Breadcrumbs

DIR 125

Commercial release of genetically modified vaccine to protect chickens against pathogenic Escherichia coli

Licence details

Licence number:
DIR 125
Licence status:
Current
Category:
Agricultural
Release:
Commercial
Organisation:

Zoetis Australia Research & Manufacturing Pty Ltd

Parent organism:

Escherichia coli

Modified trait:

Vaccine - attenuation

Licence issue date:
Description:

This licence allows Zoetis Australia Research & Manufacturing Pty Ltd to commence the commercial release of genetically modified vaccine to protect chickens against pathogenic Escherichia coli. A disease causing E. coli was isolated from an infected chicken. This E. coli was genetically modified by deleting part of a gene, aroA. The resulting GM E. coli cannot make some essential nutrients and does not cause disease in chickens. Nevertheless, it can help provide immunity to some disease causing E. coli strains. The GM E. coli is sensitive to the same antibiotics as its parent.

The Regulator has not imposed any specific measures to manage risk, as the risk assessment concluded that this release of GM E. coli poses negligible risks to the health and safety of people and the environment.  The APVMA regulates the use of veterinary medicines in Australia. Zoetis will also require authorisation from APVMA prior to commercial use.

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.