The Bureau of Industry and Security has issued a final rule implementing a multilateral agreement to control certain biotechnology software that has substantial beneficial civilian applications but can also be misused for biological weapons purposes.

This rule amends the Export Administration Regulations to implement an August 2021 decision by the Australia Group adding controls on nucleic acid assembler and synthesizer software that is capable of designing and building functional genetic elements from digital sequence data. This software, as controlled under new ECCN 2D352, requires a license for chemical and biological weapons reasons and anti-terrorism reasons to the destinations indicated under CB Column 2 and AT Column 1, respectively, on the Commerce Country Chart in the EAR. A license also is required to certain destinations in accordance with the embargoes and other special controls described in part 746 of the EAR.

BIS states that this rule is part of its continuing work to add emerging technologies to the Commerce Control List pursuant to Section 1758 of the Export Control Reform Act of 2018. Prior to the AG decision BIS, consistent with the interagency process described in ECRA, identified this software as a technology to be evaluated as an emerging technology. BIS states that adding this software to the CCL ensures the proper level of control to protect against its misuse, while the multilateral control provides a level playing field for U.S. companies.
For more information on export controls, please contact attorney Kristine Pirnia via email.

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