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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.
OGTR Newsletter Issue 4
This issue focusses 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).
Communique of GTTAC meeting of 15 October 2018
This communique covers matters considered at the 16th video conference of the Gene Technology Advisory Committee (15 October 2018).
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.
Risk Assessment Reference: Methods of Plant Genetic Modification
This document describes how the potential risks of plant genetic modification (plant transformation) are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).
Communique of GTTAC meeting of 27 July 2018
This Communiqué covers matters considered at the 15th video conference of the Gene Technology Technical Advisory Committee (27 July 2018).
Quarterly activities report for January – March 2018
Details of OGTR monitoring and compliance activities during the quarter ended 31 March 2018.
OGTR Monitoring and Compliance Framework July 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.
Oral trial of a cholera vaccine in Australia
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.
What is gene technology?
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’.
Communique of GTECCC meeting of 12 June 2018
This Communique covers matters considered at the 11th meeting of the Gene Technology Ethics and Community Consultative Committee (12 June 2018, Canberra).
Monitoring Compliance Update June 2018
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.
OGTR Newsletter Issue 3
This issues focusses on low-level (PC1 & PC2) facility certification processes.
Communique of GTTAC meeting of 23 April 2018
This Communique covers matters considered at the 54th meeting of the Gene Technology Technical Advisory Committee (23 April 2018, Canberra)
Quarterly activities report for October – December 2017
Details of OGTR monitoring and compliance activities during the quarter ended 31 December 2017.
Communiqué of GTTAC meeting 28 February 2018
This Communiqué covers matters considered at the 14th video conference of the Gene Technology Technical Advisory Committee (28 February 2018).
Guidelines for Certification of a Physical Containment Level 2 Large Scale Facility
These guidelines contain the requirements and conditions for certification of a Physical Containment Level 2 (PC2) Large Scale Facility issued pursuant to section 90 of the Gene Technology Act 2000 (the Act).
Annual Inspection Checklist for a PC2 Large Scale Facility
Checklist for annual inspection against the usual Conditions of Certification of the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 2 Large Scale Facility
Application Checklist for a Physical Containment Level 2 Large Scale Facility
Checklist against the requirements of the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 2 Large Scale Facility.
Guidelines and checklists for certification of PC2 facilities
Documents supporting applications for the certification of Physical Containment Level 2 (PC2) facilities.