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DOC/BIS RIN: 0694-AI21 Publication ID: Fall 2022 
Title: Implementation of Australia Group Decisions (November 2021 and March 2022 Virtual Implementation Meetings; July 2022 Plenary): Controls on Marine Toxins, Plant Pathogens and Biological Equipment 
Abstract:

The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to reflect decisions made at the November 2021 and March 2022 Australia Group (AG) Virtual Implementation Meetings and the AG Plenary Meeting held in July 2022.  Consistent with decisions made at the AG Virtual Implementation Meetings, this rule amends Export Control Classification Number (ECCN) 1C353 on the Commerce Control List to clarify that the controls on genetic elements and genetically modified organisms include, inter alia, any gene(s) or translated product(s) specific to any controlled virus.  In addition, ECCN 2B352 is amended to clarify the scope of the exclusion that applies to medical isolators "specially designed” for barrier nursing or transportation of infected patients.  Consistent with the decisions made at the July 2022 Plenary Meeting, this final rule amends ECCN 1C351 by adding four naturally occurring, dual-use marine toxins (specifically, brevetoxins, gonyautoxins, nodularins and palytoxin) and removing cholera toxin.  The addition of these four toxins is consistent with the emerging and foundational technologies requirement in Section 1758 of the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852), as codified under 50 U.S.C. 4817.  This rule also amends ECCN 1C354 to reflect the AG Plenary updates to the nomenclature of certain bacteria and fungi.  In addition, ECCN 2B352 is amended to reflect an AG clarification to the definition of disinfected” as it applies to certain biological equipment.

 
Agency: Department of Commerce(DOC)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 15 CFR 740    15 CFR 742    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  05/23/2022  87 FR 31195   
NPRM Comment Period End  06/22/2022 
Final Action  12/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
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