Commonwealth Consolidated Regulations

GENE TECHNOLOGY REGULATIONS 2001

- made under the Gene Technology Act 2000

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

   1.      Name of Regulations  
   3.      Definitions  

   PART 2--INTERPRETATION--AND GENERAL OPERATION

   4.      Techniques not constituting gene technology  
   4A.     Organisms that are genetically modified organisms  
   5.      Organisms that are not genetically modified organisms  

   PART 2A--GENE--TECHNOLOGY REGULATOR

   5A.     Functions of the Regulator  

   PART 3--DEALINGS--WITH GMOS

           Division 1--Licensing system

   6.      Dealings exempt from licensing  
   7.      Application for licence -- prescribed fee  
   8.      Time limit for deciding an application  
   9.      Prescribed authorities  
   9A.     Risks posed by dealings proposed to be authorised by licence  
   10.     Risk assessment -- matters to be taken into account  
   11.     Prescribed conditions of licence  
   11A.    Time limit for deciding variation application  

           Division 2--Notifiable low risk dealings

   12.     Notifiable low risk dealings  
   13.     Requirements for undertaking notifiable low risk dealings  
   13B.    Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals  
   13C.    Information to be kept or given to the Regulator by persons or accredited organisations  

           Division 3--Certification and accreditation

   14.     Regulator to decide certification application within 90 days  
   15.     Application for certification -- failure to provide section 85 information  
   16.     Regulator to decide accreditation application within 90 days  
   17.     Application for accreditation -- failure to provide section 93 information  

   PART 4--GENE--TECHNOLOGY TECHNICAL ADVISORY COMMITTEE

           Division 1--Conditions of appointment

   18.     GTTAC members and advisers -- term of appointment  
   19.     GTTAC members and advisers -- resignation  
   20.     GTTAC members -- disclosure of interests  
   21.     GTTAC members and advisers -- termination of appointment  
   22.     GTTAC members -- leave of absence  
   23.     Expert advisers -- disclosure of interests  

           Division 2--Committee procedures

   24.     Committee procedures generally  
   25.     Committee meetings  
   26.     Presiding member  
   27.     Quorum  
   28.     Voting  
   29.     Records and Reports  

           Division 3--Subcommittees

   30.     Operation of subcommittees  

   PART 5--ETHICS--AND COMMUNITY COMMITTEE

   31.     Ethics and Community Committee -- conditions of appointment  
   32.     Ethics and Community Committee -- Committee procedures  
   33.     Ethics and Community Committee -- operation of subcommittees  

   PART 7--MISCELLANEOUS

   37.     Reviewable State decisions  
   38.     Review of decisions  
   39.     Record of GMO Dealings  
   40.     Inspector identity card  

   PART 8--APPLICATION--AND TRANSITIONAL PROVISIONS

           Division 1--Amendments made by the Gene Technology Amendment (2019 Measures No. 1)Regulations 2019

   41.     Changed requirements for dealings  
   42.     Previous assessment by an Institutional Biosafety Committee  
   43.     New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year  
           SCHEDULE 1A Techniques that are not gene technology
           SCHEDULE 1B Organisms that are genetically modified organisms
           SCHEDULE 1 Organisms that are not genetically modified organisms
           SCHEDULE 2 Dealings exempt from licensing
           SCHEDULE 3 Notifiable low risk dealings in relation to a GMO