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OPERATIONS OF THE GENE TECHNOLOGY REGULATOR

Annual Report 2010–11

The object of the Gene Technology Act 2000 is:to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms

Print ISBN: 978-1-74241-555-0 Online ISBN: 978-1-74241-556-7

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Paper-based publications© Commonwealth of Australia 2011

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Operations of the Gene Technology Regulator Annual Report 2010–11 iii

Letter of transmittal

The Hon Catherine King MP Parliamentary Secretary for Health and Ageing Parliament House Canberra ACT 2600

Dear Parliamentary Secretary

I am pleased to present to you the Annual Report on the operations of the Gene Technology Regulator covering the period 1 July 2010 to 30 June 2011.

The Annual Report details the operations of the Gene Technology Regulator against the performance indicators for the Office of the Gene Technology Regulator contained in Outcome 1, Population Health, of the Department of Health and Ageing Portfolio Budget Statements for the period 1 July 2010 to 30 June 2011.

The Annual Report has been prepared in accordance with section 136(1) of the Gene Technology Act 2000 and the guidelines approved by the Joint Committee of Public Accounts and Audit referred to in sections 63(2) and 70(2) of the Public Service Act 1999.

Section 136(2) of the Gene Technology Act 2000 requires you to present this report to each House of the Parliament within 15 sitting days of that House after the day you are given the report. The guidelines referred to in section 70(2) of the Public Service Act 1999 require that this presentation occur on or before 31 October 2011.

Yours sincerely

Dr Joe Smith Gene Technology Regulator 15 September 2011

iv Operations of the Gene Technology Regulator Annual Report 2010–11

Contacts

Office of the Gene Technology Regulator MDP 54 GPO Box 9848 Canberra ACT 2601 Australia

Level 1 Pharmacy Guild House 15 National Circuit Barton ACT 2600

Telephone: 1800 181 030 Fax: (02) 6271 4202 Email: [email protected] Website: www.ogtr.gov.au

ABN 15 862 053 538

Annual report web page <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1>.

Enquiries about the content of this report may be directed to the Business Management and Communications Section, Regulatory Practice and Compliance Branch, Office of the Gene Technology Regulator.

Operations of the Gene Technology Regulator Annual Report 2010–11 v

Office of the Gene Technology Regulator

Our vision

To be recognised as an international leader in gene technology regulation for a healthy and sustainable future.

Our mission

To safeguard health and protect the environment through application of good regulatory practice for gene technology.

Our role

To protect the health and safety of people and the environment by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms.

Our objective

Our activities contribute to Outcome 1 (Population Health)1 of the Health and Ageing Portfolio Budget Statements.

Through the Gene Technology Regulation component of Outcome 1, the Australian Government aims to protect the health and safety of people and the environment by regulating dealings with genetically modified organisms.

Our people

As at 30 June 2011, the Office of the Gene Technology Regulator comprised 55 scientific, legal, policy, professional, and administrative staff. We value our people and seek to attract and retain appropriately qualified and skilled people by providing an environment that builds capability, motivates, inspires and supports.

1. Outcome 1 Statement: A reduction in the incidence of preventable mortality and morbidity in Australia, including through regulation and national initiatives that support healthy lifestyles and disease prevention.

vi Operations of the Gene Technology Regulator Annual Report 2010–11

Our values

We are committed to the Australian Public Service Values and Code of Conduct in all aspects of our business. We value:

• professionalism through integrity, objectivity, excellence, commitment and consistency

• accountability through open and transparent processes

• achievement through effective, efficient and flexible work practices that are focused on delivering timely outcomes

• respect for each other and our stakeholders through open and effective communication and quality service.

Operations of the Gene Technology Regulator Annual Report 2010–11 vii

About this report

This annual report is prepared in accordance with the Requirements for Annual Reports, as issued by the Department of the Prime Minister and Cabinet and approved by the Joint Committee of Public Accounts and Audit under sections 63(2) and 70(2) of the Public Service Act 1999.

The report is a formal accountability document that details the operations of the Gene Technology Regulator (the Regulator) during 2010–11 against deliverables and key performance indicators for the Office of the Gene Technology Regulator (OGTR) contained in Outcome 1, Population Health, of the Department of Health and Ageing (the Department) 2010–11 Portfolio Budget Statement (PBS).

This report describes the roles and responsibilities of the Regulator and the OGTR and provides readers with a useful and informative picture of the OGTR’s performance over the last 12 months.

This report is arranged in four chapters and contains a number of appendices. The chapters comprise:

• Gene Technology Regulator’s review provides a summary of the OGTR’s activities over the past year, including major achievements and the outlook for the coming year.

• Corporate overview provides a brief description of the OGTR’s corporate governance arrangements and a summary of performance against the reporting structure set out in the Department’s 2010–11 PBS.

• Operational performance describes the OGTR achievements against the priorities for the reporting year. Deliverables and performance targets achieved in the areas of Assessments and Approvals, Monitoring and Compliance, Consultation with Stakeholders, and International Relationships are discussed in detail along with other information on activities relating to the Regulator’s statutory functions as prescribed by the Gene Technology Act 2000. Classes of dealings and authorisations outline the types of dealings with genetically modified organisms (GMOs) defined by the Gene Technology Act 2000, the Gene Technology Regulations 2001 and corresponding state and territory laws. A summary of classes of dealings, process for authorisations and statutory timeframes are detailed in chapter 3.

• Management and accountability provides an overview of OGTR’s human resource management practices and its adherence to Australian Government accountability principles.

The appendices provide a range of statistical and other information including compliance with mandatory annual reporting requirements. The appendices also contain detailed information on the history and structure of the gene technology regulatory system and the types of GMO dealings and their assessment processes.

viii Operations of the Gene Technology Regulator Annual Report 2010–11

A glossary and alphabetical index are provided as aids to reader access and a list of requirements is provided to accord with the Department of the Prime Minister and Cabinet’s Requirements for Annual Reports.

Note: The Department of Health and Ageing 2010–11 annual report also contains information about the OGTR. This includes the OGTR financial statements, which are consolidated into the Department’s financial statements.

Unless otherwise stated, all information provided in this report is sourced from the OGTR.

Operations of the Gene Technology Regulator Annual Report 2010–11 ix

Contents

Letter of transmittal iiiContacts ivOffice of the Gene Technology Regulator vAbout this report vii1. Gene Technology Regulator’s review 12. Corporate overview 6

Corporate governance 7Organisational structure 8Gene Technology Regulator 8Evaluation Branch 9Regulatory Practice and Compliance Branch 10Financial performance 10

3. Operational performance 15Classes of GMO dealings and authorisations 16Classes of GMO dealings 16Timeframes 18Operational performance 19Assessments and approvals 19Monitoring of genetically modified organisms 29Compliance with the Gene Technology Act 2000 37Consultation with stakeholders 41International regulatory liaison 45Other functions of the Gene Technology Regulator 46

4. Management and accountability 47Human resources 48Occupational health and safety 50Freedom of information 50Consultancies 53Assets management 53Exempt contracts 53Purchasing 54Advertising and market research 54Annual reporting requirements 54Quarterly reporting requirements 54National Disability Strategy 55Ecologically sustainable development and environmental performance 55

x Operations of the Gene Technology Regulator Annual Report 2010–11

Appendices Appendix 1 History and structure of the gene technology regulatory system 58Appendix 2 Types of applications, authorisations, monitoring and compliance 63Appendix 3 Membership of statutory committees and attendance at meetings 74Appendix 4 Staff profile and training and development activities 78Appendix 5 Publications and guidance documents 81Appendix 6 International meetings and forums 82Appendix 7 Presentations and meetings on gene technology in Australia 84Appendix 8 Stakeholder and public access to the OGTR 85

Glossary 88Indexes

List of requirements 90Alphabetical index 93

Figures and tablesFigure 1: Organisational structure of the OGTR, 2010–11 8Figure 2: DIR licences issued since commencement of the Gene Technology Act 2000 22Figure 3: Research focus of DNIRs approved in 2010–11 22Figure 4: Types of organisations that were issued DNIR licences in 2010–11 24Figure 5: Organisations accredited as at 30 June 2011, by type of organisation 26Figure 6: Organisations accredited as at 30 June 2011, by location of headquarters 26Figure 7: Physical containment facilities certified as at 30 June 2011, by location 27Figure 8: Number of DIR field trial sites inspected in 2010–11, by crop type 31Figure 9: Number of field trial sites at beginning of 2010–11 (left), transition of location status (centre), and number of field trial sites at end of 2010–11 (right) 31Figure 10: Number of field trial sites inspected in 2010–11, by state and territory 32Figure 11: Location by local government area and field trial types during 2010–11 33Figure 12: Field trial sites and locations inspected in 2010–11, by local government area 34Figure 13: Number of certified facilities as at 2010–11, by state and territory 36Figure 14: Number of certified facility inspections in 2010–11, by state and territory 36Figure 15: Number of certified facilities as at 2010–11, by organisation type 37Figure 16: Number of certified facility inspections in 2010–11, by organisation type 37Figure 17: Governance arrangements for the Gene Technology Regulator 59Figure 18: DNIR assessment process 66Figure 19: DIR eight-stage assessment process 67

Operations of the Gene Technology Regulator Annual Report 2010–11 xi

Table 1: Australian Government funding for the OGTR, 2010–11 to 2014–15 11Table 2: Qualitative deliverables, 2010–11 11Table 3: Classes of GMO dealings under the Gene Technology Act 2000 18Table 4: Prescribed timeframes 19Table 5: Applications and notifications, 2010–11 20Table 6: DIR applications approved, 2010–11 21Table 7: DNIR applications approved, 2010–11 23Table 8: Number of facilities certified at 30 June 2011, by physical containment level and type 27Table 9: Trend data for approval of main types of applications, 2007–08 to 2010–11 28Table 10: Number and proportion of inspections performed in each quarter of 2010–11 29Table 11: Number of licensed DIR sites, by crop type/parent organism at beginning of 2010–11 and end of 2010–11; and number of inspections conducted during 2010–11 30Table 12: Number of field trial sites and OGTR inspections in 2010–11, by state and territory 32Table 13: Number of certification types at end of 2010–11, and inspections conducted during 2010–11 35Table 14: Number of non-compliances identified in certified facilities during 2010–11, by non-compliance type 38Table 15: Components of national strategy for unintended presence of unapproved GMOs 41Table 16: Non-salary benefits 49Table 17: Consultancy services let during 2010–11, of $10 000 or more 53Table 18: Media advertising organisations engaged, 2010–11 54Table 19: Regulatory agencies in Australia with a role in regulating gene technology 62Table 20: Attendance at GTTAC meetings during 2010–11 74Table 21: Members of GTTAC, at 30 June 2011 75Table 22: Attendance at GTECCC meetings during 2010–11 76Table 23: Members of GTECCC, at 30 June 2011 77Table 24: OGTR staffing profile, at 30 June 2011 78Table 25: SES and non-SES bonus payments, 1 July 2010 to 30 June 2011 78Table 26: Internal legal issue training presentations, 2010–11 79Table 27: Other Internal training presentations, 2010–11 79Table 28: Presentations at OGTR Forum, 2010–11 80Table 29: Presentations and representations at international meetings and conferences, 2010–11 82Table 30: Presentations and representations made in Australia, 2010–11 84Table 31: Website activity, 2010–11 and 2009–10 85Table 32: Email and free call 1800 number activity, 2010–11 and 2009–10 86

xii Operations of the Gene Technology Regulator Annual Report 2010–11

CHAPTER 1

Gene Technology Regulator’s review

2 Operations of the Gene Technology Regulator Annual Report 2010–11

1. Gene Technology Regulator’s review

Australia’s national system for gene technology regulation has now been functioning for a decade since the commencement, in June 2001, of the Gene Technology Act 2000. In our tenth year of operation, the OGTR has continued to deliver effective and efficient regulation, consolidating existing processes and pursuing reforms to ensure Australia remains at the forefront of regulatory practices for gene technology.

In administering the Gene Technology Act 2000 and relevant state and territory legislation, we have achieved all of the objectives that support our goal of protecting the health and safety of people and the environment by regulating dealings with genetically modified organisms (GMOs).

We were able to do this by maintaining a strong commitment to:

• firmly basing our regulatory decisions and actions on sound science and robust risk analysis

• transparent and widespread consultation with all of our stakeholder groups and the general public

• monitoring, facilitating and ensuring compliance of the regulated community

• liaising with other Australian regulators with related responsibilities to enhance regulatory coordination and avoid duplication

• optimising our processes and requirements, including through review of regulations and guidelines

• actively engaging nationally and internationally so we continue to reflect current scientific knowledge and best international practice.

Performance targets metWe met all performance targets set for us in the Department’s 2010–11 PBS.2

All 710 of the decisions on applications for licences for dealings with GMOs, accreditation of organisations or certification of facilities received by the OGTR were made within legislated timeframes. The diversity of GMOs in licence applications continued to increase. Applications ranged from crops with traits such as enhanced nutritional qualities, drought tolerance, nutrient uptake and herbicide tolerance, through to research involving GMOs to investigate treatment of human diseases and human and animal pathogens, and approval of a vaccine to protect against Japanese encephalitis.

2. The PBS describes objectives and major activities for planned programs in terms of deliverables and performance targets. For 2010–11, the OGTR contributed to Outcome 1 (Population Health) of the Health and Ageing PBS. OGTR performance against the PBS is reported in the Department of Health and Ageing annual report, this annual report and quarterly reports to Parliament. In keeping with the national regulatory scheme, OGTR operations are also reported to the Gene Technology Ministerial Council (see appendix 1).

Operations of the Gene Technology Regulator Annual Report 2010–11 3

Effective compliance is an essential part of any regulatory framework, and the OGTR compliance and monitoring programs provided critical oversight and assurance that organisations and individuals meet regulatory requirements. The OGTR inspected 40 per cent of field trials and 23 per cent of higher-level containment facilities, exceeding the 20 per cent target. No significant risks to public health or the environment were identified and no breaches of containment were identified at any sites, including those in locations affected by extreme weather events in early 2011.

Transparent, consultative regulationAgainst a background of increasing public interest in gene technology during the year, particularly in relation to agriculture and food, it was more important than ever to make sure our regulatory activities were conducted with the highest levels of transparency and consultation.

Exceeding legislative requirements, we consulted extensively with the general public, expert bodies, regulated communities, other regulatory agencies and the states and territories on all applications for intentional release of GMOs, ensuring wide input to, and awareness of, our regulatory activities. Comprehensive information such as detailed risk assessments, regulatory decisions, conditions of licences and locations of field trials, continued to be provided on the OGTR website.

Input from consultation with a range of stakeholders, was also important in completing major projects such as revision of guidelines and preparation of the Gene Technology Amendment Regulations 2011. Any organisation conducting dealings with GMOs must have access to an Institutional Biosafety Committee (IBC), and IBCs play a pivotal role in the gene technology regulatory system. In June 2011, we held our fourth National IBC Forum, a major focus of which was discussion about change, particularly implementation of the Amendment Regulations.

A key strength of the gene technology regulatory scheme is the contribution of two expert independent advisory committees – the Gene Technology Technical Advisory Committee (GTTAC) and the Gene Technology Ethics and Community Consultative Committee (GTECCC). During the year, following agreement of the Gene Technology Ministerial Council, the Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP, appointed the members of these two committees for the 2011–14 triennium, including reappointment of Professors John Rasko and Don Chalmers as the respective chairs of GTTAC and GTECCC. Both committees play a vital role in the regulatory system: all applications for intentional release of a GMO to the environment require advice from GTTAC; and GTECCC provides important advice on broader issues relating to ethics and stakeholder communication.

An integrated regulatory frameworkAustralia’s national regulatory scheme for GMOs is designed to integrate closely with other regulatory systems, particularly for food, agricultural chemicals and human therapeutics. This is essential to ensure consistent and thorough regulatory oversight, without inappropriate duplication. Throughout the year, therefore, we have again worked closely with agencies such as Food Standards Australia New Zealand; the Australian Pesticides and Veterinary Medicines Authority; the Therapeutic Goods Administration; the National Industrial Chemicals Notification and Assessment Scheme; the Department of Agriculture, Fisheries and Forestry; and the Department of Sustainability, Environment, Water, Population and Communities.


Ongoing reformsWith responsibility for regulating a continually evolving field like gene technology, it is important that our requirements and processes maintain their currency. Drawing on the experience of our first decade and developments in regulatory practices and science in Australia and elsewhere, we strive to ensure our approach to regulating GMOs keeps pace with contemporary best practice.

In this vein, we completed a major review of the Gene Technology Regulations 2001 and following Gene Technology Ministerial Council (GTMC) approval the Gene Technology Amendment Regulations 2011 were made in June 2011. The Amendment Regulations represent the outcome of an extensive review that focused on ensuring classification and regulation of dealings with GMOs remain commensurate with risk and current scientific understanding. In parallel with the Regulation review, the new Guidelines for Transport, Storage and Disposal of GMOs were finalised, consolidating and updating previous guidelines covering these activities.

International participation Built into the legislated framework for gene technology regulation are clear expectations that the Regulator will ensure the work of the OGTR both reflects and contributes to development and harmonisation of regulatory best practice internationally. To this end, during 2010–11, OGTR staff engaged in the work of multilateral forums, such as the OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology and the United Nations Convention on Biological Diversity to develop common approaches to risk assessment for GMOs and a World Health Organization project developing guidelines for risk assessment of genetically modified (GM) dengue fever vaccines.

Our collaboration with counterpart regulators in other countries continued. In recognition of the respect for Australian gene technology regulatory practices, OGTR staff were invited to contribute to capacity building, training and information exchange with regulators in Malaysia, Vietnam, Ghana, India, Brazil, South Korea and Cambodia.

Team effortOf course, the critical ingredient in our continued effective regulation of GMOs is the work of our highly dedicated and professional staff. I thank them sincerely for their continued and tireless efforts to keep providing the rigorous and transparent regulation that has, in its first decade of operation, firmly established the OGTR as an international benchmark for good regulatory practice.

The futureThe next 10 years will no doubt see emergence of new challenges for regulation and an increasing awareness and understanding of gene technology by the broader community. New developments in gene technology, be it in relation to agriculture, human health, animal health, or areas such as bioremediation, will make it more important than ever to maintain our commitment to keeping up with the science and supporting robust regulatory risk analysis. It will also be particularly important to ensure we communicate effectively and maintain the high level of transparency that has so far been a feature of this regulatory system, and to work even harder to engage effectively with our stakeholders.


The GTMC is conducting its second five-year review of gene technology legislation. We look forward to the findings of that review and to implementing any agreed recommendations. During the year, we will also be working with the regulated community, and particularly with the IBCs, to implement the new Gene Technology Amendment Regulations 2011 and the Guidelines for the Transport, Storage and Disposal of GMOs that come into effect on 1 September 2011.

The OGTR Risk Analysis Framework is a key document that details the risk analysis methodology we apply in reaching regulatory decisions. In the coming year, we will review the framework to ensure it reflects the best, contemporary risk assessment methodology. Importantly, and in consultation with GTECCC, we will examine our approaches to risk communication, with a view to ensuring we are communicating as effectively as possible. We will also continue periodically reviewing our guidelines and requirements so they remain relevant and effective, and will continue refining our operational practices to ensure we use our resources efficiently.

Through ongoing reforms such as these, and a continued commitment to excellence, the OGTR will work hard to meet the challenges posed by the rapidly advancing science of gene technology and continue to provide a regulatory system in which Australia can have confidence.

Dr Joe Smith Gene Technology Regulator 15 September 2011


CHAPTER 2

Corporateoverview


2. Corporate overview

This chapter provides an overview of the corporate governance arrangements for the Gene Technology Regulator (the Regulator) and a description of the OGTR’s organisational structure. It also describes the OGTR’s human resource management practices, and reports its performance against outcomes set out in Outcome 1, Population Health, of the Department of Health and Ageing 2010–11 PBS.

Corporate governance

The Regulator is a statutory office holder with specific powers and functions under the Gene Technology Act 2000. In exercising these functions, the Regulator is directly responsible to the Australian Parliament. The Parliamentary Secretary for Health and Ageing has portfolio responsibility for matters relating to the OGTR, which resides within the Australian Government Department of Health and Ageing. The Regulator has provided a Statement of Intent in response to the Statement of Expectations the Parliamentary Secretary issued to him. The Secretary of the Department of Health and Ageing provides staff to the OGTR under section 133 of the Gene Technology Act 2000.

The OGTR has service level agreements in place with the Department to access a range of business management and reporting services (information technology, financial reporting and accounting, human resources management, ministerial support and property management). These arrangements are negotiated annually.

The employment framework for the OGTR is the Public Service Act 1999 and staff are covered by the Department’s Collective Agreement and governance policies and practices. These include application of appropriate ethical standards under the APS Values and Code of Conduct, compliance with Australian Government freedom of information, privacy and occupational health and safety legislation, the National Disability Strategy and workplace diversity policy.

The Financial Management and Accountability Act 1997 establishes the financial framework for OGTR governance. Integrity in financial reporting is maintained through the internal audit arrangements of the service level agreement with the Department. The OGTR complies with the Commonwealth Fraud Control Guidelines as required by the Department.

OGTR internal policies and practices also cover the physical security and protection of confidential commercial information (CCI) received from applicants in support of their applications.

The OGTR maintains its own Business Risk Management Plan, which senior OGTR staff review periodically.


Organisational structure

The OGTR comprises the Evaluation Branch and the Regulatory Practice and Compliance Branch; each branch includes various sections that focus on particular activities relating to regulation of gene technology (figure 1).

Figure 1: Organisational structure of the OGTR, 2010–11

Gene Technology Regulator

The Gene Technology Regulator is an independent statutory office holder who administers the Gene Technology Act 2000 and corresponding state and territory laws.3 In administering the gene technology regulatory system, the Regulator has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and to manage those risks through regulating certain dealings with GMOs.

Dr Joe Smith commenced as Gene Technology Regulator on 23 March 2009. Dr Smith has a diverse background in both the public and private sector involving scientific research, services and regulation. He has more than 20 years experience in senior government regulatory and related roles, including as Chief Executive of the Australian Pesticides and Veterinary Medicines Authority, Director of the Therapeutic Goods Administration Laboratories and as Australian Government Analyst. Dr Smith has been actively engaged in international standards setting activities through forums such as the OECD and FAO/WHO and in building cooperation with counterpart regulators in other countries.

3. See <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/legislation-2>.


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 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 Plant Evaluation Section prepares risk assessment and risk management plans (RARMPs) for dealings involving intentional releases (DIRs) of genetically modified (GM) plants into the environment, for the Regulator’s consideration. 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 within OGTR and stakeholders.

The Contained Dealings Evaluation Section prepares RARMPs for dealings not involving intentional releases (DNIRs) of GMOs into the environment, also known as ‘contained dealings’ and non-plant DIR applications. The section provides advice to accredited organisations and/or Institutional Biosafety Committees (IBCs) on the classification of dealings with GMOs, and inspects and certifies high-level and large-scale containment facilities.

The Application and Licence Management 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 Science Cohort develops and manages science-related projects that affect the office, including ongoing review and implementation of the Risk Analysis Framework. It provides scientific advice, trains staff in risk analysis, and provides input to policies and processes associated with risk analysis. As well, it organises seminars and supports national and international input into regulatory harmonisation programs, and oversees the OGTR library and Reference Manager database.


Regulatory Practice and Compliance Branch

Mr Andrew Radanovich has been the acting Assistant Secretary Regulatory Practice and Compliance Branch since February 2011. Mr Radanovich joined the OGTR in 2002 as an inspector and has managed the Compliance Section since 2003. As acting Assistant Secretary he is responsible for coordinating OGTR’s enforcement and compliance activities, corporate business services, international cooperation, expert advisory committees and legal arrangements.

In partnership with the Department, the Business Management, Communications and Post Release Review Section delivers administrative and financial reporting services. Other roles include account payments, financial planning, procurement, human resource management, staff training and coordination, accommodation and property and asset management. The section produces the annual and quarterly reports, staffs the free call 1800 181 030 number, coordinates responses to email enquiries to <[email protected]> and manages the OGTR website. It has developed the Post Release Review Framework to guide ongoing oversight of commercial or general release GMOs. The section provides science policy advice and input to international regulatory harmonisation programs.

The Monitoring Section monitors and inspects dealings with GMOs conducted at field trial sites and within contained facilities certified by the Regulator. The aim of these activities is to ensure 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 managing dealings to ensure dissemination of a GMO and its genetic material is minimised, persistence of a GMO in the environment is managed, and effective management of the GMO is maintained.

The Compliance and Investigation Section conducts audits, reviews and investigations of organisations and individuals involved with GMO dealings (including self-reported incidents and allegations made by third parties) to ensure the dealings are undertaken in accordance with the Gene Technology Act 2000.

The Regulatory Practice and Secretariat 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. This section is coordinating conduct of the review of the Gene Technology Regulations 2001. It provides secretariat services to the Gene Technology Ethics and Community Consultative Committee (GTECCC), and the Gene Technology Technical Advisory Committee (GTTAC).

The Legal Section 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 CCI. It conducts introductory and ongoing training for OGTR staff on legal issues.

Financial performance

The Gene Technology Account is a Special Account for the purposes of the Financial Management and Accountability Act 1997. The Special Account receives all monies appropriated by the Parliament and makes payments for expenses the Regulator incurs in performing his functions. The OGTR prepares accrual accounting financial statements in accordance with the Department of Finance and Deregulation Guidelines. The Australian National Audit Office


performs an annual audit of these statements, which are then consolidated into the Department of Health and Ageing Financial Statements for the year ended 30 June. The receipts and expenditure of the OGTR’s Special Account are shown in the Department’s financial statements for the year ended 30 June.

The Executive and section managers are responsible for ensuring appropriate use of resources. Under the OGTR’s organisational structure, the Business Management, Communications and Post Release Review Section coordinates financial reporting and management.

The OGTR 2010–11 Federal Budget measures are published in the Department’s 2010–11 PBS and are summarised in table 1.

Table 1: Australian Government funding for the OGTR, 2010–11 to 2014–15

Departmental 2010–11($m) 2011–12($m) 2012–13($m) 2013–14($m) 2014–15($m)

8.017 8.026 8.048 8.107 8.179

The OGTR’s activities for 2010–11 are described under sub-program 1.4.4 in Outcome 1 – Population Health, of the Department’s 2010–11 PBS (pp. 87–90).4 The key strategic direction of this sub-program aims to:

• protect the health and safety of people and the environment by regulating dealings with genetically modified organisms.

The OGTR’s performance against deliverables and key performance indicators, as also reported in the Department’s 2010–11 Annual Report, is summarised in table 2.

Table 2: Qualitative deliverables, 2010–11

Outcome 1 – Population HealthSub-program 1.4.4 Gene Technology Regulation

Qualitative deliverable: Review of Gene Technology Regulations 2001

2010–11 reference point: Finalise amendments in mid 2010–11 and implement revised regulations by end of 2010–11

Result: Deliverable substantially met.

The review culminated in the making of the Gene Technology Amendment Regulations 2011 on 2 June 2011. The commencement date was 1 September 2011, which allowed time for stakeholders to comply with changes. The OGTR substantially met the target for this deliverable but finalisation and making of the Amendment Regulations was delayed for additional consultation following feedback from stakeholders in June 2010. The OGTR initiated a program to inform regulated organisations of the changes, including through the fourth National Institutional Biosafety Committee Forum in June 2011.

The Amendment Regulations will ensure classification and regulation of dealings with GMOs remains commensurate with current scientific understanding of risk and will assist the regulated community better understand and comply with their legislative obligations.

4. A copy of the 2010–11 PBS is available at <www.health.gov.au/internet/budget/publishing.nsf/Content/2009–10_ Health_PBS>.


Qualitative deliverable: Thorough assessment and management of risks posed by GMOs or as a result of gene technology

2010–11 reference point: Risks posed by GMOs or gene technology managed appropriately

Result: Deliverable met.

In 2010–11, the Regulator prepared comprehensive risk assessments and risk management plans for proposed activities with GMOs. Stringent licence conditions were imposed, where appropriate, to ensure containment of GMOs and management of identified risks. There was a high level of compliance with the gene technology legislation and risks to human health or the environment were managed appropriately.

During this period, the Regulator also developed, in consultation with stakeholders, revised Guidelines for the Transport, Storage and Disposal of GMOs. The guidelines will support operation of the Amendment Regulations; both will come into effect on 1 September 2011.

Qualitative deliverable: Consultation with key stakeholders on draft guidelines and on licence applications for intentional release of GMOs into the environment

2010–11 reference point: Seek feedback from stakeholders on draft guidelines and intentional release licence applications in a timely and transparent manner in accordance with the legislation


In January 2011, the Regulator sought feedback from key stakeholders on draft Guidelines for the Transport, Storage and Disposal of GMOs, which were developed to support the proposed Amendment Regulations 2011. Most submissions indicated broad support for the proposed revised guidelines and the Regulator issued the guidelines on 2 June 2011. The new guidelines will come into effect from 1 September 2011.

The Regulator consults a wide range of stakeholders including the public before making a decision on whether to issue any intentional release licence in accordance with gene technology legislation. During 2010–11, the Regulator consulted on six intentional release applications. Consultation periods exceeded the minimum specified timeframe of 30 days stipulated by legislation.

These activities contributed to ensuring a responsive, efficient and effective regulatory scheme that protects people and the environment and minimises regulatory burden.

Qualitative key performance indicator:

Protect people and the environment through identification and management of risks from GMOs

2010–11 reference point: High level of compliance with the gene technology legislation and no adverse effect on human health or environment from GMOs

Result: Indicator met.

Routine monitoring and auditing of the regulated community demonstrated a high level of compliance with gene technology legislation. The OGTR identified a small number of minor non-compliances or alleged breaches during routine monitoring of containment facilities and licensed dealings involving GMOs.


In all instances, the Regulator determined that findings of non-compliances presented negligible risk to human health and safety or to the environment, were minor in nature, involved negligible or zero culpability, and were resolved by reminders, education and/or cooperative compliance. No adverse effects on human health or the environment from GMOs were reported.

Qualitative key performance indicator:

Facilitate cooperation and prevent duplication in the implementation of GMO regulation

2010–11 reference point: High degree of cooperation with relevant regulatory agencies


The Regulator consulted other relevant regulatory agencies before making decisions for all intentional release licence applications for GMOs to ensure any risks to human health or the environment were managed effectively through coordinated action plans and decision making. The OGTR facilitated cooperation and harmonisation through the Regulators Forum and its working group activities, and through bilateral cooperation with relevant regulators.

In 2010–11, the Regulator and the OGTR participated in the Regulators Forum to exchange information with relevant regulatory agencies (Food Standards Australia New Zealand, National Industrial Chemicals Notification and Assessment Scheme, Therapeutic Goods Administration, Australian Pesticides and Veterinary Medicines Authority and Biosecurity Services Group within the Department of Agriculture, Fisheries and Forestry).

The OGTR also engaged in international forums focusing on harmonisation of risk assessment and regulation of GMOs, including the OECD and Cartagena Protocol on Biosafety.

The OGTR was invited to contribute to capacity-building workshops on risk assessment and regulation of GMOs including in the region covered by the Association of South/South-East Asian Nations and in West Africa. The OGTR hosted a study tour from the Malaysian Department of Biosafety.

Quantitative key performance indicator:

Percentage of licence decisions made within statutory timeframes

2010–11 target: 100%

2010–11 actual: 100%


The Regulator made decisions on all licence applications within the applicable statutory timeframes, maintaining the 100 per cent record of previous reporting periods. There were no appeals of decisions made by the Regulator.

Quantitative deliverable: Percentage of GMO licences issued under the Gene Technology Act 2000 that are entered onto a publicly accessible record on the OGTR website.

2010–11 target: 100%

2010–11 actual: 100%

Result: Deliverable met


During 2010–11, the Regulator issued six licences for intentional release of GMOs into the environment. The OGTR entered the licences and decision documents for the six licences onto the publicly accessible GMO Record page on the OGTR website.5

Quantitative deliverable: Percentage of field trial sites and higher level containment facilities inspected

2010–11 target: 20%

2010–11 actual: 40% and 23%


Field trial sites are inspected to monitor for compliance with licence conditions so risks to human health and safety and the environment are managed. In 2010–11, the OGTR inspected 40 per cent of current and post-harvest genetically modified crop field trial sites.

The sites inspected were across South Australia, Western Australia, New South Wales, Victoria, Queensland and the Australian Capital Territory. Genetically modified crop field trials inspected included canola, wheat, barley, cotton, Indian mustard, papaya, pineapple and white clover. The OGTR also inspected 23 per cent of higher-level containment facilities.

Quantitative deliverable: Percentage of variance between actual and budgeted expenses

2010–11 target: ≤0.5%

2010–11 actual: ≤0.5%


During 2010–11 OGTR managed their funding responsibly and achieved a result of –0.5%, in line with the target.

5. Available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ir-1>.


CHAPTER 3

Operationalperformance


3. Operational performance

As an introduction to operational activities, the first part of this chapter outlines the types of dealings with GMOs that are defined by the Gene Technology Act 2000, the Regulations and corresponding state and territory laws. It also provides a summary of classes of dealings, the process for authorisations and the statutory timeframe for consideration of each type of application and other statutory functions (such as certification and accreditation) that help the Regulator manage risks to health and safety of people and the environment. The second part of the chapter describes operational performance.

Classes of GMO dealings and authorisations

Section 10 of the Gene Technology Act 2000 defines ‘deal with’, in relation to a GMO, as:

(a) conduct experiments with the GMO

(b) make, develop or manufacture the GMO

(c) breed the GMO

(d) propagate the GMO

(e) use the GMO in the course of manufacture of a thing that is not the GMO

(f) grow, raise or culture the GMO

(g) import the GMO

(h) transport the GMO

(i) dispose of the GMO

and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i).

The Gene Technology Act 2000 defines a GMO as any organism that has been modified by gene technology, offspring derived from such an organism, or anything declared as a GMO in the Regulations.

Classes of GMO dealings

The Gene Technology Act 2000 forms the basis of a prohibitory scheme that makes dealing with a GMO a criminal offence unless, as outlined in section 31, the dealing is:

• an exempt dealing

• a notifiable low risk dealing (NLRD)


• authorised by a licence

• included on the GMO Register, or

• specified in an emergency dealing determination (EDD).

Exempt dealings and NLRDs are defined in the Regulations and are not considered to pose risks to either people or the environment that require direct scrutiny by the Regulator in the form of case-by-case risk assessment. These kinds of dealings are routine laboratory techniques involving GMOs, have been used safely for many years, and represent minimal risk dealings when performed in appropriate conditions.

Dealings authorised by a licence are further categorised into dealings not involving intentional release (DNIRs) that are conducted in contained facilities, dealings involving intentional release (DIRs) that involve release into the environment and inadvertent dealings.

For both DNIRs and DIRs the legislation requires the Regulator to prepare a RARMP as part of the process of making a decision on whether to issue a licence (sections 47 and 50 of the Gene Technology Act 2000 respectively). Part 5 of the Gene Technology Act 2000 allows the Regulator to grant a temporary licence (no longer than 12 months and for the purposes of disposing of the GMO) to a person who finds they are inadvertently dealing with an unlicensed GMO.

For dealings to be listed on the GMO Register, the Regulator must determine there are minimal risks and that it is no longer necessary for people undertaking the dealings to be licensed.

The EDD provision in Part 5A of the Gene Technology Act 2000 gives the Minister the power to expedite an approval of dealings with a GMO in an emergency.

Table 3 provides a summary of the classes of dealings, outlining the level of risk and the extent of management conditions (such as containment in certified facilities).

The licensing system is centred on a rigorous process of risk assessment based on scientific evidence. For DIRs, the legislation requires consultation with a wide range of experts, agencies and authorities, as well as the public. These include GTTAC, state and territory governments, Australian Government agencies prescribed in the Regulations, the Environment Minister, and relevant local councils.

The Regulator may, directly or upon application, vary an issued licence or other instruments. Variations involve changes to conditions applied to an instrument or a licence. The Regulator must not vary the licence unless he is satisfied that any risks posed by the dealings proposed to be authorised by the licence as varied are able to be managed in such a way as to protect the health and safety of people and the environment. The Regulator cannot vary a DNIR licence to authorise intentional release of a GMO into the environment.

More information on the various classes of GMO dealings and their assessment process is in appendix 2.6

6. A complete listing of DNIR and DIR licence applications and approvals and NLRDs is at <www.ogtr.gov.au/internet/ ogtr/publishing.nsf/Content/gmorec-index-1>.


Table 3: Classes of GMO dealings under the Gene Technology Act 2000

Category Licence required Containment

DIR (except for limited and controlled releases)

Yes, applications must be reviewed by IBC; consultation on application, RARMP prepared, consultation on RARMP and licence decision by the Regulator

Containment measures may be required, determined on a case-by-case basis and other licence conditions will apply

DIR (limited and controlled) Yes, applications must be reviewed by IBC; RARMP prepared, consultation on RARMP and licence decision by the Regulator

Containment measures will be required based on size/scope of release sought by applicant and other licence conditions will apply

DNIR Yes, applications must be assessed by IBC; RARMP prepared and licence decision by the Regulator

Yes, PC2 (usually)

EDD No, determination by Minister, subject to advice of threat and utility of GMO from competent authorities and risk assessment advice from Regulator

Containment and/or disposal measures may be included in EDD conditions

Exempt No, dealings classified as exempt are scheduled in the Regulations

No intentional release to the environment

GMO Register No, but must be previously licensed Review of related RARMPs

Containment measures may be required

Inadvertent dealing Yes, licence decision by the Regulator only for the purposes of disposal of the GMO

Containment and/or disposal measures will apply

NLRD No, dealings classified as NLRDs are scheduled in Regulations, conduct of NLRDs requires prior assessment by IBC to confirm proper classification; notified in annual report

Yes, PC1 or PC2 (usually)

Notes: DIR = dealing involving intentional release of a GMO into the environment; DNIR = contained dealing with a GMO not involving intentional release of the GMO into the environment; EDD = emergency dealing determination; GMO = genetically modified organism; IBC = Institutional Biosafety Committee; NLRD = Notifiable low risk dealing; PC = physical containment; RARMP = risk assessment and risk management plan

An organisation undertaking certain dealings with GMOs will be required to be accredited by the Regulator. Accreditation of organisations and certification of individual physical containment facilities helps manage risks that may be associated with dealings with GMOs (see also appendix 2).

Timeframes

Under section 43(3) of the Gene Technology Act 2000 the Regulator must issue or refuse to issue a licence within a time limit prescribed by the Regulations. Similarly, the Regulations prescribe a timeframe for consideration of applications to accredit organisations and to certify facilities. These statutory timeframes are shown in table 4. Apart from the timeframes for licence variations, they do not include weekends or public holidays in the Australian Capital Territory or periods where the Regulator has sought more information from the applicant, including


information to resolve a CCI claim, and the Regulator cannot proceed with the decision-making process until that information is provided. In these instances the statutory timeframe clock is regarded as stopped (clock stop).

Table 4: Prescribed timeframes

Category Timeframe

Accreditation 90 working days (Regulation 16)

Certification 90 working days (Regulation 14)

DIR – limited and controlled, no significant risk 150 working days (Regulation 8)

DIR – limited and controlled, significant risk 170 working days (Regulation 8)

DIR (except for limited and controlled releases) 255 working days (Regulation 8)

DNIR 90 working days (Regulation 8)

Licence variation 90 days (Regulation 11A)

Notes: DIR = dealing involving intentional release of a GMO into the environment; DNIR = contained dealing with a GMO not involving intentional release of the GMO into the environment

Operational performance

The second part of this chapter describes the Regulator’s achievements against Outcome 1, Population Health, of the Department of Health and Ageing 2010–11 PBS. It provides details of achievements on deliverables and performance indicators in the key areas of:

• assessments and approvals/authorisations under the Gene Technology Act 2000

• monitoring of GMOs

• compliance with the Gene Technology Act 2000

• consultation with stakeholders

• cooperation with relevant regulatory agencies.

Assessments and approvals

Information on performance against deliverables and key performance indicators, as set out in the Department’s 2010–11 PBS, is summarised in table 2.

In 2010–11 the OGTR received 1345 applications and notifications as defined under the Gene Technology Act 2000 (table 5). Year-to-year fluctuations in the timing and volume of applications can be influenced by research grant funding cycles and seasonal agricultural factors, as well as changes to legislation.


Table 5: Applications and notifications, 2010–11

Application type Received Withdrawn Approveda Ceased considerationb

Under considerationc

Accreditation 7 0 7 0 0

CCI declaration for DIR licence 5 3 6 0 4

CCI declaration for DNIR licence

3 1 0 0 3

Certification 193 2 171 0 26

DIR licence 3 1 6 0 3

DNIR licence 15 3 14 0 6

Lifting suspension of certification

23 0 22 0 1

NLRD notification 553 0 0 0 0

Surrender of accreditation 3 0 4 0 0

Surrender of certification 145 1 120 0 29

Surrender of DIR licence 6 0 10 0 0

Surrender of DNIR licence 11 3 6 0 3

Suspension of certification 53 3 50 0 0

Transfer of certification 5 0 1 0 4

Transfer of DIR licence 1 0 1 0 0

Transfer of DNIR licence 8 0 3 0 5

Variation of certification 218 5 203 0 23

Variation of DIR licence 10 1 11 0 4

Variation of DNIR licence 83 7 75 0 16

Total 1345 30 710 0 127

Notes: CCI = confidential commercial information; DIR = dealing involving intentional release of a GMO into the environment; DNIR = contained dealing with a GMO not involving intentional release of the GMO into the environment; NLRD = notifiable low risk dealing

a Some applications reported as approved in this financial year were received in the previous financial year. b Includes both ‘ceased consideration’ and ‘not considered’ under section 42 of the Gene Technology Act 2000 c Under consideration as at 30 June 2011

The Regulator also initiated variations to three DIR licences (DIR 105 and two variations to DIR 100), and one DNIR licence (DNIR 384).

Licences for dealings involving intentional releaseDIR licence applications have a statutory timeframe of up to 255 working days for processing, unless the application is for a limited and controlled release. The statutory timeframe for making a decision on limited and controlled release applications is 150 working days, or 170 working days if the proposed dealings may pose a significant risk to the health and safety of people or to the environment.


During 2010–11, the Regulator issued six DIR licences (table 6) and at 30 June 2011 he was considering a further three licence applications. All six approved applications for DIR licences were received before 1 July 2010. All licence decisions were made within statutory timeframes (table 2).

Five of the six DIR licences approved in 2010–11 were for limited and controlled release of GM plants, and continued the trend of applications focusing on traits intended to provide benefits to agricultural production. These DIR licences were issued for limited and controlled release of GM plants modified to improve disease resistance, insect resistance and herbicide tolerance, to enhance yield and delay leaf senescence, and to introduce a hybrid breeding system.

A commercial release of a genetically modified live viral vaccine (IMOJEV®) to protect against Japanese encephalitis was also approved in 2010–11.

Of the three DIR applications received in 2010–11, two were submitted by private companies and one by a university. Of the 89 DIR licences issued since commencement of the Gene Technology Act 2000, 47 (53%) have been to private companies, 33 (37%) have been to government agencies, and 9 (10%) to universities (figure 2).

Table 6: DIR applications approved, 2010–11

DIR no. Applicant Parent organism

Introduced trait

Type of release

Received Issued

DIR-107 Queensland University of Technology

Banana Disease resistance

Limited and controlled release

11/6/2010 12/1/2011

DIR-105 Monsanto Australia Limited

Canola Herbicide tolerance

Limited and controlled Release

8/6/2010 22/12/2010

DIR-104 Bayer CropScience Pty Ltd

Canola and Indian mustard

Herbicide tolerance with or without a hybrid breeding system


22/2/2010 28/9/2010

DIR-103 Department of Primary Industries, Victoria

Canola Enhanced yield and delayed leaf senescence


4/1/2010 6/8/2010

DIR-101 Monsanto Australia Limited

Cotton Insect resistance and herbicide tolerance


8/12/2009 16/7/2010

DIR-098 Sanofi–Aventis Australia Pty Ltd

Yellow fever virus (YF17D)

Attenuation, Japanese encephalitis vaccine

Commercial release

11/8/2009 19/8/2010


Figure 2: Types of organisations issued DIR licences since commencement of the Gene Technology Act 2000

Licences for dealings not involving intentional release

Licences for DNIRs authorise dealings with GMOs that are conducted in laboratories and other physical containment facilities. These licence applications have a statutory timeframe of 90 working days within which the Regulator must make a decision.

In 2010–11, the Regulator approved 14 DNIR licence applications (table 7). All were assessed within the statutory timeframe of 90 working days. The Regulator was considering a further six applications at 30 June 2011. The research focus of DNIRs approved in 2010–11 is shown in figure 3.

Nine licences were approved for the study of human and animal pathogens. Three DNIR licences authorised dealings with GM viral vectors for research into human diseases. One DNIR licence authorised dealings with GMOs for pre-clinical development of therapy for HIV and another licence authorised dealings to generate proteins that may aid in the treatment of snakebites.

Three DNIR applications were withdrawn during the reporting period. In two of these cases, the OGTR determined that the proposed dealings were more appropriately classified as notifiable low risk dealings (NLRD). The submission of these applications for the higher classification reflects the cautious approach of researchers and accredited organisations.

Most DNIR licences issued in 2010–11 were to publicly funded organisations, the largest single group of which was CSIRO (5 licences). Research institutes, universities, and a state health service were also represented in 8 DNIR licences. One DNIR licence was issued to a private company.

Figure 3: Research focus of DNIRs approved in 2010–11


Table 7: DNIR applications approved, 2010–11

DNIR no. Applicant Title Received Approved

DNIR-498 Western Sydney Local Health Network

Isolation and characterisation of genes involved in antifungal drug metabolism including drug resistance in pathogenic yeasts

8/9/2010 19/1/2011

DNIR-497 University of Queensland Expression and characterisation of novel genes from Australian snakes

2/9/2010 13/1/2011

DNIR-496 CSIRO Characterisation of the molecular determinants of host range and pathogenicity for henipaviruses

30/8/2010 5/1/2011

DNIR-495 CSIRO Generation of recombinant rabbit caliciviruses

27/8/2010 22/12/2010

DNIR-494 Peter MacCallum Cancer Centre Regulation of tumour suppression 22/7/2010 29/11/2010

DNIR-493 University of Queensland Molecular analysis of streptococcus pyogenes

20/7/2010 24/11/2010

DNIR-492 CSIRO Construction of a taura syndrome virus infectious clone

29/6/2010 28/10/2010

DNIR-491 Australian Institute of Marine Science

Cloning and over-expression of a metalloprotease implicated in the virulence of a coral pathogen vibrio corallilyticus

28/6/2010 31/10/2010

DNIR-490 CSIRO Identification of determinants of virulence and vector competence factors in ephemeroviruses

16/6/2010 22/10/2010

DNIR-489 St Vincent’s Institute of Medical Research

The role of micro-RNAs in Cancer Models

27/4/2010 1/9/2010

DNIR-488 CSIRO Identification of determinants of virulence and vector competence factors in bluetongue virus

27/4/2010 30/8/2010

DNIR-487 Western Australian Institute for Medical Research

The use of short hairpin microRNAi lentiviral based constructs and libraries for functional analysis

21/4/2010 25/8/2010

DNIR-486 Calimmune Australia Pty Ltd Gene therapy for HIV 15/3/2010 20/7/2010

DNIR-485 Queensland Institute of Medical Research

Mouse studies using EcoHIV 10/3/2010 15/7/2010

Notes: CSIRO = Commonwealth Scientific and Industrial Research Organisation; DNIR = A contained dealing with a GMO not involving intentional release of the GMO into the environment; HIV = human immunodeficiency virus; RNA = ribonucleic acid


Figure 4: Types of organisations that were issued DNIR licences in 2010–11

Notifiable low risk dealings

Notifiable low risk dealings (NLRDs) have been assessed, based on previous experience and current scientific knowledge, as posing low risk. Dealings with GMOs classified as NLRDs are listed in the Regulations under Schedule 3 Part 1 (NLRDs appropriate for PC1 facilities) and Schedule 3 Part 2 (NLRDs appropriate for PC2 facilities). Conduct of NLRDs does not require prior authorisation from the Regulator but the dealings must have been assessed by an IBC as meeting the NLRD classification, must not involve intentional release of GMOs into the environment, and must comply with the requirements specified in the Regulations. NLRDs must be notified to the Regulator annually.

The Regulator received 553 NLRD notifications during 2010–11. Of these, 545 were for NLRDs assessed as meeting NLRD classification by IBCs during 2010–11, five were additional NLRDs reported by IBCs for dealings assessed before 1 July 2010, and three were assessed by IBCs in the beginning of 2010–11, before the organisations submitting their annual reports of NLRDs to the Regulator.

A considerable proportion of NLRD work is primarily for research purposes only and not intended for commercialisation. Most NLRDs involve research into, for example, the fundamentals of cellular process, gene expression and disease progression and are mostly undertaken in PC2 facilities. As with GMO dealings undertaken through DNIR licences, work undertaken as NLRDs may never proceed beyond contained research.

Dealings placed on the GMO Register

The GMO Register is a list of dealings with GMOs that the Regulator is satisfied pose minimal risk to human health and safety and the environment and can therefore be undertaken by anyone, subject to any specified conditions, without oversight of a licence holder. The Regulator may, under section 78 of the Gene Technology Act 2000, determine that dealings with a GMO previously authorised by a licence are to be included on the GMO Register. Such determinations are disallowable legislative instruments and must be tabled in Parliament. The Regulator entered no new listings on the GMO Register during 2010–11.

More information on the types of dealings conducted under each category is provided in appendix 2.7

7. Listings of DIR, DNIR, NLRD and GMO Register applications and notifications are available at <www.ogtr.gov.au>.


Sections 78 and 79 of the Gene Technology Act 2000 allow the Regulator to place GMOs on the GMO Register provided they have been licensed, pose minimal risks to people or the environment, and are safe for anyone to use without the need for a licence.

During 2010–11 the Regulator received no applications to place any dealings on the GMO Register and none were under consideration.

Emergency Dealing Determination

An Emergency Dealing Determination (EDD) is a legislative instrument made under the Gene Technology Act 2000; the Regulator does not make an EDD. Sections 72A to 72E of the Gene Technology Act 2000 give the responsible Minister the power to expedite approval of dealings with a GMO in an emergency. This recognises that situations may arise in which a rapid approval of a dealing with a GMO may be required. An EDD can only be made to have effect for up to six months but may be extended by the Minister. The emergency provisions further the object of the Gene Technology Act 2000: to protect the health and safety of people and to protect the environment.

Before making an EDD, the Minister must be satisfied that: (a) there is an actual or imminent threat to the health and safety of people or to the environment; (b) the dealings proposed to be specified in the EDD would, or would be likely to, adequately address the threat; and (c) any risks posed by the dealings proposed to be specified in the EDD are able to be managed in such a way as to protect the health and safety of people and the environment.

The Minister must have received advice relating to (a) the threat and (b) addressing the threat, from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer, or the Commonwealth Chief Plant Protection Officer; and in relation to (c) management of risks, from the Gene Technology Regulator. The states and territories must also have been consulted.

Under the Gene Technology Act 2000, the Regulator has powers to monitor compliance with the conditions of the EDD.

During 2010–11, the Regulator did not receive any requests for advice in relation to making any EDDs, and none were in effect.

Accredited organisations

The Regulator requires organisations licensed to conduct work with GMOs to remain accredited. To achieve and retain accreditation, the Regulator must be satisfied that an organisation has, or has access to, a properly constituted and resourced IBC and complies with other requirements of the Regulator’s Guidelines for Accreditation of Organisations. Accreditation applications have a statutory timeframe of 90 working days within which the Regulator must make a decision.

As at 30 June 2011, 162 organisations were accredited. These ranged from organisations with one IBC overseeing a few NLRDs to large organisations with several IBCs conducting a range of dealings with GMOs at multiple locations.

Although companies comprise the largest proportion (33%), of all accredited organisations, figure 5 shows that 67 per cent of accredited organisations are primarily public sector funded, the same proportion as last year. The largest single group of public sector funded, accredited organisations is universities. Victoria has the highest proportion of accredited organisations’ headquarters (figure 6).


Figure 5: Organisations accredited as at 30 June 2011, by type of organisation

Figure 6: Organisations accredited as at 30 June 2011, by location of headquarters

Certified physical containment facilitiesApplications for certification of physical containment (PC) facilities in accordance with the Regulator’s Certification Guidelines also have a statutory timeframe of 90 working days within which the Regulator must make a decision.

Physical containment facilities are classified according to levels of stringency in the containment measures for GMOs. The classifications relate to structural integrity of buildings and equipment used as well as the handling practices employed by those working in the facility. Physical containment level 1 (PC1) facilities are used to contain organisms posing the lowest risk to human health and the environment. Physical containment level 4 (PC4) facilities provide the most secure and stringent containment conditions. The type and number of facilities certified at 30 June 2011 are listed in table 8.

The percentage of certified PC1 facilities at 30 June 2011 was approximately 14 per cent of all certified facilities, up significantly from 2 per cent at 30 June 2007, and slightly higher than at 30 June 2010 (approximately 13%).

The percentage of certified PC2 facilities was 84 per cent at 30 June 2011. Most (68%) certified PC2 facilities are laboratories that mainly handle microorganisms (such as certain bacteria or viruses) and cell tissue cultures while other PC2 facility types incorporate requirements specific to handling particular organisms (animals 14%, plants 10%, aquatic 1% and arthropods 2%).

PC3 facilities comprise approximately 2 per cent of the total number of certified physical containment facilities. At 30 June 2011 only three PC4 facilities were certified to conduct work with GMOs.


During 2010–11, 171 applications to certify physical containment facilities were approved (table 5).

OGTR certified physical containment facilities are located in all Australian jurisdictions (figure 7).

Table 8: Number of facilities certified at 30 June 2011, by physical containment level and type

Facility type PC1 PC2 PC3 PC4 Total

Animal – 229 4 – 233

Aquatic organism – 26 – – 26

Arthropod/invertebrate – 34 1 – 35

Constant temperature room – 65 – – 65

Facility 238 – – 3 241

Laboratory – 1139 24 – 1163

Large grazing animal 38 – – – 38

Large scale – 16 – – 16

Plant – 161 – – 161

Total 276 1670 29 3 1978

Note: PC = physical containment

Figure 7: Physical containment facilities certified as at 30 June 2011, by location

Physical containment facilities range from a small, single room to a large suite of contiguous laboratories and associated support rooms that are encompassed by one certification instrument. In one year a single organisation can redevelop its old containment facilities and build a new building, thereby skewing the proportion of applications received from that organisation type in a given year. While private companies form the largest proportion of accredited organisations (33%), they submit the least number of applications for certification (less than 5%). This reflects the commercial focus of company dealings, as opposed to the greater research focus of universities, where most dealings require physical containment.


Trend data for approval of main types of applicationsThe number of certification approvals has fallen to 171, less than the previous four years, but higher than 2005–06 and 2006–07 (table 9). There has been a recent tendency for organisations to construct large facilities with multiple laboratory rooms, which are laid out to enable certification of a large floor area under a single certification instrument. In some cases this has resulted in organisations decommissioning their older facilities, which are typically smaller, non-continuous laboratory areas covered by multiple certification instruments.

Table 9: Trend data for approval of main types of applications, 2007–08 to 2010–11

Application type 2010–11 2009–10 2008–09 2007–08

Accreditation 7 8 6 8

Certification 171 182 242 230

DIR licence 6 8 13 5

DNIR licence 14 18 14 19

NLRD notification 553 629 533 19

Notes: DIR = a dealing involving intentional release of a GMO into the environment; DNIR = a contained dealing with a GMO not involving intentional release of the GMO into the environment; NLRD = notifiable low risk dealing

Applications can be made to the Regulator under section 184 of the Gene Technology Act 2000 for specified information (that has not previously been made public) to be declared confidential commercial information (CCI). The extent of CCI claims can be the subject of considerable discussion with the applicant and may require the OGTR to independently verify what information is already in the public domain. The Gene Technology Act 2000 does not assign a statutory timeframe within which the Regulator must make a decision on CCI applications and the evaluation of a licence application may be paused if significant CCI claims need to be resolved. During 2010–11, the Regulator made six CCI declarations; decisions on seven CCI applications were pending at 30 June 2011.

Surrender of licences and certifications usually occurs when dealings have concluded. Before surrender is approved, the Regulator must be satisfied that all conditions (such as post-harvest monitoring) have been met and that any required cleaning and/or decommissioning of facilities has taken place. The OGTR received 165 surrender requests during 2010–11 and approved 140. These included approval of 120 applications for surrender of certifications of facilities, and approval of six applications to surrender DNIR licences as well as approval of 10 applications to surrender DIR licences.

The Regulator may initiate variations to instruments issued under the Gene Technology Act 2000 (licence, certification or accreditation) and instrument holders may also apply to the Regulator for variations. Variations to licences range from minor changes to a dealing (such as a change of project supervisor) to major changes (such as a request to grow the GM crop in an additional or new site). Variations also include evaluation of changes arising from renovations to a certified facility or new methods to handle GMOs.

During 2010–11, the Regulator approved 203 certification variations. Approximately 66 per cent of these were to extend the period of certification; 20 per cent were to add or remove rooms from the area certified; 7 per cent were to change the facility title; 3 per cent were to vary standard conditions of certification; 3 per cent were to change the physical containment level; and 1 per cent was to change the type of facility.


Monitoring of genetically modified organisms

The Regulator’s quarterly reports8 provide detailed information about monitoring inspections the OGTR conducted. This section provides information on the range of inspection activities the OGTR conducted during 2010–11.

Inspections of DIR licences

The OGTR strategy for conducting field trial monitoring draws on accumulated operational experience of compliance risk profiling.9

During 2010–11, 17 accredited organisations held the 56 DIR licences in force. Seven licences were for commercial release of GMOs. None of these licences imposed conditions that necessitate monitoring. Of those licences for limited and controlled release of a GMO four were for disease–vaccine trials, and 45 were for limited and controlled trials of GM crop varieties. The OGTR inspected 12 of the 45 licences for limited and controlled trials of GM crop varieties. Each licence may contain a number of trial sites.

Overview of inspection activities

The OGTR’s operational objective is to monitor at least 20 per cent of all limited and controlled field trial locations annually. A further target within this operational benchmark is to inspect a minimum of 5 per cent of all limited and controlled field trial sites during each quarter of the year. In 2010–11, the OGTR exceeded its operational benchmark and either met or exceeded its quarterly objective. At the beginning of 2010–11, 62 licensed field trial sites were operating, 18 of which were current and 44 of which were subject to post-harvest monitoring conditions. The OGTR inspected 25 sites during 2010–11, 13 current and 12 post-harvest monitoring sites representing 40 per cent of total sites, thereby exceeding the minimum target of 20 per cent of field trial sites each year (table 2). A breakdown of the number and proportion of inspections is in table 10.

In addition to the routine monitoring of field trial sites, inspections were conducted of a number of field trial sites in Queensland and Victoria that were located in areas affected by floods and/or by cyclone Yasi. Nineteen sites comprising 12 current sites and seven sites subject to post-harvest monitoring were inspected. All were compliant with licence conditions at the time of inspection and, while there was some damage, there was no evidence that loss of containment of GMOs had occurred at any of the sites.

Table 10: Number and proportion of inspections performed in each quarter of 2010–11

Quarter No. and proportion of current sites inspected

No. and proportion of PHM sites inspected

July – September 2010 1/18 (6%) 3/44 (7%)

October – December 2010 2/20 (10%) 2/40 (5%)

January – March 2011 3/29 (10%) 2/32 (6%)

April – June 2011 7/26 (27%) 5/33 (15%)

Note: PHM = post-harvest monitoring

8. Available from OGTR or at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1>.

9. Find more detail from the Monitoring Protocol at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/mc- protocols-1>.


Trial types

The licences in force authorised the limited and controlled release of a range of crop and plant types including banana, barley, canola, cotton, grapevine, Indian mustard, maize, papaya, perennial ryegrass/tall fescue, pineapple, sugarcane, torenia, wheat and white clover. Although licences were in force, planting has not occurred in all cases. Canola was the most prevalent crop, collectively trialled at 17 sites. The OGTR performed 25 inspections of field trial sites across seven crop types during 2010–11 (table 11 and figure 8).

Table 11: Number of licensed DIR sites, by crop type/parent organism at beginning of 2010–11 and end of 2010–11; and number of inspections conducted during 2010–11

Crop type/parent organism No. of DIR trial sites at beginning

of 2010–11

No. of DIR trial sites at end of 2010–11

No. of DIR trial sites inspected in

2010–11

Banana 2 2 0b

Canola 11 17 7

Canola, Indian mustarda 3 2 0b

Cotton 16 8 4b

Grapevine 1 0 0

Indian mustard 1 1 0

Maize 1 1 0

Papaya 1 1 1

Perennial ryegrass/tall fescuea 1 1 0b

Pineapple 3 1 1

Sugarcane 13 16 0b

Torenia 1 0 0

Wheat 3 3 2b

Wheat and barleya 3 11 9

White clover 2 2 1b

Total 62 66 25

Notes: DIR = a dealing involving intentional release of a GMO into the environment.

a Some DIR licences authorise trials with two similar crop species. In this table, trial sites authorised under such licences are listed separately to those relating to licences authorising single crop species.

b In addition inspections were conducted of three cotton, one banana, nine sugarcane, one wheat, one white clover, one perennial ryegrass/tall fescue, and three canola and Indian mustard sites after the Queensland and Victoria floods and/or cyclone Yasi.


Figure 8: Number of DIR field trial sites inspected in 2010–11, by crop type

Cycle and status of field trial sitesDuring each year, the status of limited and controlled trials of GM crops undergoes significant change; new trials are planted, some trials are harvested and enter into a post-harvest monitoring period, and licence obligations for other trial sites are signed off. When the latter occurs, OGTR signs off the location as having completed all necessary licence obligations.

Figure 9 provides a summary of the number of field trial sites at the beginning and end of 2010–11, and the transition of location status during the year.

Figure 9: Number of field trial sites at beginning of 2010–11 (left), transition of location status (centre), and number of field trial sites at end of 2010–11 (right)

Location by jurisdictionDuring 2010–11, the OGTR conducted 25 inspections of 62 field trial sites (table 12) across a number of states and territories. Queensland (24) and Victoria (16) contained the highest numbers of trial sites. Victoria contained the highest numbers of plant/crop types with eight different species being trialled. Figure 10 shows the location and diversity of field trials and includes information on the local government areas where trials proceeded.


Table 12: Number of field trial sites and OGTR inspections in 2010–11, by state and territory

Jurisdiction No. of field trial sites at 1 July 2010

No. of field trial sites inspected in 2010–11

New South Wales 12 6

Victoria 16 7

Queensland 24 2

Western Australia 0 1

South Australia 6 2

Tasmania 0 0

Northern Territory 0 0

Australian Capital Territory 4 7

Total 62 25

The OGTR performed inspections in five states and one territory (figure 11), in line with the proportion of field trial sites in those states. Of the 27 local government areas where field trials took place in 2010–11, OGTR inspected trials in 10 (figure 12).

Figure 10: Number of field trial sites inspected in 2010–11, by state and territory


Figure 11: Location by local government area and field trial types during 2010–11


Figure 12: Field trial sites and locations inspected in 2010–11, by local government area


Inspections of contained dealingsThe monitoring program also encompasses dealings conducted in contained facilities under DNIR licences, NLRDs, and exempt dealings. As part of these activities a minimum of 20 per cent of higher-level physical containment (PC) facilities (PC4, PC3 and PC2 large-scale) are monitored annually.

As well as examining the integrity of the physical structure of the facility, inspections cover the general work practices employed in handling DNIR and NLRDs.

At 30 June 2011, 128 accredited organisations held 1978 certification instruments for containment facilities. During 2010–11, certified facilities operated by 21 accredited organisations were monitored. For the purposes of monitoring, certified facilities are grouped into higher and lower containment types; that is, PC4, PC3 and PC2 large-scale laboratories are categorised as higher-level containment facilities, and the remaining facility types are categorised as lower-level containment facilities. The OGTR conducted 39 inspections across the range of facility types (table 13). Of the 52 higher-level containment facilities that had certification instruments in force at the beginning of 2010–11, 12 were inspected. This figure represented 23 per cent of higher-level containment facilities and exceeded the minimum target of inspecting 20 per cent of such facilities each year (table 2).

In addition, 26 DNIR licences in force during 2010–11 were monitored.

Table 13: Number of certification types at end of 2010–11, and inspections conducted during 2010–11

Containment type Physical containment level and facility type

No. of certifications No. of inspections

Lower-level containment facilities

PC1 Large grazing animal 38 0

PC1 Laboratory 0 0

PC1 Facility 238 0

PC2 Animal 229 7

PC2 Aquatic organism 26 0

PC2 Constant temperature room

65 0

PC2 Arthropod 34 0

PC2 Laboratory 1139 19

PC2 Plant 161 1

Higher-level containment facilities

PC2 Large scale 16 5

PC3 Animal 4 0

PC3 Arthropod 1 0

PC3 Laboratory 24 7

PC4 Facility 3 0

Total 1978 39


Inspections by stateCertified facilities are located in all Australian states and territories (figure 13). In 2010–11, monitoring activities were carried out in each state and territory except Tasmania and the Northern Territory (figure 14). The number of OGTR inspections of facilities reflects, as far as practicable, the number of facilities located in each state and territory.

Figure 13: Number of certified facilities as at 2010–11, by state and territory

Figure 14: Number of certified facility inspections in 2010–11, by state and territory

Inspections by organisation typeOf the five OGTR categories of applicant organisation, universities held the greatest number of certifications during 2010–11 (figure 15). In 2010–11, monitoring activities were carried out in each category (figure 16). The number of OGTR inspections of facilities in each category reflects, as far as practicable, the number of facilities present in each category.


Figure 15: Number of certified facilities as at 2010–11, by organisation type

Figure 16: Number of certified facility inspections in 2010–11, by organisation type

Compliance with the Gene Technology Act 2000

During 2010–11, the regulated community demonstrated a high level of compliance with gene technology legislation (table 2).

In conducting routine inspections, the OGTR found some inconsistencies between an event or state of affairs and the requirements imposed by licence or certification conditions, which are referred to here as non-compliances. However, non-compliance is not regarded as a breach of the Gene Technology Act 2000 unless, after investigation, it is proven to be so. Each incident of non-compliance was assessed according to established OGTR protocols and found to present negligible risk to human health and safety or to the environment.10

The Regulator’s response to all non-compliance incidents is informed by the OGTR’s Non-Compliance Protocol to ensure consistent responses proportional to the risks posed to human health and safety or to the environment.11

10. These incidents are discussed in the Regulator’s quarterly reports available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1>.

11. The Protocol is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/mc-protocols-1>.


This section provides a summary of the types of non-compliances found and the responses implemented. The results and findings of all OGTR inspections are reviewed and used to inform future monitoring activities and to continue improving accredited organisations’ compliance with the Gene Technology Act 2000.

Non-compliancesOne finding of non-compliance was identified during monitoring of DIR licences during 2010–11. This non-compliance related to a failure to update signed statements of training following a variation to the licence.

In addition, nine findings of non-compliance were identified during monitoring of DNIR licences. These included contraventions of the requirement for staff to undergo appropriate training and provide signed statements, conducting dealings in facilities not listed on the licence, deficient labelling of containers used in transporting GMOs, failure to follow specific work practices and notify the Regulator as soon as practicable following an incident.

A number of minor non-compliances were also identified during routine monitoring of containment facilities (table 14). Non-compliances in such facilities were due to lapsed maintenance and validation of equipment, inadequate training, expired or unlabelled disinfectants, incorrect transport procedures and minor defects in structural components of the facilities.

Table 14: Number of non-compliances identified in certified facilities during 2010–11, by non-compliance type

Nature of non-compliance No. of non-compliances

Equipment 4

Structure 3

Transport 2

Waste disposal 1

Work practices 8

In all instances the Regulator determined that findings of non-compliance presented negligible risk to human health and safety or to the environment, were minor in nature, involved negligible or zero culpability, and were resolved by reminders, education and/or cooperative compliance.

Compliance and investigationsThe OGTR recognises that both compliance and enforcement mechanisms are necessary to provide an effective and flexible regulatory system that enables the most appropriate response to a given issue or incident. The OGTR Compliance and Investigation Section assesses and manages contraventions of the Gene Technology Act 2000 through:

• a program of practice reviews and audits, which apply investigation practices and performance audit techniques to identify and prevent contraventions of legislation through cooperative capacity building of regulated stakeholders’ compliance management arrangements


• assessment of regulated-party annual reports and other information collected under the regulatory system

• third-party reporting, including a high degree of cooperative self-reporting of compliance issues by regulated parties

• contribution of feedback toward continual improvement of OGTR regulatory specifications and arrangements

• investigations, which can draw on monitoring and any of the above compliance management activities, as necessary.

The OGTR investigates all reported or detected contraventions of legislation it administers in accordance with the OGTR Compliance and Enforcement Policy.12 This is initiated through a preliminary assessment of relevant facts and likely impacts in order to decide on the likelihood that a contravention has occurred or is about to occur, its seriousness and its likely consequences. Based on the outcome of this initial assessment and the relevant provisions of legislation, the OGTR determines the appropriate level, if any, of further investigation and response.

During 2010–11, the OGTR undertook one practice review, which is discussed below.

Equipment practice reviewA practice review was conducted to seek information on:

• regulated end-users’ operational practices for managing acquisition, maintenance, performance and use of equipment

• state of the market and whether there are any barriers to effective compliance on the part of regulated parties

• availability of appropriate goods and effective maintenance services

• any issues that could impinge on regulated parties’ effective compliance performance.

The review canvassed representatives of the supply chains for biological safety cabinets and autoclaves. This included standards committee representatives, the National Association of Testing Authorities, manufacturers, importers and suppliers of maintenance services.

The review incorporated information obtained from 16 regulated end-users of the equipment in these supply chains. These were the Australian Institute of Marine Sciences; Australian National University; Central Queensland University (Rockhampton); Children Youth and Women’s Health Service; Darwin Region [Joint] IBC; Institute of Medical and Veterinary Science (IMVS Patholology); James Cook University; Ozgene Pty Ltd; Queensland Institute of Medical Research (QIMR); Royal Perth Hospital; SA Pathology; Sydney West Area Health Service; Tethlon Institute for Child Health Research; University of Adelaide; University of Melbourne; and University of Western Australia.

The review found that:

• no non-compliances or breaches were evident

12. The policy is available at <www.ogtr.gov.au> via the links to Monitoring and Compliance.


• participating accredited organisations had efficient tailored arrangements to obtain and manage the equipment to meet national gene technology regulatory requirements

• a number of best practice techniques and some potential equipment selection and management risks were relevant to managing equipment quality control and compliance performance which were recorded for dissemination to the regulated community

• notwithstanding the evolving nature of this industry, there appears to be sufficient market options for reliable equipment goods and services at this time

• the interviews and the documentation, provided as part of the audit interview and site visits, are valuable inclusions to data on organisation compliance, which would be drawn upon in future OGTR education and awareness activities.

National strategy for unintended presence of unapproved GMOsIn 2005, the Australian Government Biotechnology Ministerial Council endorsed a risk-based national strategy to manage the unintended presence of unapproved GMOs in imported seeds for sowing. The strategy was developed by an interdepartmental working group chaired by Biotechnology Australia and comprising the Department of Agriculture, Fisheries and Forestry; the Department of the Environment and Heritage;13 the Department of Foreign Affairs and Trade; the Department of Education, Science and Training;14 the Department of Industry, Tourism and Resources;15 the Department of Health and Ageing; Food Standards Australia New Zealand; and the OGTR.

The OGTR is responsible for implementing the strategy, which has six components (table 15) and employs a risk management approach, with resources dedicated to the areas posing the highest likelihood of unintended presence. The focus to date has been on seeds for sowing, which has been assessed as the highest priority.

In recent years, the OGTR has worked with the Australian Seed Federation to develop a voluntary auditing and testing program of existing industry quality assurance measures and has assessed the effectiveness of the first stage of reviews completed in 2007. No issues of concern were identified for the five companies that participated in the quality assurance reviews.

In 2009–10 the OGTR began quality assurance reviews of Australian and state government breeding programs, including the Tasmanian Department of Primary Industries, Parks, Water and Environment; the Victorian Department of Primary Industries; and the CSIRO’s Plant Industry Division. In 2010–11 the breeding programs of Industry & Investment New South Wales were assessed and no issues of concern were identified.

13. Now the Department of Sustainability, Environment, Water, Population and Communities.

14. Now the Department of Education, Employment and Workplace Relations.

15. Now the Department of Innovation, Industry, Science and Research.


Table 15: Components of national strategy for unintended presence of unapproved GMOs

Component Description

Risk profiling – identifying seed imports posing the highest likelihood of unintended presence

The OGTR has established a memorandum of understanding with AQIS to access data on imports. Data on imported seeds for sowing, together with information on overseas commercial production of GMOs and input from the Australian Government Department of Sustainability, Environment, Water, Population and Communities, and other relevant agencies was used to identify 12 priority crops.

Quality assurance and identity preservation Industry uses quality assurance and identity preservation systems for seed quality purposes. The OGTR has developed a program for auditing and testing industry quality assurance systems that industry has agreed and adopted.

Laboratory testing The OGTR’s voluntary code of conduct refers to industry testing programs. Industry needs to be able to assure itself that it is managing the risk of importing unapproved seeds. Discussions between the OGTR and the National Measurement Institute about appropriate testing methodologies are ongoing.

Approvals/advance risk assessments for Australia’s regulatory agencies

The OGTR has prepared GMO incident response documents for 12 crops identified through risk profiling as having the highest likelihood of unintended presence in imports of seeds for sowing (canola, cotton, maize, potato, tomato, papaya, soybean, squash, alfalfa, grasses, rice and wheat). These documents will provide a basis for rapid risk assessment and management actions, should an unintended presence of an unapproved GMO be detected.

Post market detection The OGTR recognises the legislative limitations of preventing unintended imports of unapproved GMOs and has worked cooperatively with industry to develop a voluntary code. The code aims to isolate risks as early as possible in the commercial seed supply chain.

This is supported by the standard OGTR practice of investigating information about potential and possible incidents.

Enforcement action In the event of detection of unapproved GMOs, appropriate responses would be determined on a case-by-case risk management basis. The OGTR continues consultation with Australian Government agencies, relevant industry organisations and states and territories to finalise an incident response plan.

Consultation with stakeholders

The Regulator’s functions, as prescribed by section 27 of the Gene Technology Act 2000, include:

• issuing technical and procedural guidelines in relation to GMOs

• providing advice to the Gene Technology Ministerial Council (GTMC) about:

– the operations of the Regulator and the GTTAC

– the effectiveness of the legislative framework for regulating GMOs, including in relation to possible amendments of the legislation


• providing information and advice to other regulatory agencies about GMOs and GM products

• providing information and advice to the public about regulating GMOs.

Regulator’s review of Gene Technology Regulations 2001The Administrator of the Commonwealth of Australia made the Gene Technology Amendment Regulations 2011 (Amendment Regulations 2011) on 2 June 2011. The Amendment Regulations 2011 are a disallowable instrument and were tabled in the House of Representatives on 14 June 2011 and the Senate on 15 June 2011.

The Amendment Regulations 2011 represent the culmination of a technical review of the Gene Technology Regulations 2001 initiated by the Regulator in 2008. The scope of the review was limited to issues that do not affect policy settings of the regulatory scheme and that are consistent with achieving the object of the Gene Technology Act 2000, with a primary focus on classification of GMO dealings in the exempt and notifiable low risk dealing (NLRD) categories.

Consultation on proposed amendments with a wide range of stakeholders was undertaken in May–June 2010. The consultation included all regulated organisations and IBCs, state and territory governments, Australian Government agencies, GTTAC and the general public. The Amendment Regulations 2011 were finalised taking into account feedback from submissions received.

The Amendment Regulations 2011 include changes to: classification of some GMO dealings as exempt dealings or NLRDs, classification of some GMO dealings involving viral vectors, and oversight and timeframes of NLRDs. These amendments will ensure classification and regulation of dealings with GMOs remains commensurate with risk and contemporary scientific understanding.

The Amendment Regulations will commence on 1 September 2011. This delayed commencement date allows time for regulated organisations and their IBCs to become familiar with the changes and be ready to implement and comply with them. The OGTR will provide information to regulated organisations and the public to inform them of the changes.

Security Sensitive Biological Agents Regulatory SchemeThe National Health Security Act 2007 implements a scheme for regulating security sensitive biological agents (SSBAs). The SSBA Regulatory Scheme effects recommendations agreed by the Council of Australian Governments (COAG). The Office of Health Protection within the Department of Health and Ageing has responsibility for administering the National Health Security Act 2007. Because of the similarities between elements of gene technology regulation and the SSBA Regulatory Scheme, inspectors from the OGTR undertake inspections under the scheme, in line with COAG recommendations.

The Gene Technology Regulations 2001 were amended (the Gene Technology Amendment Regulations 2009) in April 2009 to allow inspectors from the existing Gene Technology Regulatory Scheme to monitor laboratories and facilities handling the SSBA for compliance with the National Health Security Act 2007.


The amendment enables payment to the Regulator for SSBA monitoring activities from the SSBA Regulatory Scheme funds. The OGTR has worked with the Office of Health Protection to develop operational monitoring requirements. Commencing early in 2009–10, inspection activities have continued throughout 2010–11.

Revised guidelinesDuring 2010–11, the Regulator issued the new Guidelines for the Transport, Storage and Disposal of GMOs. Commencement date of the new guidelines will be 1 September 2011, to coincide with the commencement date of the Gene Technology Amendment Regulations 2011 (No. 1). The amended regulations provide for transport, storage or disposal of NLRDs outside facilities certified by the Regulator, so long as these activities are conducted in accordance with the new guidelines.

Advice to the Gene Technology Ministerial CouncilThe GTMC did not meet in 2010–11. During the year the OGTR provided advice to the GTMC and Gene Technology Standing Committee (GTSC) about the review of the Regulations, the GTSC supports the GTMC. Under the intergovernmental Gene Technology Agreement 2001, changes to the Commonwealth gene technology legislation require approval by the GTMC. The GTMC approved the Amendment Regulations 2011, as proposed by the Regulator in March 2011. The OGTR also facilitated consultation with the GTSC and GTMC on the nomination and selection process for new appointments to GTTAC and GTECCC.

Appointment of gene technology advisory committeesThe Gene Technology Act 2000 provides that the term of appointment for members of the two statutory advisory committees – GTTAC and GTECCC – is up to three years, and that the Minister is responsible for committee appointments. Committee memberships for 2008–11 expired on 31 January 2011. The appointment process commenced in May 2010 with a public call for nominations for the 2011–14 triennium of GTTAC and GTECCC. The Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP, made appointments to the two committees in February 2011. Find more details about advisory committees, including a list of members for each committee, in appendix 3.

Accredited organisations and Institutional Biosafety Committee trainingThe fourth National Institutional Biosafety Committee Forum was held in Canberra on 7 and 8 June 2011 at the National Gallery of Australia. Representatives from all states and territories except the Northern Territory attended; 137 delegates represented 64 accredited organisations.

The forum was opened with an address from the Vice-Chancellor of the University of Tasmania, Professor Peter Rathjen, and the Regulator followed with an update of OGTR’s achievements. A number of guest speakers from other Australian Government agencies and IBCs, as well as officers from several sections of the OGTR, also gave presentations.

The forum facilitated exchange of information between IBCs and the OGTR and provided an arena in which to discuss the impending changes to the Gene Technology Regulations. The two-day meeting also provided an opportunity for delegates to discuss specific issues with OGTR staff.


Feedback was strongly positive. Delegates found the forum interesting and informative, valued the opportunity to meet OGTR staff in person, and to exchange ideas with IBC members from other organisations.

Advice on GMOs and GM productsDuring 2010–11 the OGTR provided advice on GMOs and GM products to other regulatory agencies and to the public.

Advice to other regulatory agenciesTo facilitate reciprocal exchange of information with the other product regulatory agencies on assessment and approval of GMOs and GM products required by their respective legislation,16 the OGTR developed memoranda of understanding with Food Standards Australia New Zealand, the Therapeutic Goods Administration, the Australian Pesticides and Veterinary Medicines Authority and the Australian Quarantine and Inspection Service. The OGTR progressed reviews of several of these memoranda of understanding in 2010–11.

The OGTR also has a memorandum of understanding with the Department of Sustainability, Environment, Water, Population and Communities in relation to consultation with the Environment Minister on DIR licence applications prescribed under the Gene Technology Act 2000.

In line with recommendations from the 2006 Statutory Review, a Regulators’ Forum has been established to promote and facilitate information sharing between these regulatory agencies and the Regulator. The forum met in August and December in 2010 and in March 2011 discussing a work program for enhancing overall regulatory effectiveness through improved cross-agency collaboration.

Advice to the publicThe Gene Technology Act 2000 requires the Regulator to maintain a record of GMO and GM product dealings (the GMO Record). Details of licences issued, information about NLRDs, GMO dealings included on the GMO Register, EDDs and information about GM products approved by other Australian regulatory authorities, are included on the GMO Record. The GMO Record was maintained and updated throughout 2010–11 to incorporate approvals of GMOs under the Gene Technology Act 2000 and GM product approvals notified to the Regulator by other agencies (appendix 8).

OGTR website and contact pointsThe OGTR maintains a comprehensive website <www.ogtr.gov.au> that includes extensive information on the regulatory system and decisions made by the Regulator. This information includes a number of fact sheets on relevant issues and copies of the full risk assessment and risk management plans for each GMO released into the environment. Find details of use and statistics in appendix 8.

16. The OGTR maintains the GMO Record, as a source of public information on such approvals, on its website at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gmoregister-1>. The Gene Technology Consequential Amendments Act 2000 provides for product regulators to seek advice from FSANZ, TGA, NICNAS and APVMA on GM products.


The OGTR also has a 1800 free call number (1800 181 030) and an email address or inbox <[email protected]> that provide points of contact for members of the public and other interested parties. Assistance with specific questions and additional mechanisms for public feedback are among some of the services provided by these facilities. On average, 95 emails and 89 free calls were received each month in 2010–11 (102 emails and 108 free calls in 2009–10; appendix 8).

The OGTR maintains a client register, which is a list of individuals and organisations that have registered their interest in regulation of gene technology with the Office. Members receive notifications of new GMO applications and licences issued to release a GMO into the environment, significant changes to the gene technology legislation, and an invitation to comment on consultation risk assessment and risk management plans developed for each application to release a GMO into the environment. Approximately 620 individuals and organisations are listed on the OGTR client register. Interested parties may also register on the OGTR client register to receive notifications from the Office.

During 2010–11, the Regulator and the OGTR participated in a range of presentations and meetings on gene technology wherever possible to inform users, the Australian community and stakeholders, about the regulatory system (appendix 7).

International regulatory liaison

Under section 27 of the Gene Technology Act 2000, the Regulator’s functions include:

• monitoring international practice in relation to regulation of GMOs

• maintaining links with international organisations that regulate GMOs in countries outside Australia

• promoting harmonisation of risk assessments relating to GMOs and GM products by regulatory agencies.

Active participation in international forums enables Australia to inform and influence developments in GMO regulation, based on the Australian experience, and helps ensure Australia’s regulatory scheme takes account of best international practice. The Regulator and the OGTR have established a significant international presence and feedback from meetings indicates that the Australian gene technology regulatory system is highly regarded.

During 2010–11 the OGTR actively engaged in international forums focusing on harmonising the risk assessment and regulation of GMOs. This included contributing to development of guidance documents by groups under the OECD and UN Cartagena Protocol on Biosafety.

The OGTR continued interacting directly with key regulatory counterparts in other countries through bilateral discussions and participation in international forums in 2010–11. These activities included:

• making a keynote presentation at an OECD Cooperative Research Program symposium: ‘Decision Making and Science: the balancing of risk based decision that influence the sustainability of agricultural production’ on 6–8 October 2010 in Berlin, Germany

• participating in the eleventh International Symposium on the Biosafety of Genetically Modified Organisms on 15–19 November 2010 in Buenos Aires, Argentina

• contributing to capacity building workshops on risk assessment and regulation of GMOs


including in the region covered by the Association of South/South-East Asian Nations and in West Africa

• hosting a study tour from the Malaysian Department of Biosafety in November 2010 seeking to gain insight from the Australian regulatory system.

An OGTR officer participated in and provided expert advice to the Australian delegation to the Fifth Meeting of the Parties to the UN Cartagena Protocol on Biosafety in Nagoya, Japan in October 2010. In addition an OGTR officer participated as a member of the Ad Hoc Technical Experts Group on Risk Assessment and Risk Management under the Cartagena Protocol on Biosafety.

Find a full list of OGTR activities at international meetings, forums and conferences in appendix 6.

Other functions of the Gene Technology Regulator

The Gene Technology Act 2000 requires the Regulator to undertake functions that contribute to the OGTR’s capacity to conduct high quality assessments based on regulatory best practice and relevant scientific data. Section 27 of the Gene Technology Act 2000 provides for the Regulator to:

• undertake or commission research in relation to risk assessment and the biosafety of GMOs

• promote harmonisation of risk assessment relating to GMOs and GM products by regulatory agencies.

Undertake or commission researchThe Regulator commissioned research on the potential for wild birds to spread seeds through ingestion and transport in the gut. This was addressed by testing if seed viability of a number of agricultural crops was affected by passage through the gut of three common wild bird species.

Promote harmonisationThe OGTR is represented on the subcommittee for revision of Australian/New Zealand Standard Safety in Laboratories, Part 3: Microbiological aspects and containment facilities. Involvement in this subcommittee contributes to harmonisation of OGTR requirements for physical containment facilities with those of other national agencies, such as the Australian Quarantine and Inspection Service and more broadly with those organisations complying with Standards Australia.


CHAPTER 4

Managementand accountability


4. Management and accountability

The OGTR’s management and accountability practices encompass human resources, occupational health and safety, and the Commonwealth Disability Strategy. The OGTR also adheres to Australian Government purchasing and assets management, contracting, consultancy policies as well as advertising and market research policies, and ecologically sustainable development. The Regulator reports to the Parliament annually as well as quarterly, as required by legislation.

Human resources

The OGTR has a workforce of 55 employees that includes 10 part-time staff. Of these, 50 were ongoing employees and five were non-ongoing employees (appendix 4).

The terms and conditions for non-SES staff at OGTR are covered by the Department of Health and Ageing’s Collective Agreement 5 2007–11 (CA5), which was made under section 328 of the Workplace Relations Act 1996. CA5 is a principles-based agreement, with most detail on operation of conditions in supporting guidelines. The CA5 has a flexibility clause that enables the department to provide additional terms and conditions where necessary, and as approved by the department’s Remuneration Committee (table 16).

The OGTR continued to build a strong team culture in its tenth year of operation; all-staff Friday morning tea was a successful way of keeping staff up-to-date on major issues, and allowed opportunities for input, participation and feedback. Friday was also promoted as casual day and staff were encouraged to contribute a gold coin for donations to:

• Cancer Council Australia

• Children’s Medical Research Institute – ‘Jeans for Genes’

• Movember Foundation

• National Breast Cancer Foundation

• Ovarian Cancer Australia

• Salvation Army – Red Shield Appeal.

OGTR staff also participated in ‘Australia’s Biggest Morning Tea’ in support of cancer research, prevention and support services for all Australians.

The OGTR endeavoured to maintain staff skills and motivation through appropriate training and development, and ensure recruitment was conducted in a timely manner.

Staff undertook 241 days (227 days in 2009–10 and 217 days in 2008–09) of formal training during the year, in addition to orientation and induction training for all new starters.


Table 16: Non-salary benefits

Agreement BenefitsCollective Agreement 5 Access to negotiated discount registration or memberships fees to join a fitness or health

club

Access to the Employee Assistance Program

Award scheme

Eligibility for performance based pay

Extended purchased leave

Flexible working hours

Flexible working locations including, where appropriate, access to lap-top computers, dial-in facilities and mobile phones

Flextime

Influenza and hepatitis B vaccinations for staff who are required to come into regular contact with members of the community classified as at increased risk of exposure to influenza

Leave for compelling reasons and exceptional circumstances

Maternity and adoption leave

Parental leave

Pay-out of additional duty in certain circumstances

Recognition of travel time

Reimbursement of eyesight testing and eyewear costs prescribed specifically for use with screen-based equipment

Study assistance

Support for professional and personal development

Senior Executive Service Staff

All of the above benefits except flextime

Airport lounge membership

Car parking

Home office equipment

Private use of motor vehicles or an allowance in lieu (not all officers)

OGTR staff are able to access professional development opportunities through the Department’s Performance Development Scheme. At the beginning of each 12-month cycle, each employee and manager agrees on the key commitments the employee will undertake, and the performance measures and development requirements needed to complete the commitment.

In 2010–11 refresher training for the OGTR emergency control team consisting of one floor warden, two fire wardens and two first aid officers was conducted. Members of the emergency control team are self-nominated and on completion of the required training receive an allowance in accordance with CA5.

In keeping with OGTR’s objective of providing a supportive working environment, staff are provided with access to departmental assistance measures. The measures include financial support for eyesight testing, occupational health and safety workstation assessments, problem resolution procedures, and an employee assistance program. The assistance program is a free short-term professional, confidential counselling and advice service provided by Davidson Trahaire Corpsych. OGTR staff and/or members of their immediate family can use the program.


As a family-friendly organisation the OGTR has endeavoured to be responsive to employee needs and circumstances through provision of flexible working arrangements in recognition of the importance of work–life balance. The OGTR has a high proportion of part-time employees (appendix 4). Staff have also accessed extended maternity leave on half pay and the 48/52 provision that allows for additional unpaid leave while averaging salary payments over the year.

Occupational health and safety

Occupational health and safety inspections were undertaken at the OGTR premises in Barton during 2010–11 and no major health or safety issues were identified. Electrical equipment safety testing and air quality testing were among the tests conducted.

Occupational health and safety seminars were presented to staff throughout the year and the ergonomic requirements of all staff were met.

Other occupational health and safety support included provision of training in first aid, emergency evacuation systems and fire safety systems. All staff were offered the opportunity to receive an influenza vaccination, which the department made available at low cost. Staff who are likely to inspect contained facilities were also offered appropriate immunisations.

Freedom of information

From 1 May 2011 agencies subject to the Freedom of Information Act 1982 are required to publish information to the public as part of the Information Publication Scheme. This requirement is in Part II of the Freedom of Information Act 1982 and has replaced the former requirement to publish a section 8 statement in an annual report. The Information Publication Scheme promotes transparency and a proactive approach to publishing government information. The Regulator has prepared an Information Publication Scheme Plan that outlines how and what information the Regulator proposes to publish, the approach and the mechanisms the OGTR has in place to help the Regulator proactively identify and disclose information to the public, as specified in sections 8(1), 8(2), and 8(4) of the Freedom of Information Act 1982.17

From 1 July 2010 to 30 April 2011 the Regulator was required under section 8 of the Freedom of Information Act 1982 to publish in its annual report information about functions and its decision-making powers that affect the public. The Regulator was also required to comment on arrangements for public participation in formulation of policy, the categories of documents held by the OGTR, and how the public can access these documents. This information is covered here.

Decision-making powersThe Regulator exercised decision-making powers under the Gene Technology Act 2000 and the corresponding state and territory laws.18

Categories of documents the OGTR maintainsThe OGTR maintains records relating to the functions of the Regulator and OGTR as part of the Health and Ageing portfolio in various forms and locations. Records are retained for varying

17. The Regulator’s agency plan is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ips-1>.

18. See <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/legislation-2>.


periods, depending on their administrative and historical value; and are disposed of in accordance with standards and practices approved by the National Archives of Australia. The following categories of documents were common in 2010–11:

• agreements, memoranda of understanding between the Commonwealth, governments and other bodies and organisations

• briefing papers and minutes prepared for the Ministers, the Parliamentary Secretary and senior departmental officers

• Cabinet documents, including Cabinet submissions/memoranda and documents submitted to Cabinet

• committee records

• correspondence with non-government parties

• documents prepared by international agencies

• documents prepared for the Executive Council

• documents relating to development of, and explanatory memoranda to the Gene Technology Act 2000, Regulations and other legislative instruments

• documents submitted by third parties

• financial reports, expenditure estimates and expenditure reports

• instruments of appointment

• interdepartmental and general correspondence and papers

• internal administration documents relating to staff management and the OGTR’s organisation and operation, including personnel records, organisational and staffing records, financial and resource management records, audit records, internal operating procedures, requests for tender, instructions and indexes

• legal documents, including legislation, contracts, leases, instruments of delegation and legal advices

• mailing lists

• maps, charts, photographs, technical drawings, specifications and technical manuals

• media releases

• ministerial and departmental responses to correspondence and parliamentary questions

• OGTR publications and occasional papers

• policy documents, including those used in implementing government and office policy, recommendations and decisions

• records of meetings and teleconferences with both internal and external stakeholders, including agendas and minutes

• reports prepared by other government agencies and consultants relevant to the OGTR

• requests for information under the Freedom of Information Act 1982 and files and papers relevant to consideration of those requests


• standard operating procedures and fact sheets

• statistics and databases

• training materials.

In addition, a large number of OGTR publications were available free of charge to the public. Find a list of these publications at <www.ogtr.gov.au> where many are available for download.

Facilities for public access to OGTR documentsThe OGTR provides appropriate facilities for inspecting documents under the Freedom of Information Act 1982.

OGTR manualsIn accordance with section 9 of the Freedom of Information Act 1982, the OGTR has compiled a list of unpublished manuals and other documents provided to officers to help make decisions or recommendations that affect the public. The list, as at July 2011, is available on request from the Freedom of Information Coordinator or any office of the National Archives of Australia.

Freedom of information proceduresBefore 1 November 2010 a request for access to documents under the Freedom of Information Act 1982 had to be made in writing and applicants may have been liable to pay charges at rates prescribed by the Freedom of Information (fees and charges) Regulations. In certain circumstances the fee was not required or could be remitted. To enable a prompt response and to help the OGTR meet its obligations under the Freedom of Information Act 1982, applicants should provide as much information as possible about the documents they are seeking. A telephone number or an email address should also be included in case OGTR officers need clarification.

From 1 November 2010 a number of changes arising from the Australian Information Commissioner Act 2010 and the Freedom of Information Amendment (Reform) Act 2010 were implemented, including removal of an application fee and the first hour of decision making to be free.

Contact detailsEnquiries about submission of a formal request under the Freedom of Information Act 1982 should initially be directed to the Freedom of Information Coordinator on 1800 181 030.

Formal requests should be sent to:

Freedom of Information Coordinator Office of the Gene Technology Regulator MDP 54 GPO Box 9848 Canberra ACT 2601

In accordance with the Electronic Transactions Act 1999, freedom of information requests may be emailed to <[email protected]>.


The OGTR received one request for access under freedom of information legislation during the reporting period; it was finalised within the statutory timeframes.

The Regulator is required by the Freedom of Information Act 1982 section 11C to publish a disclosure log on the OGTR website. The disclosure log lists information that has been released in response to a freedom of information access request.19

Assets management

The OGTR applies a whole-of-life asset management strategy that is consistent with the Department’s asset management program. In May 2011 the OGTR undertook a stocktake of fixed and intangible assets, in accordance with Australian Accounting Standard 136 Impairment of Assets. This confirmed the location and condition of OGTR’s assets and ensured the assets are carried at a value above the recoverable amount.

Exempt contracts

No exempt contracts were awarded in 2010–11.

Consultancies

During 2010–11, two new consultancy contracts were entered into involving total actual expenditure of $83 553 (table 17).

Table 17: Consultancy services let during 2010–11, of $10 000 or more

Consultant name Description Contract price

Selection process (1)

Justification (2)

Deakin University To conduct a study on seed digestion by birds

$51 273 Select tender B

UoM Commercial Ltd, University of Melbourne

To undertake a review of the risk communication chapter of the Regulator’s Risk Analysis Framework

$32 280 Direct sourcing A

TOTAL $83 553

(1) Explanation of selection process terms drawn from the Commonwealth Procurement Guidelines (December 2008):

Select tender: A procurement procedure in which the procuring agency selects which potential suppliers are invited to submit tenders (this includes tenders submitted through Multi Use Lists). This procurement process may only be used under certain defined circumstances.

Direct sourcing: A form of restricted tendering, available only under certain defined circumstances, with a single potential supplier or suppliers being invited to bid because of their unique expertise and/or their special ability to supply the goods and/or services sought.

(2) Justification for decision to use consultancy:

A – skills currently unavailable within agency B – need for specialised or professional skills

19. Find details by viewing the log at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ips-plan>.


Purchasing

In 2010–11 the OGTR complied with the Australian Government’s purchasing policies as articulated in the Commonwealth Procurement Guidelines.

Advertising and market research

The OGTR incurred $19 837 in advertising costs during 2010–11 ($83 032 in 2009–10) to invite the public to comment on risk assessment and risk management plans for DIR licence applications and place advertisements for staff recruitment (table 18).

Table 18: Media advertising organisations engaged, 2010–11

Organisation Service provided Amount paid

2010–11 2009–10

ADCORP Australia Ltd Placing advertisements regarding regulatory activities

$8 296 $46 369

ADCORP Australia Ltd Placing advertisements for recruitment of staff $11 541 $36 663

Total $19 837 $83 032

Note: Amounts listed are inclusive of GST

Annual reporting requirements

Section 136 of the Gene Technology Act 2000 requires the Regulator to prepare and provide an annual report to the Minister on the Regulator’s operations during that year for tabling in the Australian Parliament.

The Annual Report on the Operations of the Gene Technology Regulator 2009–10 was tabled in Parliament on 27 October 2010.20

Quarterly reporting requirements

Section 136A(2) of the Gene Technology Act 2000 requires the Regulator to prepare and provide a quarterly report to the Minister on the operations of the Regulator during that quarter for tabling in the Australian Parliament. The Act requires the report to include information on:

• GMO licences issued during the quarter

• any breaches of conditions of a GMO licence that have come to the Regulator’s attention during the quarter

• auditing and monitoring of dealings with GMOs under the Gene Technology Act 2000 by the Regulator or an inspector during the quarter.

Find a list of 2010–11 quarterly reports the OGTR published in appendix 5.21

20. The report is available from the OGTR Information Officer or at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1>.


National Disability Strategy

Since 1994, Australian Government departments and agencies have reported on their performance as policy adviser, purchaser, employer, regulator and provider under the Commonwealth Disability Strategy. In 2007–08, reporting on the employer role was transferred to the Australian Public Service Commission’s State of the Service Report and the APS Statistical Bulletin.22 From 2010–11, departments and agencies are no longer required to report on these functions.

The Commonwealth Disability Strategy has been overtaken by a new National Disability Strategy, which sets out a 10-year national policy framework for improving life for Australians with disability, their families and carers. The Standing Council on Community, Housing and Disability Services will produce a high-level report for COAG to track progress for people with disability at a national level. 23

The Social Inclusion Measurement and Reporting Strategy agreed by the government in December 2009 will also include some reporting on disability matters in its regular How Australia is Faring report and, if appropriate, in strategic change indicators in agency annual reports.24

Ecologically sustainable development and environmental performance

The OGTR supports the Australian Government’s commitment to ecologically sustainable development principles and reports here on its operations during 2010–11 against section 516A of the Environment Protection and Biodiversity Conservation Act 1999.

The Regulator administers the Gene Technology Act 2000. This Act aims to protect the health and safety of people and the environment by identifying risks posed by gene technology and managing those risks through regulating dealings with genetically modified organisms.

In 2010–11, the OGTR continued to support the Regulator in regulating activities involving live and viable genetically modified organisms. These activities ranged from contained work in certified laboratories to releases of genetically modified organisms into the environment. The Regulator imposed licence conditions to protect the environment, and used extensive powers to monitor and enforce those conditions.

Section 516A(6)(a): Legislation administered by the Regulator during 2010–11 which accords with ecologically sustainable development principlesThe Regulator administers the Gene Technology Act 2000, which aims to protect the health and safety of people and the environment by identifying risks posed by gene technology and managing those risks through regulating dealings with GMOs.

21. These are also available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1> or as hard copy by contacting the OGTR Information Officer.

22. These reports are available at <www.apsc.gov.au>.

23. The report will be available at <www.fahcsia.gov.au>.

24. Find more detail on social inclusion matters at <www.socialinclusion.gov.au>.


Section 516(6)(b): How the OGTR outcomes have contributed to ecologically sustainable development during 2010–11In 2010–11, the OGTR continued to support the Regulator in regulating activities involving live and viable GMOs. These activities ranged from contained work in certified laboratories to releases of GMOs into the environment. The Regulator imposed licence conditions to protect the environment, and had extensive powers to monitor and enforce those conditions.

In 2010–11, the Regulator received 18 licence applications; three were for DIRs and 15 were for DNIRs. In addition, the Regulator issued 20 licences to deal with GMOs, comprising six DIRs and 14 DNIRs (chapter 4).

The OGTR submits a nil response to sections 516A(6)(c), (d) and (e).


Appendicies


Appendix 1 History and structure of the gene technology regulatory system

This appendix provides a brief description of development of the Gene Technology Act 2000, governance arrangements for the regulatory system and how gene technology is regulated in Australia.

Development of the Gene Technology Act 2000Voluntary oversight of gene technology in Australia began in the mid 1970s, primarily on the initiative of the Australian Academy of Sciences, and later the Australian Government. Significant advances in applications of gene technology and resulting elevated community concern about GMOs led, in November 1998, to the cooperative process between the state, territory and Australian governments to establish a uniform national approach to regulating gene technology. After wide consultation the Gene Technology Act 2000 and Regulations came into effect on 21 June 2001.

In establishing the regulatory scheme, governments sought to recognise and balance the potential of gene technology to contribute to society with community concerns over its development and deployment. The extensive consultation conducted during development of the regulatory scheme reflected the emphasis placed on community input and participation in the decision-making process, and generated strong agreement about what should be included and excluded from the scope of the legislation. Broad consensus that the Regulator should consider only gene technology and that other forms of genetic manipulation used in conventional breeding should be excluded from assessments was reached. Other matters out of scope included trade and marketability, cost–benefit considerations, comparisons with alternative technologies, intellectual property, and human cloning.

This led to the object of the Gene Technology Act 2000 being defined as:

to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs.

The intergovernmental Gene Technology Agreement underpins the national regulatory system. This agreement, signed by all Australian jurisdictions, sets out the understanding between governments about the nationally consistent regulatory system and commits the states and territories to pass corresponding laws.

Governance arrangementsThe Gene Technology Act 2000 and the Regulations and corresponding state and territory laws provide a nationally consistent system to regulate development and use of gene technology in Australia. The legislation establishes an independent statutory office holder to administer the national scheme, the Regulator, who is charged with performing functions and exercising powers under the Gene Technology Act 2000 (figure 17).


While the Regulator must consider risks to human health and safety and the environment relating to dealings with GMOs, other agencies have responsibility for regulating GMOs or GM products as part of a broader or different mandate. Therefore, these agencies also have relevant and complementary expertise. During development of the gene technology legislation, it was determined that the Regulator’s activities should not override existing Commonwealth legislation or result in duplication. Hence, the Gene Technology Act 2000 incorporates a requirement for the Regulator to consult other prescribed agencies identified in the Regulations on DIR applications. The Gene Technology Act 2000 was accompanied by consequential amendments of the other relevant Acts relating to requirements for mutual consultation and exchange of information regarding their assessments and approvals. Accordingly, where other agencies approve GM products25 they seek advice from the Regulator and provide notification of their decisions to the Regulator for placing on the Record of GMO and GM Product Dealings.

Figure 17: Governance arrangements for the Gene Technology Regulator

Notes: APVMA = Australian Pesticides and Veterinary Medicines Authority; AQIS = Australian Quarantine and Inspection Service; FSANZ = Food Standards Australia New Zealand; GTECCC = Gene Technology Community Consultative Committee; GTTAC = Gene Technology Technical Advisory Committee; NICNAS = National Industrial Chemicals Notification and Assessment Scheme; TGA = Therapeutic Goods Administration

25. A thing (other than a GMO) derived or produced from a GMO.


Role of the Gene Technology Ministerial CouncilThe GTMC oversees implementation of the national regulatory scheme for gene technology.

The GTMC was established under clause 13 of the Agreement and comprises a representative from each state and territory. Its role is to provide policy guidance for operation of the Gene Technology Act 2000. In addition, the GTMC approves appointment of the Regulator and the Chairs of the statutory advisory committees (appendix 3) and provides advice to the Australian Government Minister for Health and Ageing on appointment of committee members.

The Gene Technology Act 2000 provides for the GTMC to issue policy principles on ethical issues about GMOs and recognition of areas designated under state law for the purpose of preserving the identity of either GM crops or non-GM crops for marketing purposes (section 21).

On 31 July 2003, the GTMC issued the policy principle, Gene Technology (Recognition of Designated Areas) Principle 2003, which came into effect on 5 September 2003.

The Gene Technology Standing Committee supports the GTMC. To separate the Regulator’s responsibilities relating to implementing the Gene Technology Act 2000, and developing policy relating to the Gene Technology Act 2000 itself, the Department of Health and Ageing provides the secretariat for the GTMC and its standing committee.

In 2010, the GTMC agreed consequential amendments to the Gene Technology Act 2000 proposed by the Superannuation Legislation (Consequential Amendments and Transitional Provisions) Bill 2010. These amendments commenced on 1 July 2011 following enactment of the Superannuation Legislation (Consequential Amendments and Transitional Provisions) Act 2011 (Cwlth) on 28 June 2011.

Changes to gene technology legislationOne of the Regulator’s prescribed functions is to advise the Ministerial Council about the effectiveness of the legislative framework for regulating GMOs, including possible amendments to legislation. Since its inception, the Gene Technology Act 2000 and Regulations have been amended to:

• Improve the effectiveness and efficiency of the Regulations. Three sets of amendments to the Regulations have been made: Amendment Regulations 2006 (as a result of the 2004–06 Regulator’s review), Amendment Regulations 2007 (consequential amendments due to the review of the Gene Technology Act 2000) and Amendment Regulations 2011 (as a result of the 2008–11 Regulator’s review, due to commence on 1 September 2011).

• Improve the operation of the Gene Technology Act 2000 at the margins. These generally minor amendments included addition of emergency powers to the Gene Technology Act 2000, which give the Minister the ability to expedite approval of a GMO in emergencies. These amendments were made as a result of the 2005–06 Statutory Review of the Gene Technology Act 2000 and the Gene Technology Agreement (Gene Technology Amendment Act 2007 and the Gene Technology Amendment Regulations 2007).

• Confer on the Regulator the function of making available inspectors appointed under section 150 of the Gene Technology Act 2000 to be appointed as inspectors under Part 3 Division 7 of the National Health Security Act 2007. These amendments were in line


with COAG’s recommendations providing for OGTR inspectors to undertake monitoring inspections under the SSBA regulatory scheme (Gene Technology Amendment Regulations 2009).

Coordination with prescribed agenciesSometimes conduct of particular activities with a GMO will require approval by both the Regulator and another regulatory body. For example, while the Regulator must issue a licence to deal with a human medicine that is a GMO, such as some live GM vaccines, the TGA would need to authorise its administration to people. Similarly, while the Regulator must approve release of GM insecticide- or herbicide-tolerant plants into the environment, the Australian Pesticides and Veterinary Medicines Authority, which is responsible for regulating all agricultural chemicals, must register the insecticide product produced in the GM plant or approve application of the herbicide to which the GM plants are tolerant.

Although the focus and responsibility of other agencies, which regulate products that involve GMOs or GM products are distinct from those of the Regulator, where there is a requirement for regulation, the Regulator has a policy of aligning the decision-making processes to the extent that it is practicable. The OGTR and other regulatory agencies work together to ensure thorough coordinated assessments of parallel applications are undertaken and, wherever possible, that the timing of decisions by both agencies coincide.

There are, however, examples of where it is not possible to align regulatory agency decision-making processes; such as, when Food Standards Australia New Zealand is asked to assess the safety of a GM product that will be imported for sale for human food where no application has been submitted to the Regulator to grow, in Australia, the GMO from which the GM product is derived.

The respective roles of the various regulatory agencies that regulate GMOs or GM products along with the relevant legislation are listed in table 19.


Table 19: Regulatory agencies in Australia with a role in regulating gene technology

GMO/GM products

Agency Portfolio Scope Relevant legislation

GMO dealings

OGTR

Gene Technology Regulator and Office

Health and Ageing

OGTR underpins the national scheme for regulating GMOs in Australia, and aims to protect human health and safety and the environment by identifying risks posed by or as a result of gene technology, and managing those risks by regulating certain dealings with GMOs.

Gene Technology Act 2000

Medicines, medical devices, blood and tissues

TGA

Therapeutic Goods Administration

Health and Ageing

TGA administers legislation that provides a national framework for regulating therapeutic products in Australia and ensures their quality, safety and efficacy.

Therapeutic Goods Act 1989

Food FSANZ

Food Standards Australia New Zealand

Health and Ageing

FSANZ is responsible for the Australia New Zealand Food Standards Code that prohibits use of food products produced using gene technology in Australia unless there is specific approval for sale of these foods following a safety assessment. The Code also contains provisions for labelling GM foods.

Food Standards Australia New Zealand Act 1991

Agricultural and veterinary chemicals

APVMA

Australian Pesticides and Veterinary Medicines Authority

Agriculture, Fisheries and Forestry

APVMA operates the national system that evaluates, registers and regulates all agricultural chemicals (including those that are, or are used on, GM crops) and veterinary therapeutic products. Assessments consider human and environmental safety, product efficacy (including insecticide and herbicide resistance management), and trade issues relating to residues.

Agricultural and Veterinary Chemicals (Code) Act 1994

Agricultural and Veterinary Chemicals Administration Act 1994

Industrial chemicals

NICNAS

National Industrial Chemicals Notification and Assessment Scheme

Health and Ageing

NICNAS provides a national notification and assessment scheme to protect the health of the public, workers and the environment from the harmful effects of industrial chemicals.

Industrial Chemicals (Notification and Assessment) Act 1989

Quarantine AQIS

Australian Quarantine and Inspection Service

Agriculture, Fisheries and Forestry

AQIS regulates importation into Australia of all animal, plant and biological products that may pose a quarantine pest and/or disease risk.

Quarantine Act 1908

Imported Food Control Act 1992


Appendix 2

Types of applications, authorisations, monitoring and compliance

This appendix outlines the classes of dealings with GMOs that are defined by the Gene Technology Act 2000, the Regulations and corresponding state and territory laws, as well as the procedures followed for each type of application and other instruments that help the Regulator manage risks to health and safety of people and the environment. It also describes activities the OGTR undertakes to monitor dealings with GMOs for compliance with legislation and actions it takes in response to non-compliances.

The GMO RegisterThe GMO Register is a register provided by Part 6 Division 3 of the Gene Technology Act 2000. The Regulator may make a determination to include dealings with GMOs on the GMO Register26 according to section 78 of the Gene Technology Act 2000. To be included on the GMO Register, the dealings must first have been authorised by a GMO licence. Dealings will not be entered onto the GMO Register until the Regulator is satisfied that the risks posed by the dealings are minimal and that it is not necessary for anyone conducting the dealings to be covered by a licence in order to protect the health and safety of people or the environment. After inclusion on the Register these dealings would no longer require authorisation by a licence from the Regulator but may still have conditions attached to their registration. One GMO dealing (for a colour modified carnation) is currently on the GMO Register.

Exempt dealingsExempt dealings are dealings with GMOs that have been assessed over time as posing negligible27 risks to people or to the environment. They comprise basic molecular biology techniques that are used extensively in laboratories worldwide. The criteria for exempt dealings are specified in the Regulations (Schedule 2). Exempt dealings must not involve intentional release into the environment but do not require a specified level of containment. Guidance on appropriate containment measures for exempt dealings is provided on the OGTR website. If dealings fall within the classification in the Regulations for exempt dealings they do not require a case-by-case risk assessment. Examples of exempt dealings include dealings with:

• an animal into which GM somatic cells have been introduced, where the introduced somatic cells do not produce infectious agents

• small volumes (less than 10 litres) of an approved host/vector system into which low-risk genetic material has been introduced (for example, the gene must not be uncharacterised, be derived from a pathogenic organism, or code for a toxin).

26. It is important to note the difference between the GMO Record and the GMO Register. The GMO Register lists GMOs that no longer require a licence and will only ever be a subset of dealings included on the GMO Record. The GMO Record is a comprehensive listing of all dealings with GMOs including licensed dealings, NLRDs and GM products.

27. The term ‘negligible’ is defined in Chapter 3 of the Risk Analysis Framework and is used here for consistency.


Notifiable low risk dealingsNLRDs are dealings with GMOs that have been assessed as posing negligible risks provided certain management conditions are met. The Regulations specify the GMO dealings that are classified as NLRDs (Schedule 3 Parts 1 and 2) and requirements for undertaking NLRDs (Regulation 13). Such dealings may only be undertaken in a facility certified by the Regulator at least to a specified physical containment level (usually PC1 or PC2 certified facilities) and is of an appropriate design for the kind of dealing undertaken. Conducting NLRDs requires prior assessment by an IBC to confirm that proposed dealings with GMOs are properly classified as NLRDs and that personnel have the appropriate training or experience. Organisations must keep a record of all current NLRDs and notify them in an annual report to the Regulator. NLRDs are included on the Record of GMO and GM Product Dealings but do not require case-by-case risk assessment by the Regulator.

An example of an NLRD that may be conducted in PC1 facilities is dealing with GM laboratory mice or rats. Examples of NLRDs that may be conducted in PC2 facilities include dealings with:

• a GM animal (other than a mouse or rat) including invertebrates

• a GM plant, provided the dealing occurs in a facility designed to prevent release of its pollen and seed

• an approved host/vector system into which a gene that may pose a higher level of risk has been introduced (for example, the gene may encode a pathogenic determinant or uncharacterised gene from a pathogen).

Licensed dealingsAny dealing with a GMO not classified as exempt or as an NLRD or listed on the GMO Register or authorised by an Emergency Dealing Determination must not be conducted unless licensed. The Regulator considers all licence applications on a case-by-case basis. The Regulator must consider whether the risks posed by the dealing can be managed in such a way as to protect human health and safety and the environment. The Regulator must make a decision on whether to issue a licence to allow dealing and (if a licence were to be issued) the management conditions to be imposed to manage any risks.

The legislation sets out a series of actions the Regulator must take in considering applications for licences both for contained dealings (DNIRs) and those involving intentional release (DIRs). The Gene Technology Act 2000 details steps that must be taken in assessing the application, and the application forms detail the information an applicant must provide.

For both DNIRs and DIRs, the Regulator requires an applicant to identify risks the dealings may pose to human health and safety and the environment and any measures proposed to manage those risks and that the organisation’s IBC supports the application.

The Gene Technology Act 2000 requires the Regulator to prepare a RARMP for both DNIR and DIR applications. The risk assessment takes account of any risks to human health and safety and the environment posed by the dealing and the risk management plan determines how those risks can be managed.

The requirements of the legislation have been framed so as to place greater scrutiny on dealings that involve intentional release of GMOs to the environment (DIRs). The Regulator


may impose conditions on all licences; for example, for all DIRs determined to be limited and controlled releases, measures will be imposed to restrict the persistence and spread of the GMO and its genetic material. Non-compliance with conditions placed on licences issued under the Gene Technology Act 2000 is a criminal offence.

For both DNIR and DIR applications, the applicant must provide information specified in the Gene Technology Act 2000 as to their suitability to hold a licence. This information includes any relevant convictions, revocations or suspensions of licences under laws relating to human health and safety or the environment and an assessment of the applicant’s capacity to manage any risks posed by the proposed dealings.

While the Gene Technology Act 2000 is highly prescriptive about the process to be followed in assessing licence applications, it is not explicit in directing how the Regulator should undertake risk analyses. The Risk Analysis Framework was, therefore, developed to provide guidance on how the Regulator and the OGTR should apply internationally recognised risk analysis practice in the context of the legislation. The framework was applied to all licence applications processed during 2010–11.28

Dealings not involving intentional releaseDNIRs usually take place under specified physical containment conditions in certified facilities, which minimise risks to the environment. The Gene Technology Act 2000 requires preparation of a RARMP for DNIR applications (section 47). The application form specifies the information the Regulator requires.

The legislation provides that in relation to DNIR licences the Regulator may consult GTTAC, the states and territories, relevant Australian Government agencies, and any other person the Regulator considers appropriate.

The Regulator considers the RARMP in deciding whether to issue a licence and in determining the licence conditions that should be imposed (if a licence were to be issued). Typical licence conditions require the applicant to conduct the dealings in certified facilities, to follow particular handling requirements (such as avoiding use of ‘sharps’ and using biosafety cabinets), to train and supervise staff, to transport and dispose of the GMO appropriately, and to have, and if necessary implement, contingency plans.

The process required in respect of DNIR applications is described in figure 18.

28. The Risk Analysis Framework is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/riskassessments-1>.


Figure 18: DNIR assessment process

Dealings involving intentional releaseThe application form is the same for all DIRs (including limited and controlled releases) and the Regulator will, on a case-by-case basis, use information the applicant submitted (as specified in the application form) to determine which consultation process will apply and the timeframe allowed under the Gene Technology Act 2000 for processing the application.

This Risk Analysis Framework outlines the approach taken to risk analysis and preparing RARMPs. The eight-stage process adopted in respect of DIR applications is shown in figure 19 and described below.


Figure 19: DIR eight-stage assessment process

Stage 1 – The applicant must prepare comprehensive information about the proposed dealings with the GMO, possible risks posed by the dealings and proposed ways that each risk would be managed. The applicant must ensure all responses to the Regulator’s information requirements are supported by appropriate data and literature citations. Wherever possible quantitative data should be provided. It is expected that applicants will collect relevant data during contained work and early trials to support applications for dealings involving intentional releases of GMOs.

Stage 2 – The IBC reviews the application and appends an evaluation report setting out its advice as to the completeness of the application form. The IBC’s role is to ensure the quality of applications submitted to the Regulator.


Stage 3 – Section 50A of the Gene Technology Act 2000 allows the Regulator to make a determination on the application as to whether it is for a limited and controlled release which would follow a shorter process.

Section 50A(1) of the Gene Technology Act 2000 specifies limited and controlled release applications as applying, if the Regulator is satisfied that:

• the principal purpose of the application is to enable the licence holder, and persons covered by the licence to conduct experiments

• the application proposes, in relation to any GMO in respect of which dealings are proposed to be authorised:

– controls to restrict dissemination or persistence of the GMO and its genetic material into the environment

– limits on the proposed release of the GMO

• the Regulator is satisfied that the controls and limits are of such a kind that it is appropriate for the Regulator not to seek the advice referred to in section 50(3).

Section 50A(2) of the Gene Technology Act 2000 describes the term ‘controls’ as including:

(a) methods to restrict the dissemination or persistence of the GMO or its genetic material into the environment

(b) methods for disposal of the GMO or its genetic material

(c) data collection, including studies to be conducted about the GMO or its genetic material

(d) the geographic area in which the proposed dealings with the GMO or its genetic material may occur

(e) compliance, in relation to dealings with the GMO or its genetic material, with:

i. a code of practice issued under section 24, or

ii. a technical or procedural guideline issued under section 27.

Section 50A(3) describes the term ‘limits’ as including:

(a) the scope of the dealings with the GMO

(b) the scale of the dealings with the GMO

(c) the locations of the dealings with the GMO

(d) the duration of the dealings with the GMO

(e) the persons who are to be permitted to conduct the dealings with the GMO.

Stage 4 – A Notification of Application is sent out for all DIR applications to those on the OGTR mailing list and placed on the website advising when the consultation RARMP is expected to be released for comment. This is not a requirement of the Gene Technology Act 2000 but increases the transparency of the regulatory system and aims to increase participation in the consultation process.


The Regulator must provide a copy of the application (excluding any information the Regulator has declared to be, or is under consideration as, confidential commercial information) to anyone that requests a copy (section 54 of the Gene Technology Act 2000).

Stage 5 – The Regulator must seek advice on the application regarding matters relevant to preparation of the RARMP, under section 50 of the Gene Technology Act 2000, from GTTAC, the states and territories, prescribed Australian Government agencies, the Environment Minister, and appropriate local government authorities. The Regulator usually consults local government authorities where the release is proposed to occur. In addition, the Regulator routinely seeks advice from other relevant Australian Government agencies such as the Department of Agriculture, Fisheries and Forestry and the Department of Foreign Affairs and Trade. If the application is for a limited and controlled release, this consultation stage is not required.

Stage 6 – Section 51 of the Gene Technology Act 2000 requires the Regulator to prepare a RARMP (consultation version), and to take account of submissions received during any consultation on the application under section 50 of the Gene Technology Act 2000.

The actual risk assessment process is, to some extent, shaped by the data requirements set out in the DIR application form; however, the Regulator can require submission of any data required to comprehensively identify and evaluate risks posed by the dealing. The Regulator is specifically permitted by the legislation to seek and take into account any other relevant information such as independent research, independent literature searches, and the advice of any person or group. The Regulator may also request more information from the applicant or hold a public hearing.

Preparation of the risk assessment involves developing risk scenarios that describe how risks that may be posed by the dealings with the GMO could result in harm, identifying risks that require more detailed characterisation and estimating the level of risk based on the likelihood of the event occurring and the likely consequences of that occurrence. Risks are then evaluated to determine which require treatment in order to protect people and the environment.

The risk management plan considers how risks to human health and safety or to the environment posed by the dealing with the GMO that require management may be able to be managed. This then provides the basis for conditions that may be applied to the licence and draft conditions are included in the consultation version of the RARMP.

Stage 7 – Once the consultation version of the RARMP is prepared for a DIR application, the Regulator must determine if any of the proposed dealings pose a significant risk to the health and safety of people or to the environment. The minimum consultation period specified in the Gene Technology Act 2000 is 50 days if the Regulator is satisfied that the dealings may pose a significant risk to the health and safety of people or to the environment. If the Regulator considers that the proposed dealings do not pose significant risks, a minimum 30-day consultation period is specified (section 52(2)).

The statutory timeframe allowed for consideration of a DIR application, except for a limited and controlled release application, is 255 days. For a limited and controlled release application this timeframe is either 170 days (for dealings that may pose a significant risk) or 150 days (for dealings that do not pose a significant risk).

The Regulator is required to seek public comment on the consultation RARMP through advertisements in a national newspaper, in the Australian Government Gazette, and from notices placed on the Regulator’s website. In practice the Regulator advertises more broadly, including in metropolitan and regional newspapers and specialist interest press and will advise


by mail or email all people and organisations that have registered their interest in receiving such information on the OGTR mailing lists. Under section 52(3) of the Gene Technology Act 2000 the Regulator must also seek advice on the RARMP from the expert groups, agencies and authorities listed in table 19 (for consultation on the application).

The Regulator is required to consult with the Australian Government Environment Minister on DIR licence applications.

Stage 8 – The Regulator finalises the RARMP, taking into account the advice provided in relation to the consultation version of the RARMP, in accordance with section 56(2) of the Gene Technology Act 2000. The Regulator makes the decision on issuing the licence, and any conditions to be imposed, based upon the finalised RARMP, having regard to any policy principles issued by the GTMC. The Regulator must notify the applicant in writing that a licence decision has been made. The Regulator also publishes the finalised RARMP on the OGTR website, advises all experts, agencies and authorities that were consulted and people or organisations that made submissions, and notifies registered recipients on the OGTR mailing list.

Inadvertent dealingsPart 5 of the Gene Technology Act 2000 allows the Regulator to grant a temporary licence (no longer than 12 months) to a person who finds they are inadvertently dealing with an unlicensed GMO. The licence may be issued to the person for the purposes of disposing of the GMO. There is no requirement to prepare a RARMP or consult in relation to inadvertent dealing applications but the Regulator must not issue a licence unless satisfied that the risks posed by the dealings can be managed in such a way as to protect the health and safety of people and the environment.

Emergency dealing determinationsThe EDD provision in Part 5A (section 72A–E) of the Gene Technology Act 2000 provides the Minister with the power to expedite approval of a dealing with a GMO in an emergency. This recognises that situations may arise in which a rapid assessment of a proposed dealing with a GMO may be needed. An EDD can only be made for a limited period (up to six months) but may be extended by the Minister. Before making an EDD, the Minister must be satisfied that:

• there is an actual or imminent threat to the health and safety of people or to the environment

• the dealings proposed to be specified in the EDD would, or would be likely to, adequately address the threat

• any risks posed by the dealings proposed to be specified in the EDD are able to be managed in such a way as to protect the health and safety of people and the environment.

The Minister must receive advice about addressing the threat from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer, or the Commonwealth Chief Plant Protection Officer, about managing risks from the Gene Technology Regulator. The states and territories must also be consulted.

In developing the risk assessment advice for the Minister, the Regulator will apply the principles embodied in the Risk Analysis Framework but is not required to follow the consultation processes that apply to DIR applications.


The GMO RecordSection 138 of the Gene Technology Act 2000 requires the Regulator to maintain a Record of GMO and GM Product Dealings (the GMO Record). Details of licences issued (DNIR, DIR, Inadvertent Dealings), information about NLRDs, GMO dealings included on the GMO Register, EDDs and information about GM products approved by other regulatory authorities, are included on the GMO Record.29

The GMO Record is currently divided into separate sections for recording:

• Notifiable low risk dealings

• Contained dealings – DNIR licences

• Intentional releases – DIR licences

• Inadvertent dealing licences

• GMO Register

• Emergency Dealing Determinations

• GM products – those used in food processing, therapeutics, and pesticides and veterinary medicines authorised by other regulatory agencies.

Accreditation and certificationAccreditation of organisations and certification of individual physical containment facilities helps manage risk that may be associated with dealings with GMOs.

The Regulator will require an organisation undertaking certain dealings with GMOs to be accredited. The process of accreditation enables the Regulator to assess if the organisation has the resources and the internal processes in place to enable it to effectively oversee work with GMOs. Before an organisation can be accredited, it must have established, or have access to, an appropriately constituted IBC.

IBCs provide on-site scrutiny of low risk contained dealings that do not require case-by-case consideration by the Regulator. IBCs are required to comprise a range of suitable experts and an independent person and they provide a quality assurance mechanism that reviews the information applicants submit to the Regulator.

Certain dealings must be undertaken in certified facilities that meet defined requirements to ensure adequate containment of GMOs. The legislation allows the Regulator to certify laboratory or production facilities to ensure appropriate standards are met for containment of GMOs and that trained and competent staff are carrying out procedures and practices. The Regulator has issued guidelines to help organisations meet certification requirements for certification of each type of facility (laboratory, plant and animal, etc.) to physical containment (PC) levels 1, 2, 3 or 4, which must be complied with before a facility can be certified. All certified facilities must be inspected before certification, and annually thereafter (except for those certified as a PC1 facility). The OGTR inspects all high-level facilities (large-scale PC2, PC3 and PC4) before certification and re-certification.30

29. The GMO Record can be viewed at <www.ogtr.gov.au/gmorec/index.htm>

30. The Guidelines for Accreditation of Organisations and the Guidelines and Forms for Certifications of Physical Containment Facilities are available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/forms-guidelines-1>.


Monitoring and complianceThe aim of OGTR monitoring and compliance activities is to ensure dealings with GMOs comply with legislative obligations and are consistent with the object of the Gene Technology Act 2000, bearing in mind that non-compliance with conditions placed on licences issued under the Gene Technology Act 2000 is a criminal offence. The OGTR has adopted an operational philosophy that places strong emphasis on helping accredited organisations and licence holders comply with their legislative obligations.

In particular, monitoring activities focus on managing dealings at field trial sites and within certified physical containment facilities to ensure:

• dissemination of a GMO and its genetic material is minimised

• persistence of a GMO in the environment is managed

• effective management of the GMO is maintained.

OGTR monitoring activities comprise the functions of routine monitoring, including spot checks, assessment of monitoring findings and, where necessary, recommending corrective action and follow-up activities.

The OGTR Monitoring Section conducts routine monitoring visits to a minimum of 20 per cent of field trial sites each year. The OGTR strategy for conducting field trial monitoring draws on accumulated operational experience of risk profiling in relation to compliance. For example, OGTR field trial monitoring coincides, where possible, with periods or circumstances when non-compliance with licence conditions designed to limit the spread and persistence of the GMOs or their genetic material is more likely to occur (for example, during flowering and/or harvesting of GM crops).

The monitoring program for contained dealings involves inspecting DNIRs and the facilities in which those dealings are conducted, as well as monitoring a minimum of 20 per cent of PC4, PC3 and PC2 large-scale facilities per year. These inspections focus on the integrity of the physical structure of a facility and on the general laboratory practices followed in that facility, including those practices followed for DNIRs and NLRDs.

OGTR compliance activities comprise reviews of potential compliance risks, audits, investigations, and related enforcement activities.

The OGTR may initiate practice reviews in response to observations made during monitoring activities, or to follow up incident reports that may relate to non-compliance with licence conditions by accredited organisations. Their objective is to determine if licence conditions can be, and are being, effectively implemented. An accredited organisation may seek a practice review to assess the effectiveness of systems its IBCs use to ensure dealings are being conducted in accordance with the Gene Technology Act 2000.

The OGTR or an accredited organisation can initiate an audit that can entail documentary evidence, observations and/or assessments of procedures and practices. These activities are conducted to:

• verify that an accredited organisation has relevant and effective management procedures and practices to meet requirements under the Gene Technology Act 2000, including accreditation requirements, guidelines and any licence conditions applicable to a dealing


• assess whether procedures and practices provide mechanisms to identify and resolve emerging risks

• suggest improvements to procedures and practices, where appropriate.

An investigation is an inquiry into a suspected non-compliance with the Gene Technology Act 2000 and corresponding state or territory laws with the aim of gathering evidence. Such investigations are not restricted to purely criminal aspects – in the wider context they may include advice on detected flaws and vulnerability in policies, practices and procedures. An investigation may be initiated as a consequence of OGTR monitoring, self-reporting by an accredited organisation, or by third-party reporting.


Appendix 3

Membership of statutory committees and attendance at meetings

The Gene Technology Act 2000 established two statutory committees to provide advice to the Regulator and the Gene Technology Ministerial Council, namely the:

• Gene Technology Technical Advisory Committee (GTTAC)

• Gene Technology Ethics and Community Consultative Committee (GTECCC).

The Parliamentary Secretary to the Minister for Health and Ageing, the Hon Catherine King MP, made appointments to both committees in February 2011 that included a mix of new and ongoing members.

Gene Technology Technical Advisory CommitteeGTTAC’s functions, as set out in section 101 of the Gene Technology Act 2000, are to provide scientific and technical advice, at the request of the Regulator or the Ministerial Council, on gene technology, GMOs, GM products, applications made under the Gene Technology Act 2000, the biosafety aspects of gene technology and the need for policy principles, policy guidelines, codes of practice, technical and procedural guidelines in relation to GMOs and GM products and the content of such principles and codes. GTTAC met twice during 2010–11 (table 20).

Table 20: Attendance at GTTAC meetings during 2010–11

Meeting date No. of GTTAC members in attendance

23 November 2010 13

11–12 May 2011 16

In addition, GTTAC sought out-of-session advice on three other occasions.

Chair of GTTACProfessor John Rasko BSc (Med), MBBS (Hons), PhD, MAICD, FFSc (RCPA), FRCPA, FRACP has relevant skills and experience in molecular biology, virology, risk assessment, clinical medicine, biochemistry, animal biology and immunology. He is a clinical haematologist who directs the Department of Cell and Molecular Therapies at Royal Prince Alfred Hospital and heads the Gene and Stem Cell Therapy Program at the Centenary Institute, University of Sydney. Professor Rasko has made major contributions to the understanding of stem cells and blood cells, gene transfer technologies, cancer, and human kidney disorders.

His contributions to scientific organisations include co-founding (2000) and past-President (2003–05) of the Australasian Gene Therapy Society; Vice President, International Society


for Cellular Therapy (ISCT, 2008–12) and founder (2009) ISCT-Australia; Scientific Advisory Committee for Philanthropic Foundations; and several Ethics Committees. He has served on GTTAC (2001–03, 2004–07) and was Chair (2008–10).

Members of GTTAC

Table 21: Members of GTTAC, at 30 June 2011

Dr Jason Able Lecturer in Plant Breeding & Durum Wheat Breeder, School of Agriculture, Food & Wine, University of Adelaide (South Australia)

Dr Lesley Ashton Leader, Molecular Epidemiology Group, Children’s Cancer Institute Australia, Lowy Cancer Research Centre. GTECCC cross-member appointed under section 100(7A) of the Gene Technology Act 2000 (New South Wales)

Dr Gabrielle Belz Laboratory Head, Division of Immunology, Walter and Eliza Hall Institute of Medical Research (Victoria)

Dr Graham Bonnett Theme Leader, CSIRO Plant Industry, Queensland Bioscience Precinct (Queensland)

Professor Ian Godwin Professor in Plant Molecular Genetics School of Land, Crop and Food Sciences, University of Queensland (Queensland)

Associate Professor Jonathan Iredell Director, Infectious Diseases, Westmead Hospital (New South Wales)

Dr Rodney Mahon Past Principal Research Scientist, CSIRO Entomology (Australian Capital Territory)

Dr Michael Michael Medical Scientist, Department of Gastroenterology and Hepatology, Flinders Medical Centre (South Australia)

Dr Robert Moore Group Leader: CSIRO Livestock Industries, Australian Animal Health Laboratory (Victoria)

Mrs Pamela Moore OAM Past State Agricultural Environment Officer, Country Women’s Association of NSW. Layperson appointed under section 100(6) of the Gene Technology Act 2000 (New South Wales)

Dr Gabrielle O’Sullivan Executive Officer and Member, Institutional Biosafety Committee, Royal Prince Alfred Hospital (New South Wales)

Professor Brian Priestly Director, Australian Centre for Human Health Risk Assessment (Victoria)

Professor John Rasko Director, Cell & Molecular Therapies, Royal Prince Alfred Hospital & Centenary Institute. Chair of GTTAC (New South Wales)

Dr Kevin Smith Managing Director, AbacusBio Australia Pty Ltd (Victoria)

Associate Professor Jason Smythe Senior Vice President, Horizon Science Pty Ltd (Victoria)

Dr Elizabeth Tegg Staff Specialist, Pathology Department Royal Hobart Hospital (Tasmania)

Dr Diane Webster Laboratory Head, School of Biological Sciences, Monash University (Victoria)

Professor Paul Young Reader/Group Leader, Centre for Infectious Disease Research School of Chemistry & Molecular Biosciences, University of Queensland (Queensland)


Gene Technology Ethics and Community Consultative CommitteeGTECCC’s functions are set out in section 107 of the Gene Technology Act 2000. They are to provide advice, at the request of the Regulator or the GTMC, on ethical issues relating to gene technology and on matters of general concern identified by the Regulator relating to applications made under the Gene Technology Act 2000, community consultation about the process for applications for licences covering dealings that involve the intentional release of a GMO into the environment, risk communication matters relating to dealings that involve intentional release of a GMO into the environment, matters of general concern relating to GMOs and the need for policy principles, policy guidelines, codes of practice, technical and procedural guidelines relating to GMOs and GM products and the content of such principles and codes. GTECCC met twice during 2010–11 (table 22).31

Table 22: Attendance at GTECCC meetings during 2010–11

Meeting date No. of GTECCC members in attendance

9 December 2010 9

14–15 April 2011 9

In addition, some GTECCC members participated in two working group meetings during the year.

In July 2010, members of a GTECCC working group presented a paper on environmental ethics at the Australasian Association of Bioethics and Health Law (AABHL) Conference in Adelaide. GTECCC subsequently finalised a discussion paper entitled ‘Environmental Ethics as it Relates to Gene Technology in Australia’.32

The review of the National Framework for the Development of Ethical Principles in Gene Technology33was continued during the year. A working group developed a revised document informed by feedback from stakeholders received through an online survey ORIMA Research Pty Ltd conducted in March–April 2010. GTECCC undertook further consultation in May–June 2011, sending the revised Framework to accredited organisation’s IBCs for comment. The proposed changes were also presented at the fourth National IBC Forum in Canberra on 8 June 2011.

Chair of GTECCCProfessor Donald Chalmers LLB, LLM, Professor of Law at the University of Tasmania, former Dean of the Faculty of Law and Head of the Law School, University of Tasmania, was Law Reform Commissioner in Tasmania (1991–97) and has authored or contributed to a number of government reports, books on various aspects of law and major legal treatises. In 1985 he chaired the Tasmanian Inquiry into Artificial Conception and in 1995 chaired the Commonwealth Ministerial Review of the National Institutional Ethics Committee System.

Professor Chalmers has had significant involvement with a number of committees dealing with genetics, and is the recipient of a number of Australian Research Council grants to research legal and ethical implications of developments in genetics. Since 1999 he has chaired the

31. Find more information about GTECCC at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gteccc-2n>.

32. The paper is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/commpub-1>.

33. The Framework is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/commpub-1>.


Australian Red Cross Human Research Ethics Committee, and since 2004 has been a member of the Scientific Review Panel of Genome Canada. He has also been Deputy Chair of the National Health and Medical Research Council (NHMRC) Licensing Committee since 2003, Chair of the NHMRC Australian Health Ethics Committee (1994–2000) and a member of the NHMRC Human Genetics Advisory Committee (2006–09).

He was Chair of GTECCC (2008–10), and Chair of the former GTEC and Gene Technology Community Consultative Committee (GTCCC).

Members of GTECCC

Table 23: Members of GTECCC, at 30 June 2011

Associate Professor Rachel Ankeny Associate Dean (International), Faculty of Humanities & Social Sciences, School of History and Politics, University of Adelaide (South Australia)

Dr Lesley Ashton Leader, Molecular Epidemiology Group, Children’s Cancer Institute Australia, Lowy Cancer Research Centre. GTTAC cross-member appointed under section 100(7A) of the Gene Technology Act 2000 (New South Wales)

Professor Don Chalmers Director, Centre for Law and Genetics, University of Tasmania Chair of GTECCC (Tasmania)

Rabbi Dr Jeffrey Cohen Academic Advisor and Counselor, Melbourne Institute of Technology, Sydney (New South Wales)

Ms Julie Kimber Formerly researcher and seed production manager, Botanical Resources Australia (Tasmania)

Ms Corinna Lange Communication Manager, Australian Biosecurity Cooperative Research Centre for Emerging Infectious Disease (Queensland)

Associate Professor Vaughan Monamy Course Coordinator/Senior Lecturer, School of Arts and Sciences, Australian Catholic University (New South Wales)

Ms Meg Parkinson President, Free Range Egg and Poultry Australia Ltd and member of the former Victorian Biotechnology Ethics Advisory Committee (Victoria)

Professor Alan Petersen Professor of Sociology, Discipline Convener, School of Political and Social Inquiry, Monash University (Victoria)

Mr Hugh Roberts OAM Farmer and former member of the NSW Expert Committee on Gene Technology and of the Biotechnology Australia Advisory Council

Dr Nikolajs Zeps Research Manager, St John of God Pathology and Radiation Oncology, Sir Charles Gairdner Hospital. AHEC cross-member appointed under section 108(4) (Western Australia)

Remuneration and allowances for committee membersThe Remuneration Tribunal is an independent statutory body that determines the remuneration and allowances for all members of OGTR committees. Committee members are part-time office holders for the purposes of the Remuneration Tribunal and are paid in accordance with the current determination for part-time office holders.34

34. Find more information at <www.remtribunal.gov.au/determinationsReports/byYear/2008/2008-07Determination.pdf>.


Appendix 4

Staff profile and training and development activities

At 30 June 2011, the OGTR employed 55 staff (table 24). Of these, 50 were ongoing APS employees, five were non-ongoing employees and one was on maternity leave. This equates to 51 full-time equivalent staff at 30 June 2011.

Table 24: OGTR staffing profile, at 30 June 2011

Classification of officers Male Female Total

Full-time Part-time Full-time Part-time

Statutory Office Holder 1 – – – 1

Senior Executive Service 2 – – – 2

Legal Officer Level 2 1 – – – 1

Executive Level 2 6 – 2 – 8

Executive Level 1 7 – 4 4 15

APS Level 5–6 9 – 12 4 25

APS Level 1–4 – – 1 2 3

Total as 30 June 2011 26 – 19 10 55

Total as 30 June 2010 23 – 21 12 56

Performance payMost performance payments made in 2010–11 related to assessments for the 2009–10 cycle. Due to the small numbers of staff at the SES level, details for SES and non-SES staff have been combined (table 25). Payments have been aggregated to preserve employees’ privacy. The OGTR makes performance bonus payments available to staff working under a current Australian Workplace Agreement or via individual determination under section 24(1) of the Public Service Act 1999. Determinations are produced following negotiations with the staff member and the department regarding terms and conditions of employment.

Table 25: SES and non-SES bonus payments, 1 July 2010 to 30 June 2011

Level Number

SES Band 1 and non-SES staff 11


Internal training presentationsDuring 2010–11, OGTR’s Legal Officer, Mr Alceo Turello, conducted introductory and ongoing training for OGTR staff on legal issues (table 26). The Science Cohort Section also conducted training on risk assessments (table 27).

Table 26: Internal legal issue training presentations, 2010–11

Date Topic

June 2011 Review of the Gene Technology Act 2000

May 2011 GTTAC the Gene Technology Act

New Gene Technology Regulations

April 2011 GTECCC the Gene Technology Act

Information disclosure

March 2011 Import as an offence

Gene Technology Act: Just for starters

February 2011 Monitoring and Compliance: Entry to premises and exercise for monitoring powers under the Gene Technology Act 2000

January 2011 Hoffman v Monsanto: Suing for GM contamination

December 2010 US GM sugar beet litigation

October 2010 Making a valid decision

August 2010 Certification

July 2010 US GM alfalfa litigation

Table 27: Other Internal training presentations, 2010–11

Date Topic

June 2011 Clear English workshop

February 2011 Introduction to risk analysis

The OGTR Forum provides a venue where, in addition to presentations by visiting experts, current information is shared among staff on topics such as scientific and risk assessment issues, summaries of recent conferences or feedback from international meetings. A range of OGTR staff and guest speakers made presentations at the OGTR Forum during 2010–11 (table 28).


Table 28: Presentations at OGTR Forum, 2010–11

Date Topic Speaker

May 2011 Report on WHO guidelines on quality, safety and efficacy of live dengue vaccines meeting, Switzerland

Dr Michael Dornbusch

Report on OECD working group on Harmonisation of Regulatory Oversight in Biotechnology 25th meeting, France

Dr Peter Thygesen

Sexual reproduction and ecology of sugarcane Dr Graham Bonnet, CSIRO

February 2011 Simple graphical tools for better risk assessments Dr Terry Walshe, University of Melbourne

December 2010 Report on risk assessment workshop for Cambodian scientific advisory team, Cambodia


Report on Biosafety Protocol meeting, Japan Dr Peter Thygesen

Report on 11th International Symposium on the Biosafety of Genetically Modified Organisms, Argentina

Dr Joe Smith, Dr Paul Keese

November 2010 Overview of Malaysian regulatory system for GMOs Malaysian regulatory delegation

Community attitudes to biotechnology 2010 Mr Craig Cormick, DIISR

October 2010 Report on 17th Australasian Weeds Conference, New Zealand

Dr Andrea Robold

Report on Australian/New Zealand Society for Risk Analysis conference, Sydney

Dr Brian Weir, Ms Deirdre Sharkey, Dr Paul Keese

Report on international biotechnology and risk assessment workshop, Korea


Report on OzBio 2010 conference, Melbourne Dr Leisa Hindmarsh, Dr Alison Wardrop, Dr Claire Anderson

Report on OECD Cooperative Research Program Symposium ‘Decision Making and Science – the balancing of risk based decisions that influence sustainability of agricultural production’, Germany

Dr Joe Smith

September 2010 TGA’s Risk Framework Dr Leonie Hunt, TGA

Report on capacity building workshop on field trials of GM crops, Ghana

Mr Will Tucker

Report on problem formulation workshop, Brazil Dr Paul Keese

August 2010 Regulation of agricultural biotechnology by US Department of Agriculture

Dr Terri Dunahay, USDA

July 2010 Report on Australia group meeting, France Dr Robyn Cleland

Security Sensitive Biological Agent (SSBA) Regulatory Scheme

Mr Greg Barber


Appendix 5

Publications and guidance documents

All the documents listed in this appendix were published during 2009–10. Copies are available at <www.ogtr.gov.au>. Paper copies of certain publications are also available from the OGTR Information Officer.

Quarterly reportsQuarterly Report for the period 1 April 2009–30 June 2010

Quarterly Report for the period 1 July 2010–30 September 2010

Quarterly Report for the period 1 October 2010–31 December 2010

Quarterly Report for the period 1 January 2011–31 March 2011

GuidelinesGuidelines for the Transport, Storage and Disposal of GMOs Version 1.1 (issued 2 June 2011 with effect 1 September 2011).


Appendix 6

International meetings and forums

The Regulator and OGTR staff participate in various international meetings, forums and conferences for the purpose of ensuring Australia’s gene technology regulatory system both keeps pace with and influences international best practice.

Presentations and representations at international meetings and conferencesThe Regulator and OGTR staff regularly present papers to international meetings, forums and conferences and visiting international delegations.

Table 29: Presentations and representations at international meetings and conferences, 2010–11

Date Event/delegate Location

27–29 June 2011 International Life Sciences Institute (ILSI) Conference on Environmental Risk Assessment of Genetically Modified Crops

Dr Paul Keese

Hanoi, Vietnam

16–18 May 2011 ILSI Conference on Risk Assessment of Genetically Modified Crops

Dr Joe Smith

New Delhi, India

11 May 2011 ILSI Biotechnology Workshop 2011

Dr Peter Thygesen

Paris, France

9–10 May 2011 OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology 25th meeting

Dr Peter Thygesen

Paris, France

11–12 Apr 2011 World Health Organization (WHO) informal consultation on guidelines for environmental risk assessment of GM Dengue vaccines


Geneva, Switzerland

21 Feb 2011 Canadian Food Inspection Agency’s International Science Symposium

Dr Paul Keese

Montreal, Ottawa, Canada

15–19 Nov 2010 Eleventh International Symposium on the Biosafety of Genetically Modified Organisms

Dr Joe Smith & Dr Paul Keese

Buenos Aires, Argentina

15 Nov 2010 Meeting with Namibian regulatory officials

Mr Will Tucker

Canberra, Australia

10–12 Nov 2010 Risk analysis discussion with Brazilian regulators

Dr Paul Keese

Recife, Brazil

(Continued...)


Table 29: Presentations and representations at international meetings and conferences, 2010–11 (Cont.)


8–12 Nov 2010 Hosted Malaysian Ministry of Natural Resources and Environment Biosafety core team visit

Various OGTR senior staff

Canberra, Australia

1–5 Nov 2010 Conducted a risk assessment workshop for Cambodian government agencies


Sihanoukville, Cambodia

11–15 Oct 2010 Part of Australian delegation to 5th Meeting of the Parties to the UN Cartagena Protocol on Biosafety

Dr Peter Thygesen

Nagoya, Japan

6–8 October 2010 OECD Cooperative Research Program Symposium ‘Decision Making and Science – the balancing of risk-based decisions that influence sustainability of agricultural production’

Dr Joe Smith

Berlin, Germany

4–5 October 2010 Meeting with officials of the European Food Safety Authority, the Netherlands Institute of Food Safety, the Netherlands National Institute for Public Health and Environment

Dr Joe Smith

Bilthoven, Netherlands

26–30 Sep 2010 17th Australasian Weeds Conference

Dr Andrea Robold

Christchurch, New Zealand

7 Sep 2010 International Biotechnology and Risk Assessment Workshop


Seoul, Korea

30 Aug–3 Sep 2010 Training workshop on confined field trial for genetically modified crops: a theoretical and practical course for regulators, applicant, reviewers and inspectors of confined field trials

Mr Will Tucker

Accra, Ghana

16–17 Aug 2010 International risk assessment workshop for Brazilian regulators and researchers

Dr Paul Keese

Brasilia, Brazil


Appendix 7

Presentations and meetings on gene technology in Australia

The Regulator and OGTR staff regularly present papers to, and attend meetings, forums and conferences in Australia.

Table 30: Presentations and representations made in Australia, 2010–11


15 June 2011 Weed risk assessment workshop

Attended and presented by Evaluation Branch staff

Canberra

4–6 May 2011 7th Meeting of the Australasian Gene Therapy Society

Dr Megan Downie, Dr Anuj Srivastava

Melbourne

3–6 May 2011 33rd Conference of Australian Society of Sugarcane Technologists

Dr Heidi Mitchell

Mackay

27 April 2011 Exploring the impact of social technologies on science communication

Dr Vidya Jagadish, Ms Maria Ong

Brisbane

18 Mar 2011 Clinical Waste Workshop

Ms Maryanne Shoobridge, Mr Ian Coleman

Melbourne

1–2 Mar 2011 ABARES Outlook 2011 Conference

Dr Kylie Tattersall

Canberra

6–7 Dec 2010 Darwin Symposium ‘Evolution in Science, Technology and Society’ 2010 (Victorian Department of Primary Industries, La Trobe University

Dr Peter Thygesen

Melbourne

27 Sep–1 Oct 2010 OzBio 2010 Conference

Dr Alison Wardrop, Dr Liesa Hindmarsh, Dr Claire Anderson, Ms Maryanne Shoobridge

Melbourne

27–29 Sep 2010 Society for Risk Analysis Conference

Dr Paul Keese, Ms Deirdre Sharkey, Dr Brian Weir

Sydney

7 Sep 2010 Risk Communication Master Class

Dr Paul Keese

Melbourne

16–19 Aug 2010 Australian Seed Federation Conference

Mr Greg Barber, Mr Peter Wenzel

Cairns

15–20 Aug 2010 International Congress on Parasitology XII

Dr Megan Downie

Melbourne

27 Jul 2010 CSIRO Protein Expression workshop

Dr Jeremy Turner

Melbourne

4–8 Jul 2010 Australian Society for Microbiology 2010 Conference

Dr Jeremy Turner

Sydney

2 Jul 2010 Australasian Association of Bioethics and Health Law Conference

Ms Michelle Green

Adelaide


Appendix 8

Stakeholder and public access to the OGTR

The OGTR facilitates accredited agency, stakeholder and public access to its services through a website, an email address and a free call 1800 number.

Website usageTable 31 lists the successful hits on the OGTR website, and the most requested information sheets and website pages are listed below.

Table 31: Website activity, 2010–11 and 2009–10

Month Hits Visits

2010–11 2009–10 2010–11 2009–10

July 185 257 194 433 23 272 25 822

August 206 331 191 850 24 676 32 869

September 200 194 195 675 23 994 34 346

October 199 974 214 000 24 554 39 892

November 201 940 136 268 26 498 24 264

December 167 125 119 106 22 021 24 912

January 177 675 182 882 24 043 34 912

February 198 663 165 524 24 480 30 844

March 212 248 203 861 27 507 36 471

April 190 842 173 099 24 028 31 066

May 214 302 209 244 24 770 31 710

June 218 873 199 472 22 423 23 495

The most popular pages viewed on the OGTR website during 2010–11 were:

What’s New

Guidelines and forms for Certification of Physical Containment Facilities

Maps

List of applications and licences for Dealings involving Intentional Release (DIR) of GMOs into the environment

About the OGTR

List of Genetically Modified Product approvals


List of Intentional Release Licence Applications under evaluation

Application Assessment Process

Publications and Legislation

IBC & Accredited Organisations Information

The most popular downloaded documents in 2010–11 were:

Risk Analysis Framework

The Biology of Carica papaya L. (Papaya, pawpaw, paw paw)

The Biology and Ecology of Rice (Oryza sativa) in Australia

The Biology of Gossypium hirsutum L. and Gossypium barbadeuse L. (Cotton)

The Biology of Ananas comosus var. comosus (Pineapple)

PC2 Laboratory guidelines

The Biology of Saccharum spp. (Sugarcane)

The Biology of Hybrid Tea Rose (Rosa x hybrida)

Operation of the Gene Technology Regulator Annual Report 2009–10

The Biology of Triticum aestivum L. em Thell. (bread wheat)

Email address and free call numberThe 1800 number and the OGTR email address <[email protected]> are points of contact for members of the public and other interested parties. Assistance with specific questions and additional mechanisms for public feedback are among some of the services the 1800 line and email facilities provide. While there were some peaks in usage of the 1800 number, overall usage of both services declined in 2010–11 compared to 2009–10 (table 32).

Table 32: Email and free call 1800 number activity, 2010–11 and 2009–10

Month Emails 1800 number

2010–11 2009–10 2010–11 2009–10July 76 105 130 105

August 79 76 100 102

September 76 99 74 131

October 79 125 98 136

November 118 92 92 146

December 102 60 71 99

January 77 117 49 60

February 79 91 85 89

March 97 128 91 99

April 100 112 78 101

May 175 118 107 113

June 84 107 94 112

Total 1142 1230 1069 1293


The Monitoring Section maintains an email inbox to facilitate efficient communication with accredited organisations. The inbox provides a central point through which accredited organisations can contact the section with queries, legislative notifications and self-reporting of non-compliances. The Monitoring Section email inbox ensures all communications are answered efficiently while staff are away from the office. The inbox received 530 emails during 2010–11 (450 in 2009–10).

The Regulatory Practice and Secretariat Section maintain an email inbox to facilitate efficient communication between advisory committee members and secretariat staff. The inbox ensures that secretariat staff answer all communications in a timely manner. The inbox received 1 124 emails during 2010–11 (854 in 2009–10).

The Application and Licence Management Section maintains an email inbox to provide a central, shared communication point to allow efficient coordination of responses to correspondence and queries about applications the section received. The inbox received 1829 emails during 2010–11 (1640 in 2009–10).

The OGTR welcomes feedback on ways to improve provision of information on gene technology regulation.


Glossary

The terms described in this glossary are important to understanding this report; they do not, however, substitute for the definitions of terms relevant to the operation of the gene technology regulatory system contained in section 10 of the Gene Technology Act 2000.

Accredited organisation An organisation that is accredited under section 92 of the Gene Technology Act 2000

Act Gene Technology Act 2000

Agreement The inter-governmental Gene Technology Agreement that all Australian jurisdictions signed in 2001 that underpins the nationally consistent regulatory framework for gene technology

APS Australian Public Service

APVMA Australian Pesticides and Veterinary Medicines Authority

AQIS Australian Quarantine and Inspection Service

CCI Confidential commercial information declared under section 185 of the Gene Technology Act 2000

Certification Guidelines Guidelines for Certification of a Physical Containment Facility

Collective Agreement A collective agreement for staff of the Department of Health and Ageing 2007–11

Clock stop The period during which the statutory time limit for making a decision on an application is suspended – usually because evaluation cannot proceed until additional information requested from an applicant is received

COAG Council of Australian Governments

Contained dealing see DNIR

CSIRO Commonwealth Scientific and Industrial Research Organisation

Dealing To ‘deal with’ a GMO is defined in section 10 of the Gene Technology Act 2000 and includes (but is not limited to) experiment with, manufacture, breed, propagate, grow, culture, import, and to possess, supply, use, transport, or dispose of a GMO

Department Australian Government Department of Health and Ageing

DIR A dealing involving intentional release of a GMO into the environment (for example, field trial or commercial release)

DNIR A contained dealing with a GMO not involving intentional release of the GMO into the environment (for example, experiments in a certified facility such as a laboratory)

EDD emergency dealing determination

FAO Food and Agriculture Organization

FSANZ Food Standards Australian New Zealand

GM genetically modified

GM product A thing (other than a GMO) derived or produced from a GMO


GMO genetically modified organism

GMO Record Record of GMO and GM product dealings

GST goods and services tax

GTCCC Gene Technology Community Consultative Committee

GTEC Gene Technology Ethics Committee

GTECCC Gene Technology Ethics and Community Consultative Committee

GTMC Gene Technology Ministerial Council

GTSC Gene Technology Standing Committee

GTTAC Gene Technology Technical Advisory Committee

IBC Institutional Biosafety Committee

Incident A self-reported event that may constitute a non-compliance with regulatory requirements and a public health or environment risk

NHMRC National Health and Medical Research Council

NICNAS National Industrial Chemicals Notification and Assessment Scheme

NLRD Notifiable low risk dealing (for example, plant or tissue culture work undertaken in a certified physical containment facility)

OECD Organisation for Economic Co-operation and Development

OGTR Office of the Gene Technology Regulator

PBS Portfolio Budget Statement

PC1/PC2/PC3/PC4 physical containment (PC) levels of facilities certified by the Regulator

PHM post-harvest monitoring

Physical containment facility A building or place certified by the Regulator to a specified containment level under section 84 of the Gene Technology Act 2000

RARMP risk assessment and risk management plan

Regulations Gene Technology Regulations 2001

Regulator Gene Technology Regulator

SSBA security sensitive biological agents

TGA Therapeutic Goods Administration

Volunteer Regrowth of plant from seed that has remained on a site after a trial has been completed

WHO World Health Organization


List of requirements

Part of report Description Page

Letter of transmittal iii

Table of contents ix

Index 93

Glossary 88

Contact officer(s) iv

Internet home page address and Internet address for report iv

Review by Secretary

Summary of significant issues and developments

Review by departmental secretary 2–5

Overview of department’s performance and financial results 10–14

Outlook for following year 4

Significant issues and developments – portfolio n/a

Departmental overview Overview description of department 9–10

Role and functions v, 9–10

Organisational structure 8

Outcome and program structure 11–14

Where outcome and program structures differ from PBS/PAES or other portfolio statements accompanying any other additional appropriation bills (other portfolio statements), details of variation and reasons for change

n/a

Portfolio structure n/a

Report on performance Review of performance during the year in relation to programs and contribution to outcomes

16–46

Actual performance in relation to deliverables and Key Performance Indicators set out in PBS/PAES or other portfolio statements

11–14

Where performance targets differ from the PBS/PAES, details of both former and new targets, and reasons for the change

n/a

Narrative discussion and analysis of performance 16–46

Trend information 21, 28

Significant changes in nature of principal functions/ services 4

Factors, events or trends influencing departmental performance 4, 60

Contribution of risk management in achieving objectives

5, 7

Social justice and equity impacts 55

Performance against service charter customer service standards, complaints data, and the department’s response to complaints

85–87

Discussion and analysis of the department’s financial performance *

Discussion of any significant changes from the prior year or from budget *


Agency resource statement and summary resource tables by outcomes *

Developments since the end of the financial year that have affected or may significantly affect the department’s operations or financial results in future

*

Management accountability

Corporate governance Statement of the main corporate governance practices in place 7, 58–61

Names of the senior executive and their responsibilities 8 –10

Senior management committees and their roles 74–77

Corporate and operational planning and associated performance reporting and review

7–14

Approach adopted to identifying areas of significant financial or operational risk

5

Agency heads are required to certify that their agency comply with the Commonwealth Fraud Control Guidelines

* 7

Policy and practices on the establishment and maintenance of appropriate ethical standards

•

How nature and amount of remuneration for SES officers is determined *

External scrutiny Significant developments in external scrutiny n/a

Judicial decisions and decisions of administrative tribunals

n/a

Reports by the Auditor-General, a Parliamentary Committee or the Commonwealth Ombudsman

*

Management of human resources

Assessment of effectiveness in managing and developing human resources to achieve departmental objectives

*

Workforce planning, staff turnover and retention 11, 48

Impact and features of enterprise or collective agreements, determinations, common law contracts and AWAs

48–49

Training and development undertaken and its impact 49–50, 78–80

Occupational health and safety performance 50

Productivity gains n/a

Statistics on staffing 78

Enterprise or collective agreements, determinations, common law contracts and AWAs

48–49

Performance pay 78

Assets management Assessment of effectiveness of assets management 53

Purchasing Assessment of purchasing against core policies and principles 54

Consultants Number of new consultancy services contracts let during the year; total actual expenditure on all new consultancy contracts let during the year; number of ongoing consultancy contracts that were active in the reporting year; and total actual expenditure in the reporting year on ongoing consultancy contracts. Information on contracts and consultancies is available through the AusTender website.

53

Australian National Audit Office access clauses

Absence of provisions in contracts allowing access by the Auditor-General *

Exempt contracts Contracts exempt from the AusTender 53


Commonwealth Disability Strategy

Report on performance in implementing the Commonwealth (National) Disability Strategy

55

Financial statements Financial statements *

Other information Occupational health and safety * 50

Freedom of information 50–53

Advertising and market research and statement on advertising campaigns 54

Ecologically sustainable development and environmental performance * 55–56

Other Grant programs n/a

Correction of material errors in previous annual report n/a

List of requirements 90

Note: * refer to the Department of Health and Ageing 2010–11 Annual Report.


Alphabetical index

1800 number, 86–87

Aabbreviations, 88–89

accountability see management and accountability

accredited organisations, 25–26, 71

training, 43–44

trend data, 28

advertising, 54

advice on GMOs and GM products, 44

advisory committees, 43

allowances for committee members, 77

Annual Report preparation, vii–viii, 54

Application and Licence Management Section, 9

applications and notifications, 20

DIR licence applications, 20–21

trend data for approval of main types of applications, 28

APS Values and Code of Conduct, vi

assessments and approvals, 19, 66–70

assets management, 53

Australian Information Commissioner Act 2010, 52

Australian Pesticides and Veterinary Medicines Authority, 3, 13

Australian Public Service Values, vi

authorisations: classes of, 16

Bbanana, 30

barley, 30

bonus payments, 78

budget, 10–11, 14

Business Management, Communications and Post Release Review Section, 10

Ccanola, 30

certified physical containment facilities, 26–28, 71

inspections of, 35–37

number of, 27

trend data, 28

see also dealings not involving intentional release (DNIRs)

Chalmers, Donald, 76–77

charity donations, 48

classes of GMO dealings, 16–18

clover, white, 30

Code of Conduct, vi

committees, 74–77

member allowances, 77

compliance

with Gene Technology Act 2000, 37–41

monitoring and, 72–73

Compliance and Investigation Section, 10

compliance index, 90

conduct see Code of Conduct

conferences see meetings and forums

consultancies, 53

consultation with stakeholders, 41–45

access to the OGTR, 85–87

qualitative deliverables, 12–13

consultative regulation, 3

contact details, iv, 44–45, 86–87

for FOI requests, 52–53

contained dealings see certified physical containment facilities

Contained Dealings Evaluation Section, 9

contracts, 53

coordination with prescribed agencies, 61–62

corporate governance, 7

corporate overview, 7–14

cotton, 30

crop types in trials, 30–31, 33–34

Ddealings, emergency, 25, 70

dealings, exempt, 63

inspections of, 35

dealings, inadvertent, 70

dealings, notifiable low risk (NLRDs), 17–18, 20, 22, 24, 28, 42–44, 64


inspections of, 35

trend data, 28

dealings authorised by licence, 9, 12–13, 20–28, 64–65

applications for, 2, 12–14, 19–20

classes of, 16–18

surrender of licences, 20, 28

unlicensed GMOs, 17, 70

variations, 17

see also dealings involving intentional release (DIRs); dealings not involving intentional release (DNIRs)

dealings involving intentional release (DIRs), 20–21, 66

applications approved, 20–21

assessment process, 67–70

inspection of, 29–34

licences, 17–18, 20–22

non-compliances, 38

non-plant, 9

trend data, 28

trial sites, 30–31, 33–34

dealings not involving intentional release (DNIRs), 22, 65

applications approved/withdrawn, 23

assessment process, 66

inspections of, 35

licences, 17–18, 22–24

research focus, 22

trend data, 28

see also certified physical containment facilities

dealings placed on GMO Register, 17–18, 24–25, 44, 63–64, 71

dealings with GMOs: classes of, 16–18

definitions of terminology, 88–89

deliverables see qualitative deliverables

Department of Agriculture, Fisheries and Forestry, 3, 13, 40, 69

Department of Education, Science and Training, 40

Department of Foreign Affairs and Trade, 40, 69

Department of Health and Ageing, vii–viii, 7, 40, 42, 48, 60

financial statements, 11

Outcome 1 (Population Health), 11–14

Department of Industry, Tourism and Resources, 40

Department of Sustainability, Environment, Water, Population and Communities, 3, 44

Department of the Environment and Heritage, 40

DIRs see dealings involving intentional release (DIRs)

disabilities, 55

disease progression, 24

diseases: research into, 2, 22

diversity in the workplace, 7

DNIRs see dealings not involving intentional release (DNIRs)

documents

documents downloaded from website, 86

documents maintained, 50–52

guidance documents, 81

Eecologically sustainable development, 55–56

Electronic Transactions Act 1999, 52

email addresses, 86–87

emergency control team, 49

Emergency Dealing Determination (EDD), 25, 70

emergency dealings see dealings, emergency

employees see staff

employment framework, 7

Environment Protection and Biodiversity Conservation Act 1999, 55

environmental performance, 55–56

equipment practice review, 39–40

ethical standards, 3, 7, 10, 60, 74, 76–77

Evaluation Branch, 9

exempt contracts, 53

Ffacilities for public access, 52

female staff, 78

field trials, 31–34

Financial Management and Accountability Act 1997, 7, 10

financial performance, 10–11

flexible working arrangements, 50

Food Standards Australia New Zealand, 3, 13, 40

forums see meetings and forums

free call number, 86–87

freedom of information, 50–53

Freedom of Information Act 1982, 50–53

full-time staff, 78

functions, v, vii

funding for OCTR, 10–11, 14

future, 4–5

GGene Technology Act 2000, vii, 2, 17–18, 56

amendments to, 60–61

assessment process and, 67–70


classes of GMO dealings under, 16–18

compliance and investigations, 37–41

development of, 58

GMO definition in, 16

non-compliance, 38

section 10, 16

section 50A, 68

section 133, 7

section 516, 55, 56

gene technology advisory committees, 43

Gene Technology Amendment Act 2007, 7, 60

Gene Technology Amendment Regulations, 60, 61

Gene Technology Ethics and Community Consultative Committee (GTECCC), 74, 76–77

Gene Technology Ministerial Council, 43, 60

Gene Technology Regulations 2001, vii

amendments to, 60–61

regulator’s review of, 42

Gene Technology Regulator

corporate overview, 8

governance arrangements, 58–59

harmonisation promotion by, 46

letter of transmittal, iii

other functions of, 46

review by, 2–5

undertake or commission research, 46

gene technology regulatory system

consultative regulation, 3

history and structure, 58–62

integrated regulatory framework, 3

international regulatory liaison, 45–46


regulatory agencies with role in, 61–62

Gene Technology Technical Advisory Committee (GTTAC ), 74–75

genetically-modified organisms (GMOs) see GMOs and GM products

glossary, 88–89

GMO Record, 63, 71

GMO Register, 17–18, 24–25, 44, 63–64, 71

GMOs and GM products

advice on, 44

classes of GMO dealings and authorisations, 16

ecologically sustainable development principles and, 55–56

harmonisation relating to, 46

monitoring of, 29–37

national strategy for unintended presence of unapproved GMOs, 40–41

plants, 9, 21, 61


government funding, 10–11, 14

grapevine (plant), 30

guidance documents, 81

Guidelines for the Transport, Storage and Disposal of GMOs, 43, 81

Hharmonisation relating to GMOs, 46

health and safety, 50

human resources see staff

Iinadvertent dealings, 70

Indian mustard, 30

inspection activities, 29–37

Institutional Biosafety Committee, 43–44

integrated regulatory framework, 3

internal audit, 7

internal training presentations, 79

international meetings and forums, 82–83

international regulatory liaison, 4, 13, 45–46

investigations, 38–39

see also compliance

LLegal Section, 10, 79

legislation: amendments to, 60–61


licensed dealings see dealings authorised by licence

list of requirements, 90

Mmaize, 30

male staff, 78

management and accountability, 48–56

market research, 54

maternity leave, 50, 78

media advertising, 54

meetings and forums

Australian, 84–85

international, 82–83

mission, v


monitoring and compliance activities, 29–37, 72–73

Monitoring Section, 10

NNational Disability Strategy, 55

National Health Security Act 2007, 42, 60–61

National Industrial Chemicals Notification and Assessment Scheme, 3, 13

national strategy for unintended presence of unapproved GMOs, 40–41

NLRDs see dealings, notifiable low risk (NLRDs)

non-compliance, 38

non-plant DIR applications, 9

non-salary benefits, 49

notifiable low risk dealings (NLRDs) see dealings, notifiable low risk (NLRDs)

Ooccupational health and safety, 50

OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology, 4

Office of the Gene Technology Regulator, v–viii

access to, 85–87

government funding, 10–11, 14

manuals, 52

national strategy and, 40

OGTR Forum, 79–80


website, 45, 85–86

operational performance, 19–46

organisational structure, 8

organisations, accredited see accredited organisations

Outcome 1 (Population Health), 11–14

outlook, 4–5

Ppapaya, 30

part-time staff, 78

pathogens, 22

perennial ryegrass/tall fescue, 30

performance, operational see operational performance

performance targets, 2–3

personnel see staff

physical containment facilities see certified physical containment facilities

pineapple, 30

Plant Evaluation Section, 9

plant types in trials, 30–31, 33–34

policies and procedures, 60, 74, 76

freedom of information, 52

OGTR Compliance and Enforcement Policy, 71–73

Population Health see Department of Health and Ageing

prescribed agencies: coordination with, 61–62

presentations see meetings and forums

privacy, 7

procedures see policies and procedures

procurement, 54

public access, 85–87

advice from OGTR, 44

freedom of information, 52

Public Service Act 1999, vii, 7, 78

publications, 81

purchasing, 54

Qqualitative deliverables, 11–14

quarterly reporting requirements, 81

quarterly reports, 54

RRasko, John, 74–75

recruitment, 54

reforms, 4

regulation see gene technology regulatory system

Regulator see Gene Technology Regulator

regulatory bodies

advice to, 44

coordination with, 61–62

Regulatory Practice and Compliance Branch, 10

Regulatory Practice and Secretariat Section, 10

remuneration, 78

committee members, 77

reporting requirements, 54

annual and quarterly, 81

representations see meetings and forums

research, 46

Risk Analysis Framework, 66

risk assessments, 12–13

role, v, vii

SScience Cohort, 9

security, 7

Security Sensitive Biological Agents Regulatory Scheme, 42–43


Senior Executive Service, 49, 78

Smith, Joe

corporate overview, 8

Gene Technology Regulator’s review, 2–5


see also Gene Technology Regulator

staff, v, 48–50

non-salary benefits, 49

performance payments, 78

recruitment of, 54

staff profile, 78–80

team work, 4

staff training and development, 49, 79–80

internal training presentations, 79

OGTR Forum, 79–80

stakeholders see consultation with stakeholders

Statement of Intent, 7

statutory committees, 74–77

remuneration and allowances, 77

strategic direction, 11

structure see organisational structure

sugarcane, 30

Superannuation Legislation (Consequential Amendments and Transitional Provisions) Act 2011, 60

surrender of licences, 20

Ttall fescue/perennial ryegrass, 30

team culture, 48

telephone number for OGTR, 86–87

terminology, 88–89

Therapeutic Goods Administration, 3, 13

timeframes, 18–19

torenia, 30

training see staff training and development

transparency, 3–4, 50, 68

trials, field, 31–34

Uunintended presence of unapproved GMOs, 40–41

United Nations Convention on Biological Diversity, 4

unlicensed GMOs, 17, 70

Vvaccines, 2, 4, 21, 29, 61

values, vi

vision, v

Wwebsite, 45, 85–86

wheat, 30

white clover, 30

work–life balance, 50

workplace health and safety, 50

Workplace Relations Act 1996, 42

World Health Organization, 4

Yyear ahead (future outlook), 4–5

www.ogtr.gov.au

All information in this publication is correct as of October 2011 D04

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annual report 2010 11 - parliament of victoria...operations of the gene technology regulator annual...

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