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 .......................................................... 20

Part 4--Regulation of dealings with GMOs                                                         21

Division 1--Simplified outline                                                                                 21

31.......... Simplified outline .............................................................................. 21

Division 2--Dealings with GMOs must be licensed                                     22

32.......... Person not to deal with a GMO without a licence ............................. 22

33.......... Person not to deal with a GMO without a licence--strict liability offence                23

34.......... Person must not breach conditions of a GMO licence ...................... 23

35.......... Person must not breach conditions of a GMO licence--strict liability offence          24

35A....... Person must not breach conditions of emergency dealing determination   25

35B....... Person must not breach conditions of emergency dealing determination--strict liability offence              25

36.......... Person must not breach conditions on GMO Register ...................... 26

37.......... Offence relating to notifiable low risk dealings ................................. 26

38.......... Aggravated offences--significant damage to health or safety of people or to the environment                 27

Part 5--Licensing system                                                                                                 28

Division 1--Simplified outline                                                                                 28

39.......... Simplified outline .............................................................................. 28

Division 2--Licence applications                                                                           29

40.......... Person may apply for a licence .......................................................... 29

40A....... Licences relating to inadvertent dealings ........................................... 29

41.......... Application may be withdrawn ......................................................... 30

42.......... Regulator may require applicant to give further information ............. 30

43.......... Regulator must consider applications except in certain circumstances 30

44.......... Regulator may consult with applicant ................................................ 31

45.......... Regulator must not use certain information in considering licence application          31

Division 3--Initial consideration of licences for dealings not involving intentional release of a GMO into the environment                                                                                    32

46.......... Applications to which this Division applies ...................................... 32

46A....... Division does not apply to an application relating to inadvertent dealings                 32

47.......... What the Regulator must do in relation to application ....................... 32

Division 4--Initial consideration of licences for dealings involving intentional release of a GMO into the environment                                                                                            34

48.......... Applications to which this Division applies ...................................... 34

49.......... Division does not apply to an application relating to inadvertent dealings                 34

50.......... Regulator must prepare risk assessment and risk management plan .. 34

50A....... Limited and controlled release applications ....................................... 35

51.......... Matters Regulator must take into account in preparing risk assessment and risk management plan          36

52.......... Public notification of risk assessment and risk management plan ..... 37

53.......... Regulator may take other actions ....................................................... 38

54.......... Person may request copies of certain documents .............................. 39

Division 5--Decision on licence etc.                                                                     40

55.......... Regulator must make a decision on licence and licence conditions .... 40

56.......... Regulator must not issue the licence unless satisfied as to risk management             40

57.......... Other circumstances in which Regulator must not issue the licence .. 41

58.......... Matters to be taken into account in deciding whether a person is suitable to hold a licence       41

59.......... Notification of licence decision ......................................................... 42

60.......... Period of licence ................................................................................ 42

Division 6--Conditions of licences                                                                        44

61.......... Licence is subject to conditions ......................................................... 44

62.......... Conditions that may be prescribed or imposed .................................. 44

63.......... Condition about informing people of obligations .............................. 45

64.......... Condition about monitoring and audits ............................................. 45

65.......... Condition about additional information to be given to the Regulator . 46

66.......... Person may give information to Regulator ........................................ 46

67.......... Protection of persons who give information ..................................... 47

Division 7--Suspension, cancellation and variation of licences            48

68.......... Suspension and cancellation of licence .............................................. 48

69.......... Surrender of licence .......................................................................... 48

70.......... Transfer of licences ........................................................................... 48

71.......... Variation of licence ........................................................................... 49

72.......... Regulator to notify of proposed suspension, cancellation or variation 51

Part 5A--Emergency dealing determinations                                                     53

Division 1--Simplified outline                                                                                 53

72A....... Simplified outline .............................................................................. 53

Division 2--Making of emergency dealing determination                       54

72B....... Minister may make emergency dealing determination ....................... 54

72C....... Period of effect of emergency dealing determination ......................... 55

Division 3--Effect and conditions of emergency dealing determination                57

72D....... Emergency dealing determination authorises dealings, subject to conditions             57

Division 4--Variation, suspension and revocation of emergency dealing determination             59

72E........ Variation, suspension and revocation of emergency dealing determination               59

Part 6--Regulation of notifiable low risk dealings and dealings on the GMO Register 61

Division 1--Simplified outline                                                                                 61

73.......... Simplified outline .............................................................................. 61

Division 2--Notifiable low risk dealings                                                            62

74.......... Notifiable low risk dealings .............................................................. 62

75.......... Regulation of notifiable low risk dealings ......................................... 62

Division 3--The GMO Register                                                                             64

76.......... GMO Register .................................................................................. 64

77.......... Contents of Register .......................................................................... 64

78.......... Regulator may include dealings with GMOs on GMO Register ....... 64

79.......... Regulator not to make determination unless risks can be managed ... 65

80.......... Variation of GMO Register .............................................................. 65

81.......... Inspection of Register ....................................................................... 66

Part 7--Certification and accreditation                                                                  67

Division 1--Simplified outline                                                                                 67

82.......... Simplified outline .............................................................................. 67

Division 2--Certification                                                                                           68

83.......... Application for certification ............................................................... 68

84.......... When the Regulator may certify the facility ....................................... 68

85.......... Regulator may require applicant to give further information ............. 68

86.......... Conditions of certification ................................................................. 68

87.......... Variation of certification .................................................................... 69

88.......... Suspension or cancellation of certification ........................................ 69

89.......... Regulator to notify of proposed suspension, cancellation or variation 69

89A....... Transfer of certification ..................................................................... 70

90.......... Guidelines ......................................................................................... 71

Division 3--Accredited organisations                                                                72

91.......... Application for accreditation ............................................................. 72

92.......... Regulator may accredit organisations ................................................ 72

93.......... Regulator may require applicant to give further information ............. 73

94.......... Conditions of accreditation ................................................................ 73

95.......... Variation of accreditation .................................................................. 73

96.......... Suspension or cancellation of accreditation ....................................... 73

97.......... Regulator to notify of proposed suspension, cancellation or variation 74

98.......... Guidelines ......................................................................................... 75

Part 8--The Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee                                                    76

Division 1--Simplified outline                                                                                 76

99.......... Simplified outline .............................................................................. 76

Division 2--The Gene Technology Technical Advisory Committee 77

100........ The Gene Technology Technical Advisory Committee ..................... 77

101........ Function of the Gene Technology Technical Advisory Committee ... 78

102........ Expert advisers .................................................................................. 79

103........ Remuneration .................................................................................... 79

104........ Members and procedures .................................................................. 79

105........ Subcommittees .................................................................................. 80

Division 3--The Gene Technology Ethics and Community Consultative Committee     81

106........ The Gene Technology Ethics and Community Consultative Committee .. 81

107........ Function of Ethics and Community Committee ................................. 81

108........ Membership ...................................................................................... 81

109........ Remuneration .................................................................................... 83

110........ Membership and Procedures ............................................................. 83

111........ Subcommittees .................................................................................. 84

112........ Expert advisers .................................................................................. 84

Part 9--Administration                                                                                                     85

Division 1--Simplified outline                                                                                 85

117........ Simplified outline .............................................................................. 85

Division 2--Appointment and conditions of Regulator                             86

118........ Appointment of the Regulator ........................................................... 86

119........ Termination of appointment .............................................................. 86

120........ Disclosure of interests ....................................................................... 88

121........ Acting appointment ........................................................................... 88

122........ Terms and conditions ........................................................................ 88

123........ Outside employment ......................................................................... 88

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

125........ Leave of absence ............................................................................... 89

126........ Resignation ....................................................................................... 89

Division 3--Money                                                                                                        90

127........ Regulator may charge for services .................................................... 90

128........ Notional payments by the Commonwealth ........................................ 90

129........ Gene Technology Account ................................................................ 90

130........ Credits to Account ............................................................................ 90

131........ Recovery of amounts ........................................................................ 91

132........ Purposes of Account ......................................................................... 91

Division 4--Staffing                                                                                                      93

133........ Staff assisting the Regulator .............................................................. 93

134........ Consultants ....................................................................................... 93

135........ Seconded officers .............................................................................. 93

Division 5--Reporting requirements                                                                   94

136........ Annual Report ................................................................................... 94

136A..... Quarterly reports ............................................................................... 94

137........ Reports to Parliament ........................................................................ 95

Division 6--Record of GMO and GM Product Dealings                         96

138........ Record of GMO and GM Product Dealings ..................................... 96

139........ Inspection of Record ......................................................................... 97

Division 7--Reviews of notifiable low risk dealings and exemptions 98

140........ Regulator may review notifiable low risk dealings ............................ 98

141........ Regulator may review exemptions .................................................... 98

142........ Regulator may give notice of consideration ....................................... 98

143........ What Regulator may do after consideration ....................................... 99

144........ Regulator not required to review matters ......................................... 100

Part 10--Enforcement                                                                                                     101

145........ Simplified outline ............................................................................ 101

146........ Regulator may give directions ......................................................... 101

147........ Injunctions ...................................................................................... 104

148........ Forfeiture ........................................................................................ 105

Part 11--Powers of inspection                                                                                    106

Division 1--Simplified outline                                                                               106

149........ Simplified outline ............................................................................ 106

Division 2--Appointment of inspectors and identity cards                   107

150........ Appointment of inspectors .............................................................. 107

151........ Identity card .................................................................................... 107

Division 3--Monitoring powers                                                                           108

152........ Powers available to inspectors for monitoring compliance .............. 108

153........ Monitoring powers ......................................................................... 108

Division 4--Offence-related powers                                                                  110

154........ Searches and seizures related to offences ........................................ 110

155........ Offence-related powers of inspectors in relation to premises .......... 110

156........ Use of equipment at premises ......................................................... 111

Division 5--Expert assistance                                                                               112

157........ Expert assistance to operate a thing ................................................. 112

Division 6--Emergency powers                                                                           113

158........ Powers available to inspectors for dealing with dangerous situations 113

Division 7--Obligations and incidental powers of inspectors              114

159........ Inspector must produce identity card on request ............................. 114

160........ Consent ........................................................................................... 114

161........ Details of warrant to be given to occupier etc. ................................. 114

162........ Announcement before entry ............................................................ 114

163........ Compensation for damage ............................................................... 115

Division 8--Power to search goods, baggage etc.                                     116

164........ Power to search goods, baggage etc. ............................................... 116

165........ Seizure of goods ............................................................................. 116

Division 9--General provisions relating to search and seizure          117

166........ Copies of seized things to be provided ............................................ 117

167........ Occupier entitled to be present during search .................................. 117

168........ Receipts for things seized ................................................................ 118

169........ Retention of seized things ............................................................... 118

170........ Magistrate may permit a thing to be retained ................................... 119

171........ Disposal of goods if there is no owner or owner cannot be located 119

Division 10--Warrants                                                                                             120

172........ Monitoring warrants ....................................................................... 120

173........ Offence-related warrants ................................................................. 120

174........ Offence-related warrants by telephone, telex, fax etc. ..................... 121

175........ Offences relating to warrants .......................................................... 123

Division 11--Other matters                                                                                   125

176........ Part not to abrogate privilege against self-incrimination .................. 125

177........ Part does not limit power to impose conditions ............................... 125

Part 12--Miscellaneous                                                                                                   126

Division 1--Simplified outline                                                                               126

178........ Simplified outline ............................................................................ 126

Division 2--Review of decisions                                                                          127

179........ Meaning of terms ............................................................................ 127

180........ Notification of decisions and review rights ..................................... 128

181........ Internal review ................................................................................ 128

182........ Deadlines for making reviewable decisions .................................... 129

183........ Review of decisions by Administrative Appeals Tribunal .............. 129

183A..... Extended standing for judicial review ............................................. 130

Division 3--Confidential commercial information                                    131

184........ Application for protection of confidential commercial information . 131

185........ Regulator may declare that information is confidential commercial information        131

186........ Revocation of declaration ................................................................ 133

187........ Confidential commercial information must not be disclosed ........... 133

Division 4--Conduct by directors, employees and agents                     135

188........ Conduct by directors, employees and agents ................................... 135

189........ Meaning of terms ............................................................................ 136

Division 5--Transitional provisions                                                                  137

190........ Transitional provision--dealings covered by Genetic Manipulation Advisory Committee advice to proceed           137

191........ Regulations may relate to transitional matters .................................. 138

Division 6--Other                                                                                                        139

192........ False or misleading information or document ................................. 139

192A..... Interference with dealings with GMOs ........................................... 139

193........ Regulations ..................................................................................... 140

194........ Review of operation of Act ............................................................. 140

Notes                                                                                                                                            143

  

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, 129, 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	Schedule 3 (item 2): 1 July 2002 ( see Gazette 2002, No. GN30) (a)	--
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	--
Crimes Legislation Amendment (Serious and Organised Crime) Act (No. 2) 2010	4, 2010	19 Feb 2010	Schedule 11 (item 11): 20 Feb 2010	--
Acts Interpretation Amendment Act 2011	46, 2011	27 June 2011	Schedule 2 (items 650-652) and Schedule 3 (items 10, 11): 27 Dec 2011	Sch. 3 (items 10, 11)
Superannuation Legislation (Consequential Amendments and Transitional Provisions) Act 2011	58, 2011	28 June 2011	Schedule 1 (items 90-93): (b)	--

(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(2) and (5) of which provide as follows:

                 (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.

(b)     Subsection 2(1) (item 2) of the Superannuation Legislation (Consequential Amendments and Transitional Provisions) Act 2011 provides as follows:

                 (1)   Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information
Column 1	Column 2	Column 3
Provision(s)	Commencement	Date/Details
2.  Schedules 1 and 2	Immediately after the commencement of section 2 of the Governance of Australian Government Superannuation Schemes Act 2011.	1 July 2011

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; No. 58, 2011
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; No. 58, 2011
S. 121..................................	am. No. 46, 2011
Note to s. 121.....................	ad. No. 46, 2011
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 4
S. 189..................................	am. No. 4, 2010
Division 6
S. 192A...............................	am. No. 99, 2007
Ss. 192B-192D...................	rep. No. 144, 2002

Table A

Application, saving or transitional provisions

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.

Acts Interpretation Amendment Act 2011 (No. 46, 2011)

Schedule 3

10  Saving--appointments

The amendments made by Schedule 2 do not affect the validity of an appointment that was made under an Act before the commencement of this item and that was in force immediately before that commencement.

11  Transitional regulations

The Governor-General may make regulations prescribing matters of a transitional nature (including prescribing any saving or application provisions) relating to the amendments and repeals made by Schedules 1 and 2.