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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
purpose of the technology. Furthermore, the respondent noted that an exporter could be unaware that a given technology is capable of performing a function for which the technology was not designed and for which it is not commonly used.
BIS response: The consensus of the interagency process followed in accordance with Section 4817 of ECRA
was that emerging technology controls should apply to software designed for nucleic acid assemblers and synthesizers controlled by 2B352.j that is capable of designing and building functional genetic elements from digital sequence data. The scope of this control is also consistent with the decision made at the AGs May 2021 Virtual Implementation Meeting session to add this software to its Control List of Dual-Use Biological Equipment and Related Technology and Software. If the controls on this software applied only to software designed or specially designed for the purpose of generating pathogens and toxins without the need to acquire controlled genetic elements and organisms, the scope of the controls would have been far too narrow. Consequently, there would have been a significantly increased risk that certain software not captured by narrower controls could have been exploited for biological weapons purposes.
Comment: One respondent stated that the software controls proposed to be implemented in new ECCN 2D352, and all future emerging and foundational technology controls, should be implemented multilaterally, rather than unilaterally. The respondent noted that a multilateral approach to export controls would increase their effectiveness and minimize their impact on U.S. industry. Specifically, multilateral export controls are preferable to unilateral controls, because the former typically place U.S. industry on a more level playing field versus producers/suppliers in other countries.
BIS response: This final rule imposes controls on software designed for nucleic acid assemblers and synthesizers controlled by 2B352.j to reflect the decision made at the AGs May 2021 Virtual Implementation Meeting session to add such software to its Control List of Dual-Use Biological Equipment and Related Technology and Software. This action by BIS is in accordance with Section 4817c of ECRA, which specifies that the Secretary of State, in consultation with the Secretary of Commerce and the Secretary of Defense, and the heads of other Federal agencies, as appropriate, shall propose that any
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technology identified pursuant to Section 4817a of ECRA be added to the list of technologies controlled by the relevant multilateral export control regimes.
Comment: One respondent recommended that BIS issue emerging and foundational technology controls as proposed rules and closely follow ECRAs statutory requirements and guidance. This would provide industry with the opportunity to provide formal comments to government officials so that the latter could address industrys questions and concerns. The respondent further noted that such consultations are critical to the effectiveness of regulations in achieving national security goals, without placing undue or unintended burdens on U.S. exports.
BIS response: Consistent with the emerging and foundational technologies notice and comment requirements in Section 4817a2C of ECRA, BIS
published a proposed rule on November 6, 2020 85 FR 71012, to provide the public with notice and the opportunity to comment on adding a new ECCN
2D352 to control software for the operation of nucleic acid assemblers and synthesizers described in ECCN
2B352.j that is capable of designing and building functional genetic elements from digital sequence data. As indicated above, BIS received comments from four respondents in response to the publication of its November 6 proposed rule. These comments are addressed by BIS in the preamble of this final rule.
Comment: One respondent expressed concern that the acquisition of the nucleic acid assembler and synthesizer software proposed for control under new ECCN 2D352 by BISs November 6
proposed rule could be used to generate pathogens and toxins without the need to directly acquire controlled genetic elements and organisms. This respondent indicated that the capabilities of this software lower the bar for acquisition of controlled genetic elements and so represent an increase in the risk of proliferation of biological weapons-related technology.
According to this respondent, automated benchtop synthesis devices could allow unskilled individuals to create DNA sequences that might be used to produce a biological weapon.
This respondent also expressed a growing concern about the potential for active circumvention of software for the operation of nucleic acid assemblers and synthesizers. For example, software for operating benchtop nucleic acid synthesis devices could be written to incorporate biosecurity screening onboard the device.
Consequently, if such software were
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easily acquired e.g., in the absence of export controls, these devices could be hacked to circumvent biosecurity screening, thereby enabling covert synthesis of otherwise controlled genetic elements. For this reason, these devices and, in certain instances, their components and operating software should be subject to export controls. In this regard, the respondent indicated a preference for multilateral export controls e.g., the adoption of export controls by the Australia Group.
BIS Response: The views expressed by this respondent support, and expand upon, the rationale provided by BIS
both in its November 6 proposed rule and in this final rule for the imposition of controls on this nucleic acid assembler/synthesizer software under new ECCN 2D352. In addition, as noted in response to other comments described in this final rule, the controls on this software reflect the decision made at the AGs May 2021 Virtual Implementation Meeting session and, consequently, are being imposed multilaterally by all AG participating countries including the United States.
Comment: One respondent expressed concern that the establishment by BIS of more restrictive controls on software for the operation of certain automated nucleic acid assemblers and synthesizers could damage trade and collaboration in this field with certain U.S. allies and thereby decrease the United States global competitiveness in this field. Consequently, this respondent stated that any controls that are placed on such software should not impair the ability of the United States and its allies to trade in intermediate goods or to collaborate on R&D, both of which are crucial to maintaining their shared advantages vis-a-vis other foreign competitors. In this regard, the respondent noted that the methods for manipulating, growing, recovering, concentrating, stabilizing, and testing biological materials for use in weapons employ many of the same materials and equipment used to produce vaccines, pharmaceuticals, and a wide variety of food products.
BIS response: As indicated above, new ECCN 2D352 controls software designed for nucleic acid assemblers and synthesizers controlled by 2B352.j, consistent with the decision made at the AGs May 2021 Virtual Implementation Meeting session to add such software to its Control List of Dual-Use Biological Equipment and Related Technology and Software. This software, as controlled under new ECCN 2D352, requires a license for CB
reasons and AT reasons to the destinations indicated under CB

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