Australian Capital Territory Numbered Regulations

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GENE TECHNOLOGY AMENDMENT REGULATION 2011 (NO 1) (NO 26 OF 2011) - REG 14

Schedule 2, part 2.1, item 4

substitute

4

(1)     Subject to subsection (1), a dealing involving a host/vector system mentioned in part 2.2 and producing not more than 25L of GMO culture in each vessel containing the resultant culture.

(2)     The donor nucleic acid—

(a)     must meet either of the following requirements:

(i)     the acid 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)     the acid 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 par (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.

Note     An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

(b)     must not code for a toxin with an LD50 of less than 100μg/kg; and

(c)     must not code for a toxin with an LD50 of 100μg/kg 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)     must not include a viral sequence, unless the donor nucleic acid—

(i)     is missing at least 1 gene essential for viral multiplication that—

(A)     is not available in the cell into which the nucleic acid is introduced; and

(B)     will not become available during the dealing; and

(ii)     cannot restore replication competence to the vector.



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