Commonwealth Consolidated Regulations

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GENE TECHNOLOGY REGULATIONS 2001 - REG 13C

Information to be kept or given to the Regulator by persons or accredited organisations

  (1)   A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph   13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.

  (2)   A record of a dealing for the purposes of subregulation   (1) must include:

  (a)   the particulars, prescribed under regulation   39 in relation to the dealing, to be included in the Record of GMO Dealings; and

  (b)   the name of the Committee that assessed the proposal relating to the dealing; and

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

  (2A)   The record must be given to the Regulator:

  (a)   in a form approved by the Regulator; and

  (b)   no later than 30   September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.

  (2B)   An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:

  (a)   include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or

  (b)   certify in the annual report that the record has previously been given to the Regulator.

  (3)   A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph   13B(b) 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 persons or organisations further 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 subregulation   (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.



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