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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations destinations in accordance with the embargoes and other special controls described in part 746 of the EAR.
ECCN 2E001 Amended To Include technology for New ECCN 2D352
In addition, this rule amends ECCN
2E001 which controls, inter alia, technology for the development of the nucleic acid assemblers and synthesizers described in ECCN 2B352.j to indicate that technology for the development of software controlled by new ECCN 2D352 is controlled by ECCN 2E001 for CB reasons and AT
reasons to the destinations indicated under CB Column 2 and AT Column 1, respectively, on the Commerce Country Chart in Supplement No. 1 to part 738
of the EAR. The CB control entry in the License Requirements table for ECCN
2E001 is amended to reflect this change.
The heading of ECCN 2E001 does not need to be amended to reflect this change because the ECCN heading indicates that, with limited specified exceptions, this ECCN controls technology for the development of software listed under Category 2D of the CCL, which now includes new ECCN 2D352.

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Conforming Amendments to 742.2
Proliferation of Chemical and Biological Weapons Consistent with the May 2021 AG
decision described above, this final rule amends Section 742.2 of the EAR by revising paragraphs a2viii and a2ix to reflect the addition of ECCN
2D352 to the CCL and to indicate that technology for the development of software controlled by new ECCN
2D352 is controlled by ECCN 2E001.
These changes were not included in a proposed rule that BIS published on November 6, 2020 85 FR 71012, which is described in more detail, below.
However, because they are merely conforming changes that cross reference the aforementioned amendments to the CCL, BIS is making the changes in this final rule.
Evaluation of Nucleic Acid Assembler/
Synthesizer Software as an Emerging Technology 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
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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.
Consistent with the emerging and foundational technologies notice and comment requirements in Section 1758a2C of ECRA 50 U.S.C.
4817a2C, BIS published a proposed rule on November 6, 2020 85 FR 71012
hereinafter, November 6 proposed rule, to provide the public with notice and the opportunity to comment on adding 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. The November 6
proposed rule also indicated that technology for the development of such software would be controlled under ECCN 2E001.
As stated above, the imposition of controls on this software by this final rule under new ECCN 2D352 reflects a decision by the AG to add this software to its biological equipment control list. Consequently, this action by BIS also conforms with Section 1758c 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 technology identified pursuant to Section 1758a of ECRA be added to the list of technologies controlled by the relevant multilateral export control regimes.
Comments Submitted in Response to BISs November 6 Proposed Rule BIS received comments from four respondents in response to the publication of its November 6 proposed rule. The comments from these respondents, together with BISs responses, are described below.
Comment: One respondent stated that BIS should not treat commodities and software as potential emerging technologies, because Section 1758 of ECRA, which provides the statutory standard for establishing new controls on emerging and foundational technologies, refers only to technology, as defined in Section 1742 of ECRA codified at 50 U.S.C.
4801. The respondent noted that Section 1758 of ECRA makes no mention of commodities or software, which, together with technology, are
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included in the statutory definition of item. The respondent further observed that the term item is included in other sections of ECRA and that its absence from Section 1758 is given meaning by considering only technology as defined in Section 1742
of ECRA. The respondent also noted that this interpretation would be consistent with the EAR definition of technology, which does not include commodities or software.
Consequently, the respondent recommended that BIS should follow this interpretation of the statute, as well as its own regulations regarding the definition of technology, by identifying only emerging technology and not related emerging commodities and software.
BIS response: The terms technologies, emerging technologies and critical technologies are used in Section 1758
of ECRA 50 U.S.C. 4817 and Section 721a6 of the Defense Production Act of 1950 DPA, as amended 50 U.S.C.
4565a6, with the latter defining critical technologies to mean those described in 50 U.S.C. 4565a6Ai through vi. The DPA indicates that the term critical technologies includes by definition emerging and foundational technologies controlled pursuant to Section 1758 of ECRA, as well as items included on the Commerce Control List for multilateral reasons or for surreptitious listening or regional stability reasons. As the respondent noted, the term items includes commodities, software and technology. Consequently, the term technologies, as used within the context of these ECRA and DPA
provisions, encompasses commodities, software and technology, and not technology only e.g., as that term is more narrowly defined in Section 1742 of ECRA.
Furthermore, note that BISs August 27, 2020 85 FR 52934, advance notice of proposed rulemaking on the identification and review of controls for certain foundational technologies stated that the term technologies, as used in Section 1758 of ECRA, includes not only technology, but also commodities and software as those terms are used in the EAR.
Comment: One respondent observed that the capable of standard does not place sufficient emphasis upon the purpose for which an item is designed.
Consequently, this standard might inadvertently control technology that is not designed to produce a controlled item, even when the ability of the technology to produce the controlled item is wholly unrelated to the primary
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