Treasury Proposes to Include Biotechnology as Prohibited Technology under COINS Act
On October 26, 2026, the U.S. Department of the Treasury’s (Treasury) Office of Investment Security published a proposed rule setting forth regulations that would implement Subtitle C of the Comprehensive Outbound Investment National Security (COINS) Act, which is codified at Title VIII of the Defense Production Act. 91 Fed. Reg. 67396. The proposed rule would require U.S. persons to notify Treasury regarding certain transactions involving foreign persons that are engaged in notifiable technologies, including biotechnology, and prohibit U.S. persons from engaging in certain other transactions involving foreign persons that are engaged in prohibited technologies. Treasury’s October 22, 2026, press release notes that the COINS Act authorizes the Treasury Secretary to prescribe regulations with technical parameters for “prohibited technology” and “notifiable technology” in five technology sectors: semiconductor technologies and microelectronics; artificial intelligence systems; quantum information technologies; high-performance computing and supercomputing; and hypersonic systems. The COINS Act also authorizes the Secretary to add and define technologies that enable the military, intelligence, surveillance, or cyber-enabled capabilities of a country of concern. The press release states that “[a]ccordingly, the Secretary has added biotechnology to the proposed regulations.”
The proposed rule proposes to define “prohibited technology” to include the development, engineering, or use of a biological system, or component of a biological system, to modify, enhance, produce, or control:
- Certain export-controlled agents or toxins, as well as novel agents and toxins capable of similar effects as those currently export-controlled;
- Energetic precursors or energetic materials;
- Novel or high-performance functional materials (i.e., bio-derived products that exhibit novel or enhanced properties, such as adaptive or protective coatings, materials for agile infrastructure, materials capable of self-repair or self-assembly, and biosensors);
- Pharmaceutical compounds (e.g., small molecules, polymers, vaccines, blood and blood components, allergenics, cell and gene therapies, and monoclonal antibodies or other recombinant therapeutic proteins), as well as their delivery systems; and
- Biofuels (i.e., fuels made or derived from bio-based feedstock).
The proposed rule also would define prohibited technology to include “the development or production of brain computer interfaces and the development, construction, or production of biomanufacturing equipment, including components and associated software or technology,” as well as “the development or production of certain other related technology or equipment (including components and associated software), to include: biological sequencing technology, including short-read or long-read sequencing; certain flow cytometers and cell sorters; certain liquid chromatography mass spectrometry instruments; certain computational or bioinformatics tools; and hardware, robotics, or software for automated scientific discovery or experimentation, including laboratory automation or cloud lab infrastructure.” Comments on the proposed rule are due December 7, 2026.