On 21 May 2025, the European Commission published the Omnibus IV simplification package, aimed at simplify EU rules and reduce bureaucracy across the Single Market. It was accompanied by a press release and factsheet.
The Omnibus IV contains several proposals, notably the following:
Administrative agencies are in an era of reform. Since the US Supreme Court overturned Chevron deference, the scope of agency authority under the law has been uncertain. Simultaneously, the Trump administration has been pushing for increased efficiency within administrative agencies, issuing directives for streamlined decision making to promote the expansion of American industry. Perhaps surprising within this tumultuous backdrop, the US Supreme Court recently reached an 8-0 consensus related to administrative authority in Seven County Infrastructure Coalition v. Eagle County, 605 U.S. ____ (2025) (“Seven County”). Something of a departure from trends toward curtailing agency authority and scope, the majority holding promotes judicial deference in the context of the National Environmental Policy Act (NEPA).
Under NEPA, a federal agency involved with an infrastructure project must consider the environmental impacts of the proposed project; in Seven County, the proposed project is an 88-mile railroad line to be used for oil transport. Construction of railroads necessitates approval by the federal Surface Transportation Board. In weighing the environmental impacts of this proposal over the course of its over 3,600-page analysis, the agency considered direct effects of the project, like increased air pollution and potential impacts to wetlands. It also considered more attenuated effects, like the consequences of increased oil drilling, refining, and traffic in the region. However, it declined to consider certain risks factors which were even further removed, including those related to hypothesized industrial developments related to the railroad. Seven counties in Colorado, along with several environmental organizations, sued the Surface Transportation Board, claiming its potential environmental effects analysis was inadequate in scope and depth. More specifically, they claimed that “reasonably foreseeable impacts” should have been construed more broadly and considered more rigorously. The D.C. Circuit agreed.
On appeal, the US Supreme Court reversed the lower court, providing a fundamental reset concerning the purpose and scope of NEPA, while emphasizing the expansiveness of substantive agency discretion in this context. Justice Kavanaugh penned the majority opinion, describing NEPA as a “legislative acorn” that “has grown over the years into a judicial oak that has hindered infrastructure development ‘under the guise’ of just a little more process” (Seven County at 13). He reminded the reader that “NEPA is a purely procedural statute. Under NEPA, an agency’s only obligation is to prepare an adequate report” (Seven County at 2) (emphasis in original). Consequently, NEPA does not impose substantive requirements and agencies are delegated with the authority to weigh factors as they see fit. Departing from the Loper Bright general rule which prioritizes judicial authority, the majority emphasizes the importance of “substantial judicial deference” to agency decision-making in the context of NEPA. It reads NEPA to explicitly grant agencies with decision making authority, and holds that, in such contexts, courts should defer to reasonable agency action.
As applied to this matter, the parties disputed the degree of attenuated causality an agency is required to consider. The Court held that the focus NEPA is the “proposed action,” described as the “project at hand,” referencing 42 U.S.C § 4332(2)(C) (2018). Again, the Court emphasized agency discretion, holding that “courts should defer to agencies’ decisions regarding where to draw the line” on the contours or reach of the project. (Seven County at 2). Here, specifically, the Court held that the agency was not required to consider factors like the upstream and downstream environmental effects of oil and gas development. The scope of regulatory authority was crucial for the Court; it held that “agencies are not required to analyze the effects of projects over which they do not exercise regulatory authority” (Seven County at 17). This discretionary approach continues in discussion of NEPA remedies. The Court found that, even in instances where an agency’s environmental analysis was too narrow or imperfect, it would be inappropriate to use that flaw in isolation as justification to vacate an agency approval. Though reaching the same conclusion, the concurrence narrows its reasoning to the authority granted to NEPA more specifically, rather than the broader context of executive agencies and the scope of their authority. It emphasizes that agencies are charged under NEPA to consider environmental factors for which they are responsible, not more generalized potential impacts.
In the end, the Court held that agencies are due “substantial deference” in the NEPA context, a contrast to the restriction of agency authority in Loper Bright and an executive push towards limitations of agency authority. Within the narrow context of NEPA, at least, the Court found consensus in upholding agency authority to weigh environmental impacts. The Court opined that NEPA had evolved overtime from “a modest procedural requirement into a blunt and haphazard tool” wielded by those who seek to grind projects to a halt (Seven County at 12); at least within the context of NEPA, the Court held that embracing agency discretion was an appropriate remedy to administrative stagnation. And while the holding itself is narrow, the majority’s discussion indicates that other statutes with similar discretionary mandates could be spaces where it would uphold agency discretion.
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 on the 510(k) requirements in the context of such transactions. Read the full publication here.
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.
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s 2024 Rule regulating as “devices” under the Food, Drug, and Cosmetic Act FDCA, certain laboratory-developed tests used to diagnose, monitor, or determine treatment for diseases and conditions. The decision, American Clinical Laboratory Assoc. v. FDA, No. 4:24-CV-479-SDJ, 2025 WL 964238 (E.D. Tex. Mar. 31, 2025), marks another application of the Supreme Court’s recent Loper Bright decision rejecting the longstanding Chevron principle of deference to agency statutory interpretation. Loper Bright continues to fundamentally rework the legal framework for challenging agency actions. For more details, see our post on this issue here.
After what has amounted to a multi-year rulemaking process, the California Office of Environmental Health Hazard Assessment (OEHHA) finalized amendments to the short-form warnings under Proposition 65 on December 6, 2024. The amendments (outlined in full here) require that short-form warnings include at least one chemical name, along with other options for safe harbor warning. There is also a specialized short-form warning for food. Specific long-form warnings were also added for Passenger, or Off-Highway Motor Vehicle Parts and Recreational Marine Vessel Parts. While the amendments become effective on January 1, 2025, OEHHA has provided businesses that currently rely on the existing short-form warnings three years (until January 1, 2028) to transition to the new short-form content.
Read the full insight to learn more about these amendments.
Automotive manufacturers, regulators and consumers face considerable uncertainty on how the incoming Trump Administration will attempt to reshape the automotive industry when President Donald Trump returns to the White House on January 20, 2025. Significant changes are on the horizon, with President Trump’s major campaign themes, including protectionist trade policies and an “all of the above” energy policy, reflecting a noteworthy shift from President Biden’s globalist and clean energy platform. As in 2017, President Trump’s approach to economic and environmental issues is near certain to create ripple effects throughout the automotive industry.
Changes may be most pronounced on EV policy – a political lightning rod for Republicans in recent years – despite Tesla CEO Elon Musk’s role in the upcoming Trump Administration. Future proposals are likely to further President Trump’s promises to eliminate government incentives for EV manufacturing and purchases, with the aim of tipping the scales back in favor of gas-powered vehicles, and the oil industry.
Read the full insight to learn more about these initiatives.
As evidenced by the Department of Justice’s recent announcement of a US$2 million criminal fine assessed against the owners of the tanker P/S Dream as part of a guilty plea, violations of federal environmental laws governing vessel discharge can carry significant consequences.
Stakeholders should take note that the EPA recently announced the final Vessel Incidental National Standards of Performance (VINSP Final Rule) that applies to the release of pollutants and invasive species from approximately 85,000 vessels operating in US waters. The Final Rule applies to nonrecreational, non-Armed Forces vessels 79 feet in length and above, as well as ballast water only from fishing vessels of any size and non-recreational, non-Armed Forces vessels less than 79 feet in length.
The VINSP Final Rule is aimed at a diverse cross-section of commercial vessels operating in US territorial waters and the contiguous zone. As stated in an EPA press release: “Clean water and healthy aquatic ecosystems provide multiple benefits to nearby communities. They support commerce and commercial fishing, they serve as sources of drinking water and they connect people to nature,” said EPA Principal Deputy Assistant Administrator for Water Bruno Pigott. “EPA’s final rule will help protect our vital waterways while reducing the spread of invasive species, like zebra mussels. The agency’s final rule also delivers on Congress’ direction to establish nationwide requirements that replace the current patchwork of federal, state and local requirements.”
As the EU intensifies its focus on ESG, the new Corporate Sustainability Due Diligence Directive (CS3D) is poised to enforce stricter environmental accountability across corporate operations. This directive, along with recent EU court rulings, underscores the critical need for companies to strengthen their environmental due diligence to avoid significant legal and financial penalties. For a deeper dive into these developments and their implications, read the full analysis on SPB’s Global Investigations & Compliance Review blog here.
Keith Bradly, Squire Patton Boggs (US) LLP Partner and Co-Chair of the Appellate and Supreme Court Practice, authored an article for Bloomberg Law discussing the U.S. Supreme Court’s recent decision in SEC v. Jarkesy. The Court found that when the Securities Exchange Commission (SEC) seeks civil penalties for securities fraud, the Seventh Amendment affords a defendant the right to a jury trial in federal court because such claims are legal in nature. Although this case involves the SEC, it may have a ripple effect for other agencies, raising the question of whether enforcement matters, including environmental enforcement actions, are similar to claims at law or equity. It may also lead to less administrative enforcement actions but increased and more expensive federal litigation. Read the full article at Supreme Court’s Jarkesy Ruling Upends SEC Enforcement Practices (bloomberglaw.com).
