On April 15, 2025, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) released an Interim Final Rule (IFR) implementing targeted export controls on certain laboratory instruments. The United States recognizes that ensuring the responsible use of biotechnology, particularly when combined with advances in artificial intelligence (AI) and data science, is essential to safeguard public health, agriculture and food production, and the environment.

At the same time, the United States needs to address the benefits and risks of biotechnology given the potential that its use, particularly when coupled with AI and biological design tools, could strengthen the military capabilities of countries of concern and pose threats to U.S. national security.

As noted in Executive Order 14081, emerging biotechnology capabilities have inherently dual-use applications: they promise great improvements in human wellbeing but have the potential to be misused by malign actors. The instruments controlled by this IFR 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. This information has a wide range of civil and commercial applications. However, evidence suggests that certain countries are actively pursuing strategy to exploit these techniques for asymmetric military advantage. 

This IFR controls the following instruments: High-parameter and spectral flow cytometers and cell sorters and Certain liquid chromatography mass spectrometers. While this IFR imposes new license requirements for these instruments, license exceptions will be available for certain destinations. Exporters will also be required to file Electronic Export Information in the Automated Export System for certain exports.