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Jackson, Ryan[jackson.ryan@epa.gov] Bloomberg BNA Mon 8/28/2017 12:15:24 PM Aug. 28 - EHS Federal Regulatory Alert
EHS Federal Regulatory Alert
August 28, 2017 - Number 165
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Summaries
AIR Alaska SIP/Minor Source Permitting, Transportatic > 'mforrrm < AIR
Final rule of the EPA approves revisions to the Alaska SIP that update the version of incorporated federal regulations, update minor source permitting requirements, and remove obsolete source specific requirements. The revisions also update certain general conformity and transportation conformity provisions concerning interagency consultation and public involvement. The rule is effective Sept. 27, 2017. Contact: Randall Ruddick; EPA Region 10, Office of Air and Waste; 206 553-1999; ruddick.randall@epa.gov. Citations: 40 CFR 52.70
82 FR 40712 (08/28/2017)
Regulatory Update
AIR Kentucky SIP/Louisville Metro Air Pollution Control District AIR
Final rule of the EPA approves portions of revisions to the Kentucky SIP concerning the Louisville Metro Air Pollution Control District's stationary source emissions monitoring and reporting requirements. The revisions authorize the district to require emissions monitoring at stationary sources and require specified sources to maintain emissions records and provide annual emissions statements to the district. The rule is effective Sept, 27, 2017. Contact: Richard Wong, EPA Region 4, Air Planning and Implementation Branch; 404-562-8726; wong.richard@epa.gov. Citations: 40 CFR 52.920
82 FR 40701 (08/28/2017)
Regulatory Update
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002691 -00001
AIR
Maryland SIP/National Gypsu
nit
AIR
Direct final rule of the EPA approves revisions to the Maryland SIP concerning alternative volatile organic compound (VOC) emission standards for the National Gypsum Co. facility near Baltimore. The revisions concern an alternative VOC emission limit in the state permit-toconstruct and the conditions to ensure that National Gypsum remains a minor stationary source of VOCs. The rule is effective Nov. 27, 2017, unless adverse comments are received by Sept. 27, 2017. Contact: Gregory Becoat; EPA Region 3; 215-814-2036 becoat.gregory@epa.gov. Citations: 40 CFR 52.1070
82 FR 40715 (08/28/2017)
Regulatory Update
AIR
Maryland SIP/National Gypsu
nit
AIR
Proposed rule of the EPA would approve revisions to the Maryland SIP concerning alternative volatile organic compound (VOC) emission standards for the National Gypsum Co. facility near Baltimore. The revisions concern an alternative VOC emission limit in the state permit-toconstruct and the conditions to ensure that National Gypsum remains a minor stationary source of VOCs. A concurrent direct final rule adopts the revisions, effective Nov. 27, 2017. Comments are due Sept. 27, 2017. Contact: Gregory Becoat; EPA Region 3; 215-814-2036 becoat.gregory@epa.gov. Citations: 40 CFR 52.1070
82 FR 40743 (08/28/2017)
Regulatory Update
AIR Maryland SIP/Permitting AIR
Final rule of the EPA approves revisions to the Maryland SIP regarding procedures for issuance, denial, and appeal of permits. The revisions eliminate the contested case process and the Office of Administrative Hearings' adjudicatory hearing process for major permits and substitute direct judicial review. The revisions also expand standing for challenges to major permits and include public notice requirements for certain sources. The rule is effective Sept. 27, 2017. Contact: David Talley; EPA Region 3; 215-814-2117; talley.david@epa.gov. Citations: 40 CFR 52.1070
82 FR 40710 (08/28/2017)
Regulatory Update
AIR Tennessee SIP/Knoxville PM-2.5 Nonattainment Area AIR
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002691 -00002
Final rule of the EPA redesignates the Knoxville-Sevierville-La Follette, Tenn., fine particulate matter (PM-2.5) nonattainment area to attainment for the 2006 24-hour PM-2.5 NAAQS. The agency has determined that the area has attained the NAAQS based on 2013-2015 monitoring data. The rule also approves and incorporates into the SIP the state's reasonably available control measures determination for the area. In addition, the rule approves the maintenance plan, including motor vehicle emission budgets for nitrogen oxides and PM-2.5 for 2014 and 2028. The rule is effective Sept. 27, 2017. Contact: Sean Lakeman; EPA Region 4, Air Planning and Implementation Branch; 404-562-9043; lakeman.sean@epa.govCitations: 40 CFR 52.2220, 81.343
82 FR 40718 (08/28/2017)
Regulatory Update
AIR Virginia SIP/Major New Source Review AIR
Final rule of the EPA approves revisions to the Virginia SIP regarding major source new source review (NSR) standards. The revisions allow the use of a 10-year lookback period to calculate pre change emissions for sources other than electric utility steam generating units and the use of different lookback periods for different regulated NSR pollutants. The revisions also extend the effective period for plantwide applicability limits to 10 years and allow replacement units to be treated as existing units, providing the ability to use baseline actual and projected actual emissions when determining applicability. The rule is effective Sept. 27, 2017. Contact: David Talley; EPA Region 3; 215-814-2117; talley.david@epa.gov. Citations: 40 CFR 52.2420
82 FR 40703 (08/28/2017)
Regulatory Update
COASTAL ZONE Puerto Rico/Jol COASTAL ZONE
rtional Estuarine Research Reserve
Notice of NOAA, Office for Coastal Management, announces a request for comments on the revised management plan for the Jobos Bay National Estuarine Research Reserve in Puerto Rico. The revised plan describes the administrative structure, research and monitoring, stewardship, education and training programs, and priorities of the reserve; plans for a proposed boundary expansion through future land acquisition; and facility development priorities. The revised plan also reflects a reduction in the acreage within the reserve to 2,800 acres and updates to monitoring, education, and other programs since the last plan was approved in 2000. Comments are due Sept. 27, 2017. Contact: Nina Garfield; NOAA, Office for Coastal Management; 240-533 0817
82 FR 40752 (08/28/2017)
Regulatory Update
COASTAL ZONE Washington State/Padilla Bay National Estuarine Research Reserve COASTAL ZONE
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002691 -00003
Notice of the Office for Coastal Management announces a meeting to discuss the performance evaluation of the Padilla Bay National Estuarine Research Reserve in Washington state. The office will consider the extent to which the state has met national objectives and adhered to its approved management plan and the terms of financial assistance under the Coastal Zone Management Act, The meeting is scheduled for Sept 27, 2017, in Mount Vernon, Wash. Comments are due Oct. 6, 2017. Contact: Ralph Cantral; NOAA, Office for Coastal Management; 240-533-0729; Ralph.Cantral@noaa.gov
82 FR 40750 (08/28/2017)
Regulatory Update
FOOD SAFETY National Advisory Committee on Microbiological Criteria for Foods Nominations FOOD SAFETY
Notice of the Food Safety and Inspection Service announces the reopening of the nomination period (81 FR 88197; 12/07/2016) for membership on the National Advisory Committee on Microbiological Criteria for Foods. The committee advises the secretaries of the departments of Agriculture and Health and Human Services on the development of microbiological criteria for the assessment of the safety and wholesomeness of food. Nominations are sought from individuals with expertise in the fields of epidemiology, food technology, microbiology, toxicology, risk assessment, infectious disease, biostatistics, and related sciences. The agency has reopened the period due to an increase in committee vacancies from 15 to 17. Nominations submitted during the original period do not need to be resubmitted. Nominations now are due Sept. 27, 2017. Contact: Karen Thomas-Sharp; FSIS; 202-690-6620; karen.thomas-sharp@fsis.usda.gov
82 FR 40744 (08/28/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Affirmative Procurement of Biobased Products GENERAL ENVIRONMENT AND SAFETY
Notice announces the intention of the Defense Department, General Services Administration, and National Aeronautics and Space Administration to seek OMB approval for a continuing information collection request regarding affirmative procurement of biobased products under services and construction contracts. The collection addresses requirements for prime contractors to annually report product types and dollar values of Agriculture Departmentdesignated biobased products purchased to the System for Award Management website. The information collected allows federal agencies to annually report to the Office of Federal Procurement Policy on actions taken to implement and measure progress in carrying out the preference for biobased products. Comments are due Oct. 27, 2017. Contact: Charles Gray; GSA, Office of Governmentwide Acquisition Policy; 703-795-6328; charles.gray@gsa.gov. Citations: 48 CFR 52.223-2
82 FR 40769 (08/28/2017)
Regulatory Update
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002691 -00004
GENERAL ENVIRONMENT AND SAFETY Bone, Reproductive and Urologic Drugs Advis GENERAL ENVIRONMENT AND SAFETY
nmittee Meeting
Notice of the FDA announces a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The agenda includes discussion of appropriate patient selection criteria and clinical trial design features and acceptable endpoints for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The agenda also includes discussion of whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations and whether it is appropriate to assess efficacy in the same way for both conditions. The meeting is scheduled for Dec. 7, 2017, in Silver Spring, Md, Comments are due Nov. 22, 2017. Contact: Kalyani Bhatt; FDA, Center for Drug Evaluation and Research; 301-796 9001; kalyani.bhatt@fda.hhs.gov
82 FR 40771 (08/28/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Cellular, Tissue and Gene Therapies Advisory Committee Meeting GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee to discuss a biologies license application for voretigene neparvovec (BLA 125610) submitted by Spark Therapeutics Inc., of Philadelphia. The proposed indication for the product is the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy. The meeting is scheduled for Oct. 12, 2017, in Silver Spring, Md. Comments are due Oct 4, 2017. Contact: Prabhakara Atreya; FDA, Center for Biologies Evaluation and Research; 240-402-8006; prabhakara.atreya@fda.hhs.gov
82 FR 40770 (08/28/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Idaho/Gateway West Transmission Line Project GENERAL ENVIRONMENT AND SAFETY
Notice announces the intention of the Bureau of Land Management to prepare an environmental assessment to reconsider the Jan. 19, 2017, record of decision approving the right-of-way application from PacifiCorp, of Portland, Ore., for Segments 8 and 9 of the Gateway West 500kilovolt Transmission Line Project in Idaho. The bureau will identify issues associated with the reconsideration, including the potential amendment of several resource management plans and management framework plans in the project area. The reconsideration is due to the enactment of the Morley Nelson Snake River Birds of Prey NCA Boundary Modification Act, which directed the bureau to issue a right-of-way grant for portions of the project specified in Alternative 1 from the 2016 final supplemental EIS (81 FR 69845; 10/07/2016). Comments are due Sept. 27, 2017. Contact: Courtney Busse; BLM, Boise District Office; 208-373-3872; cbusse@blm.gov
82 FR 40797 (08/28/2017)
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002691 -00005
Regulatory Update
HAZARDOUS MATERIALS TRANSPORTATION Improving Motor Carrier Safety Measurement Report HAZARDOUS MATERIALS TRANSPORTATION
Notice of the Federal Motor Carrier Safety Administration announces the availability of a report by the National Academy of Sciences concerning motor carrier safety measurement. The document reviews the accuracy and methodologies of FMCSA's Compliance, Safety, Accountability program and the Safety Measurement System for identifying noncompliance and prioritizing motor carriers for interventions. The document also includes recommendations and an action plan for improvement of the system. A meeting is scheduled for Sept. 8, 2017, in Arlington, Va. Comments are due Sept, 27, 2017. Contact: Theresa Rowlett; FMCSA; 202-360 2924; Theresa.Rowlett@dot.gov
82 FR 40828 (08/28/2017)
Regulatory Update
RADIATION Licensing for Land Disposal of Low-Level Radioactive Waste RADIATION
Notice of the NRC announces the submission of a continuing information collection request to the OMB regarding licensing requirements for land disposal of radioactive waste. The collection addresses applications for licenses for land disposal of low-level radioactive waste by licensees, including agreement state licensees. Comments are due Sept. 27, 2017. Contact: David Cullison; NRC; 301-415-2084; INFOCOLLECTS.Resource@nrc.gov. Citations: 10 CFR 61
82 FR 40808 (08/28/2017)
Regulatory Update
RADIATION Registration for In Vitro Testing with Byproduct Material Under General License RADIATION
Notice announces the intention of the NRC to seek OMB approval for a revised information collection request concerning registration for in vitro testing with byproduct material under a general license. The collection concerns one-time submittal of NRC Form 483 for registration by any physician, veterinarian, clinical laboratory, or hospital for a general license to receive, acquire, possess, transfer, or use specified units of byproduct material in certain in vitro clinical or laboratory tests. The revisions update instructions and regulatory language. Comments are due Oct 27, 2017. Contact: David Cullison; NRC; 301-415-2084; INFOCOLLECTS.Resource@NRC.GOV
82 FR 40809 (08/28/2017)
Regulatory Update
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002691 -00006
WATER Definition of Waters of the U.S. Under the CWA WATER
Notice of the U.S. Army Corps of Engineers and the EPA announces meetings to hear recommendations from stakeholders on revising the definition of "waters of the United States" under the Clean Water Act. There will be 10 teleconferences, with nine tailored to specific industries and one open to the general public, and one in-person meeting with small entities. The current action is intended to lead to a proposed rule to revise the definition and is part of the second step in a two-step process to implement Executive Order 13778 (82 FR 12497; 03/03/2017). The first step is being taken in a July 27, 2017, proposed rule (82 FR 34899) that would restore the definition to what it was prior to a June 29, 2015, final rule (80 FR 37054). The teleconferences will be held every Tuesday from Sept. 19 through Nov. 21, 2017. The in-person meeting with small entities is scheduled for Oct. 23, 2017, in Washington, D.C. Comments are due Nov. 28, 2017. Contact: Damaris Christensen; EPA, Office of Water; 202-566-2428; CWAwotus@epa.gov. Citations: 33 CFR 328; 40 CFR 110 through 401 (nonconsecutive)
82 FR 40742 (08/28/2017)
Regulatory Update
WATER Wastewater Analysis and Sampling Test Procedures WATER
Final rule of the EPA revises the test procedures for analysis and sampling of pollutants in applications and reports required under the Clean Water Act NPDES program and state certifications under CWA Section 401. The rule adds analytical methods developed by the EPA and voluntary consensus standard bodies and updates versions of currently approved methods. The rule also approves six methods reviewed under the alternative test procedures program (ATP), clarifies the process for approval of nationwide ATP approvals and the regional ATP coordinator's role in limited use ATP approvals, and corrects previously approved methods. In addition, the rule revises the procedure for determination of the method detection limits to address laboratory contamination and to account for intra-laboratory variability. The rule is effective Sept. 27, 2017. Contact: Adrian Hanley; EPA, Engineering and Analysis Division; 202-564 1564; hanley.adrian@epa.gov. Citations: 40 CFR 136.1 through 136.6, Appendices A, B
82 FR 40836 (08/28/2017)
Regulatory Update
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EHS Federal Regulatory Alert
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00002691 -00007