Commerce Control List: Expansion of Controls on Certain Biological Equipment “Software”

The Bureau of Industry and Security (BIS) publishes this final rule to amend the Export Administration Regulations (EAR) to implement the 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 decision 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 this 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 the 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).