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:
        1. human beings; or
        2. animals; or
        3. plants; or
        4. 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:

        1. provides an advantage; or
        2. adds a potential host species or mode of transmission; or
        3. increases its virulence, pathogenicity or transmissibility; and
    2. must not code for a toxin with an LD50 of less than 100 g/kg; and
    3. must not code for a toxin with an LD50 of 100 g/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:
        1. is not available in the cell into which the nucleic acid is introduced; and
        2. will not become available during the dealing; and
      2. 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.

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
    1. lambda
    2. lambdoid
    3. 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)
Streptomycesspecified 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
  1. Non-conjugative plasmids
  2. None (non-vector systems)
Synechococcus specified strains:
  1. PCC 7002
  2. PCC 7942
  3. WH 8102
Synechocystis species strain PCC 6803
Vibrio cholerae CVD103-HgR
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 Tissue 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)