The Commerce Department’s Bureau of Industry and Security (BIS) has released a final rule to implement a multilateral agreement to control certain biotechnology software that could be misused for biological weapons purposes. This final rule amends the Export Administration Regulations (EAR) to implement the decision finalized by the Australia Group (AG) on August 6, 2021. The AG is a multilateral forum consisting of 42 participating countries and the European Union.  Its main purpose is to coordinate and maintain export controls on a list of chemicals, biological agents, and related equipment, software and technology that could be used in chemical or biological weapon programs. This AG decision and BIS’ final rule add export controls on nucleic acid assembler and synthesizer software that is capable of designing and building functional genetic elements from digital sequence data.  While this software has substantial beneficial civilian applications, it can be misused for biological weapons purposes.  This new licensing requirement could be significant for U.S. life sciences companies and other medical-related entities as the new export controls on such software cover a multitude of countries.

The final rule adds a new Export Control Classification Number (ECCN) to control “software” designed for certain nucleic acid assemblers and synthesizers (i.e., ECCN 2D352).  Specifically, the new software controls apply to nucleic acid assemblers and synthesizers that are both: (i) partly or entirely automated; and (ii) designed to generate continuous nucleic acids greater than 1.5 kilobases in length with error rates less than 5% in a single run.  Exports of this software will now require a license from BIS for chemical and biological weapons reasons and anti-terrorism reasons.  Further, BIS has also amended a related ECCN to cover the “technology” for the development of such nucleic acid assemblers and synthesizers software.

By strengthening export controls on software that could be inappropriately used for biological weapons proliferation, BIS has stated that this final rule “represents another step forward in preventing the misuse of this emerging technology by foreign adversaries and strengthening export control regimes in coordination with allies and partners.”  This final rule and the encompassing export controls on such software and related technology are effective as of October 5, 2021.