U.S. rule amending CCL, biological equipment “software”

Final rule amends the Export Administration Regulations (EAR) to implement a decision made at the Australia Group (AG) virtual implementation meeting

Final rule amends the Export Administration Regulations (EAR)

The Bureau of Industry and Security (BIS) of the U.S. Commerce Department today released for publication in the Federal Register a final rule that amends the Commerce Control List (CCL) to include certain biological equipment—specifically nucleic acid assembler and synthesizer “software” that is capable of designing and building functional genetic elements from digital sequence data.

Today’s final rule [PDF 323 KB] amends the Export Administration Regulations (EAR) to implement a decision made at the Australia Group (AG)* virtual implementation meeting session held in May 2021, and later adopted pursuant to the AG’s silence procedure. This action updated the AG Common Control List for dual-use biological equipment by adding controls on nucleic acid assembler and synthesizer “software” that is capable of designing and building functional genetic elements from digital sequence data.

Prior to the AG decision, BIS—consistent with the interagency process described in the Export Control Reform Act of 2018 (ECRA)—identified this “software” as a technology to be evaluated as an emerging technology.

The decision by BIS to amend the CCL to include this “software” complies with the requirements of ECRA and also reflects the decision of the AG to add it to that regime’s Common Control List, thereby making exports of this “software” subject to multilateral control through the implementation of these changes by individual AG participating countries (including the United States). 

* The AG is a multilateral forum consisting of 42 participating countries and the European Union. These participants maintain export controls on a list of chemicals, biological agents, and related equipment and technology that could be used in a chemical or biological weapons program. The AG periodically reviews items on its control list to enhance the effectiveness of participating governments’ national controls and to achieve greater harmonization among these controls.

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