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Guidance for IBCs: Regulatory requirements for contained research with GMOs containing engineered gene drives
This document provides guidance for Institutional Biosafety Committees (IBCs) and researchers on the regulatory requirements for organisms containing engineered ‘gene drives’, including the physical containment (PC) level of facilities for notifiable low risk dealings (NLRDs).
Guidance on the classification of contained dealings with viral vectors
Look-up tables for classification of contained dealings with viral vectors based on the vector type, characteristics and whether in vitro or in vivo.
Application for a licence for dealings not involving intentional release of a GMO (DNIR)
This application form must be used for applications for a licence for dealings (activities) NOT involving the intentional release of a GMO into the environment (DNIR).
Operational policy NLRDs in alternate facilities - Update September 2019
The purpose of this document is to inform researchers undertaking NLRDs about the Gene Technology Regulator’s (the Regulator’s) operational policy for considering requests to conduct NLRDs in alternate facilities, pursuant to regulation 13(2)(c).
Allegation by Third Parties Protocol In accordance with the Gene Technology Act 2000
This protocol is to provide inquiring third parties with the appropriate information on how to report matters of non-compliance to the OGTR.
Communique of GTTAC meeting of 22 July 2019
This Communique covers matters considered at the 17th video conference of the Gene Technology Technical Advisory Committee (22 July 2019)
OGTR Allegations Protocol
Allegation by Third Parties Protocol In accordance with the Gene Technology Act 2000
Risk Assessment Reference: Regulatory sequences in GM plants
This document describes how the potential risks of regulatory sequences in GM plants are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).
Risk Assessment Reference: Unintended effects
This document describes how the potential risks of unintended effects are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).
Communique of GTECCC meeting of 25-26 June 2019
This Communique covers matters considered at the 12th meeting of the Gene Technology Ethics and Community Consultative Committee (25-26 June 2019, Melbourne).
Quarterly activities report for January – March 2019
Details of OGTR monitoring and compliance activities during the quarter ended 31 March 2019.
Generic Risk Assessment Framework for Organisms
This conceptual discussion paper proposes a generic framework for the environmental risk assessment (ERA) of organisms including a set of generic risk factors based on biological attributes of organisms and bio-physical characteristics of interactions of organisms with the environment.
Risk assessment reference documents
These documents support the Risk Assessment and Risk Management Plans (RARMPs) prepared for applications for dealings involving intentional release (DIRs) of GMOs into the environment. They address matters common to many DIR risk assessments and are referred to in relevant RARMPs.
Decision Regulation Impact Statement
This impact statement assesses the changes recommended by the 2016-19 Technical Review of the Gene Technology Regulations.
Risk Assessment Reference: Field Trials of GM Plants
This document describes how the potential risks of GM crop field trials are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).
OGTR Newsletter Issue 5
This is the second issue focussed on Confidential Commercial Information (CCI), providing more details about applying for information to be declared as CCI.
Communique of GTTAC meeting of 12 March 2019
This Communiqué covers matters considered at the 55th meeting of the Gene Technology Technical Advisory Committee (12 March 2019, Canberra).
The Biology of Cicer arietinum L. (chickpea)
This document provides baseline information about the parent organism for use in risk analysis of genetically modified (GM) chickpea that may be released into the Australian environment.
Quarterly activities report for October – December 2018
Details of OGTR monitoring and compliance activities during the quarter ended 31 December 2018.
Guidance on making an application to vary a DNIR licence
This document provides guidance on the information required in the Application to vary a DNIR licence form for a range of common variation categories.
Risk Assessment Reference: RNAi technology
This document describes how the potential risks of RNAi technology (gene silencing) are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).
Application to vary a DNIR licence
Use this form to apply for a variation of a licence for dealings not involving intentional release (DNIR) of a GMO into the environment under the Gene Technology Act 2000 (the Act).
Application to vary a DIR licence
Use this form to apply for a variation of a licence for dealings involving intentional release (DIR) of a GMO into the environment under the Gene Technology Act 2000 (the Act).
Policy on scope for variation of GMO licences
This document provides information on the scope of changes which may be made to a genetically modified organism (GMO) licence after the licence has been issued, and outlines the Gene Technology Regulator’s (the Regulator’s) approach to considering applications to vary conditions of a GMO licence.
Application for a DIR licence for commercial release of GM plants
This application form is for dealings (activities) involving the release of GM plants into the environment that would not qualify as a limited and controlled release.