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.
California Prop 65’s Short-form Warnings Will No Longer Be Short – Summary of Amendments to Short-form Warnings under California Proposition 65 – Effective January 1, 2025 with Three-Year Grace Period
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.
Trump Administration: Major Changes May Be Coming in the Federal Government’s Posture Toward Electric Vehicles (EV’s)
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.
US Environmental Protection Agency (EPA) Announces Final Vessel Incidental Discharge Rule
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.”
ESG Due Diligence Update: First Lessons from Recent Rulings in the EU
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.
U.S. Supreme Court’s Jarkesy Ruling Shifts Power for Federal Enforcement
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).
Chevron Has Fallen: Supreme Court Seismically Shifts Regulatory Power From Agencies to Courts
On June 28, 2024, in a 6-3 decision in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the Chevron doctrine, a decades-old precedent that largely pressed federal courts to defer to federal agency interpretations of ambiguous statutes under their jurisdiction. The opportunities, the challenges, and the uncertainty will grow for a long time before the dust settles from Loper Bright. In every interaction with the federal government, it is now necessary to do a fresh assessment of just how much discretionary authority the agency actually has. Read the full publication here for details on the implications of this decision, which merit ongoing attention and preparation for a changed environment.
OSHA Final Rule Clarifies Employees’ Walkaround Representative; Opens Non-Union Workplaces to Union Representatives
The U.S. Department of Labor’s Occupational Safety & Health Administration (OSHA) published its controversial final “walkaround” rule on April 1, 2024. The final rule clarifies the rights of employees to authorize a representative – employee or non-employee – to accompany an OSHA compliance officer (CSHO) during an inspection of their workplace. This can include a “third party” (or non-employee) representative, such as a union representative, if OSHA deems the representative “may be reasonably necessary to the conduct of an effective and thorough inspection based upon skills, knowledge, or experience such as knowledge or experience with hazards or conditions in the workplace or similar workplaces, or language or communication skills” OSHA argues the authorized employee representative would accompany the CSHO for the purpose of aiding a lawful inspection under the Occupational Safety & Health (OSH) Act.
Commenters raised significant concerns, ranging from First, Fourth, Fifth, and Tenth Amendment violations to due process concerns and issues over allowing a union representative access to a non-union worksite/workplace that some believed could potentially violate the Supreme Court of the United States’ decision in Cedar Point Nursery. With respect to the latter issue, OSHA argues in the final rule:
FDA Announces End of PFAS Use in US Food Packaging
On February 28, 2024, the Food and Drug Administration (“FDA”) published a news release regarding the voluntary market phase-out of per and polyfluoroalkyl substances (PFAS) in grease-proofing substances used on food packaging. The FDA stated that the completion of this phase-out “eliminates the primary source of dietary exposure to PFAS from authorized food contact uses.”
The End of “Chevron” or Its Rebirth?
Fishermen in the small town of Cape May, New Jersey, are at the epicenter of a legal challenge that could reshape the landscape of agency authority. The fishermen are challenging the entrenched “Chevron” doctrine, which for years has afforded deference to government agencies with respect to reasonable interpretation of ambiguous statutes. Once again, the US Supreme Court (SCOTUS) is in the spotlight as it hears pivotal cases – Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo, which may presage the dismantling of “Chevron”.
