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GENE TECHNOLOGY ACT 2001


TABLE OF PROVISIONS

   PART 1--PRELIMINARY

   1.      Purpose and citation  
   2.      Commencement  
   3.      Object of Act  
   4.      Regulatory framework to achieve object  
   5.      Nationally consistent scheme  
   6.      Act to bind the Crown  
   7.      External Territories  
   8.      Offences[1]  
   8A.     Numbering[2]  
   8C.     Outlines[3]  

   PART 2--INTERPRETATION AND OPERATION OF ACT

           Division 1--Simplified outline

   9.      Simplified outline  

           Division 2--Definitions

   10.     Definitions  
   11.     Meaning of intentional release of a GMO into the environment  
   12.     Meaning of corresponding State law  

           Division 3--Operation of Act

   13.     Operation of Act  
   14.     Wind-back of reach of Act  
   15.     Relationship to other State laws  

           Division 4--Provisions to facilitate a nationally consistent scheme

              Subdivision A--General
              provisions

   16.     State laws may operate concurrently  
   17.     Conferral of functions on Commonwealth officers and bodies  
   18.     No doubling-up of liabilities  
   19.     Review of certain decisions  
   20.     Things done for multiple purposes  
   21.     Ministerial Council may issue policy principles  
   22.     Consultation on policy principles  
   23.     Ministerial Council may issue policy guidelines  
   24.     Ministerial Council may issue codes of practice  

   PART 3--THE GENE TECHNOLOGY REGULATOR

   25.     Simplified outline  
   26.     The Gene Technology Regulator  
   27.     Functions of the Regulator  
   28.     Powers of the Regulator  
   29.     Delegation  
   30.     Independence of the Regulator  

   PART 4--REGULATION OF DEALINGS WITH GMOS

           Division 1--Simplified outline

   31.     Simplified outline  

           Division 2--Dealings with GMOs must be licensed

   32.     Person not to deal with a GMO without a licence  
   33.     Person not to deal with a GMO without a licence—strict liability offence  
   34.     Person must not breach conditions of a GMO licence  
   35.     Person must not breach conditions of a GMO licence—strict liability offence  
   35A.    Person must not breach conditions of emergency dealing determination  
   35B.    Person must not breach conditions of emergency dealing determination—strict liability offence  
   36.     Person must not breach conditions on GMO Register  
   37.     Offence relating to notifiable low risk dealings  
   38.     Aggravated offences—significant damage to health or safety of people or to the environment  

   PART 5--LICENSING SYSTEM

           Division 1--Simplified outline

   39.     Simplified outline  

           Division 2--Licence applications

   40.     Person may apply for a licence  
   40A.    Licences relating to inadvertent dealings  
   41.     Application may be withdrawn  
   42.     Regulator may require applicant to give further information  
   43.     Regulator must consider applications except in certain circumstances  
   44.     Regulator may consult with applicant  
   45.     Regulator must not use certain information in considering licence application  

           Division 3--Initial consideration of licences for dealings not involving intentional release of a GMO into the environment

   46.     Applications to which this Division applies  
   46A.    Division does not apply to an application relating to inadvertent dealings  
   47.     What the Regulator must do in relation to application  

           Division 4--Initial consideration of licences for dealings involving intentional release of a GMO into the environment

   48.     Applications to which this Division applies  
   49.     Division does not apply to an application relating to inadvertent dealings  
   50.     Regulator must prepare risk assessment and risk management plan  
   50A.    Limited and controlled release applications  
   51.     Matters Regulator must take into account in preparing risk assessment and risk management plan  
   52.     Public notification of risk assessment and risk management plan  
   53.     Regulator may take other actions  
   54.     Person may request copies of certain documents  

           Division 5--Decision on licence etc.

   55.     Regulator must make a decision on licence and licence conditions  
   56.     Regulator must not issue the licence unless satisfied as to risk management  
   57.     Other circumstances in which Regulator must not issue the licence  
   58.     Matters to be taken into account in deciding whether a person is suitable to hold a licence  
   59.     Notification of licence decision  
   60.     Period of licence  

           Division 6--Conditions of licences

   61.     Licence is subject to conditions  
   62.     Conditions that may be prescribed or imposed  
   63.     Condition about informing people of obligations  
   64.     Condition about monitoring and audits  
   65.     Condition about additional information to be given to the Regulator  
   66.     Person may give information to Regulator  
   67.     Protection of persons who give information  

           Division 7--Suspension, cancellation and variation of licences

   68.     Suspension and cancellation of licence  
   69.     Surrender of licence  
   70.     Transfer of licences  
   71.     Variation of licence  
   72.     Regulator to notify of proposed suspension, cancellation or variation[4]  

           Division 8--Annual charge

   72AA.   GMO licence—annual charge[5]  

   PART 5A--EMERGENCY DEALING DETERMINATIONS

           Division 1--Simplified outline

   72A.    Simplified outline  

           Division 2--Making of emergency dealing determination

   72B.    Minister may make emergency dealing determination  
   72C.    Period of effect of emergency dealing determination  

           Division 3--Effect and conditions of emergency dealing determination

   72D.    Emergency dealing determination authorises dealings, subject to conditions  

           Division 4--Variation, suspension and revocation of emergency dealing determination

   72E.    Variation, suspension and revocation of emergency dealing determination  

   PART 6--REGULATION OF NOTIFIABLE LOW RISK DEALINGS AND DEALINGS ON THE GMO REGISTER

           Division 1--Simplified outline

   73.     Simplified outline  

           Division 2--Notifiable low risk dealings

   74.     Notifiable low risk dealings  
   75.     Regulation of notifiable low risk dealings  

           Division 3--The GMO Register

   76.     GMO Register  
   77.     Contents of Register  
   78.     Regulator may include dealings with GMOs on GMO Register  
   79.     Regulator not to make determination unless risks can be managed  
   80.     Variation of GMO Register  
   81.     Inspection of Register  

   PART 7--CERTIFICATION AND ACCREDITATION

           Division 1--Simplified outline

   82.     Simplified outline  

           Division 2--Certification

   83.     Application for certification  
   84.     When the Regulator may certify the facility  
   85.     Regulator may require applicant to give further information  
   86.     Conditions of certification  
   87.     Variation of certification  
   88.     Suspension or cancellation of certification  
   89.     Regulator to notify of proposed suspension, cancellation or variation  
   89A.    Transfer of certification  
   90.     Guidelines  

           Division 3--Accredited organisations

   91.     Application for accreditation  
   92.     Regulator may accredit organisations  
   93.     Regulator may require applicant to give further information  
   94.     Conditions of accreditation  
   95.     Variation of accreditation  
   96.     Suspension or cancellation of accreditation  
   97.     Regulator to notify of proposed suspension, cancellation or variation  
   98.     Guidelines  

   PART 8--THE GENE TECHNOLOGY TECHNICAL ADVISORY COMMITTEE AND THE GENE TECHNOLOGY ETHICS AND COMMUNITY CONSULTATIVE COMMITTEE

           Division 1--Simplified outline

   99.     Simplified outline  

           Division 2--The Gene Technology Technical Advisory Committee

   100.    The Gene Technology Technical Advisory Committee  
   101.    Function of the Gene Technology Technical Advisory Committee  
   102.    Expert advisers  
   103.    Remuneration  
   104.    Members and procedures  
   105.    Subcommittees  

           Division 3--The Gene Technology Ethics and Community Consultative Committee

   106.    The Gene Technology Ethics and Community Consultative Committee  
   107.    Function of Ethics and Community Committee  
   108.    Membership  
   109.    Remuneration  
   110.    Regulations[6]  
   111.    Subcommittees  
   112.    Expert advisers  

   PART 9--ADMINISTRATION

           Division 1--Simplified outline

   117.    Simplified outline  

           Division 2--Appointment and conditions of Regulator

   118.    Appointment of the Regulator  
   119.    Termination of appointment  
   120.    Disclosure of interests  
   121.    Acting appointment  
   122.    Terms and conditions  
   123.    Outside employment  
   124.    Remuneration  
   125.    Leave of absence  
   126.    Resignation  

           Division 3--Money

   127.    Regulator may charge for services  
   128.    Notional payments by the State  
   129.    Gene Technology Account  
   130.    Credits to Gene Technology Account  
   131.    Recovery of amounts  
   132.    Purposes of Account  

           Division 4--Staffing

   133.    Staff assisting the Regulator  
   134.    Consultants  
   135.    Seconded officers  

           Division 5--Reporting requirements

   136.    Annual report[7]  
   137.    Reports to Parliament  

           Division 6--Record of GMO Dealings

   138.    Record of GMO Dealings  
   139.    Inspection of Record  

           Division 7--Reviews of notifiable low risk dealings and exemptions

   140.    Regulator may review notifiable low risk dealings  
   141.    Regulator may review exemptions  
   142.    Regulator may give notice of consideration  
   143.    What Regulator may do after consideration  
   144.    Regulator not required to review matters  

   PART 10--ENFORCEMENT

   145.    Simplified outline  
   146.    Regulator may give directions  
   147.    Injunctions  
   148.    Forfeiture  

   PART 11--POWERS OF INSPECTION

           Division 1--Simplified outline

   149.    Simplified outline  

           Division 2--Appointment of inspectors and identity cards

   150.    Appointment of inspectors  
   151.    Identity card  

           Division 3--Monitoring powers

   152.    Powers available to inspectors for monitoring compliance  
   153.    Monitoring powers  

           Division 4--Offence-related powers

   154.    Searches and seizures related to offences  
   155.    Offence-related powers of inspectors in relation to premises  
   156.    Use of equipment at premises  

           Division 5--Expert assistance

   157.    Expert assistance to operate a thing  

           Division 6--Emergency powers

   158.    Powers available to inspectors for dealing with dangerous situations  

           Division 7--Obligations and incidental powers of inspectors

   159.    Inspector must produce identity card on request  
   160.    Consent  
   161.    Details of warrant to be given to occupier etc.  
   162.    Announcement before entry  
   163.    Compensation for damage  

           Division 8--Power to search goods, baggage etc.

   164.    Power to search goods, baggage etc.  
   165.    Seizure of goods  

           Division 9--General provisions relating to search and seizure

   166.    Copies of seized things to be provided  
   167.    Occupier entitled to be present during search  
   168.    Receipts for things seized  
   169.    Retention of seized things  
   170.    Magistrates' Court may permit a thing to be retained  
   171.    Disposal of goods if there is no owner or owner cannot be located  

           Division 10--Warrants

   172.    Monitoring warrants  
   173.    Offence-related warrants  
   174.    Offence-related warrants by telephone, telex, fax etc.  
   175.    Offences relating to warrants  

           Division 11--Other matters

   176.    Part not to abrogate privilege against self-incrimination  
   177.    Part does not limit power to impose conditions  

   PART 12--MISCELLANEOUS

           Division 1--Simplified outline

   178.    Simplified outline  

           Division 2--Review of decisions

   179.    Meaning of terms  
   180.    Notification of decisions and review rights  
   181.    Internal review  
   182.    Deadlines for making reviewable decisions  
   183.    Review of decisions by Administrative Appeals Tribunal[8]  
   183A.   Extended standing for judicial review[9]  

           Division 3--Confidential commercial information

   184.    Application for protection of confidential commercial information  
   185.    Regulator may declare that information is confidential commercial information  
   186.    Revocation of declaration  
   187.    Confidential commercial information must not be disclosed  

           Division 4--Conduct by directors, employees and agents

   188.    Conduct by directors, employees and agents  
   189.    Meaning of terms  

           Division 5--Transitional provisions

   190.    Transitional provision—dealings covered by Genetic Manipulation Advisory Committee advice to proceed  
   190A.   Transitional provision—Gene Technology Amendment Act 2016  
   191.    Regulations may relate to transitional matters  

           Division 6--Other

   192.    False or misleading information or document[10]  
   192A.   Interference with dealings with GMOs[11]  
   192E.   Attempts to commit offences against Act[12]  
   193.    Regulations  
   194.     Review of operation of Act  
           ENDNOTES


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