Breadcrumbs

DIR 207

Commercial release of a genetically modified (GM) mosquito strain to help prevent dengue outbreaks

Licence details

Licence number:
DIR 207
Licence status:
Application under evaluation
Category:
Other
Release:
Commercial
Organisation:

Oxitec Australia Pty Ltd

Description:

Oxitec Australia Pty Ltd (Oxitec) is seeking approval from the Gene Technology Regulator for commercial release of genetically modified (GM) Aedes aegypti mosquitoes. The GM mosquitoes have been modified to prevent the survival of female mosquitoes, which are a vector for diseases such as dengue fever. Only GM male mosquitoes that do not bite and cannot transmit disease will be released. These GM male mosquitoes would mate with wild female mosquitoes and only produce male offspring. The intention is to reduce the numbers of a specific type of mosquito (Aedes aegypti) that can carry dengue virus. 

Steps in the decision-making process for the GM mosquito application:

Steps 1 and 2 have been completed:

Initially, the Regulator sought advice on this application from experts, agencies and authorities, and local councils. Subsequently, this advice was considered in the preparation of the Risk Assessment and Risk Management Plan (RARMP) for the application. 

Step 3. The public consultation on the RARMP is currently open and will close on 7 July 2025.                                                                                                                   You can access the RARMP and associated documents below or via the consultation hub. We are seeking your written comments on issues relating to the protection of human health and safety and the environment as a result of the genetic modification.                                                                                                                                               Note that experts, agencies and authorises have also been asked for further advice.

Step 4. The RARMP will be finalised, taking into consideration the comments received in Step 3.

Step 5. The Regulator must decide whether or not to issue a licence by the legislative due date. The licence decision will be publicly notified, and the GMO Record updated, including on our website. If you have subscribed to receive our updates, we will automatically send you a notification once a licence decision is made.

Other approvals:

Before this GM mosquito strain can be imported, sold and used as pest control in Australia, separate regulatory assessments and approvals are required from Australian Pesticides and Veterinary Medicines Authority (APVMA), Department of Agriculture, Fisheries and Forestry (DAFF) and Department of Climate Change, Energy, the Environment and Water (DCCEEW).

Date application received:
RARMP open for public consultation:
RARMP closed for public consultation:

Documents

Licence application - invitation to comment

An invitation for written submissions from the public on the consultation version of the Risk Assessment and Risk Management Plan. It also explains how the public can access the consultation documents and the due date for submissions.

Licence application - Q&A

FAQs on the licence application and a brief outline of the assessment and public consultation processes.

Risk assessment and risk management plan (consultation) - summary

A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.

Risk assessment and risk management plan (consultation) - full version

A draft risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s).

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