Sch 2Dealings exempt from licensing

Schedule 2—Dealings exempt from licensing (regulation 6) Note: Subregulation 6(1) sets out other requirements for exempt dealings. ## Part 1 Exempt dealings ## Part 1—Exempt dealings | Item | Description of dealing | | ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 2 | A dealing with a genetically modified Caenorhabditis elegans, unless:(a) an advantage is conferred on the animal by the genetic modification; or(b) as a result of the genetic modification, the animal is capable of secreting or producing an infectious agent. | | 3 | A dealing with an animal into which genetically modified somatic cells have been introduced, if:(a) the somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and(b) the animal is not infected with a virus that is capable of recombining with the genetically modified nucleic acid in the somatic cells. | | 3A | A dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if: | | | (a) the in vivo modification occurred as part of a previous dealing; and(b) the replication defective viral vector is no longer in the animal; and | | | (c) no germ line cells have been genetically modified; and | | | (d) the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and(e) the animal is not infected with a virus that can recombine with the genetically modified nucleic acid in the somatic cells of the animal. | | 4 | (1) Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 25 litres of GMO culture in each vessel containing the resultant culture. | | | (2) The donor nucleic acid:(a) must meet either of the following requirements:(i) it must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy:(A) human beings; or(B) animals; or(C) plants; or(D) fungi;(ii) it must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm; and | | | Example: Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, in relation to the capacity of the host or vector to cause harm, it:(a) provides an advantage; or(b) adds a potential host species or mode of transmission; or(c) increases its virulence, pathogenicity or transmissibility. | | | (b) must not code for a toxin with an LD50 of less than 100 micrograms per kilogram; and(c) must not code for a toxin with an LD50 of 100 micrograms per kilogram or more, if the intention is to express the toxin at high levels; and(d) must not be uncharacterised nucleic acid from a toxin‑producing organism; and(e) if the donor nucleic acid includes a viral sequence—cannot give rise to infectious agents when introduced into any potential host species, without additional non‑host genes or gene products that:(i) are not available in the host cell into which the nucleic acid is introduced as part of the dealing; and(ii) will not become available during the dealing; and(f) if the donor nucleic acid includes a viral sequence—cannot restore replication competence to the vector. | | 5 | A dealing involving shot‑gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of this Schedule, if the donor nucleic acid is not derived from either:(a) a pathogen; or(b) a toxin‑producing organism. | ## Part 2 Host/vector systems for exempt dealings