The Office of the Gene Technology Regulator (OGTR)

The OGTR provides administrative and scientific support to the Gene Technology Regulator (the Regulator), and is part of the Commonwealth Department of Health.

The OGTR comprises an Evaluation Branch and a Regulatory Practice and Compliance Branch. Both branches include various sections that focus on particular activities relating to regulation of gene technology (figure 1).

The OGTR is located in Canberra and comprises about 50 scientific, legal, policy, compliance and administrative staff. You can contact us here.

Figure 1: Organisational structure of the OGTR
Organisational structure of the OGTR

Regulatory Practice and Compliance Branch

Mr Neil Ellis is currently the acting Executive Director and is responsible for regulatory practice policy, oversight of monitoring and compliance activities, corporate business and regulatory support, performance reporting, coordination of expert advisory committees, stakeholder communication and international cooperation activities.

The Regulatory Practice and Compliance Branch is made up of the Monitoring and Compliance Section, the Regulatory Practice Section and the Regulatory Support Unit.

The Legal Officer provides legal advice to the Regulator and the OGTR on the operation of Commonwealth, state and territory laws affecting their functions, including setting licence conditions and handling confidential commercial information. The Legal Officer is also responsible for training OGTR staff on legal issues and assists in responding to FOI requests.

The Monitoring and Compliance Section monitors and inspects dealings with GMOs conducted at field trial sites and within certified contained facilities. The aim of these activities is to ensure that dealings with GMOs comply with legislative obligations and are consistent with the object of the Act. Activities focus on monitoring compliance with conditions of licences or other instruments and restrictions, and managing risks in relation to any potential breach of conditions. Audits, reviews and investigations of organisations and individuals involved in GMO dealings (including self-reported incidents and allegations made by third parties) are conducted to ensure that any dealings are undertaken in accordance with the Act.

The branch’s Regulatory Practice Section works collaboratively with the Best Practice Regulation Branch of the department. It delivers operational policies, provides technical support and coordinates the technical review of the Regulations. Secretariat services to the Gene Technology Ethics and Community Consultative Committee and the Gene Technology Technical Advisory Committee, coordination of ministerial correspondence and briefings, and contributions to international regulatory harmonisation activities also form part of the activities of this section. It serves as the contact point for other Australian Government agencies and national and international organisations involved in regulating GMOs.

In partnership with the department, the Regulatory Support Unit undertakes corporate and administrative functions, including performance and financial reporting, budget reporting, account processing, procurement, human resource management, staff training and coordination, accommodation, and property and asset management. It produces the annual report, staffs the freecall number (1800 181 030), coordinates responses to general email inquiries (to ogtr@health.gov.au) and manages the OGTR website. It has developed the Post Release Review Framework to guide ongoing oversight of GMOs that have been released commercially or as general releases.

Evaluation Branch

Dr Michael Dornbusch heads the Evaluation Branch. Dr Dornbusch first joined the OGTR in 2003 and managed the Plant Evaluation Section from December 2006 until his appointment as Assistant Secretary in September 2009. Dr Dornbusch’s responsibilities encompass management of the evaluation of licence applications and other authorisations relating to dealings with GMOs, as well as science-related projects that maintain and improve the technical capabilities of the OGTR.

The Evaluation Branch is made up of the Application Entry Point, the Contained Dealings Evaluation Section, the Plant Evaluation Section and the Principal Regulatory Scientist.

All applications to OGTR are received and acknowledged through the Application Entry Point. Staff in this area also process accreditation applications, manage databases, provide trend and statistical analyses of application receipts and authorisations, report on workflows and undertake business improvement and efficiency initiatives. The team also supports the Evaluation Branch in sourcing scientific literature and manages a range of journal subscriptions for the office library.

The Contained Dealings Evaluation Section prepares risk assessment and risk management plans (RARMPs) in response to applications for dealings not involving intentional release of GMOs into the environment (DNIRs)—also known as ‘contained dealings’—and applications for non-plant dealings involving intentional release (DIRs). The section also processes applications for certification of containment facilities. This includes inspecting high-level and large-scale facilities, reviewing certification guidelines, and providing advice to accredited organisations and institutional biosafety committees on the classification of dealings with GMOs.

The Plant Evaluation Section assesses applications for DIRs for genetically modified (GM) plants and prepares RARMPs for consultation with key stakeholders, including the public. The section gathers scientific data and publishes reference documents to inform the risk assessment process.

The Principal Regulatory Scientist provides advice on the risk assessment of GMOs, including in review and implementation of the OGTR’s Risk Analysis Framework. The Principal Regulatory Scientist, together with other staff, is also engaged in national and international harmonisation activities in order to keep pace with developments in science and regulatory risk analysis.

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