Filter results
You can narrow down the results using the filters
Resource type
Dealings classified as exempt from 8 October 2019
This is an excerpt from the Gene Technology Regulations 2001 incorporating amendments from Schedule 1 of the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019, which commence on 8 October 2019.
Dealings classified as Notifiable Low Risk Dealings (NLRDs) from October 2019
Schedule 3 of the Gene Technology Regulations 2001 describes the types of dealings with GMOs that are classified as NLRDs. This is an excerpt from the regulations incorporating amendments which commence on 8 October 2019.
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.
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).
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.
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 focused on Confidential Commercial Information (CCI), providing more details about applying for information to be declared as CCI.
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.
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 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.
OGTR Newsletter Issue 4
This issue focuses on Confidential Commercial Information (CCI).
Quarterly activities report for July – September 2018
The quarterly activities include details of monitoring and compliance activities by the Office of the Gene Technology Regulator (OGTR) during the quarter.
Operations of the Gene Technology Regulator Annual Report 2017-18
The report describes the roles and responsibilities of the Gene Technology Regulator (the Regulator) and the Office of the Gene Technology Regulator (OGTR).
Stockfeed and genetically modified (GM) crops
Several types of GM canola and GM cotton are grown commercially in Australia. GM safflower was approved for commercial production in Australia in 2018.
How we treat Confidential Commercial Information
In order to assess the risks from the GMO the Regulator requires information about the GMO and the proposed work. While the applicant may want to keep some of this information secret, they must tell the Regulator so the right licence decision can be made.
Quarterly activities report for April – June 2018
Details of OGTR monitoring and compliance activities during the quarter ended 30 June 2018.