Treasury proposes outbound investment rules under COINS Act, adding biotechnology and five more countries; comments due Dec. 7

The Treasury Department’s proposed rules to carry out the Comprehensive Outbound Investment National Security Act went on public inspection at the Federal Register at 8:45 a.m. on Friday, Oct. 23, 2026, and are scheduled for publication on Monday, Oct. 26. Written comments must be received by Dec. 7, 2026, through regulations.gov or by mail, under docket TREAS-DO-2026-0595.¹² Treasury announced the proposal on Oct. 22.³

The proposal would create a new Part 851 in Title 31 of the Code of Federal Regulations. It would require U.S. persons to notify Treasury of certain deals with foreign persons engaged in “notifiable technologies” and bar deals involving “prohibited technologies.” It was signed by Christopher M. Pilkerton, Treasury’s assistant secretary for investment security.²

Congress passed the COINS Act as Title LXXXV of the National Defense Authorization Act for Fiscal Year 2026, Public Law 119-60, approved Dec. 18, 2025. It added a Title VIII to the Defense Production Act that puts the program into statute.⁴²

What would change from the 2024 rules

The current rules, 31 CFR Part 850, were published Nov. 15, 2024, and took effect Jan. 2, 2025. They cover China, including Hong Kong and Macau, in semiconductors and microelectronics, quantum information technologies and artificial intelligence. Treasury says it has received about 100 notifications in about 21 months.² Under the proposal:

• Countries of concern would also include Cuba, Iran, North Korea, Russia and “the Bolivarian Republic of Venezuela under the regime of Nicolás Maduro Moros,” as the proposal lists them, following the statute.²⁴ The document notes that regime “no longer exists” and that the United States recognized Delcy Rodríguez as Venezuela’s head of state on March 5, 2026.²
• High-performance computing and supercomputing, and hypersonic systems, would be added as sectors. Treasury used its authority under the law to add biotechnology to prohibited technologies, including using biological systems to produce certain controlled agents and toxins, energetic materials, novel functional materials, pharmaceutical compounds and biofuels.²
• AI systems would be renamed “super intelligence systems,” following Executive Order 14434 of Sept. 29, 2026. Instead of the current rules’ thresholds based on training compute and end uses, the development of any such system by a covered foreign person would be prohibited. Treasury says no single measure now separates advanced models.²
• Deals involving companies on two more lists would be prohibited: the Department of War’s Section 1260H list of Chinese military companies and the Office of Management and Budget’s BIOSECURE Act list of biotechnology companies of concern.²
• Transactions totaling $50,000 or less over 12 months would be excepted from notification. Limited partner commitments up to $2 million would be excepted, which Treasury says matches Part 850.²
• Criminal penalty language would be dropped because Title VIII includes none. Treasury could compel divestment of a prohibited transaction.²
• Investors could request confidential non-binding feedback on a potential prohibited transaction, and the public could confidentially submit evidence about foreign persons. Treasury is weighing a public database of covered foreign persons.²

Part 850 would continue to apply to activity from Jan. 2, 2025, until the effective date of the final rules, which Treasury says will be set later.²³

Positions

Treasury Secretary Scott Bessent said in the announcement that the administration is “committed to putting America’s national security first.”³ Terry Wilcox, chief patient advocate of the patient group Patients Rising, said the biotechnology language “puts vaccines, cell and gene therapies, antibodies, and even ordinary small-molecule medicines” in the same prohibited category as dangerous biological agents.⁵ Jennifer Crook, executive director of the American Biosecurity Initiative, said Treasury’s proposed restrictions on outbound biotechnology investment “must address specific national security risks without unnecessarily discouraging investment.”⁶

What the records do not show

• The proposal does not say when final rules will be issued or take effect.²
• The proposal does not say how the Venezuela listing would be applied given the change of government it notes.²