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Table Of Contents
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Bill
- Part 1—Preliminary
- Part 2—Registration of industrial chemical introducers
- Part 3—Categorisation and assessment of industrial chemicals
- Part 4—Evaluations initiated by Executive Director
- Part 5—Australian Inventory of Industrial Chemicals
- Part 6—Information, reporting and confidentiality
- Part 7—Enforcement
- Part 8—Administration
- Part 9—International agreements and arrangements
- Part 10—Miscellaneous
2016-2017
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Industrial Chemicals Bill 2017
No. , 2017
(Health)
A Bill for an Act to establish a national regulatory scheme for industrial chemicals, and for related purposes
Contents
1............ Short title............................................................................................. 1
2............ Commencement................................................................................... 2
3............ Act binds the Crown........................................................................... 2
4............ Alternative constitutional basis for this Act......................................... 3
5............ Extension to external Territories.......................................................... 3
6............ Relationship to other laws................................................................... 3
7............ Objects of this Act.............................................................................. 3
8............ Simplified outline of this Act.............................................................. 4
9............ Definitions.......................................................................................... 5
10.......... Definition of industrial chemical ...................................................... 16
11.......... Application of this Act to excluded introductions............................. 17
Part 2—Registration of industrial chemical introducers 18
Division 1—Simplified outline of this Part 18
12.......... Simplified outline of this Part............................................................ 18
Division 2—Registration 19
13.......... Introducers must be registered.......................................................... 19
14.......... Establishment of Register.................................................................. 19
15.......... Content of Register........................................................................... 20
16.......... Applying for registration................................................................... 20
17.......... Grant of registration.......................................................................... 20
18.......... Correction of register........................................................................ 21
19.......... Cancellation of registration................................................................ 21
Division 3—Registration charge 23
20.......... Registration charge............................................................................ 23
21.......... Amount of registration charge........................................................... 23
22.......... Other matters relating to registration charge...................................... 23
Part 3—Categorisation and assessment of industrial chemicals 24
Division 1—Simplified outline of this Part 24
23.......... Simplified outline of this Part............................................................ 24
Division 2—Introduction categories 25
24.......... Introductions must be authorised...................................................... 25
25.......... Listed introductions........................................................................... 26
26.......... Exempted introductions..................................................................... 26
27.......... Reported introductions...................................................................... 26
28.......... Assessed introductions..................................................................... 27
29.......... Commercial evaluation introductions................................................ 28
30.......... Exceptional circumstances introductions........................................... 28
Division 3—Assessment certificates 29
Subdivision A—Obtaining a certificate 29
31.......... Applying for a certificate................................................................... 29
32.......... Executive Director must consider application.................................... 29
33.......... Executive Director may request further information.......................... 30
34.......... Consultation with prescribed bodies................................................. 30
35.......... Consultation with Gene Technology Regulator................................. 31
36.......... Submissions on draft assessment statement...................................... 31
37.......... Issue of certificate and assessment statement.................................... 32
38.......... Content of certificate......................................................................... 32
39.......... When certificate is in force................................................................ 33
Subdivision B—Changes to certificate holders or persons covered by a certificate 34
40.......... Applying to change persons covered................................................ 34
41.......... Applying to change certificate holders.............................................. 35
42.......... Changing certificate holders on Executive Director’s initiative......... 35
Subdivision C—Varying the terms of an assessment certificate 36
43.......... Applying for a variation of the terms of an assessment certificate..... 36
44.......... Executive Director must consider application.................................... 37
45.......... Executive Director may request further information.......................... 38
46.......... Consultation with prescribed bodies................................................. 38
47.......... Consultation with Gene Technology Regulator................................. 39
48.......... Submissions on draft assessment statement...................................... 39
49.......... Issue of varied assessment certificate and assessment statement....... 39
50.......... Variations on Executive Director’s initiative..................................... 40
Subdivision D—Cancelling an assessment certificate 41
51.......... Applying to cancel a certificate.......................................................... 41
52.......... Cancelling on Executive Director’s initiative..................................... 42
Division 4—Commercial evaluation authorisations 43
Subdivision A—Obtaining an authorisation 43
53.......... Applying for an authorisation........................................................... 43
54.......... Executive Director must consider application.................................... 44
55.......... Executive Director may request further information.......................... 45
56.......... Consultation with prescribed bodies................................................. 45
57.......... Consultation with Gene Technology Regulator................................. 45
58.......... Issue of authorisation........................................................................ 46
59.......... Content of authorisation.................................................................... 46
Subdivision B—Changing authorisation holders 47
60.......... Applying to change authorisation holders......................................... 47
61.......... Changing authorisation holders on Executive Director’s initiative.... 48
Subdivision C—Varying the terms of an authorisation 49
62.......... Applying for a variation of the terms of an authorisation.................. 49
63.......... Issue of varied authorisation............................................................. 49
64.......... Variations on Executive Director’s initiative..................................... 50
Subdivision D—Cancelling an authorisation 51
65.......... Applying to cancel an authorisation.................................................. 51
66.......... Cancelling on Executive Director’s initiative..................................... 51
Division 5—Exceptional circumstances authorisations 53
67.......... Exceptional circumstances authorisations.......................................... 53
Part 4—Evaluations initiated by Executive Director 55
Division 1—Simplified outline of this Part 55
68.......... Simplified outline of this Part............................................................ 55
Division 2—Evaluations of introductions authorised by an assessment certificate 56
69.......... Executive Director may initiate evaluation......................................... 56
70.......... Executive Director may require information...................................... 56
71.......... Consultation with prescribed bodies................................................. 57
72.......... Submissions on draft evaluation statement........................................ 58
73.......... Issue of evaluation statement............................................................. 58
Division 3—Evaluations of other introductions or matters 60
74.......... Executive Director may initiate evaluation......................................... 60
75.......... Consultation to inform evaluation..................................................... 60
76.......... Executive Director may require information...................................... 61
77.......... Person must comply with requirement to provide information.......... 62
78.......... Issue of evaluation statement............................................................. 62
Part 5—Australian Inventory of Industrial Chemicals 64
Division 1—Simplified outline of this Part 64
79.......... Simplified outline of this Part............................................................ 64
Division 2—Establishment and contents of Inventory 65
80.......... Establishment of the Inventory.......................................................... 65
81.......... Contents of the Inventory.................................................................. 65
Division 3—Inclusion of industrial chemicals on Inventory 67
82.......... Listing on Inventory after 5 years..................................................... 67
83.......... Listing on Inventory before 5 years.................................................. 68
84.......... Listing on Inventory in other circumstances...................................... 69
Division 4—Varying the Inventory 72
Subdivision A—Variation on Executive Director’s initiative and variation relating to subsequent assessment certificates 72
85.......... Minor variations................................................................................ 72
86.......... Variations following an evaluation by the Executive Director........... 72
87.......... Variations relating to subsequent assessment certificates.................. 73
Subdivision B—Variation on application 74
88.......... Applying for variation of listing........................................................ 74
89.......... Executive Director must consider application.................................... 75
90.......... Executive Director may request further information.......................... 75
91.......... Consultation with prescribed bodies................................................. 76
92.......... Consultation with Gene Technology Regulator................................. 76
93.......... Decision on application..................................................................... 76
Subdivision C—Variation following revocation of confidential business information approval 78
94.......... Variation following revocation of confidential business information approval 78
Subdivision D—Removing listed industrial chemicals 78
95.......... Removing listed industrial chemicals................................................ 78
Part 6—Information, reporting and confidentiality 80
Division 1—Simplified outline of this Part 80
96.......... Simplified outline of this Part............................................................ 80
Division 2—Reporting 81
97.......... Pre-introduction reports for reported introductions........................... 81
98.......... Varying the terms of a pre-introduction report.................................. 82
99.......... Annual declaration for all introduction categories............................. 82
100........ Obligation to report information about hazards................................. 83
101........ Specific obligations to provide information....................................... 84
Division 3—Record keeping and information gathering 87
102........ Information required to demonstrate categorisation........................... 87
103........ Ban on animal test data for determining category for cosmetics........ 88
104........ Record keeping for all categories...................................................... 88
Division 4—Confidentiality and disclosure 90
Subdivision A—Confidentiality of proper name or end use in certain circumstances 90
105........ Applying for protection..................................................................... 90
106........ Executive Director may request further information.......................... 91
107........ Consultation with prescribed bodies................................................. 92
108........ Decision on application..................................................................... 92
109........ When an AACN or generalised end use must be used...................... 93
110........ Notice of review of protection........................................................... 94
111........ Applying for continued protection.................................................... 95
Subdivision B—Confidentiality of information in other circumstances 96
112........ Providing notice of intention to apply for protection......................... 96
113........ Notice of intention to publish information must be given.................. 97
114........ Decision on application..................................................................... 97
Subdivision C—Disclosure of information 98
115........ Disclosing information...................................................................... 98
116........ Disclosure in the course of exercising powers, or performing functions or duties 100
117........ Disclosure to certain other entities................................................... 100
118........ Disclosure with consent.................................................................. 102
119........ Disclosure of publicly available information................................... 102
120........ Disclosure to a bona fide introducer................................................ 102
121........ Disclosure to person to whom protected information relates........... 102
122........ Disclosure to person from whom protected information was obtained 102
123........ Disclosure to a Court, tribunal etc................................................... 103
124........ Disclosure for the purposes of law enforcement............................. 103
125........ Disclosure to reduce serious risk to public health........................... 104
126........ Disclosure to reduce serious risk to the environment...................... 104
Part 7—Enforcement 105
Division 1—Simplified outline of this Part 105
127........ Simplified outline of this Part.......................................................... 105
Division 2—Monitoring and investigation powers 106
128........ Monitoring powers......................................................................... 106
129........ Investigation powers....................................................................... 107
Division 3—Civil penalty provisions, infringement notices and injunctions 110
130........ Civil penalty provisions.................................................................. 110
131........ Infringement notices........................................................................ 110
132........ Enforceable undertakings................................................................ 111
133........ Injunctions...................................................................................... 111
134........ Extension to external Territories...................................................... 112
Division 4—Miscellaneous 113
135........ Physical elements of offences......................................................... 113
136........ Contravening an offence provision or a civil penalty provision...... 113
137........ Appointment of authorised inspectors............................................. 113
138........ Delegations by relevant chief executive........................................... 114
Part 8—Administration 115
Division 1—Simplified outline of this Part 115
139........ Simplified outline of this Part.......................................................... 115
Division 2—Australian Industrial Chemicals Introduction Scheme and the Executive Director 116
140........ Australian Industrial Chemicals Introduction Scheme..................... 116
141........ Executive Director........................................................................... 116
142........ Functions of Executive Director...................................................... 116
Division 3—Appointment of the Executive Director 117
143........ Appointment................................................................................... 117
144........ Term of appointment....................................................................... 117
145........ Acting Executive Director............................................................... 117
Division 4—Terms and conditions for the Executive Director 118
146........ Remuneration and allowances......................................................... 118
147........ Leave of absence............................................................................. 118
148........ Outside employment....................................................................... 118
149........ Disclosure of interests..................................................................... 118
150........ Resignation of Executive Director................................................... 119
151........ Termination of appointment of Executive Director.......................... 119
152........ Other terms and conditions of appointment of Executive Director.. 120
Division 5—Persons assisting the Executive Director 121
153........ Arrangements relating to staff of the Department............................ 121
154........ Other persons assisting the Executive Director............................... 121
Division 6—Industrial Chemicals Special Account 122
155........ Industrial Chemicals Special Account............................................. 122
156........ Credits to Industrial Chemicals Special Account............................. 122
157........ Purposes of the Industrial Chemicals Special Account................... 123
Part 9—International agreements and arrangements 124
Division 1—Simplified outline of this Part 124
158........ Simplified outline of this Part.......................................................... 124
Division 2—Information exchange under the Rotterdam Convention 125
Subdivision A—Notification of ban or restriction 125
159........ Notification of ban or restriction on introduction or use.................. 125
Subdivision B—Exchange of certain information 127
160........ Exchange of certain information about industrial chemicals............ 127
Subdivision C—Information gathering 128
161........ Executive Director may obtain information and documents............ 128
162........ Person must comply with notice under section 161........................ 128
Division 3—Movements of industrial chemicals into or out of Australia 130
163........ Movements of industrial chemicals into or out of Australia............ 130
164........ Introducing or exporting if prohibited or restricted......................... 131
Part 10—Miscellaneous 133
165........ Simplified outline of this Part.......................................................... 133
166........ Reconsideration and review of decisions........................................ 133
167........ General requirements for applications............................................. 135
168........ Ban on animal test data for applications for cosmetics.................... 137
169........ Calculating the consideration period for an application................... 137
170........ Additional provisions about fees..................................................... 141
171........ Protection from civil actions............................................................ 141
172........ Executive Director may use computer programs to make decisions 142
173........ Copies of documents....................................................................... 142
174........ Executive Director may retain documents....................................... 142
175........ Self-incrimination............................................................................ 143
176........ Delegations by Minister.................................................................. 143
177........ Delegations by Executive Director.................................................. 144
178........ Compensation for acquisition of property....................................... 144
179........ Annual report.................................................................................. 144
180........ Rules............................................................................................... 144
A Bill for an Act to establish a national regulatory scheme for industrial chemicals, and for related purposes
The Parliament of Australia enacts: