2013-2014-2015 

 

The Parliament of the 

Commonwealth of Australia 

 

HOUSE OF REPRESENTATIVES 

 

 

 

 

Presented and read a first time 

 

 

 

 

Gene Technology Amendment Bill 2015 

 

No.      , 2015 

 

(Health) 

 

 

 

A Bill for an Act to amend the Gene Technology Act 

2000, and for related purposes 

   

   

 

 

No.      , 2015 

Gene Technology Amendment Bill 2015 

i 

 

Contents 

1 

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

 

2 

Commencement ................................................................................. 1

 

3 

Schedules ........................................................................................... 2

 

Schedule 1--Gene Technology Act 2000

 

3

 

Part 1--Reporting requirements

 

3

 

Gene Technology Act 2000

 

3

 

Part 2--Inadvertent dealings

 

5

 

Gene Technology Act 2000

 

5

 

Part 3--Public notification of risk assessment etc.

 

6

 

Gene Technology Act 2000

 

6

 

Part 4--GM products

 

7

 

Gene Technology Act 2000

 

7

 

Part 5--Restrictions on licence variations

 

9

 

Gene Technology Act 2000

 

9

 

Part 6--Technical amendments

 

10

 

Gene Technology Act 2000

 

10

 

 

 

 

 

No.      , 2015 

Gene Technology Amendment Bill 2015 

1 

 

A Bill for an Act to amend the Gene Technology Act 

1 

2000, and for related purposes 

2 

The Parliament of Australia enacts: 

3 

1  Short title 

4 

 

  This Act may be cited as the Gene Technology Amendment Act 

5 

2015. 

6 

2  Commencement 

7 

 

(1)  Each provision of this Act specified in column 1 of the table 

8 

commences, or is taken to have commenced, in accordance with 

9 

column 2 of the table. Any other statement in column 2 has effect 

10 

according to its terms. 

11 

 

12 

   

   

 

 

2 

Gene Technology Amendment Bill 2015 

No.      , 2015 

 

Commencement information 

Column 1 

Column 2 

Column 3 

Provisions 

Commencement 

Date/Details 

1.  Sections 1 to 3 

and anything in 

this Act not 

elsewhere covered 

by this table 

The day this Act receives the Royal Assent. 

 

2.  Schedule 1 

A single day to be fixed by Proclamation. 

However, if the provisions do not commence 

within the period of 6 months beginning on 

the day this Act receives the Royal Assent, 

they commence on the day after the end of 

that period. 

 

Note:  

This table relates only to the provisions of this Act as originally 

1 

enacted. It will not be amended to deal with any later amendments of 

2 

this Act. 

3 

 

(2)  Any information in column 3 of the table is not part of this Act. 

4 

Information may be inserted in this column, or information in it 

5 

may be edited, in any published version of this Act. 

6 

3  Schedules 

7 

 

  Legislation that is specified in a Schedule to this Act is amended or 

8 

repealed as set out in the applicable items in the Schedule 

9 

concerned, and any other item in a Schedule to this Act has effect 

10 

according to its terms. 

11 

Gene Technology Act 2000  Schedule 1 

Reporting requirements  Part 1 

 

 

No.      , 2015 

Gene Technology Amendment Bill 2015 

3 

 

Schedule 1

--Gene Technology Act 2000 

1 

Part 1

--Reporting requirements 

2 

Gene Technology Act 2000 

3 

1  After subsection 136(1) 

4 

Insert: 

5 

 

(1A)  The report must include information about the following: 

6 

 

(a)  GMO licences issued during the financial year; 

7 

 

(b)  any breaches of conditions of a GMO licence that have come 

8 

to the Regulator's attention during the financial year; 

9 

 

(c)  emergency dealing determinations made by the Minister 

10 

during the financial year; 

11 

 

(d)  any breaches of conditions of an emergency dealing 

12 

determination that have come to the Regulator's attention 

13 

during the financial year; 

14 

 

(e)  auditing and monitoring of dealings with GMOs under this 

15 

Act by the Regulator or an inspector during the financial 

16 

year. 

17 

Note:  

Auditing and monitoring may include spot checks. 

18 

2  Section 136A 

19 

Repeal the section. 

20 

3  Transitional provision 

21 

(1) 

If, when this item commences: 

22 

 

(a)  the Regulator has given a report to the Minister under 

23 

subsection 136A(1) of the old Act; and 

24 

 

(b)  the Minister has not yet caused a copy of the report to be laid 

25 

before each House of the Parliament in accordance with 

26 

subsection 136A(3) of the old Act; 

27 

subsection 136A(3) of the old Act continues to have effect, in relation 

28 

to the report, as if that subsection had not been repealed. 

29 

(2) 

In this item: 

30 

Schedule 1  Gene Technology Act 2000 

Part 1  Reporting requirements 

 

 

4 

Gene Technology Amendment Bill 2015 

No.      , 2015 

 

old Act means the Gene Technology Act 2000, as in force immediately 

1 

before the commencement of this item. 

2 

Gene Technology Act 2000  Schedule 1 

Inadvertent dealings  Part 2 

 

 

No.      , 2015 

Gene Technology Amendment Bill 2015 

5 

 

Part 2

--Inadvertent dealings 

1 

Gene Technology Act 2000 

2 

4  Paragraph 46A(a) 

3 

Repeal the paragraph, substitute: 

4 

 

(a)  the dealings proposed to be authorised by the licence are 

5 

limited to one or more of the following for purposes relating 

6 

to disposing of a GMO: 

7 

 

(i)  conducting experiments with the GMO; 

8 

 

(ii)  propagating the GMO; 

9 

 

(iii)  growing, raising or culturing the GMO; 

10 

 

(iv)  transporting the GMO; 

11 

 

(v)  any other dealings to be undertaken for the purposes of, 

12 

or for purposes relating to, disposing of the GMO; and 

13 

5  Paragraph 49(a) 

14 

Repeal the paragraph, substitute: 

15 

 

(a)  the dealings proposed to be authorised by the licence are 

16 

limited to one or more of the following for purposes relating 

17 

to disposing of a GMO: 

18 

 

(i)  conducting experiments with the GMO; 

19 

 

(ii)  propagating the GMO; 

20 

 

(iii)  growing, raising or culturing the GMO; 

21 

 

(iv)  transporting the GMO; 

22 

 

(v)  any other dealings to be undertaken for the purposes of, 

23 

or for purposes relating to, disposing of the GMO; and 

24 

6  Application 

25 

The amendments of the Gene Technology Act 2000 made by this Part 

26 

apply in relation to: 

27 

 

(a)  an inadvertent dealings application made on or after the 

28 

commencement of this item; and 

29 

 

(b)  an inadvertent dealings application made, but not decided, 

30 

before that commencement. 

31 

Schedule 1  Gene Technology Act 2000 

Part 3  Public notification of risk assessment etc. 

 

 

6 

Gene Technology Amendment Bill 2015 

No.      , 2015 

 

Part 3

--Public notification of risk assessment etc. 

1 

Gene Technology Act 2000 

2 

7  Paragraph 52(1)(b) 

3 

Repeal the paragraph, substitute: 

4 

 

(b)  in one or more newspapers that the Regulator considers 

5 

appropriate, having regard to the geographic area in which 

6 

the dealings proposed to be authorised by the licence may 

7 

occur; and 

8 

8  Paragraph 52(1)(c) 

9 

Omit "(if any)". 

10 

Gene Technology Act 2000  Schedule 1 

GM products  Part 4 

 

 

No.      , 2015 

Gene Technology Amendment Bill 2015 

7 

 

Part 4

--GM products 

1 

Gene Technology Act 2000 

2 

9  Section 10(1) (definition of Record) 

3 

Omit "and GM Product". 

4 

10  Subsection 17(5) 

5 

Omit "and GM Product". 

6 

11  Paragraph 17(6)(b) 

7 

Omit "and GM Product". 

8 

12  Section 117 (paragraph relating to Division 6) 

9 

Omit "GMOs and GM products", substitute "GMO dealings". 

10 

13  Division 6 of Part 9 (heading) 

11 

Repeal the heading, substitute: 

12 

Division 6--Record of GMO Dealings 

13 

14  Section 138 (heading) 

14 

Repeal the heading, substitute: 

15 

138  Record of GMO Dealings 

16 

15  Subsection 138(1) 

17 

Omit "and GM Product". 

18 

16  Subsection 138(2) 

19 

Omit "or GM products". 

20 

17  Subsection 138(5) 

21 

Repeal the subsection. 

22 

18  Subsection 138(8) 

23 

Omit "(4), (5)", substitute "(3A), (4)". 

24 

Schedule 1  Gene Technology Act 2000 

Part 4  GM products 

 

 

8 

Gene Technology Amendment Bill 2015 

No.      , 2015 

 

19  Transitional provision 

1 

 

After this item commences, the Regulator may remove information 

2 

from the Record of GMO Dealings if the information: 

3 

 

(a)  was on the Record as at that commencement; and 

4 

 

(b)  was included on the Record because the information involved 

5 

GM products. 

6 

Gene Technology Act 2000  Schedule 1 

Restrictions on licence variations  Part 5 

 

 

No.      , 2015 

Gene Technology Amendment Bill 2015 

9 

 

Part 5

--Restrictions on licence variations 

1 

Gene Technology Act 2000 

2 

20  Subsection 71(2B) 

3 

Repeal the subsection, substitute: 

4 

 

(2B)  If an application has been made for variation of a licence, the 

5 

Regulator must not vary the licence unless the Regulator is 

6 

satisfied that the risks posed by the dealings proposed to be 

7 

authorised by the licence as varied are covered by: 

8 

 

(a)  the risk assessment and the risk management plan in respect 

9 

of the original application for the licence; or 

10 

 

(b)  the risk assessment and the risk management plan in respect 

11 

of an application for another licence, but only if that other 

12 

licence was issued. 

13 

21  Application 

14 

The amendment of the Gene Technology Act 2000 made by this Part 

15 

applies in relation to: 

16 

 

(a)  an application for variation of a licence made on or after the 

17 

commencement of this item; and 

18 

 

(b)  an application for variation of a licence made, but not 

19 

decided, before that commencement. 

20 

Schedule 1  Gene Technology Act 2000 

Part 6  Technical amendments 

 

 

10 

Gene Technology Amendment Bill 2015 

No.      , 2015 

 

Part 6

--Technical amendments 

1 

Gene Technology Act 2000 

2 

22  Paragraph 30(a) 

3 

Repeal the paragraph, substitute: 

4 

 

(a)  whether a GMO licence is issued or refused in relation to a 

5 

particular application; or 

6 

23  Subsection 74(3) 

7 

Repeal the subsection, substitute: 

8 

 

(3)  Before the Governor-General makes regulations declaring a 

9 

dealing with a GMO to be a notifiable low risk dealing, the 

10 

Regulator must consider: 

11 

 

(a)  whether the dealing with the GMO would involve any risk to 

12 

the health and safety of people, or to the environment, taking 

13 

into account: 

14 

 

(i)  the properties of the GMO as a pathogen or pest; and 

15 

 

(ii)  the toxicity of any proteins produced by the GMO; and 

16 

 

(b)  if there is such a risk--whether one or more of the 

17 

requirements prescribed in the regulations for the purposes of 

18 

subsection 75(2) would be sufficient to manage that risk; and 

19 

 

(c)  any other matter the Regulator considers appropriate. 

20