CTHIn ForceLegislation
Gene Technology Regulations 2001
Sch 1BOrganisms that are genetically modified organisms
Start here
Get a plain-English read of Sch 1B
Turn the raw legal text into a practical explanation grounded in Gene Technology Regulations 2001.
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"><p class="TableHeading"><span>Organisms that are genetically modified organisms</span></p></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"><p class="TableHeading"><span>Item</span></p></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"><p class="TableHeading"><span>Description of organism</span></p></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"><p class="Tabletext"><span>1</span></p></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"><p class="Tabletext"><span>An organism that has had its genome modified by oligonucleotide</span><span>‑</span><span>directed mutagenesis</span></p></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"><p class="Tabletext"><span>2</span></p></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"><p class="Tabletext"><span>An organism modified by repair of single</span><span>‑</span><span>strand or double</span><span>‑</span><span>strand breaks of genomic DNA induced by a site</span><span>‑</span><span>directed nuclease, if a nucleic acid template was added to guide homology</span><span>‑</span><span>directed repair</span></p></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. |
| 3 | Naked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell. |
| 4 | 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 not added to guide homology‑directed repair. |
| 6 | A micro‑organism that results from an exchange of DNA if:(a) the donor species is also the host species; and(b) the exchanged DNA does not contain any heterologous DNA. |
| 7 | An organism that results from an exchange of DNA between the donor species and the host species if:(a) such exchange can occur by naturally occurring processes; and(b) the donor species and the host species are micro‑organisms that:(i) satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 1; and(ii) are known to exchange nucleic acid by a natural physiological process; and(c) the vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange. |
| 8 | An organism that is descended from a genetically modified organism (the initial organism), if none of the traits it has inherited from the initial organism are traits that occurred in the initial organism because of gene technology. |
| 9 | An organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, if:(a) the initial organism was not a genetically modified organism (because of the application of regulation 5); or(b) all such inherited traits are traits that occurred in the initial organism as a result of a modification described in an item in this Schedule. |
| 10 | An organism that was modified by gene technology but in which the modification, and any traits that occurred because of gene technology, are either no longer present or are epigenetic. |
| 11 | Agrobacterium radiobacter strain K1026. |
| 12 | Pasteurella multocida strain PMP1. |
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:(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
#### 2.1 Hosts and vectors
(1) A reference to a host mentioned in this Part is a reference to a host mentioned in column 2 of an item of the table in this clause.
(2) A reference to a vector mentioned in this Part is a reference to a vector mentioned in column 3 of an item of the table in this clause.
(3) A reference to a host/vector system mentioned in this Part is a reference to any of the following:
(a) a system involving a host mentioned in column 2 of an item of the table in this clause and a vector mentioned in column 3 of the same item;
(b) a non‑vector system involving a host mentioned in column 2 of an item of the table;
(c) a system involving a GMO mentioned as a vector in column 3 of an item of the table (except item 7), without a host.
> Note: Column 1 of the table is included for information only.
<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"><p class="TableHeading"><span>Hosts and vectors</span></p></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"><p class="TableHeading"><span>Item</span></p></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"><p class="TableHeading"><span>Column 1</span><br><span>Host class</span></p></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"><p class="TableHeading"><span>Column 2</span><br><span>Hosts</span></p></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"><p class="TableHeading"><span>Column 3</span><br><span>Vectors</span></p></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"><p class="Tabletext"><span>1</span></p></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"><p class="Tabletext"><span>Bacteria</span></p></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"><p class="Tabletext"><span style="font-style:italic">Escherichia coli </span><span>K12, </span><span style="font-style:italic">E. coli </span><span>B, </span><span style="font-style:italic">E. coli </span><span>C or </span><span style="font-style:italic">E. coli </span><span>Nissle 1917—any derivative that does not contain:</span></p><p class="Tablea"><span>(a) generalised transducing phages; or</span></p><p class="Tablea"><span>(b) genes able to complement the conjugation defect in a non</span><span>‑</span><span>conjugative plasmid</span></p></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"><p class="Tabletext"><span>Any of the following:</span></p><p class="Tablea"><span>(a) non</span><span>‑</span><span>conjugative plasmids;</span></p><p class="Tablea"><span>(b) lambda bacteriophage;</span></p><p class="Tablea"><span>(c) lambdoid bacteriophage;</span></p><p class="Tablea"><span>(d) Fd, F1 or M13 bacteriophage</span></p></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"><p class="Tabletext"><span>2</span></p></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"><p class="Tabletext"><span>Bacteria</span></p></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"><p class="Tabletext"><span style="font-style:italic">Bacillus—</span><span>asporogenic strains of the following species with a reversion frequency of less than 10</span><span style="font-size:6.67pt; vertical-align:super">–7</span><span>:</span></p><p class="Tablea"><span>(a) </span><span style="font-style:italic">B. amyloliquefaciens</span><span>;</span></p><p class="Tablea"><span>(b) </span><span style="font-style:italic">B. licheniformis</span><span>;</span></p><p class="Tablea"><span>(c) </span><span style="font-style:italic">B. pumilus</span><span>;</span></p><p class="Tablea"><span>(d) </span><span style="font-style:italic">B. subtilis</span><span>;</span></p><p class="Tablea"><span>(e) </span><span style="font-style:italic">B. thuringiensis</span></p></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"><p class="Tabletext"><span>Any of the following:</span></p><p class="Tablea"><span>(a) non</span><span>‑</span><span>conjugative plasmids;</span></p><p class="Tablea"><span>(b) other plasmids and phages whose host range does not include </span><span style="font-style:italic">B. cereus</span><span>, </span><span style="font-style:italic">B. anthracis</span><span style="font-weight:bold"> </span><span>or any other pathogenic strain of </span><span style="font-style:italic">Bacillus</span></p></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"><p class="Tabletext"><span>3</span></p></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"><p class="Tabletext"><span>Bacteria</span></p></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"><p class="Tabletext"><span style="font-style:italic">Pseudomonas putida</span><span> strain KT2440</span></p></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"><p class="Tabletext"><span>Non</span><span>‑</span><span>conjugative plasmids</span></p></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"><p class="Tabletext"><span>4</span></p></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"><p class="Tabletext"><span>Bacteria</span></p></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"><p class="Tabletext"><span>The following </span><span style="font-style:italic">Streptomyces</span><span> species:</span></p><p class="Tablea"><span>(a) </span><span style="font-style:italic">S. aureofaciens</span><span>;</span></p><p class="Tablea"><span>(b) </span><span style="font-style:italic">S. coelicolor</span><span>;</span></p><p class="Tablea"><span>(c) </span><span style="font-style:italic">S. cyaneus</span><span>;</span></p><p class="Tablea"><span>(d) </span><span style="font-style:italic">S. griseus</span><span>;</span></p><p class="Tablea"><span>(e) </span><span style="font-style:italic">S. lividans</span><span>;</span></p><p class="Tablea"><span>(f) </span><span style="font-style:italic">S. parvulus</span><span>;</span></p><p class="Tablea"><span>(g) </span><span style="font-style:italic">S. rimosus</span><span>;</span></p><p class="Tablea"><span>(h) </span><span style="font-style:italic">S. venezuelae</span></p></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"><p class="Tabletext"><span>Any of the following:</span></p><p class="Tablea"><span>(a) non</span><span>‑</span><span>conjugative plasmids;</span></p><p class="Tablea"><span>(b) plasmids SCP2, SLP1, SLP2, pIJ101 and derivatives;</span></p><p class="Tablea"><span>(c) actinophage phi C31 and derivatives</span></p></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"><p class="Tabletext"><span>5</span></p></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"><p class="Tabletext"><span>Bacteria</span></p></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"><p class="Tabletext"><span>Any of the following:</span></p><p class="Tablea"><span>(a) </span><span style="font-style:italic">Agrobacterium radiobacter</span><span>;</span></p><p class="Tablea"><span>(b) </span><span style="font-style:italic">Agrobacterium rhizogenes</span><span> (disarmed strains only);</span></p><p class="Tablea"><span>(c) </span><span style="font-style:italic">Agrobacterium tumefaciens</span><span> (disarmed strains only)</span></p></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"><p class="Tabletext"><span>Disarmed Ri or Ti plasmids</span></p></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"><p class="Tabletext"><span>6</span></p></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"><p class="Tabletext"><span>Bacteria</span></p></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"><p class="Tabletext"><span>Any of the following:</span></p><p class="Tablea"><span>(a) </span><span style="font-style:italic">Allorhizobium</span><span style="font-weight:bold"> </span><span>species;</span></p><p class="Tablea"><span>(b) </span><span style="font-style:italic">Corynebacterium glutamicum</span><span>;</span></p><p class="Tablea"><span>(c) </span><span style="font-style:italic">Lactobacillus</span><span style="font-weight:bold"> </span><span>species;</span></p><p class="Tablea"><span>(d) </span><span style="font-style:italic">Lactococcus lactis</span><span>;</span></p><p class="Tablea"><span>(e) </span><span style="font-style:italic">Oenococcus oeni </span><span>syn. </span><span style="font-style:italic">Leuconostoc oeni</span><span>;</span></p><p class="Tablea"><span>(f) </span><span style="font-style:italic">Pediococcus</span><span> species;</span></p><p class="Tablea"><span>(g) </span><span style="font-style:italic">Photobacterium angustum</span><span>;</span></p><p class="Tablea"><span>(h) </span><span style="font-style:italic">Pseudoalteromonas tunicata</span><span>;</span></p><p class="Tablea"><span>(i) </span><span style="font-style:italic">Rhizobium </span><span>species;</span></p><p class="Tablea"><span>(j) </span><span style="font-style:italic">Sphingopyxis alaskensis </span><span>syn. </span><span style="font-style:italic">Sphingomonas alaskensis</span><span>;</span></p><p class="Tablea"><span>(k) </span><span style="font-style:italic">Streptococcus thermophilus</span><span>;</span></p><p class="Tablea"><span>(l) </span><span style="font-style:italic">Synechococcus</span><span> species strains PCC 7002, PCC 7942 and WH 8102;</span></p><p class="Tablea"><span>(m) </span><span style="font-style:italic">Synechocystis </span><span>species strain PCC 6803;</span></p><p class="Tablea"><span>(n) </span><span style="font-style:italic">Vibrio cholerae </span><span>CVD103</span><span>‑</span><span>HgR;</span></p><p class="Tablea"><span>(o) </span><span style="font-style:italic">Zymomonas mobilis</span></p></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"><p class="Tabletext"><span>Non</span><span>‑</span><span>conjugative plasmids</span></p></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"><p class="Tabletext"><span>7</span></p></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"><p class="Tabletext"><span>Fungi</span></p></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"><p class="Tabletext"><span>Any of the following:</span></p><p class="Tablea"><span>(a) </span><span style="font-style:italic">Kluyveromyces lactis</span><span>;</span></p><p class="Tablea"><span>(b) </span><span style="font-style:italic">Neurospora crassa </span><span>(laboratory strains);</span></p><p class="Tablea"><span>(c) </span><span style="font-style:italic">Pichia pastoris</span><span>;</span></p><p class="Tablea"><span>(d) </span><span style="font-style:italic">Saccharomyces cerevisiae</span><span>;</span></p><p class="Tablea"><span>(e) </span><span style="font-style:italic">Schizosaccharomyces pombe</span><span>;</span></p><p class="Tablea"><span>(f) </span><span style="font-style:italic">Trichoderma reesei</span><span>;</span></p><p class="Tablea"><span>(g) </span><span style="font-style:italic">Yarrowia lipolytica</span></p></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"><p class="Tabletext"><span>All vectors</span></p></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"><p class="Tabletext"><span>8</span></p></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"><p class="Tabletext"><span>Slime moulds</span></p></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"><p class="Tabletext"><span style="font-style:italic">Dictyostelium </span><span>species</span></p></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"><p class="Tabletext"><span style="font-style:italic">Dictyostelium </span><span>shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2</span></p></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"><p class="Tabletext" style="page-break-after:avoid"><span>9</span></p></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"><p class="Tabletext"><span>Tissue culture</span></p></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"><p class="Tabletext"><span>Any of the following if they cannot spontaneously generate a whole animal:</span></p><p class="Tablea"><span>(a) animal or human cell cultures (including packaging cell lines);</span></p><p class="Tablea"><span>(b) isolated cells, isolated tissues or isolated organs, whether animal or human;</span></p><p class="Tablea"><span>(c) early non</span><span>‑</span><span>human mammalian embryos cultured </span><span style="font-style:italic">in vitro</span></p></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"><p class="Tabletext"><span>Any of the following:</span></p><p class="Tablea"><span>(a) plasmids;</span></p><p class="Tablea"><span>(b) replication defective viral vectors unable to transduce human cells;</span></p><p class="Tablea"><span>(c) polyhedrin minus forms of the baculovirus </span><span style="font-style:italic">Autographa californica</span><span> nuclear polyhedrosis virus (ACNPV)</span></p></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"><p class="Tabletext"><span>10</span></p></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"><p class="Tabletext"><span>Tissue culture</span></p></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"><p class="Tabletext"><span>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:</span></p><p class="Tablea"><span>(a) plant cell cultures;</span></p><p class="Tablea"><span>(b) isolated plant tissues or organs</span></p></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"><p class="Tabletext"><span>Any of the following:</span></p><p class="Tablea"><span>(a) Disarmed Ri or Ti plasmids in </span><span style="font-style:italic">Agrobacterium radiobacter</span><span>, </span><span style="font-style:italic">Agrobacterium rhizogenes</span><span> (disarmed strains only) or </span><span style="font-style:italic">Agrobacterium tumefaciens </span><span>(disarmed strains only);</span></p><p class="Tablea"><span>(b) non</span><span>‑</span><span>pathogenic viral vectors</span></p></td></tr></tbody></table>
```
## Part 3—Definitions
In this Schedule:
> code for, in relation to a toxin, means to specify the amino acid sequence of the toxin.
> non‑conjugative plasmid means a plasmid that is not self‑transmissible, and includes, but is not limited to, non‑conjugative forms of the following plasmids:
(a) bacterial artificial chromosomes (BACs);
(b) cosmids;
(c) P1 artificial chromosomes (PACs);
(d) yeast artificial chromosomes (YACs).
> non‑vector system means a system in which donor nucleic acid is or was introduced into a host cell:
(a) in the absence of a nucleic acid‑based vector; or
(b) using a nucleic acid‑based vector in the course of a previous dealing and the vector is:
(i) no longer present; or
(ii) present but cannot be remobilised from a host cell.
> Note: Example 1: A system mentioned in paragraph (a) might involve the use of electroporation or particle bombardment.
> Note: Example 2: A system mentioned in paragraph (b) might involve cells that were transduced with a replication defective retroviral vector in which no vector particles remain.