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
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Regulatory Practice and Compliance Branch
Mr Neil Ellis is currently acting Assistant Secretary and is responsible for regulatory practice, coordinating OGTR's enforcement and compliance activities, corporate business services, communication, expert advisory committees and international cooperation. He has had over 20 years of experience in the APS and has held several positions in the Departments of Environment, Agriculture and Health, and also the United Nations Environment Program, delivering functions such as risk assessment, regulatory policy, advisory committee secretariat, communications, and monitoring and compliance. He was also previously part of the Interim OGTR that developed the Gene Technology Act 2000.
The Monitoring and Compliance Section monitors and inspects dealings with GMOs conducted at field trial sites and within contained facilities certified by the Regulator, conducts audits, reviews and investigations of organisations and individuals involved with GMO dealings (including self-reported incidents and allegations made by third parties). The aim of these activities is to ensure that dealings with GMOs comply with legislative obligations and are consistent with the object of the Gene Technology Act 2000. In particular, the section focuses on maintaining compliance with conditions of licences or other instruments and management of risks in relation to any potential breach of conditions.
The Regulatory Practice Section provides operational policy, information and coordination support for the OGTR, including coordination of ministerial correspondence and briefings. It provides the contact point for Australian Government agencies and other national and international organisations involved with regulating GMOs and coordinates input to international regulatory cooperation programs. It provides secretariat services to the Gene Technology Ethics and Community Consultative Committee (GTECCC) and the Gene Technology Technical Advisory Committee (GTTAC).
In partnership with the Department, the Regulatory Support Unit delivers administrative and financial reporting services. Other roles include account processing, financial planning, procurement, human resource management, staff training and coordination, accommodation and property and asset management. The section produces the annual report, staffs the free call 1800 181 030 number, coordinates responses to email enquiries to <email@example.com> and manages the OGTR website. It has developed the Post Release Review Framework to guide ongoing oversight of commercial or general release GMOs.
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 managing evaluation of licence applications and other authorisations relating to dealings with GMOs and other science-related projects that maintain and enhance the OGTR’s technical capabilities.
The Application Entry Point Section receives and acknowledges all applications, processes accreditation and low-level certification applications, manages databases, reports on workflows and coordinates reviews of guidelines and application procedures.
The Contained Dealings Evaluation Section prepares RARMPs for dealings not involving intentional release (DNIRs) of GMOs into the environment, also known as ‘contained dealings’, and non-plant DIR applications. The section provides advice to accredited organisations and institutional biosafety committees (IBCs) on the classification of dealings with GMOs, and inspects and processes certification applications for high-level and large-scale containment facilities.
The Plant Evaluation Section prepares risk assessment and risk management plans (RARMPs) for dealings involving intentional release (DIRs) of genetically modified (GM) plants into the environment, for the Regulator’s consideration and for consultation with key stakeholders, including the public. The section gathers scientific data and produces reference documents to inform the risk assessment process. It also provides technical advice to the Regulator, other sections of OGTR and stakeholders.
The Principal Scientist develops and manages science-related projects that affect the OGTR, including ongoing review and implementation of the Risk Analysis Framework (RAF). It provides scientific advice, trains staff in risk analysis and provides input to policies and processes associated with risk analysis. It also organises seminars and supports national and international input into regulatory harmonisation programs.
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