BIS: Section 1758 Bio & Toxins Rule Set

The Bureau of Industry and Security (BIS) published the final rule to amend the Export Administration Regulations (EAR) to reflect decisions made at Australia Group (AG) Virtual Implementation Meetings and the AG Plenary Meeting held in July 2022. 

The amendments published January 17 include revisions to certain Export Control Classification Numbers to clarify the controls on genetic elements and genetically modified organisms and the scope of the exclusion that applies to medical isolators “specially designed” for barrier nursing or transportation of infected patients; and makes clarifications 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 Section 1758 of the Export Control Reform Act of 2018 (ECRA) regarding emerging and foundational technologies. 

Finally, this rule also includes amendments to reflect the AG Plenary updates to the nomenclature of certain bacteria and fungi, and the clarification of the definition of “disinfected” as it applies to certain biological equipment. [88 FR 2507]