- List
- Australia Group – Human and Animal Pathogens and Toxins – Version of 27 March 2026
- Corresponding EU entry
- 1C353
Any genetically-modified organism which contains, or genetic element that codes for, any of the following:
a. Any gene, genes, translated product, or translated products, specific to any listed virus; or
b. any gene or genes specific to any listed bacterium or fungus, and which (i) in itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health, or
(ii) could endow or enhance pathogenicity; or (c) any listed toxins or their sub-units.
Technical 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 the genetic elements control, nucleic acids from an inactivated organism, virus, or sample are considered '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. These controls do not apply to 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.
a. Any gene, genes, translated product, or translated products, specific to any listed virus; or
b. any gene or genes specific to any listed bacterium or fungus, and which (i) in itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health, or
(ii) could endow or enhance pathogenicity; or (c) any listed toxins or their sub-units.
Technical 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 the genetic elements control, nucleic acids from an inactivated organism, virus, or sample are considered '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. These controls do not apply to 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.