Under the Export Control Reform Act of 2018 (“ECRA”), the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) is authorized to establish controls on the export, reexport or in-country transfer of “emerging and foundational technologies.” On August 27, 2020, BIS issued an advance notice of proposed rulemaking, requesting comments on the definition of, criteria for and identification of certain foundational technologies.
On November 6, 2020, BIS published a proposed rule in the Federal Register proposing to add certain software to the Commerce Control List (“CCL”) and thereby place export controls on it. BIS seeks comments on its proposed rule by December 21, 2020 so that it can ensure the proposed controls are “effective and appropriate” regarding their potential impact on “commercial or scientific applications.”
Specifically, BIS determined that certain software for the operation of nucleic acid assemblers and synthesizers, which are controlled under Export Control Classification Number (“ECCN”) 2B352, are capable of being used to generate “pathogens and toxins without the need to acquire controlled genetic elements and organisms.” In other words, BIS determined that this type of software can be used to effectively circumvent export controls on genetic elements and organisms. BIS proposes to amend the CCL by adding ECCN 2D352 to control such software, in order to ensure that a lack of controls cannot be exploited to further the development of biological weapons.