The Parliament of the

Commonwealth of Australia

HOUSE OF REPRESENTATIVES

Presented and read a first time

Gene Technology (Consequential Amendments) Bill 2000

No. , 2000

(Health and Aged Care)

A Bill for an Act to deal with consequential matters arising from the enactment of the Gene Technology Act 2000, and for related purposes

ISBN: 0642 436649

Contents

Agricultural and Veterinary Chemicals (Administration) Act 1992 3

Agricultural and Veterinary Chemicals Code Act 1994 5

Australia New Zealand Food Authority Act 1991 5

Freedom of Information Act 1982 6

Industrial Chemicals (Notification and Assessment) Act 1989 6

Therapeutic Goods Act 1989 8

A Bill for an Act to deal with consequential matters arising from the enactment of the Gene Technology Act 2000, and for related purposes

The Parliament of Australia enacts:

1 Short title This Act may be cited as the Gene Technology (Consequential Amendments) Act 2000.

2 Commencement This Act commences on the same day as section 55 of the Gene Technology Act 2000.

3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

Schedule 1--Consequential amendments

Agricultural and Veterinary Chemicals (Administration) Act 1992

1 Section 4

Insert:

Gene Technology Regulator has the same meaning as in the Gene Technology Act 2000.

2 Section 4

Insert:

GM product has the same meaning as in the Gene Technology Act 2000.

3 After section 8

Insert:

8A Consultation with Gene Technology Regulator (1) This section applies to the following:

(a) an active constituent for a proposed or existing chemical product, being an active constituent that is or contains a GM product;

(b) a proposed or existing chemical product that is or contains a GM product.

(2) The NRA must consult the Gene Technology Regulator in accordance with this section for the purposes of the following:

(a) deciding whether to grant an application under the Code in relation to any of the following:

(i) approval of the active constituent;

(ii) registration of the chemical product;

(iii) approval of a label for containers for the chemical product;

(b) deciding whether to grant an application under the Code in relation to a variation of any of the following:

(i) the approval of the active constituent;

(ii) the registration of the chemical product;

(iii) the approval of a label for containers for the chemical product;

if the variation may affect the GM product;

(c) reconsidering any of the following:

(i) the approval of the active constituent;

(iii) the approval of a label for containers for the chemical product;

(d) deciding whether to issue a permit in respect of:

(i) the active constituent; or

(ii) the chemical product.

(3) If the NRA is required to consult the Gene Technology Regulator under subsection (2), the NRA must give written notice to the Gene Technology Regulator:

(a) stating that the application has been made, the reconsideration is to be undertaken, or the issue of the permit is being considered; and

(b) requesting the Gene Technology Regulator to give advice about the application, reconsideration, or issue.

(4) If the NRA gives the Gene Technology Regulator a notice under subsection (3), the Gene Technology Regulator may give written advice to the NRA about the application, reconsideration, or issue.

(5) The advice is to be given within the period specified in the notice.

(6) If the NRA receives advice from the Gene Technology Regulator in response to a notice under this section within the period specified in the notice, the NRA must:

(a) ensure that the advice is taken into account in making a decision on the application, reconsideration, or issue to which the notice relates; and

(b) inform the Gene Technology Regulator of the decision.

(7) Unless the contrary intention appears, expressions used in this section have the same meanings as in the Agricultural and Veterinary Chemicals Code Act 1994.

Agricultural and Veterinary Chemicals Code Act 1994

4 After paragraph 14(3)(c) of the Code set out in the Schedule

Insert:

(ca) that, if necessary, paragraph 8A(2)(a) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with;

5 After paragraph 29(1)(c) of the Code set out in the Schedule

Insert:

(ca) that, if necessary, paragraph 8A(2)(b) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with;

6 After paragraph 34(1)(d) of the Code set out in the Schedule

Insert:

and (da) that, if necessary, paragraph 8A(2)(c) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with;

7 After subsection 114(1) of the Code set out in the Schedule

Insert:

(1A) Before issuing a permit, the NRA must be satisfied that, if necessary, paragraph 8A(2)(d) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with.

Australia New Zealand Food Authority Act 1991

8 Subsection 3(1) (after paragraph (b) of the definition of appropriate government agency)

Insert:

(ba) the Gene Technology Regulator; or

9 Subsection 3(1)

Insert:

Gene Technology Regulator has the same meaning as in the Gene Technology Act 2000.

10 Subsection 3(1)

Insert:

GMO has the same meaning as in the Gene Technology Act 2000.

11 Subsection 3(1)

Insert:

GM product has the same meaning as in the Gene Technology Act 2000.

12 After section 11

Insert:

11A Notices to be given to the Gene Technology Regulator If a provision of this Act requires the Authority to give a notice concerning an existing or proposed food regulatory measure to the Gene Technology Regulator, the Authority is only required to give the notice if the food regulatory measure relates to food that is or contains a GMO or a GM product.

Freedom of Information Act 1982

13 Schedule 3

Insert in its appropriate alphabetical position:

14 Section 5

Insert:

Gene Technology Regulator has the same meaning as in the Gene Technology Act 2000.

15 Section 5

Insert:

GM product has the same meaning as in the Gene Technology Act 2000.

16 After section 10

Insert:

10A Consultation with Gene Technology Regulator (1) This section applies to the following:

(a) an assessment of an industrial chemical that is, or contains, a GM product;

(b) an application for a permit (however described) in relation to an industrial chemical that is, or contains, a GM product.

(2) Subject to subsection (5), the Director must give written notice to the Gene Technology Regulator:

(a) stating that the assessment is to be undertaken, or that the application for the permit has been made, as the case requires; and

(b) requesting the Gene Technology Regulator to give advice about the assessment or the application for the permit.

(3) If the Director gives the Gene Technology Regulator a notice under subsection (2), the Gene Technology Regulator may give written advice to the Director about the assessment or the application.

(4) The advice is to be given within the period specified in the notice.

(5) If an advice from the Gene Technology Regulator is in force under section 10B in relation to a class of GM products, the Director is not required to notify the Regulator under this section in relation to:

(a) an assessment of an industrial chemical that is or contains a GM product belonging to that class; or

(b) an application for a permit in respect of an industrial chemical that is or contains a GM product belonging to that class.

10B Director may seek advice about classes of GM products (1) The Director may request advice from the Gene Technology Regulator in relation to industrial chemicals that consist of, or that contain, a GM product belonging to a class of GM products specified in the request.

(2) A request for advice under subsection (1) must specify the matters to which the advice is to relate.

(3) If the Director requests advice from the Gene Technology Regulator under subsection (1), the Gene Technology Regulator may provide written advice in relation to the matters specified in the request.

(4) If the Gene Technology Regulator gives advice to the Director under subsection (3), the advice remains in force until it is withdrawn by the Gene Technology Regulator by written notice given to the Director.

10C Director to take advice into account If the Director receives advice from the Gene Technology Regulator:

(a) in response to a notice under section 10A within the period specified in the notice; or

(b) under section 10B;

the Director must:

(c) ensure that the advice is taken into account in undertaking the assessment, or in making a decision on the application for the permit, as the case requires; and

(d) inform the Gene Technology Regulator of the assessment, or the decision on the application, as the case requires.

Therapeutic Goods Act 1989

17 Subsection 3(1)

Insert:

Gene Technology Regulator has the same meaning as in the Gene Technology Act 2000.

18 Subsection 3(1)

Insert:

GM product has the same meaning as in the Gene Technology Act 2000.

19 After section 30B

Insert:

30C Consultation with Gene Technology Regulator (1) This section applies to an application for listing or registration of a therapeutic good under section 23 if the therapeutic good is, or contains,

(2) Subject to subsection (5), the Secretary must give written notice to the Gene Technology Regulator:

(a) stating that the application has been made; and

(b) requesting the Gene Technology Regulator to give advice about the application.

(3) If the Secretary gives the Gene Technology Regulator a notice under subsection (2), the Gene Technology Regulator may give written advice to the Secretary about the application.

(4) The advice is to be given within the period specified in the notice.

(5) If an advice from the Gene Technology Regulator is in force under section 30D in relation to a class of therapeutic goods, the Secretary is not required to notify the Regulator under this section in relation to an application for listing or registration of a therapeutic good belonging to that class.

30D Secretary may seek advice about classes of GM products (1) The Secretary may request advice from the Gene Technology Regulator in relation to therapeutic goods that consist of, or that contain, a GM product belonging to a class of GM products specified in the request.

(2) A request for advice under subsection (1) must specify the matters to which the advice is to relate.

(3) If the Secretary requests advice from the Gene Technology Regulator under subsection (1), the Gene Technology Regulator may provide written advice in relation to the matters specified in the request.

(4) If the Gene Technology Regulator gives advice to the Secretary under subsection (3), the advice remains in force until it is withdrawn by the Gene Technology Regulator by written notice given to the Secretary.

30E Secretary to take advice into account If the Secretary receives advice from the Gene Technology Regulator:

(a) in response to a notice under section 30C within the period specified in the notice; or

(b) under section 30D;

the Secretary must:

(c) ensure that the advice is taken into account in making a decision on the application to which the notice relates, or on an application to which the advice under section 30D relates, as the case requires; and

(d) inform the Gene Technology Regulator of the decision on the application.