On January 15, 2025, BIS issued an Interim Final Rule that amends the Export Administration Regulation (EAR) to address dual use export control concerns about biotechnology. The new rule institutes new export controls on certain biotechnology products and related technologies that, when used in conjunction with artificial intelligence and biological design tools, could pose a threat to U.S. national security.
The two categories of biotech products impacted are: (1) and (2) certain liquid chromatography mass spectrometers (LC/MS) “specially designed” for top-down proteomic analysis. BIS stated that these instruments are “highly suitable for generating large, detailed biological datasets, which can be analyzed to discover complex patterns governing the function of biological molecules, cells, and organisms” and that “evidence suggests that certain countries are actively pursuing a strategy to exploit these technologies for asymmetric military advantage.”
This new rule became effective as of January 16, 2025. There is an opportunity to submit comments to BIS on the interim final rule, with a deadline of March 17, 2025.
Re-classification of Certain ECCN 3A999 Items to 3A069.
The new rule shifts high-parameter flow cytometers and LC/MS for top-down proteomics from their current classification under ECCN 3A999, which is relatively lightly controlled, to the newly created ECCN 3A069, which is subject to much stricter controls. FDA-approved medical devices and products exempt from FDA pre-market approval under section 510(k) of the Federal Food, Drug, and Cosmetic Act and included in the list required by section 510(j) of that Act are excluded from the scope of 3A069.
Related “technology” required for the development or production of items controlled under ECCN 3A069 is now covered under new ECCN 3E069. Both ECCN 3A069 and 3E069 are controlled for the same reasons – namely, National Security, Regional Stability, and Anti-Terrorism – and are subject to the same licensing requirements.
Presumption of Denial for Certain License Applications.
For controlled devices, a license will be required for all export destinations, except those in Country Group A:1, which includes close U.S. allies. The rule states that there will be a presumption of denial for license applications to destinations in Country Group D:1 and D:5, Macau, and Country Group E. License applications for other destinations will be reviewed on a case-by-case basis.
