1.1 What is the purpose of this Explanatory Guide?

In June 2000, the Federal Government introduced a package of three Bills into Federal Parliament for the regulation of gene technology in Australia - the Gene Technology Bill 2000, the Gene Technology (Consequential Amendments) Bill 2000 and the Gene Technology (Licence Charges) Bill 2000.

During public consultations on the development of the legislative scheme, many people told us that it would be helpful to have a “plain-English” guide available to accompany the legislation. Therefore, when we released for consultation the first draft of the Gene Technology Bill 2000 we also released the “Explanatory Guide to the draft Commonwealth Gene Technology Bill – December 1999”. We received a lot of positive feedback on the explanatory guide including a number of suggestions on how to make it even more “user-friendly”.

On the basis of this experience, we have drafted this guide to accompany the three gene technology Bills which have just been introduced into Federal Parliament.
The guide:
  • uses plain language so it can be more easily understood by people who may not be used to reading and interpreting legislation;
  • provides information about the reasons behind important parts of the Bills, including why they are drafted the way that they are and what they are trying to achieve;
  • helps to explain how other important documents interact with the Bills to create a national system for regulating GMOs (such as the Gene Technology Regulations, the proposed Gene Technology Agreement, and complementary State and Territory legislation);
  • is in addition to the formal “Explanatory Memoranda” which have also been tabled in Parliament. Explanatory memoranda must be prepared for every Bill introduced into Parliament. They follow a strict format and explain each clause of a Bill. They also describe the anticipated impact of the regulation, through a Regulation Impact Statement. By contrast, this guide is less formal and summarises the legislation.
This guide is divided into a number of chapters. They are:

Chapter 2 – Gene technology and the need for legislation

This chapter sets out what gene technology is, describes the current system for controlling gene technology in Australia and why we need legislation.

Chapter 3 – A summary of the proposed legislation

This is an executive summary which describes key aspects of the Gene Technology Bill 2000. It will be useful to people who would like a ‘thumbnail sketch’ of the proposed legislation. It is also a good source of information for anyone needing to give brief information about the Bill to their organisation or others interested in the legislation.

Chapter 4 – Detailed explanation of the Gene Technology Bill 2000

This Chapter has been divided into 12 parts to correspond with the 12 parts of the Gene Technology Bill 2000. It provides a simplified outline of each part of the Bill including a description of the main policy considerations.

Chapter 5 – Commonwealth Gene Technology (Consequential Amendments) Bill 2000

This chapter describes the amendments that will be made to existing legislation (such as the Therapeutic Goods Act and the Australia New Zealand Food Act) to ensure the streamlined operation of the new gene technology legislation alongside this existing legislation.

Chapter 6 – Commonwealth Gene Technology (Licence Charges) Bill 2000

This chapter describes the purpose of the Licence Charges Bill and cost recovery for the new regulatory system.

Chapter 7 – Commonwealth Gene Technology Regulations

Regulations form part of a regulatory system but are contained in a separate document to the Bills. This chapter describes what will be covered in the regulations which will be publicly circulated in July 2000 for comments by September 2000.

Chapter 8 – Model State legislation

This chapter describes the process and purpose of model State/Territory legislation and the matters to be included in such legislation.

Chapter 9 – Gene Technology Agreement

This chapter describes the purpose of the proposed Inter-governmental agreement and the major issues it will address.

1.2 Acronyms used in this Guide

AFFAAgriculture Fisheries and Forestry Australia
ANZFA Australia New Zealand Food Authority
AQISAustralian Quarantine and Inspection Service
CSCG Commonwealth State Consultative Group on Gene
GMAC Genetic Manipulation Advisory Committee
GMO genetically modified organism
GM genetically modified
GTR Gene Technology Regulator1 (also referred to as “the
GTTAC Gene Technology Technical Advisory Committee
GTCCG Gene Technology Community Consultative Group
GTEC Gene Technology Ethics Committee
IGA Intergovernmental Agreement on Gene Technology
IOGTR Interim Office of the Gene Technology Regulator
NICNAS National Industrial Chemicals Notification and Assessment Scheme
NRA National Registration Authority for Agricultural and Veterinary Chemicals
RIS Regulation Impact Statement
TGA Therapeutic Goods Administration

1The full term is used in several places to distinguish the GTR from existing regulators