To: From: Sent: Subject:
Jackson, Ryan[jackson.ryan@epa.gov] Bloomberg BNA Wed 8/30/2017 12:39:02 PM Aug. 30 - EHS Federal Regulatory Alert
EHS Federal Regulatory Alert
August 30, 2017 - Number 167
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 Automobile and Light Tru / m port AIR
. rage Fuel Economy Standards
Notice of the National Highway Traffic Safety Administration announces the extension of the comment period for a July 26, 2017, notice of intent (82 FR 34740) 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 now are due Sept. 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 41306 (08/30/2017)
Regulatory Update
AIR Electric Motors and Small Electric Motors Test Procedures AIR
Notice of the Energy Department announces the extension of the comment period for a July 31, 2017, notice (82 FR 35468) regarding a request for information for assessing potential revisions to the test procedures and exemptions for small electric motors last updated in July 2009. The DOE seeks comments on opportunities to minimize regulatory burdens under the existing procedures in conformance with Executive Order 13771 (82 FR 9339; 02/03/2017). The previous notice discussed potential test procedures for certain types of motors beyond those subject to existing requirements. The agency seeks information to assess whether such new test procedures should be established and requests comments on the benefits and burdens of adopting any industry/voluntary consensus-based or other appropriate test procedures without
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00001717-00001
modification. Comments now are due Sept 13, 2017. Contact: Jeremy Dommu; DOE, Office of Energy Efficiency and Renewable Energy; 202-586-9870; ApplianceStandardsQuestions@ee.doe.gov. Citations: 10 CFR 431, Subpart X
82 FR 41179 (08/30/2017)
Regulatory Update
AIR Rhode Island SIP/lnterstat by < AIR
I ?iqhb y P ovision
Proposed rule of the EPA would approve revisions to the Rhode Island SIP regarding the good neighbor provisions of the 2010 primary sulfur dioxide (SO2) and 2010 primary nitrogen dioxide (NO2) NAAQS. The agency proposes to approve the state's demonstration that it is meeting its obligations concerning the transport of SO2 and NO2 emissions into other states. Comments are due Sept, 29, 2017. Contact: Donald Dahl; EPA Region 1; 617-918-1657; dahl.donald@epa.gov. Citations: 40 CFR 52
82 FR 41197 (08/30/2017)
Regulatory Update
COASTAL ZONE Florida/Gulf Coast Ecosystem Restoration Council Initial Funded Priorities List COASTAL ZONE
Notice of the Gulf Coast Ecosystem Restoration Council announces a proposed amendment to the initial funded priorities list, required by the Resources and Ecosystem Sustainability, Tourist Opportunities, and Revived Economies of the Gulf Coast States (RESTORE) Act. The list specifies the initial activities that the council proposes to prioritize for funding and further consideration in watersheds across the gulf. The amendment would approve approximately $1.32 million in implementation funding for the Robinson Preserve Wetlands Restoration Project in Bradenton, Fla. The amendment also would reallocate $470,910 from planning to implementation for the project. The funds would support the restoration of 118.2 acres of coastal habitat and related activities in Tampa Bay. NOAA has confirmed that the project is exempt from the National Environmental Policy Act. Comments are due Sept. 29, 2017. Contact: John Ettinger; Gulf Coast Ecosystem Restoration Council; 504-444-3522; john.ettinger@restorethegulf.gov
82 FR 41262 (08/30/2017)
Regulatory Update
ENDANGERED SPECIES Alaska/Biorka Island Dock Replacement Project ENDANGERED SPECIES
Notice of the National Marine Fisheries Service announces the receipt of a request from the Federal Aviation Administration for authorization to take marine mammals incidental to pile driving and removal and down-the-hole drilling associated with the Biorka Island Dock Replacement Project in Symonds Bay, Alaska. The authorization allows take of five species in the
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00001717-00002
form of Level A and Level B harassment from May 1, 2018, to April 30, 2019. Comments are due Sept 29, 2017. Contact: Laura McCue; NMFS, Office of Protected Resources; 301-427-8401; ITP.McCue@noaa.gov
82 FR 41229 (08/30/2017)
Regulatory Update
ENDANGERED SPECIES California/Central Bay Operations and Maintenance Facility Project ENDANGERED SPECIES
Notice of the National Marine Fisheries Service announces the issuance of an incidental harassment authorization to the San Francisco Water Emergency Transportation Authority to take marine mammals incidental to pile driving and removal associated with the Central Bay Operations and Maintenance Facility Project in Alameda, Calif. The authorization allows the take of seven species by level A and level B harassment during in-water construction activities from Aug. 1,2017, through Nov. 30, 2017. The authorization is valid until July 31,2018. Contact: Laura McCue; NMFS, Office of Protected Resources; 301-427-8401
82 FR 41215 (08/30/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Determination Concerning Safety and Effectiveness/Cenestin GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces a determination that Cenestin (estrogens, conjugated synthetic A) tablets, 0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination allows the FDA to approve abbreviated new drug applications for these products if all other legal and regulatory requirements are met. Contact: Bronwen Blass; FDA, Center for Drug Evaluation and Research; 301-796-5092
82 FR 41273 (08/30/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Digoxin Product-Specific Guidance GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces the availability of a draft revised guidance for industry concerning generic digoxin tablets. The product-specific guidance addresses the design of bioequivalence studies to support abbreviated new drug applications for digoxin tablets. Comments are due Oct. 30, 2017. Contact: Xiaoqiu Tang; FDA, Center for Drug Evaluation and Research; 301-796-5850
82 FR 41270 (08/30/2017)
Regulatory Update
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00001717-00003
GENERAL ENVIRONMENT AND SAFETY National Data Buoy Center GENERAL ENVIRONMENT AND SAFETY
Notice of the National Weather Service announces the availability of a draft programmatic environmental assessment for the continued operation of the NOAA National Data Buoy Center's network of moored buoys and coastal stations. The network consists of 200 buoys and 46 coastal marine automated network stations that transmit oceanographic and meteorological observations and data to users in U.S. economic sectors, such as maritime transportation and energy, to facilitate safe commercial and marine recreation activities. Comments are due Sept. 21, 2017. Contact: Joe Swaykos; NOAA, National Data Buoy Center; 228-688-4766; joe.swaykos@noaa.gov
82 FR 41214 (08/30/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Regulatory Review Period/Kengreal GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces a determination of the regulatory review period for the human drug product Kengreal (cangrelor tetrasodium) in response to an application submitted by AstraZeneca UK Ltd., of London. The product is indicated as an adjunct to percutaneous coronary intervention for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein llb/llla inhibitor. Comments are due Oct. 30, 2017. Petitions for a determination of whether the applicant for extension acted with due diligence during the regulatory review period are due Feb. 26, 2018. Contact: Beverly Friedman; FDA, Office of Regulatory Policy; 301-796-3600
82 FR 41274 (08/30/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Regulatory Review Period/Xtoro GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces a determination of the regulatory review period for the human drug product Xtoro (finafloxacin) in response to an application submitted by Alcon Pharmaceuticals Ltd., of Fribourg, Switzerland, for Bayer Intellectual Property GmbH, of Leverkusen, Germany. The product is indicated for treatment of acute otitis externa caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus. Comments are due Oct. 30, 2017. Petitions for a determination of whether the applicant for extension acted with due diligence during the regulatory review period are due Feb. 26, 2018. Contact: Beverly Friedman; FDA, Office of Regulatory Policy; 301-796-3600
82 FR 41271 (08/30/2017)
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00001717-00004
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY Withdrawal of Approval of Abbreviated New Drug Application/Propranolol Hydrochloride GENERAL ENVIRONMENT AND SAFETY
Notice of the FDA announces the withdrawal of approval of an abbreviated new drug application for propranolol hydrochloride extended-release capsules held by Upsher-Smith Laboratories Inc., of Maple Grove, Minn. The applicant requested the withdrawal because the bioequivalence data it submitted to the FDA did not demonstrate therapeutic equivalence of the product with Inderal LA. The withdrawal is effective Aug. 30, 2017. Contact: Stefanie Kraus; FDA, Center for Drug Evaluation and Research; 301-796-9585. Citations: 21 CFR 314.150
82 FR 41273 (08/30/2017)
Regulatory Update
GENERAL ENVIRONMENT AND SAFETY
Wyoming/Tallgrass Interstate Ga
smission Pipeline Abandonment
GENERAL ENVIRONMENT AND SAFETY
Notice of FERC announces the filing of an application requesting authorization to abandon a 47mile pipe segment from the discharge side of the existing Labonte Compressor Station in Converse County, Wyo., to the inlet side of the existing Guernsey Compressor Station in Platte County. The applicant, Tallgrasss Interstate Gas Transmission LLC, of Lakewood, Colo., specifies that the segment will be abandoned in place and sold to Tailgrass Midstream LLC (TMID). TMID will purchase, convert, own, and operate the pipeline segment as a crude oil pipeline to meet demand for pipeline transportation of crude oil. The agency will complete an environmental analysis or issue a notice of schedule of environmental review by Nov. 22, 2017. Comments are due Sept. 14, 2017. Contact: FERC, Office of External Affairs; 866-208-3676; FercOnlineSupport@ferc.gov
82 FR 41256 (08/30/2017)
Regulatory Update
HAZARDOUS MATERIALS TRANSPORTATION Chemical Transportation Advisory Committee Meetings HAZARDOUS MATERIALS TRANSPORTATION
Notice of the U.S. Coast Guard announces meetings of the Chemical Transportation Advisory Committee and its subcommittees to discuss issues related to the marine transportation of hazardous materials. The meetings will address safety standards for the design of vessels carrying natural gas or using natural gas as fuel, marine vapor control system regulations implementation and guidance, hazardous substance response plans for tank vessels and facilities, and international maritime organization activities. The meetings also will address regulatory reform of Coast Guard regulations per executive orders 13771 (82 FR 9339; 02/03/2017) and 13783 (82 FR 16093; 03/31/2017). The subcommittee meetings are scheduled for Oct. 3 and 4, 2017, in Washington, D.C. The full committee meeting is scheduled for Oct. 5, 2017, at the same location. Comments are due Sept. 26, 2017. Contact: Jake Lobb; USCG; 202-372-1428; jake.r.lobb@uscg.mil
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00001717-00005
82 FR 41279 (08/30/2017)
Regulatory Update
OCCUPA TIONAL SAFETY AND HEALTH Cranes and Derricks in Construction/Operator Certification OCCUPATIONAL SAFETY AND HEALTH
Proposed rule of OSHA extends for one year, until Nov. 10, 2018, the enforcement date for crane operator certification and the existing employer assessment duty to ensure crane operator competency for construction work. The provisions were originally adopted in an Aug. 9, 2010, final rule (75 FR 47906), and the deadline for operator certification and existing employers duties was extended for an additional three years, until Nov. 10, 2017, in a Sept. 26, 2014, final rule (79 FR 57785), The proposed rule would extend the existing employer duty and enforcement date for an additional year to provide that covered operators are competent to operate the equipment safely. Comments are due Sept, 29, 2017. Contact: Frank Meilinger; OSHA, Office of Communications; 202-693-1999; meilinger.francis2@dol.gov; Citations: CFR 1926.1427
82 FR 41184 (08/30/2017)
Regulatory Update
OCCUPA TIONAL SAFETY AND HEALTH Nationally Recognized Testing Laboratories/lntertek OCCUPATIONAL SAFETY AND HEALTH
Notice of OSHA announces the receipt of and the preliminary finding to grant an application from Intertek Testing Services NA, of Cortland, N.Y., for expansion of its scope of recognition as a nationally recognized testing laboratory. The expansion involves the addition of seven test standards to its scope of recognition. Comments are due Sept. 14, 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 41292 (08/30/2017)
Regulatory Update
OCCUPA TIONAL SAFETY AND HEALTH Underground Metal and Nonmetal Mines/Escape and Evacuation Plans OCCUPATIONAL SAFETY AND HEALTH
Notice of the Mine Safety and Health Administration announces the submission of a continuing information collection request to the OMB regarding the development of escape and evacuation plans to address the conditions of underground metal and nonmetal mines. The collection addresses requirements for each plan submission to include mine maps or diagrams showing principal air flow; location of escape routes; and locations of existing telephones, primary fans, primary fan controls, fire doors, ventilation doors, and refuge chambers. The collection also addresses requirements for each plan submission to include procedures to show how the miners will be notified of an emergency, an escape plan for each working area in the mine, a firefighting plan, and surface procedures to be followed in an emergency. In addition, the collection
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00001717-00006
addresses requirements for each plan submission to include a statement of the availability of emergency communication and transportation facilities, emergency power, and ventilation and the location of rescue personnel and equipment Comments are due Sept. 29, 2017. Contact: Michel Smyth; Labor Department; 202-693-4129; DOL_PRA_PUBLIC@dol.gov. Citations: 30 CFR 57.11053
82 FR 41291 (08/30/2017)
Regulatory Update
OCCUPATIONAL SAFETY AND HEALTH Underground Metal and Monmetal Mines/Rock Bur' ' 1 OCCUPATIONAL SAFETY AND HEALTH
>trol Plans
Notice of the Mine Safety and Health Administration announces the submission of a continuing information collection request to the OMB regarding rock burst control plans at underground metal and nonmetal mines. The collection addresses requirements for operators to implement rock burst control plans within 90 days after a rock burst has occurred, monitoring procedures where detection methods are used, and other measures to minimize exposure of persons to areas prone to rock bursts. The collection also addresses requirements for operators to update plans as conditions warrant and to provide the plans to inspectors and miners or their representatives. Comments are due Sept. 29, 2017. Contact: Michel Smyth; Labor Department; 202-693-4129; DOL_PRA_PUBLIC@dol.gov. Citations: 30 CFR 57.3461
82 FR 41290 (08/30/2017)
Regulatory Update
OCCUPA TIONAL SAFETY AND HEALTH Voluntary Protection Programs OCCUPATIONAL SAFETY AND HEALTH
Notice announces the intention of OSHA to seek OMB approval for a continuing information collection request regarding the Voluntary Protection Programs (VPPs), under which the agency, participating employers, and labor cooperate to address employee safety and health issues and expand employee protection. The collection gathers compliance information from employer applicants and participants, including information concerning injury and illness rates and workplace safety and health management programs. The collection also gathers application information for employees of VPP participants who wish to participate in the Special Government Employee Program for on-site evaluations, including an eligibility information sheet, current resume, financial disclosure form (OGE Form 450), and optional application for federal employment (OF 612). In addition, the collection addresses application requirements for OSHA Challenge administrators. Comments are due Oct. 30, 2017. Contact: David Hamel; OSHA, Directorate of Cooperative and State Programs; 202-693-2213
82 FR 41294 (08/30/2017)
Regulatory Update
RADIATION
N
lulatory Guidance/Petitions for Rulemaking and Submission of Proposals
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00001717-00007
RADIATION
Notice of the NRC announces the withdrawal of regulatory guide (RG) 10.12 regarding the preparation of petitions for rulemaking and the preparation and submission of proposals for regulatory guidance documents. Updated guidance is available in the revised regulations concerning petitions for rulemaking and in other communication tools, including the NRC's public website, and therefore RG 10.12 is no longer needed. The withdrawal does not alter any prior or existing licensing commitments based on its use. The withdrawal is effective Aug. 30, 2017. Contact: Harriet Karagiannis; NRC, Office of Nuclear Regulatory Research; 301-251-7477; Harriet.Karagiannis@nrc.gov. Citations: 10 CFR 2.802
82 FR 41297 (08/30/2017)
Regulatory Update
TOXIC SUBSTANCES Assessment of Chemical Exposore Investigations TOXIC SUBSTANCES
Notice announces the intention of the Agency for Toxic Substances and Disease Registry to seek OMB approval of a revised information collection request regarding assessment of chemical exposure investigations. The investigations address performing epidemiological assessments to assist state, regional, local, or tribal health departments to respond to or prepare for acute chemical releases. The revisions rename the rapid response registry form to the ACE short form, delete two insurance questions from the form, and specify that the short form will be used in time limited investigations where longer surveys are not possible. Comments are due Oct. 30, 2017. Contact: Leroy Richardson; CDC, Information Collection Review Office; 404-639-7570; omb@cdc.gov
82 FR 41263 (08/30/2017)
Regulatory Update
TOXIC SUBSTANCES Methylene Chloride/Paint and Coating Removal Prohibition TOXIC SUBSTANCES
Notice of the EPA announces a workshop on a Jan. 19, 2017, proposed rule (82 FR 7464) to prohibit the manufacture, processing, and distribution of methylene chloride for consumer and most types of commercial paint and coating removal. The workshop is intended to inform the agency's understanding of methylene chloride use in furniture refinishing and the agenda includes discussion of potential alternatives, economic impacts, and other issues. The agenda also includes presentations by subject matter experts on current use practices, the availability of safer alternatives, and worker protection measures. The workshop is scheduled for Sept. 12, 2017, in Boston. Comments are due Nov. 12, 2017. Contact: Ingrid Feustel; EPA, Office of Pollution Prevention and Toxics; 202-564-3199; Feustel.ingrid@epa.gov. Citations: 40 CFR 751.101 through 751.111 (Subpart B) and 751.201 through 751.211 (Subpart C)
82 FR 41256 (08/30/2017)
Regulatory Update
Sierra Club v. EPA, 1:17-cv-01906
ED_001523_00001717-00008
TOXIC SUBSTANCES Phthalates/Childrei TOXIC SUBSTANCES
nd Child Care Articles
Final rule of the Consumer Product Safety Commission codifies the agency's determination that four plastics with specified additives do not contain phthalates prohibited in children's toys and child care articles and therefore do not require third-party testing. The agency determined that polypropylene, polyethylene, high-impact polystyrene, and acrylonitrile butadiene styrene, with specified additives, do not contain the prohibited phthalates (DEHP, DBP, BBP, DINP, DIDP, DnOP) in concentrations above 0.1 percent with a high degree of assurance. As a result, these plastics with specified additives do not require third-party testing for compliance with the phthalates prohibitions on children's toys and child care articles under Section 108 of the Consumer Product Safety Improvement Act, The rule is effective Sept, 29, 2017. Contact: John Boja; CPSC, Office of Compliance and Field Operations; 301-504-7300; jboja@cpsc.gov. Citations: 16 CFR 1308.1,1308.2
82 FR 41163 (08/30/2017)
Regulatory Update
WATER California/Central Valley Project Improvement Act Water Management Plans WATER
Notice of the Bureau of Reclamation announces the availability of eight water management plans under the Central Valley Project Improvement Act. The plans include a description of the district, an inventory of water resources, best management practices (BMPs) for agricultural contractors, BMPs for urban contractors, plan implementation information, exemption procedures, regional criteria, and five-year revisions. Comments are due Sept. 29, 2017. Contact: Charlene Stemen; Bureau of Reclamation; 916-978-5218; cstemen@usbr.gov
82 FR 41286 (08/30/2017)
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_00001717-00009