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BIS is publishing this final rule to amend the Commerce Control List (CCL) by adding a new Export Control Classification Number (ECCN) 2D352 to control "software" that is designed for automated nucleic acid assemblers and synthesizers controlled under ECCN 2B352 and is capable of designing and building functional genetic elements from digital sequence data. These proposed amendments to the CCL are based upon a finding, consistent with the emerging and foundational technologies interagency process set forth in section 1758 of ECRA (50 U.S.C. 4817), that such "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. In addition, this rule amends ECCN 2E001 to indicate that this ECCN controls "technology" for the "development" of "software" described in the new ECCN 2D352.

Statement of Need:

The Bureau of Industry and Security (BIS) is publishing this final rule to amend the Export Administration Regulations (EAR) to implement the decision made at the Australia Group (AG) Virtual Implementation Meeting session held in May 2021, and later adopted pursuant to the AG’s silence procedure. This decision updated the AG Common Control List for dual-use biological equipment by adding controls on nucleic acid assembler and synthesizer software that is capable of designing and building functional genetic elements from digital sequence data.

Prior to the addition of nucleic acid assembler/synthesizer software to the AG biological equipment list, BIS identified this software as a technology to be evaluated as an emerging technology, consistent with the interagency process described in section 1758 of the Export Control Reform Act of 2018 (ECRA) (codified at 50 U.S.C. 4817). This identification was based on a finding that this software is capable of being used to operate nucleic acid assemblers and synthesizers controlled under ECCN 2B352 for the purpose of generating 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.

Summary of the Legal Basis:

Section 1758(a) of the Export Control Reform Act (ECRA) of 2018 (50 U.S.C. 4817(a)) outlines an interagency process for identifying emerging and foundational technologies.  Nucleic acid synthesizer software has been identified as a technology for evaluation as a potential emerging technology, consistent with the interagency process described in section 1758 of ECRA. Consequently, 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. Subsequent to the publication of this proposed rule, the Australia Group (AG) added this software to their biological equipment Common Control List.  This final rule amends the EAR to reflect the action taken by the AG.

Alternatives:

The Secretary of Commerce must establish appropriate controls on the export, reexport or transfer (in-country) of technology identified pursuant to the Section 1758 process. In so doing, the Secretary must consider the potential end-uses and end-users of emerging and foundational technologies, and the countries to which exports from the United States are restricted (e.g., embargoed countries). While the Secretary has discretion to set the level of export controls, at a minimum a license must be required for the export of such technologies to countries subject to a U.S. embargo, including those countries subject to an arms embargo.

If the interagency process results in a determination that a certain technology constitutes an emerging technology, for purposes of section 1758 of ECRA, then BIS is required, pursuant to ECRA, to institute export controls on such technology.  However, BIS does have some flexibility to ensure that the scope of any controls that may be imposed on this technology would be effective (in terms of protecting U.S. national security interests) and appropriate (with respect to minimizing their potential impact on legitimate commercial or scientific applications).  In this particular instance, the controls on this technology will be multilateral, because they have been adopted by the Australia Group (AG) for inclusion in their biological equipment Common Control List.

Anticipated Costs and Benefits:

The changes that would be made by this rule would only marginally affect the scope of the EAR controls on chemical weapons precursors, human and animal pathogens/toxins, and equipment capable of use in handling biological materials.

The number of additional license applications that would have to be submitted per year, as a result of the addition of ECCN 2D352 to the CCL, as described above, is not expected to exceed fifteen license applications.  This total represents a relatively insignificant portion of the overall trade in such items and is well within the scope of the information collection approved by the Office of Management and Budget (OMB) under control number 06940088.

Risks:

This software is capable of being used to operate nucleic acid assemblers and synthesizers controlled under ECCN 2B352 for the purpose of generating 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.