Genetic Elements & Genetically-modified Organisms

Export Control

Genetic Elements & Genetically-modified Organisms

Export Control Classification Number (ECCN): 1C353

refer to https://www.bis.doc.gov/index.php/regulations/export-administration-regulations-ear for the most recent updates

This page updated 10/16/20

Genetically modified organisms that contains, or any genetic element that codes for, any of the following

  • any gene or genes specific to any virus controlled by IC351 .a or .b or IC354.c.
  • any gene or genes specific to any bacterium controlled by  1c351.c or 1c354.a. or any fungus controlled by ic351.e or ic354.b and which
    • in itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health, or
    • could endow or enhance pathogenicity
  • any of the “toxins” controlled by 1C351.d or “sub-units of toxins” thereof.

Notes: 

  1. Genetically modified organisms include organisms in which the nucleic acid sequences have been created or altered by deliberate molecular manipulation
  2. “Genetic elements” include, inter alia, chromosomes, genomes, plasmids, transposons, vectors, and inactivated organisms containing recoverable nucleic acid fragments,  whether genetically modified or unmodified, or chemically synthesized in whole or in part.
  3. This ECCN does not control nucleic acid sequences associated with the pathogenicity of enterohaemorrhagic Escherichia coli, serogroups O26, O45, O103, O104, O111, O121, O145, O157 and other shiga toxin producing serogroups, other than those genetic elements coding for shiga toxin or its sub-units.
  4. "Endow or enhance pathogenicity" is defined as when the insertion or integration of the nucleic acid sequence or sequences is/are likely to enable or increase a recipient organism's ability to be used to deliberately cause disease or death.  This might include alterations to , inter alia, virulence, transmissibility, stability, route of infection, host range, reproducibility, ability to evade or suppress host immunity, resistance to medical countermeasures, or detectability