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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’.
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 focuses on low-level (PC1 & PC2) facility certification processes.
Quarterly activities report for October – December 2017
Details of OGTR monitoring and compliance activities during the quarter ended 31 December 2017.
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.
The Biology of Stenotaphrum secundatum (Walter) Kuntze (buffalo grass)
This document provides baseline information about the parent organism for use in risk assessments of genetically modified S. secundatum that may be released into the Australian environment.
OGTR Stakeholder Engagement Framework Summary
People and organisations wishing to work with Genetically Modified Organisms (GMOs) have been able to do so provided they follow laws designed to protect people and the environment.
OGTR Newsletter Issue 2
This issue focuses on preparing for a monitoring inspection.
Operations of the Gene Technology Regulator Annual Report 2016-17
The report describes the roles and responsibilities of the Gene Technology Regulator (the Regulator) and the OGTR during 2016-17.
Community attitudes 2017 report
This survey was conducted in 2017. It explores the awareness, attitudes and understanding of general science and technology, and specific biotechnology issues.
Quarterly activities report for July – September 2017
Details of OGTR monitoring and compliance activities during the quarter ended 30 September 2017.
Quarterly activities report for April – June 2017
Details of OGTR monitoring and compliance activities during the quarter ended 30 June 2017.
OGTR Newsletter Issue 1
This first issue focuses on Notifiable Low Risks Dealings (NLRDs).
Petunias notified as genetically modified
Details of petunias that have been notified as genetically modified in Australia.
List of GM petunia licence holders
Details of the holders of a licence for dealings with GM petunias.
GM Petunia Risk Analysis
An report on the potential risks from inadvertent dealings with petunia genetically modified for altered flower colour.
Quarterly activities report for January – March 2017
Details of OGTR monitoring and compliance activities during the quarter ended 31 March 2017.
Operations of the Gene Technology Regulator Annual Report 2015-16
The report describes the roles and responsibilities of the Gene Technology Regulator (Regulator) and the OGTR. It provides a picture of the OGTR’s performance over the past 12 months.
Application for a DIR licence involving a non-plant GMO
Use this form for applications for a licence for dealings (activities) with a non-plant GMO involving intentional release (DIR) of the GMO into the environment under the Gene Technology Act 2000.
Application for a DIR licence for commercial release of GM plants - example answers
This is a hypothetical case study provided as an example. It should not be cited as evidence in an application. Although the data and discussions are representative, this example may not include all considerations needed when assessing risks from a proposed GM plant commercial release.
Monitoring and compliance risk analysis protocol
This protocol outlines the broad framework used by the Monitoring and Compliance Section when undertaking risk assessments. It also informs any risk management plans.