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DIR 159

Limited and controlled release of genetically modified insect-specific viruses as vaccines against Kunjin virus infection in farmed crocodiles

Licence details

Licence number:
DIR 159
Licence status:
Current
Category:
Veterinary
Release:
Limited and controlled
Organisation:

The University of Queensland

Parent organism:

Insect-specific flaviviruses

Modified trait:

Vaccine – altered antigen expression

Licence issue date:
Description:

This licence allows the University of Queensland to conduct a limited and controlled release of genetically modified insect-specific viruses as vaccines against Kunjin virus infection in farmed crocodiles. The parent organisms are two distinct insect-specific viruses normally associated with mosquitoes in northern Australia. These viruses are not known to cause disease in infected mosquitoes and are not able to replicate or cause disease in humans or other animals.



Control measures include limiting access to the site to authorised staff; keeping inoculated crocodiles physically separated from non-inoculated crocodiles; and appropriate waste disposal. Inoculated crocodiles could enter general commerce, including use in human food or animal feed, however this would only be permitted once testing confirms that the GM viruses are no longer present.

The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.

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

Documents

Licence decision - notification

Outlines the Regulator’s decision to issue a licence following the assessment of this application.

Licence decision - Q&A

FAQs on the licence application and the Regulator’s decision to issue a licence for this application.

Risk assessment and risk management plan - 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 - full version

The final 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). It also includes a summary of submissions received during the public consultation process.

Licence conditions

Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.

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