Bureau of Industry and Security November 2020 – Federal Register Recent Federal Regulation Documents

The Bureau of Industry and Security (BIS), Department of Commerce, maintains controls on the export, reexport and transfer (in- country) of dual-use items and less sensitive military items through the Export Administration Regulations, including the Commerce Control List (CCL). Certain items that could be of potential concern for export control purposes are not yet listed on the CCL or controlled multilaterally, because they represent emerging technologies. Among these items is ``software'' for the operation of nucleic acid assemblers and synthesizers controlled under Export Control Classification Number (ECCN) 2B352 that is capable of designing and building functional genetic elements from digital sequence data. BIS has determined that this ``software'' is capable of being used to operate nucleic acid assemblers and synthesizers controlled under ECCN 2B352 for the purpose of generating pathogens and toxins without the need to acquire controlled genetic elements and organisms. Consequently, the absence of export controls on this ``software'' could be exploited for biological weapons purposes. In an effort to address this concern, this rule proposes to amend the CCL by adding a new ECCN 2D352 to control such ``software.'' This rule also requests public comments to ensure that the scope of these proposed controls will be effective and appropriate (with respect to their potential impact on legitimate commercial or scientific applications).