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Jackson, Ryan[jackson.ryan@epa.gov] Bloomberg BNA Fri 9/1/2017 12:32:07 PM Sep. 01 - EHS Federal Regulatory Alert
EHS Federal Regulatory Alert
September 01,2017 - Number 169
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Summaries
AIR
Indiana SIP/Cincinnati-Hamilton PM-2.5 Nonattainment Area
AIR
Final rule of the EPA redesignates the Indiana portion of the tri-state Cincinnati-Hamilton, OhioInd.-Ky., nonattainment area to attainment for the 1997 fine particulate matter (PM-2.5) NAAQS. The rule also approves the state's plan for maintaining the 1997 annual PM-2.5 NAAQS through 2027 and the state's updated emission inventory, which includes inventories for volatile organic compounds and ammonia. In addition, the rule approves and updates the budget for the mobile source contribution of PM-2.5 and nitrogen oxides to the area for transportation conformity purposes. The rule is effective Sept. 1,2017. Contact: Michelle Becker; EPA Region 5, Air Programs Branch; 312-886-3901; becker.michelle@epa.gov. Citations: 40 CFR 52.776, 81.315
82 FR 41527 (09/01/2017)
Regulatory Update
AIR
NOx Budget Trading Program
AIR
Notice of the EPA announces the submission of a continuing information collection request to the OMB regarding the NOx Budget Trading Program to reduce the regional transport of ozone. The program has been replaced by ozone-season NOx trading programs under the Cross-State Air Pollution Rule. The collection addresses emissions monitoring and reporting requirements for industrial sources in certain states that continue to report emissions data to the EPA under a NOx SIP call. Comments are due Oct 2, 2017. Contact: Karen VanSickle; EPA, Office of Air and Radiation; 202-343-9220; vansickle.karen@epa.gov. Citations: 40 CFR 75
82 FR 41620 (09/01/2017)
Regulatory Update
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00000958-00001
AIR
Rhode Island SIP/VOC E missions from Fiberglass Processing
AIR
Notice of the EPA announces the withdrawal of a July 3, 2017, direct final rule (82 FR 30747) that would have approved revisions to the Rhode Island SIP regarding volatile organic compound (VOC) emissions from fiberglass process areas operated by US Watercraft LLC, of Warren, R.l. The revisions include a closed molding process and VOC limits on gel coats and resins used to limit emissions from the facility. The revisions prohibit the use of VOC solvents for cleanup, and restrict US Watercraft to using the Seemann Composite Resin Infusion Molding Process or a roller when applying vinyl ester resin, except when applying vinyl ester resin by spray layup for corrosion proof laminate. The revisions also require tracking of VOC emissions and remove the previously approved consent agreement for the facility. The withdrawal is in response to receipt of an adverse comment. The agency will instead proceed with a final rule based on the related proposed rule (82 FR 30815; 07/03/2017). The withdrawal is effective Sept. 1, 2017. Contact: David Mackintosh; EPA Region 1, New England Regional Office; 617-918-1584; Mackintosh.David@epa.gov. Citations: 40 CFR 52.070
82 FR 41526 (09/01/2017)
Regulatory Update
FOOD SAFETY
Inspection Coverage at Siluriforr FOOD SAFETY
h Establishments
Notice of the Food Safety and Inspection Service confirms that on Sept. 1, 2017, the agency will adjust inspection coverage at official establishments that slaughter Siluriformes fish, including catfish, from all hours of operation to once per production shift. The change reduces the initial frequency of inspection coverage provided for in the Dec. 2, 2015, final rule (80 FR 75590) that established a mandatory inspection program for Siluriformes fish. The agency also provides responses to eight comments received on the May 17, 2017, notice (82 FR 22609) proposing the change and the June 16, 2017, notice (82 FR 27679) extending the comment period. Contact: Rachel Edelstein; FSIS, Office of Policy and Program Development; 202-205-0495.
82 FR 41501 (09/01/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Clinical Data Interchange Standards Consortium Study Data Tabulation Model GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces the March 15, 2018, end date for support of version 1.2 of the Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) and an update to the Data Standards Catalog for study data provided in new drug applications (NDAs), abbreviated NDAs, biologies license applications, and investigational NDAs. Support will continue for versions 1.3 and 1.4 of the SDTM, which provide a standard for formatting data for electronic submission. Comments may be submitted at any time. Contact: Fatima Frye; FDA, Center for Drug Evaluation and Research; 301-796-4863; cder-edata@fda.hhs.gov
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00000958-00002
82 FR 41624 (09/01/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Determinatii
cerning Safety and Effectiveness/Nizoral
GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces a determination that Nizoral (ketoconazole) tablets, 200 milligrams, were not withdrawn from sale for reasons of safety or effectiveness. The determination allows the FDA to approve abbreviated new drug applications that refer to Nizoral if all other legal and regulatory requirements are met. Contact: Robin Fastenau; FDA, Center for Drug Evaluation and Research; 240-402-4510
82 FR 41624 (09/01/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Environmental Impact Statements GENERAL ENVIRONMENT AND SAFETY
Notice of the EPA announces the availability of environmental impact statements filed Aug. 21-25, 2017. Contact: Dawn Roberts; EPA, Office of Federal Activities; 202-564-7146. Citations: 40 CFR 1506.9
82 FR 41621 (09/01/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
First Responder Network Authority/Central Region 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 central region of the nationwide public safety broadband network. The PEIS addresses deployment and operation of the proposed broadband network in the central region consisting of Colorado, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Montana, Nebraska, North Dakota, Ohio, South Dakota, Utah, Wisconsin, and Wyoming. 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, 571-665-6100
82 FR 41594 (09/01/2017)
Regulatory Update
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00000958-00003
GENERAL ENVIRONMENT AND SAFETY
lllinois/Brandon Road Lock and Dam Aquatic Nuisance Species Controls GENERAL ENVIRONMENT AND SAFETY
Notice of the U.S. Army Corps of Engineers announces meetings regarding the draft integrated feasibility study and environmental impact statement for the plan to prevent the spread of aquatic nuisance species between the Great Lakes and Mississippi River basins through the Chicago Sanitary and Ship Canal and other aquatic pathways. The study and EIS evaluate structural and nonstructural options and technologies near the Brandon Road Lock and Dam, in Will County, III., to prevent the upstream transfer of aquatic nuisance species. The study and EIS also identify potential adverse impacts that alternatives may have on existing uses and users of the waterways. The meetings are scheduled for Sept. 11,14, and 18, 2017, in Chicago, Muskegon, and Joliet, III., respectively. The meetings also will be held via web conference and teleconference. Comments are due Oct. 2, 2017. Contact: Andrew Leichty; USACE, Rock Island District; 309-794 5399; Andrew.L.Leichty@usace.army.mil
82 FR 41615 (09/01/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Mandatory Reliability Standard C< ' r nsmission Station Physical Attacks GENERAL ENVIRONMENT AND SAFETY
Notice announces the intention of FERC to seek OMB approval for a continuing information collection request regarding the reporting requirement under Mandatory Reliability Standard CIP014 for transmission owners and operators concerning stations, substations, and primary control centers that, if rendered inoperable or damaged as a result of a physical attack, could result in instability, uncontrolled separation, or cascading within an interconnection (Form FERC-725U). The collection requires such owners and operators to retain data or evidence to show compliance with the standard for three years unless directed by its compliance enforcement authority. Entities that are found noncompliant with the standard must retain related information until mitigation is completed or for the three years, whichever is longer. Comments are due Oct. 31,2017. Contact: Ellen Brown; FERC; 202-502-8663; DataClearance@FERC.gov
82 FR 41618 (09/01/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Medical Devices Advis
ittee Meeting Procedures
GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces the availability of a final guidance for industry that provides additional information regarding the processes for meetings of the Medical Devices Advisory Committee panels, other than the Dispute Resolution Panel. The guidance describes the general circumstances when the Center for Devices and Radiological Health (CDRH) consults with a panel; the process for exchange of information between the CDRH, panel members, industry, and the public; and the conduct of panel meetings. The guidance supplements and replaces existing FDA agencywide guidance on the conduct of advisory committee meetings. Comments may be submitted at any time. Contact: James Swink; CDRH; 301-796-6313
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00000958-00004
82 FR 41626 (09/01/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Nevada/Greater Phoenix Mine Project
GENERAL ENVIRONMENT AND SAFETY
Notice of the Bureau of Land Management announces the availability of a draft environmental impact statement for the proposed Greater Phoenix Mine Project in Lander County, Nev. The project, proposed by Newmont Mining Corp., of Greenwood Village, Colo., involves the expansion of the life of the mine until 2063; expansion of the mine boundary; and increasing surface disturbances to 11,871 acres, of which 5,896 acres involves public lands. In addition to the proposal submitted by Newmont, the agency has analyzed an enhanced/mechanical evaporation cell alternative, a treat water for agricultural cropping on private land alternative, and a no action alternative. Comments are due 45 days after the EPA publishes a notice of availability of the DEIS in the Federal Register. Contact: Christine Gabriel; BLM, Mount Lewis Field Office; 775-635-4000; blm_nv_bmdo_GreaterPhoenixProject@blm.gov
82 FR 41647 (09/01/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Royalty Policy Committee Meeting GENERAL ENVIRONMENT AND SAFETY
Notice of the Office of Natural Resources Revenue announces the first meeting of the Royalty Policy Committee. The committee provides advice to the secretary on the fair market value of, and the collection of revenues derived from, the development of energy and mineral resources on federal and Indian lands. The agenda includes the establishment of first-year priority issues and goals, a timeline for future meetings, actions to be taken in order to achieve committee goals, and subcommittee tasks and membership. The meeting is scheduled for Oct. 4, 2017, in Washington, D.C., and via teleconference. Comments are requested, but a due date is not specified. Contact: Kim Oliver: Office of Natural Resources Revenue; 202-513-0370; rpc@ios.doi.gov
82 FR 41646 (09/01/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
TVA/Freedom of Information Act
GENERAL ENVIRONMENT AND SAFETY
Final rule of the Tennessee Valley Authority amends its Freedom of Information Act (FOIA) regulations to align with the FOIA Improvement Act of 2016. The rule incorporates statutory changes that require agencies to make available for public inspection in an electronic format records that have become or are likely to become the subject of subsequent requests for substantially the same records, or that have been requested three or more times. The rule also provides a minimum of 90 days for requesters to file an administrative appeal, includes dispute
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00000958-00005
resolution procedures, and codifies the Justice Department's forseeable harm standard. In addition, the rule includes provisions to consider whether partial disclosure is possible if full disclosure is not and to take reasonable steps to separate and release nonexempt information. Finally, the rule specifies that the deliberative process privilege does not apply to records created 25 years or more before the date of the request and that such records must be released if requested. The rule is effective Sept. 1, 2017. Contact: Denise Smith; TVA; 865-632-6945; dsmith@tva.gov. Citations: 18 CFR 1301.1 through 1301.12
82 FR 41511 (09/01/2017)
Regulatory Update
HAZARDOUS MATERIALS TRANSPORTATION
National Maritime Security Advis
iittee Meeting
HAZARDOUS MATERIALS TRANSPORTATION
Notice of the U.S. Coast Guard announces a meeting of the National Maritime Security Advisory Committee. The agenda includes discussion of cybersecurity guidance in the Marine Transportation System, an update on regulatory reform efforts, and a committee member report on security developments. The agenda also includes an update on the efforts of the Extremely Hazardous Cargo Working Group and a discussion on the identification of future security issues for the Coast Guard to consider. The meeting is scheduled for Sept. 19-20, 2017, in Arlington, Va., and via webcast and teleconference. Comments are due Sept. 20, 2017. Contact: Ryan Owens; USCG; 202-372-1108; ryan.f.owens@uscg.mil
82 FR 41633 (09/01/2017)
Regulatory Update
HAZARDOUS WASTE CLEANUP
West Virginia/Par Industries Inc. Superfund Site
HAZARDOUS WASTE CLEANUP
Notice of the Justice Department announces a proposed consent decree in United States v. PAR Industrial Corp. (Civil Action No. 3:16-cv-1703), lodged on Aug. 25, 2017, with the U.S. District Court for the Southern District of West Virginia. The consent decree resolves claims under CERCLA concerning the Par Industries Inc. Superfund Site in Nitro, W.Va. The consent decree requires the defendant to pay a civil penalty of $300,000 over a three-year period. The consent also requires the defendant to endeavor to sell the majority of the property on which the site is located and to distribute the proceeds of any sale between the U.S. and defendant under a specified schedule. Comments are due Oct. 2, 2017. Contact: DOJ, Environment and Natural Resources Division; 202-514-2701
82 FR 41657 (09/01/2017)
Regulatory Update
MINING
Wyoming/Bridg
I Co. Coal Exploration License Application
MINING'*......... .........................................................................................
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00000958-00006
Notice of the Bureau of Land Management announces an invitation to participate with Bridger Coal Co., of Point of Rocks, Wyo., on a pro rata cost-sharing basis in a proposed coal exploration program (License Application WYW185631) on 1,561 acres of public lands in Sweetwater County, Wyo. The notice specifies that the exploration program is intended to obtain structural and quality information on the coal. Written notices of intent to participate are due Oct. 2, 2017. Contact: Jackie Madson; BLM; 307-775-6258; jmadson@blm.gov
82 FR 41647 (09/01/2017)
Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH
Personnel Training/Grantee Quarterly Progress Report OCCUPATIONAL SAFETY AND HEALTH
Notice of OSHA announces the submission of a continuing information collection request to the OMB concerning the grantee quarterly progress report for grant-funded training activities under the Susan Harwood Training Grants Program (Form OSHA-171). The collection addresses nonprofits that provide training courses for personnel that address proper use of safety and health equipment and the prevention of unsafe and unhealthful working conditions. Comments are due Oct. 2, 2017. Contact: Michel Smyth; Labor Department; 202-693-4129; DOL_PRA_PUBLIC@dol.gov
82 FR 41661 (09/01/2017)
Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH
Safety Complaints by Employees OCCUPATIONAL SAFETY AND HEALTH
Notice of OSHA announces the submission of a continuing information collection request to the OMB concerning the OSHA-7 Form, by which employees can report alleged safety and health hazards to the OSHA area director or compliance officer. The form also allows employees to request an inspection of the workplace and provides for the opportunity to give information directly to the OSHA compliance officer during an inspection. Comments are due Oct. 2, 2017. Contact: Theda Kenney; OSHA; 202-693-2222. Citations: 29 CFR 1903.11
82 FR 41659 (09/01/2017)
Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH
Underground Construction Standard OCCUPATIONAL SAFETY AND HEALTH
Notice of OSHA announces the submission of a continuing information collection request to the OMB regarding the underground construction standard. The collection addresses requirements for employers to develop records for air quality tests; to post warning signs or notices during underground construction; and to inspect and load test hoists upon installation, repair, and after tripping a hoist safety device. The collection also addresses requirements for employers to
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00000958-00007
prepare and maintain certification records of inspections and load tests. Comments are due Oct. 2, 2017. Contact: Michel Smyth; Labor Department; 202-693-4129; DOL_PRA_PUBLIC@dol.gov. Citations: 29 CFR 1926.800
82 FR 41659 (09/01/2017)
Regulatory Update
OIL AND GAS INDUSTRY
Exxon Valdez Oil Spill Public Advisory Committee Meeting OIL AND GAS INDUSTRY
Notice of the Interior Department announces a meeting of the Exxon Valdez Oil Spill Public Advisory Committee. The agenda includes a review of the fiscal year 2018 work plan, the annual program budget, and habitat issues. The meeting is scheduled for Sept. 28, 2017, in Anchorage, Alaska. Comments are request, but a due date is not specified. Contact: Philip Johnson; Interior Department, Office of Environmental Policy and Compliance; 907-271-5011
82 FR 41646 (09/01/2017)
Regulatory Update
OIL AND GAS INDUSTRY
Small-Scale Natural Gas Exports OIL AND GAS INDUSTRY
Proposed rule of the Energy Department would expedite certain applications for export of natural gas, including liquefied natural gas, to countries with which the U.S. has not entered into a free trade agreement requiring national treatment for trade in natural gas and with which trade is not prohibited. The rule would exempt from the notice of application and procedure process and provide for issuance upon receipt any complete application for export of natural gas in a volume up to and including 0.14 billion cubic feet per day, provided the action does not require an environmental impact statement or an environmental assessment. Comments are due Oct. 16, 2017. Contact: Amy Sweeney; DOE, Office of Regulation and International Engagement; 202-586 2627. Citations: 10 CFR 590.102, 590.208
82 FR 41570 (09/01/2017)
Regulatory Update
RADIATION
Advisory Committee on Reactor Safeguards Meeting
RADIATION
Notice of the NRC announces a meeting of the Advisory Committee on Reactor Safeguards. The agenda includes discussion regarding the Advanced Power Reactor 1400 Design Certification, Planning and Procedures Subcommittee recommendations and ACRS proposed reports. The agenda also includes discussion concerning the quality assessment on the project on validation of computational fluid dynamics methods using prototypic light water reactor spent fuel assembly thermal hydraulic data. The meeting is scheduled for Sept. 7-8, 2017, in Rockville, Md., and via video teleconference. Comments are due Sept. 7, 2017. Contact: Quynh Nguyen; NRC;
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00000958-00008
301-415-5844; Quynh.Nguyen@nrc.gov
82 FR 41669 (09/01/2017)
Regulatory Update
RADIATION
Environmental Management Advisory Board/Hanford
RADIATION
Notice of the Energy Department announces the cancellation of a Sept. 6-7, 2017, meeting of the Environmental Management Site-Specific Advisory Board, Hanford (82 FR 39572; 08/21/2017). The agenda would have included discussion of the fiscal year 2019 budget, state-of-the-site meetings, Tri-Party Agreement agencies' updates, and Hanford Advisory Board Committee reports. Contact: Kristen Holmes; DOE, Richland Operations Office; 509-376-5803; kristen.l.holmes@rl.doe.gov
82 FR 41616 (09/01/2017)
Regulatory Update
RADIATION
Environmental Management Advisory Board/Nevada RADIATION
Notice of the Energy Department announces a meeting of the Environmental Management Site Specific Advisory Board, Nevada. The board makes recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities. The agenda addresses fiscal year 2018 work plan development and recommendation development for communication improvement opportunities. The meeting is scheduled for Sept. 20, 2017, in Las Vegas. Comments are requested, but a due date is not specified. Contact: Barbara Ulmer; DOE; 702-630-0522; NSSAB@nnsa.doe.gov
82 FR 41617 (09/01/2017)
Regulatory Update
TOXIC SUBSTANCES
Dispensing Records of Individual Practitioners
TOXIC SUBSTANCES
Notice of the Drug Enforcement Agency announces the submission of a continuing information collection request to the OMB regarding recordkeeping and associated requirements for individual practitioners registered with the DEA. The collection addresses the biennial inventory and maintenance of records for each narcotic and non-narcotic controlled substance manufactured, received, sold, delivered, or disposed of by registrants. Registrants are responsible for keeping such records for at least two years for inspection and copying by authorized U.S. officers or employees. Comments are due Oct. 2, 2017. Contact: Michael Lewis; DEA, Diversion Control Division; 202-598-6812; OIRA_submission@omb.eop.gov
82 FR 41658 (09/01/2017)
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00000958-00009
Regulatory Update
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EHS Federal Regulatory Alert
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00000958-00010