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Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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…
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.
- Area of Law
- Environmental Law
- Instrument
- Act
- Concepts
- Commencement Provisions
- Consultation Requirements
- Regulatory Standards