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ARTICLE · 10 FEBRUARY 2025

BIS Increases Export Controls On Key Biotech Equipment

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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.

United StatesInternational Law

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."

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