Commonwealth Consolidated Regulations

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GENE TECHNOLOGY REGULATIONS 2001 - REG 10

Risk assessment--matters to be taken into account

  (1)   For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:

  (a)   subject to section   45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and

  (b)   the potential of the GMO concerned to:

  (i)   be harmful to other organisms; and

  (ii)   adversely affect any ecosystems; and

  (iii)   transfer genetic material to another organism; and

  (iv)   spread, or persist, in the environment; and

  (v)   have, in comparison to related organisms, an advantage in the environment; and

  (vi)   be toxic, allergenic or pathogenic to other organisms.

  (2)   In taking into account a risk mentioned in subsection   51(1) of the Act, or a potential capacity mentioned in subregulation   (1), the Regulator must consider both the short term and the long term.



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