Difficult to Compound List Nominations GENERAL ENVIRONMENT AND SAFETY Notice of the FDA announces the establishment of a docket to accept nominations of drug products or drug product categories for inclusion on the list of drugs that present demonstrable difficulties in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. The docket is intended for nominations not previously submitted under a Dec. 4, 2013, request (78 FR 72840); resubmission of previous nominations with additional supporting information; and comments. The FDA requests that nominations include the name of the product or category and the reason for inclusion on the list, taking into account risks and benefits to patients. The FDA also seeks responses to six questions related to agency criteria presented to the Pharmacy Compounding Advisory Committee for evaluating whether drug products or categories of products are difficult to compound. Comments and nominations for the list may be submitted at any time. Contact: Pawanprit Singh; FDA, Center for Drug Evaluation and Research; 240-402-8866 82 FR 35214 (07/28/2017) Regulatory Update Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00001999-00005 GENERAL ENVIRONMENT AND SAFETY Environmental Impact Statements GENERAL ENVIRONMENT AND SAFETY Notice of the EPA announces the availability of environmental impact statements filed July 17-21, 2017. Contact: Dawn Roberts; EPA, Office of Federal Activities; 202-564-7146. Citations: 40 CFR 1506.9 82 FR 35200 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Genetically Engineered Canola/Determination of Status GENERAL ENVIRONMENT AND SAFETY Notice of the Animal and Plant Health Inspection Service announces the determination to extend the nonregulated status of the InVigor MS8 canola to the canola event MS11 in response to a request from Bayer CropScience LP, of Research Triangle Park, N.C. MS11 has been genetically engineered for male sterility and resistance to the herbicide glufosinate-ammonium using the same mechanism of action as MSB canola. Bayer stated that the MS11 canola is unlikely to pose a plant pest risk due to its similarity to MS8 canola, the antecedent organism. The determination is effective July 28, 2017. Contact: Cindy Eck; APHIS, Biotechnology Regulatory Services; 301 851-3954; cynthia.a.eck@aphis.usda.gov. Citations: 7 CFR 340 82 FR 35172 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Pennsylvania/Henderson Storage Field GENERAL ENVIRONMENT AND SAFETY Notice of FERC announces the filing of a prior notice request by National Fuel Gas Supply Corp., of Williamsville, N.Y., to abandon one injection/withdrawal storage well (Well 3168) in its Henderson Storage Field and remove a 30-foot portion of the associated well line, all located in Irwin Township, Pa. The agency plans to complete an environmental assessment or issue a notice of schedule of environmental review by Oct. 23, 2017. Protests and motions to intervene are due Sept. 22, 2017. Contact: FERC, Office of External Affairs; 866-208-3676; FERCOnlineSupport@ferc.gov 82 FR 35194 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Procurement/Environmentally Sound Products GENERAL ENVIRONMENT AND SAFETY Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00001999-00006 Notice of the Defense Department, the GSA, and NASA announces the submission of a continuing information collection request to the OMB concerning environmentally sound products. The collection concerns requirements for contractors to report the estimated percentage of total recovered material content when a contract requires the delivery of or use of an EPA-designated item. The requirements apply to contracts that exceed $150,000, except for acquisitions of commercially available, off-the-shelf items. Comments are due Aug. 28, 2017. Contact: Charles Gray; General Services Administration; 703-795-6328; charles.gray@gsa.gov. Citations: 48 CFR 52.223-9 82 FR 35204 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Software Precertification Pilot Program GENERAL ENVIRONMENT AND SAFETY Notice of the FDA, Center for Devices and Radiological Health, announces the issuance of the Digital Health Innovation Action Plan concerning the regulation of digital health technologies that are medical devices, and the launch of the Software Precertification Pilot Program to evaluate the agency's approach toward software products. The agency intends to develop a precertification program to replace the need for premarket submissions in certain instances. The pilot program, which is a part of the action plan, will assess companies that perform high-quality software design and testing and allow for input from participants regarding the development of the precertification program. The agency intends to accept requests for voluntary participation in the pilot program beginning Aug. 1,2017, and the program will begin on Sept. 1,2017. Comments are requested, but a due date is not specified. Contact: Bakul Patel; FDA, Center for Devices and Radiological Health; 301-796-5528; bakul.patel@fda.hhs.gov 82 FR 35216 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Tennessee Valley Authority NEPA Implementing Procedures GENERAL ENVIRONMENT AND SAFETY Notice of the Tennessee Valley Authority announces an extension of the comment period for a June 8, 2017, proposed rule (82 FR 26620) that would update and codify the agency's procedures for implementing the National Environmental Policy Act (NEPA). The rule would update organizational references and reflect modern notification and communication methods. The rule also would revise the list of categorical exclusions to include common actions demonstrated to have little effect on the human environment and to remove categorical exclusions for actions that TVA rarely or no longer uses. In addition, the rule would incorporate federal flood risk management standards and the process for soliciting and considering stakeholder input required by Executive Order 13690 (81 FR 91150; 12/16/2016). Comments now are due Sept. 6, 2017. Contact: Matthew Higdon; TVA; 865-632-8051; mshigdon@tva.gov. Citations: 18 CFR 1318.10 through 1318.605, Appendix A 82 FR 35133 (07/28/2017) Regulatory Update Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00001999-00007 GENERAL ENVIRONMENT AND SAFETY West Virginia/Marshall County Mine Panel 18W Project GENERAL ENVIRONMENT AND SAFETY Notice announces the intention of FERC to prepare an environmental assessment for the Marshall County Mine Panel 18W Project, proposed by Texas Eastern Transmission LP, of Houston. The project involves the excavation, elevation, and replacement of four different sections of pipelines located in the county in advance of long-wall mining activities that will be conducted by the Marshall County Coal Co. beginning October 2018. Comments are due Aug. 23, 2017. Contact: FERC, Office of External Affairs; 866-208-3676; FercOnlineSupport@ferc.gov 82 FR 35196 (07/28/2017) Regulatory Update GENERAL ENVIRONMENT AND SAFETY Wyominq/West Antelope 3 Tract Coal Lease GENERAL ENVIRONMENT AND SAFETY Notice announces the intention of the Bureau of Land Management to prepare an environmental impact statement on the potential impacts of the leasing of an approximately 3,508 acre tract of federal coal by Antelope Coal LLC, of Gillette, Wyo. The West Antelope 3 Tract contains approximately 441 million tons of in-place coal and is adjacent to the Antelope Mine in Campbell and Converse counties, Wyo. A meeting is scheduled for Sept. 20, 2017, in Wright, Wyo. Comments are due Sept. 26, 2017. Contact: Teresa Johnson; BLM, High Plains District Office; 307 261-7600 82 FR 35237 (07/28/2017) Regulatory Update HAZARDOUS MATERIALS TRANSPORTATION Carriage of Bulk Solids Requiring Special Handling HAZARDOUS MATERIALS TRANSPORTATION Notice of the U.S. Coast Guard announces the submission of a continuing information collection request to the OMB regarding carriage of bulk solids requiring special handling. The collection addresses a special permit used by the USCG to determine the manner of safe carriage for unlisted materials. The collection also addresses information in dangerous cargo manifests and shipping papers that allows vessel crews and emergency personnel to properly and safely respond to accidents involving hazardous substances. Comments are due Aug. 28, 2017. Contact: Anthony Smith; USCG, Office of Information Management; 202-475-3532. Citations: 46 CFR 148 82 FR 35235 (07/28/2017) Regulatory Update PESTICIDES Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00001999-00008 Pesticide Tolerance Exemption/Pseudomonas Chlororaphis Strain AFS009 PESTICIDES Final rule of the EPA establishes an exemption from the requirement of a tolerance for residues of pseudomonas chlororaphis strain AFS009 in or on all food commodities when used in accordance with label directions and good agricultural practices. The rule eliminates the need to establish a maximum permissible level for the residues when used in accordance with approved conditions. The rule is issued in response to a petition filed by AFS009 Plant Protections Inc., of Durham, N.C. The rule is effective July 28, 2017. Objections and hearing requests are due Sept. 26, 2017. Contact: Robert McNally; EPA, Office of Pesticide Programs; 703-305-7090; BPPDFRNotices@epa.gov. Citations: 40 CFR 180.1341 82 FR 35120 (07/28/2017) Regulatory Update PESTICIDES Pesticide Tolerances/Fenamidone PESTICIDES Final rule of the EPA establishes tolerances for residues of the pesticide fenamidone in or on basil, dried leaves at 200 ppm; basil, fresh leaves at 30 ppm; celtuce at 60 ppm; cottonseed subgroup 20C at 0.02 ppm; fennel, Florence, fresh leaves and stalk at 60 ppm; kohlrabi at 5.0 ppm; leaf petiole vegetable subgroup 22B at 60 ppm; leafy vegetable group 4-16 at 60 ppm; and the vegetable, Brassica, head and stem, group 5-16 at 5.0 ppm. The tolerances generally are established as petitioned for by Interregional Research Project Number 4, of Princeton, N.J. The petitioner sought separate tolerances on the subgroups 4-16A and 4-15B, but the EPA established a single tolerance for the whole group. The rule removes several existing crop group tolerances because those groups are covered under the new tolerances. In addition, the name of the existing entry for cilantro is changed to cilantro, fresh leaves. The rule is effective July 28, 2017. Objections and hearing requests are due Sept. 26, 2017. Contact: Michael Goodis; EPA, Office of Pesticide Programs; 703-305-7090; RDFRNotices@epa.gov. Citations: 40 CFR 180.579 82 FR 35109 (07/28/2017) Regulatory Update PESTICIDES Pesticide Tolerances/Topramezone PESTICIDES Final rule of the EPA establishes tolerances for residues of the herbicide topramezone in or on sugarcane, cane at 0.01 parts per million. The rule is issued in response to a petition filed by BASF Corp., of Research Triangle Park, N.C. The rule is effective July 28, 2017. Objections and hearing requests are due Sept. 26, 2017. Contact: Michael Goodis; EPA, Office of Pesticide Programs; 703-305-7090; RDFRNotices@epa.gov. Citations: 40 CFR 180.612 82 FR 35115 (07/28/2017) Regulatory Update Sierra Club v. EPA, 1:17-cv-01906 ED_001523_00001999-00009 WATER Aquatic Life Ambient Water Quality Criteria for Aluminum WATER Notice of the EPA announces the availability of draft updated aquatic life ambient water quality criteria for aluminum in freshwater. The draft, which updates 1988 criteria, permits users to develop criteria based on site-specific water chemistry and uses a multiple linear regression model to normalize data to develop criteria based on site pH, dissolved organic carbon, and hardness. The criteria would increase the one-day total freshwater acute limit to 1,400 micrograms/liter and increase the four-day total freshwater chronic limit to 390 pg/L for water with specified pH, hardness, and dissolved organic carbon levels. Comments are requested on the science and technical approach used in the derivation of the draft criteria. Comments are due Sept. 26, 2017. Contact: Diana Eignor; EPA, Office of Water; 202-566-1143; eignor.diana@epa.gov 82 FR 35198 (07/28/2017) Regulatory Update WATER U.S. Coast Guard/Navigation and Navigable Waters WATER Final rule of the U.S. Coast Guard makes technical revisions to regulations associated with navigation and navigable waters. The revisions align the regulations with International Regulations for Preventing Collisions at Sea and clarify location and boundaries of Activities Europe Marine Inspection Zone. In addition, the revisions reflect the transfers of functions from the Secretary of War to the Secretary of Transportation to the Secretary of Homeland Security and address inland navigation standards and deepwater ports. The rule also deletes obsolete references, updates cross references, and makes editorial corrections. The rule is effective July 28, 2017. Contact: Felicia Raybon; USCG; 202-372-1499; Felicia.K.Raybon@uscg.mi. Citations: 33 CFR 3 through 181 (nonconsecutive); 46 CFR 31, 39, 153 and 154 82 FR 35073 (07/28/2017) 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_00001999-00010