On June 5, 2025, the FDA issued draft guidance addressing frequently asked questions regarding the transfer or sale of a 510(k) clearance from one 510(k) holder to another. As transfer of 510(k)s is a common issue during transactions involving medical devices, this guidance, if finalized as written, will provide helpful insight regarding the FDA’s position
Shale Law Weekly Review—Week of June 30, 2025
National Energy Policy: Department of Interior Proposes Rescission of 2024 Alaska Petroleum Reserve Regulations
On June 2, 2025, the Department of the Interior (DOI) proposed rescinding a May 2024 Biden-era rule restricting development of oil and gas resources in the Alaska Petroleum Reserve. The DOI conducted a review and concluded that the rule titled “…
Sentencing Council publishes new Guidance including higher fines for Very Large Organisations
Following the launch and review of their fourth annual consultation, the Sentencing Council for England and Wales has now published an amended version of its Sentencing Guidance, that came into force on the 1st of June 2025.
The Sentencing Council recognised concerns that current guidance did not provide sufficient clarity on sentencing Very Large Organisations (“VLO”). The concern was initially raised by the Environment Agency, with the support of Defra’s Secretary of State, who thought the wording was too limited and Courts needed clearer guidance to deal with VLOs.
Well, Well: Outlook for CCUS Projects in Texas Improves as EPA Proposes to Delegate Permitting Authority and the Texas Supreme Court Clarifies Pore Space Ownership
On June 17, the Environmental Protection Agency (EPA) published a proposed rule to approve Texas’s application for primary permitting and enforcement responsibility (primacy) for carbon dioxide (CO2) sequestration wells pursuant to the Safe Drinking Water Act’s (SDWA) Class VI Underground Injection Control (UIC) Program. Upon approval of the rule, the Railroad Commission of Texas (RRC) will have permitting and enforcement authority for the Class VI UIC program (with oversight from the EPA). This development is the culmination of lengthy negotiations between the state of Texas and the EPA, which we have previously discussed in more detail.
Agricultural Law Weekly Review—June 24, 2025
This Week—Fri. June 27 at Noon: Pennsylvania’s Clean & Green Program: County-Level Administration
Register Now—2025 PA Agricultural Law Symposium, Sept. 18, 2025, at Univ. Park, PA.
Antitrust: Federal Court Approves $398 Million Settlement in Chicken Processor Wage-Fixing Class Action
On June 5, 2025, the U.S. District Court for the District of Maryland issued…
Indispensable Party: First District Rules Petitioner’s Failure to Join Real Party in Interest Necessitates Dismissal of Action
In Citizens for a Better Eureka v. City of Eureka (2025) __ Cal. App. 5th __, the First District Court of Appeal affirmed a judgment dismissing a CEQA action that challenged an approval for the redevelopment of a City of Eureka (City) parking lot into affordable housing (Project). The Court affirmed the dismissal because Petitioner…
Texas Legislature Tilts Against Windmills: Is This the End of Wind Energy on the Texas Coast?
Much has been written in recent weeks about how the renewable energy industry in Texas dodged a bullet — several bullets actually — when three high-profile bills targeting the industry failed to pass in the recent legislative session that ended June 2. Indeed, each of those bills, S.B. 819, S.B. 388, and S.B. 715, would have had a substantial negative impact on renewable energy projects in Texas. For all the attention those bills garnered, however, and the justifiable relief felt by the industry after all three failed to pass, seemingly little attention has been paid to another bill, H.B. 3556, that did pass and was signed into law by Governor Abbot on June 22. This new law poses a serious threat to the prospects for future wind projects along the Texas coast.
Shale Law Weekly Review—Week of June 23, 2025
Environmental Impact Studies: Supreme Court Clarifies Scope of Environmental Review Under NEPA
On May 29, 2025, the Supreme Court ruled in Seven County Infrastructure Coalition v. Eagle County that environmental impact statements (EIS) under the National Environmental Policy Act (NEPA) do not need “to consider the environmental effects of upstream and downstream projects that are…
Superfund Is Unscathed So Far—What Does That Imply?
Since January, the new national administration has engaged in a large number of actions addressing scores or hundreds of regulations and programs, including environmental and energy programs. However, environmental lawyers have surely noticed that the federal Superfund program under the Comprehensive Environmental Response, Compensation and Liability Act seems to have escaped direct attention.…
