Australian Capital Territory Numbered Regulations

GENE TECHNOLOGY AMENDMENT REGULATION 2011 (NO 1) (NO 26 OF 2011) - REG 8

substitute

13A     Time limits for stopping notifiable low risk dealings

For section 13 (1) (d), the day on or before which the dealing described in the record of assessment of the dealing must stop being undertaken is—

        (a)     the day 5 years after the date of assessment, if the dealing is assessed by an institutional biosafety committee on or after 1 September 2011; and

        (b)     31 August 2016, if the dealing is assessed by an institutional biosafety committee in the period 31 March 2008 to 31 August 2011 (inclusive); and

        (c)     31 March 2015, if the dealing is assessed by an institutional biosafety committee before 31 March 2008.

Note     A person will have to apply for, and obtain, a new assessment of the dealing as a notifiable low risk dealing from an institutional biosafety committee to continue to undertake the dealing after the applicable day mentioned in this regulation.

13B     Requirements for institutional biosafety committees about records of assessments of notifiable low risk dealing proposals

An institutional biosafety committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must—

        (a)     make a record of its assessment, in a form approved by the regulator, that includes the following:

              (i)     the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation proposing to undertake the dealing;

              (ii)     a description of the dealing to be undertaken;

              (iii)     its assessment whether the dealing is a notifiable low risk dealing mentioned in schedule 3, part 3.1 or part 3.2;

              (iv)     if the committee has assessed the dealing as being a notifiable low risk dealing mentioned in schedule 3, part 3.1 or part 3.2—the kind of notifiable low risk dealing that the dealing is, in terms of those parts;

              (v)     the date of the committee's assessment of the dealing;

              (vi)     the people or classes of people considered by the committee to have the appropriate training and experience to undertake the dealing;

              (vii)     the facilities or classes of facilities the committee considers to be of the appropriate physical containment level and type for the dealing;

              (viii)     the name of the committee that assessed the proposal;

              (ix)     the name of the person or accredited organisation that submitted the proposal;

              (x)     the name of the person or accredited organisation proposing to undertake the dealing; and

        (b)     give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the committee.

13C     Information to be kept or given to the regulator by people or accredited organisations

    (1)     A person or an accredited organisation that has been given a copy of a record of assessment by an institutional biosafety committee must, if the dealing has been assessed by the committee as a notifiable low risk dealing, give the regulator a record of the proposed dealing, in the form approved by the regulator, that includes—

        (a)     the particulars, prescribed under section 39 (1) in relation to the dealing, to be included in the record of GMO and GM product dealings; and

        (b)     the name of the committee that assessed the dealing; and

        (c)     the name of the person or accredited organisation that submitted the proposal for assessment of the dealing to the committee.

    (2)     The record of the proposed dealing mentioned in subsection (1) must be given to the regulator in the financial year in which the institutional biosafety committee made the assessment—

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

        (b)     by any other person—in a report for the financial year to be given by the person to the regulator, in the form approved by the regulator.

    (3)     A person or accredited organisation given a copy of a record of assessment by an institutional biosafety committee must keep a copy of the committee's record of assessment for 8 years after the date of the assessment.

    (4)     The regulator may at any time, by written notice, require from the following people or organisations more information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:

        (a)     the person or accredited organisation that submitted the proposal for assessment of the dealing;

        (b)     any other person involved with undertaking the dealing.

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