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Jackson, Ryan[jackson.ryan@epa.gov] Bloomberg BNA Wed 7/26/2017 12:55:04 PM July 26 - EHS Federal Regulatory Alert
EHS Federal Regulatory Alert
July 26, 2017-Number 142
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Summaries
AIR
Automobile and Light Tru / m porz
AIR
. rage Fuel Economy Standards
Notice announces the intention of the National Highway Traffic Safety Administration to prepare an environmental impact statement for proposed corporate average fuel economy standards for model years 2022-2025 passenger automobiles and light trucks. NHTSA intends to issue a proposed rule that would specify attribute-based standards for passenger cars and light trucks for each model year with vehicle footprint as the attribute. It also would establish specific fuel economy targets based on vehicle footprint. A draft EIS will be made available concurrently with the proposed rule. Comments are due Aug. 25, 2017. Contact: Ken Katz; NHTSA, Office of International Vehicle, Fuel Economy, and Consumer Standards; 202-366-4936; Ken.Katz@dot.gov. Citations: 49 CFR 531,533
82 FR 34740 (07/26/2017)
Regulatory Update
AIR
Review of Primary NAAQS for NO2
AIR
Proposed rule of the EPA would retain the current primary NAAQS for nitrogen dioxide (NO2) as protective of public health with an adequate margin of safety. The rule would retain the one-hour standard of 100 parts per billion (ppb), based on the three-year average of the 98th percentile of the annual distribution of daily maximum one-hour concentrations. It also would retain the annual standard of 53 ppb, based on average annual concentrations. The rule is being proposed following review of the standards, as required under the CAA and under a federal court order which requires a final determination by April 6, 2018. The proposed rule is based on the assessment of the evidence in the integrated science assessment (81 FR 4910; 01/28/2016), analyses and considerations in the policy assessment (82 FR 17947; 04/14/2017), and the advice and recommendations of the Clean Air Scientific Advisory Committee. Hearing requests are due
Sierra Club v. EPA, 1:17-cv-01906
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Aug. 2, 2017. Comments are due Sept. 25, 2017. Contact: Breanna Alman; EPA, Office of Air Quality Planning and Standards; 919-541-2351; alman.breanna@epa.gov. Citations: 40 CFR 50
82 FR 34792 (07/26/2017)
Regulatory Update
ENDANGERED SPECIES
Alaska/Marine Mammals Incideni
;
ENDANGERED SPECIES
Notice of the National Marine Fisheries Service announces the receipt of a request from the City and Borough of Sitka, Alaska, for authorization to take five species of marine mammals incidental to pile driving and removal activities at the Gary Paxton Industrial Park dock in Sawmill Cove, Alaska. The authorization would allow take in the form of Level A and B harassment of the humpback whale, killer whale, harbor porpoise, Stellar sea lion, and harbor seal for 16 days from Oct. 1 through Dec. 31, 2017. Comments are due Aug. 25, 2017. Contact: Jaclyn Daly; NMFS, Office of Protected Resources; 301-427-8401
82 FR 34632 (07/26/2017)
Regulatory Update
FOOD SAFETY
Food Additi FOOD SAFETY
tion/Calcium, Vitamin D3 in Juice Products
Notice of the FDA announces the filing of a food additive petition by the Juice Products Association, of Washington, D.C., to replace the current recommended daily intake percentage values of calcium in fruit juices and fruit juice drinks for vitamin D3 with absolute values and to update the specifications for vitamin D3. The changes would allow manufacturers of fruit juices and fruit juice drinks that are fortified with calcium to maintain the absolute level of added calcium at 330 milligrams and 130 mg, respectively. The FDA has determined that a categorical exclusion applies and neither an environmental assessment nor an environmental impact statement is required. Contact: Judith Kidwell; FDA, Center for Food Safety and Applied Nutrition; 240-402-1071. Citations: 21 CFR 172.380
82 FR 34615 (07/26/2017)
Regulatory Update
FOOD SAFETY
Food Additive Petition/Zir FOOD SAFETY
lenomethionine, Silicon Dioxide
Notice of the FDA announces the filing of a food additive petition by Zinpro Corp., of Eden Prairie, Minn., to provide for the safe use of zinc-L-selenomethionine as a nutritional source of selenium in complete feed for laying hens and for the safe use of silicon dioxide as an anticaking agent for use with zinc-L-selenomethionine as a feed component. If the FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. Contact: Chelsea Trull; FDA, Center for Veterinary Medicine; 240-402-6729;
Sierra Club v. EPA, 1:17-cv-01906
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Chelsea.trull@fda.hhs.gov. Citations: 21 CFR 573
82 FR 34615 (07/26/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Application for Issuance of Securities, Assumption of Liabilities GENERAL ENVIRONMENT AND SAFETY
Notice of FERC announces the submission of a continuing information collection request to the OMB regarding the application for authorization for the issuance of securities or the assumption of liabilities (FERC-523). The collection addresses requirements for public utilities or licensees to receive commission approval to issue securities or assume an obligation or liability as guarantor, endorser, surety, or otherwise for a security. Comments are due Aug. 25, 2017. Contact: Ellen Brown; FERC; 202-502-8663; DataClearance@FERC.gov. Citations: 18 CFR 34,131.43,131.50
82 FR 34653 (07/26/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
California/LauncherOne Launches GENERAL ENVIRONMENT AND SAFETY
Notice of the Federal Aviation Administration, Office of Commercial Space Transportation, announces the availability of the final environmental assessment and finding of no significant impact for issuing a license to LauncherOne LLC, of New York, to launch the LauncherOne rocket at the Mojave Air and Space Port, in Kern County, Calif. The proposed launch system consists of the rocket and a Boeing 747 to conduct a maximum number of 115 launches from 2017-2021, to transport small satellites into a variety of low Earth orbits. Contact: Daniel Czelusniak; FAA; 202 267-5924; Daniel.Czelusniak@faa.gov
82 FR 34737 (07/26/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Consumer Antiseptic Wash Products GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces the availability of a guidance for industry related to the Sept. 6, 2016, consumer antiseptic wash final rule (81 FR 61106), which specified that 19 active ingredients used in over-the-counter products are not generally recognized as safe and effective and are misbranded. The guidance explains the scope of the rule, describes how and when manufacturers must comply with its provisions, and addresses the significance of triclosan and triclocarban. The guidance also identifies active ingredients that were deferred from the rule and the effectiveness and safety criteria for those ingredients. Comments may be submitted at any time. Contact: Pranvera Ikonomi; FDA, Center for Drug Evaluation and Research; 240-402-0272. Citations: 21 CFR 310.545
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002611 -00003
82 FR 34680 (07/26/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
EPA Science Advisory Board Meeting GENERAL ENVIRONMENT AND SAFETY
Notice of the EPA Science Advisory Board Office announces a meeting of the Chartered SAB to conduct quality reviews of the SAB peer review of three draft reports. The reports address the toxicological review of hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX); economy-wide modeling of the benefits and costs of environmental regulation; and the EPA's framework for assessing biogenic carbon dioxide emissions from stationary sources. The meeting also will include briefings on SAB projects and future topics from the EPA. The meeting is scheduled for Aug. 29 30, 2017, in Arlington, Va. Comments are due Aug. 21, 2017. Contact: Thomas Carpenter; EPA, Science Advisory Board; 202-564-4885; carpenter.thomas@epa.gov
82 FR 34663 (07/26/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Generic Drug User Fee Amendments of 2012
GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces the availability of a final guidance for industry regarding the Generic Drug User Fee Amendments of 2012. The guidance provides answers to common questions from generic drug industry participants and others involved in the development and/or testing of generic drug products. The guidance includes three categories of questions and answers, including self-identification of facilities, the review of generic drug submissions, and inspections and compliance. The FDA finalized related guidance on fees on Nov. 18, 2016 (81 FR 81774). Comments may be submitted at any time. Contact: Sonia Kim; FDA, Center for Drug Evaluation and Research; 240-402-5118
82 FR 34679 (07/26/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Greenhouse Gas Emissions/ Production and rat asport of Sugar Beets GENERAL ENVIRONMENT AND SAFETY
Notice of the EPA announces the availability of its analysis of greenhouse gas emissions associated with production and transport of sugar beets as a feedstock for biofuel production. The analysis addresses scenarios in which noncellulosic beet sugar is extracted for conversion to biofuel and the remaining beet pulp coproduct is used as animal feed. The analysis also addresses trade restrictions between the U.S. and other countries. The EPA anticipates that biofuels produced from sugar beets could qualify as renewable fuel or advanced biofuel under certain circumstances and invites comment on the analysis of beet pulp and its effect on agricultural markets. Comments are due Aug. 25, 2017. Contact: Christopher Ramig; EPA, Office of Transportation and Air Quality; 202-564-1372; ramig.christopher@epa.gov
Sierra Club v. EPA, 1:17-cv-01906
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82 FR 34656 (07/26/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Patient Engagement Advisory Committee GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces a meeting of the Center for Devices and Radiological Health Patient Engagement Advisory Committee. The committee provides advice and recommendations to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. The agenda includes discussion of patient input into medical device clinical trials. The meeting is scheduled for Oct. 11-12, 2017, in Gaithersburg, Md. Comments are due Sept. 20, 2017. Contact: Letise Williams; FDA, Center for Devices and Radiological Health; 301-796-8398; Letise.Williams@fda.hhs.gov
82 FR 34681 (07/26/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Tennessee Valley Authority Regional Energy Resource Council Charter Renewal GENERAL ENVIRONMENT AND SAFETY
Notice of the Tennessee Valley Authority announces the renewal of the charter of the Regional Energy Resource Council for two years beginning Aug. 1, 2017. The council provides advice to the TVA on its energy-related resource activities, which include the construction and operation of fossil-fueled power plants, nuclear plants, hydroelectric dams, and renewable resources; the development and management of demand-side resources; the design, construction, and operation of power delivery systems; and the integration of all of these energy resources into plans for meeting future demands for electricity in the region. Contact: Barbie Perdue; TVA; 865 632-6113; baperdue@tva.gov
82 FR 34734 (07/26/2017)
Regulatory Update
HAZARDOUS MATERIALS TRANSPORTATION
U.S. Postal Service/Mailing Standards for Lithium Batteries
HAZARDOUS MATERIALS TRANSPORTATION
Notice of the U.S. Postal Service announces revisions to Publication 52 regarding mailing standards for hazardous, restricted, and perishable materials, including lithium batteries. The revisions add new mailing standards for lithium batteries to align with the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Air, and the Pipeline and Hazardous Materials Safety Administration final rule (82 FR 15796; 03/30/2017) to maintain consistency with international standards concerning packing groups and air transport quantity limitations. The revisions will be published in the Postal Bulletin on Aug. 17, 2017, and mailers will have until Jan. 1,2018, to comply. Contact: Michelle Lassiter; USPS; 202-268-2914
Sierra Club v. EPA, 1:17-cv-01906
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82 FR 34712 (07/26/2017)
Regulatory Update
HAZARDOUS WASTE CLEANUP
California/Sycamore Superfund Removal Site HAZARDOUS WASTE CLEANUP
Notice of the EPA announces a proposed settlement agreement under CERCLA with 953 N Sycamore LLC, of Camden, Del., regarding the Sycamore Superfund Removal Site in Hollywood, Calif. The agreement requires Sycamore to perform a removal action to clean up soil and soil gas contaminated with chlorinated volatile organic compounds, including tetrachloroethylene, trichloroethylene, and cis-1,2-dichloroethylene, and aromatic VOCs, including benzene, toluene, and xylene, resulting from historical dry cleaning operations at the site. The agreement also requires Sycamore to pay the EPA's costs for oversight of the removal activities. Comments are due Aug. 25, 2017. Contact: Taly Jolish; EPA Region 9, Office of Regional Counsel; 415-972-3925; Jolish.Taly@epa.gov
82 FR 34655 (07/26/2017)
Regulatory Update
HAZARDOUS WASTE CLEANUP
Florida/Coronet Industries Superfunci Site
HAZARDOUS WASTE CLEANUP
Notice of the EPA announces a proposed settlement agreement under CERCLA with CEMEX Construction Materials Florida LLC, of West Palm Beach, Fla., and Hexion Inc., of Columbus, Ohio, regarding the Coronet Industries Superfund site in Plant City, Fla. The settlement addresses the recovery of costs for EPA response actions at the site. Comments are due Aug. 25, 2017. Contact: Paula Painter; EPA Region 4, Superfund Division; 404-562-8887; Painter.Paula@epa.gov
82 FR 34655 (07/26/2017)
Regulatory Update
HAZARDOUS WASTE MANAGEMENT
International Standards on Transport of Dangerous Goods
HAZARDOUS WASTE MANAGEMENT
Notice of PHMSA requests comments on issues being considered during the 51st and 52nd sessions of the UN Subcommittee of Experts on the Transport of Dangerous Goods, to be held July 3-7 and Nov. 27-Dec. 6, 2017, in Geneva. The sessions will address explosives; listing, classification and packing; electric storage systems; transport of gases; global harmonization of transport of dangerous goods regulations with the model regulations and amendments to the model regulations; guiding principles for the model regulations; cooperation with the International Atomic Energy Agency; and issues relating to the Globally Harmonized System of Classification and Labeling of Chemicals. Comments are due Nov. 17, 2017. Contact: Steven Webb; PHMSA, Office of Hazardous Materials Safety; 202-366-8553
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002611 -00006
82 FR 34745 (07/26/2017)
Regulatory Update
OCCUPA TIONAL SAFETY AND HEALTH
Certification and Qualification to Examii OCCUPATIONAL SAFETY AND HEALTH
t, Operate Hoists in Mines
Notice announces the intention of the Mine Safety and Health Administration to seek OMB approval for a continuing information collection request concerning certification and qualification to examine, test, and operate hoists and perform other duties. The collection addresses requirements for coal mine operators to maintain a list of persons who are certified and/or qualified to perform duties such as conduct examinations for hazardous conditions, conduct tests for methane and oxygen deficiency, conduct tests of air flow, perform electrical work, repair energized surface high-voltage lines, and perform duties of hoisting engineer. The collection also addresses mine operator maintenance of an approved training plan to train and retrain qualified and certified persons to effectively perform tasks and the application for qualification or certification of a training plan for hoisting engineers in the absence of a state program (Form 5000-41). Comments are due Sept, 25, 2017. Contact: Sheila McConnell; MSHA, Office of Standards, Regulations, and Variances; 202-693-9440; MSHA.information.collections@dol.gov. Citations: 30 CFR 75, 77
82 FR 34698 (07/26/2017)
Regulatory Update
OCCUPA TIONAL SAFETY AND HEALTH
Petiti1 '> " / Modification of
", rfety Standards
OCCUPATIONAL SAFETY AND HEALTH
Notice of the Mine Safety and Health Administration announces the receipt of three petitions to modify the application of existing mandatory safety standards. Peabody Gateway North Mining LLC, of Coulterville, III. requests modification of standards to allow the use of nonpermissible electronic testing equipment in two locations at the Gateway North Mine in Randolph County, III. Marion County Coal Co., of Mertz, W.Va., requests modification of standards that require the operation and maintenance of barriers around surface directional drilled wells to allow for the use of a proposed alternative. Comments are due Aug. 25, 2017. Contact: Barbara Barron; MSHA, Office of Standards, Regulations, and Variances; 202-693-9447; barron.barbara@dol.gov. Citations: 30 CFR 75.500(d), 30 CFR 75.507-1 (a), 30 CFR 75.1700
82 FR 34701 (07/26/2017)
Regulatory Update
OCCUPA TIONAL SAFETY AND HEALTH
Petitions for Modification of Mine Safety Standards OCCUPATIONAL SAFETY AND HEALTH
Notice of the Mine Safety and Health Administration announces the receipt of two petitions to modify the application of existing mandatory safety standards. Texas Westmoreland Coal Co., of
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002611 -00007
Jewett, Texas, requests modification of the standard for use of a special procedure when the dragline boom/mast is raised or lowered during necessary repairs/dismantling. Martin Marietta Materials, of Des Moines, Iowa, requests modification of the existing standard to permit an alternative method of compliance to permit use of bottled water in refuge areas instead of waterlines. Comments are due Aug. 25, 2017. Contact: Barbara Barron; MSHA, Office of Standards, Regulations and Variances; 202-693-9447; barron.barbara@dol.gov. Citations: 30 CFR 57.11052 and 77.803
82 FR 34699 (07/26/2017)
Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH
Pharmacy Compounding/Test Protocol for Closed System Transfer Devices OCCUPATIONAL SAFETY AND HEALTH
Notice of the National Institute for Occupational Safety and Health announces an extension of the comment period for a Sept. 15, 2016, notice (81 FR 63482) regarding a draft universal performance test protocol for closed system drug-transfer devices used during pharmacy compounding and administration of hazardous drugs. The additional time is intended to allow companies to test the protocol with the proposed challenge agents. Comments now are due Feb. 28, 2018. Contact: Deborah Hirst; NIOSH, Division of Applied Research and Technology; 513-841 4141; DHirst@cdc.gov
82 FR 34674 (07/26/2017)
Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH
Standard on Manlifts OCCUPATIONAL SAFETY AND HEALTH
Notice of OSHA announces the submission of a continuing information collection request to the OMB regarding the standard on manlifts. The collection concerns requirements for manlifts to be inspected at least once every 30 days and for limit switches to be checked weekly. The collection also addresses requirements for certification records of inspection to be prepared and for employers to maintain certification records and make them available to OSHA compliance officers. Comments are due Aug. 25, 2017. Contact: Michael Smyth; OSHA; 202-693-4129; DOL_PRA_PUBLIC@dol.gov. Citations: 29 CFR 1910.68
82 FR 34697 (07/26/2017)
Regulatory Update
PESTICIDES
Pesticide Product Registrations/New Active Ingredients PESTICIDES
Notice of the EPA announces the receipt of four applications to register pesticide products containing active ingredients not included in any currently registered products. The applications were submitted by FMC Corp., of Philadelphia, and include active ingredients intended for
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002611 -00008
various uses. Comments are due Aug. 25, 2017. Contact: Robert McNally; EPA, Office of Pesticide Programs; 703-305-7090; BPPDFRNotices@epa.gov
82 FR 34666 (07/26/2017)
Regulatory Update
PESTICIDES
Pesticide Tolerance Petitions PESTICIDES
Notice of the EPA announces the receipt of initial filings of petitions to establish new and amended tolerances and exemptions for residues of certain pesticides in or on various food commodities. The notice includes nine filings for new and amended tolerances and tolerance exemptions for inerts and noninerts. Comments are due Aug. 25, 2017. Contact: Robert McNally; EPA, Office of Pesticide Programs; 703-305-7090; BPPDFRNotices@epa.gov. Citations: 40 CFR 180
82 FR 34664 (07/26/2017)
Regulatory Update
TOXIC SUBSTANCES AND HAZARDOUS MATERIALS
NCEH/ATSE' 1 rd of Scientific Counselors Meeting TOXIC SUBSTANCES AND HAZARDOUS MATERIALS
Notice of the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ATSDR) announces a meeting of the Board of Scientific Counselors. The agenda addresses noise-induced hearing loss, the Flint Registry, program responses to the board's guidance and action items, the status of blood lead level reference value updates, and legislative requirements of the new Lead Exposure Poisoning Federal Advisory Committee. The agenda also includes updates concerning the amyotrophic lateral sclerosis, lead poisoning prevention, and environmental health tracking programs. In addition, the agenda includes updates from the center's director and from the NIH, the EPA, the National Institute for Occupational Safety and Health, and the Energy Department. The meeting is scheduled for Sept. 13-14, 2017, in Atlanta and via teleconference. Contact: Shirley Little; CDC, NCEH/ATSDR; 770-488-0577; sn17@cdc.gov
82 FR 34674 (07/26/2017)
Regulatory Update
WATER
Susquehanna River Basin Commission/Projects Approved for Consumptive Water Uses
WATER
Notice of the Susquehanna River Basin Commission announces a list of projects approved for consumptive use of water during the period June 1-30, 2017. The notice addresses 13 projects approved for consumptive use, including uses related to unconventional natural gas and other hydrocarbon development. Contact: Jason Oyler; SRBC; 717-238-0423; joyler@srbc.net. Citations: 18 CFR 806.22
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002611 -00009
82 FR 34733 (07/26/2017)
Regulatory Update
WATER
Susquehanna River Basin Commission/Projects Rescinded 1
WATER
sumptive Uses of Water
Notice of the Susquehanna River Basin Commission lists the projects rescinded for the consumptive use of water during the period June 1-30, 2017. The list includes five projects at various locations in Pennsylvania. Contact: Jason Oyler; SRBC; 717-238-0423; joyler@srbc.net. Citations: 18 CFR 806.22
82 FR 34734 (07/26/2017)
Regulatory Update
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EHS Federal Regulatory Alert
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002611 -00010