All’s Well That Ends Well: The CFTC Amends Its Wells Notice Process and Other Rules of Practice for the Better
For years, the Commodity Futures Trading Commission (CFTC or Commission) has exercised broad discretion in investigating and prosecuting potential violations of the law, with its sanctions and penalties infrequently subject to challenge. The industry has long criticized this process as being opaque and lacking fairness. Joining the chorus of critics, CFTC Acting Chairman Caroline D. Pham has been vocal about her objections to the Commission’s prior enforcement practices, emphasizing the need for higher standards of integrity, diligence and excellence in enforcement actions to maintain public trust.
To address these longstanding criticisms, the CFTC published amendments to Rule of Practice and Rules Relating to Investigations (the Amendments) on December 1, 2025, to improve transparency, fairness and the preservation of constitutional rights in the Commission’s enforcement procedures.[1] By clarifying certain procedures, expanding response times and ensuring objectivity in internal recommendations, the CFTC is taking concrete steps to uphold the integrity of its enforcement program and restore public confidence in its oversight of US derivatives markets.
The following is Katten’s forward-looking analysis of the Amendments, which unpacks critical enhancements to the Commission’s Wells Process, extended response timelines and reinforced due process protections, as well as the internal process reforms designed to elevate transparency and objectivity in CFTC investigations and enforcement actions.
Key Amendments to the Rules of Practice
The Amendments represent a comprehensive effort to address the concerns noted above and to modernize the agency’s enforcement framework. The Amendments fall into five main categories:
revising procedures for notifying individuals or entities who may be named in enforcement actions, including the Wells process;
clarifying (and, in effect, materially broadening) the definition of adjudicatory proceedings to capture certain actions, including (a) Commission orders instituting proceedings pursuant to the Commodity Exchange Act, (b) Commission findings, and (c) Commission-imposed remedial sanctions;
establishing new requirements for the form and content of recommendation memoranda from the CFTC’s Division of Enforcement (Division);
removing references to outdated regulations and obsolete communication methods; and
clarifying the Commission’s authority to accept settlement offers by order.
Enhancements to the Wells Process
A central focus of the Amendments is the reform of the Wells process, which governs how the Division notifies individuals or entities that may be subject to enforcement action. The Amendments now require that notice of potential charges and the relevant facts supporting those allegations be provided in writing whenever possible, with oral notices to be promptly confirmed in writing. The written notice must identify the specific charges the Division has made a preliminary determination to recommend to the Commission and may refer to specific evidence supporting the recommendation. This change is intended to end the practice of “secret” charges and ensure that those potentially subject to enforcement action are fully informed of the allegations against them.
The Amendments also significantly expand the time allowed for recipients of a Wells notice to respond. Previously, individuals or entities had as little as two days — and in some cases, only 14 days — to make a Wells submission. Under the Amendments, a minimum of 30 days is provided for such responses, unless good cause is shown and approved by senior Division attorneys. This ensures that respondents have adequate time to prepare a thorough and meaningful submission.
Acting Chairman Pham highlighted the importance of this change. She noted that “[t]hese reforms ensure due process, such as providing a proper Wells notice and discontinuing the practice of ‘secret’ charges and providing a minimum of 30 days — instead of as little as 2 days in the past — to make a Wells submission that is shared with the Commission promptly”.[2]
Objective and Comprehensive Internal Memoranda
Another major reform is the requirement that the Division’s recommendation memoranda to the CFTC be objective, comprehensive and consistent with applicable rules of professional conduct. As a result of the Amendments, these memos must now provide a thorough explanation of the factual and legal basis for the recommendation, distinguish unfavorable facts or legal precedents and be supported by citations to evidence in the investigative record or stipulations by the parties. Legal arguments must be supported by points and authorities. This change is a significant departure from prior practice, which did not require the Division to preview or discuss unhelpful facts or law that may favor the recipient of a Wells notice. This change is intended to ensure an accurate and complete administrative record and to prevent bias in the CFTC’s decision-making process.
Transparency and Fairness in Enforcement Proceedings
The Amendments also require that all written statements submitted in response to a Wells notice be forwarded to the full Commission, not just upon the submitter’s request, as was previously the case. The Amendments also permit the recipient of a Wells notice to request that their response be “promptly” provided to the Commission, which could expedite the resolution of the matter and also inform the Commission of the pending matter, potentially before the Division makes a charging recommendation. These changes ensure that the CFTC has a complete and accurate record when considering whether to commence an enforcement action.
Impact on the Industry, Next Steps
The Amendments collectively aim to “end lawfare so that all are treated fairly with respect for basic rights in CFTC enforcement actions,” as Acting Chairman Pham put it. She further emphasized, “[t]he Commission must be an objective finder of fact and neutral arbiter of law that respects the Constitution and Constitutional rights. There must be no bias in the administration of justice and due process”.
The Amendments will become effective upon their publication in the Federal Register. In short, the Amendments are expected to benefit enforcement respondents by enhancing transparency, efficiency, and due process in the CFTC’s core enforcement activities.
Footnotes
[1] See CFTC Press Release Number 9144-25, “Acting Chairman Pham Announces Reforms to Wells Process, Amends Rules of Practice and Rules Relating to Investigations,” available at https://www.cftc.gov/PressRoom/PressReleases/9144-25.
[2] See CFTC Acting Chairman Caroline D. Pham’s Comments on her LinkedIn page, post dated Dec. 1, 2025, available at https://www.linkedin.com/posts/carolinedpham_acting-chairman-pham-announces-reforms-to-activity-7401370451618238465-mEWI?utm_medium=ios_app&rcm=ACoAAADQT1wBabWzk31dfuh0uI7P9vxmSvuXofg&utm_source=social_share_send&utm_campaign=mail.
White House OSTP Issues RFI Regarding “Accelerating the American Scientific Enterprise”
On Thanksgiving Eve, November 26, 2025, the White House Office of Science and Technology Policy (OSTP) requested input from interested parties on federal policy updates “that aim to accelerate the American scientific enterprise, enable groundbreaking discoveries, and ensure that scientific progress and technological innovation benefit all Americans.” 90 Fed. Reg. 54412. OSTP states that “[t]hrough this Request for Information (RFI), OSTP seeks input from academia; private sector organizations; industry groups; state, local, and tribal governments; and other stakeholders regarding priorities for strengthening the science and technology (S&T) ecosystem to support both the expansion of scientific knowledge and the mechanisms to transition these discoveries into the marketplace.” According to OSTP, the RFI “will inform the formulation of Executive branch efforts to advance and maintain U.S. S&T leadership.” Responses are due on Boxing Day, December 26, 2025.
According to OSTP, multiple forces are reshaping how scientific research is conducted. OSTP states that new institutional models such as focused research organizations operate outside traditional academic structures; emerging questions in fields like quantum information science and biology require ever-closer collaboration between engineering and basic science; and rapid progress in artificial intelligence (AI) promises to accelerate discovery cycles. These shifts demand continuous improvement in how the federal government supports scientific research. OSTP notes that simultaneously, “America’s strategic competitors have placed unprecedented focus on scientific advancement.” The convergence of new scientific opportunities, intensifying global competition, and evidence that traditional approaches to research could be greatly improved “call for a comprehensive assessment of how the Federal government prioritizes and structures scientific research.”
Questions Included in the RFI
OSTP invites responses to one or more of the following questions:
(i) What policy changes to federal funding mechanisms, procurement processes, or partnership authorities would enable stronger public-private collaboration and allow America to tap into its vast private sector to drive better use-inspired basic and early-stage applied research?
(ii) How can the federal government better support the translation of scientific discoveries from academia, national laboratories, and other research institutions into practical applications? Specifically, what changes to technology transfer policies, translational programs, or commercial incentives would accelerate the path from laboratory to market?
(iii) What policies would encourage the formation and scaling of regional innovation ecosystems that connect local businesses, universities, educational institutions, and the local workforce — particularly in areas where the federal government has existing research assets like national laboratories or federally-funded research centers?
(iv) How can federal policies strengthen the role played by small- and medium-sized businesses as both drivers of innovation and as early adopters of emerging technologies?
(v) What empirically grounded findings from metascience research and progress studies could inform federal grantmaking processes to maximize scientific productivity and increase total return on investment?
(vi) What reforms will enable the American scientific enterprise to pursue more high-risk, high-reward research that could transform our scientific understanding and unlock new technologies, while sustaining the incremental science essential for cumulative production of knowledge?
(vii) How can the federal government support novel institutional models for research that complement traditional university structures and enable projects that require vast resources, interdisciplinary coordination, or extended timelines?
(viii) How can the federal government leverage and prepare for advances in AI systems that may transform scientific research — including automated hypothesis generation, experimental design, literature synthesis, and autonomous experimentation? What infrastructure investments, organizational models, and workforce development strategies are needed to realize these capabilities while maintaining scientific rigor and research integrity?
(ix) What specific federal statutes, regulations, or policies create unnecessary barriers to scientific research or the deployment of research outcomes?
(x) How can federal programs better identify and develop scientific talent across the country, particularly leveraging digital tools and distributed research models to engage researchers outside traditional academic centers?
(xi) How can the federal government foster closer collaboration among scientists, engineers, and skilled technical workers, and better integrate training pathways, recognizing that breakthrough research often requires deep collaboration between theoretical and applied expertise?
(xii) What policy mechanisms would ensure that the benefits of federally-funded research — including access to resulting technologies, economic opportunities, and improved quality of life — reach all Americans?
(xiii) How can the federal government strengthen research security to protect sensitive technologies and dual-use research while minimizing compliance burdens on researchers?
Commentary
The “valley of death” — the gap between basic science and commercial viability — is an acute point of failure in the U.S. innovation pipeline. Overcoming this requires policy adjustments that treat industry partners as essential co-creators, not merely customers. OSTP’s request comes on the heels of efforts to restore “Gold Standard Science” to improve the federal scientific enterprise — a broader push to reshape all aspects of scientific activities and to ensure the United States remains a global leader in rigorous, evidence-based science. The RFI comes at a pivotal moment as the current scientific ecosystem is being rapidly reshaped by emerging fields (e.g., computing/physics (quantum), life sciences (biology/chemistry), and automation/data analysis (AI)) and intensifying global competition. To maintain U.S. leadership, the federal government must pivot from relying solely on traditional support models such as grants to universities and national laboratories to a framework that emphasizes efficient public-private collaboration and modern, science-driven regulation.
This RFI provides an opportunity to advocate to the White House for an improved pipeline from lab bench to commercial products. From a toxicological and regulatory perspective, implementation of the Toxic Substances Control Act (TSCA) is a relevant topic to consider. Regulatory uncertainty and delays in the implementation of TSCA, especially new chemical reviews, push an increasingly insurmountable obstacle to innovation onto businesses that are working to develop sustainable product chemistries. For sectors like advanced materials, biotechnology, and the chemical industry — fields fundamental to the Administration’s science and technology goals — the regulatory path to market must be transparent, timely, and risk-based. In addition, the U.S. Environmental Protection Agency’s (EPA) timely and risk-based review of existing chemicals will put de-selection pressure on traditional, high-hazard technologies. The implementation of TSCA provides a critical case study in how federal policy can inadvertently erect unnecessary barriers to bringing new, more sustainable chemistries and downstream products to market.
The current implementation of TSCA’s new chemical review process has, in practice, led to extended review times and a higher regulatory burden, particularly for sustainable and novel chemistries intended to replace older, less-safe legacy substances. Much can and should be done to improve this process. EPA must adhere strictly to statutory deadlines for premanufacture notice (PMN) review, especially for chemicals identified as low-volume, low-exposure, or those deemed inherently safer by design (e.g., green chemistry products). TSCA implementation must also better balance safety to human health and the environment with the goals of the circular economy. EPA should provide clear, explicit, and consistent guidance on how recycling, upcycling, and the reprocessing of materials — which may involve trace legacy substances — are treated under the new chemical and significant new use notice (SNUN) provisions. EPA must make both the PMN and SNUN review processes faster, more consistent, and considerate of actual risk (i.e., hazard and exposure), especially for innovations designed to be inherently safer or part of a sustainable circular economy. Punitive or ambiguous interpretations of these rules hinder domestic efforts to establish resilient supply chains for critical materials. Our domestic capability to manufacture chemical products is being off shored by some to avoid unknown and unpredictable regulatory outcomes under the current implementation of TSCA. Innovators are finding even the high barrier for market entry under the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) easier than commercializing under TSCA.
Some food for thought:
Are there ways to strengthen public-private collaboration and commercialization, especially for small- and medium-sized businesses?
Should EPA increase its use of robust computational toxicology and new approach methodologies to speed up assessments without sacrificing safety?
How can EPA adopt smart policies and regulations to ensure public safety and environmental protection while reducing unnecessary barriers to innovation and providing market certainty for industry to confidently invest in research and development?
Consider submitting comments to OSTP with your ideas on how to advance the American (and global) scientific enterprise, perhaps by creating a regulatory approach that is effective, efficient, and science-based, with a clear and predictable pathway to market.
We Get AI for Work™: Where to Start When Evaluating AI Tools [Video, Podcast]
Although it is tempting to rush to implement the newest AI tools, taking inventory of what tools your organization uses, which laws you are subject to and which obligations flow from those laws are all critical steps to maintain legal compliance.
Texas Senate Bill 17: Implications for Real Property and Commercial Leasing Transactions
OverviewTexas Senate Bill 17 (SB 17), signed by Governor Greg Abbott on June 20, 2025, and effective September 1, 2025, establishes sweeping restrictions on the acquisition of real property interests by individuals and entities connected to certain “designated countries,” currently China, Russia, Iran, and North Korea. The law is codified in Subchapter H of Chapter 5 of the Texas Property Code and reflects the state’s stated national security concerns about foreign influence and ownership of land within its borders.
SB 17 applies prospectively only. The statute expressly provides that transactions occurring before September 1, 2025, are governed by prior law. However, acquisitions on or after the effective date (including new commercial leases of one year or more) fall squarely within the new restrictions.
Scope of the LawSB 17 prohibits the purchase or acquisition of any “interest in real property,” a phrase defined broadly to include fee simple title, leasehold interests of one year or more, easements, mineral and water rights, groundwater, standing timber, mines, quarries, agricultural land and improvements, commercial property, industrial property, and residential property. This expansive definition is identical to the statutory language and was emphasized in multiple industry commentaries.For commercial real estate practitioners, the most significant impact is the treatment of long-term leases as acquisitions of an interest in real property. Under SB 17, a commercial lease with a term of one year or longer is treated the same as a purchase for compliance purposes.
Who Is Prohibited?SB 17 prohibits the following persons and entities from acquiring interests in Texas real estate:
Governments of designated countries.
Entities headquartered in a designated country, directly or indirectly held or controlled by a designated-country government, designated by the governor as national security threats, or majority-owned by prohibited individuals.
Entities majority-owned by other prohibited entities.
Individuals who are:a. domiciled in a designated country (with a narrow homestead exception),b. citizens of a designated country residing abroad without naturalization in their country of residence,c. unlawfully present in the United States,d. acting as agents of a designated country, ore. members of the ruling political party of a designated country.
SB 17 also allows the governor, after consulting the Department of Public Safety (DPS) and the Homeland Security Council, to designate additional countries, transnational criminal organizations, or other entities as prohibited.
ExemptionsThe following are exempt from the law:
U.S. citizens and lawful permanent residents.
Entities owned or controlled exclusively by U.S. citizens or lawful permanent residents, provided no prohibited individual holds an interest or control.
Leasehold interests shorter than one year.
Individuals from designated countries who are lawfully present and residing in the U.S. acquiring a residential homestead.
The exemptions function as safe harbors, but they do not resolve certain ambiguities—particularly involving minority ownership or passive investment by foreign individuals in multilayered entity structures.
Enforcement and PenaltiesThe Texas Attorney General (AG) is responsible for implementing, investigating, and enforcing SB 17. The AG must establish procedures for reviewing real estate transactions, conducting investigations, and determining whether enforcement actions are appropriate.
If a violation is suspected or found:
The AG may bring an in rem action against the property in the district court of the county where it is located.
The AG must record notice of the action in the county property records.
If a court determines a violation occurred, it must order divestiture and appoint a receiver to manage and sell or dispose of the property interest.
Penalties include:
Civil penalties for companies and entities of the greater of $250,000 or 50% of the market value of the property interest.
State jail felony charges for individuals who intentionally or knowingly violate the law.
Forced divestiture, with proceeds (after liens and state enforcement costs) returned to the violator.
Importantly, a purchase or acquisition that violates SB 17 is not automatically void. However, a leasehold interest of one year or more acquired in violation of the Act is void and unenforceable. This distinction creates elevated risk for commercial landlords and tenants.
Impact on Commercial Leasing TransactionsBecause commercial leases with terms of at least one year constitute an “interest in real property,” SB 17 has significant implications for Texas landlords, tenants, lenders, and property managers.
Key effects include:
Leases acquired by prohibited parties on or after September 1, 2025, are void and unenforceable.
While sellers and lessors bear no statutory duty to investigate a counterparty’s compliance, entering into a void lease can cause material disruption.
Renewals or extensions of leases may constitute new “acquisitions,” though the statute does not expressly address this. Lessors should assume that renewals require fresh compliance review.
Indirect ownership raises unresolved questions; for example, whether a minority investment by a prohibited individual in an upper-tier entity affects eligibility. Current statutory language suggests the prohibition applies only to entities majority-owned or majority-controlled by prohibited individuals, but this remains an area where AG rulemaking may provide further clarity.
Practical Guidance for Commercial Landlords and Counsel
Screen Tenants Early: Conduct due diligence on ownership, control, and beneficial owners before negotiating or executing any lease.
Add SB 17 Compliance Clauses: Include representations, warranties, covenants, and indemnification provisions tailored to SB 17.
No Duty to Investigate, but Risk Remains: Although lessors are not required to verify compliance, prudent parties should adopt procedures to avoid entanglement with void leases or AG enforcement actions.
Track Rulemaking: The AG is required to adopt rules; guidance is expected in late 2025.
Coordinate with Lenders: Lenders may require compliance certifications as conditions precedent in financing transactions.
Monitor Renewals: Treat renewals and extensions as potential new acquisitions requiring updated compliance review.
Litigation and Constitutional Challenges
On July 3, 2025, the Chinese American Legal Defense Alliance (CALDA) filed a federal lawsuit challenging SB 17 on multiple grounds, including:
Equal Protection and Due Process violations,
federal preemption under FIRRMA and CFIUS authority,
Fair Housing Act violations, and
vagueness regarding key statutory terms such as “domicile.”
The outcome of this litigation could significantly affect enforcement, particularly in the context of commercial leasing and entity ownership.
ConclusionSB 17 represents a major shift in Texas property law and applies far beyond traditional land purchases. Commercial leases of one year or more, easements, and other partial interests are now regulated acquisitions. While the law aims to address national security risks, it introduces new compliance obligations and substantial uncertainty into Texas real estate markets, particularly for commercial landlords and tenants.
Until further rulemaking and judicial interpretation occur, prudent parties should adopt enhanced due diligence and robust contractual protections when engaging in commercial leasing transactions involving any foreign individuals or entities.
C&I Solar Rooftop Installations are now Exempted from Building Modification Permit (Aor.1)
As Thailand seeks to streamline its processes related to the installation and adoption of renewable energy, the Thai government has announced Interior Ministerial Regulation No. 72, B.E. 2568 (2025), issued under the Building Control Act B.E. 2522 (1979). This regulation exempts the installation of solar rooftop panels weighing less than 20 kilograms per square meter from being classified as a “building modification”, thereby exempting the need to apply for a building modification permit for such installation.
What is the new regulation exactly?
Before this new regulation, a building modification permit was exempted for the installation of solar rooftops only on residential buildings and under certain conditions, as further detailed below.
The new regulation significantly broadens the scope of exemption for solar rooftop installations as follows:
Building Type: The exemption now applies to any type of building, whereas previously it was limited to just residential buildings and not commercial and industrial buildings.
Conditions: All previous conditions, such as area limit, structural safety certification, and prior notification, have been removed. The only remaining requirement is that the installation must not exceed 20 kilograms per square meter in weight.
Criteria
Old Exemption(Before November 19, 2025)
New Exemption(Effective November 19, 2025)
Building Type
Only residential buildings
Any type of building
Area Limit
Installation area not exceeding 160 sq.m.
No area limit specified
Weight Limit
Total weight not exceeding 20 kg per sq.m.
Total weight not exceeding 20 kg per sq.m. (unchanged)
Structural Safety Check
Must have structural stability inspection and certification by a licensed civil engineer
No requirement for structural safety certification mentioned
Notification to Local Officer
Must notify local authority before installation
No notification requirement mentioned
The exemption does not apply to ground-mounted or floating solar projects.
What effect will this have on solar C&I development in Thailand?
Based on (i) similar regulatory relaxations, such as the recent easing of factory licensing for solar rooftops and (ii) our discussion with officers from relevant governmental agencies, if the proposed solar rooftop projects meet the weight requirement, we anticipate the following:
Projects without submitted applications: Developers may proceed with installation and will not be required to submit a modification permit application.
Projects with pending applications: Applications that have already been submitted but not yet approved may be discontinued, with no further action required. The installation can commence regardless of the application status.
Area Coverage: This relaxation applies to projects both inside and outside industrial estate areas without further implementing regulations to be issued by the Industrial Estate Authority of Thailand.
It is essential to ensure that all projects remain fully compliant with all applicable energy-related laws, regulations, and standards throughout the development process. In addition, where required by law, developers must secure the appropriate licenses and permits from the Energy Regulatory Commission prior to commencing any construction activities. Failure to obtain these approvals may result in legal penalties, project delays, or suspension of operations.
Are there potential challenges for this regulation?
While the regulation has only been recently introduced, we have identified two practical concerns with the new regulation as follows:
Self-Assessment and Structural Assurance: The exemption removes permit and certification requirements entirely, introducing a self-assessment model similar to tax compliance. No authority or independent engineer is required to verify compliance with the 20 kg/sq.m. threshold. This raises a critical question for building owners: How can they ensure contractors have calculated weight correctly? Without oversight, errors or poor workmanship could lead to structural issues and legal liability.
To reduce risk, parties should consider:
Engaging reputable contractors or power producers with a track record of compliance and technical competence.
Addressing compliance obligations in contracts, including warranties and indemnities related to structural safety and weight limits.
Opting for a high-level technical review by an independent engineer, even though not legally required, to confirm that the installation meets the 20 kg/sq.m. threshold.
Aor. 5 Complications: Projects that previously required a building modification certificate (Aor. 5) because an Aor. 1 was issued under the old regulation may now face uncertainty. For example, if a solar rooftop project is installed on a mall or a large factory and the local authority required Aor. 5 under the old regime, the exemption of Aor. 1 under the new regulation logically suggests that Aor. 5 should also be exempted. However, local authorities may hesitate to forego Aor. 5 requirements for such projects, given their linkage to permits issued under the old regulation.
Until any further clarification/guideline from a governmental authority is issued, developers of existing projects should consult with the responsible local authority to confirm whether Aor. 5 is still required or can be exempted under the new regulation.
What to Watch: Continued DTC Advertising Enforcement
Just before Thanksgiving, the Food and Drug Administration’s (“FDA’s”) Office of Prescription Drug Promotion (“OPDP”) silently published three untitled letters, furthering this administration’s promise to crack down on direct-to-consumer (“DTC”) prescription drug advertising.[1] The letters (which we’ll call “Letter 1,” “Letter 2,” and “Letter 3”) addressed familiar enforcement themes, such as omission or minimization of risk information, ad presentation and form, and promotion consistent with FDA-required labeling (“CFL”). The letters appeared to have been leftovers from the shutdown, dated from earlier in September when the crackdown was in full swing. This is why we refresh these pages daily.
Letter 1OPDP found a television ad for an oral cardiovascular medication misleading and, therefore, misbranded under the Food, Drug, and Cosmetics Act (“FDCA”), because it overstated the drug’s approved indication. Specifically, the ad represented that the drug was approved on the single endpoint of “reducing the risk of cardiovascular death” in adults with chronic kidney disease (“CDK”) or heart failure (“HF”); however, the drug’s FDA-approved Prescribing Information indicates that approval was based on more granular composite endpoints, including reduction of sustained estimated glomerular filtration rate decline, progression to end-stage kidney disease, cardiovascular or renal death in CDK patients, and reduction of cardiovascular death, hospital visits, or urgent visits in HF patients.
Letter 2OPDP found a webpage for a ketamine injection intended for surgical pain management misleading and, therefore, misbranded under the FDCA, because it promoted the benefits of the drug without communicating risk information and overstated the drug’s approved indication. Specifically, the webpage promoted the drug for pain management in all surgical and diagnostic procedures, but failed to communicate important use limitations from the drug’s FDA-approved Prescribing Information, including an exclusion for procedures requiring skeletal muscle relaxation and specifications that it be used before and/or as a supplement to other general anesthetic agents. OPDP found this especially concerning because this particular drug is a generic and the webpage misleadingly suggested that its intended use was broader than that of its reference listed drug. To wrap up its letter, OPDP also cited the company for failing to submit a copy of the webpage under a Form FDA-2253 prior to initial publication, as required by FDA regulations.
Letter 3OPDP found a television ad for an oral seizure medication misleading and, therefore, misbranded under the FDCA, because it promoted the benefits of the drug with minimized presentation of risk information. Specifically, the ad (i) excluded a warning concerning the risk of liver injury from the drug’s Prescribing Information; (ii) failed to disclose the risk of problems with the heart’s electrical system, as included in the drug’s FDA-approved labeling, despite the fact that the ad stated “[s]erious, life threatening allergic reactions or rash can occur, which may affect the liver, other organs, body parts, or blood cells, as can problems with the heart.” Additionally, certain material information from the drug’s major statement (i.e. the presentation of major risks required for all pharmaceutical television ads) was included in SUPERS but not in the corresponding audio, even though benefits were presented via SUPERS and audio.
FOOTNOTES
[1] See our post on OPDP’s previous enforcement under this administration.
Agencies Issue Four Proposals to Improve Endangered Species Regulations
On November 21, the US Fish and Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS) (together, the Services) published four proposed rules to amend the Endangered Species Act (ESA) implementing regulations. These proposals would amend the Section 7 Consultation Regulations, Criteria for Listing Species and Designating Critical Habitat, Protections for Threatened Species, and Exclusions from Critical Habitat Designation.
These proposals would amend regulations that were issued in 2024 and, in many cases, would reinstate language from the first Trump Administration’s 2019 regulations. Notably, the proposals would clarify the scope of agency review for ESA section 7 consultation, narrow the criteria for listing species and designating critical habitat, reestablish the practice of promulgating species-specific 4(d) rules for newly listed threatened species, and expand considerations for determining whether an area should be excluded from critical habitat designation. The Services will take public comment on each of the four rules for 30 days, through December 22, 2025. Overall, the proposed changes are expected to be favorable to regulated parties because they will reinstate key clarifications and limitations.
Section 7 Consultation Regulations
Under section 7 of the ESA, federal agencies are required to consult with the Services to ensure federal actions do not jeopardize the continued existence of any listed species or adversely modify designated critical habitats. ESA section 7 consultation is often a key hurdle to timely federal permitting of new infrastructure and development projects. The proposal would largely reinstate the 2019 regulations with a few additions. The Services propose to:
Reinstate the 2019 definition of “effects of the action,” which removes redundant language and references the proposed § 402.17 to confirm the proximate cause standard for evaluating whether a consequence is appropriately attributable to a proposed action.
Reinsert § 402.17, titled “Other Provisions,” to provide more clarity on “effects of the action” that are “reasonably certain to occur” and “caused by the proposed action.” Consistent with principles recognized in the Supreme Court’s recent NEPA decision in Seven County Infrastructure Coalition v. Eagle County, Colorado, the Services propose to add language to confirm that the Services need not consider effects that the agency has no ability to prevent.
Modify the definition of “environmental baseline” to emphasize that the agency looks to the best available scientific information at the time of the proposed action to inform its understanding of the condition of the listed species or its designated critical habitat and make it clear that ongoing actions that the agency has no discretion to prevent are part of the environmental baseline.
Reinstate the 2019 definition of “reasonable and prudent measures” because the Services find that it is consistent with recent executive orders and caselaw.
Remove language that encouraged “offsetting” reasonable prudent measures (RPM) (i.e., measures intended to compensate for the impacts of incidental take on listed species).
Criteria for Listing Species and Designating Critical Habitat
Section 4 of the ESA outlines the process for listing endangered and threatened species, delisting species, and designating critical habitats. The Services propose to reinstate the relevant 2019 provisions, which recognized important limits for listing determinations. Specifically, the proposals would:
Clarify that “foreseeable future” under 50 C.F.R. § 424.11(d) extends only so far as the Services can both determine the future threats to species and species’ responses to those threats.
Remove extraneous language in the regulations, including examples of when a species should be removed from the lists of endangered or threatened species to clarify that the standard for delisting a species is the same as the standard for listing.
Clarify that designation of critical habitat may not be prudent where the threats to a species’ habitat stem solely from causes that cannot be addressed by section 7 consultation.
Reestablish a stepwise approach to designation of unoccupied habitat whereby the Service can only consider designating unoccupied areas where it first determines that a designation limited to occupied areas would be “inadequate to ensure the conservation of species.”
Protections for Threatened Species (FWS only)
Section 4(d) of the ESA directs the Secretary of the Interior to issue protective regulations pertaining to threatened species which, under the act, includes all the protections awarded to endangered species under ESA section 9. Previously, species listed as threatened by FWS automatically received the same protections as endangered species, absent a species-specific rule. This is known as the “blanket rule.” The FWS blanket rule was removed in 2019 and reinstated in 2024. The Services are proposing to remove the 4(d) blanket rule and reinstate a species-specific framework for threatened species protection. If finalized, the proposal would:
Remove the 2024 “blanket rule,” which automatically extended all of the section 9 protections to threatened species unless the Service issued a species-specific rule.
Require FWS to conduct species-specific determinations for newly listed threatened species. The proposal would not impact threatened species that are currently protected by the blanket rule unless they are reclassified in the future.
Add regulatory text at 50 C.F.R. § 17.71(d) to explain that whenever FWS proposes a species-specific rule, they will ensure that each rule includes necessary and advisable determination (including consideration of conservation and economic impacts) and will seek public comment on that determination.
Exclusions from Critical Habitat Designation (FWS only)
ESA section 4(b)(2) requires consideration of the economic impact, impact on national security, and any other relevant impact of designating any particular area as critical habitat. It also authorizes exclusion of areas from critical habitat if the benefits of excluding the area outweigh the benefits of designating as critical habitat and such exclusion will not result in the extinction of the species. The ESA affords the Services with broad discretion in deciding whether to exclude an area from critical habitat designation. FWS proposes to reinstate 50 C.F.R. § 17.90 pertaining to the impact analysis and exclusions from critical habitat. Notably, this proposal would:
Articulate when and how FWS will determine whether the benefits of excluding an area outweigh the benefits of designating the area as critical habitat.
Expand considerations of whether an area should be excluded from critical habitat status to include national security and “other relevant impacts” (g., public health and safety, community interests, and the environment).
Set out a mandatory requirement that the FWS consider the economic impact, impact on national security, and any other relevant impacts prior to designation.
ESA requirements can be key hurdles to timely federal permitting of mining, development, energy, and infrastructure projects. These proposed changes will likely improve the species listing, critical habitat designation, and consultation processes.
Connecticut DEEP Reissues Stormwater and Pretreatment General Permits
The Connecticut Department of Energy and Environmental Protection (DEEP) has been busy reissuing its suite of general permits (GPs) for wastewater and stormwater discharges. In October, DEEP reissued the Commercial Stormwater General Permit, Industrial Stormwater General Permit, and Pretreatment General Permits for Significant Industrial Users and Non-Significant Industrial Users. Below are highlights of significant changes to each reissued GP, as well as important compliance deadlines and considerations for regulated entities.
1. The Commercial Stormwater General Permit (CSGP) covers commercial sites with 5 or more acres of contiguous impervious surface, including shopping centers, business parks, schools, retail complexes, car dealerships, and financial and health services with large campuses. The reissued CSGP includes the following notable changes:
Expanded Industry Coverage: The new CSGP uses an updated definition of “Commercial Activities” referencing Standard Industrial Classification (SIC) and North American Industry Classification System (NAICS) codes and capturing a broader range of commercial activities than the previous permit. Businesses should review Appendix A of the CSGP to determine if their SIC/NAICS code is listed.
New Registration Requirements: Online registration through a yet-to-be-announced platform; $625 fee.
Stormwater Management Plan: Required for all registrants, with expanded control measures and annual analytical plus quarterly visual monitoring.
Other Updates: Updated control measure requirements including new measures on deicing practices, spill prevention and cleanup, and lawn and garden center Best Management Practices. New quarterly visual monitoring and annual analytical monitoring of 19 parameters to better assess water quality impacts.
Deadlines: Registration opens December 1, 2025. Existing permittees must register by April 1, 2026. Existing sites without permit coverage (not previously registered) must register by December 1, 2026. New sites must apply at least 60 days before beginning discharge.
Potential Compliance Traps: Many facilities not previously regulated (e.g., large retail, educational campuses) may now be required to register. Failure to review the new SIC/NAICS applicability could result in unintentional noncompliance.
2. The Industrial Stormwater General Permit(IGP) covers industrial facilities, as defined by SIC/NAICS codes in Appendix A to the IGP, that discharge stormwater to waters of the state. Industrial facilities should check their SIC/NAICS code against Appendix A to the IGP. The reissued IGP includes the following notable changes:
Alignment with EPA’s 2021 MSGP: Incorporates new “Resilience Measure” requirements in the Stormwater Pollution Prevention Plan (SWPPP) tracking the federal government’s Multi Sector General Permit.
Corrective Actions Framework: New requirements for documenting and implementing corrective actions.
Annual Reports: Now required each April for the prior calendar year.
Electronic Reporting: Discharge Monitoring Reports (DMRs) must be submitted via NetDMR; online noncompliance reporting is now mandatory.
Registration Fees: $1,250 for larger companies; $625 for smaller companies, federal, state and municipal-operated industrial activities
Signage: Facilities must post a sign indicating permit coverage.
Deadlines: Registration opens November 1, 2025. Existing permittees must register by April 1, 2026. New sites must register at least 90 days before discharge.
Potential Compliance Traps: If stormwater contacts industrial materials, activities, or operations, it is likely that the facility needs coverage. If all industrial facilities are fully sheltered and qualify under related DEEP rules, such facilities may qualify for a No Exposure Certification. In addition, the expanded monitoring, reporting, and corrective action requirements are more rigorous. Facilities must update SWPPPs and ensure timely electronic submissions to avoid enforcement.
3. DEEP also reissued two Pretreatment General Permits for Significant Industrial Users (SIU GP) and Non-Significant Industrial Users (Non-SIU GP). The SIU GP covers indirect discharges from significant industrial users (SIUs), including metal finishing, process, and non-process wastewaters, as well as dewatering and remediation wastewaters to sanitary sewers. The Non-SIU GP covers non-significant industrial users (Non-SIUs) not subject to federal categorical standards. DEEP issued a Pretreatment Permit Decision Chart to aid entities in determining which pretreatment permit may be applicable. The reissued Pretreatment GPs include the following notable changes:
Updated Definitions: Flow thresholds now based on average monthly flow (≥25,000 gpd of all process wastewater for SIUs).
Expanded Coverage: Dewatering and remediation discharges to Publicly Owned Treatment Works (POTWs) are now included in the SIU GP.
Application Fees: For SIU GP, between $1,000 and $6,250 depending on the discharge type. For the Non-SIU GP, there is no DEEP fee but the POTWs reserve the right to collect fees associated with initial submission of a Notification Form.
Effluent Limits: New limits for mercury, PFAS, pH, temperature, and PCBs. Facilities may need to invest in new treatment or monitoring technologies to meet these limits.
Streamlined Process: Certification of No Change is a registration option for existing permittees; Non-SIU GP registration is notification-only.
Deadlines: Registration opens December 1, 2025. Existing SIUs and Non-SIUs must register by March 1, 2026. New SIUs must register at least 180 days prior to discharge. New Non-SIUs must submit a Notification Form at least 60 days prior to discharge.
Potential Compliance Trap: The removal of Qualified Professional Engineer (QPE) and Natural Diversity Data Base (NDDB) certification requirements is intended to streamline the process, but new effluent limits (especially for PFAS and mercury) may require operational changes.
Important Considerations and Practical Tips
The reissued GPs bring significant changes and expanded coverage to stormwater and pretreatment permit requirements. Regulated entities should carefully review the reissued GPs to determine if their activities are subject to permitting registration and compliance requirements, including electronic registration, updated reporting requirements, application fees, and expanded monitoring, BMPs, and corrective action requirements. Facilities should review and update their plans (e.g., SWPPP, SMP, SPCP) and train staff accordingly. Existing permittees must pay close attention to registration deadlines to maintain interim coverage.
DEEP has also made it abundantly clear that, in an effort to increase permit processing timelines, incomplete applications will be rejected and a new application, with a new fee, will need to be submitted. DEEP has shared that the most common reasons for incomplete applications in the past were missing or improperly signed Registrant Certification and missing or incomplete sampling data.
HMRC Launches Strengthened Tax Whistleblower Reward Scheme- A New Era for UK Tax Compliance
The United Kingdom has officially launched its Strengthened Reward Scheme for tax whistleblowers, marking a historic transformation in the country’s approach to combating serious tax avoidance and evasion.
Announced on November 28 by His Majesty’s Revenue and Customs (HMRC), the new program adopts a US-style incentive model that could deliver multi-million-pound rewards to individuals who report high-value tax fraud.
A Fundamental Shift in UK Tax Enforcement
The new scheme represents a dramatic departure from the UK’s previous informer payment system, which has long been criticized for offering minimal, discretionary awards that failed to incentivize reporting of serious tax crimes.
Under the old model governed by the Commissioners for Revenue and Customs Act 2005, HMRC paid out just £978,256 to all informants combined in the 2023/24 fiscal year—a figure dwarfed by the UK’s estimated £46.8 billion tax gap.
The Strengthened Reward Scheme changes everything. It supplements the existing 2005 Act by creating a parallel pathway specifically designed for high-value cases involving large corporations, wealthy individuals, and offshore or tax avoidance schemes.
Key Features of the New Program
According to HMRC’s official guidance released today, the scheme includes several groundbreaking enhancements:
US-Style Percentage-Based Rewards
The most significant change: whistleblowers can now qualify for rewards between 15% and 30% of the tax collected if their information leads to the collection of at least £1.5 million in tax (excluding penalties and interest). This mirrors the highly successful IRS whistleblower program, which has recovered over $7.4 billion in unpaid taxes since 2007.
No Upper Cap
Unlike many reward programs, there is no maximum limit on payments. A tip that leading to the recovery of £100 million could yield a reward of £15 million to £30 million for the whistleblower, creating a genuine incentive for insiders with knowledge of massive fraud schemes to come forward.
Clear Qualification Guidelines
HMRC has published transparent criteria for what constitutes a qualifying disclosure and the factors that determine the final reward percentage, including the quality of information provided and the degree of assistance offered during the investigation.
Enhanced Process
The new system provides clearer pathways for reporting, with HMRC committing to notify whistleblowers when their report is received and to contact them if more information is needed or if they are eligible for a reward.
Who Can Qualify?
To be eligible for a reward under the Strengthened Reward Scheme, several conditions must be met:
You can qualify if:
Your information leads to the collection of at least £1.5 million in tax
The information is original, specific, and not already known to HMRC
You are not the taxpayer involved in the evasion or someone who planned the fraudulent activity
You are not a current or former civil servant who obtained the information through your employment
You cannot qualify if:
You obtained information through government employment
You are acting anonymously (anonymous reports are accepted but cannot receive payment)
You are acting on behalf of someone else
The information could have been identified through HMRC’s routine processes
You are required by law to disclose or not disclose the information
Why This Matters
The UK’s tax gap—the difference between tax owed and tax collected—stood at £46.8 billion for the 2023/24 fiscal year, representing approximately 5.3% of total tax liabilities. Much of this gap stems from sophisticated schemes by large corporations and wealthy individuals that are extremely difficult for authorities to detect without inside information.
Research has consistently demonstrated that financial incentives dramatically increase whistleblower reporting. A landmark 2010 study found that in US industries with substantial monetary rewards for whistleblowers, employees exposed 41% of fraudulent activity, compared to just 14% in those without such incentives — a stark 27-percentage-point difference.
The Royal United Services Institute (RUSI), in its report “The Inside Track,” concluded that financial rewards are empirically proven to drive greater insider reporting, provide actionable intelligence, and deter economic crime.
Important Considerations
While the new scheme represents a major advancement, HMRC emphasizes that rewards remain discretionary and are not guaranteed. This differs from the US model, where qualifying whistleblowers have a statutory right to payment.
Experts advise potential whistleblowers to:
Seek experienced legal counsel before making a disclosure
Consider negotiating a written agreement with HMRC regarding award terms
Understand that tax investigations can take years to complete
Never attempt to gather additional information or let anyone know about the report
Do not make multiple reports on the same activity
How to Report
Individuals with information about serious tax avoidance or evasion can report through HMRC’s official reporting system at www.gov.uk/report-tax-fraud. All information provided will be treated as private and confidential. Reports should include:
Detailed description of the activity (up to 1,200 characters)
How you know about the activity
Your relationship to the individual or business
Duration of the fraudulent activity
Total value or estimation
Description of supporting information available
Looking Ahead
However, the program’s ultimate success will depend on HMRC’s commitment to honoring its reward promises and the government’s willingness to strengthen anti-retaliation protections for whistleblowers who risk their careers to expose wrongdoing.
For individuals considering reporting tax fraud, the message is clear: the UK has fundamentally changed how it values and rewards those who help protect the public treasury.
This article was authored by Joseph Orr
Complying with the EU’s Forced Labor Regulation- Compliance Obligations for Business
The EU’s new Forced Labor Regulation (the “EUFLR” or “the Regulation”) was published in the EU’s Official Journal on December 12, 2024.[1] Under the new Regulation, products that have been created through the use of forced labor will no longer be allowed to be introduced into the EU market or permitted to be exported from it.[2] Although the EUFLR will not come into effect until December 2027, businesses are wise to begin taking steps to ensure that they are compliant well before that time.[3] The Regulation introduces substantial new compliance obligations on all businesses operating in the EU market (or exporting from it), which may require a significant effort from companies that are affected to ensure conformity.
In this post, we offer an overview of the relevant compliance obligations that businesses impacted by the EUFLR need to be aware of. This includes, but is not limited to, implied due diligence obligations that may not be readily apparent and that many companies may not have encountered before.
Who does the EUFLR apply to?
The EUFLR presents challenges to companies that are trying to comply because of how broad it is in scope. The Regulation applies to all companies regardless of size, and is product-based in its application regardless of the industry sector that is involved.[4] It bans products that have been created using forced labor in whole or in part, at any stage of the extraction, harvest, production or manufacturing process. It applies not only to the primary products that have been created using forced labor, but also to their components.[5]
Products of any origin are affected, whether they were manufactured within the EU, present or made available in the EU market, or exported from the EU.[6] The EUFLR also impacts products that are offered online or through other forms of “distance sales” to end-users in the EU.[7] It does not, however, apply to the withdrawal of products that have already reached end users in the EU market.[8]
The EUFLR will be enforced
The EUFLR will be enforced by various supervisory authorities designated by the EU Member States.[9] The supervisory authorities will conduct investigations, including field inspections, when they suspect forced labor has been involved in the extraction, harvest, production or manufacture of a product.[10] Following the completion of its investigation, the supervisory authority will either close the investigation or issue a decision if it determines that a company has violated the Regulation.[11] Other grounds for finding a violation include cases of bad faith on the part of the company, or when the company has failed or refused to provide requested information.[12] Companies are therefore encouraged to cooperate with the supervisory authorities during the course of the investigation.
When a potential violation of the EUFLR has been identified, supervisory authorities have broad powers to take an enforcement action against the company perceived to be in violation. This includes prohibiting the company from (1) placing products in the marketplace, (2) making products available to customers, or (3) exporting products internationally. Authorities may also order the business to withdraw the products from the EU market, or to dispose of the relevant products or components.[13]
The Member States will establish effective and proportionate penalties applicable to companies that fail to comply with decisions of the supervisory authorities.[14]
Relevant obligations, including implied due diligence obligations
Companies face a challenge in trying to ensure that their products have not been made using forced labor. The EUFLR states explicitly that it does not impose additional due diligence obligations on companies “other than those already provided for in Union or national law.”[15] This clarification might appear counterintuitive, given that identifying the risks of forced labor in value chains would seemingly require some form of due diligence. The EUFLR emphasizes that companies must already address forced labor risks through existing EU due diligence laws, including the Corporate Sustainability Due Diligence Directive (CS3D),[16] which the Regulation is designed to complement.
The CS3D (see our post here) requires companies to identify and address adverse human rights and environmental impacts in their own operations and value chain. The CS3D entered into force on July 25, 2024, but the legislation is currently pending after the Commission adopted an Omnibus package in February 2025 to simplify its due diligence requirements, among other things. The CS3D’s future is even more uncertain as the EU has agreed – within the framework of the EU-US Joint Statement on Transatlantic Trade and Investment (the “Joint Statement”) – to consult with the US on CS3D-related issues, with the intention of avoiding an unnecessary administrative burden.[17] The Joint Statement’s Q&A noted, however, that this cooperation will not lead to any changes to EU domestic rules.[18]
Current negotiations around the Omnibus package include a proposal to significantly raise the thresholds for the CS3D so that it applies only to very large companies. Because the EUFLR applies to all companies, if these thresholds are confirmed very few companies will be within the scope of both the CS3D and the EUFLR.
Taking compliance steps
The first step companies should take to ensure compliance with the EUFLR is to assess whether they fall under the scope of the modified CS3D (as soon as possible following the Omnibus negotiation). For companies that are not subject to the CS3D, companies should ensure that they identify, prevent, mitigate, end or remediate any potential risk of forced labor being used in their operations or supply chains.
Companies should also keep in mind that due diligence measures will play a significant role in how they are evaluated by supervisory authorities under the EUFLR. For example, during the preliminary phase, supervisory authorities will ask companies about the status of their due diligence measures.[19] These authorities will grant companies considerable flexibility regarding their due diligence framework, as the EUFLR provides a broad range of acceptable due diligence measures:
applicable EU or national law setting out due diligence and transparency requirements regarding forced labor,
guidelines issued by the Commission,
due diligence guidelines or recommendations of the UN, ILO, OECD or other relevant international organizations,
any other meaningful due diligence efforts related to forced labor in their supply chain.[20]
A supervisory authority should not initiative an investigation if it determines that there is no substantiated concern, or that any such concern has been addressed. Applying due diligence measures that effectively mitigate, prevent, or eliminate the risk of forced labor is the most effective way to prevent an investigation from being initiated.[21]
The Commission will publish guidelines in relation to forced labor by June 14, 2026.[22] These guidelines will be based on the July 2021 due diligence guidance for EU businesses to help address the risk of forced labor in operations and supply chains.[23]
Conclusion and how we can help
The EUFLR creates certain obligations that companies operating in the EU must be ready to comply with by December 14, 2027. Businesses must take preparatory steps, including embedding responsible business conduct into policies and management systems, identifying and assessing impacts in operations, supply chains and relationships, ceasing, preventing and mitigating adverse impacts, etc.
We stand ready to assist with your preparations for the EUFLR’s entry into force. From the drafting of internal policies and assessment of forced labor risks to the analysis of the international reaction to the EUFLR’s adoption and entry into force, compliance gap assessments, and internal investigations, our lawyers and full suite of services are ideally positioned to guide you throughout the Regulation conformity cycle.
[1] Regulation (EU) 2024/3015 of the European Parliament and of the Council of 27 November 2024 on prohibiting products made with forced labour on the Union market and amending Directive (EU) 2019/1937, available here.
[2] The EUFLR defines forced labor as all work or service that is exacted from any person under the menace of any penalty and for which the said person has not offered himself voluntarily. The EUFLR refers to the definition of Article 2 of International Labor Organization’s (ILO) Convention No 29.
[3] EUFLR, Article 39.
[4] EUFLR, Recital 18
[5] EUFLR, Article 2 and Recital 18.
[6] EUFLR, Article 3.
[7] EUFLR, Article 4. Distance sales refer to “products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at end users in the Union. An offer for sale shall be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State.”
[8] EUFLR, Article 1.
[9] EUFLR, Article 5.
[10] EUFLR, Article 19. See also Article 17 for the preliminary phase of the investigations and Article 18 for investigations.
[11] EUFLR, Article 20, 1.
[12] EUFLR, Article 20, 2.
[13] EUFLR, Article 20.
[14] EUFLR, Article 37.
[15] EUFLR, Article 1(3).
[16] Directive (EU) 2024/1760 of the European Parliament and of the Council of 13 June 2024 on corporate sustainability due diligence and amending Directive (EU) 2019/1937 and Regulation (EU) 2023/2859, available here.
[17] European Commission, Questions and answers on the EU-US Joint Statement on Transatlantic Trade and Investment, 21 August 2025.
[18] European Commission, Questions and answers on the EU-US Joint Statement on Transatlantic Trade and Investment, 21 August 2025.
[19] EUFLR, Article 17.
[20] EUFLR, Article 17.
[21] EUFLR, Article 17(5).
[22] EUFLR, Article 11.
[23] EUFLR, Recital 36; European Union External Action, Guidance on due diligence for EU businesses to address the risk of forced labour in their operations and supply chains.
Preparing Your Vehicle for Michigan’s Winter Roads- Legal and Safety Tips
Michigan winters bring freezing temperatures, heavy snow, and icy roads that can make even a short drive challenging. Preparing your vehicle before winter weather arrives helps prevent accidents, avoid breakdowns, and stay compliant with Michigan’s traffic laws. A few basic steps can make a major difference once the snow starts to fall.
Why Winter Vehicle Prep Matters
Snow and ice reduce traction, increase stopping distances, and make it harder to control your vehicle. Cold temperatures also affect tire pressure, battery strength, and overall vehicle performance. Many winter car accidents result from slippery roads, black ice, poor visibility, or mechanical issues that become more noticeable in freezing weather. Problems such as worn tires, weak brakes, or uncleared windows or lights can increase these risks. Preparing your vehicle ahead of time helps minimize these hazards and lowers the chance of an emergency during dangerous conditions.
Check Your Tires
Your tires play a crucial role in winter safety. Good tires improve handling, braking, and overall control on slippery roads.
Make sure your tires have proper tread depth. Worn tires reduce traction on snow and ice.
Consider switching to winter tires for better grip in low temperatures.
Check tire pressure often since cold air causes it to drop.
Inspect Lights, Wipers, and Washer Fluid
Michigan law requires headlights when visibility is limited, making proper lighting both a safety and legal priority. Visibility becomes more difficult in winter due to snow, early sunsets, and fog.
Replace dim or broken headlights, taillights, and turn signals.
Install fresh wiper blades if they leave streaks.
Fill the washer fluid reservoir with a winter formula that will not freeze.
Test Your Battery and Brakes
Cold temperatures are tough on vehicle systems. A strong battery and reliable brakes help prevent breakdowns and reduce the risk of collisions on icy roads.
Have your battery tested to ensure it can hold a charge in freezing conditions.
Check your brake pads and listen for grinding or squeaking sounds.
Clear Ice and Snow Before Driving
Michigan drivers are required to maintain a clear field of vision. Failing to remove ice or snow from windows, the windshield, mirrors, roof, or lights can create serious hazards. Snow blowing off a vehicle can impair your visibility and reduce visibility for other drivers. Always take a few minutes to completely clear your vehicle before getting on the road, and this will help you avoid possible citations as well.
Check Heating and Defrosting Systems
Heating and defrosting systems are essential for comfort and visibility. Make sure the interior heats properly and that the front and rear defrosters can melt ice efficiently. Fogged or iced-over windows can severely limit your ability to see the road.
Pack a Winter Emergency Kit
Even well-prepared drivers can face delays or breakdowns. A winter emergency kit can help you stay safe and warm until help arrives. Some useful items include:
Blanket, gloves, and warm clothing
Water and nonperishable snacks
Jumper cables
Flashlight and batteries
Phone charger
Ice scraper and small shovel
These supplies can make a big difference if you become stranded or need assistance.
Keep Up with Routine Maintenance
Regular maintenance prevents small issues from turning into emergencies. Stay up to date with oil changes and fluid checks, address dashboard alerts as soon as possible, and have unusual noises inspected by a professional. Winter puts extra stress on every part of your vehicle, so early attention is key.
Conclusion
Preparing your vehicle for winter is one of the best ways to stay safe and avoid legal issues on Michigan’s roads. A few preventive steps now can prevent accidents, injuries, and costly repairs later.
CMS Releases the Proposed 2027 Medicare Advantage and Part D Rules
Last week, the Centers for Medicare & Medicaid Services (CMS) released its proposed Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program (Proposed 2027 Rules).
As is common for the annual proposed rules, the Proposed 2027 Rules cover a broad range of topics. In the last few years, the agency has lost multiple legal cases challenging the validity of its rules and/or how it implements its rules – it has lost cases relating to Star Ratings, its updated marketing and communications rules that were adopted for 2025, and most recently, the risk adjustment extrapolation rule. The Proposed 2027 Rules broadly touch on all of these regulatory areas. In its very brief summary of the Proposed 2027 Rules, CMS also highlights changes to Part D drug coverage, the enrollment process, and special needs plans. The Proposed 2027 Rules also include multiple Requests for Information (RFI). Below are some initial takeaways.
Star Ratings
With the Proposed 2027 Rules, CMS explains that its aim is to simplify and refocus on the Star Ratings system. It proposes to refocus the measure set on clinical care, outcomes, and patient experience measures where plans have not topped out performance and believes that decreasing the number of measures will allow more focus on the measures that remain, including those aligned with the Make America Healthy Again initiative. Specifically, CMS is seeking to remove 12 measures: seven focused on operational and administrative performance, three focused on the process of care, and two focused on patient care experience. CMS also does not intend to move forward with the Health Equity Index rewards under the Star Ratings program. As discussed below, CMS is also seeking interested parties’ thoughts on the quality bonus payment system that is driven by Star Ratings.
Marketing and Communications
The Proposed 2027 Rules include both proposed changes to the Medicare Advantage and Part D rules addressing marketing and communications and an RFI relating to this area. For regulatory changes, CMS proposes changes to the definition of third-party marketing organizations (TPMOs) and changes to rules regarding translations, enrollment verification, and the use of testimonials, among other things. CMS requests that interested parties provide information regarding ways to modernize the agency’s marketing oversight that will help reduce the general burden, but at the same time ensure beneficiaries continue to receive accurate information. CMS is specifically interested in finding ways that it can take appropriate actions against TPMOs that are “bad actors” in a manner that does not hinder organizations that are operating appropriately.
Risk Adjustment
CMS proposed changes to the permissible uses for risk adjustment data. Historically, CMS has been limited in the ways that it can use risk adjustment data, and many of those permitted uses were adopted in regulation. The Proposed 2027 Rules propose to remove the enumerated permitted uses and instead recognize CMS’s ability to more broadly use and release the data to government entities and external parties. CMS specifically states that “CMS does not believe the statute restricts our use of risk adjustment data.” The proposed changes also allow risk adjustment data to be released prior to reconciliation, much more broadly than the current rules. CMS intends to continue to protect beneficiary confidentiality. CMS does not directly address the court decision that invalidated its extrapolation methodology.
IRA
Over 25% of the Proposed 2027 Rules address the many changes that aim to fully implement the redesign of Medicare Part D that was adopted in the Inflation Reduction Act (IRA). Similar to past years, many of the changes that CMS is proposing have been previously introduced through sub-regulatory guidance over the last few years. Some of the changes include formally sunsetting the Coverage Gap Discount Program, further implementing the Manufacturer Discount Program, clarifications regarding medical loss ratio, and changes relating to amounts that accrue towards TrOOP.
Reporting and Data Simplification
CMS is exploring ways that current Medicare reporting obligations can be simplified. Some of the referenced considerations would appear to reduce the burden on Medicare Advantage organizations and Part D plan sponsors, and others aim to reduce the burden on the agency. CMS gives examples of reporting obligations relating to provider networks, medical loss ratios, the utilization of benefits, and special needs plans’ models of care. CMS is specifically looking for ways that the reporting can be streamlined, potentially through the use of automated data sharing and different technology solutions that would make the import and use of the data less burdensome.
Very Broad RFI
The Proposed 2027 Rules include a broad RFI regarding the future direction of the Medicare Advantage program and specifically focus on risk adjustment and quality bonus payments. The agency is looking for ways to improve the program and positively impact the following areas: data transparency, beneficiaries’ ability to select the best plan for them, overall quality, enhance competition, reduce fraud, waste and abuse, and generate taxpayer savings.