Commonwealth Consolidated Regulations

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GENE TECHNOLOGY REGULATIONS 2001 - REG 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 that submitted the proposal;

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

  (iii)   its assessment whether the dealing is a kind of dealing mentioned in Part   1 or 2 of Schedule   3, and not mentioned in Part   3 of Schedule   3;

  (iv)   if the Committee has assessed the dealing as being a kind of dealing mentioned in Part   1 or 2 of Schedule   3 (and not mentioned in Part   3 of Schedule   3)--which kind of dealing in those Parts that the dealing is;

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

  (vi)   the persons or classes of persons 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, having regard to the requirements of subregulation   13(2);

  (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 person or persons 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.



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