New ECCN proposed for emerging software used to operate nucleic acid assemblers and synthesisers

The US Department of Commerce, Bureau of Industry and Security (BIS) has proposed a new Export Control Classification Number (ECCN), 2D352, to control software that is capable of being used to operate nucleic acid assemblers and synthesisers due to concerns that such software could be used to create pathogens and toxins as biological weapons.

BIS is concerned that the software is "capable of being utilized in the production of pathogens and toxins and, consequently, the absence of export controls on such 'software' could be exploited for biological weapons purposes".

The nucleic acid assemblers and synthesisers that are referred to in ECCN2B352.j are nucleic acid assemblers and synthesisers that are both:

• partly or entirely automated (j.1); and
• designed to generate continuous nucleic acids greater than 1.5 kilobases in length with error rates of less than 5% in a single run (j.2).

Since this ECCN is not yet on the Australia Group list, the new ECCN 2D352 would be unilateral – unless the United States can convince the Australia Group to adopt the ECCN. Further, because the technology ECCN 2E001 controls technology for the development of software listed under Category 2D, the creation of this ECCN would also create a new technology control in 2E001 on the technology to develop ECCN 2D352 software.

The new ECCN 2D352 would require a licence for CB2 column reasons, meaning that exports of the software to any country with an X in the CB2 column of the Commerce Country Chart would require a licence from BIS. The control would also require a deemed export licence to allow software engineers from such countries in the United States on visas to gain access to the development technology.

Comments must be filed by 21 December 2020.

If adopted, this will be the fifth set of emerging technology controls that BIS has published and the second set of unilateral emerging technology controls. And software companies beware – it is the second unilateral emerging technology control on software.

For further information on this topic please contact Kay C Georgi or Sylvia G Costelloe at Arent Fox LLP by telephone (+1 202 857 6000) or email (kay.georgi@arentfox.com or sylvia.costelloe@arentfox.com). The Arent Fox LLP website can be accessed at www.arentfox.com.