Document ID: chunk:federal_register_of_legislation:F2025C00199:reg:13:p1
Version: federal_register_of_legislation:F2025C00199
Segment Type: reg
Provision Reference: reg 13 (pt 1/2)
Character Range: 20727–23409

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 paragraph (1)(f) and subregulation (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