The Bureau of Industry and Security has issued an interim final rule implementing targeted export controls on certain laboratory instruments to address the risks that biotechnology, particularly when coupled with artificial intelligence and biological design tools, could strengthen the military capabilities of countries of concern.
This rule controls (1) high-parameter and spectral flow cytometers and cell sorters, which are used to simultaneously measure multiple features of individual cells or particles, and (2) certain liquid chromatography mass spectrometers specially designed for proteomics, the study of all or a significant portion of proteins produced and/or modified by an organism to elucidate the interactions, function, composition, and structures of proteins and their cellular activities.
A BIS press release states that these instruments are highly suitable for rapidly generating large, detailed biological datasets that can be analyzed to discover complex patterns governing the function of biological molecules, cells, and organisms. They can thus be used toward innovative solutions in health, climate change, energy, food, and agriculture, BIS states, but they can also be used to train AI systems for the development of militarily-relevant applications such as human performance enhancement, brain-machine interfaces, biologically-inspired synthetic materials, and possibly biological weapons.
BIS is therefore imposing new license requirements for exports of these instruments to destinations that present a concern of potential misuse or diversion to activities of national security concern. The rule moves these instruments from ECCN 3A999 into new ECCN 3A069 and technology for the development or production of these instruments will be described in new ECCN 3E069. Both of these ECCNs will be controlled for national security, regional stability, and anti-terrorism reasons, though some license exceptions will be available for certain destinations.
Comments on this rule are due no later than March 17. The rule was effective as of Jan. 16 but shipments of items removed from eligibility for a license exception or export, reexport, or transfer (in-country) without a license (NLR) as a result of this rule that were en route aboard a carrier to a port of export, reexport, or transfer as of that date pursuant to actual orders for export, reexport, or transfer may proceed to that destination under the previous eligibility before Feb. 18 Any such items not actually exported, reexported or transferred before midnight on Feb. 18 will require a license in accordance with this rule.
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