ECCN 1C353: Genetic Elements and Genetically-Modified Organisms
Last Updated January 16, 2023
a. Any genetically modified organism that contains, or any genetic element that codes for, any of the following:
- Any gene, genes, translated product or translated products specific to any virus controlled by 1C351.a or .b or 1C354.c
- Any gene or genes specific to any bacterium controlled by 1C351.c or 1C354.a, or any fungus controlled by 1C351.e or 1C354.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; or
- Any toxins, or their subunits, controlled by 1C351.d.
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. For the purposes of this ECCN 1C353, nucleic acids from an inactivated organism, virus, or sample are considered to be ‘recoverable’ if the inactivation and preparation of the material is intended or known to facilitate isolation, purification, amplification, detection, or identification of nucleic acids.
3. This ECCN does not control nucleic acid sequences of shiga toxin producing Escherichia coli of 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 for its subunits.
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.
