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BIS Moving Forward With Export Control on Certain Biological Equipment Software

The Bureau of Industry and Security this week sent a final rule for interagency review that would expand export controls on certain biological equipment software. The rule, received by the Office of Information and Regulatory Affairs Sept. 13, would amend the Commerce Control List by adding a new Export Control Classification Number to control software “for the operation of automated nucleic acid assemblers and synthesizers” that are “capable of designing and building functional genetic elements from digital sequence data.”

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BIS previously issued the rule in proposed form in November and requested comments (see 2011050043). In that rule, the agency said it would control not only “software” used for the operation of the assemblers and synthesizers but also technology for the development of such software. The agency said it received three comments, but they aren't available to view.

The control would be part of BIS’s emerging and foundational technology control effort, the agency said. Export restrictions are warranted because the software can be used to produce pathogens and toxins. “[C]onsequently,” BIS said, “the absence of export controls on such software could be exploited for biological weapons purposes.” The agency will again request public comments in the final rule stage to ensure the controls “will be effective and appropriate,” BIS said.