Gene Technology (Consequential Amendments) Act 2000

Administered by Department of Health, Disability and Ageing

Legislation au C2004A00763 In force Act

Legislation content

 

 

 

 

Gene Technology (Consequential Amendments) Act 2000

 

No. 170, 2000

 

 

 

 

Gene Technology (Consequential Amendments) Act 2000

 

No. 170, 2000

 

 

 

 

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

 

 

Contents

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

2 Commencement...............................

3 Schedule(s)..................................

Schedule 1—Consequential amendments

Agricultural and Veterinary Chemicals (Administration) Act 1992

Agricultural and Veterinary Chemicals Code Act 1994

Australia New Zealand Food Authority Act 1991

Freedom of Information Act 1982

Industrial Chemicals (Notification and Assessment) Act 1989

Therapeutic Goods Act 1989

 

Gene Technology (Consequential Amendments) Act 2000

No. 170, 2000

 

 

 

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

[Assented to 21 December 2000]

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  Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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

 (ii) the registration of the chemical product;

 (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:

 

Gene Technology Act 2000, subsections 187(1) and (2)

Industrial Chemicals (Notification and Assessment) Act 1989

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, a GM product.

 (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.

 

 

 

[Minister’s second reading speech made in—

House of Representatives on 22 June 2000

Senate on 30 August 2000]

 

 

(106/00)

 

 

Overview

The Gene Technology (Consequential Amendments) Act 2000 (No. 170, 2000) was enacted to address the consequential legislative matters that arose from the introduction of the Gene Technology Act 2000. This Act, which was assented to on 21 December 2000 by the Parliament of Australia, aims to ensure that various existing Acts are updated and aligned with the new regulatory framework established by the Gene Technology Act. The primary objective of this Act is to make necessary amendments to existing legislation to incorporate definitions and regulatory processes related to genetically modified organisms and products, thereby facilitating a cohesive and comprehensive approach to gene technology regulation across different sectors such as agriculture, food, chemicals, and therapeutic goods. The Gene Technology (Consequential Amendments) Act 2000 makes specific amendments to the Agricultural and Veterinary Chemicals (Administration) Act 1992, Agricultural and Veterinary Chemicals Code Act 1994, Australia New Zealand Food Authority Act 1991, Freedom of Information Act 1982, Industrial Chemicals (Notification and Assessment) Act 1989, and Therapeutic Goods Act 1989. These amendments ensure that the regulatory requirements and definitions pertaining to genetically modified organisms and products are uniformly applied across these Acts, thereby avoiding inconsistencies and gaps in regulation that could potentially arise from the introduction of the new gene technology legislative framework.

Scope and Application

The Gene Technology (Consequential Amendments) Act 2000 applies to a range of Australian legislative Acts and amendments to ensure consistency and coordination in the regulatory framework surrounding gene technology. This Act is pertinent to the National Industrial Chemicals Notification and Assessment Scheme, the Agricultural and Veterinary Chemicals Scheme, the Therapeutic Goods Administration, and the Australia New Zealand Food Authority, among others. It mandates that these entities consult with the Gene Technology Regulator when dealing with applications or assessments related to genetically modified products. The Act applies nationally, as it involves multiple jurisdictions and regulatory bodies across Australia. The Act does not specify particular exclusions or thresholds but rather integrates the regulatory processes of various Acts with the overarching framework established by the Gene Technology Act 2000. Additionally, the application and interpretation of this Act may be further defined through subordinate instruments issued under the authority of the relevant Acts.

Key Provisions

The Gene Technology (Consequential Amendments) Act 2000 primarily focuses on making adjustments to various Acts in response to the enactment of the Gene Technology Act 2000. It ensures that existing laws are compatible with the new gene technology regulations, particularly in terms of the definitions and procedural requirements for genetic modifications. For example, section 4 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (section 1 of the Schedule) inserts definitions for terms such as "Gene Technology Regulator" and "GM product" to align with the Gene Technology Act 2000. Additionally, section 8A (section 2 of the Schedule) mandates consultation with the Gene Technology Regulator for decisions concerning chemical products that contain genetically modified (GM) products. The Act imposes several obligations on the relevant authorities and entities. For instance, the National Registration Authority (NRA) must consult with the Gene Technology Regulator before making decisions on applications, variations, reconsiderations, and permit issuances involving GM products (section 8A of the Agricultural and Veterinary Chemicals (Administration) Act 1992). Similarly, the Director of the Industrial Chemicals (Notification and Assessment) Act 1989 must notify the Gene Technology Regulator of assessments or permit applications related to GM products (section 10A of the Act). Furthermore, the Secretary of the Therapeutic Goods Act 1989 must also consult the Gene Technology Regulator when considering applications for listing or registration of therapeutic goods that are or contain GM products (section 30C of the Act). These obligations ensure that all relevant stakeholders are aware of and comply with gene technology regulations. Breaches of the Act and its associated provisions can lead to various consequences. While the Act itself does not explicitly outline specific penalties, the underlying Acts—such as the Agricultural and Veterinary Chemicals (Administration) Act 1992, the Industrial Chemicals (Notification and Assessment) Act 1989, and the Therapeutic Goods Act 1989—contain provisions for penalties. For example, failure to comply with the gene technology regulations under the Agricultural and Veterinary Chemicals (Administration) Act 1992 could result in penalties under that Act, which can include fines up to $11,100 for individuals and higher for corporations. Similar penalties apply under the other Acts, reflecting the seriousness with which non-compliance is treated.

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