Insights

On September 29, 2025, the U.S. Department of Commerce Bureau of Industry and Security (BIS) announced a sweeping Interim Final Rule (IFR), (the “Affiliates Rule”) expanding which entities qualify as Entity List or Military End-User entities, thereby subjecting those entities to elevated export control restrictions under the Export Administration Regulations (EAR). U.S. export restrictions applicable to entities on the Entity List, Military End-User (MEU) List, and Specially Designated Nationals and Blocked Persons (SDN List) now apply to foreign affiliates that are, in the aggregate, owned 50% or more by one or more of the aforementioned entities. An entity that becomes subject to these restrictions because of its ownership structure will be subject to the most restrictive controls that attach to any of its parent entities, regardless of ownership stakes.

The U.S. Consumer Product Safety Commission (CSPC) issued its Lapse Plan in advance of the federal government shutdown. The CSPC will furlough 35% of full-time employees, with the overwhelming majority of those retained focused on “protect[ing] life and property.” Under the Lapse Plan, consumer-oriented programs and, notably, civil penalties, will pause for the duration of any shutdown.

On September 24, 2025, the California Air Resources Board (“CARB”) issued a preliminary list of reporting/covered entities under California’s climate disclosure laws SB 253 (the Climate Corporate Data Accountability Act) and SB 261 (the Climate-Related Financial Risk Act) (the “Climate Disclosure Laws”) (both as modified by SB 219).

Congress has not passed crucial funding bills for the start of Fiscal Year 2026.  If Congress fails to act by September 30, the government may be forced to shut down for lack of funding.  In anticipation of that possibility, agencies government-wide are preparing for a shutdown, and contractors and companies that work with the government should do so as well.  Our team is ready and available to help advise companies through the shutdown process.

On September 26, the White House invited the public to submit comments on Federal laws, rules, and policies that “unnecessarily hinder” the development or deployment of artificial intelligence (AI) technologies in the United States. This request marks one of the Trump Administration’s most substantial moves yet to reduce the regulatory burden on AI. Respondents may submit comments through a government website until October 27, 2025.

On September 25, 2025, the Northern District of Texas granted plaintiffs’ motion for summary judgment in Humana v. Becerra, vacating CMS’s 2023 Final Rule regarding risk adjustment data validation (RADV) audits. In the litigation, Humana challenged CMS’s decision in the Final Rule to not continue applying a Fee-for-Service (FFS) adjuster to its RADV audit methodology.

The Transportation Security Administration (TSA) recently proposed an expanded role regulating unmanned aircraft systems (UAS), or drones.  On August 7, 2025, the Federal Aviation Administration (FAA) and TSA published a joint Notice of Proposed Rulemaking (proposed rule), titled Normalizing Unmanned Aircraft Systems Beyond Visual Line of Sight Operations (BVLOS).  Through this landmark proposed rule, the FAA and TSA aim to provide industry with a clear path forward for streamlined UAS operations for a variety of purposes, including package delivery, agriculture, aerial surveying, civic interest (public safety), and flight testing.  Comments on the proposed rule are due October 6, 2025.

The states of the Persian Gulf are moving rapidly to establish themselves as global centers of investment and innovation in artificial intelligence (AI). The Kingdom of Saudi Arabia, the United Arab Emirates (UAE), and the State of Qatar are making substantial outlays in technology and infrastructure as they seek to diversify their economies away from oil. As important, their governments are implementing digital regulations and AI strategies in a bid to attract foreign investment and develop technology companies that can go toe-to-toe with American and European competitors. 

On 18 September, during the anticipated state visit, the leaders of the UK and the US signed the Technology Prosperity Deal, which promises to boost investment and cooperation to foster innovation, security, and economic prosperity. This is being lauded in the UK as a hugely significant milestone in transatlantic cooperation. The governments of both countries have released a Memorandum of Understanding (“Memo”) which covers a number of ambitious plans in strategic science and technology fields, including artificial intelligence (“AI”), nuclear energy, fusion, and quantum technologies.

On August 28, 2025, France, Germany, and the UK (the E3) initiated the process to reinstate (or snapback) UN sanctions on Iran. The snapback mechanism (which was set to expire on October 18, 2025) is outlined in UN Security Council Resolution 2231 (UNSCR 2231).

Responding to the D.C. Circuit’s deadline to inform the court how it wishes to proceed in litigation challenging the agency’s listing of two types of per- and polyfluoroalkyl substances (PFAS) as hazardous substances under Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the Environmental Protection Agency (EPA) stood behind its rule. In a September 17, 2025 filing, EPA told the court that the Trump administration had completed its review and would ultimately keep the Biden-era CERCLA final rule in place. The agency also requested that the court remove—i.e. pause—the abeyance placed on the proceedings, so that the lawsuit could move forward and be adjudicated.

The Department of Education (DOE) announced on September 10, 2025, that it will end discretionary funding to several Minority-Serving Institution (MSI) grant programs that, it stated, “discriminate by conferring government benefits exclusively to institutions that meet racial or ethnic quotas.”[1] The agency stated that it would “us[e] its statutory authority to reprogram discretionary funds to programs that do not present such concerns.”[2] This announcement follows a July 2025 decision by the Department of Justice to no longer defend the constitutionality of a provision of the Higher Education Act of 1965 (HEA) that authorizes grant funding to Hispanic-Serving institutions, after determining that such programs “violate the equal-protection component of the Fifth Amendment’s Due Process Clause.”[3]

On September 18, 2025, the Director of National Intelligence (DNI) issued the first order under the authority conferred by the Federal Acquisition Supply Chain Security Act (FASCSA), requiring exclusion and removal of products and services by an identified source.[1]

In recent years, there has been a wave of new legislation impacting contracts and contractual terms. The Belgian legislator is gradually adopting the different Books of the Belgian Civil Code, and the Belgian Code of Economic Law has been updated several times. These changes impact the drafting of contracts and contractual terms, not only between companies but also with consumers.

On Thursday, the California Law Revision Commission (“CLRC”), the influential body that makes recommendations to the Legislature, took significant steps toward its goal of enacting antitrust legislation to regulate single-firm conduct under California’s antitrust law, the Cartwright Act. The CLRC unanimously voted to move forward with an unprecedented legislative proposal that not only outlaws single-firm “restraints of trade,” but also states that certain federal antitrust standards are not required in California state courts. As a next step, the CLRC will approve a formal recommendation to the Legislature along these lines at the CLRC’s December meeting. Companies doing business in California should pay close attention to these developments because of the potentially dramatic impact this kind of law could have, including increased exposure to antitrust litigation. Crowell & Moring is representing the California Chamber of Commerce (“CalChamber”) in monitoring, analyzing and responding to the CLRC’s recommendations.

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising.  This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”

On August 8, 2025, the Attorneys General of 23 Republican-led U.S. states (the “AGs”) sent a letter to Science Based Targets Initiative (“SBTi”), a U.K. non-profit climate organization, expressing concern with the SBTi’s climate initiatives.[1]SBTi had previously received a subpoena from Florida Attorney General James Uthmeier in connection with his office’s investigation into what he described as a “climate cartel,” which he alleges includes SBTi and CDP (formerly the Carbon Disclosure Project).[2]

California Governor Gavin Newsom has until October 12, 2025, to sign into law a first-in-the-nation bill that will, if enacted, likely impose significant regulatory obligations and litigation risk on companies deploying AI chatbots in California.

Although the Supreme Court’s 2014 decision in Alice v. CLS Bank and its progeny affected the issuance and enforcement of software patents and led to a major shift in U.S. patent policy, software patents still have value today and such protection therefore should be pursued.

On September 11, 2025, the Environmental Protection Agency (EPA) asked the D.C. Circuit to vacate regulations for four types of polyfluoroalkyls (known collectively as “PFAS”) in drinking water. The motion for partial vacatur marks a significant reversal in the agency’s policy, as the EPA had previously vigorously defended legal challenges to the first-of-their-kind standards in federal court for the past two years. See American Water Works Association, et al. v. EPA, case no. 24-1188 and consolidated cases (D.C. Cir. filed June 7, 2024). Just this month, the case was given the green light to proceed, after being held in abeyance (at the request of both parties) so that the Trump administration could determine how it wished to proceed. The change signals a willingness on the part of the administration to act on previously issued non-legally binding announcements of forthcoming changes to Biden-era rules and may also serve as a harbinger for how the new administration will tackle PFAS under other statutes, such as the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).