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 LD 50 of less than 100 micrograms per kilogram; and

(c) must not code for a toxin with an LD 50 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.

1

Bacteria

Escherichia coli K12, E. coli B, E. coli C or E. coli Nissle 1917--any derivative that does not contain:

(a) generalised transducing phages; or

(b) genes able to complement the conjugation defect in a non - conjugative plasmid

Any of the following:

(a) non - conjugative plasmids;

(b) lambda bacteriophage;

(c) lambdoid bacteriophage;

(d) Fd, F1 or M13 bacteriophage

2

Bacteria

Bacillus-- asporogenic strains of the following species with a reversion frequency of less than 10 -7 :

(a) B. amyloliquefaciens ;

(b) B. licheniformis ;

(c) B. pumilus ;

(d) B. subtilis ;

(e) B. thuringiensis

Any of the following:

(a) non - conjugative plasmids;

(b) other plasmids and phages whose host range does not include B. cereus , B. anthracis or any other pathogenic strain of Bacillus

3

Bacteria

Pseudomonas putida strain KT2440

Non - conjugative plasmids

4

Bacteria

The following Streptomyces species:

(a) S. aureofaciens ;

(b) S. coelicolor ;

(c) S. cyaneus ;

(d) S. griseus ;

(e) S. lividans ;

(f) S. parvulus ;

(g) S. rimosus ;

(h) S. venezuelae

Any of the following:

(a) non - conjugative plasmids;

(b) plasmids SCP2, SLP1, SLP2, pIJ101 and derivatives;

(c) actinophage phi C31 and derivatives

5

Bacteria

Any of the following:

(a) Agrobacterium radiobacter ;

(b) Agrobacterium rhizogenes (disarmed strains only);

(c) Agrobacterium tumefaciens (disarmed strains only)

Disarmed Ri or Ti plasmids

6

Bacteria

Any of the following:

(a) Allorhizobium species;

(b) Corynebacterium glutamicum ;

(c) Lactobacillus species;

(d) Lactococcus lactis ;

(e) Oenococcus oeni syn. Leuconostoc oeni ;

(f) Pediococcus species;

(g) Photobacterium angustum ;

(h) Pseudoalteromonas tunicata ;

(i) Rhizobium species;

(j) Sphingopyxis alaskensis syn. Sphingomonas alaskensis ;

(k) Streptococcus thermophilus ;

(l) Synechococcus species strains PCC 7002, PCC 7942 and WH 8102;

(m) Synechocystis species strain PCC 6803;

(n) Vibrio cholerae CVD103 - HgR;

(o) Zymomonas mobilis

Non - conjugative plasmids

7

Fungi

Any of the following:

(a) Kluyveromyces lactis ;

(b) Neurospora crassa (laboratory strains);

(c) Pichia pastoris ;

(d) Saccharomyces cerevisiae ;

(e) Schizosaccharomyces pombe ;

(f) Trichoderma reesei ;

(g) Yarrowia lipolytica

All vectors

8

Slime moulds

Dictyostelium species

Dictyostelium shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2

9

Tissue culture

Any of the following if they cannot spontaneously generate a whole animal:

(a) animal or human cell cultures (including packaging cell lines);

(b) isolated cells, isolated tissues or isolated organs, whether animal or human;

(c) early non - human mammalian embryos cultured in vitro

Any of the following:

(a) plasmids;

(b) replication defective viral vectors unable to transduce human cells;

(c) polyhedrin minus forms of the baculovirus Autographa californica nuclear polyhedrosis virus (ACNPV)

10

Tissue culture

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:

(a) plant cell cultures;

(b) isolated plant tissues or organs

Any of the following:

(a) Disarmed Ri or Ti plasmids in Agrobacterium radiobacter , Agrobacterium rhizogenes (disarmed strains only) or Agrobacterium tumefaciens (disarmed strains only);

(b) non - pathogenic viral vectors