Bioproperties Pty Ltd
Infectious laryngotracheitis virus (Gallid herpesvirus 1).
Vaccine - attenuation
This licence allows Bioproperties Pty Ltd to conduct a limited and controlled release of a GM vaccine for chickens, Vaxsafe® ILT. The parent organism is Infectious laryngotracheitis virus (ILTV) which causes an acute respiratory disease mainly affecting chickens. Although ILTV can potentially infect some other bird species such as turkeys, peafowls and pheasants, it does not infect people or other animals.
The proposed trial would take place on selected chicken farms in New South Wales and Victoria, over a five year period. Up to 2 million broiler chickens would be vaccinated during the trial. The control measures imposed include isolating the trial sites at least 1 km from poultry located on other poultry farms, administration of the GM vaccine only by trained and supervised personnel; limiting access to the site to authorised persons; shed exit procedures for people; not harvesting and transporting chickens to processing facilities until at least 14 days after treatment or if displaying virus symptoms; decontamination of sheds and equipment; and appropriate waste disposal. As is common in veterinary vaccine trials, the vaccinated chickens could enter general commerce, including use in human food or animal feed. APVMA has responsibility for regulating veterinary medicines in Australia and so Bioproperties will also need authorisation from APVMA prior to commencing the trial.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
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.
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.
Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.