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DOC/BIS RIN: 0694-AI08 Publication ID: Spring 2022 
Title: Commerce Control List: Expansion of Controls on Certain Biological Equipment "Software" 
Abstract:

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.

 
Agency: Department of Commerce(DOC)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 15 CFR 774   
Legal Authority: 50 U.S.C. 4801 to 4852    50 U.S.C. 4601 et seq.    50 U.S.C. 1701 et seq.    10 U.S.C. 8720   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/06/2020  85 FR 71012   
NPRM Comment Period End  12/21/2020 
Final Action  10/05/2021  86 FR 54814   
Final Action Effective  10/05/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Willard Fisher
Export Administration Specialist
Department of Commerce
Bureau of Industry and Security
14th Street and Pennsylvania Avenue NW,
Washington, DC 20230
Phone:202 482-2440
Fax:202 482-3355
Email: willard.fisher@bis.doc.gov