Australian Capital Territory Numbered Regulations

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GENE TECHNOLOGY AMENDMENT REGULATION 2008 (NO 1) (NO 17 OF 2008) - REG 19

Section 13

substitute

13     Requirements in relation to undertaking notifiable low risk dealings

    (1)     A person may undertake a notifiable low risk dealing only if—

        (a)     a person or an accredited organisation has requested an institutional biosafety committee to assess whether the proposed dealing is a notifiable low risk dealing; and

        (b)     the committee has assessed the proposed dealing to be a notifiable low risk dealing; and

        (c)     the person who proposes to undertake the proposed dealing and the project supervisor for the proposed dealing have been notified that the committee—

              (i)     has assessed the proposed dealing to be a notifiable low risk dealing; and

              (ii)     considers that the personnel to be involved in the proposed dealing have appropriate training and experience.

    (2)     A notifiable low risk dealing must comply with the following requirements:

(a)     the dealing must be conducted—

              (i)     for a kind of dealing mentioned in schedule 3, part 3.1— in a facility that is certified by the regulator to at least physical containment level 1 and is of appropriate design for the kind of dealing being undertaken; or

              (ii)         for a kind of dealing mentioned in schedule 3, part 3.2— in a facility that is certified by the regulator to at least physical containment level 2 and is of appropriate design for the kind of dealing being undertaken; or

              (iii)         in another facility in accordance with any technical and procedural guidelines relating to containment of GMOs, as in force from time to time under the Act, section 27 (d) that the regulator has determined in writing are appropriate for conducting the dealing;

        (b)     to the extent that the dealing involves transporting a GMO, the transporting must be conducted in accordance with applicable technical and procedural guidelines, as in force from time to time under the Act, section 27 (d).

13A     Requirements in relation to notifying regulator of notifiable low risk dealings

    (1)     An institutional biosafety committee that has assessed a proposed dealing to be a notifiable low risk dealing must—

        (a)     make a record of the proposed dealing in a form approved by the regulator; and

        (b)     if the regulator, by written notice given to the committee, requests a copy of the record—give a copy of the record to the regulator by the end of the period mentioned in the notice; and

        (c)     give a copy of the record to—

              (i)         the person or accredited organisation that requested the committee to assess the proposed dealing; and

              (ii)     the project supervisor for the proposed dealing.

    (2)     The person or accredited organisation must—

        (a)     for the financial year in which the committee assessed the proposed dealing, include a copy of the committee's record—

              (i)         for an accredited organisation—in the annual report given to the regulator by the organisation for the financial year; or

              (ii)         in any other case—in a report given to the regulator, in the form approved by the regulator, by the person for the financial year; and

        (b)     retain a copy of the committee's record for 3 years after the date that the person or accredited organisation ceased to be involved with the conduct of the dealing.

    (3)     The regulator may, by written notice, require—

        (a)     the committee; or

        (b)     the person or accredited organisation; or

        (c)     any other person involved with the conduct of the proposed dealing;

to give the regulator any further information about the dealing that the regulator requires in order to be satisfied that the dealing is a notifiable low risk dealing.

    (4)     A committee, person or accredited organisation receiving a notice under subsection (3) must, by the end of the period mentioned in the notice, give the regulator the information required by the notice.



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