More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs ...
On February 12, 2018 the Mexican Secretariat of Communications and Transportation (“SCT”) published the draft of Mexican Environmental Standard PROY-NOM-036-SCT3-2017 in the Official Daily Gazette, which sets forth the maximum allowable limits of noise generated by aircraft. Within the next 60 calendar days, any interested party may provide comments to the National Consultation Committee of Air Transportation Standardization ...
On February 22, 2018, the Center for Biological Diversity (CBD) sent the Environmental Protection Agency (EPA) a notice of intent to sue letter for failure to approve Kentucky’s air quality plan for limiting fine particulate (PM2.5) emissions in the Louisville, Kentucky area. Kentucky’s Energy and Environment Cabinet submitted a revision to the Jefferson County portion of the Kentucky State Implementation Plan (SIP) to EPA December 21, 2016 ...
On February 13, 2018, Mexico’s Federal Electricity Commission (“CFE”) announced the bidding process for its Ixtepec Potencia – Yautepec Potencia Transmission Line in Oaxaca (“Project”). The transmission lines will cross the following states: State of Mexico, Morelos, Puebla, Oaxaca, Mexico City and Veracruz. The estimated investment is US$1.7 billion and it will have a transmission capacity of 3,000 MW at a voltage level of 500 kV ...
Earlier this year, and five years after being presented before the National Congress, Law 21,064 that “Introduces modifications to the regulatory framework that rules water on inspection and sanctions matters”, was enacted and published in the Official Gazette (Bulletin 8149-09) (the Law). The main modifications introduced by the Law to the current regulatory framework are the following: 1 ...
On February 9, 2018, the Ministry of Energy (“SENER”) published in the Official Federal Gazette the “Guidelines for Interconnection of Power Plants and Connection of Load Centers” (Manual para la Interconexión de Centrales Eléctricas y Conexión de Centros de Carga) ...
On January 31, 2017, the First Appellate District Court in the case Santa Barbara Channelkeeper v. City of San Buenaventura found that an allegation of excessive water diversion to protect endangered fish species under the rule of reasonableness and the public trust doctrine, could not be resolved without consideration of all competing water users in the system ...
On January 31, 2018 the National Hydrocarbons Commission (“CNH”) conducted the long-awaited event for submission and opening of bids for the Deep Water “Round 2.4” E&P license contracts. The bid round comprised 29 offshore deep waters blocks and the overall result was very successful for Mexico ...
In a major departure from over 20 years of practice, the EPA announced on January 25 that it is withdrawing the “once in, always in” (OIAI) interpretation of the hazardous air pollutants (HAPs) program. The OIAI required sources of HAPs to permanently comply with Maximum Achievable Control Technology (MACT) standards applicable to major sources of HAPs, even when those sources’ emissions are below major source levels ...
The National Hydrocarbons Commission (CNH) published the call for the second bid of Round 3 on January 25, 2018. This new bid round (Round 3 ...
We previously reported on oral arguments before the Supreme Court regarding which court has original jurisdiction to hear challenges to the Clean Water Act’s “waters of the United States” (“WOTUS”) definition. On January 22, 2018, the Supreme Court issued a unanimous decision in National Association of Manufacturers v. Department of Defense that only district courts have original jurisdiction to hear such challenges ...
Companies looking to purchase non-operating working interests will review longstanding operating agreements, or negotiate the terms of new operating agreements, to ensure that appropriate non-operator rights are present and enforceable ...
On January 4, 2018, the U.S. Department of the Interior ("Department") announced its draft proposal of the 2019-2024 Outer Continental Shelf ("OCS") Oil and Gas Leasing Program that would reopen nearly all federal waters to offshore leasing for new oil and gas operations ...
In January 2018, Mexico’s Ministry of Energy (“SENER”) published several Guidelines as part of the applicable rules for the Wholesale Power Market (“WEM”) in the Federal Gazette. This Haynes and Boone alert is important to all participants of the WEM, including qualified users, suppliers, marketers, non-suppliers and generators. 1 ...
The Serbian Competition Commission (the "Commission") recently fined four undertakings for bid rigging in the public procurement for the maintenance of train wagons. The contracting authority, the "Nikola Tesla" power plant, which represents the largest electricity-producing complex in Serbia, informed the Commission about possible collusion in public procurement for repair services for the train wagons it uses in coal transportation ...
The U.S. International Trade Commission (“ITC”) issued a determination at the end of 2017, finding that solar panel imports are hurting domestic businesses that operate in the solar industry. The ITC’s determination was issued in connection with a trade case filedby a Georgia-based company, Suniva, Inc., shortly after filing for bankruptcy protection. SolarWorld Americas, Inc. joined Suniva’s petition ...
As of late this year [1], the Agency of Natural Resources and Energy announced that it has issued deadlines for the submission of renewable energy application documents, etc. based on the FIT Act in FY 2017. Upon submission of these applications, etc. they will be reviewed by the Ministry of Economy, Trade and Industry (METI), however, every year, the review process tends to be stalled because of the large number of applications submitted at the end of the fiscal year ...
On October 16, 2017, EPA Administrator Pruitt issued the “Directive Promoting Transparency and Public Participation in Consent Decrees and Settlement Agreements.” At the same time, Pruitt issued a memorandum to EPA assistant administrators, regional administrators and the office of general counsel explaining the rejection of “sue and settle” tactics by his administration ...
For many years EPA has taken the position it could take enforcement action based on agency review and calculation of projected emissions in determining New Source Review (NSR) applicability for pre-construction permitting for modification of an existing source ...
On October 16, 2017, EPA Administrator Scott Pruitt signed an order reversing a long-standing EPA position that EPA has the authority to review previous state decisions on new source permitting applicability when reviewing Title V permits. The order denied a petition by Sierra Club requesting that EPA object to the issuance of a Title V operating permit to the Hunter Power Plant in Castle Dale, Utah ...
Kentucky Regulatory Amendments On September 15, 2017, the Division for Air Quality submitted amendments to 401 KAR 59:015 for new indirect heat exchangers and 401 KAR 61:015 for existing indirect heat exchangers. The Division stated the amendments were necessary to provide clarity for regulated entities and to remove duplicative requirements covered by federal regulations ...
EPA continues to make progress in its effort to repeal and replace the Clean Power Plan (CPP). EPA held public hearings on November 28-29, 2017, in Charleston, West Virginia to take testimony on its October 10, 2017, proposal to repeal the rule. EPA is accepting comments on the proposal to repeal the rule through January 16, 2018. EPA announced it will hold three additional public comment sessions due to the “overwhelming response” to the West Virginia hearing ...
In its bill, Extended Environmental Crime Provisions, from earlier this year, the government has proposed extending the scope of offences for environmental crime committed in conjunction with waste management. The proposal means that all waste management that can cause significant pollution, which is harmful to human health, animals or plants or that can cause other significant environmental nuisance is to be punishable. The penalty for the crime is a fine or imprisonment for up to two years ...
