Contents

Part 1--Preliminary                                                                                                                1

1............ Short title [see Note 1] ....................................................................... 1

2............ Commencement [see Note 1] .............................................................. 1

3............ Object of Act ...................................................................................... 1

4............ Regulatory framework to achieve object ............................................ 1

5............ Nationally consistent scheme ............................................................. 2

6............ Act to bind the Crown ........................................................................ 2

7............ External Territories ............................................................................. 2

8............ Offences .............................................................................................. 2

Part 2--Interpretation and operation of Act                                                             3

Division 1--Simplified outline                                                                                   3

9............ Simplified outline ................................................................................ 3

Division 2--Definitions                                                                                                 4

10.......... Definitions .......................................................................................... 4

11.......... Meaning of intentional release of a GMO into the environment ......... 9

12.......... Meaning of corresponding State law .................................................. 9

Division 3--Operation of Act                                                                                  11

13.......... Operation of Act .............................................................................. 11

14.......... Wind‑back of reach of Act ................................................................ 11

15.......... Relationship to other Commonwealth laws ..................................... 12

Division 4--Provisions to facilitate a nationally consistent scheme   13

Subdivision A--General provisions                                                                        13

16.......... State laws may operate concurrently ............................................... 13

17.......... Conferral of functions on Commonwealth officers and bodies ........ 13

18.......... No doubling‑up of liabilities ............................................................. 14

19.......... Review of certain decisions .............................................................. 14

20.......... Things done for multiple purposes .................................................. 15

Subdivision B--Policy principles, policy guidelines and codes of practice     15

21.......... Ministerial Council may issue policy principles .............................. 15

22.......... Consultation on policy principles .................................................... 16

23.......... Ministerial Council may issue policy guidelines .............................. 16

24.......... Ministerial Council may issue codes of practice .............................. 17

Part 3--The Gene Technology Regulator                                                               18

25.......... Simplified outline .............................................................................. 18

26.......... The Gene Technology Regulator ...................................................... 18

27.......... Functions of the Regulator ............................................................... 18

28.......... Powers of the Regulator ................................................................... 19

29.......... Delegation ......................................................................................... 19

30.......... Independence of the Regulator ......................................................... 19

Part 4--Regulation of dealings with GMOs                                                           20

Division 1--Simplified outline                                                                                 20

31.......... Simplified outline .............................................................................. 20

Division 2--Dealings with GMOs must be licensed                                   21

32.......... Person not to deal with a GMO without a licence ........................... 21

33.......... Person not to deal with a GMO without a licence--strict liability offence             22

34.......... Person must not breach conditions of a GMO licence ..................... 22

35.......... Person must not breach conditions of a GMO licence--strict liability offence       23

35A....... Person must not breach conditions of emergency dealing determination 24

35B....... Person must not breach conditions of emergency dealing determination--strict liability offence           24

36.......... Person must not breach conditions on GMO Register ..................... 25

37.......... Offence relating to notifiable low risk dealings ................................. 25

38.......... Aggravated offences--significant damage to health or safety of people or to the environment               26

Part 5--Licensing system                                                                                                  27

Division 1--Simplified outline                                                                                 27

39.......... Simplified outline .............................................................................. 27

Division 2--Licence applications                                                                          28

40.......... Person may apply for a licence ........................................................ 28

40A....... Licences relating to inadvertent dealings ........................................... 28

41.......... Application may be withdrawn ........................................................ 29

42.......... Regulator may require applicant to give further information ........... 29

43.......... Regulator must consider applications except in certain circumstances 29

44.......... Regulator may consult with applicant .............................................. 30

45.......... Regulator must not use certain information in considering licence application        30

Division 3--Initial consideration of licences for dealings not involving intentional release of a GMO into the environment                                                                                   31

46.......... Applications to which this Division applies .................................... 31

46A....... Division does not apply to an application relating to inadvertent dealings              31

47.......... What the Regulator must do in relation to application ..................... 31

Division 4--Initial consideration of licences for dealings involving intentional release of a GMO into the environment                                                                                           33

48.......... Applications to which this Division applies .................................... 33

49.......... Division does not apply to an application relating to inadvertent dealings              33

50.......... Regulator must prepare risk assessment and risk management plan 33

50A....... Limited and controlled release applications ...................................... 34

51.......... Matters Regulator must take into account in preparing risk assessment and risk management plan       35

52.......... Public notification of risk assessment and risk management plan .... 36

53.......... Regulator may take other actions ..................................................... 37

54.......... Person may request copies of certain documents ............................. 38

Division 5--Decision on licence etc.                                                                   39

55.......... Regulator must make a decision on licence and licence conditions ... 39

56.......... Regulator must not issue the licence unless satisfied as to risk management           39

57.......... Other circumstances in which Regulator must not issue the licence 40

58.......... Matters to be taken into account in deciding whether a person is suitable to hold a licence    40

59.......... Notification of licence decision ......................................................... 41

60.......... Period of licence ................................................................................ 41

Division 6--Conditions of licences                                                                      43

61.......... Licence is subject to conditions ........................................................ 43

62.......... Conditions that may be prescribed or imposed ................................ 43

63.......... Condition about informing people of obligations ............................. 44

64.......... Condition about monitoring and audits ............................................ 44

65.......... Condition about additional information to be given to the Regulator 45

66.......... Person may give information to Regulator ....................................... 45

67.......... Protection of persons who give information .................................... 46

Division 7--Suspension, cancellation and variation of licences            47

68.......... Suspension and cancellation of licence ............................................. 47

69.......... Surrender of licence ........................................................................... 47

70.......... Transfer of licences ........................................................................... 47

71.......... Variation of licence ........................................................................... 48

72.......... Regulator to notify of proposed suspension, cancellation or variation 50

Part 5A--Emergency dealing determinations                                                        52

Division 1--Simplified outline                                                                                 52

72A....... Simplified outline .............................................................................. 52

Division 2--Making of emergency dealing determination                      53

72B....... Minister may make emergency dealing determination ...................... 53

72C....... Period of effect of emergency dealing determination ........................ 54

Division 3--Effect and conditions of emergency dealing determination                56

72D....... Emergency dealing determination authorises dealings, subject to conditions           56

Division 4--Variation, suspension and revocation of emergency dealing determination             58

72E........ Variation, suspension and revocation of emergency dealing determination              58

Part 6--Regulation of notifiable low risk dealings and dealings on the GMO Register     60

Division 1--Simplified outline                                                                                 60

73.......... Simplified outline .............................................................................. 60

Division 2--Notifiable low risk dealings                                                           61

74.......... Notifiable low risk dealings .............................................................. 61

75.......... Regulation of notifiable low risk dealings ......................................... 61

Division 3--The GMO Register                                                                           63

76.......... GMO Register .................................................................................. 63

77.......... Contents of Register ......................................................................... 63

78.......... Regulator may include dealings with GMOs on GMO Register ...... 63

79.......... Regulator not to make determination unless risks can be managed .. 64

80.......... Variation of GMO Register .............................................................. 64

81.......... Inspection of Register ....................................................................... 65

Part 7--Certification and accreditation                                                                     66

Division 1--Simplified outline                                                                                 66

82.......... Simplified outline .............................................................................. 66

Division 2--Certification                                                                                           67

83.......... Application for certification ............................................................. 67

84.......... When the Regulator may certify the facility .................................... 67

85.......... Regulator may require applicant to give further information ........... 67

86.......... Conditions of certification ................................................................ 67

87.......... Variation of certification ................................................................... 68

88.......... Suspension or cancellation of certification ....................................... 68

89.......... Regulator to notify of proposed suspension, cancellation or variation 68

89A....... Transfer of certification .................................................................... 69

90.......... Guidelines ......................................................................................... 70

Division 3--Accredited organisations                                                                71

91.......... Application for accreditation ............................................................ 71

92.......... Regulator may accredit organisations ............................................... 71

93.......... Regulator may require applicant to give further information ........... 72

94.......... Conditions of accreditation ............................................................... 72

95.......... Variation of accreditation .................................................................. 72

96.......... Suspension or cancellation of accreditation ...................................... 72

97.......... Regulator to notify of proposed suspension, cancellation or variation 73

98.......... Guidelines ......................................................................................... 74

Part 8--The Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee                                                       75

Division 1--Simplified outline                                                                                 75

99.......... Simplified outline .............................................................................. 75

Division 2--The Gene Technology Technical Advisory Committee 76

100........ The Gene Technology Technical Advisory Committee ................... 76

101........ Function of the Gene Technology Technical Advisory Committee . 77

102........ Expert advisers ................................................................................. 78

103........ Remuneration .................................................................................... 78

104........ Members and procedures ................................................................. 78

105........ Subcommittees .................................................................................. 79

Division 3--The Gene Technology Ethics and Community Consultative Committee   80

106........ The Gene Technology Ethics and Community Consultative Committee                 80

107........ Function of Ethics and Community Committee ............................... 80

108........ Membership ..................................................................................... 80

109........ Remuneration .................................................................................... 82

110........ Membership and Procedures ............................................................ 82

111........ Subcommittees .................................................................................. 83

112........ Expert advisers ................................................................................. 83

Part 9--Administration                                                                                                       84

Division 1--Simplified outline                                                                                 84

117........ Simplified outline .............................................................................. 84

Division 2--Appointment and conditions of Regulator                             85

118........ Appointment of the Regulator ......................................................... 85

119........ Termination of appointment ............................................................ 85

120........ Disclosure of interests ...................................................................... 87

121........ Acting appointment .......................................................................... 87

122........ Terms and conditions ....................................................................... 87

123........ Outside employment ........................................................................ 87

124........ Remuneration .................................................................................... 88

125........ Leave of absence ............................................................................... 88

126........ Resignation ....................................................................................... 88

Division 3--Money                                                                                                       89

127........ Regulator may charge for services .................................................... 89

128........ Notional payments by the Commonwealth ..................................... 89

129........ Gene Technology Account ............................................................... 89

130........ Credits to Account ........................................................................... 89

131........ Recovery of amounts ........................................................................ 90

132........ Purposes of Account ........................................................................ 90

Division 4--Staffing                                                                                                      92

133........ Staff assisting the Regulator ............................................................. 92

134........ Consultants ....................................................................................... 92

135........ Seconded officers .............................................................................. 92

Division 5--Reporting requirements                                                                  93

136........ Annual Report .................................................................................. 93

136A..... Quarterly reports .............................................................................. 93

137........ Reports to Parliament ....................................................................... 94

Division 6--Record of GMO and GM Product Dealings                         95

138........ Record of GMO and GM Product Dealings .................................... 95

139........ Inspection of Record ........................................................................ 96

Division 7--Reviews of notifiable low risk dealings and exemptions 97

140........ Regulator may review notifiable low risk dealings ........................... 97

141........ Regulator may review exemptions .................................................... 97

142........ Regulator may give notice of consideration ...................................... 97

143........ What Regulator may do after consideration ..................................... 98

144........ Regulator not required to review matters ......................................... 99

Part 10--Enforcement                                                                                                       100

145........ Simplified outline ............................................................................ 100

146........ Regulator may give directions ......................................................... 100

147........ Injunctions ...................................................................................... 103

148........ Forfeiture ........................................................................................ 104

Part 11--Powers of inspection                                                                                      105

Division 1--Simplified outline                                                                               105

149........ Simplified outline ............................................................................ 105

Division 2--Appointment of inspectors and identity cards                   106

150........ Appointment of inspectors ............................................................ 106

151........ Identity card ................................................................................... 106

Division 3--Monitoring powers                                                                           107

152........ Powers available to inspectors for monitoring compliance ............ 107

153........ Monitoring powers ......................................................................... 107

Division 4--Offence‑related powers                                                                 109

154........ Searches and seizures related to offences ....................................... 109

155........ Offence‑related powers of inspectors in relation to premises ........ 109

156........ Use of equipment at premises ........................................................ 110

Division 5--Expert assistance                                                                              111

157........ Expert assistance to operate a thing ............................................... 111

Division 6--Emergency powers                                                                           112

158........ Powers available to inspectors for dealing with dangerous situations 112

Division 7--Obligations and incidental powers of inspectors              113

159........ Inspector must produce identity card on request ........................... 113

160........ Consent ........................................................................................... 113

161........ Details of warrant to be given to occupier etc. ............................... 113

162........ Announcement before entry ........................................................... 113

163........ Compensation for damage .............................................................. 114

Division 8--Power to search goods, baggage etc.                                     115

164........ Power to search goods, baggage etc. ............................................... 115

165........ Seizure of goods .............................................................................. 115

Division 9--General provisions relating to search and seizure          116

166........ Copies of seized things to be provided .......................................... 116

167........ Occupier entitled to be present during search ................................ 116

168........ Receipts for things seized ............................................................... 116

169........ Retention of seized things .............................................................. 117

170........ Magistrate may permit a thing to be retained ................................. 117

171........ Disposal of goods if there is no owner or owner cannot be located 118

Division 10--Warrants                                                                                              119

172........ Monitoring warrants ....................................................................... 119

173........ Offence‑related warrants ................................................................ 119

174........ Offence‑related warrants by telephone, telex, fax etc. .................... 120

175........ Offences relating to warrants .......................................................... 122

Division 11--Other matters                                                                                   124

176........ Part not to abrogate privilege against self‑incrimination ................. 124

177........ Part does not limit power to impose conditions ............................ 124

Part 12--Miscellaneous                                                                                                   125

Division 1--Simplified outline                                                                               125

178........ Simplified outline ............................................................................ 125

Division 2--Review of decisions                                                                         126

179........ Meaning of terms ............................................................................ 126

180........ Notification of decisions and review rights .................................... 127

181........ Internal review ................................................................................ 127

182........ Deadlines for making reviewable decisions ..................................... 128

183........ Review of decisions by Administrative Appeals Tribunal ............ 128

183A..... Extended standing for judicial review ............................................. 129

Division 3--Confidential commercial information                                      130

184........ Application for protection of confidential commercial information 130

185........ Regulator may declare that information is confidential commercial information      130

186........ Revocation of declaration ............................................................... 132

187........ Confidential commercial information must not be disclosed .......... 132

Division 4--Conduct by directors, employees and agents                    134

188........ Conduct by directors, employees and agents ................................. 134

189........ Meaning of terms ............................................................................ 135

Division 5--Transitional provisions                                                                  136

190........ Transitional provision--dealings covered by Genetic Manipulation Advisory Committee advice to proceed       136

191........ Regulations may relate to transitional matters ............................... 137

Division 6--Other                                                                                                       138

192........ False or misleading information or document ................................. 138

192A..... Interference with dealings with GMOs .......................................... 138

193........ Regulations ..................................................................................... 139

194........ Review of operation of Act ............................................................ 139

Notes                                                                                                                                           141

  

Notes to the Gene Technology Act 2000

Note 1

The Gene Technology Act 2000 as shown in this compilation comprises Act No. 169, 2000 amended as indicated in the Tables below.

For all relevant information pertaining to application, saving or transitional provisions see Table A.

Table of Acts

Act	Number and year	Date of Assent	Date of commencement	Application, saving or transitional provisions
Gene Technology Act 2000	169, 2000	21 Dec 2000	Ss. 1 and 2: Royal Assent Ss. 10, 26, 27(b)-(l), 28-30, 120, 121, 130 and 132-135: 20 Apr 2001 (see Gazette 2001, No. S140) Remainder: 22 June 2001
Australia New Zealand Food Authority Amendment Act 2001	81, 2001	10 July 2001	S. 2(6): Royal Assent (a) Schedule 3 (item 2): 1 July 2002 (see Gazette 2002, No. GN30)	--
Prohibition of Human Cloning Act 2002	144, 2002	19 Dec 2002	Ss. 3-26 and Schedule 1: 16 Jan 2003 Remainder: Royal Assent	--
Financial Framework Legislation Amendment Act (No. 1) 2006	30, 2006	6 Apr 2006	Schedule 1 (items 25-28): 7 Apr 2006	--
Gene Technology Amendment Act 2007	99, 2007	28 June 2007	Schedule 1 (items 1-23, 36-61) and Schedule 2: 1 July 2007 Schedule 1 (items 24-35): 1 Jan 2008 Remainder: Royal Assent	Sch. 1 (item 35)
Superannuation Legislation Amendment (Trustee Board and Other Measures) (Consequential Amendments) Act 2008	26, 2008	23 June 2008	Schedule 1 (items 73-76): Royal Assent	--

(a)     The Gene Technology Act 2000 was amended by Schedule 3 (item 2) only of the Australia New Zealand Food Authority Amendment Act 2001, subsections 2(1)(a), (2) and (5) of which provide as follows:

                 (1)   The following provisions commence on the day on which this Act receives the Royal Assent:

                              (a)   sections 1, 2 and 3;

                 (2)   Part 1 of Schedule 1 (other than item 120A), and Schedule 3, commence on the first day after the commencement of this section on which an amendment of the Australia New Zealand Joint Food Standards Agreement comes into force in accordance with Article 10 of that Agreement.

                 (5)   As soon as practicable after the commencement of the following provisions:

                              (a)   Part 1 of Schedule 1 (other than item 120A);

                              (b)   Schedule 3;

                         the Minister must cause to be published in the Gazette a notice specifying the day on which those provisions commenced.

Table of Amendments

ad. = added or inserted     am. = amended     rep. = repealed     rs. = repealed and substituted
Provision affected	How affected
Part 2
Division 2
S. 10....................................	am. No. 99, 2007
Division 4
Subdivision A
S. 17....................................	am. No. 99, 2007
Subdivision B
S. 22....................................	am. No. 99, 2007
S. 24....................................	am. No. 99, 2007
Part 4
Division 1
S. 31....................................	am. No. 99, 2007
Division 2
Ss. 32-34............................	am. No. 99, 2007
Ss. 35A, 35B.......................	ad. No. 99, 2007
Part 5
Division 2
S. 40A.................................	ad. No. 99, 2007
Ss. 42, 43............................	am. No. 99, 2007
Division 3
S. 46A.................................	ad. No. 99, 2007
Division 4
S. 49....................................	rs. No. 99, 2007
S. 50....................................	am. No. 99, 2007
S. 50A.................................	ad. No. 99, 2007
Ss. 51, 52............................	am. No. 99, 2007
Division 5
S. 56....................................	am. No. 99, 2007
Note to s. 56........................	ad. No. 99, 2007
S. 57....................................	am. No. 99, 2007
S. 60....................................	am. No. 99, 2007
Division 6
S. 67....................................	am. No. 99, 2007
Division 7
Ss. 71, 72............................	am. No. 99, 2007
Part 5A
Part 5A................................	ad. No. 99, 2007
Division 1
S. 72A.................................	ad. No. 99, 2007
Division 2
Ss. 72B, 72C.......................	ad. No. 99, 2007
Division 3
S. 72D.................................	ad. No. 99, 2007
Division 4
S. 72E..................................	ad. No. 99, 2007
Part 6
Division 3
S. 78....................................	am. No. 99, 2007
Part 7
Division 1
S. 82....................................	am. No. 99, 2007
Division 2
Note to s. 83(2)...................	am. No. 99, 2007
S. 89....................................	am. No. 99, 2007
S. 89A.................................	ad. No. 99, 2007
Division 3
Note to s. 91(1)...................	rep. No. 99, 2007
Notes 1, 2 to s. 91(1)..........	ad. No. 99, 2007
S. 92....................................	am. No. 99, 2007
S. 97....................................	am. No. 99, 2007
Part 8
Heading to Part 8.................	rs. No. 99, 2007
Division 1
S. 99....................................	am. No. 99, 2007
Division 2
S. 100..................................	am. No. 99, 2007
Division 3
Div. 3 of Part 8....................	rs. No. 99, 2007
Ss. 106-110........................	rs. No. 99, 2007
S. 110A...............................	rep. No. 99, 2007
Ss. 111, 112........................	rs. No. 99, 2007
Div. 4 of Part 8....................	rep. No. 99, 2007
Ss. 113-116........................	rep. No. 99, 2007
Part 9
Division 2
S. 119..................................	am. No. 26, 2008
Division 3
S. 130..................................	am. No. 30, 2006
Note to s. 130(1).................	ad. No. 30, 2006
Division 5
S. 136A...............................	am. No. 99, 2007
Division 6
S. 138..................................	am. No. 81, 2001; No. 99, 2007
Part 10
Ss. 145, 146........................	am. No. 99, 2007
Part 11
Division 1
S. 149..................................	am. No. 99, 2007
Division 3
S. 152..................................	am. No. 99, 2007
Division 11
Heading to s. 177................	am. No. 99, 2007
S. 177..................................	am. No. 99, 2007
Part 12
Division 2
S. 179..................................	am. No. 99, 2007
S. 182..................................	am. No. 99, 2007
Division 3
S. 185..................................	am. No. 99, 2007
Division 6
S. 192A...............................	am. No. 99, 2007
Ss. 192B-192D...................	rep. No. 144, 2002

Table A

Application, saving or transitional provisions

Australia New Zealand Food Authority Amendment Act 2001 (No. 81, 2001)

           2(6)  In this section:

Australia New Zealand Joint Food Standards Agreement means the Agreement between the Government of Australia and the Government of New Zealand Establishing a System for the Development of Joint Food Standards, signed at Wellington on 5 December 1995.

Gene Technology Amendment Act 2007 (No. 99, 2007)

Schedule 1

35  Transitional provision

(1)        This item applies if functions are conferred by a corresponding State law upon the Ethics Committee or the Consultative Committee.

(2)        Despite the repeals and amendments made by this Part:

                     (a)  the Ethics Committee and the Consultative Committee that were in existence immediately before the commencement of this item:

                              (i)  continue in existence after the commencement of this item; and

                             (ii)  the members of the Ethics and Community Committee are taken to constitute the Ethics Committee and the Consultative Committee, respectively; and

                     (b)  if, after the commencement of this item, the Ethics and Community Committee performs a function corresponding to a function conferred on the Ethics Committee or the Consultative Committee by a corresponding State law, the Ethics Committee or the Consultative Committee, as continued in existence by this item, is taken to have performed the function.

(3)        Despite the repeals and amendments made by this Part, the authority:

                     (a)  given by section 17 of the Gene Technology Act 2000 (as in force immediately before the commencement of this item); and

                     (b)  that permits a corresponding State law to confer functions, powers and duties on the Ethics Committee or the Consultative Committee;

continues in effect as if those repeals and amendments had not happened.

(4)        In this item:

Consultative Committee has the meaning given by the Gene Technology Act 2000, as in force immediately before the commencement of this item.

Ethics Committee has the meaning given by the Gene Technology Act 2000, as in force immediately before the commencement of this item.