letter of transmittal - department of health · letter of transmittal. iv contacts office of the...

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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

ISBN: 978-1-74241-321-1

Online ISBN: 978-1-74241-322-8

Publications Number: D0034

© Commonwealth of Australia 2010

Paper-based publicationsThis work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth.

Requests and enquiries concerning reproduction and rights should be addressed to:

The Commonwealth Copyright Administration Attorney-General’s Department 3-5 National Circuit Barton ACT 2600

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Designed by Giraffe vcm

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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 2009 to 30 June 2010.

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 2009 to 30 June 2010.

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 2010.

Yours sincerely

Dr Joe Smith

Gene Technology Regulator 13 September 2010

Letter of transmittal

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ContactsOffice 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

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.

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Office of the Gene Technology Regulator

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

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

Our roleTo 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 GMOs.

Our objectiveOur 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 GMOs. The Gene Technology Regulator, supported by the OGTR, is to achieve this by administering a responsive, efficient, effective and science-based national scheme for the regulation of gene technology that revolves around a system of prohibitions and approvals.

Our peopleAs at 30 June 2010, the OGTR comprised 56 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. As part of the Commonwealth Health and Ageing portfolio, we are also guided by the Department’s People Strategy – Performance through People 2010–2015.

Our valuesWe are committed to the Australian Public Service (APS) 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.

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.

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About this reportThis 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.

This report is a formal accountability document that details the operations of the Gene Technology Regulator (the Regulator) during 2009–10 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) 2009–10 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 2009–10 PBS.

• Operational performance describes the OGTR achievements against the priorities for the reporting year and the challenges overcome along the way. 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; and a summary of classes of dealings, process for authorisations and statutory timeframes that help the Regulator manage risks to health and safety of people and the environment.

• 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 relating to the OGTR, 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.

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 Requirements for Annual Reports.

Note: The Department of Health and Ageing 2009–10 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.

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ContentsLetter of transmittal iii

Contacts iv

Office of the Gene Technology Regulator v

Our vision v

Our mission v

Our role v

Our objective v

Our people v

Our values v

About this report vi

1. Gene Technology Regulator’s review 2

Targets achieved 2

Transparency a feature 3

Regulation keeping pace 3

Cooperation with other agencies 3

International engagement 3

Dedicated staff 4

The way ahead 4

2. Corporate overview 6

Corporate governance 6

Organisational structure 7

Financial performance 9

Summary of performance against deliverables and key performance indicators 10

3. Operational performance 16

Classes of GMO dealings and authorisations 16

Classes of GMO dealings 16

Timeframes 18

Operational performance 18

Assessments and approvals 19

Monitoring and inspection 29

Compliance with the Gene Technology Act 2000 38

Consultation with stakeholders 42

International regulatory liaison 46

Other functions of the Gene Technology Regulator 47

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4. Management and accountability 50

Human resources 50

Occupational health and safety 51

Freedom of information 51

Purchasing 54

Assets management 54

Exempt contracts 54

Consultancies 54

Advertising and market research 54

Annual reporting requirements 54

Quarterly reporting requirements 55

Commonwealth Disability Strategy 55

Ecologically sustainable development 55

5. Appendices 54

Appendix 1 History and structure of the gene technology regulatory system 58

Appendix 2 Types of applications, authorisations, monitoring and compliance 62

Appendix 3 Membership of statutory committees and attendance at 2009–10 meetings 72

Appendix 4 Staff profile and training and development activities 76

Appendix 5 Publications and guidance documents 80

Appendix 6 International meetings and forums 81

Appendix 7 Presentations and meetings on gene technology in Australia 82

Appendix 8 Stakeholder and public access to the OGTR 83

Glossary 86

Indexes 88

List of requirements 88

Alphabetical index 91

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List of figures

Figure 1: Organisational structure of the OGTR, 2009–10 7

Figure 2: DIR licences issued since commencement of the Act 22

Figure 3: Research focus of DNIRs approved in 2009–10 23

Figure 4: Types of organisations that received DNIR licences in 2009–10 25

Figure 5: Organisations accredited as at 30 June 2010, by type of organisation 26

Figure 6: Organisations accredited as at 30 June 2010, by location of headquarters 27

Figure 7: Physical containment facilities certified as at 30 June 2010, by location 28

Figure 8: Number of DIR field trial sites inspected in 2009–10, by crop type 31

Figure 9: Number of field trial sites at beginning of 2009–10 (left), transition of location status (centre), and number of field trial sites at end of 2009–10 (right) 32

Figure 10: Location by local government area and field trial types during 2009–10 33

Figure 11: Number of field trial sites inspected in 2009–10, by state and territory 34

Figure 12: Field trial sites and locations inspected in 2009–10, by local government area 35

Figure 13: Number of certified facilities as at 2009–10, by state and territory 37

Figure 14: Number of certified facility inspections in 2009–10, by state and territory 37

Figure 15: Number of certified facilities as at 2009–10, by organisation type 38

Figure 16: Number of certified facility inspections in 2009–10, by organisation type 38

Figure 17: Governance arrangements for the Gene Technology Regulator 59

Figure 18: DNIR assessment process 64

Figure 19: DIR eight-stage assessment process 68

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List of tables

Table 1: Australian Government funding for the OGTR, 2009–10 to 2013–14 9

Table 2: Qualitative deliverables, 2009–10 10

Table 3: Quantitative deliverables, 2009–10 10

Table 4: Qualitative key performance indicators, 2009–10 12

Table 5: Quantitative key performance indicators, 2009–10 13

Table 6: Classes of GMO dealings under the Gene Technology Act 2000 17

Table 7: Prescribed timeframes 18

Table 8: Applications and notifications, 2009–10 19

Table 9: DIR applications approved, 2009–10 22

Table 10: DNIR applications approved, 2009–10 24

Table 11: Number of facilities certified as at 30 June 2010, by physical containment level and type 28

Table 12: Trend data for main types of applications, 2006–07 to 2009–10 29

Table 13: Number and proportion of inspections performed in each quarter of 2009–10 30

Table 14: Number of licensed DIR sites, by crop type/parent organism at beginning of 2009–10 and end of 2009–10; and number of inspections conducted during the period 31

Table 15: Number of field trial sites and OGTR inspections in 2009–10, by state and territory 32

Table 16: Number of certification types at end of 2009–10 and inspections conducted during the period 36

Table 17: Number of non-compliances identified in certified facilities during 2009–10, by non-compliance type 39

Table 18: Components of national strategy for unintended presence of unapproved GMOs 42

Table 19: Media advertising organisations engaged, 2009–10 54

Table 20: Regulatory agencies in Australia with a role in regulating gene technology 61

Table 21: Attendance at GTTAC meetings during 2009–10 72

Table 22: Members of GTTAC, as at 30 June 2010 73

Table 23: Attendance at GTECCC meetings during 2009–10 74

Table 24: Members of GTECCC, as at 30 June 2010 74

Table 25: OGTR staffing profile, at 30 June 2010 76

Table 26: Membership of equal employment opportunity groups, 2009 and 2010 76

Table 27: SES and non-SES bonus payments, 1 July 2009 to 30 June 2010 77

Table 28: Non-salary benefits afforded non-SES staff employed under the Certified Agreement 5 or current Australian Workplace Agreement 77

Table 29: Internal legal issue training presentations, 2009–10 78

Table 30: Internal risk assessment training presentations, 2009–10 78

Table 31: Presentations at OGTR Forum, 2009–10 79

Table 32: Presentations and representations at international meetings and conferences, 2009–10 81

Table 33: Presentations and representations at national meetings and conferences, 2009–10 82

Table 34: Website activity, 2009–10 and 2008–09 83

Table 35: Email and free call 1800 number activity, 2009–10 and 2008–09 84

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Gene TechnOLOGy ReGuLaTOR’S Review 1

1 Gene Technology Regulator’s review

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1. Gene Technology Regulator’s review2009–10 has been another successful year for the OGTR. It has seen us achieve all of our regulatory objectives and advance a range of initiatives to strengthen further the performance of Australia’s national system for regulation of gene technology, which we administer under the Gene Technology Act 2000 and relevant state and territory legislation.

Given the continuing developments in the science and application of gene technology, it is critical that the regulatory system keeps pace with and maintains its ability to fulfil, as effectively and efficiently as possible, its legislated aim of protecting the health and safety of people and the environment. Reflecting this, the key strategic direction set down for the OGTR (Department of Health and

Ageing Portfolio Budget Statements – PBS2) was to ensure that the regulatory system for gene technology continues to be responsive, efficient, effective and science-based. To achieve this, we:

• maintained a strong emphasis on sound science and robust risk analysis to support our regulatory decisions

• consulted widely with experts, the regulated community and the broader public

• engaged actively in national and international activities so our approaches continued to reflect current science and influence international best practice

• pursued an active program to monitor, facilitate and ensure compliance with regulatory requirements

• continued to review our requirements and processes, particularly through the current review of the Gene Technology Regulations 2001 to ensure optimal effectiveness and currency

• strengthened liaison with other Australian Government regulators to enhance coordinated decision-making and avoid regulatory duplication.

Targets achievedPursuing these strategies, we achieved the deliverables and targets set down for us in the PBS, while strengthening our performance as an effective regulator. The OGTR made 100 per cent of the 794 decisions on applications for licences for dealings with GMOs and accreditation of organisations or certification of facilities within legislated timeframes.

The trend in recent years of increasing diversity in the nature of licence applications continued in 2009–10. Licence applications this year ranged from field trials of crops with traits such as drought and salt tolerance, and enhanced nutrient uptake and herbicide tolerance, to research involving GMOs to treat human diseases, research into human and animal pathogens, and development of vaccines against cancer and infectious diseases. Our risk analysis and approval activities were again very effectively complemented by monitoring and compliance programs to ensure licence holders were actually meeting regulatory requirements.

Exceeding our target, 53 per cent of field trials and 22 per cent of higher-level containment facilities were inspected, and all alleged compliance breaches were investigated within 10 working days. No significant risks to public health or the environment were identified.

2 The PBS describes strategic directions, major activities for the planned programs in terms of deliverables and key performance indicators and targets. For 2009–10, the OGTR contributed to Outcome 1 (Population health) of the health and ageing PBS. OGTR performance against the PBS is reported in the Department’s annual Report, this annual Report and Quarterly Reports to Parliament. in keeping with the national nature of the regulatory scheme, OGTR operations are also reported to the Gene Technology Ministerial council (see appendix 1).

Gene Technology Regulator’s review 1

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Transparency a featureTransparency was again a feature of our regulatory decision-making. Extensive consultation continued with the general public, expert bodies, regulated organisations, other regulatory agencies and the states and territories on all licences for intentional release of GMOs, and on revision of guidelines and development of amended regulations. An upgrade of the OGTR website mapping function, which provides a visual representation of the location of all licensed GMO field trial sites, was an important development in our public interface tools during 2009–10. The functionality of the mapping site was enhanced to allow improved search functions and better links to risk assessments and licences associated with each field trial.

Regulation keeping paceWe have focused on maintaining our awareness of scientific developments and regulatory practices, and ensuring our approach to regulation of GMOs reflected contemporary developments, our operational experience and feedback from stakeholders. In this vein, the updated OGTR Risk Analysis Framework, revised to reflect the latest developments in risk analysis methodology, was implemented throughout the year and revised Guidelines for the Certification of Physical Containment Level 3 Animal Facilities were issued as part of the ongoing review of guidelines to ensure they reflect current knowledge and best practice. A major review of the Gene Technology Regulations 2001 (the Regulations) was also progressed, following in-principle policy approval from the Gene Technology Ministerial Council. The review will be finalised in 2010–11, taking into account comments received from consultation undertaken during the year on the draft amendments.

Cooperation with other agenciesAustralia’s national gene technology regulatory system operates as part of an integrated legislative framework that enhances coordinated decision making and avoids duplication. To this end, we have worked closely with colleagues in other agencies that also have a role in regulating GMOs or GM products, 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 the Environment, Water, Heritage and the Arts. More broadly, the Regulators Forum in which relevant agencies and the OGTR come together to optimise the effectiveness and integration of the overall regulatory system through sharing knowledge and combining expertise has progressed initiatives in important areas such as addressing future skills needs, emergency response management and stakeholder communication.

International engagementOGTR staff have participated actively in a range of local forums and been engaged in the international arena to receive feedback, raise awareness and help ensure our regulatory approaches were aligned with, and contributing to, best international practice, consistent with key legislated functions of the Gene Technology Regulator. In addition to strengthening bilateral cooperation with experts and counterpart regulators in Europe, North America, South America, New Zealand, Asia and South Africa, OGTR staff have made major contributions to the work of organisations such as the Organisation for Economic Co-operation and Development (OECD) Working Group on Harmonisation of Regulatory Oversight in Biotechnology and the United Nations Convention on Biological Diversity. The OGTR’s high international standing has been reflected in many ways throughout the year. We have been invited to lead the

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1 Gene Technology Regulator’s review

preparation of OECD consensus documents on the biology of sugarcane and eucalyptus, and been asked to give presentations or conduct GMO risk assessment training workshops to support development of regulatory systems in Malaysia, Thailand and Vietnam.

Dedicated staffUnderpinning every aspect of our performance has, of course, been the outstanding professionalism of OGTR staff, dedicated to ensuring we deliver a high quality, effective and transparent gene technology regulatory system. I thank them for their ongoing commitment to excellence, which we have endeavoured to support by providing a workplace that is encouraging and rewarding. Staff have been supported in maintaining their regulatory and scientific awareness through participation in relevant scientific conferences, our active internal training program on legal issues associated with regulation of GMOs and regular OGTR forums at which staff and invited experts present on topics of current interest.

The way aheadAs we enter our tenth year of operation, we will build on the achievements of the past year, being guided by the new OGTR Strategic Plan 2010–13 and the priorities articulated within it.

Through active and targeted engagement with national and international agencies and organisations, we will ensure the regulatory processes we use to deliver our legislative objectives remain contemporary, able to accommodate scientific advances and consistent with the best practices employed around the world. We will finish reviewing the Regulations and implement the revised Regulations, as well as providing input to the scheduled review of the national legislative framework for gene technology regulation.

Guided by examination of our existing consultation processes, we will seek to enhance our external communications to maintain a strong focus on stakeholder engagement and transparency in regulatory decision making. We will hold another Institutional Biosafety Committee Forum to update and seek feedback from our regulated community and, through both bilateral endeavours and activities such as the Regulators Forum, strengthen our interaction with other agencies with an interest in gene technology.

Informed by review of our operations, including the strategic review of administrative arrangements within the Health and Ageing Portfolio, we will ensure optimal use of our resources. Importantly, we will continue to strive to provide an environment that is both challenging and rewarding for our staff, so we can maintain the highest standards of gene technology regulation for Australia.

Dr Joe Smith

Gene Technology Regulator

13 September 2010

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cORPORaTe OveRview 2

2 corporate overview

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2. Corporate overviewThis chapter provides an overview of the corporate governance arrangements for the Gene Technology Regulator (the Regulator) and a description of the organisational structure of the OGTR. It also describes the OGTR’s human resource management practices, as well as the transition in reporting from an outputs and outcomes structure to an outcomes and programs structure as set out in Outcome 1, Population Health, of the Department of Health and Ageing 2009–10 PBS.

Corporate governanceThe 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 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 issued to him by the Parliamentary Secretary. The Secretary of the Department of Health and Ageing provides staff to the OGTR under section 133 of the Act.

The OGTR has service level agreements in place with the Department to access a range of business management and reporting services (for example, 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 Commonwealth 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 internal audit arrangements via the service level agreement with the Department. 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.

corporate overview 2

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

Figure 1: Organisational structure of the OGTR, 2009–10

Gene Technology Regulator

Regulatory Practice and Compliance Branch Evaluation Branch

Regulatory Practice and Secretariat Plant evaluation Section

Business Management, communications and Post Release Review Section

contained Dealings evaluation Section

Monitoring Section application and Licence Management Section

compliance and investigation Section Science cohort

Legal Section

Gene Technology RegulatorThe Gene Technology Regulator is an independent statutory office holder who administers the Act and corresponding state and territory laws.3 In administering implementation of 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 an extensive and diverse background spanning some 30 years in both the public and private sector involving scientific research, services and regulation. He has over 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.

Evaluation BranchDr Michael Dornbusch heads the Evaluation Branch. Dr Dornbusch first joined the OGTR in 2003 and managed the Plant Evaluation Section from December 2006 until March 2009. After acting in the role of Assistant Secretary, Evaluation Branch since 30 March 2009, Dr Dornbusch was appointed to the role permanently 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.

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


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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. It provides advice on notifiable low risk dealings (NLRDs), conducts training for accredited organisations and/or Institutional Biosafety Committees (IBCs), 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 the Reference Manager database.

Regulatory Practice and Compliance BranchMr Greg Barber has been the acting Assistant Secretary Regulatory Practice and Compliance Branch since April 2010 at which time Ms Elizabeth Flynn was seconded to work in another portfolio agency. Mr Barber joined the OGTR in 2001 as an inspector and has managed the Monitoring Section since 2004. Currently 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.

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 current review of the Gene Technology Regulations 2001 (the Regulations). 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 Confidential Commercial Information (CCI). It conducts introductory and ongoing training for OGTR staff on legal issues.

The Business Management, Communications and Post Release Review Section delivers administrative and financial reporting services, in partnership with the Department. 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 of GMOs. The section provides science policy advice and input to international regulatory harmonisation programs.


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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 Act. In particular, the Monitoring 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 Act.

Financial performanceThe 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 coordinate financial reporting and management.

The OGTR 2009–10 Federal Budget measures are published in the Department’s Portfolio Budget Statement 2009–10 and are summarised in Table 1.

Table 1: Australian Government funding for the OGTR, 2009–10 to 2013–14

2009–10 ($m)

2010–11 ($m)

2011–12 ($m)

2012–13 ($m)

2013–14 ($m)

Departmental 8.028 8.017 8.072 8.133 8.197

The OGTR’s activities for 2009–10 are reported on pages 87–89 under the sub-program 1.4.4 in Outcome 1 – Population Health, of the Department’s 2009–10 PBS.4 The key strategic direction of this sub-program aims to:

• work to ensure that regulatory system for gene technology continues to be a responsive, efficient and effective science-based system for the regulation of activities involving genetically modified organisms.

4 a copy of the 2009–10 PBS is available at <www.health.gov.au/internet/budget/publishing.nsf/content/2009–10_health_PBS>.


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Summary of performance against deliverables and key performance indicators In 2009–10 the PBS underwent transition from an outputs and outcomes structure to outcomes and programs. This year’s annual report reflects those changes, including deliverables and performance indicators. These are shown in the Tables 2 to 5.

Table 2: Qualitative deliverables, 2009–10

Outcome 1 – Population Health

Sub-program 1.4.4 Gene Technology Regulation

Qualitative deliverable: Timely and thorough consultation with key stakeholders on regulatory change in relation to GMOs. Measured through stakeholder feedback on proposed amendments to the Gene Technology Regulations 2001

Result: Deliverable met

During 2009–10, in conjunction with the Office of Legislative Drafting and Publishing, the Office prepared and consulted with key stakeholders on the Draft Gene Technology Amendment Regulations 2010. The proposed changes are intended to ensure that dealings with GMOs continue to be classified appropriately according to current understanding of risks they may pose; improve the efficiency and effectiveness of the system; and help users better understand and comply with their legislative obligations. Overall, it is expected that the net effect of the proposed changes will reduce the regulatory burden on organisations undertaking dealings with GMOs.

In May–June 2010 the Regulator consulted with a wide range of stakeholders on the Draft Gene Technology Amendment Regulations 2010. Submissions were received from a range of stakeholders including the public. Most submissions indicated broad support for the proposed changes. It is anticipated that amendments will be made by mid 2010–11 and take effect by the end of 2010–11.

Table 3: Quantitative deliverables, 2009–10



Quantitative deliverable: Number of risk assessment and risk management plans produced

2009–10 Target: 26* 2009–10 Actual: 26*


The office prepares risk assessment and risk management plans for all licence applications, which form the basis of the Regulator’s decisions on whether or not to issue licences and on conditions of each licence. In 2009–10, the office produced 26 risk assessment and risk management plans in response to licence applications received by the Regulator. A risk assessment and risk management plan was produced in respect of every application for which a decision was required to be made in 2009–10.

Quantitative deliverable: Number of licences issued for intentional release

2009–10 Target: 10* 2009–10 Actual: 8*

Result: Deliverable substantially met

During this reporting period, the Regulator issued eight licences for activities involving intentional release of genetically modified organisms. All decisions on licence applications have been made within applicable statutory timeframes.

In 2009–10, the Regulator received 10 licence applications for dealings involving intentional release of GMOs into the environment. Three applications, received in June 2010, are still under consideration as the decision-making process has a statutory timeframe of up to 255 days.


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Quantitative deliverable: Number of licences issued for contained dealings

2009–10 Target: 16* 2009–10 Actual: 18*


In 2009–10, the Regulator issued 18 licences for conducting contained dealings with GMOs as at 30 June 2010. This exceeded the target for the number of licences issued for contained dealings in 2009–10.

Quantitative deliverable: Number of assessments of alleged breaches assessed within 10 working days and appropriate response initiated

2009–10 Target: 100% 2009–10 Actual: 100%


During 2009–10, three cases of non-compliances (alleged breaches) with the gene technology legislation required formal investigation. Each case was assessed based on Australian Government investigation standards within 10 working days and resolved through corrective actions. All three presented negligible risk to human health and safety or to the environment.

Quantitative deliverable: Number of organisations accredited

2009–10 Target: 7 2009–10 Actual: 8


In 2009–10, the office received eight applications for accreditation of organisations. The Regulator accredited all eight organisations during the reporting period, exceeding the target for this deliverable.

Quantitative deliverable: Number of facilities certified

2009–10 Target: 215* 2009–10 Actual: 182*

Result: Deliverable substantially met

During the reporting period, the Regulator certified 182 physical containment facilities for organisations that continue to work or intend to work with genetically modified organisms. As indicated in the data caveats, the number of certifications issued depends on the timing and numbers of applications received, which are not controlled by the office. All decisions on certification were made within statutory timeframes.

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

2009–10 Target: 20% 2009–10 Actual: 53% and 22%


Field trial sites are inspected to monitor for compliance with licence conditions to ensure that risks to human health and safety and the environment are managed. In 2009–10, the office inspected 53% of current and post-harvest GM crop field trial sites. The field trial sites inspected were spread across South Australia, New South Wales, Victoria, Queensland and the Australian Capital Territory. GM crop trials inspected included canola, wheat, barley, banana, sugarcane, cotton, Indian mustard and grapevines.

Of the 54 higher-level containment facilities that had certification instruments in force at the beginning of 2009–10, 12 were inspected, representing 22% of higher-level containment facilities, exceeding the target.

Quantitative deliverable: Number of variations to licences and other instruments processed

2009–10 Target: 329* 2009–10 Actual: 357*


In 2009–10, the office processed 357 variations to licences and other instruments, exceeding the target for this deliverable.

Data caveats: * Numbers of licence or other applications received (and assessed/licence issued) are highly variable and particularly difficult to predict as these are dependent on external factors such as research direction, funding or the financial viability and commercial decisions of the applicant organisations.


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Table 4: Qualitative key performance indicators, 2009–10



Qualitative indicator: Protection of people and the environment through identification and management of risks from GMOs. Measured by high level of compliance with the gene technology legislation and no adverse human health or environmental outcomes from GMOs

Result: Indicator met

Impact of program in 2009–10:

In 2009–10, the Regulator with the support of the office, prepared comprehensive risk assessments and risk management plans for proposed activities with GMOs. Stringent licence conditions were imposed to ensure containment of GMOs and to manage any identified risks.

During the reporting period there was a high level of compliance with the gene technology legislation and no adverse effects on human health or the environment as a result of activities with the GMOs were reported.

Qualitative indicator: Most stakeholders satisfied with OGTR’s efficient and effective regulatory system for GMOs, communication and consultation processes. Measured by high level of stakeholder satisfaction


Impact of program in 2009–10:

The Regulator was invited to participate in a number of public forums in 2009–10 and continued on a national program of visits to key stakeholders throughout Australia. The Regulator and office received positive feedback from the regulated community and state and territory officials. There were no appeals of decisions made by the Regulator. The office has also received positive feedback from stakeholders from the public consultation on the proposed changes to the Gene Technology Regulations 2001, especially about the rationale for reclassifying dealings with viral vectors.

The office was invited to contribute to a number of international workshops to build capacity in the region for risk assessment of GMOs. One of the host countries has subsequently arranged to have the OGTR Risk Analysis Framework translated into their language. The office received very positive feedback from these workshops, indicating that the Australian regulatory system is well regarded and is considered as a good international model for gene technology regulation.


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Table 5: Quantitative key performance indicators, 2009–10



Quantitative key performance indicator:

High level of compliance with the Gene Technology Act 2000

2009–10 Target: 100% 2009–10 Actual: 100%


The regulated community demonstrated high-level compliance with the gene technology legislation, consistent with the trend observed over the last three reporting periods. The office identified a small number of minor non-compliances or alleged breaches during routine monitoring of containment facilities and licensed dealings involving genetically modified organisms. 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.


Percentage of licence decisions made within statutory timeframes

2009–10 Target: 100% 2009–10 Actual: 100%


The Regulator made decisions on all licences within the applicable statutory timeframes, as has been the trend for the last three reporting periods. There were no appeals of decisions made by the Regulator.


Percentage of field trial sites and higher-level containment facilities inspected

2009–10 Target: 20% 2009–10 Actual: 53% and 22%


The office inspected 53% of current and post-harvest genetically modified crop field trial sites. This compares with 59% of field trials inspected in 2008–09, 51% in 2007–08, and 37% in 2006–07.

Of the 54 higher-level containment facilities that had certification instruments in force at the beginning of 2009–10, 12 were inspected, representing 22% of higher-level containment facilities. This compares with 27% in 2008–09 and 28% in 2007–08.

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OPeRaTiOnaL PeRFORMance 3

3 Operational performance

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3. Operational performanceAs an introduction to operational activities, the first part of this chapter outlines the types of dealings with GMOs that are defined by the Act, 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 this chapter describes operational performance.

Classes of GMO dealings and authorisationsSection 10 of the Act 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 Act 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 dealingsThe Act forms the basis of a prohibitory scheme that makes dealing with a GMO a criminal offence unless, as outlined in section 31 of the Act, 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.


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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 Act respectively). Part 5 of the Act 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 Act gives the Minister the power to expedite an approval of dealings with a GMO in an emergency.

Table 6 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).

Table 6: Classes of GMO dealings under the Gene Technology Act 2000

Category Licence required Containment

Exempt No, dealings classified as Exempt are scheduled in the Regulations No intentional release to the environment

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

Yes PC1 or PC2 (usually)

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

Yes PC2 (usually)

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

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

Containment and/or disposal measures will apply

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

Containment measures may be required

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

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

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

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.


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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.

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).5

TimeframesUnder section 43(3) of the Act 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 7. 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 7: 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 performanceThe second part of this chapter describes the achievements the Regulator has made against Outcome 1, Population Health, of the Department of Health and Ageing, 2009–10 PBS. It provides details of achievements on deliverables and performance indicators in the key areas of:

• assessments and approvals/authorisations under the Act

• monitoring of GMOs

• compliance with the Act

• consultation with stakeholders

• cooperation with relevant regulatory agencies.

5 a complete listing of DniR and DiR licence applications and approvals, and nLRDs is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/gmorec-index-1>.


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Assessments and approvalsInformation comparing the actual and predicted numbers of risk assessment and risk management plans, licences issued and variations to licences and other instruments is given in Table 3, Chapter 2.

In 2009–10 the OGTR received 1,400 applications and notifications as defined under the Act (see Table 8). Fluctuations in the timing and volume of application lodgement can be influenced by research grant funding cycles and seasonal agricultural factors, as well as changes to legislation, as was the case in 2008–09.

Table 8: Applications and notifications, 2009–10

Application type Received Withdrawn ApprovedbCeased

considerationcUnder

considerationd

Accreditation 8 0 8 0 0

CCI declaration for DIR licence 11 2 4 0 8

CCI declaration for DNIR licence 1 0 0 0 1

CCI declaration for NLRD notification 1 0 1 0 0

Certification 168 6 182 0 6

DIR licence 10 0 8 0 7

DNIR licence 25 5 18 0 8

Lifting suspension of certification 27 0 28 0 0

NLRD notification 629 0 0 0 0

Surrender of accreditation 4 0 3 0 1

Surrender of certification 89 0 104 0 5

Surrender of DIR licence 8 1 5 0 4

Surrender of DNIR licence 8 1 9 0 1

Suspension of certification 36 0 45 0 0

Transfer of certification 19 0 19 0 0

Transfer of DNIR licence 2 0 3 0 0

Variation of accreditationa 7 1 6 0 0

Variation of certificationa 249 2 259 0 13

Variation of DIR licencea 22 0 22 0 2

Variation of DNIR licencea 76 4 70 3 14

Total 1,400 22 794 3 70

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 Also includes variations initiated by the Regulator

b Some applications reported as approved in 2009–10 were received in 2008–09

c Includes both ‘ceased consideration’ and ‘not considered’ under section 42 of the Act

d Under consideration as at 30 June 2010


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DIR 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 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. All decisions made during 2009–10 were made within the relevant statutory timeframe. Decisions on applications do not necessarily occur in the same year as applications are received.

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. All decisions made during 2009–10 were made within the statutory timeframe.

Notifiable low risk dealings (NLRDs) have been assessed as posing low risk based on previous national and international experience. Dealings classified as NLRDs are specified in the Regulations. Conduct of NLRDs requires prior assessment by an IBC and notification to the Regulator in an annual report.

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 Act, 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 2009–10.

More information on the types of dealings conducted under each category is provided in Appendix 2.6

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.

Applications for certification of physical containment facilities in accordance with the Regulator’s Certification Guidelines also have a statutory timeframe of 90 working days.

Applications can be made to the Regulator under section 184 of the Act for specified information (that has not previously been made public) to be declared as 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 Act does not assign a statutory timeframe for the Regulator to 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 2009–10, the Regulator made five CCI declarations; decisions on nine CCI applications were pending at 30 June 2010.

Surrender of licences and certifications usually occurs when dealings have concluded. Before surrender is approved, the Regulator must be satisfied that all conditions (for example, post-harvest monitoring) have been met and that any required cleaning and/or decommissioning of facilities has taken place. The OGTR received 109 surrender requests during 2009–10 and approved 121. These included approval of 104 applications for surrender of certifications of facilities, and approval of seven applications to surrender DNIR licences as well as approval of five applications to surrender DIR licences.

6 Listings of DiR, DniR, nLRD and GMO Register applications and notifications are available at <www.ogtr.gov.au>.


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The Regulator or holder of an instrument (licence, certification or accreditation) issued under the Act can initiate variations to these instruments. 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 2009–10, the Regulator approved 259 certification variations. Approximately 58 per cent of these were to renew facilities previously certified for five years; 19 per cent were to add or remove rooms from the area certified; 15 per cent were to vary standard conditions of certification; and 4 per cent were to change the facility title.

Applications may be withdrawn for various reasons, including when research has changed direction, when the dealings are incorporated within other authorisations, where the application did not meet the specified requirements and/or when the project has no prospect of progressing (for example, unsatisfactory research results, lack of funding).

Licences for dealings involving intentional releaseDuring 2009–10, the Regulator issued eight DIR licences and at 30 June 2010 he was considering a further seven licence applications (see Table 9). Five of the eight approved applications for DIR licences were received before 1 July 2009. All licences were completed within statutory timeframes (see Table 5, Chapter 2).

Six of the DIR licences approved in 2009–10 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. DIR licences were issued for limited and controlled releases of GM plants modified to improve tolerance to abiotic stresses, enhance nutrient uptake and to improve agricultural management of crops. The GM plants included wheat, barley and sugarcane.

GM traits intended to provide benefits to consumers are also evident in DIR research work, with one DIR licence involving GM wheat and barley with altered grain composition. Another DIR licence issued included research on GM sugarcane aimed at increasing sucrose accumulation and enhancing efficiency of biofuel production from cellulose.

In addition, one DIR licence was issued for a limited and controlled release to trial a GM vaccine designed to prevent certain childhood respiratory diseases.

A commercial release of a GM cotton modified for insect resistance was also approved in 2009–10.

Of the 10 DIR applications received in 2009–10, four were submitted by private companies, three by government agencies and three by universities. Of the 83 DIR licences issued since commencement of the Act, 43 (51%) have been to private companies, 32 (39%) have been to government agencies, and eight (10%) to universities (see Figure 2).


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Table 9: DIR applications approved, 2009–10

DIR number Applicant

Parent organism

Introduced trait Type of release

Date received

Date issued

DIR-102 University of Adelaide

Wheat and barley

Abiotic stress resistance and enhanced nutrient utilisation

Limited and controlled release

10-12-2009 29-6-2010

DIR-100 CSIRO Wheat Enhanced carbon assimilation, grain weight, heat tolerance and/or water use efficiency, herbicide tolerance


11-11-2009 23-6-2010

DIR-099 CSIRO Wheat and barley

Altered grain composition, nutrient utilisation efficiency


9-11-2009 11-6-2010

DIR-097 PPD Australia Pty Ltd

Bovine Parainfluenza Vaccine

Attenuation, foreign antigen expression


22-6-2009 15-1-2010

DIR-096 BSES Limited Sugarcane Herbicide tolerance Limited and controlled release

14-4-2009 11-11-2009

DIR-095 BSES Limited Sugarcane Altered plant growth, enhanced drought tolerance, enhanced nitrogen use efficiency, altered sucrose accumulation, and improved cellulosic ethanol production from sugarcane biomass


18-12-2008 24-7-2009

DIR-094 CSIRO Wheat and barley

Enhanced nutrient utilisation efficiency


16-12-2008 10-7-2009

DIR-091 Dow AgroSciences Australia Pty Ltd

Cotton Insect resistance General and commercial release

23-7-2008 25-11-2009

Notes: CSIRO = Commonwealth Scientific and Industrial Research Organisation; DIR = a dealing involving intentional release of a GMO into the environment.

Figure 2: DIR licences issued since commencement of the Act

University, 8 10%

Company, 43 51%

Government, 32 39%


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Licences for dealings not involving intentional releaseMuch of the research conducted under DNIR licences is aimed at improving the understanding of the mechanisms of disease, including the ways in which pathogenic organisms cause disease and how host organisms respond to infection. Other areas of research explore the normal and abnormal operation of fundamental biological processes, such as organ development, in order to understand diseases such as cancer. Some DNIR licences involve dealings to investigate how to detect and prevent disease and can involve production of diagnostic agents and therapeutic products for use in clinical trials.

DNIR licences include research with human and animal pathogens. Dealings with GMOs where the parent organism is classified as Risk Group 2 under the AS/NZ Standard 2243.3:2002 Safety in laboratories, Part 3: Microbiological aspects and containment facilities are usually required to be conducted in certified PC2 facilities while GMOs derived from Risk Group 3 organisms require certified PC3 facilities. A high proportion of research conducted under DNIR licences may never lead to release of the GMOs to the environment under a DIR licence.

In 2009–10, the Regulator approved 18 DNIR licence applications (see Table 10). All were assessed within the statutory timeframe of 90 working days. The Regulator was considering a further eight DNIR applications at 30 June 2010. The research focus of DNIRs approved in 2009–10 is shown in Figure 3.

Figure 3: Research focus of DNIRs approved in 2009–10

Treatment/prevention, 3 17%

Gene function/expression, 8 44%

Pathogenesis, 7 39%

Three DNIR licence applications approved dealings with GMOs for pre-clinical development of vaccines against cancer and infectious diseases. Eight DNIR licences authorised dealings with GM viral vectors for basic and applied research into treatment of human diseases and seven licences were approved for study of virulence and replication of human and animal pathogens.

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

Most DNIR licences issued in 2009–10 were to publicly funded organisations, the largest group of which was universities. Government and health service/hospitals were also represented, with two DNIR licences (see Figure 4).


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Table 10: DNIR applications approved, 2009–10

DNIR number Applicant Title

Date received

Date approved

DNIR-483 University of QueenslandManipulation of the immune system in mouse skin using immunoregulatory cytokines

25-1-2010 1-6-2010

DNIR-482Telethon Institute for Child Health Research

Comparative analysis of human and kangaroo Leishmania: defining human pathogenicity genes

18-1-2010 28-5-2010

DNIR-480 University of QueenslandIn vivo modification of target cell populations to study signalling pathways

17-12-2009 5-5-2010

DNIR-479 University of MelbourneModulation of brain activity for understanding cardiovascular diseases

18-11-2009 30-3-2010

DNIR-478Australian National University

Interferon-adjuvanted flavivirus vaccine 11-11-2009 23-3-2010

DNIR-477Children, Youth and Women’s Health Service

Human immunodeficiency vaccine studies 23-10-2009 12-4-2010

DNIR-476Murdoch Childrens Research Institute

Developing lentiviral vectors for gene therapy of friedreich ataxia

21-10-2009 2-3-2010

DNIR-475Bernard O’Brien Institute of Microsurgery

Targeting NADPH oxidase in angiogenesis 8-10-2009 15-2-2010

DNIR-474 University of MelbourneThe impact of influenza A virus PB1-F2 protein on host immunity and potential for therapeutic targeting

24-9-2009 15-1-2010

DNIR-473 University of MelbourneCardiovascular reactivity to stress: role of redox signalling in the hypothalamus and brainstem

14-8-2009 21-12-2009

DNIR-472 University of Queensland Vector competence studies on selected flavivirus mutants 6-7-2009 9-11-2009

DNIR-471 University of SydneyAdeno-associated virus expression of immunosuppressive genes in rodent livers

15-7-2009 16-10-2009

DNIR-470 University of Melbourne Pathogenesis in staphylococcus aureus 13-7-2009 13-11-2009

DNIR-469 University of MelbourneComplementation of mycobacterium spp. and streptomyces spp. with genes required for the synthesis of mycolactones

13-7-2009 26-10-2009

DNIR-468Queensland Institute of Medical Research

Investigation of malaria parasite proteins 8-7-2009 30-10-2009

DNIR-467St Vincent’s Institute of Medical Research

The role of LIMK1 and its interacting proteins in cancer metastasis

17-6-2009 13-10-2009

DNIR-465South Eastern Sydney and Illawarra Area Health Service

Investigation of polymerase (PB1) fidelity from different influenza strains

19-5-2009 6-9-2009

DNIR-463 Griffith University Engineering anaerobic bacteria for multimodal cancer therapy 30-3-2009 30-9-2009

Note: DNIR = A contained dealing with a GMO not involving intentional release of the GMO into the environment


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Figure 4: Types of organisations that received DNIR licences in 2009–10

Health Service/Hospital, 2 11%

University, 11 61%

Research Institute, 5 28%

Notifiable low risk dealings

NLRDs involve genetic modifications that are unlikely to significantly increase the virulence, infectivity or pathogenicity of the original organism. Most NLRDs involve research into the fundamentals of cellular process and are mostly undertaken in PC2 facilities. As a result of the 2007 amendments to the Regulations, certain NLRDs can now be conducted in PC1 facilities.

Dealings classified as NLRDs are listed in Schedule 3 Part 1 (NLRDs appropriate for PC1 facilities) and Schedule 3 Part 2 (NLRDs appropriate for PC2 facilities) of the Regulations. 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.

The Regulator received 629 NLRD notifications during 2009–10. Of these, 609 were for NLRDs assessed as meeting NLRD classification by IBCs during 2009–10. Twenty were additional NLRDs reported by IBCs for dealings assessed before 1 July 2008.

A considerable proportion of NLRD work is primarily for research purposes only and not intended for commercialisation. It includes examination of how complex processes, such as cell function, gene expression and disease progression, occur. Therefore, as with dealings undertaken through DNIR licences, work undertaken as NLRDs may never proceed beyond contained research.

Dealings placed on the GMO RegisterSections 78 and 79 of the Act 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 2009–10 the Regulator received no applications to place any dealings on the GMO Register and none were under consideration.


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Emergency Dealing DeterminationAn Emergency Dealing Determination (EDD) is a legislative instrument made under the Act; the Regulator does not make an EDD. Sections 72A to 72E of the Act, which commenced on 1 July 2007, give the responsible Minister the power to expedite an 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 Act: 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 in relation 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 Act, the Regulator has powers to monitor compliance with the conditions of the EDD.

During 2009–10, the Regulator did not receive any requests for advice in relation to making any EDDs, and none were in effect.

Accredited organisationsAs at 30 June 2010, 159 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. This is similar to last year and the largest single group of these is universities.

Figure 5: Organisations accredited as at 30 June 2010, by type of organisation

Government, 18 11%



University, 36 23%

Company, 51 33%


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Eight new organisations were accredited in 2009–10 (see Table 3, Chapter 2). Newly accredited organisations were SGS Australia Pty Ltd, AstraZeneca Pty Ltd, Calimmune Australia Pty Ltd, vivoPharm Pty Ltd, Australian Centre for Plant Functional Genomics Pty Ltd, The Royal Women’s Hospital, ANZAC Health and Medical Research Foundation, and Asbestos Disease Research Institute.

Accreditations surrendered during 2009–10 were from Stem Cell Sciences Limited, Cytopia Pty Ltd, and Cerylid Pty Ltd.

Figure 6: Organisations accredited as at 30 June 2010, by location of headquarters

ACT, 9 6%

NSW, 40 25%

NT, 3 2%

QLD, 25 16%

SA, 15 9%

TAS, 1 1%

VIC, 50 31%

WA, 15 9%

USA, 1 1%

Certified physical containment facilitiesPhysical containment (PC) 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. Level 1 (PC1) facilities are used to contain organisms posing the lowest risk to human health and the environment. PC4 facilities provide the most secure and stringent containment conditions. The type and number of facilities certified as at 30 June 2010 are provided in Table 11.

As a result of amendments to the Regulations that took effect on 1 July 2007, which now permit certain NLRDs (including knockout mice and rats) to be conducted in PC1 facilities, the percentage of certified PC1 facilities at 30 June 2010 is now approximately 13 per cent of all certified facilities, up significantly from 2 per cent as at 30 June 2007.

Consequently, the percentage of PC2 facilities has fallen to 85 per cent at 30 June 2010, from 95 per cent at 30 June 2007. 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 (for example, animals 14 per cent, plants 10 per cent, aquatic 1 per cent, and arthropods 2 per cent).

PC3 facilities comprise approximately 2 per cent of the total number of certified physical containment facilities respectively, while only three PC4 facilities were certified to conduct work with GMOs at 30 June 2010.

During 2009–10, 182 physical containment facilities were certified (see Table 3, Chapter 2).


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Table 11: Number of facilities certified as at 30 June 2010, by physical containment level and type

Facility type PC1 PC2 PC3 PC4 Total

Animal 231 4 239

Aquatic organism 23 23

Arthropod 29 2 31

Constant temperature room 70 70

Facility 212 3 215

Laboratory 3 1,134 26 1,162

Large grazing animal 35 35

Large scale 17 18

Plant 162 161

Total 250 1,666 32 3 1,951

Note: PC = physical containment

OGTR certified physical containment facilities are located in all Australian jurisdictions (see Figure 7). The relatively large proportion of facilities in the Australian Capital Territory relates to the significant level of research undertaken by the CSIRO, and the Australian National University.

Figure 7: Physical containment facilities certified as at 30 June 2010, by location

ACT, 180 9%

NSW, 394 20%

NT, 14 1%

QLD, 318 16%

SA, 191 10%

TAS, 16 1%

VIC, 699 36%

WA, 139 7%

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 companies form the largest proportion of accredited organisations (33%), they submit the least number of applications for certification (less than 4%). This reflects the commercial focus of company dealings, as opposed to the greater research focus of universities, where most dealings require physical containment.


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Trend data for main types of applicationsTable 12 shows a return to average approvals of DIR and DNIR licences, and certifications and accreditations.

The increase in the number of NLRDs is a continuation of an upward trend that flows from introduction of new categories of PC1 NLRDs in July 2007. The July 2007 Regulation changes also saw introduction of annual reporting of NLRDs to the Regulator. NLRDs assessed by IBCs during 2007–08 were received in the OGTR during 2008–09, hence the low number received in 2007–08. Likewise, the NLRDs assessed by IBCs in 2008–09 were received in the OGTR during 2009–10.

Table 12: Trend data for main types of applications, 2006–07 to 2009–10

Application type 2009–10 2008–09 2007–08 2006–07

Accreditation 8 6 8 11

Certification 182 242 230 125

DIR licence 8 13 5 10

DNIR licence 18 14 19 17

NLRD notification 629 533 19 366

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

Monitoring and inspectionThe Regulator’s quarterly reports7 provide detailed information, on a quarter-by-quarter basis, of monitoring inspections the OGTR conducted. This section provides information on the range of inspection activities the OGTR conducted during 2009–10.

Inspections of DIR licencesThe OGTR strategy for conducting field trial monitoring draws on accumulated operational experience of compliance risk profiling.8

During 2009–10, 16 accredited organisations held the 55 DIR licences in force. Six licences were for commercial release of GMOs. These licences do not impose conditions that necessitate monitoring. Four were for disease–vaccine trials, and 45 were in force for limited and controlled trials of GM crop varieties. The OGTR inspected 21 of the 45 licences for limited and controlled trials of GM crop varieties. Each licence may contain a number of trial sites.

7 available from OGTR or at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/reports-1>.8 More detail can be obtained from the Monitoring Protocol at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/mc-protocols-1>.


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Overview of inspection activitiesThe OGTR’s operational objective is to monitor 20 per cent of all limited and controlled field trial locations annually. A further target within this operational benchmark is to inspect 5 per cent of all limited and controlled field trial sites during each quarter of the year. In 2009–10, the Monitoring Section exceeded the operational benchmark and either met or exceeded the quarterly objectives. At the beginning of 2009–10, 64 licensed field trial sites were operating, 18 of which were current, and 46 of which were subject to post-harvest monitoring conditions. The Monitoring Section inspected 34 sites during 2009–10, 16 current and 18 post-harvest monitoring sites representing 53 per cent of total sites, thereby exceeding the minimum target of 20 per cent of field trial sites each year (see Table 5, Chapter 2). A breakdown of the number and proportion of inspections is given in Table 13.

Table 13: Number and proportion of inspections performed in each quarter of 2009–10

Quarter No. and proportion of current sites inspected No. and proportion of PHM sites inspected

July–September 2009 6/18 (33%) 5/46 (11%)

October–December 2009 2/22 (9%) 5/40 (13%)

January–March 2010 4/28 (14%) 3/41 (7%)

April–June 2010 4/20(20%) 5/46 (11%)

Note: PHM = post-harvest monitoring

Trial typesThe licences in force authorised the limited and controlled release of a range of crop and plant types including GM barley, banana, canola, cotton, grapevine, Indian mustard, maize, papaya, perennial ryegrass, pineapple, sugarcane, tall fescue, torenia, wheat and white clover. Although licences were in force, planting has not occurred in all cases. Cotton was the most prevalent crop, collectively trialled at 24 sites. The OGTR performed 34 inspections of field trial sites across eight crop types during 2009–10 (see Table 14 and Figure 8).


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Table 14: Number of licensed DIR sites, by crop type/parent organism at beginning of 2009–10 and end of 2009–10; and number of inspections conducted during the period

Crop type/parent organismNo. of DIR trial sites at beginning of 2009–10

No. of DIR trial sites at end of 2009–10

No. of DIR trial sites inspected in 2009–10

Banana 2 2 2

Canola 8 11 3

Canola, Indian mustard* 3 3 0

Cotton 24 16 13

Grapevines 1 1 1

Indian mustard 3 1 1

Maize 1 1 0

Papaya 1 1 0

Perennial ryegrass/tall fescue* 1 1 0

Pineapple 3 3 0

Sugarcane 8 13 8

Torenia 2 1 0

Wheat 5 3 3

Wheat and barley* 1 3 3

White clover 1 2 0

Total 64 62 34

Notes: DIR = a dealing involving intentional release of a GMO into the environment. * 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 licence authorising single crop species.

Figure 8: Number of DIR field trial sites inspected in 2009–10, by crop type

Banana 2

Canola 3

Cotton 13

Grapevines 1

Indian Mustard 1

Sugarcane 8

Wheat 3

Wheat & Barley 3


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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 cease. 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 2009–10, and the transition of location status during the year.

Figure 9: Number of field trial sites at beginning of 2009–10 (left), transition of location status (centre), and number of field trial sites at end of 2009–10 (right)

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18 18

0 5 10 15 20

Planted 18

Current to PHM 18

Signed off/License conditions ceased 20

Note: PHM = post-harvest monitoring

Location by jurisdictionDuring 2009–10 the OGTR undertook 34 inspections in 64 field trial sites (see Table 15) across a number of states and territories. Queensland (22) and Victoria (19) 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 15: Number of field trial sites and OGTR inspections in 2009–10, by state and territory

JurisdictionNo. of field trial sites,

as at 1 July 2009No. of field trial sites inspected

during 2009–10

New South Wales 16 9

Victoria 19 7

Queensland 22 14

Western Australia 0 0

South Australia 5 1

Tasmania 0 0

Northern Territory 0 0

Australian Capital Territory 2 3

Total 64 34

Current PHM


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Figure 10: Location by local government area and field trial types during 2009–10


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The Monitoring Section performed inspections in four states and one territory (see Figure 11), reflecting the higher proportion of field trial sites in those states. Of the 25 local government areas where field trials took place in 2009–10, OGTR inspected trials in 15 (see Figure 12).

Figure 11: Number of field trial sites inspected in 2009–10, by state and territory

ACT, 3 9%

NSW, 9 26%

QLD, 14 41%

SA, 1 3%

VIC, 7 21%


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Figure 12: Field trial sites and locations inspected in 2009–10, by local government area


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Inspections of contained dealingsThe monitoring program also encompasses dealings conducted in contained facilities under DNIR licences, as 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 also cover the general work practices employed in handling DNIR and NLRDs.

At the end of 2009–10, 128 accredited organisations held 1,951 certification instruments for containment facilities. During the course of the year, certified facilities operated by 19 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 40 inspections across the range of facility types (see Table 16). Of the 54 higher-level containment facilities that had certification instruments in force at the beginning of 2009–10, 12 were inspected. This figure represented 22 per cent of higher-level containment facilities and exceeding the minimum target of inspecting 20 per cent of such facilities each year (see Table 5, Chapter 2).

In addition, 21 DNIR licences that were in force during the reporting period were monitored.

Table 16: Number of certification types at end of 2009–10 and inspections conducted during the period

Containment typePhysical containment level and facility type No. of certifications No. of inspections

Lower-level containment facilities PC1 Large grazing animal 35 0

PC1 Laboratory 3 0

PC1 Facility* 212 0

PC2 Animal 231 8

PC2 Aquatic organism 23 0

PC2 Constant temperature room 70 0

PC2 Arthropod 29 1

PC2 Laboratory 1,134 18

PC2 Plant 162 1

Higher-level containment facilities PC2 Large scale 17 1

PC3 Animal 4 2

PC3 Arthropod 2 0

PC3 Laboratory 26 6

PC4 Facility* 3 3

Total 1,951 40

Note: * ‘Facility’ is the official term used to describe the various laboratories covered by certification guidelines for all PC4 facility types and several PC1 facility types after amalgamation of several guidelines in 2007.


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Inspections by stateCertified facilities are located in each Australian state and territory (see Figure 13). In 2009–10, monitoring activities were carried out in each, except Tasmania and the Northern Territory (see 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 2009–10, by state and territory

ACT, 180 9%

NSW, 394 20%

NT, 14 1%

QLD, 318 16%

SA, 191 10%

TAS, 16 1%

VIC, 699 36%

WA, 139 7%

Figure 14: Number of certified facility inspections in 2009–10, by state and territory

NSW, 3 8%

QLD, 8 20%

SA, 6 15%

VIC, 17 42%

WA, 6 15%

Inspections by organisation typeOf the five OGTR categories of applicant organisation, universities held the greatest number of certifications during 2009–10 (see Figure 15). In 2009–10, monitoring activities were carried out in each category (see 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.


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Figure 15: Number of certified facilities as at 2009–10, by organisation type

Government, 297 15%



University, 1,009 51%

Company, 69 4%

Figure 16: Number of certified facility inspections in 2009–10, by organisation type

Government, 9 23%



University, 14 34%

Company, 4 10%

Compliance with the Gene Technology Act 2000During 2009–10, the regulated community demonstrated a high level of compliance with gene technology legislation (see Table 5, Chapter 2).

In conducting routine inspections, the OGTR found 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 Act 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.9

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.10

9 These incidents are discussed in the Regulator’s quarterly reports available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/reports-1>.10 The Protocol is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/mc-protocols-1>.


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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 Act.

Non-compliancesFour findings of non-compliance were identified during monitoring of DIR licences during 2009–10. These non-compliances related to transport of material to an unapproved location, planting of unapproved crops, failure to destroy plant material according to licence conditions, incorrect transport procedures and contraventions of reporting requirements.

In addition, four 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, and failure to update contact details as required.

A number of minor non-compliances were also identified during routine monitoring of containment facilities (see Table 17). Non-compliances in such facilities were due to defects in structural components of facilities, defects and incorrect maintenance and operation of equipment and incorrect transport procedures.

Table 17: Number of non-compliances identified in certified facilities during 2009–10, by non-compliance type

Nature of non-compliance No. of non-compliances

Equipment 7

Personal protective equipment 1

Structure 11

Transport 2

Waste disposal 3

Work practices 22

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 be chosen for a given issue or incident. The OGTR Compliance and Investigation Section assesses and manages contraventions of the Act 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


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• contribution of feedback towards 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.11 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 2009–10, the OGTR undertook a number of investigations, audits and practice reviews. They are discussed below.

InvestigationsDuring 2009–10, three cases of non-compliances (alleged breaches) with the gene technology legislation required formal investigation; all were investigated within the 10 working day target (see Table 2, Chapter 5). The Queensland Institute of Medical Research made one self-report about a possible non-compliance occurring in relation to an NLRD. Details about this investigation were provided in the 1 October to 31 December 2009 Quarterly Report to Parliament. The other two were investigated and found to be unsubstantiated.

An allegation was made that do-it-yourself biological researchers were conducting dealings under the Act. While no evidence was found to support the allegation at that time, a number of people with a possible interest in do-it-yourself biological research were identified. These parties were advised about the compliance requirements related to dealings with GMOs. Additionally, the OGTR has provided compliance advice for such researchers on the OGTR Monitoring and Compliance website page.

The Biosecurity Service Group (BSG) of the Department of Agriculture, Fisheries and Forestry (now incorporating the Australian Quarantine and Inspection Service) refers any possible importations of suspected GM ornamental fish to the OGTR for assessment. No offence applies where the importation of a GMO is not intended, and where the importation is terminated during the importation through voluntary surrender of the organisms for humane destruction. Where necessary, the OGTR provides biological testing to determine the GMO status of these imports. During 2009–10, importers voluntarily surrendered all imports found to be genetically modified to BSG for humane destruction. A small number of importers voluntarily surrendered imports to BSG for destruction without testing.

AuditsThree audits were conducted in 2009–10. The audited parties were Cargill Australia Pty Ltd, Imugene Pty Ltd and Flinders University. The audits confirmed that the audited parties’ compliance management arrangements were adequate to support compliance under the national regulatory system. In each case, the audit team proposed a number of compliance performance risk management techniques to be considered as part of ongoing improvement. As part of these audits, the audited parties also contributed to the 2009–10 People Management Practice Review discussed below.

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


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Practice reviewsA People Management Practice Review was conducted to assess the policies, instructions, procedures and corporate culture of organisations in relation to people management risks to compliance under the Act. The review team proposed adoption of a number of compliance risk management techniques to be considered as part of ongoing improvement.

An Equipment Practice Review has commenced into the efficacy of key equipment. It will be completed in 2010–11, and aims to assess the adequacy of the supply, use and maintenance of equipment for regulatory compliance purposes and to inform ongoing development of regulatory specifications.

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;12 the Department of Foreign Affairs and Trade; the Department of Education, Science and Training;13 the Department of Industry, Tourism and Resources;14 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 (see Table 18) 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 2010, the OGTR commenced quality assurance reviews of Australian and state government breeding programs. The breeding programs of the Tasmanian Department of Primary Industries, Parks, Water and Environment; the Victorian Department of Primary Industries; and the CSIRO’s Plant Industry Division were assessed and no issues of concern were identified.

12 now the Department of the environment, water, heritage and the arts.13 now the Department of education, employment and workplace Relations.14 now the Department of innovation, industry, Science and Research.


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Table 18: 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 BSG (formerly 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 Department of the Environment, Water, Heritage and the Arts, 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 develop an incident response plan.

Notes: AQIS = Australian Quarantine and Inspection Service; BSG = Biosecurity Service Group; GMO = genetically modified organism; OGTR = Office of the Gene Technology Regulator.

Consultation with stakeholdersThe Regulator’s functions, as prescribed by section 27 of the Act, 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.


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Regulator’s review of Gene Technology Regulations 2001In order to advise GTMC about possible amendments to legislation, the Regulator initiated a technical review of the Gene Technology Regulations 2001 in 2008–09, which was progressed during 2009–10. The scope of the review was limited to issues that do not affect the policy settings of the regulatory scheme and that are consistent with achieving the object of the Act, with a primary focus on classification of GMO dealings in the exempt and notifiable low risk dealing (NLRD) categories. Proposals for amendment were developed based on operational experience of the office and a targeted stakeholder consultation undertaken in 2008–09.

GTMC provided policy approval for drafting amendments in May 2009. The Regulator sought advice from GTTAC in October 2009 on risk assessments prepared in respect of proposals for reclassification of dealings. The Office of Legislative Drafting and Publishing subsequently prepared the Draft Gene Technology Amendment Regulations 2010 based on instructions from the Regulator. The proposed changes are intended to ensure that dealings with GMOs continue to be classified appropriately according to current understanding of risks they may pose; improve the efficiency and effectiveness of the system; and help users better understand and comply with their legislative obligations. It is expected that the net effect of the proposed changes will be to reduce the regulatory burden on organisations undertaking dealings with GMOs.

In May–June 2010, in accordance with the requirements of section 142 of the Act, the Regulator undertook public consultations on the draft Gene Technology Amendment Regulations 2010. The consultation was supported by comprehensive papers explaining the rationale and intended operation of proposed changes in five key areas of amendment; specifically, classification of exempt and notifiable low risk dealings (NLRDs), classification of dealings with viral vectors, oversight of NLRDs, and administrative changes.

Advice was sought from a wide range of stakeholders including all regulated organisations and IBCs, state and territory governments, Australian Government agencies, GTTAC, and the general public. A range of stakeholders contributed 32 submissions; most indicated broad support for the proposed changes. A number of technical and other issues have been raised that will be taken into account in finalising the amendment regulations. Pending agreement of the GTMC, it is anticipated that the amendments will be made by mid 2010–11 and take effect by the end of 2010–11.

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 and inspection activities commenced from early 2009–10.


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Operational policiesOperational policies provide information to stakeholders on the Regulator’s approach to specific issues and activities under the Act. During 2008–09 the OGTR revised the operational policies on variation of GMO licences (to clarify the Regulator’s approach to variations to these legislative instruments) and on post-harvest crops.15

Revised GuidelinesDuring 2009–10, the OGTR completed revision of the Guidelines for the Certification of a PC3 Animal Facility after consultation with relevant stakeholders.

Revised certification guidelines issued from 2006 have been restructured to provide greater clarity about requirements to be met before certification and conditions that apply after certification. Overall, the revised guidelines adopt an outcome-oriented approach that focuses specifically on containment of GMOs. Where appropriate, the guidelines are also consistent with the requirements of Standards Australia and BSG (formerly AQIS).

Advice to the Gene Technology Ministerial CouncilThe GTMC did not meet in 2009–10. The Gene Technology Standing Committee (GTSC) supports the GTMC. During 2009–10 the OGTR:

• provided an update to the GTSC on the Regulator’s current operations

• obtained endorsement from the GTSC for the nomination and consultation process to be followed for selection of members for the gene technology advisory committees (GTTAC and GTECCC).

Nomination process for reappointment of gene technology advisory committeesThe Act provides that the term of appointment for members of the two statutory advisory committees – GTTAC and GTECCC – is for up to three years and the Minister makes the appointments. In 2009–10, the process for nomination, selection and appointment of members for the next triennium of GTTAC and GTECCC was endorsed by the GTSC with the OGTR providing secretariat support. A call for nominations was placed in newspapers, on the OGTR website, and circulated to some 400 organisations and individuals in April 2010. Nominations closed on 31 May 2010. It is anticipated that new appointments will be made by mid 2010–11.

Review of National Framework for the Development of Ethical Principles in Gene TechnologyThe National Framework for the Development of Ethical Principles in Gene Technology (the framework) was published in 2006 and was developed by the former Gene Technology Ethics Committee and published to provide a resource to inform and facilitate consideration of ethical issues in decision making at all levels of gene technology activity. The framework provides the Australian community, and particularly scientists working in gene technology, with a national reference point for ethical considerations.

15 OGTR operational policies are available at <www.ogtr.gov.au>.


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GTECCC is currently reviewing the framework. ORIMA Research Pty Ltd was commissioned to undertake an online survey in March–April 2010 to obtain stakeholders; views to inform the review. The survey was open to the public via a notice on the OGTR website. Input was also sought by direct invitation from stakeholders including:

• accredited organisations regulated under the Act and related arrangements

• relevant Commonwealth and state and territory government agencies

• ethics organisations

• university biotechnology departments

• registered clients on the OGTR Client Register.

GTECCC is incorporating the information obtained from survey responses and analysis undertaken by ORIMA Research in its review of the framework. Comments received confirmed that respondents considered the framework a useful source of guidance.16

Advice on GMOs and GM productsDuring 2009–10 the OGTR provided advice on GMOs and GM products to other regulatory agencies and to the public.

Advice to other regulatory agenciesThe OGTR has memoranda of understanding with the Australian Pesticides and Veterinary Medicines Authority, Food Standards Australia New Zealand and the Therapeutic Goods Administration. These facilitate reciprocal exchange of information on assessment and approval of GMOs and GM products required by their respective legislation.17

The OGTR also has a memorandum of understanding with the Department of the Environment, Water, Heritage and the Arts, in relation to consultation with the Environment Minister on DIR licence applications prescribed under the Act.

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 November 2009 and again in May 2010 discussing a work program for enhancing overall regulatory effectiveness through improved cross-agency collaboration.

Advice to the publicThe Act requires the Regulator to maintain a record of approved 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 2009–10 to incorporate approvals of GMOs under the Act and GM product approvals notified to the Regulator by other agencies (see Appendix 8).18

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. Details of use and statistics are provided in Appendix 8.

16 The framework is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/commpub-1>.17 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>.18 The GMO Record can be viewed through the OGTR website at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/gmoregister-1>.


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The OGTR also has a 1800 free call number (1800 181 030) and an OGTR 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, 102 emails and 108 free calls were received each month in 2009–10 (126 emails and 109 free calls in 2008–09; see 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 2009–10, 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 (see Appendix 7).

International regulatory liaisonUnder section 27 of the Act, 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 development in GMO regulation, based on the Australian experience, and helps ensure Australia’s regulatory scheme takes account of the best international practice. The Regulator and the OGTR have established a significant international presence and feedback from meetings indicates that the Australian system is considered a good model for gene technology regulation.

During 2009–10, senior OGTR officials presented papers at a number of international forums about aspects of Australia’s gene technology regulatory system. This included a presentation at the Canadian Food Inspection Agency symposium ‘Getting ready for tomorrow: Integrating foresight and emerging trends into timely science advice for plant risk assessments’.

The OGTR continued to interact directly with key regulatory counterparts in many other countries through bilateral discussions and participation in international forums in 2009–10. In particular, the OGTR participated in the OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology (WGHROB), providing input to a number of documents being prepared by the group. In addition, in October 2009 the WGHROB agreed to OGTR proposals to develop two consensus documents on the biology of Eucalyptus spp. and sugarcane respectively. OGTR is currently coordinating development of these documents.

The OGTR provides expert advice to the Department of Foreign Affairs and Trade on the Australian regulatory system for GMOs in relation to relevant international treaties. During 2009–10, OGTR officers participated in online conferences on risk assessment and risk management of living modified organisms under the United Nations Cartagena Protocol on Biosafety (the Biosafety Protocol) and an OGTR officer participated in a meeting of the Ad Hoc Technical Experts Group on Risk Assessment and Risk Management under the Biosafety Protocol held in October 2009 in The Hague, Netherlands, and via teleconference, in April 2010 in Ljubljana, Slovenia.

A full list of OGTR activities at international meetings, forums and conferences is in Appendix 6.


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Other functions of the Gene Technology RegulatorThe Act 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 Act 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.

Harmonisation relating to GMOs and GM productsThe OGTR is represented on the subcommittee for revision of Australian/New Zealand Standard Safety in Laboratories, Part 3: Microbiological aspects and containment facilities to provide expertise in relation to these requirements. Involvement in this subcommittee contributes to harmonisation of OGTR requirements for physical containment facilities with those of other national agencies, such as BSG and more broadly with those organisations complying with Standards Australia.

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ManaGeMenT anD accOunTaBiLiTy 4

4 Management and accountability

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4. Management and accountabilityThe 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 resourcesThe OGTR has a workforce of 56 employees that includes 12 part-time staff. Of these, 54 were ongoing employees and two were non-ongoing employees (see Appendix 4).

OGTR staff are covered by the Department of Health and Ageing’s Collective Agreement 5 2007–11, which was made under section 328 of the Workplace Relations Act 1996. Collective Agreement 5 is designed to ensure OGTR has a tailored employment framework that promotes innovation and flexibility, and supports staff in achieving OGTR’s corporate and business goals. It has been developed to build on the significant cultural changes initiated under previous certified agreements.

The objectives of Collective Agreement 5 are to:

• deliver a flexible and competitive employment framework

• maintain a strong commitment to staff health, safety and wellbeing

• foster an environment of quality, high performing and innovative individuals and teams

• build and support effective systems and a diverse and skilled workforce to enable successful delivery of Australian Government priorities

• support the Departmental Corporate Plan and values.

The OGTR continued to build a strong team culture in its ninth 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’

• National Breast Cancer Foundation

• Ovarian Cancer Australia

• The Salvation Army – Red Shield Appeal

• The Movember Foundation.

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 that recruitment was conducted in a timely manner.

Staff undertook 227 days (217 days in 2008–09 and 213 days in 2007–08) of formal training during the year, in addition to orientation and induction training for all new starters.

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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 2009–10 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 Collective Agreement 5.

The OGTR also organised on-site training on ‘Decision Making in Action APS’. The course is designed to guide participants through a typical day in the department, where teams of participants work through a range of issues, making decisions and exercising judgement in accordance with the legislation, policies and guidelines that dictate how we work. Staff also received group training in organisational skills and time management for improved personal efficiency.

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 currently 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 (see 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 safetyOccupational health and safety inspections were undertaken at the OGTR’s premises in Barton during 2009–10 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. Monitoring and compliance staff, who are often required to travel to rural and remote locations, were also provided with defensive driver training. 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 informationThe OGTR is 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 OGTR is also required to comment on arrangements for public participation in the formulation of policy, the categories of documents that are held by the OGTR, and how the public can access these documents.


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Decision-making powersThe Regulator exercised decision-making powers under the Gene Technology Act 2000 and the corresponding state and territory laws.19

No requests for access were received during the reporting period.

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 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 2009–10:

• 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

• documents prepared for the Executive Council

• documents relating to development of, and explanatory memoranda to the Acts, Regulations and other legislative instruments

• 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

• instruments of appointment

• ministerial and departmental responses to correspondence and parliamentary questions

• interdepartmental and general correspondence and papers

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

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

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

• 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

• correspondence with non-government parties

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

• financial reports, expenditure estimates and expenditure reports

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

• statistics and databases

• documents prepared by international agencies

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

• documents submitted by third parties

• OGTR publications and occasional papers

19 See <www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/legislation-2>.


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• training materials

• media releases

• committee records

• mailing lists.

In addition, a large number of OGTR publications were available free of charge to the public. A list of these publications can be accessed 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 2010, is available on request from the Freedom of Information Coordinator or any office of the National Archives of Australia.

Freedom of information procedures A request for access to documents under the Freedom of Information Act 1982 must be made in writing and be accompanied by a $30 application fee and an address in Australia to which notices can be sent. In certain circumstances the fee is not required or can be remitted. To enable a prompt response and to help the OGTR to 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. Applicants may be liable to pay charges at rates prescribed by the Freedom of Information (Fees and Charges) Regulations.

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]>. However, as an application fee must accompany requests, in most cases no action will be taken until the application fee is received or a request has been made for the remission of the application fee.

No freedom of information requests were received during the reporting period.


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PurchasingIn 2009–10 the OGTR complied with the Australian Government’s purchasing policies as articulated in the Commonwealth Procurement Guidelines.

Assets managementThe OGTR applies a whole-of-life asset management strategy, which is consistent with the Department’s asset management program. In May 2010 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 contractsNo exempt contracts were awarded in 2009–10.

ConsultanciesThe OGTR did not engage any consultants in 2009–10.

Advertising and market researchThe OGTR incurred $83,032 in advertising costs during 2009–10 ($48,580 in 2008–09) primarily to invite the public to comment on risk assessment and risk management plans for DIR licence applications (see Table 19).

Table 19: Media advertising organisations engaged, 2009–10

Organisation Service provided Amount paid

2009–10 2008–09

ADCORP Australia Ltd Placing advertisements regarding regulatory activities $46,369 $32,483

ADCORP Australia Ltd Placing advertisements for recruitment of staff $36,663 $16,097

Total $83,032 $48,580

Note: Amounts listed are inclusive of GST

Annual reporting requirementsSection 136 of the Act 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 2008–09 was tabled in Parliament on 23 October 2009.20

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


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Quarterly reporting requirementsSection 136A(2) of the Act 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 Act by the Regulator or an inspector during the quarter.

Quarterly reports the OGTR published in 2009–10 are listed in Appendix 5.21

Commonwealth Disability StrategyThe OGTR continues to be committed to the principles of the Commonwealth Disability Strategy.

In its employer role, OGTR’s employment policies, procedures and practices comply with the requirements of the Disability Discrimination Act 1992. Recruitment information is available in electronic formats and OGTR encourages and welcomes applications from people with a disability. OGTR continues to make the organisation accessible to people with disabilities by:

• advertising all vacancies in alternative media and on the Internet

• allowing potential applicants to apply for positions using email

• ensuring applicants short-listed for interview have an opportunity to indicate any needs they may have.

In 2009–10 the OGTR regularly updated its website with information on its regulatory functions and activities. This included licences issued, RARMPs prepared for applications to release GMOs into the environment, quarterly and annual reports, legislative amendments and revised guidelines. The OGTR also maintained a free call 1800 number to respond to enquiries. Callers to this number were able to access hard copies of all publicly available material.

The OGTR website <www.ogtr.gov.au> contains public information about the Scheme and meets the Government Online minimum standards with regard to accessible formats for people with disabilities.

Ecologically sustainable developmentThe OGTR supports the Australian Government’s commitment to ecologically sustainable development principles and reports here on its operations during 2009–10 against section 516A of the Environment Protection and Biodiversity Conservation Act 1999.

The OGTR has reduced its level of waste production by introducing a secure GovDex website for providing information to all members of the two Gene Technology Advisory Committees. This has significantly reduced the amount of paper waste produced by removing the need to print copies of all documents for all committee members. Meeting papers, information documents and relevant updates are all provided to members electronically via the GovDex website.

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.

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Section 516A(6)(a): Legislation administered by the Regulator during 2009–10 which accords with ecologically sustainable development principlesThe Regulator administers the Act, 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.

Section 516(6)(b): How the OGTR outcomes have contributed to ecologically sustainable development during 2009–10In 2009–10, 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 2009–10, the Regulator received 35 licence applications; 10 were for DIRs and 25 were for DNIRs. In addition, the Regulator issued 26 licences to deal with GMOs, comprising eight DIRs and 18 DNIRs (see Chapter 4).

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


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aPPenDicieS 5

5 appendices

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Appendix 1 History and structure of the gene technology regulatory system

This Appendix provides a brief description of development of the Act, 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 Act and the 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. There was 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. 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 Act 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 Act 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, the Regulator, who is charged with performing functions and exercising powers under the Act (see 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 legislation or result in duplication. Hence, the Act incorporates a requirement for the Regulator to consult other prescribed agencies identified in the Regulations on DIR applications. The Act was accompanied by consequential amendments of the other relevant Acts relating to requirements for mutual consultation and exchange of information regarding their assessments and

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approvals. Accordingly, where other agencies approve GM products22 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; BSG = Biosecurity Services Group, Department of Agriculture, Fisheries and Forestry (now incorporates AQIS); 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.

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

Technical Regulatory Consultation

Prov

ide

advi

ce a

t the

requ

est o

f the

M

inis

teria

l Cou

ncil

or th

e Re

gula

tor

Public

INTeRGOveRNMeNTAL AGReeMeNT GeNe TeCHNOLOGy ACTS

GeNe TeCHNOLOGy MINISTeRIAL COUNCIL

GeNe TeCHNOLOGy STANDING COMMITTee

States and territories

Regulated community

GTTAC

GTeCCC

environment Minister TGA FSANZ APvMA NICNAS BSG Local councils

GeNe TeCHNOLOGy ReGULATOR

Office of the Gene Technology

Regulator

Governance

Consultation

Advice

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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 Act. In addition, the GTMC approves appointment of the Regulator and the Chairs of the statutory advisory committees (see below) and provides advice to the Australian Government Minister for Health and Ageing on appointment of committee members.

The Act 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 Act, and developing policy relating to the Act 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 Act proposed by the Superannuation Legislation (Consequential Amendments and Transitional Provisions) Bill 2010.

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 Act and Regulations have been amended to:

• Improve the effectiveness of the Regulations and clarify some provisions. These amendments were made as a result of the 2004–06 Regulator’s review of the Gene Technology Regulations (Gene Technology Amendment Regulations 2006).

• Improve the operation of the Act at the margins. These generally minor amendments included addition of emergency powers to the Act, which give the Minister the ability to expedite approval of a GMO in emergencies. These amendments were made as a result of the 2006–07 Statutory Review of the Act 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 Act to be appointed as inspectors under Division 7 of Part 3 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 approval of particular dealings 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.

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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 20.

Table 20: 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

Health and Ageing The Regulator, supported by the OGTR administors 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 and New Zealand

Health and Ageing FSANZ is responsible for the Australia New Zealand Food Standards Code (the Code) that prohibits the 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 of 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 BSG Biosecurity Services Group

Agriculture, Fisheries and Forestry

BSG (formerly 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

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Appendix 2 Types of applications, authorisations, monitoring and compliance

This appendix outlines the classes of dealings with GMOs that are defined by the Act, 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 Act. The Regulator may make a determination to include dealings with GMOs on the GMO Register23 according to section 78 of the Act. 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 negligible24 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, nor code for a toxin).

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 Part 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

23 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.

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

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properly classified as NLRDs and that personnel have the appropriate training or experience. Organisations must keep a record of all current NLRDs and include them in an annual report to the Regulator. NLRDs are included on the Record of GMO and GM Product Dealings (see below) 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 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 Act 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. Both also require the organisation’s IBC to support the application.

The Act 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 release 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 Act is a criminal offence.

For both DNIR and DIR applications, the applicant must provide information specified in the Act 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 Act 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 2009–10.25

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

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Dealings not involving intentional releaseDNIRs usually take place under specified physical containment conditions in certified facilities, which minimise risks to the environment. The Act 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.

As a guide to the legislative requirements, the process required in respect of DNIR applications is described in Figure 18.

Figure 18: DNIR assessment process

YES

YES

YES

NO

NO

NO

Sufficient information?

Prepare consultation RARMP

Consultation?

Finalise RARMP

Can the risks be managed to protect people and the environment?

Finalise license conditions

APPLICATION FOR DIR LICeNCe

Consultation

ISSUe LICeNCe ReFUSe TO ISSUe LICeNCe

ReJeCT APPLICATION

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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 Act for processing the application.

This Risk Analysis Framework outlines the approach taken to risk analysis and preparing RARMPs. As a guide to the legislative and administrative requirements, the eight-stage process adopted in respect of DIR applications is shown in Figure 19 and is described below.

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 Regulator’s information requirements are set out in detail on the application form. The applicant must ensure all responses 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 Act 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 Act 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 Act 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.

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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 Act 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 Act).

Stage 5 – The Regulator must seek advice on the application regarding matters relevant to preparation of the RARMP, under section 50 of the Act, 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 step is not required.

Stage 6 – Section 51 of the Act 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 Act.

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.

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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 Act 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 persons and organisations that have registered their interest in receiving such information on the OGTR mailing lists. Under section 52(3) of the Act the Regulator must also seek advice on the RARMP from the expert groups, agencies and authorities mentioned above (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 then 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 Act. The Regulator then 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.

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Figure 19: DIR eight-stage assessment process

YES

YES

YES

YES

NO

NO

NO

NO

Sufficient information?

Prepare consultation RARMP

Do the dealings pose a significant risk?

Is the release limited & controlled?

Finalise RARMP

Can the risks be managed to protect people and the environment?

Finalise licence conditions

ReJeCT APPLICATION

ISSUe LICeNCe ReFUSe TO ISSUe LICeNCe

APPLICATION FOR DIR LICeNCe

Consultation minimum 50 working days

Consultation minimum 30 working days

Seek advice

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Inadvertent dealingsPart 5 of the Act 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 as 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 Act 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 Act requires the Regulator to maintain a record of approved GMOs and GM product dealings. 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.26

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.

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

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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, and 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.27

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 Act, bearing in mind that non-compliance with conditions placed on licences issued under the Act 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).

27 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>.

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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 Act.

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 Act, 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 Act 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.

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Appendix 3 Membership of statutory committees and attendance at 2009–10 meetings

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

• Gene Technology Technical Advisory Committee (GTTAC)

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

The then Parliamentary Secretary to the Minister for Health and Ageing, Senator the Hon Jan McLucas, made appointments to the two gene technology advisory committees in January 2008 for a three-year term ending January 2011. Senator McLucas also appointed a toxicologist to GTTAC in November 2008.

Gene Technology Technical Advisory CommitteeGTTAC’s functions, as set out in section 101 of the Act, are to provide scientific and technical advice, on the request of the Regulator or the Ministerial Council, on gene technology, GMOs, GM products, applications made under the Act, 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 2009–10 (see Table 21).

Table 21: Attendance at GTTAC meetings during 2009–10

Meeting date No. of GTTAC members in attendancea

14 October 2009 17

10 May 2010 15

Note: a includes the expert adviser

In addition, GTTAC members were consulted on three other occasions through provision of out-of-session packages for comment.

Chair of GTTACProf John Rasko, BSc (Med), MBBS (Hons), PhD, FRCPA, FRACP, Professor, Faculty of Medicine, University of Sydney: has relevant skills and experience in molecular biology, virology, risk assessment, clinical medicine, biochemistry, animal biology and immunology. He is Director of the Cell and Molecular Therapy Unit, Royal Prince Alfred Hospital, and Head of the Gene and Stem Cell Therapy Program, Centenary Institute of Cancer Medicine and Cell Biology. Since 2002 he has been a member of the National Health and Medical Research Council (NHMRC) and Cancer Council Grant Review Panels, and a leading member of the Leukaemia Foundation of New South Wales Medical and Scientific Advisory Committee. He has been a member of GTTAC since 2002.

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Members of GTTAC

Table 22: Members of GTTAC, as at 30 June 2010

Dr Lesley Ashton Group Leader, Molecular Epidemiology Group, Children’s Cancer Institute Australia. Cross member with GTECCC (New South Wales)

Professor Robert Birch Professor of Plant Molecular Biology, School of Life Sciences, University of Queensland (Queensland)

Mr Richard Davies Managing Director, CEO Partnerships (Victoria)

Professor Peter Gresshoff Director, ARC Centre of Excellence for Integrative Legume Research, University of Queensland (Queensland)

Dr Richard Groves Honorary Research Fellow, CSIRO Plant Industry (Australian Capital Territory)

Professor Geoff Gurr Professor of Applied Ecology, Charles Sturt University (New South Wales)

Dr Jay Hetzel Managing Director, Byron Cattle Pty Ltd (New South Wales)

Associate Professor Gordon Howarth Cancer Council South Australia Research Fellow, School of Agriculture, Food and Wine, University of Adelaide; Senior Research Scientist, Women’s and Children’s Hospital (South Australia)

Dr John Manners Assistant Chief, CSIRO Plant Industry (Queensland)

Professor Oliver Mayo Research Fellow, CSIRO Division of Livestock Industries (South Australia)

Mrs Pam Moore Past State Agricultural Environmental Officer, Country Women’s Association of NSW. Layperson appointed under section 100(6) of the Act (New South Wales)

Dr Robert Moore Project Leader, Australian Animal Health Laboratory, CSIRO (Victoria)

Professor Stephen Powles (Expert Adviser) Research Director, Western Australia Herbicide Resistance Initiative, University of Western Australia. Expert Adviser on GTTAC (Western Australia)

Professor Brian Priestly Director, Australian Centre for Human Health Risk Assessment, Department of Epidemiology and Preventive Medicine, Monash University, School of Public Health and Preventive Medicine, The Alfred Hospital (Victoria)

Dr Paul Reddell Chief Scientific Officer, EcoBiotics Ltd (Queensland)

Dr Nancy Schellhorn Research Scientist/Team Leader Spatial Ecology, CSIRO Division of Entomology (Queensland)

Dr Jason Smythe Chief Scientific Officer, Benitec Limited (Victoria)

Associate Professor Paul Young Reader/Group Leader, University of Queensland (Queensland)

Dr Peter Young Managing Director, Q-Vax Pty Ltd (Queensland)

Gene Technology Ethics and Community Consultative CommitteeGTECCC’s functions are set out in section 107 of the Act. 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 Act, 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 once during 2009–10 (see Table 23).28

28 More information about the work of GTeccc is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/gteccc-2n>.

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Table 23: Attendance at GTECCC meetings during 2009–10

Meeting date No. of GTeCCC members in attendance

18 February 2010 9

In addition, GTECCC members were consulted on one other occasion through provision of an out-of-session package for comment.

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: Professor Chalmers 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 ARC grants to research legal and ethical implications of developments in genetics. Since 1999 he has chaired the 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 NHMRC Licensing Committee since 2003, and a member of the NHMRC Human Genetics Advisory Committee from 2006.

Professor Chalmers was also Chair of the former GTEC and GTCCC.

Members of GTECCC

Table 24: Members of GTECCC, as at 30 June 2010

Associate Professor Rachel Ankeny Senior Lecturer, School of History and Politics, University of Adelaide (South Australia)

Dr Lesley Ashton Group Leader, Molecular Epidemiology Group, Children’s Cancer Institute Australia. Cross member with GTTAC (New South Wales)

Mrs Jill Boehm OAM Director, Cancer Institute NSW and Cancer Council NSW (New South Wales)

Reverend Dr John Fleming President, Campion College Australia (New South Wales)

Mr Eric Lockett Research Forester, Community Representative (Tasmania)

Ms Gayle McNaught National Public Relations and Media Manager, Juvenile Diabetes Research Foundation (New South Wales)

Ms Toni Meek Manager Community Engagement, Yarra Valley Water (Victoria)

Dr Vaughan Monamy Course Coordinator/Senior Lecturer, Environmental Science Program, School of Arts and Sciences, Australian Catholic University (New South Wales)

Ms Roma O’Callaghan Manager People and Organisation Development and Acting Manager Governance, Yarra City Council (Victoria)

Mr Bob Phelps Executive Director, Gene Ethics Network (Victoria)

Dr Nikolajs Zeps Research Manager, Radiation Oncology, Sir Charles Gairdner Hospital. Cross member with the National Health and Medical Research Council’s (NHMRC’s) Australian Health Ethics Committee (Western Australia)

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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.29

29 More information is available at <www.remtribunal.gov.au/determinationsReports/byyear/2008/2008-07Determination.pdf>.

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Appendix 4 Staff profile and training and development activities

At 30 June 2010, the OGTR employed 56 staff (see Table 25). Of these, 54 were ongoing APS employees, two were non-ongoing employees and two officers were on maternity leave. This equates to 51 full-time equivalent staff at 30 June 2010.

Staff membership of equal employment opportunity groups has changed little since the last reporting period except that four more women were employed (58% compared to 52% in 2008–09: see Table 26).

Table 25: OGTR staffing profile, at 30 June 2010

Classification of officers

Male Female Total

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

Statutory Office Holder 1 – – – 1

Senior Executive Service 2 – 1 – 3

Legal Officer Level 2 1 – – – 1

Executive Level 2 6 – 2 – 8

Executive Level 1 8 – 6 3 17

APS Level 5–6 5 – 11 7 23

APS Level 1–4 – – 1 2 3

Total as 30 June 2010 23 – 21 12 56

Total as 30 June 2009 25 2 19 8 54

Total at 30 June 2008 21 1 20 11 51

Table 26: Membership of equal employment opportunity groups, 2009 and 2010

equal employment opportunity group

2010 2009

No. % No. %

Women 32 58 28 52

Aboriginal and Torres Strait Islander staff 0 – 0 –

Non-English speaking background 9 16 9 17

Staff with disabilities 0 – 0 –

Performance pay

Most performance payments made in 2009–10 related to assessments for the 2008–09 cycle. Due to the small numbers of staff at the SES Band 1 level, details for SES Band 1 and non-SES staff have been combined (see Table 27). Payments have been aggregated to preserve employees’ privacy. The OGTR makes performance bonus payments available to staff working under a current Australian Workplace Agreement and under section 24(1) determinations which provides eligibility. As well, a range of non-salary benefits is afforded to non-SES staff employed under Collective Agreement 5 or current Australian Workplace Agreements (see Table 28).

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Table 27: SES and non-SES bonus payments, 1 July 2009 to 30 June 2010

Level Number

SES Band 1 and non-SES staff 8

Table 28: Non-salary benefits afforded non-SES staff employed under the Certified Agreement 5 or current Australian Workplace Agreement

Agreement Benefits

Collective Agreement 5 Access to the Employee Assistance Program

Extended purchased leave

Flextime

Study assistance

Support for professional and personal development

Award scheme

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

Access to negotiated discount registration or memberships fees to join a fitness or health club

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

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

Flexible working hours

Parental leave

Leave for compelling reasons and exceptional circumstances

Pay-out of additional duty in certain circumstances

Recognition of travel time

Australian Workplace Agreement All of the above benefits except flextime

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

Internal training presentationsDuring 2009–10, OGTR’s Legal Officer, Mr Alceo Turello, conducted introductory and ongoing training for OGTR staff on legal issues (see Table 29). The Science Cohort Section also conducted training on Risk Assessments (see Table 30).

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Table 29: Internal legal issue training presentations, 2009–10

Date Topic

June 2010 Accountability and Administrative Law

Review of the Gene Technology Act

April 2010 Providing advice

March 2010 Confidential Commercial Information for newcomers

Administrative Law Fundamentals

February 2010 The Gene Technology Act for newcomers

November 2009 The Sugar Beet Case

October 2009 The Gene Technology Regulations

September 2009 Stacking of GMOs

August 2009 Confidential Commercial Information and the Public Interest

July 2009 The ERMA case

Table 30: Internal risk assessment training presentations, 2009–10

Date Topic

July 2009 Advanced Risk Analysis – Are risk and safety assessments equivalent?

May 2009 Introduction to Risk Assessment

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 2009–10 (see Table 31).

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Table 31: Presentations at OGTR Forum, 2009–10

Month Topic Speaker

June 2010 Report on OECD meetings

Working Group on Harmonisation of Regulatory Oversight of Biotechnology

Taskforce for the Safety of Novel Foods and Feeds

Dr Peter Thygesen

Eucalyptus genomics Professor Zander Myburg, University of Pretoria, South Africa

Eucalyptus breeding/genetics in Brazil Professor Dario Grattapaglia, Catholic University of Brasilia, Brazil

Report on Managing Regulation, Enforcement and Compliance Workshop

Mr Andrew Radanovich

Report on Biotechnology Regulatory Workshop Dr Kylie Tattersall

Report on meetings with European regulators Dr Joe Smith

April 2010 Virus resistant GM maize, GM vaccines and biosafety issues: A South African perspective

Professor Ed Rybicki, University of Cape Town, South Africa

Report on risk assessment workshop, Vietnam Dr Michael Dornbusch, Dr Brian Weir

Risk communication and public perception Dr Janet Gough, Environmental Risk Management Authority, New Zealand

March 2010 Report on Canadian Food Inspection Agency Symposium: integrating foresight and emerging trends into timely scientific advice

Dr Paul Keese

December 2009 Report on Australian Centre for Plant Functional Genomics Salinity Symposium

Dr Alison Wardrop

Report on forth International Conference on coexistence between genetically modified and non-GM based agricultural supply chains

Mr Greg Barber, Mr Peter Wenzel, Dr Kylie Tattersall

Report on Biosecurity in the new Bioeconomy: threats and opportunities conference

Dr Joe Smith, Mr Will Tucker, Dr Meena Rajagopal Murthi, Dr José ten Have, Dr Heidi Mitchell

November 2009 Report on risk assessment workshop in Malaysia Dr Michael Dornbusch

Honeybees Doug Somerville, New South Wales Department of Primary Industries

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Appendix 5 Publications and guidance documentsAll 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 2009

Quarterly Report for the period 1 July 2009 – 30 September 2009

Quarterly Report for the period 1 October 2009 – 31 December 2009

Quarterly Report for the period 1 January 2010 – 31 March 2010

GuidelinesGuidelines for Certification of a Physical Containment Level 3 Animal Facility, Version 2.1

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Appendix 6 International meetings and forumsOGTR staff participate in various international meetings, forums and conferences for the purpose of ensuring that Australia’s gene technology regulatory system both keeps pace with and influences international best practice.

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

Table 32: Presentations and representations at international meetings and conferences, 2009–10

Date event/delegate Location

7–10 June 2010 OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology (WGHROB) and the OECD Task Force for the Safety of Novel Foods and FeedsDr Peter Thygesen

Paris, France

31 May – 4 June 2010 Australian delegation for 2010 Australia Group Plenary meetingDr Robyn Cleland

Paris, France

13 May 2010 Biotechnology Regulatory WorkshopDr Kylie Tattersall

Wellington, NZ

10–16 April 2010 Prepared and conducted a training workshop on risk analysis of GMOsDr Michael Dornbusch and Dr Brian Weir

Ha Long, Vietnam

6–11 December 2009 ComBio 2009 annual conferenceDr Louisa Matthew

Christchurch, NZ

6–10 February 2010 Canadian Food Inspection Agency international symposiumDr Paul Keese

Ottawa, Canada

6–9 December 2009 Risk Assessment Workshop on Transgenic TreesDr Kylie Tattersall

Malaysia

3–7 November 2009 Proposed and conducted a risk assessment workshop for members of the Malaysian Genetic Modification Advisory CommitteeDr Michael Dornbusch

Petaling Jaya, Malaysia

19–21 October 2009 23rd Session of the OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology (WGHROB)Dr Peter Thygesen

Paris, France

10–14 October 2009 Attended meeting of Ad Hoc Technical Expert Group on Risk Assessment and Risk Management under the UN Cartagena Biosafety ProtocolDr Paul Keese

The Hague, Netherlands

1–2 October 2009 International Conference on Knowledge Management in Agricultural Biotechnology: The Asian ExperienceDr Michael Dornbusch

Bangkok, Thailand

29–30 September 2009 Measures of Hope and Promises Delivered: An International Conference on Socioeconomic and Environmental Impact Assessment of Biotech CropsDr Michael Dornbusch

Bangkok, Thailand

17–18 September 2009 Meeting with German Federal Office for Consumer AffairsDr Joe Smith

Berlin, Germany

14–15 September 2009 European Food Safety Authority Conference on Risk Assessment of GMOs for Human Health and the EnvironmentDr Joe Smith

Brussels, Belgium

10–11 September 2009 Meeting with United Kingdom Advisory Committee on Releases to the Environment and Department of Environment, Food and Rural AffairsDr Joe Smith

London, England

5 appendices

82

Appendix 7 Presentations and meetings on gene technology in Australia

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

Table 33: Presentations and representations at national meetings and conferences, 2009–10

Date event/delegate Location

17 June 2010 Australian Association for Professional and Applied Ethics – The Ethical Challenges of New TechnologiesDr Fiona Murray, Ms Michelle Green

Sydney

11–14 May 2010 Australian Society of Sugar Cane Technologists 2010 ConferenceDr Heidi Mitchell

Bundaberg

2–7 May 2010 Australia New Zealand School of Government Workshop – Managing Regulation and ComplianceMr Andrew Radanovich

Melbourne

22–26 March 2010 Mega Biocontainment WorkshopDr Anuj Srivastava, Mr Greg Barber, Ms Rachel Walsh, Ms Maryanne Shoobridge, Dr Jeremy Turner

Perth

2 March 2010 Australian Bureau of Agricultural and Resource Economics – Outlook 2010Dr Fiona Murray

Canberra

17 February 2010 Future State: Business Intelligence and AnalyticsMr Ian Coleman

Canberra

19–21 November 2009 OECD/CSIRO Biosecurity in the new Bioeconomy – Threats and OpportunitiesDr Joe Smith, Mr Will Tucker, Dr Meena Rajagopal Murthi, Dr José ten Have, Dr Heidi Mitchell

Canberra

16–18 November 2009 The Genomics of Salinity ConferenceDr Alison Wardrop

Adelaide

12 November 2009 Food and the New Consumer 2009 ForumDr Joe Smith

Sydney

9–12 November 2009 Genetically Modified Crops Coexistence ConferenceMr Greg Barber, Mr Peter Wenzel, Dr Kylie Tattersall

Melbourne

16–18 October 2009 International Society for Cellular Therapy WorkshopDr Robyn Cleland

Adelaide

12 October 2009 Western Australia Department of Agriculture and Food Forum on GMOsDr Joe Smith

Perth

16–17 September 2009 Australasian Environmental Law Enforcements and Regulators Network ConferenceMr Andrew Radanovich, Mr Shaun Andrews, Mr Al Turello

Hobart

10–14 August 2009 14th Australian Plant Breeding and 11th Society for the Advancement of Breeding Research in Asia and Oceania ConferenceDr Michael Dornbusch, Dr José ten Have, Dr Brian Weir

Cairns

6–10 July 2009 Australian Society of Microbiology 2009 ConferenceMs Maryanne Shoobridge

Perth

appendices 5

83

Appendix 8 Stakeholder and public access to the OGTRThe 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 34 lists the successful hits on the OGTR website, the number of visitor sessions and their activity level on each day of the week, as well as most requested information sheets and website pages.

Table 34: Website activity, 2009–10 and 2008–09

Month Hits visits

2009–10 2008–09 2009–10 2008–09

July 194,433 1,263,457 25,822 18,536

August 191,850 273,922 32,869 53,600

September 195,675 1,801,587 34,346 39,433

October 214,000 201,156 39,892 20,019

November 136,268 184,453 24,264 17,474

December 119,106 179,223 24,912 13,004

January 182,882 194,327 34,912 14,285

February 165,524 195,632 30,844 16,153

March 203,861 213,065 36,471 18,517

April 173,099 188,652 31,066 18,158

May 209,244 226,639 31,710 24,980

June 199,472 202,830 23,495 23,437

Day of the week 2009–10 2008–09 2009–10 2008–09

Sunday 180,664 468,007 45,227 23,955

Monday 335,205 816,707 52,837 34,476

Tuesday 349,474 915,505 53,321 37,205

Wednesday 350,265 952,710 52,971 34,375

Thursday 352,692 798,830 52,229 34,066

Friday 382,848 752,082 51,653 34,864

Saturday 234,266 560,364 45,746 24,483

The most popular pages viewed on the OGTR website during 2009–10 were:

• What’s New

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

• List of Genetically Modified Product approvals

• About the OGTR

• Guidelines and forms for Certification of Physical Containment Facilities

• IBC and Accredited Organisations Information

5 appendices

84

• Application Assessment Process

• Review of the Gene Technology Regulations

• Publications and Legislation

• Reports

The most popular downloaded documents in 2009–10 were:

• The Biology and Ecology of Cotton (Gossypium hirsutum L.) in Australia

• The Biology and Ecology of Papaya (Carica papaya) in Australia

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

• PC2 Laboratory guidelines

• The Biology and Ecology of Pineapple (Ananas comosus var. comosus) in Australia

• The Biology and Ecology of Sugarcane (Saccharum spp.) in Australia

• The Biology of Hybrid Tea Rose (Rosa x hybrida)

• The Biology of Musa L. (banana) in Australia

• The Biology and Ecology of Dianthus caryophyllus L. (Carnation)

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 2009–10 compared to 2008–09 (see Table 35).

Table 35: Email and free call 1800 number activity, 2009–10 and 2008–09

Month emails 1800 number

2009–10 2008–09 2009–10 2008–09

July 105 130 105 123

August 76 108 102 126

September 99 123 131 135

October 125 120 136 89

November 92 133 146 111

December 60 139 99 79

January 117 123 60 87

February 91 118 89 84

March 128 142 99 121

April 112 93 101 132

May 118 129 113 108

June 107 159 112 107

Total 1,230 1,517 1,293 1,302

appendices 5

85

The Monitoring Section maintains an email inbox to facilitate efficient communication with accredited organisations. The inbox provides a central point for accredited organisations to 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 450 emails during 2009–10 (472 in 2008–09).

The Regulatory Practice and Secretariat Section maintains 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 854 emails during the 2009–10 (667 in 2008–09).

The Application and Licence Management Section created an email inbox in September 2007 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 1,640 emails during 2009–10 (2,562 in 2008–09).

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

86

GlossaryThe 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 Act

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 (now BSG)

BSG Biosecurity Services Group, Department of Agriculture, Fisheries and Forestry (now incorporates AQIS)

CCI Confidential commercial information declared under section 185 of the Act

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 Act 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

87

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 Cooperation 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 Act

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

WGHROB Working Group on Harmonisation of Regulatory Oversight in Biotechnology

WHO World Health Organization

88

Indexes

List of requirements

Part of report Description Page

Letter of transmittal iii

Table of contents vii

Index 91

Glossary 86

Contact officer(s) iv

Internet home page address and Internet address for report iv

Review by Secretary Review by departmental secretary 2-4

Summary of significant issues and developments 2-4

Overview of department’s performance and financial results 2-4

Outlook for following year 4

Significant issues and developments – portfolio 3

Departmental overview Overview description of department 6

Role and functions v, 7-9

Organisational structure 7

Outcome and program structure 10-13

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

10-13

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

10-13

Performance of purchaser/ provider arrangements n/a

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 18-47

Trend information 2

Significant changes in nature of principal functions/ services n/a

Factors, events or trends influencing departmental performance 11

Contribution of risk management in achieving objectives 17-26

Social justice and equity impacts n/a

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

83-85

Discussion and analysis of the department’s financial performance * 9

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

89


Report on performance 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

* n/a

Management accountability

50-56

Corporate governance Statement of the main corporate governance practices in place 6, 58-61

Names of the senior executive and their responsibilities 7-9

Senior management committees and their roles n/a

Corporate and operational planning and associated performance reporting and review

6-13

Approach adopted to identifying areas of significant financial or operational risk 6

Compliance with the Commonwealth Fraud Control Guidelines * 6

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

44

How nature and amount of remuneration for SES officers is determined * 76

External scrutiny Significant developments in external scrutiny 42-43

Judicial decisions and decisions of administrative tribunals 13

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

* 50-51

Workforce planning, staff turnover and retention *

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

50

Training and development undertaken and its impact 50-51

Occupational health and safety performance 51

Productivity gains n/a

Statistics on staffing 50, 76

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

50

Performance pay 76

Assets management Assessment of effectiveness of assets management 54

Purchasing Assessment of purchasing against core policies and principles 54

90


Consultants Summary statement detailing the number of new consultancy services contracts let during the year; the total actual expenditure on all new consultancy contracts let during the year (inclusive of GST); the number of ongoing consultancy contracts that were active in the reporting year; and the total actual expenditure in the reporting year on the ongoing consultancy contracts (inclusive of GST). Statement noting that information on contracts and consultancies is available through the AusTender website.

54

Australian National Audit Office access clauses

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

Exempt contracts Contracts exempt from AusTender 54

Commonwealth Disability Strategy

Report on performance in implementing the Commonwealth Disability Strategy 55

Financial statements Financial Statements * 9

Other information Occupational health and safety (section 74 of the Occupational Health and Safety Act 1991)

* 51

Freedom of Information (subsection 8(1) of the Freedom of Information Act 1982)

51-53

Advertising and Market Research (Section 311A of the Commonwealth Electoral Act 1918) and statement on advertising campaigns

54

Ecologically sustainable development and environmental performance (Section 516A of the Environment Protection and Biodiversity Conservation Act 1999)

55

Other Grant programs n/a

Correction of material errors in previous annual report n/a

List of requirements 88

Note: * refer to the Department of Health and Ageing 2009–10 Annual Report

91

Alphabetical index

Aabbreviations, 86–87Aboriginal and Torres Strait Islander staff, 76access to documents, 53accountability see management and

accountabilityaccreditation of organisations licensed to

conduct work with GMOs, 20, 70surrender of, 19

accredited organisations, 26–27advertising and market research, 54advice on GMOs and GM products, 45–46advice to the public, 45animal pathogens, 23annual reporting requirements, 54Application and Licence Management Section, 8applications and notifications, 19, 20applications for certification, 20appropriations see financial performanceassessments and approvals, 19–29assets management, 54audits, 6, 9, 40Australian National Audit Office, 9Australian Pesticides and Veterinary Medicines

Authority, 3, 45Australian Public Service Values and Code of

Conduct, v, 6Australian Quarantine and Inspection Service, 40Australian Seed Federation, 41Australian Workplace Agreements, 76, 77

Bbanana, 30barley, 21, 30biofuels, 21Biosafety Protocol, 46Biotechnology Australia, 41bonuses see performance paybreaches of Gene Technology Act 2000, 38breeding programs

quality assurance reviews of, 41Business Management, Communications and

Post Release Review Section, 8business management services, 6Business Risk Management Plan, 6

Ccancer, 23canola, 30cell function, 25cellular process, 25certification of containment facilities, 70

applications for, 20revised guidelines, 44surrender of, 19, 20trend data, 29variations, 21

certified physical containment facilities, 27–28classes of GMO dealings, 17inspections of, 36–38non-compliances, 39PC1, 27, 28, 36, 62, 63, 70, 71PC2, 23, 27, 28, 36, 62, 63, 70, 71PC3, 23, 27, 28, 36, 44, 70, 71PC4, 27, 28, 36, 70, 71

changes to gene technology legislation, 60charitable donations, 50classification levels of staff, 76

performance pay, 76–77workplace agreements, 77

client register, 45clover, white, 30Code of Conduct, v, 6Collective Agreement 5, 50, 76, 77commercial information, confidential, 6committees, statutory, 44, 72–75Commonwealth Disability Strategy, 55Commonwealth Health and Ageing portfolio, vcompliance

with Gene Technology Act 2000, 38–42monitoring and compliance, 70–71

Compliance and Investigation Section, 9conduct, code of, v, 6conferences see international meetings and

forumsconfidential commercial information (CCI), 6, 20consultancies, 54consultation with stakeholders, 3, 42–46contact information, iv, 45–46contained dealings see dealings not involving

intentional releases (DNIRs)Contained Dealings Evaluation Section, 8cooperation with other agencies, 3, 60–61corporate governance, 6cotton, 21, 30Council of Australian Governments (COAG), 43crop research, 2

Ddealings, emergency, 26, 69dealings, exempt, 16, 17, 62

inspections of, 36dealings, inadvertent, 69dealings, notifiable low risk (NLRDs), 8, 16, 20,

23, 25, 62–63inspections of, 36trend data, 29

92

dealings authorised by licence, 16, 63applications for, 19, 20intentional release into the environment,

21–22not involving intentional release into the

environment, 23–25surrender of licences, 19, 20variations, 21see also dealings involving intentional releases

(DIRs); dealings not involving intentional releases (DNIRs)

dealings involving intentional releases (DIRs), 8, 16, 17, 65

applications approved, 22assessment process, 68inspections of, 29–35licences for, 19, 20, 21–22non-compliances, 39non-plant, 8trend data, 29trial sites, 31

dealings not involving intentional releases (DNIRs), 8, 16, 17, 20

applications approved/withdrawn, 23, 24assessment process, 64inspections of, 36–38licenses for, 19, 20, 23–25non-compliances, 39research focus, 23trend data, 29

dealings placed on GMO Register, 16, 17, 25, 63

see also GMO Registerdealings with GMOs

classes of, 16–18definitions of terminology, 86–87deliverables, 10–11Department of Agriculture, Fisheries and

Forestry, 3, 40, 41Department of Education, Science and Training,

41Department of Foreign Affairs and Trade, 41, 46Department of Health and Ageing, 6, 41, 50Department of Industry, Tourism and Resources,

41Department of the Environment, Water, Heritage

and the Arts, 3, 45Department of the Environment and Heritage, 41disabilities, people with, 55disabilities, staff with, 76Disability Discrimination Act 1992, 55disease progression, 25diseases

research into, 23vaccine trial, 21

diversity in the workplace, 76documents maintained, 52–53drought and salt tolerance in crops, 2

Eecologically sustainable development, 55–56Electronic Transactions Act 1999, 53email address, 46, 84–85email inbox, 85emergency control team, 51Emergency Dealing Determination (EDD), 26, 69emergency dealings see dealings, emergencyemployees see staffemployment framework, 6, 50Environment Protection and Biodiversity

Conservation Act 1999, 55environmental performance see ecologically

sustainable developmentequal opportunity groups, 76Equipment Practice Review, 41ethical issues in decision-making, 44ethical standards, v, 6eucalyptus, 4, 46Evaluation Branch, 7–8exempt contracts, 54exempt dealings see dealings, exempt

Ffamily-friendly organisation, 51feedback from the public, 45, 84female staff, 76fescue, tall, 30field trials, 30

location of, 33–35sites, 31, 32types, 30, 31website mapping of, 3

financial framework, 6Financial Management and Accountability Act

1997, 6, 9financial performance, 9financial reporting, 6fish, ornamental, 40flexible working arrangements, v, 51Food Standards Australia New Zealand, 3, 41,

45freecall number, 46, 84–85freedom of information, 51–53Freedom of Information Act 1982, 51full-time staff, 76functions see role and functions

93

Ggender of staff, 76gene expression, 25Gene Technology Act 2000, ii, 2, 6, 58

compliance with, 38–42Gene Technology Amendment Regulations

2009, 43Gene Technology Amendment Regulations 2010

(draft), 43Gene Technology Ethics and Community

Consultative Committee (GTECCC), 44, 73–74

gene technology legislationchanges to, 60

Gene Technology Ministerial Council (GTMC), 44, 60

Gene Technology Regulations 2001review of, 3, 43

Gene Technology Regulator, 7governance arrangements, 58–59operational policies, 44powers and functions, 6, 42, 47, 52review of the Gene Technology Regulations

2001, 43review of year, 1–4Statement of Intent, 6

gene technology regulatory systemhistory and structure of, 58–61

Gene Technology Standing Committee (GTSC), 44

Gene Technology Technical Advisory Committee (GTTAC), 44, 72–73

GM plants, 21GMO Record, 45, 69GMO Register, 20, 62

see also dealings placed on GMO RegisterGMOs and GM products, 3, 8, 9, 40, 42, 58,

61advice on, 45–46GMO Record, 69harmonisation relating to, 69

governance arrangements, 6grapevine, 30Guidelines for Accreditation of Organisations, 20Guidelines for the Certification of a PC3 Animal

Facility, 3, 44, 80

Hharmonisation relating to GMOs and GM

products, 47Health and Ageing Portfolio, vhealth and safety, 51herbicide tolerance in crops, 2human and animal pathogens, 23human resources see staff

Iimported ornamental fish, 40imported seeds for sowing, 41inadvertent dealings, 69Indian mustard, 30insect resistance in cotton, 21inspection activities, 29–38internal audit, 6internal training presentations, 77–78international meetings and forums, 46, 81international regulatory liaison, 2, 3–4, 46investigations under Gene Technology Act 2000,

39–40

Kkey performance indicators see performance

indicators

LLegal Section, 8legislation, changes to, 60letter of transmittal, iiilicensed dealings see dealings authorised by

licencelicensing system, 17location of field trials, 3, 33–35

Mmaize, 30male staff, 76management and accountability, 50–56mapping function on website, 3market research see advertising and market

researchmaternity leave (staff), 76medical research, 21, 23meetings on gene technology

in Australia, 82international, 46, 81

memorandum of understanding, 45mission statement, vmonitoring and compliance, 70–71Monitoring Section, 9

email inbox, 85

NNational Archives of Australia, 53National Framework for the Development of

Ethical Principles in Gene Technologyreview of, 44

National Health Security Act 2007, 43National Industrial Chemicals Notification and

Assessment Scheme (NICNAS), 3national strategy for unintended presence of

unapproved GMOs, 41–42

94

non-compliances, 38–46management of, 39–40see also compliance

non-English speaking background of staff, 76non-ongoing staff, 76non-plant dealings involving intentional releases,

8non-salary benefits, 76, 77notifiable low risk dealings (NLRDs) see dealings,

notifiable low risk (NLRDs)nutrient uptake in crops, 2

Oobjective, voccupational health and safety, 51OECD Working Group on Harmonisation of

Regulatory Oversight in Biotechnology (WGHROB), 46

Office of the Gene Technology Regulator, vaccess to, 83–85advice on GMOs and GM products, 45–46client register, 45corporate overview, 6–13employment framework, 6, 50Guidelines for the Certification of a PC3

Animal Facility, 44management and accountability, 50–56national strategy for unintended presence of

unapproved GMOs, 41Non-Compliance Protocol, 38OGTR Compliance and Enforcement Policy,

40operational performance, 18–47

OGTR Forum, 79OGTR manuals, 53ongoing staff, 76operational performance, 18–47organ development, 23organisational structure, 7–9organisations licensed to conduct work with

GMOs, 25, 70see also accredited organisations

our people see people management; staffOutcome 1 (Population Health), voutlook for year ahead, 4outside participation, arrangements for, 3

see also stakeholders

Ppapaya, 30Parliamentary Secretary for Health, 6

Statement of Expectations, 6part-time staff, 50pathogens, human and animal, 23people management, 50–51People Management Practice Review, 41People Strategy – Performance through People

2010–2015, vpeople with a disability, 55, 76Performance Development Scheme, 51performance indicators, 12–13performance pay, 76–77personnel see staffphysical containment (PC) facilities see certified

physical containment facilitiesphysical security, 6pineapple, 30plans and planning

Business Risk Management Plan, 6risk assessment and risk management plans

(RARMPs), 8, 19, 45, 54, 63, 66Plant Evaluation Section, 8population health, vPortfolio Budget Statements, v, 2practice reviews, 41prescribed agencies, 60–61presentations

in Australia, 82at international meetings and conferences, 81

privacy, 6, 76professional development see staff training and

developmentpublic access to OGTR, 83–85Public Service Act 1999, 6publications and guidance documents, 52–53,

80purchasing, 54

Qquarterly reports, 55, 80

RRegulator see Gene Technology RegulatorRegulators’ Forum, 3, 45regulatory agencies, 61Regulatory Practice and Compliance Branch,

8–9Regulatory Practice and Secretariat Section, 8regulatory system

history and structure of, 58–61remuneration and allowances for committee

members, 75

95

reporting requirements, 55reporting services, 6reviews

breeding programs, 41Equipment Practice Review, 41Gene Technology Regulations 2001, 3, 43National Framework for the Development of

Ethical Principles in Gene Technology, 44

People Management Practice Review, 41Risk Analysis Framework, 3, 65–67risk assessment and risk management plans

(RARMPs), 8, 19, 45, 54, 63, 65–67, 66risk management, 56role and functions, vryegrass, perennial, 30

SSafety in laboratories, Part 3: Microbiological

aspects and containment facilities, 23salt tolerance in crops, 2Science Cohort, 8section 24(1) determinations (employment), 76security, 6Security Sensitive Biological Agents Regulatory

Scheme, 43seeds for sowing, 41service level agreements with the Department, 6staff, 76–79staff recruitment, 55staff training and development, 50–51

internal training presentations, 77–78OGTR Forum, 79

stakeholdersaccess to OGTR, 83–85consultation with, 3, 42–46

Statement of ExpectationsParliamentary Secretary for Health, 6

Statement of Intent, 6statutory committees, 44, 72–75strategic direction, 2, 9structure see organisational structuresugarcane, 4, 21, 30surrender of licences and certifications, 19, 20

Ttall fescue, 30team culture, 50terminology (definitions), 86–87Therapeutic Goods Administration, 3, 45timeframes, 18torenia, 30training see staff training and developmenttransparency in decision-making, 3

Uunintended presence of unapproved GMOs

national strategy for, 41–42United Nations Cartagena Protocol on Biosafety

(the Biosafety Protocol), 46United Nations Convention on Biological

Diversity, 3unlicensed GMOs, 17, 69

Vvaccines, 21, 23values, v, 6vision, v

Wwaste management, 55website and contact points, 45, 83–85website usage, 83–84wheat, 21, 30white clover, 30work-life balance, 51workplace agreements, 5, 50, 76, 77workplace diversity, 76workplace health and safety, 51Workplace Relations Act 1996, 50

Yyear ahead, outlook for, 4

letter of transmittal - department of health · letter of transmittal. iv contacts office of the...

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