About the National Gene Drive Policy Guide

About the guide

A draft National Gene Drive Policy Guide has been developed in consultation with all Australian governments and experts from research and industry. The guide will help proponents of gene drive technology understand:

how gene drive technology and organisms are regulated in Australia
what to consider before applying for gene drive technology research or environmental release.

Read about the consultation on the draft guide.

Purpose

All dealings involving a genetically modified (GM) gene drive organism are regulated under the National Gene Technology Scheme and require a licence from the Gene Technology Regulator. The regulator issues licences according to the requirements of the Gene Technology Act 2000. The regulator may impose conditions that are considered necessary to manage risks posed by the dealing. This is achieved through the Risk Assessment and Risk Management Plan.

The scheme is also complemented by various Commonwealth, state, and territory legislation, which may be triggered depending on the type of GM gene drive organism.

As an evolving technology, the regulation of any application to environmentally release a GMO or GM gene drive organism may be more complex than applications for contained research in a laboratory. The National Gene Drive Policy Guide aims to provide guidance and information to improve stakeholders’ understanding of the regulatory environment and additional risk considerations that may apply to them.

While the guide aims to provide proponents with an understanding of what they need to consider, the list of considerations may not be exhaustive. Proponents must take responsibility for fulfilling the conditions that their application(s) require.

Draft National Gene Drive Policy Guide

Guideline

The draft National Gene Drive Policy Guide aims to provide guidance and information to improve stakeholders’ understanding of the regulatory environment and additional risk considerations that apply to gene drives.

Case studies

Different applications of gene drives could have different regulatory requirements. The Gene Technology Regulator will assess applications based on the specific circumstances including any unique risks they may pose.

These hypothetical case studies provide an example of the many different considerations and how these may vary depending on the application of a GM gene drive (or other applications for environmental release of GMOs).

Note that these are hypothetical examples only. Consult the Gene Technology Regulator about your requirements.

Hypothetical gene drive environmental release case studies

Fact sheet

This document presents 4 hypothetical scenarios developed to demonstrate regulatory requirements and risk considerations that may apply to environmental release of gene drives.

Potentially applicable legislation

GM gene drives may trigger different legislative and regulatory requirements depending on what the gene drive does and the risks it poses. A GM gene drive may also trigger different legislation in different states and territories.

The tables below show a range of Commonwealth, state and territory legislation that may apply to a GM gene drive application. Follow the links to read the legislation.

State and territory legislation that may apply to an application for environmental release of a GM gene drive or GMO
State	Gene technology legislation	Potential legislation that may need to be considered
Australian Capital Territory	Gene Technology Act 2003 Gene Technology Regulation 2004 Gene Technology (GM Crop Moratorium) Act 2004	Animal Welfare Act 1992 Pest Plants and Animals Act 2005 Animal Diseases Act 2005 Plant Diseases Act 2002 Nature Conservation Act 2014 Fisheries Act 2000 Environment Protection Act 1997 Food Act 2001 National Environment Protection Council Act 1994 Public Health Act 1997 Biological Control Act 1984
New South Wales	Gene Technology (New South Wales) Act 2003	Biological Control Act 1985 Biosecurity Act 2015 Animal Research Act 1985 Biodiversity Conservation Act 2016 Food Act 2003 Prevention of Cruelty to Animals Act 1979 Protection of the Environment Administration Act 1991 Protection of the Environment Operations Act 1979 Public Health Act 2010
Northern Territory	Gene Technology (Northern Territory) Act 2004	Agriculture and Veterinary Chemicals (Northern Territory) Act 1994 Biological Control Act 1986 Animal Protection Act 2018 Aboriginal Land Rights Act 1976 Territory Parks and Wildlife Conservation Act 1976 Environment Protection Act 2019 Biological Resources Act 2006 Food Act 2004 Public and Environmental Health Act 2011
Queensland	Gene Technology (Queensland) Act 2016	Agricultural and Veterinary Chemicals (Queensland) Act 1994 Biological Control Act 1987 Animal Care and Protection Act 2001 Biosecurity Act 2014 Biodiscovery Act 2004 Environmental Protection Act 1994 Nature Conservation Act 1992 Environmental Protection Act 1994 Food Act 2006 Pest Management Act 2001 Public Health Act 2005
South Australia	Gene Technology Act 2001 Genetically Modified Crops Management Act 2004 Genetically Modified Crops Management Regulations 2008	Biological Control Act 1986 Agricultural and Veterinary Chemicals (South Australia) Act 1994 Plant Health Act 2009 Animal Welfare Act 1985 National Parks and Wildlife Act 1972 Landscape South Australia Act 2019 Environment Protection Act 1993 Public Health Act 2011 Food Act 2001 Marine Parks Act 2007 Fisheries Management Act 2007
Tasmania	Gene Technology (Tasmania) Act 2012 Tasmanian Genetically Modified Organisms Control Act 2004 Genetically Modified Organisms Control (GMO-free Area) Order 2005	Agricultural and Veterinary Chemicals (Tasmania) Act 1994 Animal Welfare Act 1993 Biological Control Act 1986 Biosecurity Act 2019 Environmental Management and Pollution Control Act 1994 Food Act 2003 Threatened Species Protection Act 1995 Public Health Act 1997 Nature Conservation Act 2002 Living Marine Resources Management Act 1995
Victoria	Gene Technology Act 2001 Gene Technology Regulations 2011 Control of Genetically Modified Crops Act 2004	Biological Control Act 1986 Prevention of Cruelty to Animals Act 1986 Agricultural and Veterinary Chemicals (Victoria) Act 1994 Plant Biosecurity Act 2010 Environment Protection Act 1970 Catchment and Land Protection Act 1994 Conservation, Forests and Land Act 1987 Food Act 1984 Flora and Fauna Guarantee Act 1988 Heritage Rivers Act 1992 National Parks Act 1975 Wildlife Act 1975
Western Australia	Gene Technology Act 2006 Gene Technology Regulations 2007	Biological Control Act 1986 Agriculture and Related Resources Protection Act 1976 Agricultural and Veterinary Chemicals (WA) Act 1995 Animal Welfare Act 2002 Biosecurity and Agriculture Management Act 2007 Biodiversity Conservation Act 2016 Intergovernmental Agreement on the Environment 1992 National Environment Protection Council Act 1994 Conservation and Land Management Act 1984 Agricultural Produce Commission Act 1988 Environmental Protection Act 1986

Commonwealth legislation that may apply to an application for environmental release of a GM gene drive or GMO
Department of Health and Aged Care	Department of Agriculture, Fisheries and Forestry	Department of Climate Change, Energy, the Environment and Water	Australian Pesticides and Veterinary Medicines Authority (APVMA)
Gene Technology Act 2000 Gene Technology Regulations 2001 Biosecurity Act 2015 Biosecurity Regulations	Biological Control Act 1985 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)	Environment Protection and Biodiversity Conservation Act 1999 Australian code for the care and use of animals for scientific purposes	Agricultural and Veterinary Chemicals (Administration) Act 1992 Agricultural and Veterinary Chemicals Code Act 1994 Agricultural and Veterinary Chemicals Act 1994

The tables above may not list all applicable legislation and legislation could change over time. Applicants wishing to environmentally release a gene drive or GMO need to ensure they understand the requirements prior to applying. Applications may need to comply with multiple state and territory laws.

Last updated:

24 April 2024