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GENE TECHNOLOGY REGULATIONS 2021 - REG 13

Requirements for 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 prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and

        (b)     the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and

        (c)     the dealing undertaken is the dealing described in the Institutional Biosafety Committee's record of assessment of the proposal; and

        (d)     the dealing is only undertaken no later than the day 5 years after the date of the assessment; and

        (e)     the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee's record of assessment as having the appropriate training and experience to undertake the dealing; and

        (f)     subject to subregulation (3), the dealing is undertaken in facilities that—

              (i)     are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee's record of assessment as being appropriate for the dealing; and

              (ii)     are facilities in which subregulation (2) permits the dealing to be undertaken; and

        (g)     the person keeps or can give, on request, a copy of the Institutional Biosafety Committee's record of assessment to an inspector; and

        (h)     the person does not compromise the containment of a GMO involved in the dealing.

    (2)     A notifiable low risk dealing must be undertaken—

        (a)     for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or

        (b)     for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or

        (ba)     for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or

        (c)     in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken.

    (3)     If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with subregulations (1)(f) and (2), if it is conducted in accordance with—

        (a)     the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under section 27(d) of the Act; or

        (b)     transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.

    (4)     For subregulation (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.

Note

This regulation differs from regulation 13 of the Commonwealth Regulations.



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