Australian Capital Territory Numbered Regulations

GENE TECHNOLOGY AMENDMENT REGULATION 2011 (NO 1) (NO 26 OF 2011) - REG 7

substitute

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 notifiable low risk dealing mentioned in schedule 3, part 3.1 or part 3.2; 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 before the day mentioned in section 13A for the dealing; and

    (e)     the person is mentioned in the institutional biosafety committee's record of assessment as having the appropriate training and experience to undertake the dealing; and

        (f)     the dealing is undertaken in facilities mentioned in the institutional biosafety committee's record of assessment as being appropriate for the dealing; 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; and

              (i)     the person undertakes the dealing in accordance with subsections (2) and (3).

Note     A person complies with par (e) if the person is in a class of people that an institutional biosafety committee has included in the record of assessment as having the appropriate training and experience to undertake the dealing. Similarly, a person complies with par (f) if the facility in which the person undertakes the dealing is in a class of facilities that an institutional biosafety committee has included in the record of assessment as being appropriate for the dealing.

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

        (a)     for a kind of dealing mentioned in schedule 3, part 3.1—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 schedule 3, part 3.2—

              (i)     that is not a dealing mentioned in subparagraph (ii)—in a facility certified by the regulator to at least physical containment level 2 and that is appropriate for the dealing; or

              (ii)     that involves a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 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)     However, if a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal—

        (a)     may only be undertaken before the day mentioned in section 13A as being the day on or before which the dealing must stop being undertaken; and

        (b)     may happen outside a facility mentioned in subsection (2), but in that case must be conducted in accordance with—

              (i)     the Guidelines for the Transport, Storage and Disposal of GMOs , as in force on 1 September 2011, that have been issued by the regulator for this purpose under the Act, section 27 (d); or

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

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