Schedule Sch 1B - Gene Technology Regulations 2001 - Organisms that are genetically modified organisms

Schedule 1B—Organisms that are genetically modified organisms

Note: See regulation 4A.

1.1 Genetically modified organisms

For the purposes of regulation 4A, an organism is a genetically modified organism if an item in the following table applies to the organism.

<table cellspacing="0" cellpadding="0" style="border-collapse:collapse"><thead><tr><td colspan="2" style="width:416.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Organisms that are genetically modified organisms</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Item</td><td style="width:379.05pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Description of organism</td></tr></thead><tbody><tr><td style="width:26.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1</td><td style="width:379.05pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">An organism that has had its genome modified by oligonucleotide‑directed mutagenesis</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">2</td><td style="width:379.05pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">An organism modified by repair of single‑strand or double‑strand breaks of genomic DNA induced by a site‑directed nuclease, if a nucleic acid template was added to guide homology‑directed repair</td></tr></tbody></table> ```

Schedule 1—Organisms that are not genetically modified organisms

(regulation 5)

Item	Description of organism
2	A whole animal, or a human being, modified by the introduction of naked recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is incapable of giving rise to infectious agents.

<table cellspacing="0" cellpadding="0" style="width:428.35pt; border-collapse:collapse"><thead><tr><td colspan="4" style="width:417.55pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Hosts and vectors</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Item</td><td style="width:43.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 1 Host class</td><td style="width:180.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 2 Hosts</td><td style="width:134.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 3 Vectors</td></tr></thead><tbody><tr><td style="width:26.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1</td><td style="width:43.8pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Bacteria</td><td style="width:180.25pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td><td style="width:134.8pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Any of the following:(a) non‑conjugative plasmids;(b) lambda bacteriophage;(c) lambdoid bacteriophage;(d) Fd, F1 or M13 bacteriophage</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">2</td><td style="width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Bacteria</td><td style="width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td><td style="width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">3</td><td style="width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Bacteria</td><td style="width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Pseudomonas putida strain KT2440</td><td style="width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Non‑conjugative plasmids</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">4</td><td style="width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Bacteria</td><td style="width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td><td style="width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Any of the following:(a) non‑conjugative plasmids;(b) plasmids SCP2, SLP1, SLP2, pIJ101 and derivatives;(c) actinophage phi C31 and derivatives</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">5</td><td style="width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Bacteria</td><td style="width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Any of the following:(a) Agrobacterium radiobacter;(b) Agrobacterium rhizogenes (disarmed strains only);(c) Agrobacterium tumefaciens (disarmed strains only)</td><td style="width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Disarmed Ri or Ti plasmids</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">6</td><td style="width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Bacteria</td><td style="width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td><td style="width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Non‑conjugative plasmids</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">7</td><td style="width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Fungi</td><td style="width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td><td style="width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">All vectors</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">8</td><td style="width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Slime moulds</td><td style="width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Dictyostelium species</td><td style="width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Dictyostelium shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">9</td><td style="width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Tissue culture</td><td style="width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td><td style="width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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)</td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">10</td><td style="width:43.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Tissue culture</td><td style="width:180.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td><td style="width:134.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">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</td></tr></tbody></table> ```

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.

Sch 1BOrganisms that are genetically modified organisms

Get a plain-English read of Sch 1B

1.1 Genetically modified organisms

Part 1—Exempt dealings

Part 2—Host/vector systems for exempt dealings

2.1 Hosts and vectors

Part 3—Definitions