Arnold Porter

DECEMBER 20, 2021

FDA’s decision to issue this investigator-specific guidance follows publication of a draft sponsor-specific safety reporting guidance in June 2021, and is part of an effort to ultimately replace the older guidance documents with role-specific guidance. 2021) (RWE Draft Guidance). A summary of these documents follows below.

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PA Environment Daily

DECEMBER 13, 2021

which outlines the evaluations needed for a waste to qualify as a product-- or “coproduct” as defined in DEP’s Residual Waste regulations. DEP’s Oil and Gas Program banned the practice of disposing of unconventional (shale) drilling wastewater by road spreading in regulations adopted in 2016. DEP regulations at 25 Pa Code Chapter 287.8

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Waste Regulations 2020 2010 75

Arnold Porter

AUGUST 12, 2021

This question, and FDA’s discretion to determine a product’s regulatory classification, was at the heart of the DC Circuit’s April 2021 decision in Genus Med. Under the FDCA, whether a product is regulated as a drug or device turns on the intended use of the product. N: Genus Med. Food and Drug Administration, 994 F.3d

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Regulations 2021 Government Law 40

Arnold Porter

JUNE 2, 2021

However, Commerce notes that most cryptographic libraries and modules themselves will likely not be impacted by this change because the mass market note (Note 3 to Category 5, Part 2 or the "Cryptography Note") specifically excludes items whose primary function is "information security.". c or 5D992.c Conclusion.

Technology 52

Technology Technology 2021 2019 52

Greenbuilding Law

JULY 25, 2021

The Phase l Environmental Site Assessment Standard E1527-13 will sunset in late 2021, eight years from its approval on November 6, 2013. There is no doubt that the uninitiated have been confused that a CREC is a subset of a REC, but the examples are problematic in that they stray into the category of HRECs, which are not RECs.

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2013 2005 Regulations Environmental Responsibility 98

Manning Law

DECEMBER 21, 2021

Today, the Government of Canada announced that draft regulations prohibiting certain single-use plastics have been published for public comment. It is the Government’s intention to finalize these Regulations and bring the ban into force as quickly as possible and as early as late 2022 after reviewing and considering comments received.

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Regulations Recycling Law 2020 45

E2 Law Blog

JUNE 13, 2022

offices from the Environmental Practice of global law firm Greenberg Traurig, LLP are recognized in The Legal 500 United States 2022 Guide. The annual Guide once again recognized the Environmental Practice in the following categories: Dispute Resolutions > Product Liability, Mass Tort, and Class Action – Defense: Toxic Tort.

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2022 Law Regulations Natural Resources 52

Arnold Porter

DECEMBER 9, 2021

On December 8, 2021, the Financial Crimes Enforcement Network (FinCEN) took a key step toward implementing the highly anticipated beneficial ownership information (BOI) reporting requirements of the Corporate Transparency Act (CTA). a passport or driver’s license number) of the individual.

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Regulations 2001 Law 2016 52

Arnold Porter

OCTOBER 6, 2021

The deadline to submit comments is November 8, 2021. Definitions and Categories. How the Agency resolves these questions in regulations critically impact what covered businesses need to do to steer clear of Agency enforcement actions in the years to come. © Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved.

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Regulations 2020 2021 Government 52

Arnold Porter

SEPTEMBER 9, 2021

On August 27, 2021, the US Department of the Treasury (Treasury) announced that it had reached a settlement agreement (the Settlement Agreement) with Romanian bank First Bank SA (First Bank) and its US parent company, JC Flowers & Co. (JC Euro-Denominated Payments to Iran as a Foreign Subsidiary of a US Company.

2018 52

2018 2016 Regulations 2021 52

Arnold Porter

SEPTEMBER 1, 2021

Sponsors, target companies, their respective directors and officers, and their investment banks would be well advised to anticipate the likelihood of increasing and enhanced scrutiny of SPACs by the plaintiffs’ bar and regulators. E.Merge et al , 1:21-cv-07072 (SDNY August 20, 2021); Assad v. 1:21-cv-07076 (SDNY August 20, 2021).

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Law 2021 Government Regulations 52

The Energy Law Blog

FEBRUARY 17, 2021

The Corporate Transparency Act, adopted as part of the 2021 National Defense Authorization Act (the “Act”), will require certain business entities (defined as “reporting companies”) to disclose to the U.S. Reporting will not begin until the Treasury adopts regulations, which the Act mandates must be done by January 1, 2022.

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Regulations Law Government 2021 52

PA Environment Daily

DECEMBER 29, 2022

The report looked at environmental compliance in the industry between 2017 through 2021. Overview Of Non-Compliance DEP reports between 2017 through 2021, the agency did 63,026 inspections of wells belonging to 1,512 conventional oil and gas well owners operating 34,812 wells.

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Waste 2017 Regulations Environmental Protection 97

Arnold Porter

JUNE 2, 2021

On March 2, 2021, Virginia Governor Ralph Northam signed into law the Consumer Data Protection Act (the VCDPA or the Act), making Virginia the second state, following California, to grant consumers broad privacy rights with respect to their personal information as collected by businesses both within and outside the state.

Law 52

Law Regulations Technology Technology 52

The Energy Law Blog

FEBRUARY 17, 2021

The Corporate Transparency Act, adopted as part of the 2021 National Defense Authorization Act (the “Act”), will require certain business entities (defined as “reporting companies”) to disclose to the U.S. Reporting will not begin until the Treasury adopts regulations, which the Act mandates must be done by January 1, 2022.

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Regulations Law Government 2021 40

Acoel

MAY 24, 2023

Posted May 24, 2023 by Tracy Hester In a jurisprudential pile-up, the Fifth Circuit has become the arena for two simultaneous legal battles that may shape the law of standing and realign federal environmental law. While all eyes are on the U.S. 8, the Texas abortion bounty statute.

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Law Clean Air Act Clean Water Act Politics 52

Arnold Porter

JANUARY 21, 2022

In October 2021, we discussed the U.S. For example: In June 2021, Belgian security firm G4S Secure Solutions NV agreed to plead guilty to criminal antitrust conspiracy and agreed to pay a $15 million criminal fine;[[N:Press Release, U.S. 18, 2021), [link]. ]] pled guilty to rigging bids for U.S. 16, 2021), [link]. ]].

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2019 Government 2020 2021 52

Greenbuilding Law

NOVEMBER 21, 2021

I am excited to be presenting a fast paced and fun one hour virtual program, “Environmental Social Governance (ESG) an Emergent and Fast Growing Area of the Law” for the Maryland State Bar Association, and Not just for lawyers, on December 14, 2021 at noon. Register today for the live virtual program. yes, this blog will continue).

2013 52

2013 Law 2005 Regulations 52

Vermont Law

AUGUST 3, 2020

identifies issues that need to be addressed, determines alternatives that would correct the issues, studies any potential environmental issues, complies with environmental regulations, and involves the public throughout the process. forthcoming 2021. NEPA process. If the action may have significant environmental impacts, then an.

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Law 2015 Regulations 2021 52

Arnold Porter

JUNE 2, 2021

Included as part of the Consolidated Appropriations Act of 2021 ,[[N:H.R. HHS will further define the IDR process via upcoming regulation. The federal No Surprises Act does not include a preemption clause, meaning the new federal law does not replace or supersede any existing state laws regulating surprise medical bills.

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Law 2020 Regulations 2021 52

Smith Enviorment

DECEMBER 14, 2023

Section 14 of Senate Bill 582 d irects DEQ and the EMC to replace the current general permit (in effect since December 1, 2021) with the previous version of NCG530000. Reverting to the earlier permit will eliminate water quality monitoring requirements for nitrogen and phosphorus that were added to the permit in 2021. Under the N.C.

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2023 Clean Water Act Waste Law 52

Legal Planet

MAY 19, 2022

This is a problem, because affordable housing is essentially a deal between the public and developers—trading money or relaxed regulations in exchange for an agreement to restrict rents on the building—and the specifics of that deal make a big difference as to whether the public is getting a fair bargain. Enter the Area Median Income.

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Law Columbia

MAY 19, 2023

Since President Biden took office in January 2021, his administration has been proactive in its efforts to fulfill his campaign promise to place climate issues at the forefront of his presidential agenda. and its economy, infrastructure, and markets.

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Regulations Climate Change 2021 Government 57

Arnold Porter

DECEMBER 10, 2021

On December 8, 2021, the Financial Crimes Enforcement Network (FinCEN) published a notice as an initial step in addressing potential money laundering vulnerabilities associated with non-financed transactions in the US real estate market.[[N: N: Anti-Money Laundering Regulations for Real Estate Transactions , 86 Fed. 29, 2021).]].

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Regulations 2021 2016 2022 52

Law Columbia

FEBRUARY 12, 2024

A civil law breakthrough came in 2021, with the ruling of a Dutch court against Shell. The Court found that he had – the impacts of climate change would indeed engage rights that fit within the categories identified in existing case law. And it should put corporations on notice: failing to reduce GHG emissions is a legal risk.

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Law Climate Change Regulations Ocean 64

CEQA Developments

MARCH 9, 2022

In an opinion filed on December 16, 2021, and belatedly ordered published on January 13, 2022, the Fourth District Court of Appeal rejected a CEQA challenge to a small multifamily project in the City of Santa Cruz. City of Santa Cruz (2021) 73 Cal.App.5th Ocean Street Extension Neighborhood Assn. 5th 985 (“ OSENA ”).

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Conservation Law Regulations 2010 90

PA Environment Daily

FEBRUARY 11, 2022

He also repeatedly made the point in recounting the history of conventional drilling that drillers took no action to properly plug or case their oil and gas wells to protect groundwater and prevent methane migration, unless there was a law and regulations making them do it. And the New Testament essentially went through perhaps three phases.

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Regulations Waste 2020 Law 52

Brag

NOVEMBER 29, 2021

Environmental Protection Agency (EPA) announced on November 23, 2021, legally mandated changes to the fee requirements under the Toxic Substances Control Act (TSCA). EPA calculated the inflation rate by dividing the Producer Price Index (PPI) for September 2021 (348.8) By Richard E. Engler, Ph.D. , and Carla N.

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Toxic Substances Control Act 2018 2016 2019 45

Arnold Porter

JULY 13, 2021

On July 7, 2021, Colorado Governor Jared Polis signed into law the Colorado Privacy Act (CPA or the Act), a far-reaching statute providing Colorado residents new rights to control the collection, use and disclosure of their personal information by businesses active in the state. Such consent must be clear, informed and unambiguous.

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Law Regulations 2024 Government 52

Arnold Porter

JULY 22, 2021

Federal agencies could prepare programmatic environmental impact statements (EIS’s) for categories of CCS projects, for example, which would allow much shorter and faster environmental assessments on a project-specific basis. © Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved.

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Regulations Government Renewable Energy Technology 52

CEQA Developments

OCTOBER 21, 2021

In a 53-page published opinion filed October 8, 2021, the Fourth District Court of Appeal mostly affirmed, but reversed in part, a judgment in a CEQA action challenging two sets of projects of the City of San Diego to underground overhead utility wires in several neighborhoods. City of San Diego (2021) Cal.App.5th.

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Law 2013 2012 2016 80

Law Columbia

MAY 10, 2023

The Legal Effect of Oil and Gas Leases Oil and gas leases issued by BLM grant the lessee “the exclusive right to drill for, mine, extract, remove and dispose of all the oil and gas. The company has a legal right to those leases. BLM’s] options are limited when there are legal contracts in place.” in the land.”

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Fossil Fuels Greenhouse Regulations Climate Change 100

Circle of Blue

MARCH 28, 2022

Last year Scottsdale authorities, concerned about the effects of the megadrought and the August 2021 federal Colorado River water shortage declaration, decided to protect the city’s 241,000 residents. Nabity and Simpson had waded into the complexity of Arizona law and regulation, and the rugged terrain of politics, to find a solution.

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Law 2022 Politics Climate Change 362

Arnold Porter

SEPTEMBER 28, 2021

As we previously reported , President Biden issued an executive order on September 9, 2021 charting a path for implementing COVID-19 safeguards for government contractors (EO). Applicability. Vaccine Mandate v. masking and social distancing) are workplace-specific. ”); id. However, the Guidance provides clarity on the timing.

Government 52

Government 2021 Regulations Law 52

PA Environment Daily

JANUARY 10, 2024

DEP issued 1,360 NOVs to unconventional shale gas well operators in 2022 and 1,323 NOVs in 2021, according to DEP’s 2022 Oil and Gas Program Annual Report. Unconventional shale gas operators were issued a total of 1,310 notices of violation in 2023, according to DEP’s December 29 Workload Report.

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2023 Natural Gas 2022 Waste 115

Arnold Porter

DECEMBER 20, 2022

We also report on recent updates in relation to sanctions and the growth of cryptoasset-related regulation. Regulators concluding the HBOS investigation with no further action against senior managers. million for misleading its regulator, the FRC. Economic Crime and Corporate Transparency Bill 2022. KPMG fined £18.4

Government 52

Government Law Regulations 2022 52

Arnold Porter

JUNE 2, 2021

A discussion of ESG disclosures, and what the industry may expect from these other financial regulators on ESG matters under the Biden-Harris Administration, will be the subject of an upcoming Advisory. * * * * *. Transition to a Sustainable Low-Carbon Economy , issued today, February 18, 2021. N: See also , The U.S.

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Climate Change 2020 Regulations 2021 52