Australian Capital Territory Numbered Regulations

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GENE TECHNOLOGY REGULATIONS 2004 (NO 17 OF 2004) - REG 7

Application for licence—prescribed information—Act, s 40 (2) (a)

    (1)     The following information must be contained in an application for a licence:

        (a)     for an application to which the Act, division 5.3 applies—the information stated in schedule 4, part 4.1;

        (b)     for an application to which the Act, division 5.4 applies—the information stated in schedule 4, part 4.2.

    (2)     In preparing the information, an applicant must take account of risks that the proposed dealing, or dealings, with a GMO may incur in relation to the health and safety of people and the environment.

    (3)     The information to be given in the application must be—

        (a)     as comprehensive as existing scientific knowledge, when the application is made, permits; and

        (b)     supported by whatever relevant data and references are available to the applicant.

    (4)     To the extent that compliance with subregulation (3) (b) does not provide relevant data and references, the applicant must include in the application—

        (a)     a statement that specified information is incomplete or unavailable; and

        (b)     an indication of the significance of the incomplete or unavailable information to the evaluation of the possible risks of the proposal in relation to the health and safety of people and the environment; and

        (c)     a summary of known existing scientific evidence relevant to the evaluation; and

        (d)     applying that summary, an evaluation of the possible risks based on theoretical approaches, and research methods, generally accepted in the scientific community.

Note     Additional information, specified in writing by the regulator, may also be required.



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