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US Proposes Export Control on Emerging Technology Software to Operate Automated Nucleic Acid Assemblers and Synthesizers

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 synthesizers due to concerns the software could be used to create pathogens and toxins as biological weapons.

A link to the proposal is here.

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 synthesizers that are referred to in ECCN2B352.j. are nucleic acid assemblers and synthesizers that are both: j.1 Partly or entirely automated; and j.2. Designed to generate continuous nucleic acids greater than 1.5 kilobases in length with error rates less than 5% in a single run.

Since this ECCN is not yet on the Australia Group list, the new ECCN 2D352 would be unilateral – unless the US can convince the Australia Group to adopt the ECCN. And 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 license 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 license from BIS. The control would also require a deemed export license 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 December 21, 2020.

If adopted this will be the fifth set of Emerging Technology controls 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.

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