BIS Proposes Emerging Tech Export Control on Software for Development of Biological Weapons

The Bureau of Industry and Security is considering export controls on certain “software” that can be exploited to develop biological weapons (see 2010010003) and requested feedback from industry about the impact of the controls, the agency said in a Nov. 5 notice. The controls would target software “for the operation of nucleic acid assemblers and synthesizers” that can design and build “functional genetic elements from digital sequence data.” The controls would fall under BIS’s emerging technology effort, and comments are due Dec. 21.

BIS said this software can be used to generate 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,” the agency said. BIS proposed adding a new Export Control Classification Number to control the technology.

BIS said that it did not receive any comments on controlling this software from its 2018 pre-rule on emerging technologies but said it thinks restrictions are warranted. If the proposal were to take effect, BIS stressed, the rule would not only control “software” used for the operation of the assemblers and synthesizers, but also technology for the development of such software. The agency also acknowledged that the technology is not controlled by the Australia Group -- an international and multilateral export regime -- and therefore BIS’s control would be “unilateral in nature.”

Public comments will help BIS “identify and assess the appropriate level of controls” that should be applied to the software, the notice said. The agency is specifically looking for feedback about whether the proposed controls are “clear” and “adequately address” emerging and foundational technologies “within the context of biological weapons related capabilities and developments.” BIS also wants comments on the “current capability” of the development of this software in the U.S. and other countries, including whether the restrictions would “inadvertently control any ‘software’ that is suitable almost exclusively for legitimate commercial or scientific applications.” Commenters should also give feedback on what type of impact this control will have on the future development of this software -- and related technologies -- in the U.S., as well as whether the controls would effectively limit the availability of this software abroad.

While the rule, as written, would place unilateral controls on the software, BIS acknowledged that “multilateral export controls are preferable to unilateral controls” and said it “welcomes” comments about whether the controls should be implemented multilaterally. The agency said multilateral controls tend to minimize impact on industry and “place U.S. industry on a more level playing field versus producers/suppliers in other countries.”

BIS also said the software and related technology is used in research and development at “many” universities and military laboratories. As a result, the control would likely result in deemed export license applications -- requests to transfer the software or technology to foreign nationals in the U.S. -- due to foreign students and employees working at U.S. universities and biotechnical firms. There would also “most likely” be an increase in deemed reexport license applications “for the release of this ‘technology’ to third-country foreign nationals located in foreign countries,” BIS said.

The agency estimated that the rule would result in about six license applications per year from small businesses that would be impacted by the change. BIS also expects “the total burden hours” for small businesses due to this change to “increase only slightly.” The rule would also “trigger a small information collection burden” under the Census Bureau’s Foreign Trade regulations due to required Electronic Export Information filing requirements.

The agency does not expect the rule to create a large increase in workload for industry. It said “the reclassification process would need to be done only once per license applicant for exports,” essentially resulting in a “one-time burden” for each applicant. “To the extent that compliance with the changes proposed in this rule would impose a burden on persons, including small businesses, BIS believes the burden would be minimal,” the notice said.

The agency added that it could have “proposed a much broader control” on the software “that would have captured a greater amount” of items and technology, which would have had “a greater impact not only on small businesses, but also on R&D laboratories (both academic and corporate).” The agency said this version of the proposed control is “the least disruptive alternative for implementing export controls.”