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What Dealings With GMOs are Classified as Exempt Dealings?

Excerpt from the Gene Technology Regulations 2001 (Statutory Rules 2001 No. 106 as amended) (the Regulations), effective from 1 September 2011

Part 1 of Schedule 2 of the Regulations describes the type of dealings with are classified as exempt. Part 2 of Schedule 2 determines the host/vector system relevant to Item 4 of Part 1. These host/vector systems are also relevant to the classification of Notifiable Low Risk Dealings (NLRDs) and Dealings not involving Intentional Release (DNIR) in Schedule 3 of the Regulations.

Schedule 2 Dealings exempt from licensing

(regulation 6)
Note Subregulation 6 (1) sets out other requirements for exempt dealings

Part 1 Exempt dealings


Item Description of dealing
2 A dealing with a genetically modified Caenorhabditis elegans, unless:
  1. an advantage is conferred on the animal by the genetic modification; or
  2. 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:
  1. the somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and
  2. 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
  1. the in vivo modification occurred as part of a previous dealing; and
  2. the replication defective viral vector is no longer in the animal; and
  3. no germ line cells have been genetically modified; and
  4. the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and
  5. 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:
    1. must meet either of the following requirements:
      1. 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;
      2. 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

      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; and
    2. must not code for a toxin with an LD50of less than 100 microg/kg; and
    3. must not code for a toxin with an LD50 of 100 microg/kg or more, if the intention is to express the toxin at high levels; and
    4. must not be uncharacterised nucleic acid from a toxin-producing organism; and
    5. must not include a viral sequence, unless the donor nucleic acid:
      1. is missing at least 1 gene essential for viral multiplication that

      2. (A) is not available in the cell into which the nucleic acid is introduced; and
        (B) will not become available during the dealing; and
      3. 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 item 1 of Part 2 of this Schedule, if the donor nucleic acid is not derived from either:
  1. a pathogen; or
  2. a toxin-producing organism


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Part 2 Host/vector systems for exempt dealings


Item Class Host Vector
1 Bacteria Escherichia coli K12, E. coli B , E. coli C or E. coli Nissle 1917 — any derivative that does not contain:
  1. generalised transducing phages; or
  2. genes able to complement the conjugation defect in a non-conjugative plasmid
  1. Non-conjugative plasmids
  2. Bacteriophage
    (a) lambda
    (b) lambdoid
    (c) Fd or F1 (eg M13)
  3. None (non-vector systems)
Bacillus — specified species — asporogenic strains with a reversion frequency of less than 10-7:
  1. B. amyloliquefaciens
  2. B. licheniformis
  3. B. pumilus
  4. B. subtilis
  5. B. thuringiensis
  1. Non-conjugative plasmids
  2. Plasmids and phages whose host range does not include B. cereus, B. anthracis or any other pathogenic strain of Bacillus
  3. None (non-vector systems)
Pseudomonas putida — strain KT 2440
  1. Non-conjugative plasmids including certified plasmids: pKT 262, pKT 263, pKT 264
  2. None (non-vector systems
Streptomyces — specified species:
  1. S. aureofaciens
  2. S. coelicolor
  3. S. cyaneus
  4. S. griseus
  5. S. lividans
  6. S. parvulus
  7. S. rimosus
  8. S. venezuelae
  1. Non-conjugative plasmids
  2. Certified plasmids: SCP2, SLP1, SLP2, PIJ101 and derivatives
  3. Actinophage phi C31 and derivatives
  4. None (non-vector systems)
Agrobacterium radiobacter
Agrobacterium rhizogenes — disarmed strains
Agrobacterium tumefaciens — disarmed strains
  1. Non-tumorigenic disarmed Ti plasmid vectors, or Ri plasmid vectors
  2. None (non-vector systems)
Lactobacillus
Lactococcus lactis
Oenococcus oeni syn.
Leuconostoc oeni
Pediococcus
Photobacterium angustum
Pseudoalteromonas tunicata
Rhizobium (including the genus Allorhizobium)
Sphingopyxis alaskensis syn.
Sphingomonas alaskensis
Streptococcus thermophilus
Synechococcus — specified strains:
(a) PCC 7002
(b) PCC 7942
(c) WH 8102
Synechocystis species — strain PCC 6803
Vibrio cholerae CVD103-HgR
  1. Non-conjugative plasmids
  2. None (non-vector systems)
2 Fungi Kluyveromyces lactis
Neurospora crassa — laboratory strains
Pichia pastoris
Saccharomyces cerevisiae
Schizosaccharomyces pombe
Trichoderma reesei
Yarrowia lipolytica
  1. All vectors
  2. None (non-vector systems)
3 Slime moulds Dictyostelium species
  1. Dictyostelium shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2
  2. None (non-vector systems)
4 Tisse culture Any of the following if they cannot spontaneously generate a whole animal:
  1. animal or human cell cultures (including packaging cell lines);
  2. isolated cells, isolated tissues or isolated organs, whether animal or human;
  3. early non-human mammalian embryos cultured in vitro
  1. Non-conjugative plasmids
  2. Non-viral vectors, or replication defective viral vectors unable to transduce human cells
  3. Baculovirus (Autographa californica nuclear polyhedrosis virus), polyhedrin minus
  4. None (non-vector systems)
Either of the following if they are not intended, and are not likely without human intervention, to vegetatively propagate, flower or regenerate into a whole plant:
  1. plant cell cultures;
  2. isolated plant tissues or organs
  1. Non-tumorigenic disarmed Ti plasmid vectors, or Ri plasmid vectors, in Agrobacterium tumefaciens, Agrobacterium radiobacter or Agrobacterium rhizogenes
  2. Non-pathogenic viral vectors
  3. None (non-vector systems)


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