The Bureau of Industry and Security (BIS) has issued a proposed rule to add certain genetic element design software to the Commerce Control List. Specifically, on November 6, 2020, BIS issued a proposal to add “software” for the operation of nucleic acid assemblers and synthesizers already controlled under ECCN 2B352 that is capable of designing and building functional genetic elements from digital sequence data to the Commerce Control List (CCL) under new ECCN 2D352.

The notice stated that “BIS has determined that this “software” is capable of being used … 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.” BIS also noted that this software is not currently included on any of the Australia Group (AG) common control lists; therefore, the new controls would be unilateral.

The description of ECCN 2E001 already controls technology for the development of software controlled under Category 2D of the CCL. Therefore, if the proposed rule goes into effect, ECCN 2E001 would control “technology” for the “development” of the “software” that would be controlled under new ECCN 2D352.

BIS requested comment on whether these new controls should be multilateral instead of unilateral.  In addition, BIS specifically requested comment on:

  1. Whether the proposed controls are clear and adequately address “emerging and foundational technologies” within the context of biological weapons related capabilities and developments (to the extent that this is not the case, comments should identify specific control text that would be more appropriate to these ends);
  2. The current capability for the “development” of such “software” in the United States and other countries, including the extent to which the proposed controls would affect “software” that is currently being produced and/or sold, either within or outside the United States (e.g., whether the proposed controls would inadvertently control any “software” that is suitable almost exclusively for legitimate commercial or scientific applications);
  3. The effect that implementation of the proposed controls would have on the future “development” of such “software” and related “technology” in the United States; and
  4. The effectiveness of the proposed controls in terms of limiting the availability of such “software” and related “technology” abroad.

The comment period is open until December 21, 2020. Comments may be filed on the Federal eRulemaking Portal: on Docket Number BIS-2020-0024.