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Gene Technology Bill 2000

1998-1999-2000

 

The Parliament of the

Commonwealth of Australia

 

HOUSE OF REPRESENTATIVES

 

 

 

 

Presented and read a first time

 

 

 

 

 

 

 

 

 

Gene Technology Bill 2000

 

No.      , 2000

 

(Health and Aged Care)

 

 

 

A Bill for an Act to regulate activities involving gene technology, and for related purposes

   

   

   



Contents

Part 1—Preliminary                                                                                                              1

1............ Short title............................................................................................. 1

2............ Commencement................................................................................... 1

3............ Object of Act....................................................................................... 2

4............ Regulatory framework to achieve object............................................. 2

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

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

7............ External Territories.............................................................................. 3

8............ Offences.............................................................................................. 3

Part 2—Interpretation and operation of Act                                                         4

Division 1—Simplified outline                                                                                   4

9............ Simplified outline................................................................................ 4

Division 2—Definitions                                                                                                 5

10.......... Definitions.......................................................................................... 5

11.......... Meaning of intentional release of a GMO into the environment ....... 10

12.......... Meaning of corresponding State law ................................................ 10

Division 3—Operation of Act                                                                                  12

13.......... Operation of Act............................................................................... 12

14.......... Wind-back of reach of Act................................................................ 12

15.......... Relationship to other Commonwealth laws....................................... 13

Division 4—Provisions to facilitate a nationally consistent scheme   14

Subdivision A—General provisions                                                                     14

16.......... State laws may operate concurrently................................................. 14

17.......... Conferral of functions on Commonwealth officers and bodies......... 14

18.......... No doubling-up of liabilities............................................................. 15

19.......... Review of certain decisions............................................................... 16

20.......... Things done for multiple purposes.................................................... 16

Subdivision B—Policy principles, policy guidelines and codes of practice 16

21.......... Ministerial Council may issue policy principles................................ 16

22.......... Consultation on policy principles...................................................... 17

23.......... Ministerial Council may issue policy guidelines............................... 17

24.......... Ministerial Council may issue codes of practice................................ 18

Part 3—The Gene Technology Regulator                                                              19

25.......... Simplified outline.............................................................................. 19

26.......... The Gene Technology Regulator....................................................... 19

27.......... Functions of the Regulator................................................................ 19

28.......... Powers of the Regulator.................................................................... 20

29.......... Delegation......................................................................................... 20

30.......... Independence of the Regulator.......................................................... 20

Part 4—Regulation of dealings with GMOs                                                         22

Division 1—Simplified outline                                                                                 22

31.......... Simplified outline.............................................................................. 22

Division 2—Dealings with GMOs must be licensed                                     23

32.......... Person not to deal with a GMO without a licence............................. 23

33.......... Person not to deal with a GMO without a licence—strict liability offence               24

34.......... Person must not breach conditions of a GMO licence...................... 24

35.......... Person must not breach conditions of a GMO licence—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

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

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................................................ 30

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

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                                                                                           33

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

49.......... Dealings that may pose significant risks to the health and safety of people or the environment               33

50.......... Regulator must prepare risk assessment and risk management plan.. 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                                                                        42

61.......... Licence is subject to conditions......................................................... 42

62.......... Conditions that may be prescribed or imposed.................................. 42

63.......... Condition about informing people of obligations.............................. 43

64.......... Condition about monitoring and audits............................................. 43

65.......... Condition about additional information to be given to the Regulator. 44

66.......... Person may give information to Regulator........................................ 44

67.......... Protection of persons who give information..................................... 45

Division 7—Suspension, cancellation and variation of licences            46

68.......... Suspension and cancellation of licence.............................................. 46

69.......... Surrender of licence.......................................................................... 46

70.......... Transfer of licences........................................................................... 46

71.......... Variation of licence........................................................................... 47

72.......... Regulator to notify of proposed suspension, cancellation or variation 48

Part 6—Regulation of notifiable low risk dealings and dealings on the GMO Register 50

Division 1—Simplified outline                                                                                 50

73.......... Simplified outline.............................................................................. 50

Division 2—Notifiable low risk dealings                                                           51

74.......... Notifiable low risk dealings.............................................................. 51

75.......... Regulation of notifiable low risk dealings......................................... 51

Division 3—The GMO Register                                                                             53

76.......... GMO Register.................................................................................. 53

77.......... Contents of Register.......................................................................... 53

78.......... Regulator may include dealings with GMOs on GMO Register....... 53

79.......... Regulator not to make determination unless risks can be managed... 54

80.......... Variation of GMO Register.............................................................. 54

81.......... Inspection of Register....................................................................... 55

Part 7—Certification and accreditation                                                                  56

Division 1—Simplified outline                                                                                 56

82.......... Simplified outline.............................................................................. 56

Division 2—Certification                                                                                           57

83.......... Application for certification............................................................... 57

84.......... When the Regulator may certify the facility....................................... 57

85.......... Regulator may require applicant to give further information............. 57

86.......... Conditions of certification................................................................. 57

87.......... Variation of certification.................................................................... 58

88.......... Suspension or cancellation of certification........................................ 58

89.......... Regulator to notify of proposed suspension, cancellation or variation 58

90.......... Guidelines......................................................................................... 59

Division 3—Accredited organisations                                                                60

91.......... Application for accreditation............................................................. 60

92.......... Regulator may accredit organisations................................................ 60

93.......... Regulator may require applicant to give further information............. 60

94.......... Conditions of accreditation................................................................ 61

95.......... Variation of accreditation.................................................................. 61

96.......... Suspension or cancellation of accreditation....................................... 61

97.......... Regulator to notify of proposed suspension, cancellation or variation 61

98.......... Guidelines......................................................................................... 62

Part 8—The Gene Technology Technical Advisory Committee, the Gene Technology Community Consultative Group and the Gene Technology Ethics Committee            64

Division 1—Simplified outline                                                                                 64

99.......... Simplified outline.............................................................................. 64

Division 2—The Gene Technology Technical Advisory Committee 65

100........ The Gene Technology Technical Advisory Committee..................... 65

101........ Function of the Gene Technology Technical Advisory Committee... 66

102........ Expert advisers.................................................................................. 67

103........ Remuneration.................................................................................... 67

104........ Members and procedures.................................................................. 67

105........ Subcommittees.................................................................................. 68

Division 3—The Gene Technology Community Consultative Group 69

106........ The Gene Technology Community Consultative Group................... 69

107........ Function of Consultative Group........................................................ 69

108........ Membership...................................................................................... 69

109........ Remuneration.................................................................................... 70

110........ Regulations....................................................................................... 71

Division 4—The Gene Technology Ethics Committee                               72

111........ The Gene Technology Ethics Committee.......................................... 72

112........ Function of the Gene Technology Ethics Committee........................ 73

113........ Expert advisers.................................................................................. 73

114........ Remuneration.................................................................................... 73

115........ Members and procedures.................................................................. 74

116........ Subcommittees.................................................................................. 75

Part 9—Administration                                                                                                     76

Division 1—Simplified outline                                                                                 76

117........ Simplified outline.............................................................................. 76

Division 2—Appointment and conditions of Regulator                             77

118........ Appointment of the Regulator........................................................... 77

119........ Termination of appointment.............................................................. 77

120........ Disclosure of interests....................................................................... 78

121........ Acting appointment........................................................................... 78

122........ Terms and conditions........................................................................ 79

123........ Outside employment......................................................................... 79

124........ Remuneration.................................................................................... 79

125........ Leave of absence............................................................................... 80

126........ Resignation....................................................................................... 80

Division 3—Money                                                                                                        81

127........ Regulator may charge for services.................................................... 81

128........ Notional payments by the Commonwealth........................................ 81

129........ Gene Technology Account................................................................ 81

130........ Credits to Account............................................................................ 81

131........ Recovery of amounts........................................................................ 82

132........ Purposes of Account......................................................................... 82

Division 4—Staffing                                                                                                      84

133........ Staff assisting the Regulator.............................................................. 84

134........ Consultants....................................................................................... 84

135........ Seconded officers.............................................................................. 84

Division 5—Reporting requirements                                                                  85

136........ Annual Report................................................................................... 85

137........ Reports to Parliament........................................................................ 85

Division 6—Record of GMO and GM Product Dealings                         86

138........ Record of GMO and GM Product Dealings..................................... 86

139........ Inspection of Record......................................................................... 87

Division 7—Reviews of notifiable low risk dealings and exemptions 88

140........ Regulator may review notifiable low risk dealings............................ 88

141........ Regulator may review exemptions.................................................... 88

142........ Regulator may give notice of consideration....................................... 88

143........ What Regulator may do after consideration....................................... 89

144........ Regulator not required to review matters........................................... 90

Part 10—Enforcement                                                                                                       91

145........ Simplified outline.............................................................................. 91

146........ Regulator may give directions........................................................... 91

147........ Injunctions........................................................................................ 93

148........ Forfeiture.......................................................................................... 93

Part 11—Powers of inspection                                                                                      95

Division 1—Simplified outline                                                                                 95

149........ Simplified outline.............................................................................. 95

Division 2—Appointment of inspectors and identity cards                     96

150........ Appointment of inspectors................................................................ 96

151........ Identity card...................................................................................... 96

Division 3—Monitoring powers                                                                             97

152........ Powers available to inspectors for monitoring compliance................ 97

153........ Monitoring powers........................................................................... 97

Division 4—Offence-related powers                                                                    99

154........ Searches and seizures related to offences.......................................... 99

155........ Offence-related powers of inspectors in relation to premises............ 99

156........ Use of equipment at premises......................................................... 100

Division 5—Expert assistance                                                                               102

157........ Expert assistance to operate a thing................................................. 102

Division 6—Emergency powers                                                                           103

158........ Powers available to inspectors for dealing with dangerous situations 103

Division 7—Obligations and incidental powers of inspectors              104

159........ Inspector must produce identity card on request............................. 104

160........ Consent........................................................................................... 104

161........ Details of warrant to be given to occupier etc.................................. 104

162........ Announcement before entry............................................................ 104

163........ Compensation for damage............................................................... 105

Division 8—Power to search goods, baggage etc.                                     106

164........ Power to search goods, baggage etc................................................ 106

165........ Seizure of goods............................................................................. 106

Division 9—General provisions relating to search and seizure          107

166........ Copies of seized things to be provided............................................ 107

167........ Occupier entitled to be present during search.................................. 107

168........ Receipts for things seized................................................................ 108

169........ Retention of seized things............................................................... 108

170........ Magistrate may permit a thing to be retained................................... 109

171........ Disposal of goods if there is no owner or owner cannot be located 109

Division 10—Warrants                                                                                             110

172........ Monitoring warrants....................................................................... 110

173........ Offence-related warrants................................................................. 110

174........ Offence-related warrants by telephone, telex, fax etc...................... 111

175........ Offences relating to warrants.......................................................... 113

Division 11—Other matters                                                                                   115

176........ Part not to abrogate privilege against self-incrimination.................. 115

177........ Part does not limit power to impose licence conditions................... 115

Part 12—Miscellaneous                                                                                                   116

Division 1—Simplified outline                                                                               116

178........ Simplified outline............................................................................ 116

Division 2—Review of decisions                                                                          117

179........ Meaning of terms............................................................................ 117

180........ Notification of decisions and review rights..................................... 118

181........ Internal review................................................................................ 118

182........ Deadlines for making reviewable decisions.................................... 119

183........ Review of decisions by Administrative Appeals Tribunal.............. 119

Division 3—Confidential commercial information                                   120

184........ Application for protection of confidential commercial information. 120

185........ Regulator may declare that information is confidential commercial information       120

186........ Revocation of declaration................................................................ 121

187........ Confidential commercial information must not be disclosed........... 121

Division 4—Conduct by directors, employees and agents                     123

188........ Conduct by directors, employees and agents................................... 123

189........ Meaning of terms............................................................................ 124

Division 5—Transitional provisions                                                                  125

190........ Transitional provision—dealings covered by Genetic Manipulation Advisory Committee advice to proceed          125

191........ Regulations may relate to transitional matters.................................. 126

Division 6—Other                                                                                                        127

192........ False or misleading information or document................................. 127

193........ Regulations..................................................................................... 127

 



A Bill for an Act to regulate activities involving gene technology, and for related purposes

The Parliament of Australia enacts: