EPA Proposes Modifications to PFAS Reporting Rule
Earlier this year, the US Environmental Protection Agency (EPA) announced that it planned to move forward with implementing certain per- and polyfluoroalkyl substance (PFAS) regulations and to make modifications to several aspects of other PFAS rules. See alert (dated 7 May 2025). On 10 November 2025, the EPA announced a proposed rule that would add exemptions to the final rule related to PFAS reporting under Section 8(a)(7) of the Toxic Substances Control Act, published on 11 October 2023 (Proposed Rule). See alert (dated 30 January 2024) for details on the October 2023 rule. Comments on this new Proposed Rule are due by 29 December 2025.
The Proposed Rule adds several exemptions to the existing reporting requirements, which are intended to “maintain important reporting on PFAS, consistent with statutory requirements, while exempting reporting on activities about which manufacturers are least likely to know or reasonably ascertain.”1 Specifically, the Proposed Rule would exempt the following activities from PFAS reporting:
De Minimis Concentrations
This exemption would eliminate reporting requirements for PFAS in mixtures or articles when the PFAS concentration is under 0.1%.
Imported Articles
This exemption would eliminate reporting requirements for PFAS imported as part of an article from the reporting requirement. Using the definition in 40 CFR 704.3, the Proposed Rule defines articles as:
“a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end-use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.”
Byproducts, Impurities, and Non-Isolated Intermediates
This exemption would also eliminate reporting for PFASs manufactured as byproducts, impurities, or non-isolated intermediates, as each is defined by existing regulation:
Byproducts are “a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s).”2
Impurities are chemical substances unintentionally present with another chemical substance.3 This unintentional presence distinguishes impurities from byproducts where the produced PFAS is an intended part of the manufacturing process. Unlike byproducts, impurities lack independent commercial purpose, and they are not manufactured for distribution.
Non-isolated intermediates are substances produced and contained within a closed system during the manufacture of another chemical substance. There is no effort to remove these substances from the system or to store, package, or transport them.4
Research and Development (R&D) Chemicals
The Proposed Rule would exempt PFAS manufactured or imported in small quantities for R&D purposes.5
In addition to these proposed exemptions, the Proposed Rule would again modify the submission deadline. Namely, the submission period would open 60 days after the final rule’s effective date and remain open for three months. This is now the third time the EPA has delayed the reporting deadline, which was originally set for May 2025, then January 2026, and most recently for October 2026. The Proposed Rule would eliminate the reporting deadline for small manufacturers reporting exclusively as article importers since they would not be required to report under the “imported articles” exemption.
Additionally, the Proposed Rule seeks to clarify elements of the reporting format by eliminating OECD-harmonized template reporting for exposure-related information that is also reported in “fielded data elements.” The Proposed Rule would also update the category names for “specific consumer and commercial products” under 40 CFR 705.15(c)(4) and would revise the “product category code names associated with CC217 through CC221 and CC305” to better identify covered articles and materials.
Finally, in addition to seeking public comment on the proposed exemptions and modifications discussed herein, the EPA requests feedback on two specific questions:
Should EPA amend the scope of reportable chemicals?
Should EPA modify any assumptions or cost savings calculations in its Economic Analysis?6
The Proposed Rule can be found here.
1 prepubcopy_7902.3-01_fr_doc_esignature_admin_verified.pdf
2 40 CFR 704.3
3 40 CFR 704.3
4 40 CFR 704.3
5 The rule indicates that small quantities is to be understood as quantities “not greater than reasonably necessary for such purposes.” 40 CFR 704.3
6 EPA’s Economic Analysis seeks to estimate the potential economic cost to industry based on familiarization and compliance with Rule. See Proposed Rule Supplementary Information Section I(E).
The H-1B Holiday Rush Towards H-1B Enforcement
Highlights
The U.S. Department of Labor (DOL)’s new “Project Firewall” significantly intensifies H-1B enforcement, enabling expanded audits, interagency data sharing, stricter penalties (including debarment), and increased scrutiny of patterns like offsite placements, wage discrepancies, and inconsistent job information.
Employers face a heightened year-end compliance push, as the initiative places renewed focus on documentation, accurate filings, and monitoring of third-party placements, with the DOL publishing an H-1B Compliance Assistance Toolkit to guide expectations.
Proactive, collaborative compliance is now essential, and employers are urged to conduct regular audits, strengthen internal processes, and work closely with immigration counsel ahead of the FY 2027 H-1B registration season.
With the holidays just around the corner, Project Firewall, a new enforcement initiative launched by the DOL, will ensure H-1B compliance does not take any time off.
The H-1B nonimmigrant work visa is the most popular work visa used by U.S. employers to employ foreign nationals in professional, highly skilled positions that require at least a bachelor’s degree.
However, there are difficulties associated with this visa type. Under current worksite enforcement initiatives, the H-1B visa category continues to receive heightened scrutiny. Additionally, the systematic shortcomings of the H-1B lottery atmosphere make it increasingly difficult to secure these visas, namely a high volume of submissions, an increase in the likelihood of fraud, and duplicative submissions for the same H-1B beneficiary. Now, employers will face new challenges because of new compliance initiatives.
Project Firewall: An Enforcement Gift to the Department of Labor
The DOL announced Project Firewall in September 2025, stating the program would strengthen investigative efforts to promote employer compliance with H-1B visa program obligations.
Project Firewall is the compliance gift that just keeps on giving new methods of enforcement to the DOL. It empowers the DOL in the following ways:
Permits the Secretary of the DOL to initiate employer audits;
Expands data sharing between the U.S. Departments of Labor, Homeland Security, and State;
Allows punishment through years-long debarment in addition to civil penalties;
Facilitates referrals to U.S. Citizenship and Immigration Services for status revocation; and
Permits orders for the payment of back wages and public disclosure.
Since its inception, Project Firewall has enabled the initiation of audits based upon the DOL’s observation of patterns of offsite placements, wage-level discrepances, and higher ratios of H-1B employees. Inconsistent job titles and frequent amendments have also prompted additional scrutiny.
Presenting employers with a guide to these enforcement changes, the DOL published an H-1B Compliance Assistance Toolkit in September.
An H-1B Holiday Rush to Avoid the Naughty List
The expansion in compliance enforcement has created a new form of holiday rush for employers: the rush to ensure nonimmigrant programs, particularly H-1B visa programs, meet compliance requirements. In response to this increase in compliance efforts and interdepartmental government collaboration, Barnes & Thornburg encourages employers to adopt the following five practices:
Initiate a comprehensive H-1B compliance program review with counsel;
Conduct an internal H-1B audit in coordination with counsel at least once annually;
Increase documentation practices, including changes in job duties, worksite locations, and any significant change in the circumstances of employment;
Provide regular compliance guidance to human resources and other relevant company representatives, as well as vendors and clients involved in third-party placements; and
Routinely monitor third-party placements.
Despite the icy landscape, the H-1B visa category remains an essential method to temporarily employ foreign national employees. More than ever, the category is complex, and requires a thoughtful and strategic approach, including collaboration with counsel on compliance practices far outliving the receipt of the approval notice. As such, we encourage employers and potential H-1B registrants to consult with immigration counsel prior to proactively plan to ensure compliance ahead of the Fiscal Year 2027 H-1B registration season.
A Look at Current Healthtech VC Trends
There is some good news in the healthtech space, with PitchBook’s new Emerging Tech Research showing a rebound in venture capital (VC) funding for the sector. Startups in this space raised an impressive $3.9 billion in Q3 of this year. While this was a bit lower than the previous two quarters, it was enough to move the YTD total ahead of 2024 values. According to PitchBook, this signals a strong rebound for healthtech.
Below is an overview of some key takeaways from the report and trends to watch in the healthtech sector.
Increase in Deal Volume and Size
There was a slight increase in deal volume, up 12% over the previous quarter. The analytics, operations, and telehealth segments were standouts, with each bringing in more than $800 million in funding. Even with the elevated deal count, median healthtech VC deal size still hit a record of $7.7 million, an indication that higher valuations are leading to larger deal size.
A Mixed Report on Exit Activity
While there was a sharp increase in exits in Q3 (a record of 42), the total exit value came in at $200 million. PitchBook correlates this gap between exit count and value to the significant number of acquisitions of smaller, early-stage startups. There were also no major IPOs in the sector this quarter, and their analysts are not expecting to see any other major healthtech listings as we wrap up the year. However, they are tracking several as we move into 2026.
The Continued Impact of AI
As with many other sectors, artificial intelligence (AI) continues to define healthtech. One of the areas that is quickly expanding in terms of commercial use is ambient scribes. These AI-powered tools listen to conversations between patients and providers and generate clinical notes. This is already being adopted across the healthcare space, from physicians’ offices to large health systems, demonstrating a strong demand for these kinds of AI solutions. AI-driven revenue cycle management (RCM) vendors were also a focus for investors. These tools help to reduce claim denials and improve cash flow for healthcare providers.
PitchBook notes that AI adoption for this sector is mostly on the provider side, rather than the payor side, and providers are already “realizing meaningful AI-driven revenue gains” as they deploy these tools. They do expect payors to increasingly utilize AI tools in the future as they seek to identify overpayments and make prior-authorization workflows more efficient.
This sector is expected to gain significant attention as we enter the new year and the adoption of AI grows increasingly prevalent. Notable advancements have the potential to reshape the industry, and investors are likely prepared to support technologies that will drive the future of healthcare.
Adopting an “Orphan Works” Scheme: Proposals from the Copyright Amendment Bill 2025 (Cth)
The Federal Government recently announced Australia’s first statutory orphan works scheme by way of the Copyright Amendment Bill 2025 (Cth) (Bill).
Orphan works refer to copyright materials for which the owner cannot be identified or located. The policy considerations on orphan works are discussed at length in an earlier blog post, Proposed Copyright Reform in Australia – Limited Liability Scheme for Use of Orphan Works.
The Bill also clarifies the Copyright Act 1968 (Cth) (Act) to permit use of copyright materials by schools in online teaching environments, as well as outlining other minor technical amendments to the Act.
Reasonably Diligent Searches
The Bill adds Division 2AAA to the Act, which limits the remedies available to copyright owners for copyright infringement if an owner could be identified or located at the time of infringement. Specifically, the Court cannot grant relief against an alleged infringer if:
They conducted a “reasonably diligent search” for the copyright owner;
The search was conducted within a reasonable period before the infringing use;
They maintained a record of the search;
The copyright owner could not be identified or located at the time of the infringing use and therefore permission could not be obtained; and
A clear and reasonably prominent notice was given in relation to the infringing use, stating that:
The copyright owner could not be located or identified; and
The orphan works scheme applies.
On the point of “reasonably diligent” searches, the Explanatory Memorandum explained:
Higher standards of search would be reasonably expected for types of material and uses that present a higher level of risk to rights holder interests, such as commercial uses, more vulnerable materials (including photographs and images) and culturally sensitive materials. Higher standards of search may also be required if the work is a foreign work and the copyright owner is likely to be residing overseas.
Implications of the Scheme
If a copyright owner is identified or located after allegedly infringing use, the scheme will allow the rights holder to seek reasonable payment for past use and for the parties to negotiate terms for continuing use. The scheme also empowers the Courts to set reasonable terms for continuing use or to provide injunctive relief.
However, it is explicitly stated that the scheme is not intended to support large-scale uses of orphan works for training large language models or other generative AI. Instead, the reasonable diligence conditions are likely to be too “administratively burdensome, time consuming and impractical”.1
Overall, the proposed orphan works scheme will provide copyright users with greater legal certainty and increased access to a larger collection of cultural, historical and educational works. Rights holders may also earn new income from works that have been unknowingly or unintentionally orphaned, but with which they are reunited as the owner through the diligent search requirements.
What Happens Next?
The Bill has been referred to the Legal and Constitutional Affairs Legislation Committee for inquiry, and the committee’s report is due on 19 December 2025.
Campus Event Safety- Practices for Campus Police Managing High-Profile and Controversial Events on Campus
Campus police play a critical role in ensuring the safety, security, and success of high-profile and potentially controversial events on campus. Recent incidents have highlighted the importance of proactive planning, clear protocols, and collaboration with campus stakeholders. This client alert offers practical tools and legal insights for campus law enforcement professionals and university leaders as they prepare to host large events or controversial events on campus with outside speakers.
This alert is the second in our series designed to provide colleges and universities with practical strategies for managing safety and legal risks associated with campus events. Our prior alert on campus event safety is available here. Our goal is to equip higher education leaders with actionable tips, legal insights, and best practices to ensure campus events remain safe, accessible, and consistent with institutional values and legal obligations. These are general recommendations and may not be suitable for every college or university. Institutions should work with legal counsel to develop actionable measures appropriate for their unique campus environment, policies, practices, and applicable law.
Risk management for campus police in managing high-profile or controversial events on campus starts with advance preparation and collaboration with various university departments, ensuring that potential issues are identified and mitigated early. Key risk management strategies for campus police departments include:
Early Coordination both On-Campus and Off-CampusCampus police departments must collaborate with scheduling offices, student affairs, and event organizers (and vice versa) to assess all high-profile and/or potentially controversial events. Using campus event registration forms, campus police and related campus offices are able to collect critical information for risk assessment: expected attendance, speaker profiles, event location, and planned activities.
Depending on the size and scope of the event, campus police should also be coordinating with local law enforcement in the city/town or state, as well as with the speaker’s private security detail (if applicable).
Security Planning and Threat AssessmentCampus police must develop event-specific security plans in consultation with event organizers, local law enforcement, and the speaker’s private security detail (if applicable). Campus police should use standardized tools to assess event risk, considering factors such as anticipated protest activity, speaker notoriety, crowd size and location logistics. These tools allow for risk assessment based on information about the event; however, information considered should not include the speaker’s viewpoint.
As part of this security planning, campus police need to have a designated point person (or group of persons) and assign designated security or police personnel to the event, with clear roles and authority to intervene if needed.
Infrastructure Controls and Crowd ManagementCampuses should consider holding high-risk events in venues where access can be controlled and monitored. Campus police or hired security should work with event organizers to restrict dangerous items, remove objects that could be weaponized, and set up physical barriers if warranted.
Campus event organizers should be made aware of campus policies on signs, amplified sound, and space usage. These policies apply, and should be enforced, regardless of the content of the speech at the event. Event staff, campus police, hired security, local law enforcement, and the speaker’s security detail (if applicable) should be briefed on these policies and how they are enforced on campus and during events.
Communication and TrainingEvent staff, campus police, hired security, local law enforcement, and the speaker’s security detail (if applicable) must all be briefed on emergency procedures, campus policies, and the event-specific security plan.
Depending on the risk profile of the event, tabletop exercises and scenario-based training may be used to prepare for potential protests, disruptions, or emergencies.
Monitoring and ResponseBefore and during the event, the campus should ensure that it is monitoring social media, campus communications, and local intelligence (if applicable) for indications of planned disruptions or threats. This could be led by the campus communications team with campus police support. Any relevant updates should be communicated to event organizers and campus police prior to and throughout the event.
Crisis management is activated when an incident occurs at an event and campus police respond, with swift, coordinated response to protect people, property, and institutional reputation. Key crisis management strategies include:
Activation of Emergency Protocols and Crisis TeamCampus police should be prepared to activate lockdown, evacuation, and emergency medical protocols when necessary. Key to this is ensuring rapid, clear communication with campus leadership, event organizers, and local and state police partners – and to the campus community.
Legal and Compliance ConsiderationsCampus police should remember to appropriately document all law enforcement actions and responses for Clery Act compliance and legal review. Campus legal counsel or outside counsel should be consulted before restricting speech or removing individuals from the event to ensure First Amendment and civil rights obligations are met, and to ensure that the university is complying with its own policies.
Post-Event Debrief and Policy UpdatesThe university should conduct after-action reviews with campus police, event organizers, legal counsel, and university leadership. As a result of this review, the university may want to update its policies and protocols and conduct training based on lessons learned and emerging best practices.
TCPA AVALANCHE- TCPA Class Action Numbers Continue to Spike
It makes me chuckle when other sources suggest TCPA filings were “down” in October.
Yes, there were fewer filings in October than in September, but what is being missed is there were 45% MORE filings in October, 2024 than October, 2025– and that’s what matters when comparing trends.
What is also being missed– the 171 TCPA class actions filed in October, 2025 is 48% increase over the 115 TCPA class action filings in October, 2024.
Overall there have been 1,807 TCPA class actions filed in 2025 compared to 915 in 2024-meaning filings are up 97% year over year.
Here’s the breakdown:
2025
October, 2025: 235 TCPA, 171 Class Action (72.8%)
September, 2025: 287 TCPA, 224 Class Action (78.0%)
August, 2025: 232 TCPA, 162 Class Action (69.8%)
July, 2025: 273 TCPA, 198 Class Action (72.5%)
June, 2025: 257 TCPA, 202 Class Action (78.6%)
May, 2025: 199 TCPA, 159 Class Action (79.9%)
April, 2025: 235 TCPA, 184 Class Action (78.3%)
March, 2025: 242 TCPA, 187 Class Action (77.3%)
February, 2025: 196 TCPA, 148 Class Action (75.5%)
January, 2025: 207 TCPA, 172 Class Action (83.1%)
2024
October, 2024: 161 TCPA, 115 Class Action (71.4%)
September, 2024: 137 TCPA, 79 Class Action (57.7%)
August, 2024: 156 TCPA, 103 Class Action
July, 2024: 129 TCPA, 79 Class Action (61.2%)
June, 2024: 151 TCPA, 99 Class Action (65.6%)
May, 2024: 163 TCPA, 109 Class Action (66.9%)
April, 2024: 135 TCPA, 92 Class Action (68.1%)
March, 2024: 139 TCPA, 84 Class Action (60.4%)
February, 2024: 136 TCPA, 91 Class Action (66.9%)
January, 2024: 200 TCPA, 64 Class Action (32.0%)
Just crazy numbers.
Illinois Becomes the First State to Regulate the Use of AI Mental Health Therapy Services
In early August, Illinois enacted the Wellness and Oversight for Psychological Resources Act (HB 1806, or the “Act”), making it the first state to pass a law regulating the use of AI[1] in the delivery of therapy and psychotherapy services. The Act, which took immediate effect, imposes guardrails on the use of AI to provide decision-making therapeutic support services, but permits the use of AI for administrative and supplementary tasks, subject to certain consent requirements. This blog post summarizes the Act and addresses its potential implications for the use of agentic AI by Illinois therapy providers.
Scope of the Act
Under the Act, only licensed professionals may provide, advertise, or otherwise offer therapy or psychotherapy in Illinois.[2] A “licensed professional” includes any individual who is licensed in Illinois to provide therapy or psychotherapy, such as clinical psychologists, social workers, professional counselors, and marriage and family therapists.[3] The Act addresses three categories of AI-supported services: (i) administrative support; (ii) supplementary support; and (iii) independent therapeutic decision-making or therapeutic communication.
Permitted Uses of AI in Therapy Services
The Act allows Illinois licensed professionals to use AI to provide administrative support, such as scheduling appointments, processing insurance and billing claims, and drafting general communications related to therapy logistics that do not include therapeutic advice.[4] Additionally, such professionals may continue to use AI to provide supplementary support, such as maintaining client records including therapy notes, analyzing anonymized data to track client progress, and identifying referrals.[5] However, if a client session is recorded or transcribed, the Act requires licensed professionals to obtain written consent from clients to use AI for supplementary support.[6] The client or their legally authorized representative must be informed in writing that AI will be used and the specific purpose of the AI tool or system.[7] The written consent must be affirmative and unambiguous – a general terms of use agreement (e.g., a general consent to treatment form) incorporating information about the use of AI is insufficient to establish consent under the Act.[8]
Prohibited Uses of AI in Therapy Services
Most significantly, the Act prohibits the use of AI to: (i) make independent therapeutic decisions; (ii) directly provide therapeutic communication to clients; (iii) generate therapeutic recommendations or treatment plans without review and approval by the licensed professional; or (iv) detect emotions or mental states.[9] “Therapeutic communication” is defined broadly, to include “any verbal, non-verbal, or written interaction conducted in a clinical or professional setting that is intended to diagnose, treat, or address an individual’s mental, emotional, or behavioral health concerns.”[10] Any individual, corporation, or entity found to be in violation of the Act will be subject to a civil penalty of up to $10,000 per violation, and may be subject to an investigation by the Illinois Department of Financial and Professional Regulation.[11] The Act also specifies that therapy or psychotherapy records may not be disclosed except as required under the Mental Health and Developmental Disabilities Confidentiality Act.[12]
Implications for Agentic AI
Agentic AI – autonomous AI systems capable of performing a wide range of tasks, including providing lab results, recognizing emotions and mental health concerns, and even contacting emergency services if a user is in crisis – is being deployed in therapy and psychotherapy practices across the country. The Act’s prohibition on independent therapeutic decision-making by AI poses challenges for providers and businesses looking to use agentic AI in Illinois to recognize and act upon a user’s mental health status. Providers and businesses using this technology will need to ensure that their agentic AI’s capabilities do not fall under independent therapeutic decision-making or therapeutic communication. Moreover, businesses will need to obtain clear and affirmative written consent from clients to use these tools for supplementary support tasks. While agentic AI has immense promise for the future, providers and businesses must ensure their use falls within the bounds of Illinois’s novel restrictions.
FOOTNOTES
[1] The Act references the Illinois Human Rights Act to define “artificial intelligence”: “a machine-based system that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.” 775 Ill. Comp. Stat. 5/2-101(M).
[2] HB 1806 § 20(a).
[3] HB 1806 § 10.
[4] HB 1806 § 15(a).
[5] HB 1806 § 10.
[6] HB 1806 § 15(b).
[7] HB 1806 § 15(b).
[8] HB 1806 § 10.
[9] HB 1806 § 20(b).
[10] HB 1806 § 10.
[11] HB 1806 § 30.
[12] HB 1806 § 25.
Environmental Justice Update- December
In the past several months, environmental justice (EJ) has continued to evolve through a shifting balance of federal and state action. While federal agencies have scaled back EJ initiatives, states are increasingly stepping in to fill the gap–advancing new policies, legislation, and regulatory approaches aimed at integrating EJ considerations into environmental permitting and enforcement. In this edition of the Environmental Justice Update, we examine the latest key trends, policy initiatives, and legal developments reshaping the EJ landscape.
Federal
In June 2025, a coalition of almost two dozen nonprofits, tribes, and local governments sued the US Environmental Protection Agency (EPA) for terminating over 400 grants under the Environmental and Climate Justice (ECJ) Block Grants program created under the Inflation Reduction Act (Public Law No: 117-169) (IRA), arguing that the grant terminations were unlawful. The plaintiffs contended that the termination violated the Administrative Procedure Act as arbitrary and capricious, contravened the Presentment Clause and separation of powers, and disregarded Congress’ directive to fund the grants.
In July 2025, California Attorney General Rob Bonta co-led a multistate coalition of 20 attorneys general in submitting an amicus brief supporting the plaintiffs in this class action lawsuit. Among other points, the amicus brief argued that the termination of the program disproportionately harms marginalized and historically disadvantaged communities, undermining the core purpose of Congress’s instruction to EPA when it passed the IRA.
In a 29 August 2025 opinion, US District Judge Richard Leon of the District of Columbia denied the plaintiffs’ motion for a preliminary injunction, saying: “Put simply, I cannot order the Government to reinstate contracts and pay money due on them.” (emphasis in original). Pointing to decisions from earlier this year by the US Supreme Court pertaining to Department of Education grants and grants from the National Institute of Health, Judge Leon also dismissed the case, agreeing with EPA that the suit belonged before the US Court of Federal Claims.
The majority of plaintiffs appealed Judge Leon’s decision to the US Court of Appeals for the DC Circuit on 16 September 2025. Plaintiff’s emergency motion for an injunction pending appeal was denied as the court found “that harm to the plaintiffs if the grant funds were returned to the Treasury was not irreparable.”
As this legal dispute plays out, Congress’s rescission of all unobligated funding under the ECJ Block Grants program as part of the One Big Beautiful Bill Act (Public Law No.: 119-21), increases the potential difficulty plaintiffs may face in quickly reinstating their grants.
Multistate EJ Guidance
In response to the rollback of EJ under the Trump Administration earlier this year,1 many states have recommitted to EJ protections through a multistate EJ guidance. Specifically, in June 2025, a coalition of state attorney generals from 13 states2 issued the “Multi-State Guidance Affirming the Importance and Legality of Environmental Justice Initiatives.” This document aims to identify sources of legal support for state EJ laws and to provide assurances to stakeholders that EJ practices remain legal despite the Trump Administration’s efforts to curtail them.
The “Multi-State Guidance” challenges the Trump Administration’s labeling of EJ as “illegal discrimination,” locating support for EJ in a variety of federal statutes and the US Constitution. Specifically, the document finds key support in:
The US Constitution:
The Tenth Amendment: Granting states the power to pass laws that advance “Public health, safety, and welfare.”
The Equal Protection Clause of the Fourteenth Amendment: Barring state and local governmental entities from discriminating based on race or sex.
The First Amendment: Barring the government from conditioning benefits on the waiver of free speech rights.
Civil rights statutes, including:
Title VI of the Civil Rights Act of 1964: Preventing those receiving federal funds from discriminating based on race, color, and national origin.
Section 504 of the Rehabilitation Act, the Age Discrimination Act of 1975, and Title IX of the Education Amendments of 1972: Preventing federal funding recipients from discriminating on the basis of disability, age, or sex, respectively.
Title VIII of the Federal Fair Housing Act: Outlawing public or private discrimination on the basis of race, color, religion, sex, familial status, or national origin in activities related to housing.
Federal environmental laws, such as the Clean Air Act’s requirement for public notice and public comment.
Nonprofit laws that prevent the revocation of 501(c)(3) status by presidential executive order or directive.
Treaty obligations to Native American tribes.
In addition to laying out what they see as the legal basis for EJ, and based on this analysis, the state attorneys general provide a “non-exhaustive [list of] examples of work that public entities, non-profit and philanthropic organizations, and businesses lawfully undertake to advance environmental justice.” These activities fall into several broad categories:
Education, technical assistance, and funding support
Public engagement and participation
Burden identification and analysis
Preventing and mitigating pollution exposures
Climate readiness and resilience
Enforcement and remedies
In sum, the multistate guidance seeks to offer stability and assurance to stakeholders by providing clarity on the EJ strategies and resources that remain available to communities in the wake of the federal repeal of EJ initiatives.
Alaska
The One Big Beautiful Bill Act (OBBBA), the Republican reconciliation effort passed in July 2025, has impacted US energy and natural resource development across states and industries. Alaska is one state in particular that is positioned to experience a significant change in energy policy as a result of OBBBA. Two key OBBBA provisions—mandatory lease sales in Alaska and an adjustment of revenue sharing rates—have drawn attention from Alaska’s tribal communities, both for their potential to stimulate economic development and for the increased risk of negative environmental impacts that development could bring.
Specifically, OBBBA directs the secretary of the interior to conduct oil and gas lease sales in certain sections of Alaskan land over the next 10 years, repealing the Biden Administration’s limitation on oil and gas leasing on millions of acres in Alaska and restoring leasing policies established under the first Trump Administration. In addition, OBBBA provides an adjustment of future revenue splits from oil and gas royalties between Alaska and the federal government. This change will result in additional revenue to the Alaska Permanent Fund, which provides cash dividends directly to Alaska residents, along with state and local governments and support services.
Responses to the changes in OBBBA from Native American organizations in Alaska have been mixed. Some Native American groups have shared their appreciation for the OBBBA’s reversal of Biden administration land policies, stating that the previous administration ignored “Alaska Native self-determination” by withdrawing millions of acres of Alaskan land from development and eliminating avenues of Tribal tax revenue. Other Tribal organizations in Alaska opposed OBBBA and have expressed serious concerns that the “aggressive” oil, gas, and coal development directed in the bill puts “ecologically sensitive and culturally significant” lands at risk. Tribal groups have argued that increased carbon emissions from new oil and gas developments, combined with local pollution from energy infrastructure, will exacerbate the already-significant environmental risks.
California
Earlier this year, the state of California filed a lawsuit against the city of Tulare, a small city south of Fresno, for alleged violations of the California Environmental Quality Act (CEQA). The suit, filed in January by Attorney General Rob Bonta, claims that Tulare improperly approved a zoning ordinance that allows the development of cold-storage facilities in light and heavy industrial zones. Tulare approved the zoning ordinance in 2024 without conducting an environmental review under CEQA, claiming that the ordinance was exempt from the law’s requirements. Bonta’s suit argues that these cold-storage facilities could pose increased “air pollution and cancer risks” in “a previously racially-segregated community that is now one of the most pollution-burdened and disadvantaged communities in the State.” The case was disposed on 29 April 2025. Notwithstanding, the litigation highlights the state’s efforts to put pressure on a local government to fulfill its legal obligations to mitigate potential environmental harms to residents.
Colorado
This summer, Colorado’s Environmental Justice Action Task Force (Task Force) sought nominations for communities facing environmental inequities to analyze and improve health impacts. The Task Force was originally created on 2 July 2021 with the passing of HB21-1266. Housed in the Colorado Department of Public Health and Environment (CDPHE), the main goal of the Task Force is to propose recommendations to the general assembly on how to address EJ inequalities, particularly in disproportionately impacted communities. On 14 November 2022, the Task Force published a final report detailing their work and findings over the previous year. In this report, the task force recommended that CDPHE develop a branch of the department to conduct environmental equity and cumulative impact analyses (EECIA) across the state. This recommendation led to the passing of HB24-1338 on 28 May 2024.
HB24-1338 created an Office of Environmental Justice (the Office) housed within CDPHE. This Office specifically oversees the development process of EECIAs in selected geographic areas of Colorado with the goal of understanding how environmental factors affect the health and well-being of Colorado residents. When selecting these areas, the Office must choose disproportionately impacted communities, particularly those affected by a heightened exposure to environmental contaminants. Other factors in this selection process include the proportion of low-income families, the percentage of people of color, and locations with a history of environmental racism. Once these areas are selected, the Office will partner with an academic institution or another third-party to develop an EECIA, which involves hiring a contractor to perform scientifically rigorous analyses recommended by the Task Force. Some of these recommendations include increasing oversight at petroleum refineries, improving the response of the Air Pollution Control Division to air pollution complaints, and analyzing the cumulative impacts of pollution in the air, water, and soil of these communities. Within nine months of completing the EECIA, CDPHE will prepare a report identifying its findings and recommending resources to address environmental inequities.
The impact of these EECIA analyses is intended to help direct funds and resources from the state level to the local level to address issues for communities most exposed to environmental stressors, such as pollution and extreme heat conditions.
Illinois
The Illinois Environmental Protection Agency (Illinois EPA) is drafting proposed statutory language to formally codify the agency’s EJ policy and associated environmental permitting review procedures. Illinois EPA is proposing to limit the enhanced permitting review process to census tracts scoring in the 25th percentile or higher based on certain environmental indicators, with the underlying data to be updated every three years.
At the same time, several proposed EJ bills have yet to pass, including SB1307 and SB1686, which propose to amend the Illinois Environmental Protection Act and the Illinois Environmental Justice Act respectively, and the bills remain in Assignments (Committee) after the first readings. Against this backdrop, the Illinois Pollution Control Board opened a docket for interested parties to submit proposals for procedural regulations to “provide guidance to the Board when considering EJ issues, including the selection of screening tools for identifying areas of EJ concern, in its proceedings.” Illinois EPA, the Illinois Attorney General and various environmental interest groups have submitted comments.
The proposed legislation follows a 24 March 2025 EPA announcement that Illinois EPA had satisfied its obligations under the February 2025 Informal Resolution Agreement, which was issued to resolve allegations that Illinois EPA engaged in discriminatory permitting processes. Under the Informal Resolution Agreement, Illinois EPA committed, among other objectives, to “implement[ ] enhancements to its permit review process” and “ensure [Illinois] EPA’s public involvement process will be available to all persons[.]”
Under the current EJ policy, permitting actions in “areas of EJ concern”—defined as “a census block group with a low-income and/or minority population greater than twice the statewide average”—are subject to stricter scrutiny and heightened public participation requirements. Illinois EPA currently utilizes a GIS mapping tool, known as EJ Start, to determine areas of EJ concern within the state.
Massachusetts
Enacted under Senate Bill 2521 in August 2024, the Environmental Justice Trust (Trust) was signed into Massachusetts’ state budget following a joint proposal by Attorney General (AG) Andrea Joy Campbell, Representative Brandy Fluker-Oakley, and Senator Adam Gomez. Funded through civil penalties that are received in judgments and settlements from state cases involving the Massachusetts Environmental Protection Division, the Trust seeks to benefit community health by using these funds to address economic, environmental, and health-related burdens frequently faced by residents in disadvantaged communities. The Trust will help to address longstanding disparities in environmental health faced primarily by lower-income communities in Massachusetts.
The Trust is funded by the penalties accrued from cases against:
Companies that illegally emit or emit beyond permitted amounts, toxins and other pollutants into the air;
Contractors who expose employees to asbestos during demolitions;
Companies that discharge pollutants into local rivers and streams either illegally or beyond the scope of their permits; and
Entities that wrongfully destroy essential areas of wetland and green spaces that increase flood potential in surrounding communities.
The Trust allows monies to be directed at impacted communities to address financial burdens caused by violations, rather than the monies going into the commonwealth’s general fund. The money in the Trust will specifically be used to restore impacted natural resources, investigate environmental pollution or harm caused to local property, benefit the overall health of the affected community, and provide support to academic or government-funded research to further identify environmental protection and conservation measures in these areas.
On 27 January 2025, the AG’s Office announced that the first payments of a consent judgment against four companies, totaling US$155,000, would be placed into the Trust. More recently, on 8 September 2025, a local Massachusetts company reached an agreement with the AG’s Office for a settlement of US$300,000 in civil penalties, of which US$150,000 will be deposited into the Trust for a violation of the Massachusetts Clean Air Act and illegal asbestos removal. On 10 September 2025, the AG’s Office announced another settlement agreement with a Massachusetts based company for US$115,000 in penalties, with US$55,000 going into the Trust, for illegally handling, removing, and storing asbestos.
Maryland
On 17 July 2025, Governor Wes Moore signed the Valuing Opportunity, Inclusion, and Community Equity Executive Order (The VOICE Order). The VOICE Order, which went into effect immediately, creates the Interagency Environmental Justice and Equity Advisory Council (the Council), which will strive to create a unified front among the state’s agencies to deal with the issue of environmental inequity. Made up of representatives from 14 state agencies appointed by the governor, the Council will coordinate state efforts, track relevant spending, and perform several other tasks to advise the agencies on advancing the governor’s EJ priorities. For example, the VOICE Order requires agencies to use Maryland’s EJ mapping tool, MDEnviroScreen, to “track and address disparities related to environmental hazards, exposures, risks, health outcomes, investments and benefits.”
Critically, the Council is tasked with developing enhanced public participation plans for communities with EJ concerns potentially affected by certain resource extraction, waste management, and industrial and manufacturing processes and activities. The Council will also provide technical assistance to localities in developing and implementing EJ programs and making concrete recommendations to the governor regarding how to best address disparate environmental health impacts caused by state action.
Michigan
On 1 July 2025 and 22 July 2025, Senate Bill 479 and House Bill 4742, entitled the “Protecting Overburdened Communities Act,” was introduced to amend Michigan’s Department of Environment, Great Lakes, and Energy (EGLE) environmental permitting review process. The law would require EGLE to consider the cumulative impact of all pollutant types associated with a potential project. Additionally, the bill would require the agency to account for the greater risk of harm that social and economic factors have on communities. EGLE will use its EJ screening tool, MiEJScreen, to assess projects for environmental risk. If EGLE finds a negative impact on overburdened communities without a compelling need for the project, it has authority under the legislation to deny a permit application. Further, the policy requires permit applicants to give their community 60 days’ notice for a public hearing on the permit and prepare a project impact statement. Applicants must publish the information in at least two community newspapers, including a local non-English paper.
The bill was referred to the House Committee on Natural Resources and Tourism and the Senate Committee on Energy and Environment in July and has not progressed further as of the date of this publication.
New Jersey
On 8 October 2025, the New Jersey Appellate Division held oral arguments on the New Jersey Department of Environmental Protection’s (NJDEP) adoption of N.J.A.C. 7:1C (the Rules), which implement the Environmental Justice Law N.J.S.A. 13:1D-157 to -161 (the EJ Law).
Petitioners focused on aspects of the Rules that they argue go beyond the authority granted to NJDEP under the EJ Law, such as the Rules’ application to “zero population blocks”, and the Rules’ definitions for terms such as new facility, existing facility, expansion, and geographic point of comparison. Petitioners and amici further raised the lack of predictability that the Rules provide, particularly in terms of timing of the EJ process and NJDEP’s application of the EJ stressors, which petitioners noted were implemented in the EJMAP tool without being properly subject to administrative procedures.
In response, NJDEP argued that the department reasonably and permissibly filled in the gaps provided in the law using its expertise. NJDEP and its amici also argued that the Rules’ definitions meet the plain language test and are consistent with defined terms in other NJDEP regulatory programs. The court pressed NJDEP on a number of issues including the Rules’ threshold for measuring the contribution of adverse cumulative stressors, NJDEP’s development of its EJMAP, and the fact that the Rules do not factor economic considerations. The court has taken the matter under advisement for further consideration.
Conclusion
Our EJ Task Force continues to closely monitor developments in this rapidly evolving area, including the updates highlighted above. As the EJ focus continues to evolve, businesses—particularly those operating in overburdened communities—should remain vigilant and track policy shifts and enforcement trends at both the federal and state levels. Staying informed and proactive is essential to managing risk and aligning with emerging compliance expectations.
FinReg Monthly Update November 2025
Welcome to the FinReg Monthly Update, a regular bulletin highlighting the latest developments in UK, EU and U.S. financial services regulation.
Key developments in November 2025:
Asset Management / Wealth Management
17 November – Liquidity Management RTS: The European Commission has adopted Delegated Regulations containing regulatory technical standards (RTS) on liquidity management tools under the Alternative Investment Fund Managers Directive (2011/61/EU) (AIFMD) and the UCITS Directive (2009/65/EC).
17 November – Fund Valuation Standards: The International Organization of Securities Commissions (IOSCO) published a consultation report on updated recommendations on valuing collective investment schemes.
17 November – Depositary Supervision Review: ESMA published a report on the outcome of a peer review of the supervision of depositary obligations.
Sustainable Finance / ESG
20 November – SFDR 2.0 Legislative Proposal Launched: On 20 November 2025, the European Commission officially launched their legislative proposal for the updates to the Sustainable Finance Disclosure Regulation (“SFDR”). In a significant departure from the current SFDR disclosure regime, the European Commission proposes a categorisation regime for funds in its place. Please refer to our dedicated article on this topic here.
13 November – CSRD / CSDDD Simplification Mandate: On 13 November 2025, the European Parliament adopted its negotiating mandate on the European Commission’s Omnibus proposal to reduce the scope of the Corporate Sustainability Due Diligence Directive (EU) 2024/1760) and the Corporate Sustainability Reporting Directive ((EU) 2022/2464). Please refer to our dedicated article on this topic here.
13 November – NGFS Climate Scenario Guide: The Network for Greening the Financial System (NGFS) published an updated version of its guide to climate scenario analysis for central banks and supervisors.
11 November – Taxonomy Delegated Acts Review: The European Commission has published calls for evidence (CfEs) on two proposed Delegated Regulations amending the Taxonomy Climate Delegated Act ((EU) 2021/2139) and the Taxonomy Environmental Delegated Act ((EU) 2023/2486). Please refer to our dedicated article on this topic here.
10 November – ESRS ‘Quick Fix’ Regulation: Commission Delegated Regulation (EU) 2025/1416 amending Delegated Regulation (EU) 2023/2772 as regards the postponement of the date of application of the disclosure requirements for certain undertakings (referred to as the Quick Fix Regulation) was published in the Official Journal of the European Union, on 10 November 2025.
7 November – NGFS Climate Scenario Notes: The Network for Greening the Financial System (NGFS) published a series of explanatory notes to clarify and improve the usability of its long-term climate scenarios.
5 November – EBA Environmental Scenario Analysis: The EBA published a final report (EBA/GL/2025/04) on guidelines on environmental scenario analysis under the CRD IV Directive (2013/36/EU).
4 November – Updated SFDR Q&A: The Joint Committee of the European Supervisory Authorities (ESAs) published an updated version of its questions and answers (Q&A) (JC 2023 18) on the SFDR (EU) 2019/2088) and on Commission Delegated Regulation (EU) 2022/1288, which supplements the SFDR with regard to RTS on content and presentation of information (SFDR Delegated Regulation).
Securities / Capital Markets
28 November – Bond and Derivatives SI Regime: The FCA published a policy statement (PS25/17) on removing the systematic internaliser (SI) regime for bonds, derivatives, structured finance products and emission allowances.
27 November – Credit Builders and Data Collection: The FCA has published its regulation round-up for November 2025. Among other things, the FCA outlines its findings from a review of credit builder products, explains how it is standardising the way it collects financial data at the authorisation gateway and summarises its work on improved digital forms.
27 November – UK EMIR Margin Amendments: The PRA and the FCA published a joint policy statement on changes to the UK bilateral margin requirements for non-centrally cleared derivatives under UK EMIR (648/2012) (PRA PS23/25 / FCA PS25/16), which take the form of amendments to the binding technical standards (BTS) in the UK onshored version of Commission Delegated Regulation (EU) 2016/2251, supplementing UK EMIR.
21 November – FCA Fees and Levies Consultation: The FCA published a consultation paper on policy proposals for its regulatory fees and levies for 2026/27 (CP25/33).
21 November – UK Transaction Reporting Reforms: The FCA published a consultation paper (CP25/32) on proposed improvements to the UK transaction reporting regime.
20 November – Regulated Activities Amendment Order: The Financial Services and Markets Act 2000 (Regulated Activities) (Amendment) Order 2025 (SI 2025/1205) has been published on legislation.gov.uk.
19 November – Market Conduct Codes Recognition: The FCA published an updated version of its webpage on recognised industry codes to reflect the fact it has extended its recognition of the FX Global Code, the UK Money Markets Code and version 2 of the Global Precious Metals Code.
19 November – Equity Consolidated Tape Consultation: The FCA published a consultation paper on the proposed framework for introducing an equity consolidated tape (CT) in the UK run by a consolidated tape provider (CTP) (CP25/31).
12 November – Neo-Brokers Final Report: The IOSCO published its final report on neo-brokers.
5 November – FCA Intragroup EMIR Changes: The FCA published a consultation paper (CP25/30) proposing changes to its BTS on the intragroup exemption regime under UK EMIR (648/2012). The relevant BTS are the UK version of Commission Delegated Regulation (EU) 2016/2251 (BTS 2016/2251) and the UK version of Commission Delegated Regulation (EU) 149/2013 (BTS 2013/149).
5 November – UK EMIR Intragroup Amendments: HM Treasury published a draft version of the Over the Counter Derivatives (Intragroup Transactions) Regulations 2026, together with a policy note.
3 November – Overseas Recognition Regime Regulations: The Financial Services (Overseas Recognition Regime Designations) Regulations 2025 (SI 2025/1147) published on legislation.gov.uk.
3 November – Berne Agreement FCA Guidance: The FCA published guidelines for firms on the Berne Financial Services Agreement.
Financial Crime / Conduct / Sanctions
27 November – FOS 2026/27 Plans Consultation: The Financial Ombudsman Service (FOS) published a consultation paper on its proposed plans and budget for 2026/27.
26 November – SFO Compliance Programme Guidance: The Serious Fraud Office (SFO) published updated guidance on evaluating corporate compliance programmes in England, Wales and Northern Ireland. The guidance outlines six scenarios where the SFO assesses an organisation’s compliance programme, including decisions on prosecution, deferred prosecution agreements (DPAs), compliance terms or monitorships in DPAs, defences under the Bribery Act 2010 and the Economic Crime and Corporate Transparency Act 2023, and sentencing considerations.
21 November – Updated SARs Best Practice: The National Crime Agency published UKFIU SARs best practice guidance on how to use the SAR portal to submit a SAR to the UKFIU, how to help reporters submit a high-quality SAR and how to help reporters seek a defence under Proceeds of Crime Act 2002 (POCA) and the Terrorism Act 2000.
17 November – JMLSG AML/CTF Consultation: The Joint Money Laundering Steering Group (JMLSG) published, for consultation, proposed revisions to Part I of its anti-money laundering (AML) and counter-terrorist financing (CTF) guidance for the financial services sector.
14 November – FCA Regulatory Failure Investigations Policy: The FCA published a statement of policy on statutory investigations into regulatory failure and producing reports.
11 November – FCA Financial Crime Review Findings: The FCA published the findings from a multi-firm review focused on firms’ business-wide risk assessment (BWRA) and customer risk assessment (CRA) processes. The firms involved in the review included building societies, platforms, e-money firms and wealth management firms.
5 November – Financial Inclusion Strategy: HM Treasury published its new financial inclusion strategy, which sets out a national plan aimed at removing barriers to financial participation and building financial resilience.
5 November – BNPL Credit Broking Exemption: The Financial Services and Markets Act 2000 (Regulated Activities, etc.) (Amendment) (No 2) Order 2025 (SI 2025/1154) has been laid before Parliament and published on legislation.gov.uk with an explanatory memorandum. The Order will exempt domestic premises suppliers from credit broking regulation when they offer certain buy-now-pay-later (BNPL) credit products to customers.
3 November – Central Sanctions Enforcement Hub: A new sanctions enforcement action collections page launched by the Foreign, Commonwealth and Development Office (FCDO), the Office of Financial Sanctions Implementation (OFSI), and the Office of Trade Sanctions Implementation (OTSI).
Cryptoassets / Payments
27 November 2025 – IRSG Response on Crypto Consultation: The International Regulatory Strategy Group (IRSG) published its response to the FCA’s September 2025 consultation paper on the application of its Handbook to regulated cryptoasset activities (CP25/25).
26 November – Stablecoin Sandbox Cohort: The FCA publisheda new webpage announcing the launch of a special cohort within its Regulatory Sandbox for firms issuing stablecoins.
25 November – EP Resolution on AI in Finance: The European Parliament adopted a resolution on the impact of AI on the financial sector.
20 November – Property (Digital Assets) Bill: On 19 November 2025, the Property (Digital Assets etc) Bill passedits third reading in the House of Commons with no amendments. It is now awaiting Royal Assent.
18 November – Confirmation of Payee Compliance Report: The Payment Systems Regulator (PSR) published a compliance report on Specific Direction 17, which relates to the confirmation of payee system.
12 November – Tokenised Asset Markets Report: The Investment Association, together with the Investment Management Association of Singapore, published a report examining the challenges and opportunities in tokenised asset markets across the UK and Singapore.
11 November – Tokenisation of Financial Assets Report: The IOSCO published a final report (FR/17/25) discussing observations from a monitoring exercise conducted by its Fintech Task Force to determine how tokenisation and distributed ledger technology (DLT) is being developed and adopted in capital markets products and services.
10 November – BoE Systemic Stablecoins Consultation: The Bank of England (BoE) published a consultation paper on regulating sterling-denominated systemic stablecoins for UK payments issued by non-banks.
7 November – Retail Payments Infrastructure Strategy: HM Treasury published an update on the work of the Payments Vision Delivery Committee.
Artificial Intelligence / Digital Regulation
18 November – DORA Critical ICT Providers List: The ESAs published a list of designated critical ICT third-party service providers under the Regulation on digital operational resilience for the financial sector ((EU) 2022/2554) (DORA).
12 November – ECON Report on AI in Finance: The European Parliament’s Committee on Economic and Monetary Affairs (ECON) published a report on the impact of AI on the financial sector.
5 November – HM Treasury AI Skills Commission: HM Treasury published a letter to the Financial Services Skills Commission (FSSC) from Lucy Rigby MP, Economic Secretary to the Treasury, commissioning the FSSC to research and produce a report on AI skills needs, training and innovation in financial services.
Prudential / Remuneration
28 November – PRA Credit Union Assessment: The PRA published a letter it has sent to directors of credit unions, setting out the key findings from its 2025 assessment of these firms and the actions it expects firms to take.
26 November – MIFIDPRU Reporting Quality Review: FCA published its finding following a review of MIFIDPRU Reporting Quality.
26 November – FCA Reviews Data Quality in MIFIDPRU Prudential Reporting: The FCA published its findings on the quality of prudential regulatory reporting by MIFIDPRU investment firms, identifying good practice as well as areas for improvement including inconsistent data, incorrect firm classification and errors in reporting units.
25 November – IAIS Global Monitoring Exercise: The International Association of Insurance Supervisors (IAIS) published an updated version of its global monitoring exercise (GME) document for the period 2026-28, as well as a new set of ancillary risk indicators for the individual insurer monitoring (IIM) assessment methodology within the GME.
21 November – ComFrame and ICS Consultation: The IAIS published a consultation on developing its common framework for the supervision of internationally-active insurance groups (IAIGs) (ComFrame) to reflect the international capital standard (ICS). The related materials are available on the IAIS consultation webpage.
21 November – Joint Internal Model Authorisations ITS: Commission Implementing Regulation (EU) 2025/2338, amending Commission Implementing Regulation (EU) 2016/100 which contains implementing technical standards (ITS) on the joint decision process for internal models authorisation under the Capital Requirements Regulation (575/2013) (CRR), has publishedin the Official Journal of the European Union.
20 November – FSB Global Stability Priorities: The Financial Stability Board (FSB)published a letter from Andrew Bailey, FSB Chair, to G20 finance ministers and central bank governors ahead of their meeting on 22 and 23 November 2025.
18 November – EIOPA Macroprudential RTS: EIOPA published two final reports (report 1and report 2) containing draft RTS on new macroprudential tools that have been introduced under the Solvency II Directive (2009/138/EC), as amended by the Solvency II Amending Directive ((EU) 2025/2).
12 November – PRA Leverage Ratio Threshold: The PRA published a policy statement (PS22/25) on changes to the retail deposits threshold for application of the leverage ratio requirement.
7 November – CVA Risk Supervision Peer Review: The EBA published a peer review follow-up report analysing the effectiveness of the supervisory practices of competent authorities regarding their assessment of credit valuation adjustment (CVA) risk of the institutions under their supervision.
6 November – Market Risk Framework Consultation: The European Commission published a targeted consultation on the application of the market risk prudential framework.
3 November – Third-Country Branches Authorisation Guidelines: The EBA published a consultation paper on draft guidelines relating to the authorisation of third-country branches (TCBs) under the CRD IV Directive (2013/36/EU), as amended by the CRD VI Directive ((EU) 2024/1619).
Commission Payments / Motor Finance
5 November – Motor Finance Redress Scheme Update: The FCA published a statement providing an update on the progress and timing of its consultation (CP25/27) on a possible motor finance consumer redress scheme. The consultation deadline has been extended to 12 December 2025.
EU Financial Markets
28 November – MiCA Data Standards Statement: ESMA published a statement (ESMA75-1303207761-6284) on technical specifications for implementing a number of data standards and format requirements under the Regulation on markets in cryptoassets ((EU) 2023/1114) (MiCA).
24 November – AI Act Implications Factsheet: The EBA published a factsheet on the implications of the Artificial Intelligence Act ((EU) 2024/1689) (AI Act) for the EU banking and payments sector.
20 November – SFDR and PRIIPs Amendments Proposal: The European Commission adopted a proposed Regulation amending Regulation (EU) 2019/2088 on sustainability-related disclosures in the financial services sector and Regulation (EU) 1286/2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs Regulation), and repealing Commission Delegated Regulation (EU) 2022/1288 (SFDR RTS) (COM(2025) 841 final) (2025/0361 (COD)).
19 November – CRR Market Risk Call for Evidence: The European Commission published a call for evidence on a delegated act on the own funds requirements for market risk under the Capital Requirements Regulation (575/2013) (CRR).
14 November – Gibraltar Market Access Extension: The Financial Services (Gibraltar) (Amendment) (EU Exit) Regulations 2025 (SI 2025/1182) have been published on legislation.gov.uk, together with an explanatory memorandum.
U.S. Matters – Private Funds
20 November – CFTC: The US Senate Committee on Agriculture, Nutrition and Forestry advanced President Trump’s nominee for CFTC Chairman, Michael Selig, in his confirmation process. The nomination will now move to the full US Senate for consideration.
17 November – SEC Exams: The SEC’s Division of Examinations released its 2026 exam priorities. The SEC’s Division of Examinations’ priorities included adherence to fiduciary standards of conduct, particularly in business lines serving retail investors and focused on issues involving emerging technologies like artificial intelligence.
17 November – Rule 14a-8:The SEC’s Division of Corporation Finance published a statement that, during the 2025-2026 proxy season, it will generally not respond substantively to no-action requests from companies intending to rely on any basis for exclusion of shareholder proposals under Rule 14a-8, other than requests to exclude a proposal under Rule 14a-8(i)(1), which is typically used by companies seeking to exclude “ESG” related proposals.
12 November – U.S. Government Shutdown Ends:President Trump signed a bill to fund the government, ending the longest U.S. government shutdown in history and reopening the U.S. federal government. The SEC has resumed its operations, but SEC staff are currently working through a backlog of items received during the shutdown (e.g., reviewing new filings, resuming ongoing exams, etc.). The bill only funded the government until January 30, 2026, meaning the parties will need to reach agreement on an additional extension soon in order to avoid another shutdown.
Nathan Schuur, Robert Sutton, Rachel Lowe, Sasha Burger, Sulaiman Malik, and Michael Singh contributed to this article
NUMBERS DON’T LIE- Statistics Show Why TCPA Risk is 10x Higher Than Risk Posed By Other Consumer Protection Statutes
Just did a post on the avalanche of TCPA class actions that have been filed this year.
But I want to put a finer point on these statistics.
First, the TCPA is FAR more dangerous than other consumer protection statutes and carries far higher penalties– with billions of dollars in exposure in most TCPA class cases. These cases are potentially business-enders for virtually every defendant.
Second, the volume of TCPA class actions compared to other consumer protection statutes is just staggering. Because the TCPA does not have an attorney fee provision the only way for consumer lawyers to collect large fees in most cases is to drive defendants to settle on a classwide basis– so class actions are the norm in TCPAWorld compared to other statutes.
Just how big of a difference is it?
Well in 2025 there have been 1,807 TCPA class actions filed compared to 174 FDCPA class actions and 91 FCRA class action filings.
That means there have been over 10x more TCPA class actions than FDCPA class actions filed this year– and 20x more TCPA class actions than FCRA class actions!
And look at the percentages here:
Only 4.7% of FDCPA cases were filed as class actions in 2025.
Only 1.3% of FCRA cases were filed as class actions in 2025.
Yet a full 76.4% of TCPA cases were filed as class actions in 2025!
3 out of 4 TCPA cases are filed as potential business-ending class actions– that’s insane.
Without question the TCPA is absolutely the biggest risk to YOUR business. If you are engaging in any kind of outbound calling or texting you MUST get great lawyers on your side. You can’t chatgpt your way out of this folks.
A Recent Change In Patent Office Procedures Makes Challenging Patents More Difficult
Retail and consumer products companies in the United States face a constant threat of patent infringement lawsuits and—for reasons described herein—that threat could soon increase. These lawsuits can be costly and disruptive, exposing companies to significant legal fees, discovery expenses, and the risk of large damages awards or injunctions.
In 2011, Congress enacted the Leahy-Smith America Invents Act (AIA), providing accused infringers with a way to challenge the validity of issued patents, called inter partes review (IPR). The stated intent behind the creation of the IPR process was to improve patent quality by providing a faster, less expensive, and more efficient administrative alternative to federal court litigation for challenging patent validity. As part of this process, the AIA created the Patent Trial and Appeal Board (PTAB), a tribunal within the US Patent and Trademark Office (USPTO), to handle IPRs.
Companies facing infringement lawsuits quickly saw many benefits of the IPR process. The costs of an IPR were far less than litigating a patent case to final judgment in federal court, and the standard of proof for invalidating a patent in an IPR proceeding was much lower than in federal court (preponderance of the evidence versus a clear and convincing standard). In addition, many district courts would agree to stay patent lawsuits while IPRs were pending, leading to even greater cost savings. The success rate for instituted IPR proceedings has been overwhelmingly favorable to patent challengers, with nearly 80% of challenged claims being found invalid when the PTAB issued a final written decision.
The AIA provides that an IPR may not be instituted unless the petition “shows there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition.” This provision has been interpreted to provide the Director of the USPTO with complete discretion to deny institution.
Historically, the Director delegated this authority to the PTAB; the PTAB would assess the merits of an IPR petition and institute an IPR proceeding in more than 60% of the cases. However, beginning in 2020, the PTAB started considering non-merits factors and increasingly exercising its discretion to deny institution of IPRs.
In April 2025, the interim Director of the USPTO revoked the delegation of authority to consider discretionary issues from the PTAB, and restored that authority with the Director. By mid-2025, the IPR institution rate had dropped to approximately 35%. After the new permanent Director was confirmed in September 2025, he further consolidated power and issued a memorandum stating that the Director would make all IPR institution determinations in summary fashion without providing any supporting reasoning.
Under the new procedures, the IPR institution denial rate is now near 100%. Industry groups, including the National Retail Federation, have sent letters to government officials opposing these changes, and unsuccessful IPR petitioners have filed mandamus challenges, but, thus far, those efforts have not altered the USPTO’s policies.
In light of these changes, we expect to see an uptick in patent litigation against retail and consumer products companies, as patent owners become less fearful of IPR challenges.
However, there is another defensive strategy. Accused infringers should consider the ex parte reexamination (EPR) process as an alternative to IPRs, which will become less advantageous. The EPR process was established in 1981 and allows for a post-grant review of validity before the USPTO.
EPRs offer some of the benefits of IPRs, but also come with some disadvantages. On the plus side, EPRs are not subject to any discretionary denial risk, leading to a near 95% grant rate. EPRs typically cost a fraction of an IPR, largely because, once filed, the requester no longer participates in the process. And like IPRs, an EPR proceeding can lead to a stay of district court litigation, although the stay rate is lower for EPRs because the EPR process takes longer. On the other hand, EPRs have a lower successful rate of invalidation, and provide the patent owner with the opportunity to amend the patent claims during the process, which can impact litigation strategy.
In light of this quickly changing landscape, retail and consumer products companies facing patent infringement claims should discuss with their patent counsel the pros and cons of these two administrative patent challenge processes early in any litigation for the best chance for success.
Healthcare Preview for the Week of- December 1, 2025 [Podcast]
First Day of the Last Month
The end of the calendar year is a month away, and the continuing resolution under which Congress approved funding for most of the government ends on January 30, 2026.
We will be watching for signals of an “outbreak of cooperation,” particularly around the Affordable Care Act (ACA) enhanced premium tax credits, which are set to expire December 31, 2025. There is currently no sign of a bipartisan deal. Senate Republicans have hinted at possible alternatives to extending the tax credits, but it is unclear whether there is enough support among Republicans to initiate bipartisan negotiations. It is also unclear whether President Trump will choose to insert himself again after congressional Republicans nixed the administration’s attempt last month before it was even formally proposed.
The Senate Committee on Health, Education, Labor, and Pensions will meet Wednesday on the broad topic of healthcare affordability, which will provide another avenue to publicly discuss the pending expiration of the ACA enhanced premium tax credits. The conversation may mirror the November 19, 2025, Senate Committee on Finance hearing on the rising cost of healthcare, where committee Democrats and two of the witnesses argued that extending the tax credits this month is essential before considering potential long-term solutions.
On Monday evening, the House passed HR 4313, the Hospital Inpatient Services Modernization Act. The bill, passed under suspension of the rules (which requires the support of two-thirds of the House), would extend the Acute Hospital Care at Home program for five years. We will watch to see whether the Senate decides to take it up via unanimous consent. If not, the legislation may be included in negotiations around the January 30, 2026, expiration of the government funding package, which also includes health extenders such as the hospital at home program extension.
In the administration, the Centers for Medicare & Medicaid Services (CMS) announced the ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model today. The model is intended to test “an outcome-aligned payment approach designed to give people with Original Medicare new options to improve their health and prevent and manage chronic disease with technology-supported care.” Many groups that have participated in the White House healthcare and technology ecosystem initiative will attend a private event with CMS on Thursday to discuss the model and any other Innovation Center models announced this week.
The Medicare Payment Advisory Committee will also meet on Thursday and Friday for the first time since missing meetings during the government shutdown.
Although we typically focus on previewing the week ahead, we wanted to draw your attention to a few rules the administration released last week that you may have missed because of the Thanksgiving holiday. On November 25, 2025, CMS issued a proposed rule that would make policy and technical changes to the Medicare Advantage and Part D programs for 2027 and beyond. CMS announced the agreed-upon maximum fair prices for 15 drugs selected for the 2027 Medicare Drug Price Negotiation Program. On November 28, 2025, the calendar year 2026 home health final rule, which forecasts plans for competitive bidding, was posted for public inspection.
Today’s Podcast
In this week’s Healthcare Preview podcast, Debbie Curtis and Rodney Whitlock join Maddie News to discuss the congressional calendar for this week and the rest of the year, including upcoming suspensions and hearings, and ongoing discussions of the enhanced Advance Premium Tax Credits.