Resources

This protocol is to provide inquiring third parties with the appropriate information on how to report matters of non-compliance to the OGTR.

Allegation by Third Parties Protocol In accordance with the Gene Technology Act 2000

This document describes how the potential risks of regulatory sequences in GM plants are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).

This document describes how the potential risks of unintended effects are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).

Details of OGTR monitoring and compliance activities during the quarter ended 31 March 2019.

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.

This impact statement assesses the changes recommended by the 2016-19 Technical Review of the Gene Technology Regulations.

This document describes how the potential risks of GM crop field trials are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).

This is the second issue focused on Confidential Commercial Information (CCI), providing more details about applying for information to be declared as CCI.

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.

Details of OGTR monitoring and compliance activities during the quarter ended 31 December 2018.

This document describes how the potential risks of RNAi technology (gene silencing) are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).

This issue focuses on Confidential Commercial Information (CCI).

The quarterly activities include details of monitoring and compliance activities by the Office of the Gene Technology Regulator (OGTR) during the quarter.

The report describes the roles and responsibilities of the Gene Technology Regulator (the Regulator) and the Office of the Gene Technology Regulator (OGTR).

Several types of GM canola and GM cotton are grown commercially in Australia. GM safflower was approved for commercial production in Australia in 2018.

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.

Details of OGTR monitoring and compliance activities during the quarter ended 30 June 2018.

This document describes how the potential risks of plant genetic modification (plant transformation) are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).

Details of OGTR monitoring and compliance activities during the quarter ended 31 March 2018.

The Regulator is an independent statutory office holder who administers the Act and has powers under the Act to monitor for compliance, and to take enforcement action when required.

In 2014 the Gene Technology Regulator (the Regulator) approved a trial of an oral live genetically modified cholera vaccine. Up to 1000 people were given a dose of the vaccine in a drink.

Gene technology (also known as genetic engineering or genetic modification) provides ways to make changes to genes – the sets of instructions in the cells of all living creatures. There is a large amount of overlap between ‘gene technology’ and the newer term ‘synthetic biology’.

This update outlines the work of the Office of the Gene Technology Regulator (OGTR) in ensuring compliance with Australia’s gene technology legislation and regulations.

This issues focuses on low-level (PC1 & PC2) facility certification processes.