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Gene Technology Regulator—Report for 2013-14


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ANNUAL REPORT

2013 - 14

O P E R AT I O N S O F T H E G E N E T E C H N O L O G Y R E G U L AT O R

2 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

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: 978-1-74186-175-4 Online ISBN: 978-1-74186-176-1 Publications approval number: 10866 Copyright statements: Paper-based publications

© Commonwealth of Australia 2014 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Communication Branch, Department of Health, GPO Box 9848, Canberra ACT 2601, or via email to copyright@health.gov.au.

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© Commonwealth of Australia 2014 This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Communication Branch, Department of Health, GPO Box 9848, Canberra ACT 2601, or via email to copyright@health.gov.au

3

Senator the Hon Fiona Nash Assistant Minister for Health

Parliament House Canberra ACT 2600

Dear Minister

I am pleased to present to you the Annual Report on the Operations of the Gene Technology Regulator covering the period 1 July 2013 to 30 June 2014.

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 2013 to 30 June 2014.

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 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 2014.

Yours sincerely

Dr Robyn Cleland Acting Gene Technology Regulator 19 September 2014

4 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

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

Level 1, Pharmacy Guild House 15 National Circuit Barton ACT 2600

Telephone: 1800 181 030 Fax: (02) 6271 4202 Email: ogtr@health.gov.au Website: www.ogtr.gov.au

ABN 15 862 053 538

Annual report web page .

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 vision To be a trusted and respected regulator of gene technology safeguarding the Australian people and the environment.

Our mission Dedicated to ensuring that genetically modified organisms are safely managed in Australia.

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

Strategic objectives To deliver efficient and effective regulation that protects people and the environment, and encompasses regulatory decisions and activities (science, compliance, performance) that are evidence based, outcome focused, transparent, and consistent and defensible.

To provide a safe, respectful and inclusive workplace that is productive and professionally rewarding.

To inform and engage effectively with our stakeholders so they understand and respect our decisions.

To ensure our governance arrangements are robust, exemplify best practice and fulfil all legal obligations.

Enabling strategies Sound science Effective compliance Good governance Capable, qualified staff Clear communication

6 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Outcomes • A high-perf orming organisation that fulfils the requirements of the legislation, is respected as a regulator, can adapt to government imperatives, is responsive to stakeholders’ concerns, and anticipates change.

• Regulat ory decisions that are transparent, consistent, defensible and evidence based.

• P eople that are skilled, productive and professional.

• A cooper ative and compliant regulated community that engages with the regulatory system.

Our people As at 30 June 2014, the Office of the Gene Technology Regulator comprised 53 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.

Our values Professional, transparent, accountable, proactive, collaborative, responsive, respectful, inclusive, ethical.

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ABOUT THIS REPORT

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

The report is a formal accountability document that details the operations of the Gene Technology Regulator (the Regulator) during 2013-14 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) 2013-14 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 past 12 months.

This report is arranged in four chapters and contains a number of appendices. The chapters are organised as follows:

Chapter 1 -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.

Chapter 2 - 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 2013-14 PBS.

Chapter 3 - Operational performance describes the OGTR’s achievements against the priorities for the reporting year. Deliverables and performance targets achieved in the areas of assessments and approvals, monitoring and compliance, consultation with stakeholders, and international relationships are discussed in detail along with other information on activities relating to the Regulator’s statutory functions as prescribed by the Gene Technology Act 2000. Classes of dealings and authorisations outline the types of dealings with genetically modified organisms (GMOs) defined by the Gene Technology Act 2000, the Gene Technology Regulations 2001 and corresponding state and territory laws. A summary of classes of dealings, processes for authorisations and statutory time frames are detailed in chapter three.

Chapter 4 - Management and accountability provides an overview of the OGTR’s resource management practices and its adherence to Australian Government accountability principles.

8 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

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

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

Note: The Department of Health 2013-14 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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CONTENTS

Operations of the Gene Technology Regulator Annual Report 2013-14

Contacts 4

Office of the Gene Technology Regulator 5

Our vision 5

Our mission 5

Our role 5

Our objective 6

Our people 6

Our values 6

About this report 7

Contents 9

CHAPTER 1 Gene Technology Regulator’s review 13

CHAPTER 2 Corporate overview 16

Corporate governance 16

Organisational structure 17

Gene Technology Regulator 18

Regulatory Practice and Compliance Branch 18

Evaluation Branch 19

Financial performance 20

Performance against PBS targets 21

CHAPTER 3 Operational performance 24

GMOs, dealings and authorisations 24

Time frames 28

Operational performance 29

Assessments and approvals 29

Licences for dealings involving intentional release 29

Licences for dealings not involving intentional release 35

Notifiable low-risk dealings 39

Dealings placed on the GMO Register 40

10 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Emergency dealing determination 40

Accredited organisations 41

Certified physical containment facilities 42

Trend data for approval of main types of applications 44

Monitoring of genetically modified organisms 45

Compliance with the Gene Technology Act 2000 52

Consultation and provision of advice to stakeholders 57

Investigation of cost recovery for OGTR 60

International regulatory liaison 61

Other functions of the Gene Technology Regulator 62

CHAPTER 4 Management and accountability 64

Human resources 64

Work health and safety 67

Freedom of information 68

Purchasing 69

Assets management 70

Exempt contracts 70

Consultancies 70

Advertising and market research 70

Annual reporting requirements 71

Quarterly reporting requirements 71

National Disability Strategy 71

Ecologically sustainable development and environmental performance 72

APPENDIX 1 History and structure of the gene technology regulatory system 73

Development of the Gene Technology Act 2000 73

Governance arrangements 74

Role of the Legislative and Governance Forum on Gene Technology 77

Coordination with prescribed agencies 80

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APPENDIX 2 Types of applications, authorisations, monitoring and compliance 83

The GMO Register 83

Exempt dealings 84

Notifiable low-risk dealings 84

Licensed dealings 85

Dealings not involving intentional release 86

Dealings involving intentional release 89

Inadvertent dealings 93

The GMO Record 94

Accreditation and certification 95

Monitoring and compliance 95

APPENDIX 3 Membership of statutory committees and attendance at meetings 97

Gene Technology Technical Advisory Committee 97

GTTAC chair 98

GTTAC members 2011-14 99

Gene Technology Ethics and Community Consultative Committee 100

GTECCC chair 101

Remuneration and allowances for committee members 102

GTECCC members 2011-14 102

APPENDIX 4 Staff profile and training and development activities 103

Staff profile 104

Performance pay 105

Training and development 106

APPENDIX 5 Publications and guidance documents 109

Quarterly reports 109

APPENDIX 6 Stakeholder and public access to the OGTR 110

Website usage 110

Email address and free call number 111

APPENDIX 7 Presentations and meetings on gene technology in Australia 114

Glossary 116

List of requirements 119

Index 130

CHAPTER 1 13

CHAPTER 1 GENE TECHNOLOGY REGULATOR’S REVIEW

Gene Technology Regulator

2013-14 has been a year of challenges and opportunities for OGTR as we continue to fulfil our legislative obligations in administering the national regulatory scheme for gene technology. Our Strategic Plan has guided our activities throughout the year ensuring we focused on delivering efficient and effective regulation based on sound science, actively engaged and communicated with our stakeholders, and maintained the highest standards of good governance and accountability.

The variety of genetically modified organisms (GMOs) seen in applications for environmental release continued to increase as genetic modification is applied to new species and new traits are developed. This year, two new commercial varieties of cotton were approved and field trials in canola, cotton, wheat, barley and safflower were authorised. In addition, a clinical trial of a genetically modified (GM) vaccine for cholera was also approved (previously released under DIR 33) and an application for the commercial release of a GM vaccine for poultry was received. We achieved our goal of 100 per cent of statutory decisions made on time. These decisions were underpinned by comprehensive rigorous risk assessment and risk management plans based on robust scientific evidence. We also met our target of monitoring a minimum of 20 per cent of field trial sites to ensure risks to people and the environment are managed by maintaining a high level of compliance. As always, it has been through the efforts of our skilled, productive and professional staff that we have been able to achieve this.

Efficient and effective regulation This year saw the implementation phase of the 2013 revision of the Risk Analysis Framework (RAF), the document that describes our approach to assessing and managing risks posed by work with GMOs. The revised RAF further articulates how we assess risks posed by GMOs using frameworks already in place, such as the national weed risk assessment tool. We also focused on improving our communication about such risks. Changes in our communication of scientific and regulatory decisions, to enhance clarity, have been well received by our stakeholders.

Our Science Strategy 2013-18 was developed and launched. This document will guide us in maintaining and enhancing our scientific and risk-analysis capability to meet current and future needs. The effective application of science to regulatory activities is a critical part of our performance. The Science Strategy will also be important in continuing to build the professional capacity of our staff.

14 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

The new Gene Technology Technical Advisory Committee was appointed for the 2014-17 triennium by the Assistant Minister. This group of eminent scientists provides advice to the Regulator on licence applications and other scientific matters. Professor John Rasko continued as chair of the committee. The retirement of the chair of the Gene Technology Ethics and Community Consultative Committee, Dr Don Chalmers, marked the end of more than 12 years of service. Don has made an enormous contribution to gene technology regulation both prior to the establishment of the regulatory scheme and as chair of a number of its committees. He was the inaugural chair of what was then the Gene Technology Ethics Committee and was a pivotal contributor to a number of papers produced by that committee.

Strong partnerships with other regulatory agencies are an important part of the national scheme regulating GMOs and in preventing duplication of regulatory effort. The Regulator’s Forum and the Regulatory Science Network (RSN) provided valuable platforms for engagement throughout the year. Risk communication was the focus of the RSN annual event this year, which served as a vehicle for discussing operational approaches to stakeholder communication. Engagement through partnerships also occurred internationally where OGTR had involvement in Organisation for Economic Cooperation and Development work facilitating harmonisation of risk assessment and regulation of GMOs. In 2013-14 the Regulator signed an memorandum of understanding with the International Centre for Genetic Engineering and Biotechnology to establish collaborative activities on risk assessment and regulation of GMOs with a number of African GMO regulators.

The investigation of cost recovery of OGTR services by the Department of Health continued through 2013-14. The Department is preparing a Regulation Impact Statement in line with current requirements. At OGTR we have continued to refine our internal processes to deliver efficient services through initiatives such as electronic record keeping and process improvements.

The OGTR is responsible for the National Unintended Presence Strategy developed by the Australian Government to manage the risk of unapproved GMOs in imported seed for sowing. In 2013-14 we worked with the departments of Agriculture, Environment and Foreign Affairs to develop operational guidance to ensure communication and coordination between relevant agencies in the event of an incident involving unapproved GMOs. This capacity-building work will continue through the next year to strengthen the preventative strategy in place for managing risks of unapproved GMOs. In responding to the discovery in the United States of America of unauthorised GM wheat in October 2013, the importance of a coordinated response was apparent.

Stakeholder engagement and risk communication Guidance documents are produced in consultation with our stakeholders to assist them through the regulatory process and to facilitate their understanding of regulatory requirements. The new, limited and controlled release application form finalised in December 2013 clearly articulates the type of information required for different applications and provides a communication platform for discussions between OGTR and applicants to ensure smooth progression and timely consideration of applications. This document is the culmination of a significant amount of work by staff of OGTR in identifying only relevant information required to underpin a rigorous risk assessment. The final document was also informed by detailed feedback from stakeholders.

CHAPTER 1 15

Gene technology remains a contentious area and openness and transparency are critical in maintaining confidence in the regulatory scheme. In 2013-14 work commenced on redevelopment of the OGTR website. Since the inception of OGTR, the website has provided an important platform to engage with all of our stakeholders, from applicants to interested members of the public. Analysis of the information we provide and consideration of our stakeholders’ needs led to recommendations to restructure the website and organise regulatory guidance and ‘for information’ generic material into more logical groupings. The new structure will align with feedback provided from stakeholders to make important information easier to find. These recommendations will be implemented as the website is rebuilt over the next year.

Strategic engagement OGTR is providing input to policymakers in the Department to give effect to the all Australian governments’ response to the 2011 Review of the Gene Technology Act 2000. The non-legislative recommendations accepted by governments and relevant to OGTR have been implemented and will continue to inform our practice. In exploring opportunities to use new communication tools as recommended by the review, OGTR used Twitter to tweet about the GM cholera vaccine. OGTR has actively participated in providing technical advice to inform policy considerations regarding the other recommendations. A particular challenge is the issue of definitional capture of new technologies. We will continue to be involved in discussions both within Australia and with international counterparts around the world on this matter.

The Regulator administers a national scheme underpinned by an Intergovernmental Agreement and engagement with States and Territories continued to be important in our regulatory practice. States and Territories provided useful risk assessment advice on licence applications. The Regulator made a submission based on operational experience to Queensland’s review of its gene technology legislation. It is pleasing to note that the Queensland government response will take forward a recommendation to adopt a lock step approach to amending gene technology legislation, this approach has been enacted in NSW, the Northern Territory and Tasmania. This approach offers many advantages for States and Territories.

Dr Joe Smith, the second Gene Technology Regulator, retired in March 2014. He was a great advocate of the nationally consistent scheme for gene technology and actively engaged with reviews conducted by states and territories examining their approach to legislation. It is appropriate to acknowledge his contribution to gene technology regulation in this area. His high level of integrity and very personal concern for staff made the office a great place to work.

In moving into 2014-15, our Strategic Plan and Science Strategy will provide overarching guidance in how we go forward to deliver on the government’s objectives for the regulation of gene technology. We will continue to use sound science, clear communication and good governance to deliver efficient and effective regulation of gene technology that manages the risks posed by GMOs and safeguards the Australian people and the environment.

Dr Robyn Cleland Acting Gene Technology Regulator

19 September 2014

16 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

CHAPTER 2 CORPORATE OVERVIEW

This chapter provides an overview of the corporate governance

arrangements for the Gene Technology Regulator (the Regulator) and

a description of the organisational structure of the Office of the Gene

Technology Regulator (OGTR). It also describes the OGTR’s human

resource management practices, and reports its performance against

deliverables and key performance indicators set out in Outcome 1,

Population Health, of the Department of Health and Ageing 2013-14

Portfolio Budget Statement (PBS).

CORPORATE GOVERNANCE The Regulator is a statutory office holder with specific powers and functions under the Gene Technology Act 2000. In exercising these functions, the Regulator is directly responsible to the Australian Parliament. During 2013-14, the Assistant Minister for Health had portfolio responsibility for matters relating to the OGTR, which resides within the Australian Government Department of Health (the Department). The Secretary of the Department provides staff to the OGTR under section 133 of the Gene Technology Act 2000.

The OGTR has an ongoing Head of Agreement in place with the Department to access a range of business management and reporting services (information technology, financial reporting and accounting, human resources management, ministerial support and property management). The cost of these services is reviewed annually.

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

CHAPTER 2 17

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

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

The OGTR maintains its own business risk management plan, which senior OGTR staff review periodically.

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

Figure 1: Organisational structure of the OGTR, 2013-14

Gene Technology Regulator

Regulatory Practice & Compliance Branch

Evaluation Branch

Application & Licence Management

Contained Dealings Evaluation

Plant Evaluation

Science Cohort

Business Management Communication & Post Release Review

Compliance & Investigation

Monitoring

Regulatory Practice & Secretariat

Legal

18 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

GENE TECHNOLOGY REGULATOR The Regulator is an independent statutory office holder who administers the nationally consistent scheme for regulating gene technology, comprised of the Gene Technology Act 2000 and corresponding state and territory laws.1 In administering the gene technology regulatory system, the Regulator has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by, or as a result of, gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs).

After the retirement of Dr Joe Smith in March 2014, Dr Michael Dornbusch acted in the role as Regulator until June 2014 when Dr Robyn Cleland commenced in the role.

Dr Cleland has extensive experience in regulatory agencies, including the OGTR, Food Standards Australia New Zealand and Australian Pesticides and Veterinary Medicines Authority in corporate, risk management and scientific roles.

The legal section provides legal advice to the Regulator and the OGTR on the operation of Commonwealth, state and territory laws affecting their functions, including setting licence conditions and handling CCI. It conducts training for OGTR staff on legal issues.

REGULATORY PRACTICE AND COMPLIANCE BRANCH Mr Andrew Radanovich has been the acting Assistant Secretary Regulatory Practice and Compliance Branch since June 2014. Mr Radanovich joined the OGTR in 2002 as an inspector and has managed the Compliance and Investigation Section since 2003. Currently, as acting Assistant Secretary, he is responsible for regulatory practice policy, coordinating monitoring and compliance activities, corporate business services, expert advisory committees, communication and international cooperation.

In partnership with the Department, the branch’s Business Management, Communications and Post Release Review Section delivers administrative and financial reporting services. Other roles include account processing, financial planning, procurement, human resource management, staff training and coordination, accommodation and property and asset management. The section produces the annual and quarterly reports, staffs the free call 1800 181 030 number, coordinates responses to email enquiries to and manages the OGTR website. It has developed the Post Release Review Framework to guide ongoing oversight of commercial or general-release GMOs.

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 that the dealings are undertaken in accordance with the Gene Technology Act 2000.

1 See .

CHAPTER 2 19

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 that dealings with GMOs comply with legislative obligations and are consistent with the object of the Gene Technology Act 2000. In particular, the section focuses on maintaining compliance with conditions of licences or other instruments and management of risks in relation to any potential breach of conditions.

The Regulatory Practice 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 and coordinates input to international regulatory harmonisation programs. It provides secretariat services to the Gene Technology Ethics and Community Consultative Committee and the Gene Technology Technical Advisory Committee.

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

The 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.

20 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

The Plant Evaluation Section prepares risk assessment and risk management plans (RARMPs) for dealings involving intentional release (DIRs) of genetically modified (GM) plants into the environment, for the Regulator’s consideration and for consultation with key stakeholders, including the public. The section gathers scientific data and produces reference documents to inform the risk assessment process. It also provides technical advice to the Regulator, other sections of OGTR and stakeholders.

The Contained Dealings Evaluation Section prepares RARMPs for dealings not involving intentional release of GMOs into the environment, also known as ‘contained dealings’, and non-plant DIR applications. The section provides advice to accredited organisations and institutional biosafety committees on the classification of dealings with GMOs, and inspects and processes certification applications for high-level and large-scale containment facilities.

The Science Cohort develops and manages science-related projects that affect the OGTR, 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. It also organises seminars and supports national and international input into regulatory harmonisation programs, and oversees the OGTR library and reference manager database.

FINANCIAL PERFORMANCE The Gene Technology Account is a Special Account for the purposes of the Financial Management and Accountability Act 1997. The Special Account receives all moneys appropriated by the Parliament and makes payments for expenses the Regulator incurs in performing these functions. The OGTR prepares accrual accounting financial statements in accordance with the Department of Finance and Deregulation guidelines (that department was renamed the Department of Finance in September 2013). The Australian National Audit Office performs an annual audit of these statements, which are then consolidated into the Department’s financial statements for the year ended 30 June. The receipts and expenditure of the OGTR’s Special Account are shown in the Department’s financial statements for the year ended 30 June.

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

The 2013-14 federal budget measures for the OGTR are published in the Department’s 2013- 14 PBS and are summarised in table 1.

Table 1: Australian Government funding for the OGTR, 2013-14 to 2017-18

2013-14 ($M)

2014-15 ($M)

2015-16 ($M)

2016-17 ($M)

2017-18 ($M)

Departmental 7.976 7.810 7.753 7.703 7.778

CHAPTER 2 21

PERFORMANCE AGAINST PBS TARGETS The OGTR’s activities for 2013-14 are described on pages 62 to 64, under program 1.4 in Outcome 1, Population Health, of the Department’s 2013-14 PBS.2 The key objective of this sub-program is to:

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

The OGTR’s performance against deliverables and key performance indicators, as also reported in the Department’s 2013-14 annual report, is summarised in table 2.

2 A cop y of the 2011-12 PBS is available at .

22 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Table 2: Deliverables, 2013-14 3

Qualitative deliverable: Implement changes to OGTR operations agreed by the all Australian governments’ response to the Review of the Gene Technology Act 2000.

2013-14 reference point: Implementation completed within any agreed timeframes set in the response

Result: Met. In 2013-14, OGTR implemented operational recommendations from the 2011 Review of the Gene Technology Act 2000. This included a range of activities to improve communication and consultation with regulated stakeholders and the public. Engagement with stakeholders is an ongoing priority for OGTR.

Qualitative deliverable: Provide open, transparent and effective regulation of GMOs.

2013-14 reference point: Stakeholders, including the public, consulted on all assessments for proposed release of GMOs into the environment.

Record of GMOs and maps of all field trial sites maintained and made publicly available on OGTR’s website.

Risk assessments and risk management plans prepared for all applications for licenced dealings.

Result: Met. In 2013-14, the Regulator prepared comprehensive risk assessments and risk management plans and consulted with stakeholders on seven GMO licence applications for intentional release into the environment (five field/clinical trials and two general/commercial releases). The Regulator also prepared risk assessments and risk management plans for 10 licence applications for work in contained facilities. The OGTR maintained a record of approved GMOs and maps of all field trial sites, and made them available on the OGTR website.3

Qualitative KPI: Facilitate cooperation and prevent duplication in the implementation of GMO regulation.

2013-14 reference point: High degree of cooperation with relevant regulatory agencies.

Result: Met. In 2013-14, the OGTR continued cooperative arrangements with other Australian Government regulators to enhance coordinated decision making and avoid duplication in regulation of GMOs and genetically modified products.

3 www.ogtr.gov.au

CHAPTER 2 23

Quantitative deliverable percentage of field trial sites and higher level containment facilities inspected.

2013-14 target: ≥20% 2013-14

actual: 40% and 25%

Result: Met. In 2013-14, the OGTR inspected 40% of field trial sites to monitor compliance with licence conditions ensuring risks to human health and the environment are minimised. Sites were inspected in the Australian Capital Territory, New South Wales, Victoria, Queensland and Western Australia. Inspections included genetically modified canola, wheat, barley, cotton, sugarcane, banana, safflower, and a clinical trial of genetically modified viral vaccines intended to provide protection against prostate cancer.

The OGTR also inspected 25% of higher level containment facilities to ensure compliance with certification conditions. These inspections focused on the integrity of the physical structure of the facility and on the general laboratory practices followed.

Quantitative KPI: Percentage of licence decisions made within statutory time frames.

2013-14 target: 100% 2013-14

actual: 100%

Result: Met. The Regulator made decisions on all licence applications within the applicable statutory time frames, as in previous reporting periods. There were no appeals of decisions made under the gene technology legislation.

Qualitative KPI: Protect people and the environment through identification and management of risks from GMOs.

2013-14 reference point: High level of compliance with the gene technology legislation and no adverse effect on human health or environment from GMOs

Result: Met. Routine monitoring of the regulated community found a high level of compliance with the gene technology legislation.

24 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

CHAPTER 3

OPERATIONAL PERFORMANCE

As an introduction to operational activities, the first part of this

chapter outlines the types of dealings with genetically modified

organisms (GMOs) that are defined by the Gene Technology Act 2000,

the Gene Technology Regulations 2001 and corresponding state and

territory laws.

It also provides a summary of classes of dealings, the process for authorisations and the statutory time frame for consideration of each type of application and other statutory functions (such as certification and accreditation) that help the Regulator to manage risks to health and safety of people and the environment. The second part of the chapter describes operational performance.

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

Section 10 of the Gene Technology 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 manuf acture 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

CHAPTER 3 25

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

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

• an exempt dealing

• a notifiable low risk dealing (NLRD)

• authorised by a licence

• included on the GMO Register

• specified in an emergency dealing det ermination (EDD).

Exempt dealings and NLRDs are defined in the Regulations. They 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 with GMOs involving routine laboratory techniques have been used safely for many years and represent minimal risk when performed in accordance with the requirements of the Regulations.

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

For both DNIRs and DIRs the legislation requires the Regulator to prepare a risk assessment and risk management plan (RARMP) as part of the process of making a decision on whether to issue or refuse a licence (sections 47 and 50 of the Gene Technology Act 2000 respectively). Part 5 of the Gene Technology Act also 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 so that they can dispose of the GMO.

To be included on the GMO Register, the dealings with the GMO must first have been licensed by the Regulator and the Regulator must be satisfied that there are minimal risks and that it is no longer necessary for people undertaking the dealings to be covered by a licence.

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

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

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

26 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

The Regulator may, directly or on application, vary an issued licence or other instrument. Variations involve changes to conditions applied to a licence or other instrument. The Regulator must not vary the licence unless 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 2.4

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

4 A complete listing of DNIR and DIR licence applications and appro vals and NLRDs is at .

CHAPTER 3 27

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

CATEGORY LICENCE REQUIRED CONTAINMENT

DIR (except for limited and controlled releases)

Yes Applications must be reviewed by IBC Consultation on application RARMP must be 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 must be prepared Consultation on RARMP and licence decision by the Regulator

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

DNIR Yes

Applications must be assessed by IBC RARMP must be prepared Licence decision by the Regulator

Yes, PC2 (or higher) certified facilities (usually)

EDD No

Determination by Minister, subject to advice of threat and utility of GMO from competent authorities and risk assessment advice from Regulator

Containment measures may be included in EDD conditions

Exempt No

Dealings classified as exempt are scheduled in the Regulations

No intentional release to the environment

GMO Register No, but must have been previously licensed, and relevant information is reviewed by the Regulator

Containment measures may be required

Inadvertent dealing

Yes Licence decision by the Regulator only for the purposes of disposal of the GMO

Containment and/or disposal measures will apply

NLRD No

Dealings are scheduled in Regulations Conduct of NLRDs requires prior assessment by IBC to confirm proper classification Notified in annual report

Yes, PC1 or PC2 certified facilities (usually)

Notes: DIR = dealing involving intentional release of a GMO into the environment; DNIR = contained dealing with a

28 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

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; PC1(2) = physical containment level 1(2); RARMP = risk assessment and risk management plan.

TIME FRAMES Under section 43(3) of the Gene Technology Act, the Regulator must issue or refuse to issue a licence within a time limit prescribed by the Regulations. Similarly, the Regulations prescribe a time frame for consideration of applications to accredit organisations and to certify facilities. These statutory time frames are shown in table 4. They do not include weekends or public holidays in the Australian Capital Territory or periods when the Regulator has sought more information from the applicant, including information to resolve a confidential commercial information (CCI) claim, and cannot proceed with the decision-making process until that information is provided. In these instances the statutory time frame clock is regarded as stopped (clock stop).

Table 4: Prescribed time frames

CATEGORY TIME FRAME

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 working 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.

CHAPTER 3 29

OPERATIONAL PERFORMANCE The second part of this chapter describes the Regulator’s achievements against Program 1.4 of Population Health, of the Department of Health and Ageing 2013-14 Portfolio Budget Statements (PBS). It provides details of achievements on deliverables and performance indicators in the key areas of:

• assessments and appro vals/authorisations under the Gene Technology Act 2000

• monitoring of GMOs

• compliance with the Gene Technology Act 2000

• consultation with st akeholders

• cooperation with r elevant regulatory agencies

• OGTR operational c hanges arising from the 2013 all Government response to the 2011 review of Gene Technology Act 2000.

ASSESSMENTS AND APPROVALS Information on performance against deliverables and key performance indicators, as set out in the Department’s 2013-14 PBS, is summarised in table 2.

In 2013-14 the OGTR received 472 applications and notifications as defined under the Gene Technology Act 2000 (table 5). Year-to-year fluctuations in the timing and volume of applications can be influenced by a range of factors, including research grant funding cycles and seasonal agricultural factors, as well as changes to legislation.

LICENCES FOR DEALINGS INVOLVING INTENTIONAL RELEASE DIR licence applications have a statutory time limit of up to 255 working days for making a decision, unless the application is for a limited and controlled release. The statutory time limit for decisions on limited and controlled release applications is 150 working days, or 170 working days if the proposed dealings may pose a significant risk to the health and safety of people or to the environment.

During 2013-14 the Regulator issued seven DIR licences (table 6) and at 30 June 2014 was considering a further four licence applications. Five of the DIR licences issued related to applications that were received before 1 July 2013. All licence decisions were made within statutory time frames (table 2).

Five of the DIR licences issued in 2013-14 were for limited and controlled release (e.g. field trials or clinical trials) and two were for commercial releases. While the majority of DIR applications related to crop plants with introduced traits intended to provide benefits to agricultural production, two licences were issued for field trials of genetically modified (GM) plants, modified for altered oil profiles, one of which was for nutritional enhancement and the other for industrial uses. One licence was issued for clinical testing of a vaccine against cholera. Details of the trait categories are provided in table 6.

30 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Of the seven DIR licences issued in 2013-14, five were issued to private companies, one to a government agency (CSIRO) and one to a state agency (Victorian Department of Environment and Primary Industries). Of the 106 DIR licences issued since commencement of the Gene Technology Act 2000, 56 (53 per cent) have been to private companies, 39 (37 per cent) to government agencies and 11 (10 per cent) to universities (figure 2).

On 12 July 2013, a milestone was reached with the issuing of the 100th licence for dealings involving intentional release (DIR) of a GMO. The Gene Technology Regulator approved DIR 120, an application for a field trial of a new type of cotton that has been genetically modified for insect resistance and herbicide tolerance.

CHAPTER 3 31

Table 5: Applications and notifications, 2013-14

Application type Received

A

Withdrawn Approved

B

Refused Ceased

consideration

C

Under

consideration

D

Accreditation 4 0 4 0 0 2

CCI declaration for DIR licence

10 1 15 0 0 3

CCI declaration for DNIR licence

2 0 0 0 0 5

CCI declaration for NLRD notification

2 2 0 0 0 0

CCI declaration for other information

1 0 1 0 0 0

Certification 176 4 183 0 0 28

DIR licence 6 0 7 0 0 4

DNIR licence 13 4 10 0 0 5

Lifting suspension of certification

26 0 24 0 0 2

NLRD notification 828 n/a n/a n/a n/a n/a

Surrender of accreditation 3 0 5 0 0 0

Surrender of certification 101 5 94 0 0 34

32 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Application type Received

A

Withdrawn Approved

B

Refused Ceased

consideration

C

Under

consideration

D

Surrender of DIR licence 1 0 1 0 0 1

Surrender of DNIR licence 13 1 12 0 0 2

Suspension of certification 74 1 71 0 0 2

Transfer of certification 28 0 27 0 0 1

Transfer of DNIR licence 3 1 4 0 0 0

Variation of accreditation 0 1 0 0 0 0

Variation of certification 319 5 338 0 0 41

Variation of DIR licence 14 3 21 1 0 2

Variation of DNIR licence 69 4 71 0 0 14

Total 1693 32 888 1 0 146

ained dealing with a

aried licence w or v

DNIR = cont

o issuing of a ne

onment;

ers t ef

vir

ed r

o the en

v o Appr

.

ear.

o a CCI application.

2000

elease of a GMO int w risk dealing.

Act hnology

NLRD = notifiable lo

ec

tification.

ed in the previous financial y

Gene T

elation t

entional r

our DIR licences and one cer

eceiv ation in r

olving int onment;

lar

e r

DIR = dealing inv

er

vir

ear w o a dec

under section 42 of the

o the en

ormation;

ed in this financial y

elease of the GMO int

o f y the Regulator t

cial inf

v o

o surrender of an instrument or t

‘not considered’ and

CCI = confidential commer

ed as appr

ation’

une 2014.

entional r

ed b

t epor consent t

ation at 30 J

es:

GMO not involving int

ariations initiat

‘ceased consider

ludes v

ludes both

Inc

Inc

Not

A

Some applications r B or other instrument, C Under consider D

CHAPTER 3 33

Table 6: DIR licences issued, 2013-14 DIR No. Applicant

Parent organism

Introduced trait Type of release Received Issued

DIR 118 Monsanto Australia Limited Cotton (

Gossypium barbadense

L.)

Herbicide tolerance Commercial 21-8-2012 16-8-2013

DIR 120 Monsanto Australia Limited Cotton ( Gossypium

hirsutum L.

)

Insect resistance; herbicide tolerance Limited and controlled

7-12-2012 12-7-2013

DIR 121 CSIRO Safflower

(

Carthamus tinctorius L

.)

Altered oil profile Limited and controlled 21-12-2012

22-7-2013

DIR 122 Victorian Government Department of Environment and Primary Industries

Wheat (

Triticum aestivum L.

)

Abiotic stress tolerance; yield

Limited and controlled

2-4-1013 31-10-2013

DIR 123 Nu

see

d Pty Ltd Canola

(

Brassica napus L.)

Composition—food (human nutrition); composition— animal nutrition; selectable marker

Limited and controlled

18-4-2013 13-11-2013

34 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

DIR No. Applicant

Parent organism

Introduced trait Type of release Received Issued

DIR 124 Monsanto Australia Limited Cotton (

Gossypium hirsutum L

.)

Herbicide tolerance; insect resistance; selectable markers— herbicide and antibiotic; reporter gene expression

Commercial 1-8-2013 19-6-2014

DIR 126 PaxVax Aus Pty Ltd Cholera bacterium (

Vibrio cholera)

Vaccine - attenuation, Selectable marker - mercury resistance

Limited and controlled

3-9-2013 10-4-2014

CHAPTER 3 35

Figure 2: DIR licences issued by organisation type since commencement of the Gene Technology Act 2000 (%)

LICENCES FOR DEALINGS NOT INVOLVING INTENTIONAL RELEASE OF GMOS DNIR licences authorise dealings with GMOs that are conducted in laboratories and other physical containment facilities and which may pose risks that require management through the imposition of specific licence conditions. For DNIR licence applications, the Regulator must make a decision within the statutory time frame of 90 working days.

In 2013-14, the Regulator issued 10 DNIR licences (see table 7). One of these licences (DNIR-532) incorporates two DNIR applications issued as one licence. All approvals were made within the statutory time limit of 90 working days. The Regulator was considering a further five DNIR applications at 30 June 2014. The types of GMO dealings authorised by DNIR licences issued in 2013-14 are research applications, the focus of which is shown in figure 3.

Company

0

0.3

0.1

0.4

0.2

0.5

0.6

Government University

53% 37% 10%

36 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Table 7: DNIR licences issued, 2013-14

DNIR No. Applicant Title Received Issued

DNIR-524 Macfarlane Burnet Institute for Medical Research and Public Health

Bat retroviruses 3-12-2012 22-10-2013

DNIR-532 University of New South Wales HCV founder virus evolution: evolution

and vaccine targets

25-2-2013 4-7-2013

DNIR-535 Griffith University Investigation of

malaria parasite proteins

29-4-2013 26-8-2013

DNIR-536 Ascend Biopharmaceuticals Ltd Clinical study of the efficacy and

safety of intra-tumoural injection of ASN-002 in nodular basal cell carcinoma

28-6-2013 29-10-2013

DNIR-537 CSIRO The molecular

basis of the pathogenicity of Newcastle disease in chickens

2-7-2013 2-12-2013

DNIR-539 Queensland University of Technology Development and use of a banana

streak virus-based virus vector to investigate banana-Fusarium interactions

28-8-2013 6-1-2014

DNIR-540 Flinders University Mouse model for

studies of B cells migration into the eye

26-8-2013 17-12-2013

DNIR-542 CSIRO The molecular

determinants of pathogenicity, tissue tropism and transmissibility of influenza A virus.

26-9-2013 30-1-2014

CHAPTER 3 37

DNIR No. Applicant Title Received Issued

DNIR-543 University of New South Wales HIV Biology of Latency and

Assembly

16-10-2013 21-2-2014

DNIR-546 Macquarie University Investigation of the role of glia in the control of blood pressure

20-1-2014 28-5-2014

Figure 3: Research focus of DNIRs approved, 2013-14

Four DNIR licences were issued for the study of human pathogens and one DNIR licence authorised human clinical studies. Two DNIR licences authorised dealings with viral vectors for research into human diseases. Two DNIR licences were issued for the study of animal pathogens and one DNIR licence authorised the study of plant pathogens. Four DNIR applications were withdrawn during the reporting period as the OGTR advised the applicant that the proposed dealings should be assessed as NLRDs. The submission of these applications for the more highly scrutinised DNIR classification reflects the cautious approach of researchers and accredited organisations.

Six of the 10 DNIR licences issued in 2013-14 were issued to publicly funded universities. One licence was issued to a private company, one was issued a research institute and two were issued to a government agency (CSIRO) (figure 4).

Since the commencement of the scheme, 416 DNIR licences have been issued by the Regulator. As of June 2014, the majority of DNIR licences issued by the Regulator have been to universities (figure 5).

Treatment/prevention Gene function/expression Pathogenesis

40%

20%

40%

38 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Figure 4: Types of organisations that were issued DNIR licences in 2013-14

Figure 5: DNIR licences issued since commencement of the Gene Technology Act 2000

Company

0%

30%

10%

40%

20%

50%

60%

70%

Government Research Institute University

10% 20% 60% 10%

Company

Government

Health service/ hospital

Research Institute

University

0%

15%

5%

20%

10%

25%

30%

35%

40%

45%

15% 13% 17% 40% 15%

CHAPTER 3 39

NOTIFIABLE LOW RISK DEALINGS NLRDs are types of dealings that have been assessed, based on previous experience and current scientific knowledge, as posing low risk. Dealings with GMOs classified as NLRDs are listed in the Regulations under Schedule 3, Part 1 (NLRDs appropriate for PC1 facilities) and Schedule 3, Part 2 (NLRDs appropriate for PC2 (Part 2.1) and PC3 (Part 2.2) facilities). Conduct of NLRDs does not require prior authorisation from the Regulator, but the dealings must have been assessed by an institutional biosecurity committee (IBC) as meeting the NLRD classification, must be conducted in appropriate containment facilities and must comply with other requirements specified in the Regulations. NLRDs must be notified to the Regulator annually. There is a five-year time limit on the authority to conduct an NLRD.

The Regulator received 828 NLRD notifications during 2013-14. As in past years, notified NLRDs were predominantly for research work. The types of organisations that notified NLRDs to the Regulator in 2013-14 is shown in figure 6.

Figure 6: Types of organisations that notified NLRDs in 2013-14

Company

Government

Health service/ hospital

Research Institute

University

0%

30%

10%

40%

20%

50%

60%

70%

2% 8% 21% 60% 9%

40 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

DEALINGS PLACED ON THE GMO REGISTER The GMO Register is a list of dealings with GMOs that the Regulator is satisfied pose minimal risk to human health and safety and the environment and can therefore be undertaken by anyone, subject to any specified conditions, without oversight of a licence holder. Sections 78 and 79 of the Gene Technology Act 2000 allow the Regulator to place dealings with GMOs on the GMO Register provided they have previously been licensed, pose minimal risks to people or the environment and are safe for anyone to use without the need for a licence. Such determinations are disallowable legislative instruments and must be tabled in Parliament. During 2013-14 the Regulator entered no new listings on the GMO Register, received no applications to place any dealings on the GMO Register and had no applications under consideration.

EMERGENCY DEALING DETERMINATION An EDD is a legislative instrument made by the Minister under section 72 of the Gene Technology Act 2000 to expedite approval of dealings with a GMO in an emergency. The Regulator provides risk assessment and management advice to the Minister and administers the EDD, including monitoring for compliance with any EDD conditions.

Further information about the process for making EDDs and EDDs issued under the Gene Technology Act is provided in appendix 2. Before making an EDD, the Minister must be satisfied that:

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

2. the dealings proposed t o be specified in the EDD would, or would be likely to, adequately address the threat

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

In relation to (1) the threat and (2) addressing the threat, the Minister must have received advice from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer or the Commonwealth Chief Plant Protection Officer. In relation to (3) management of risks, the Minister must have received advice from the Regulator. The states and territories must also have been consulted. EDDs can only be made to have effect for up to six months but may be extended by the Minister for additional periods of up to six months at a time, subject to similar requirements as outlined above for making the EDD.

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

During 2013-14 the Regulator did not receive any requests for advice in relation to making any EDDs, no EDDs were made and none were in effect.

To date, one EDD has been issued for the temporary authorisation of equine influenza vaccine. This was issued in September 2007, was extended once, and expired in September 2008.

CHAPTER 3 41

ACCREDITED ORGANISATIONS The Regulator requires organisations licensed to conduct work with GMOs to remain accredited. To achieve and retain accreditation, the organisation must satisfy the Regulator that it 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. For accreditation applications the Regulator must make a decision within the statutory time frame of 90 working days.

At 30 June 2014, 162 organisations were accredited. There has been no significant change in the profile of the types of organisations accredited by the Regulator. Figure 7 shows a high proportion (69 per cent) of accredited organisations are primarily publicly funded. Figure 8 shows that accredited organisations are located in all Australian jurisdictions, as well as one based in the United States of America.

Figure 7: Organisations accredited at 30 June 2014 by type of organisation

Company

0%

15%

5%

20%

10%

25%

30%

35%

Government Research

Institute

Health service/ hospital

University

31% 14% 18% 22% 15%

42 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Figure 8: Organisations accredited at 30 June 2014 by location of headquarters

0%

15%

5%

20%

10%

25%

30%

35%

5% 25% 17% 10%

1%

30% 9%

1%

2%

ACT NSW NT QLD SA TAS VIC WA USA

CERTIFIED PHYSICAL CONTAINMENT FACILITIES For applications for certification of physical containment (PC) facilities in accordance with the Regulator’s Certification Guidelines, the Regulator must make a decision within the statutory time frame of 90 working days.

PC facilities are classified according to levels of stringency of measures for containing GMOs. The classifications relate to the structural integrity of buildings and equipment used as well as to the handling practices employed by those working in the facility. PC level 1 (PC1) facilities are used to contain organisms posing the lowest risk to human health and the environment. PC level 4 (PC4) facilities provide the most secure and stringent containment conditions. The number of facilities certified as at 30 June 2014 is listed in table 8 by facility type and containment level.

During 2013-14, 183 certifications for PC facilities were issued (table 5).

OGTR-certified PC facilities are located in all Australian jurisdictions (figure 9).

CHAPTER 3 43

Table 8: Number of facilities certified at 30 June 2014 by physical containment level and type

Facility type PC1 PC2 PC3 PC4

Animal 244 4

Aquatic 28

Constant temperature room

49

Facility 266 4

Invertebrate 42 3

Laboratory 1142 28

Large grazing animal 47

Large scale 20

Plant 172

Total 313 1697 35 4

Note: This table excludes facilities for which the certifications were suspended (at the request of the certification holders) as at 30 June 2014.

Figure 9: Physical containment facilities certified at 30 June 2014 by location

0%

15%

5%

20%

10%

25%

30%

35%

40%

6% 21% 16% 11%

1%

36% 8% 1%

ACT NSW NT QLD SA TAS VIC WA

44 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Applications for certification of PC facilities in 2013-14 reflected the proportions of types of organisations involved in contained dealings (NLRDs and DNIRs). Private companies submitted only approximately 9 per cent of the applications for certification in the reporting year, compared with 12 per cent from government agencies, 3 per cent from health services/ hospitals, 26 per cent from research institutes and 50 per cent from universities.

TREND DATA FOR APPROVAL OF MAIN TYPES OF APPLICATIONS Table 9: Trend data for approval of main types of applications, 2009-10 to 2013-14

Financial year “approved” 2009-10 2010-11 2011-12 2012-13 2013-14

Accredited 8 7 5 8 4

Certified 182 171 207 199 183

DIR 8 6 6 4 7

DNIR 18 14 11 10 10*

NLRD 629 553 553 677 828

* This includes issuing of one DNIR licence that incorporated two DNIR applications.

Applications can be made to the Regulator under section 184 of the Gene Technology Act 2000 for specified information that has not previously been made public to be declared CCI. The extent of CCI claims can be the subject of considerable discussion with the applicant and may require the OGTR to independently verify what information is already in the public domain. The Gene Technology Act does not assign a statutory time frame within which the Regulator must make a decision on CCI applications, and the evaluation of a licence application may be paused if significant CCI claims need to be resolved. In 2013-14 the Regulator made 16 CCI declarations; decisions on eight CCI applications were pending at 30 June 2014.

Surrender of licences and certifications usually occurs when dealings have concluded. Before surrender is approved, the Regulator must be satisfied that all conditions (such as post-harvest monitoring) have been met and that any required cleaning and/or decommissioning of facilities has taken place. The OGTR received 118 surrender requests in 2013-14 and approved 112. The approvals included 94 for surrender of certifications of facilities, 12 to surrender DNIR licences, five to surrender accreditations and one to surrender a DIR licence.

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

The OGTR approved 430 variations in 2013-14.

CHAPTER 3 45

MONITORING OF GENETICALLY MODIFIED ORGANISMS This section provides information on the range of inspection activities the OGTR conducted during 2013-14. The Regulator’s quarterly reports5 provide detailed information about the inspections.

Inspections of DIR licences The OGTR strategy for conducting field-trial monitoring draws on accumulated operational experience of compliance risk profiling. 6

During 2013-14, 18 accredited organisations held the 55 DIR licences in force. Eight licences were for commercial release of GMOs (seven for crops, one for a vaccine). None of these licences imposed conditions that necessitate monitoring. Of those licences for limited and controlled release of a GMO, four were for vaccine trials, and 43 were for limited and controlled trials of GM crop varieties. The OGTR inspected 15 of the 43 licences for limited and controlled trials of GM crop varieties. Each licence may contain a number of trial sites. One inspection of a limited and controlled vaccine trial was undertaken.

Outcome of inspection activities The OGTR’s operational objective is to monitor at least 20 per cent of all limited and controlled field-trial locations annually. A further target within this operational benchmark is to inspect a minimum of 5 per cent of all limited and controlled field trial sites during each quarter of the year. In 2013-14 the OGTR exceeded its operational benchmark and exceeded its quarterly objective. At the beginning of 2013-14, 94 licensed field trial sites were operating, 25 of which were current and 69 of which were subject to post-harvest monitoring conditions. The OGTR inspected 38 sites in 2013-14 (19 current and 20 post-harvest monitoring sites) representing 40 per cent of total sites as of 1 July 2013, thereby exceeding the minimum target of 20 per cent of field trial sites each year (table 2). A breakdown of the number and proportion of inspections is in table 10.

Table 10: Number and proportion of inspections performed in each quarter of 2013-14

Quarter Number and proportion of

current sites inspected Number and proportion of PHM sites inspected

July-September 2013 3/25 (12%) 4/69 (6%)

October-December 2013 3/31 (10%) 4/62 (6%)

January-March 2014 5/49 (10%) 7/61 (11%)

April-June 2014 8/37 (21%) 5/72 (7%)

5 Available from OGTR, or at .

6 Find more detail fr om the Monitoring Protocol at .

46 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

GM crop field trial types The DIR licences in force authorised the limited and controlled release of a range of crop and plant types including banana, barley, canola, cotton, Indian mustard, maize, perennial ryegrass/tall fescue, safflower, sugarcane, wheat and white clover. Although licences were in force, planting has not occurred in all cases. Canola was the most prevalent crop, collectively trialled at 31 sites. The OGTR inspected 38 field-trial sites across seven crop types during 2013-14 (table 11).

Table 11: Number of licensed DIR sites by crop type/parent organism at beginning and end of 2013-14 and number of inspections conducted in 2013-14

Crop type / parent organism

Number of DIR trial sites at beginning of 2013-14

Number of DIR trial sites at end of 2013-14

Number of DIR trial sites inspected in 2013-14

Banana 5 4 5

Barley 3 4 1

Barley, wheat 8 4 3

Canola 31 39 10

Canola, Indian mustarda

2 2 0

Cotton 25 11 6

Maize 1 0 0

Perennial ryegrass 0 1 0

Perennial ryegrass, tall fescuea

1 0 0

Safflower 0 2 1

Sugarcane 11 14 7

Wheat 5 7 5

White clover 2 2 0

Total 94 90 38

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

CHAPTER 3 47

Cycle and status of field trial sites During each year the status of field trials of GM crops undergoes significant changes. New trials are planted and become subject to licence conditions to manage dissemination of the GMO from the trial site. Other trials are harvested and enter a post-harvest monitoring period. Monitoring of the trial site continues until the OGTR is satisfied that no further inspections are required to manage persistence of the GMOs. The OGTR then signs off the site as having completed all necessary licence obligations.

Figure 11: Total number of field trial sites and their status throughout 2013-14*

Note: PHM = post-harvest monitoring.*

As a result of the issuing of the licence for DIR 124 for the commercial release of Bollgard®III and Bollgard®III x Roundup Ready Flex® cotton, all DIR 101 field trial sites still subject to monitoring obligations were released from those obligations (i.e. ‘signed off’) in late June 2014.

Location by jurisdiction In 2013-14 the OGTR conducted inspections of field trial sites in all states and territories where field trials were undertaken (table 12).

0%

60

20

80

40

100

120

Current sites

PHM sites

Total sites

140

Jul-13

Jan-14

Sep-13

Mar-14

Nov-13

May-14

Aug-13

Feb-14

Oct-13

Apr-14

Dec-13

Jun-14

Jul-14

48 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Table 12: Number of field trial sites and OGTR inspections in 2013-14 by state and territory

Jurisdiction Number of DIR trial sites

at 1 July 2013 Number of field trial site inspections in 2013-14

Australian Capital Territory 6 8

New South Wales 25 8

Northern Territory 2 2

Queensland 21 12

South Australia 4 2

Tasmania 0 0

Victoria 19 4

Western Australia 17 2

Total 94 38

Inspections of contained dealings

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

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

At 30 June 2014,162 accredited organisations held 2144 certification instruments for containment facilities. During 2013-14, certified facilities operated by 21 accredited organisations were monitored. For the purposes of monitoring, certified facilities are grouped into higher and lower containment types. 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 51 inspections across the range of facility types (table 13). Of the 56 higher-level containment facilities that had certification instruments in force at the beginning of 2013-14, 14 were inspected. This figure represented 25 per cent of higher-level containment facilities and exceeded the minimum target of inspecting 20 per cent of such facilities each year (table 2).

In addition, 20 DNIR licences in force during 2013-14 were monitored.

CHAPTER 3 49

Table 13: Number of inspections of certified facilities (by type) conducted during 2013-14

Containment type Physical containment level and facility type Number of inspections

Lower-level containment facilities PC2 Animal 7

PC2 Invertebrate 2

PC2 Laboratory 23

PC2 Plant 5

Higher-level containment facilities PC2 Large scale 1

PC3 Animal 4

PC3 Laboratory 7

PC4 Facility 2

Total 51

Inspections by state Certified facilities are located in all Australian states and territories (figure 9). In 2013-14, monitoring activities were carried out in each state and territory except the Australian Capital Territory and Tasmania (figure 12). The number of OGTR inspections of facilities reflects, as far as practicable, the number of facilities in each state and territory.

50 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Figure 12: Number of certified facility inspections in 2013-14 by state and territory

Inspections by organisation type Of the five OGTR categories of applicant organisations, universities held the greatest number of certifications during 2013-14 (figure 13). The number of OGTR inspections of facilities in each organisation category reflects, as far as practicable, the number of facilities present in each category (figure 14).

0

6

2

8

4

10

12

14

16

18

NSW NT QLD SA VIC WA

CHAPTER 3 51

Figure 13: Distribution of certified facilities at 30 June 2014 by organisation type

Figure 14: Number of certified facility inspections in 2013-14 by organisation type

Company

0

600

200

800

400

1000

1200

Government Research

Institute

Health service/ hospital

University

94 287 373 1073 222

Company

0

15

5

20

10

25

Government Research

Institute

Health service/ hospital

University

52 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

COMPLIANCE WITH THE GENE TECHNOLOGY ACT 2000

During 2013-14, the regulated community demonstrated a high level of compliance with gene technology legislation (table 2).

In conducting routine inspections, the OGTR found some inconsistencies between an event or state of affairs and the requirements imposed by licence or certification conditions. Such inconsistencies are referred to here as non-compliances. Non-compliance is not regarded as a breach of the Gene Technology Act 2000 unless, after investigation, it is proven to be so. Each incident of non-compliance was assessed according to established OGTR protocols and found to present negligible risk to human health and safety or to the environment.7

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. 8

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

Non-compliances During 2013-14, OGTR monitoring of DIR licences found two instances of non-compliance where flowering volunteers were identified on post-harvest monitoring trial sites.

One instance of non-compliance was identified through monitoring of DNIR licences in 2013-14 where the licence holder had not obtained signed statements from staff undertaking licenced dealings.

A number of minor non-compliances were also identified during routine monitoring of containment facilities (table 14). Non-compliances included issues such as lapsed/failure of equipment, structural defects and issues with work practices.

7 These incidents are discussed in the Regulator’s quarterly reports, available at .

8 The protocol is available at .

CHAPTER 3 53

Table 14: Number of non-compliances identified in certified facilities during 2013-14 by non-compliance type

Nature of non-compliance Number of non-compliances

Equipment 5

Structure 3

Personal protective equipment 0

Transport 0

Waste disposal 0

Work practices 1

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

• a pr ogram 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 r egulated-party annual reports and other information collected under the regulatory system

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

• f eedback on continual improvement of OGTR regulatory specifications and arrangements

• conducting in vestigations, which can draw on monitoring and any of the above compliance management activities.

54 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

The OGTR investigates all reported or detected contraventions of legislation it administers, in accordance with the OGTR Compliance and Enforcement Policy.9 Investigations are initiated through a preliminary assessment of relevant facts and likely impacts 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 legislative provisions, the OGTR determines the appropriate level, if any, of further investigation and response.

No investigations were required in the reporting period. The OGTR completed four audits (the Australian National University, Austin Health, Murdoch University, and the University of Queensland) in 2013-14. It has also progressed four additional audits and five practice reviews in 2013-14. Audits involve a comprehensive examination of an accredited organisation’s compliance management arrangements. Practice reviews apply single compliance risk themes from audits to a number of review participants to identify and resolve compliance management risks. The review themes assessed in 2013-14 were partnerships; transport, storage and disposal; facilities and equipment notices, notifications and records; and people management. When completed, these activities are reported in the Regulator’s quarterly reports to the Parliament of Australia.

National strategy for unintended presence of unapproved GMOs In 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 the then Biotechnology Australia and comprising the Department of Agriculture, Fisheries and Forestry10; the Department of the Environment and Heritage;11 the Department of Foreign Affairs and Trade; the Department of Education, Science and Training;12 the Department of Industry, Tourism and Resources;13 the Department of Health and Ageing14; Food Standards Australia New Zealand (FSANZ); and the OGTR.

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

In recent years the OGTR has worked with the Australian Seed Federation (ASF) 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.

9 T he policy is available at via the links to Monitoring and Compliance.

10 No w the Department of Agriculture

11 No w the Department of the Environment

12 No w the Department of Education

13 Depar tment of Industry

14 No w the Department of Health

CHAPTER 3 55

In 2009-10 the OGTR began quality assurance reviews of Australian and state government and industry breeding programs. No issues of concern were identified for the six companies that participated in the quality assurance reviews conducted since this time.

In 2013-14 the OGTR continued to work with the Australian seed industry including presenting at the ASF annual conference. The OGTR also presented at a GM lucerne symposium hosted by Lucerne Australia.

In March 2014 the OGTR engaged SGA Solutions to assist in the development of an internal decision-making framework for the management of potential low-level presence (LLP) incidents, The project required development of realistic LLP scenarios to test the decision framework and hosting of a workshop with Australian Government agencies, including the Department of Agriculture, Department of Foreign Affairs and Trade, Department of Environment, and FSANZ, to test the scenarios and decision framework.

56 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

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

COMPONENT DESCRIPTION

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

The OGTR has established a memorandum of understanding with the Department of Agriculture 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 Environment 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.

Industry’s laboratory testing The voluntary code of conduct refers to testing programs. Industry needs to be able to assure itself that it is managing the risk of importing unapproved seeds.

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 engagement with Australian Government agencies, relevant industry organisations and states and territories on this issue.

CHAPTER 3 57

CONSULTATION AND PROVISION OF ADVICE TO STAKEHOLDERS The Regulator’s functions, as prescribed by section 27 of the Gene Technology Act 2000, include:

• issuing tec hnical and procedural guidelines in relation to GMOs

• providing advice to the Legislative and Governance Forum on Gene Technology (LGFGT15) about:

o the operations of the Regulat or and the GTTAC

o 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.

Security Sensitive Biological Agents Regulatory Scheme The 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 in the Department 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. Inspection activities commenced early in 2009-10 and have continued throughout 2013-14.

Revised guidelines In 2013-14, the Regulator issued the following revised guidelines:

• Guidelines for Certification of a Physical Containment Level 2 Large Grazing Animal Facility Version 1.1 (effective from 12 February 2014).

15 The Act refers to the Ministerial Council. As part of reforms by COAG, on 11 February 2011, the former Gene Technology Ministerial Council became the Legislative and Governance Forum on Gene Technology.

58 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Advice to the Legislative Governance Forum on Gene Technology The LGFGT initiated an independent review of the Gene Technology Act 2000 in June 2011 and invited public submissions. The Regulator provided a submission to the review. The report of the 2011 Independent Review of the Gene Technology Act 2000 was made publicly available in December 2011. It concluded that the national scheme is effective and efficient and the regulatory burden and compliance costs appear justifiable compared with the benefits achieved. It made a number of recommendations aimed at improving the operation of the scheme.

The LGFGT finalised an all-governments response to the review and to its recommendations in July 2013. In 2013-14, the OGTR implemented operational recommendations from the 2011 Review of the Gene Technology Act 2000. This included a range of activities to improve communication and consultation with regulated stakeholders and the public, including targeted use of social media for consultation on a DIR application (see section on advice to public), updated fact sheets in plain English available on the OGTR website, feedback from key regulated organisations and members of the client register via a survey to inform the review of the OGTR website (see section on OGTR website), and ongoing participation in relevant international forums (see section on international regulatory liaison). The OGTR also collaborated with colleagues in the Department in relation to progressing review recommendations related to legislative changes.

Advice on GMOs and GM products During 2013-14, the OGTR provided advice on the regulation of GMOs and GM products to other regulatory agencies and to the public.

Advice to other regulatory agencies To facilitate reciprocal exchange of information with the other product regulatory agencies on assessment and approval of GMOs and GM products required by their respective legislation,16 the OGTR has developed memoranda of understanding with FSANZ, the Therapeutic Goods Administration (TGA), Australian Pesticides and Veterinary Medicines Authority (APVMA) and the Australian Quarantine and Inspection Service (now Department of Agriculture Biosecurity). In 2013-14 the OGTR progressed reviews of several of these memoranda. The OGTR also provided input to a proposed overarching memorandum of understanding between the Department of Health and the Department of Agriculture. The OGTR also has a memorandum of understanding with the Department of the Environment, in relation to consultation with the Environment Minister on DIR licence applications prescribed under the Gene Technology Act 2000.

16 T he OGTR maintains the GMO Record, as a source of public information on such approvals, on its website at . The Gene Technology Consequential Amendments Act 2000 provides for product regulators FSANZ, TGA, the National Industrial Chemicals Notification and Assessment Scheme and APVMA to seek advice from the Regulator on GM products.

CHAPTER 3 59

In line with recommendations from the 2006 Statutory Review of the Gene Technology Act 2000, a Regulators’ Forum has been established to promote and facilitate information sharing between these regulatory agencies and the Regulator. The forum met three times in 2013-14, discussing a work program for enhancing overall regulatory effectiveness through improved cross-agency collaboration. The Regulatory Science Network is linked to the Regulators’ Forum and has met regularly, organising an Inter-Agency Workshop on Science Communication in which OGTR staff participated.

Advice to the public The Gene Technology Act 2000 requires the Regulator to maintain a record of GMO and GM product dealings (the GMO Record). The GMO Record includes 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. The GMO Record was maintained and updated throughout 2013-14 to incorporate approvals of GMOs under the Gene Technology Act and GM product approvals notified to the Regulator by other agencies. The general public can access the GMO Record freely on the OGTR website .

In 2013-14, the OGTR received a number of emails and phone calls from members of the public as a result of misinterpretation of technical information in various social media channels regarding the licence application DIR 126 for a GM cholera vaccine. The OGTR took immediate action to update the website with additional non-technical information. As a result of the increased public interest, the Regulator also tweeted calls for submission on the RARMP for DIR 126 using the Department of Health Twitter handle every alternate week during the six-week consultation period to enhance wider circulation of information and consultation with a broader cross section of the community.

OGTR website and contact points The OGTR maintains a comprehensive website 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 RARMPs for each licensed release of a GMO into the environment. The OGTR completed review of several fact sheets on the website to improve their readability and provide plain English information to stakeholders and the public, The updated versions of factsheets are uploaded on the OGTR website. Other new information for the public in 2013-14 included a plain English summary of the Risk Analysis Framework document, and an OGTR assessment and rebuttal of a journal article reporting adverse effects from GM feed.

In March 2014, the OGTR engaged Reading Room Australia Pty Ltd to refresh the website design and content, and improve functionality and user experience. During this project, a targeted survey of key stakeholders was conducted to receive feedback on the current website content, clarity of language, navigation, function, style, usability etc. The OGTR received constructive feedback in response to the survey which then informed the website review and will guide future redevelopment of the website. A refreshed new look OGTR website is planned to be launched in 2014-15.

Website use statistics are provided in appendix 6.

60 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Comments about the website from stakeholders

On the whole, those interviewed said they were quite happy with the content on the website, that it was quite comprehensive, some improvements to design and navigation would be helpful.

The length of pages were a specific complaint by a third of interviewees.

Certification guidelines were considered easy to understand and to implement, and many said that the OGTR guidelines are aligned well with other standards that they also need to adhere to, such as the Australian Quarantine and Inspection Service, and this led to a positive view of OGTR as a regulator.

The availability of audit information and checklists were praised as well, but participants requested more how-to information on auditing and certifying a facility, and clearer information available on the website. A common theme around certification was around the “interpretation” of the guidelines as there are grey areas that often need consultation with the OGTR to clear up, although recent guidelines have become clearer.

Perception of OGTR responses was very high, with responses considered to be very quick, any delays being indicated upfront and the information received being professional and helpful. The OGTR appeared to be quite open to discussion and proactive to work with, which further helped the overall perception of the organisation as transparent and consultative.

The OGTR also has a 1800 free call number (1800 181 030) and an email address 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 the services provided by these facilities.

The OGTR maintains a client register, which is a list of individuals and organisations that have registered their interest in regulation of gene technology. Members receive notifications of new applications for GMOs and licences issued for release of GMOs into the environment, significant changes to gene technology legislation, and invitations to comment on consultation RARMPs developed for each application to release a GMO into the environment. Approximately 472 individuals and organisations are listed on the OGTR client register. To be included on the OGTR client register and receive notifications, interested people should contact the OGTR.

During 2013-14 the Regulator and the OGTR participated in a range of presentations and meetings on gene technology to inform users, the Australian community and stakeholders about the regulatory system (appendix 7).

INVESTIGATION OF COST RECOVERY FOR OGTR The Department of Health is investigating the feasibility of cost recovery for OGTR services. Following on from an activity-based costing study of OGTR in the previous reporting period, in 2013-14 the Department conducted an economic analysis of the gene technology sector to inform policy considerations. The Department has been preparing a draft regulatory impact statement on potential costing models for consultation with the regulated community and other stakeholders during 2014-15.

CHAPTER 3 61

INTERNATIONAL REGULATORY LIAISON Under section 27 of the Gene Technology Act 2000 the Regulator’s functions include:

• monit oring international practice in relation to regulation of GMOs

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

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

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

In 2013-14 the OGTR actively engaged in international forums focusing on harmonising the risk assessment and regulation of GMOs. This included contributing to development of guidance documents by groups under the OECD and the United Nations Cartagena Protocol on Biosafety. In the OECD, Australia is represented on the Working Group on the Harmonisation of Regulatory Oversight in Biotechnology by Dr Peter Thygesen of the OGTR. The OGTR coordinated Australia’s input to current projects, including the guidance document on low-level presence in seeds and commodities, the guidance document on environmental considerations, and the sub-working group on microorganisms. The OGTR also represented Australia as the lead for consensus biology documents on sugarcane, eucalyptus and cowpea. The sugarcane document was finalised in November 2013. In February 2014, the OGTR also represented Australia at an OECD workshop on risk assessment of crops developed using new plant breeding technologies, and presented on working group activities on biotechnology to the 51st session of Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology.

As part of the OGTR’s engagement with the UN Cartagena Protocol on Biosafety, Dr Paul Keese participated in an open-ended online forum on risk assessment and risk management and on the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management.

In August 2013, the Regulator signed a Memorandum of Understanding with the International Centre for Genetic Engineering and Biotechnology for establishing collaborative activities on risk assessment and regulation of GMOs with a number of African GMO regulators to promote harmonisation, monitor international practice and maintain links with international organisations that regulate GMOs.

In November 2013 the OGTR took advantage of the presence of a number of representatives from international regulatory agencies in Australia to hold a workshop in Canberra with four international speakers to discuss international regulatory challenges in gene technology. The workshop was attended by staff from the OGTR and other Australian government agencies with an interest in gene technology regulation.

62 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

The OGTR also participated in Australian Government and international discussions around strategies for preventing and managing possible low-level presence of GM crops and attending an Food and Agriculture Organization of the United States’ meeting on LLP. The OGTR continued to liaise with other Australian Government agencies in responding to the detection of unauthorised GM wheat in the USA. The OGTR interacted with key regulatory counterparts in other countries through bilateral discussions and participation in international forums in 2013-14. These activities included presentations, consultation and/or involvement at:

• W orkshop on Biotechnology Commercialisation and Trade in APEC Economies - Biosafety regulatory Perspective, September 2013, Kuala Lumpur, Malaysia

• Int ernational Life Sciences Institute South Asia Biosafety Conference and Workshop, September 2013, Delhi, India

• Biosaf ety Inspections Workshop, Kula Lumpur, Malaysia, October 2013

• 3r d Annual Conference of the Association for Biological Safety of Australia and New Zealand, Auckland, New Zealand, November 2013

• W orkshop on International Regulatory Challenges in Gene Technology, Canberra, Australia, November 2013

• W orkshop on Genetic Basis of Unintended Effects in Modified Plants, Canadian Food Inspection Agency, January 2014, Ottawa, Canada

• OECD Workshop on Environmental Risk Assessment of Products Derived from Novel Plant Breeding Techniques, February 2014, Paris, France

• OECD F ocus Session on Biotechnology during 51st Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology, February 2014, Paris, France

• 28th meeting of the OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology, February 2014, Paris, France

• T echnical Consultation on Low Levels of Genetically Modified Crops in International Food and Feed Trade, UN Food and Agriculture Organisation, March 2014, Rome, Italy

• Eur opean Commission workshop, The Global Pipeline of GM Crops: An Outlook for 2020, Seville, Spain, June 2014

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

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

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

CHAPTER 3 63

Promote harmonisation The OGTR has continued liaison with other regulatory agencies and other Australian Government agencies on relevant issues. Regulatory harmonisation and the need to address regulation of new and emerging technologies has been a focus both nationally and internationally.

The OGTR participated in the following meetings:

• FSANZ w orkshop on New Plant Breeding Techniques. Canberra, August 2013

• LLP/Unint ended Presence (UP) Australian Government Agency meeting, Canberra, October 2013

• Regulat ory Science Network, Science Communication Workshop, Canberra, November 2013.

Find a full list of OGTR activities at Australian meetings, forums and conferences in appendix 7

64 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

CHAPTER 4 MANAGEMENT AND ACCOUNTABILITY

The Office of the Gene Technology Regulator (OGTR)’s management

and accountability practices encompass human resources, work

health and safety, and the Commonwealth Disability Strategy. The

OGTR also adheres to Australian Government purchasing and assets

management, contracting and consultancy policies, as well as

advertising and market research policies, and ecologically sustainable

development. The Gene Technology Regulator reports to the

Parliament annually as well as quarterly, as required by legislation.

HUMAN RESOURCES The OGTR has a workforce of 53 employees. Of these, 48 are ongoing employees and five are non-ongoing employees (appendix 4).

The terms and conditions for non-Senior Executive Service (SES) staff at the OGTR are covered by the Department of Health’s (the Department’s) Enterprise Agreement 2011-2014, which was made under section 172 of the Fair Work Act 2009. This is a principles-based agreement, with most detail on operation of conditions in supporting guidelines. It offers a range of non-salary benefits, listed in table 16.

The OGTR continued to build a strong team culture in its 13th year of operation. A weekly 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 dress day, and staff who took up this option were encouraged to contribute a gold coin for donations to:

• Cancer Council A ustralia

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

• Autism Australia

• Ovarian Cancer Australia

• Salvation Army - Red Shield Appeal.

CHAPTER 4 65

Feedback from the Department’s annual staff survey again indicated a high overall job satisfaction rate for OGTR staff. Survey feedback was used to inform the OGTR People Action Strategy Plan for 2013-14.

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

Two Regulator’s Achievement Awards recognising outstanding staff achievement were awarded in 2013-14: a team award to Dr Andrea Robold and Dr Brian Weir, Plant Evaluation Section, for their excellent work in finalising the revision of the licence application form for limited and controlled release of genetically modified (GM) plants, including data requirements; and an individual award to Dr Heidi Mitchell, Regulatory Practice & Secretariat Section, for sustained and high-quality briefing support to the Regulator in response to a range of priority issues. Staff undertook 120 days (240 days in 2011-12 and 241 days in 2010-11) of formal training during the year, in addition to orientation and induction training for all new starters.

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 agree on the key commitments the employee will undertake and the performance measures and development requirements needed to complete the commitment.

In 2013-14 the OGTR conducted refresher training for the emergency control team, consisting of one floor warden, two fire wardens and one first aid officer. Members of the emergency control team are self-nominated and on completion of the required training receive an allowance in accordance with the Enterprise Agreement.

66 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Table 16: Non-salary benefits

AGREEMENT BENEFITS

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

Access to the employee assistance program

Award scheme

Eligibility for performance-based pay

Extended purchased leave

Flexible working hours

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

Flex time

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

Leave for compelling reasons and exceptional circumstances

Maternity and adoption leave

Parental leave

Pay-out of additional duty in certain circumstances

Recognition of travel time

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

Study assistance

Support for professional and personal development

SES All of the above benefits except flex time

Airport lounge membership

Car parking

Home office equipment

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

CHAPTER 4 67

In keeping with the OGTR’s objective of providing a supportive working environment, staff have access to departmental assistance measures. These 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 and confidential counselling and advice service provided by OPTUM. OGTR staff and their immediate family members 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. 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.

WORK HEALTH AND SAFETY The OGTR is committed to ensuring a safe and healthy work environment for all workers, including contractors and visitors, consistent with the legislative requirements of the Work Health and Safety Act 2001 and the Safety, Rehabilitation and Compensation Act 1988.

The OGTR actively supports injured and ill employees in their return to work and provides appropriate reasonable adjustment to working environments to achieve this, including flexible working arrangements. The commitment to provide rehabilitation assistance to injured and ill employees is supported by medical examinations to determine fitness for duty and workplace rehabilitation assistance.

The OGTR has undertaken a number of activities to embed changes resulting from the introduction of the Work Health and Safety Act on 1 January 2012. Training for ‘officers’, ‘workers’ and health and safety representatives and harassment contact officer has been undertaken. An e-learning module is available for all staff, including contractors and consultants, and a Work Health and Safety Act overview is available on the Department’s intranet site. Work health and safety risk management identification strategies have been incorporated in business planning processes.

The Department undertook work on reviewing health and safety management arrangements, along with associated policies, guidelines and business processes, in order to reflect the requirements of the Work Health and Safety Act.

Initiatives to ensure workers’ health, safety and welfare The OGTR undertook a range of initiatives under its health and life strategy to increase the health and wellbeing of staff, encourage work-life balance and reduce the rates of illness and injury.

The improving wellness and motivation in the workplace: reducing unplanned leave initiative focuses on supporting the Department’s commitment to:

• creating, promoting and maintaining a safe and healthy working environment

• encouraging pr oductive working relationships

• promoting and encouraging behaviours in staff and managers to assist in the management and reduction of unscheduled absence levels.

68 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

The initiative complements existing OGTR strategies and action plans aimed at promoting a positive work environment, preventing illness and injury, optimising performance and managing workloads and work-life balance.

The OGTR provided the option of influenza vaccinations, at no cost, to all staff as part of the health and wellbeing strategy and the Enterprise Agreement.

Health and safety outcomes Information on health and safety outcomes (including the impact on injury rates of workers) achieved as a result of initiatives mentioned above or previous initiatives is incorporated into the Department’s annual report figures.

Notifiable incidents Statistics relating to any notifiable incidents of which the OGTR became aware during the year that arose from the conduct of business or undertakings by the OGTR are incorporated into the Department’s annual report figures.

Investigations under Part 10 of the Work Health and Safety Act No directions, notices or enforceable undertakings under the Occupational Health and Safety (Commonwealth Employment) Amendment Act 2006 or the Work Health and Safety Act were served on the OGTR during the year.

Work health and safety inspections were undertaken at the OGTR premises in Barton during 2013-14 and no major health or safety issues were identified.

Other work health and safety support included provision of training in first aid, emergency evacuation systems and fire safety systems.

FREEDOM OF INFORMATION Agencies subject to the Freedom of Information Act 1982 are required to publish information to the public as part of the Information Publication Scheme (IPS). This requirement (in Part II of the Freedom of Information Act) has replaced the former requirement to publish a section 8 statement in an annual report. Each agency must display on its website a plan showing what information it publishes in accordance with the IPS requirements.17

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

17 T he OGTR plan is at .

CHAPTER 4 69

To enable a prompt response and to help the OGTR meet its obligations under the Freedom of Information Act, 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.

Freedom of information contact details Enquiries about submitting a formal request under the Freedom of Information Act 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 .

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

The Regulator is required by the Freedom of Information Act (section 11C) to publish a disclosure log on the OGTR website. The disclosure log lists information that has been released in response to a freedom of information access request. 18

PURCHASING In 2013-14 the OGTR complied with the Australian Government’s purchasing policies as articulated in the Commonwealth Procurement Guidelines.

18 Find det ails by viewing the log at .

70 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

ASSETS MANAGEMENT The OGTR applies a whole-of-life asset management strategy that is consistent with the Department’s asset management program. In March 2013 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 the OGTR’s assets and ensured that the assets are carried at a value above the recoverable amount.

EXEMPT CONTRACTS No exempt contracts were awarded in 2013-14.

CONSULTANCIES No contract for consultancies were awarded in 2013-14.

The OGTR’s policy on selecting and engaging consultants accords with the Commonwealth Procurement Rules. Value for money is the core principle for selection, underpinned by a focus on encouraging competition, efficiency and effectiveness, ethical practices and accountability and transparency.

The Department’s Chief Executive Instructions and Procedural Rules further support the core principles in the Commonwealth Procurement Rules.

The OGTR contracts consultancy services to ensure the achievement of more efficient and effective delivery of regulation and related outputs.

ADVERTISING AND MARKET RESEARCH The OGTR incurred $24 473 in advertising costs during 2013-14 ($31 142 in 2012-13) Advertising was used primarily to invite the public to comment on risk assessment and risk management plans for licence applications involving intentional release (table 18).

Table 18: Media advertising organisations engaged, 2013-14

Organisation Service Provided Paid $

ADCORP Placing advertising regarding regulatory

activities

16 655

ADCORP Placing advertisements for recruitment of staff 7 818

Note: Amounts listed are inclusive of goods and services tax.

CHAPTER 4 71

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

The Annual Report on the Operations of the Gene Technology Regulator 2012-13 was tabled in Parliament on 30 October 2013. 19

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

• genetically modified organism (GMO) licences issued during the quar ter

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

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

Appendix 5 lists the quarterly reports the OGTR published in 2013-14.20

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

The Commonwealth Disability Strategy has been overtaken by a new National Disability Strategy, which sets out a 10-year national policy framework for improving life for Australians with disability, their families and carers. A high-level report to track progress for people with disability at a national level will be produced by the Standing Council on Community, Housing and Disability Services to the Council of Australian Governments and will be available at . The Social Inclusion Measurement and Reporting Strategy agreed by the Australian Government in December 2009 also includes some reporting on disability matters in its regular How Australia is Faring report and, if appropriate, in strategic change indicators in agency annual reports. More detail on social inclusion matters can be found at .

19 The report is available from the OGTR Information Officer or at .

20 These are also available at or as hard copy by contacting the OGTR Information Officer.

72 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

ECOLOGICALLY SUSTAINABLE DEVELOPMENT AND ENVIRONMENTAL PERFORMANCE The OGTR supports the Australian Government’s commitment to ecologically sustainable development principles and reports here on its operations during 2013-14 against section 516A of the Environment Protection and Biodiversity Conservation Act 1999.

Section 516A(6)(a) - Legislation administered by the Regulator during 2013-14 that accords with ecologically sustainable development principles

The Regulator administers the Gene Technology Act 2000, and corresponding state and territory legislation, 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 2013-14

In 2013-14 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 used statutory powers to monitor and enforce those conditions.

In 2013-14, the Regulator received 18 licence applications; seven were for dealings involving intentional release of a GMO into the environment (DIRs) and 13 were for dealings not involving intentional release of a GMO into the environment (DNIRs). In addition, the Regulator issued 17 licences to deal with GMOs, comprising seven DIRs and 10 DNIRs (this includes one DNIR application that was approved and integrated with another DNIR application into a combined licence) (see chapter 3).

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

APPENDIX 1 73

APPENDIX 1 HISTORY AND STRUCTURE OF THE GENE TECHNOLOGY REGULATORY SYSTEM

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

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

In establishing the regulatory scheme, governments sought to recognise and reach a balance between the potential of gene technology to contribute to society, and community concerns over its development and deployment. The extensive consultation conducted during development of the regulatory scheme reflected the emphasis placed on community input and participation in the decision-making process and generated strong agreement about what should be included and excluded from the scope of the legislation. Broad consensus was reached that the Gene Technology Regulator (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 considered to be out-of-scope, included trade and marketability, cost-benefit considerations, comparisons with alternative technologies, intellectual property and human cloning.

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

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

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

74 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

GOVERNANCE ARRANGEMENTS The Gene Technology Act 2000 and the Gene Technology Regulations 2001 and corresponding state and territory laws (table 19) provide a nationally consistent system to regulate development and use of gene technology in Australia. The legislation establishes the Regulator as an independent statutory office holder to administer the national scheme. Under the intergovernmental Gene Technology Agreement, the states and territories have committed to maintaining corresponding legislation with the Commonwealth. The Regulator is charged with performing functions and exercising powers under the Gene Technology Act and corresponding legislation (figure 15).

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 genetically modified (GM) products as part of a broader or different mandate. During development of the gene technology legislation, it was determined that the Regulator’s activities should form part of an integrated legislative framework that also includes a number of other regulatory authorities with complementary responsibilities and expertise (see figure 16). This arrangement both enhances coordinated decision-making and avoids duplication. The Gene Technology Act was accompanied by consequential amendments of the other relevant Acts relating to requirements for reciprocal request and provision of advice and exchange of information between the Regulator and other relevant regulatory agencies. These requirements include the following:

• the Regulat or must consult Commonwealth regulatory agencies prescribed in the Regulations (see table 22) on all licence applications for dealings involving the intentional release of GMOs to the environment

• ther e are requirements for agencies21 regulating GM products22 to consult and/or notify the Regulator regarding applications for registration of products that are GM or contain GMOs.

These provisions support an adequate and timely flow of information between the agencies to inform assessments and decisions. (Accordingly, where other agencies approve GM products, they seek advice from the Regulator and provide notification of their decisions to the Regulator for inclusion on the GMO Record.)

21 T herapeutic Goods Administration, Australian Pesticides and Veterinary Medicines Authority, Na-tional Industrial Chemicals Notification and Assessment Scheme, Food Standards Australia New Zealand.

22 A thing (other than a GMO) deriv ed or produced from a GMO.

APPENDIX 1 75

Figure 15: Governance arrangements for the Gene Technology Regulator

Intergovernmental Agreement Gene Technology Acts

Legislative and Governance Forum on Gene Technology

Gene Technology Standing Commitee

States and Territories

Regulated Community

Public

Environment Minister

FSANZ DOA TGA NICNAS APVMA Local Councils

GTTAC

GTECCC

Gene Technology Regulator

Office of Gene Technology Regulator

Governance Consultation Advice

Technical Regulatory Consultation

Provide advice at the request of the Legislative and Government Forum or the Regulator

76 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Table 19: Legislation administered by the Gene Technology Regulator

JURISDICTION TITLE OF ACT AND REGULATIONS*

Australian Capital Territory Gene Technology Act 2003 Gene Technology Regulations 2004

Commonwealth Gene Technology Act 2000

Gene Technology Regulations 2001

Guidelines for the Transport, Storage and Disposal of GMOs**

New South Wales Gene Technology (New South Wales) Act 2003

Northern Territory Gene Technology (Northern Territory) Act 2004

Queensland Gene Technology Act 2001

Gene Technology Regulation 2002

South Australia Gene Technology Act 2001

Gene Technology Regulations 2002

Tasmania Gene Technology (Tasmania) Act 2012

Victoria Gene Technology Act 2001

Gene Technology Regulations 2011

* New South Wales, Northern Territory and Tasmania do not have regulations, as their Acts automatically adopt any amendments to the Commonwealth Act and Regulations.

**These guidelines are a legislative instrument issued by the Regulator under section 27(d) of the Gene Technology Act.

APPENDIX 1 77

ROLE OF THE LEGISLATIVE AND GOVERNANCE FORUM ON GENE TECHNOLOGY The Legislative and Governance Forum on Gene Technology (LGFGT)23 provides oversight of the national regulatory scheme for gene technology.

The LGFGT was established by the Council of Australian Governments (COAG) under clause 20 of the intergovernmental Gene Technology Agreement and comprises a representative Minister from each state and territory. Its role is to provide policy guidance for the operation of the Gene Technology Act 2000. In addition, the LGFGT approves appointment of the Regulator and the chairs of the statutory advisory committees (appendix 3) and provides advice to the Australian Government Minister for Health on appointment of committee members.

Section 21 of the Gene Technology Act provides for the LGFGT to issue policy principles on ethical issues related to dealings with 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. Policy principles are legislative instruments and the Regulator must not issue a licence if it would be inconsistent with a policy principle. One policy principle has been issued to date.

Table 20: Policy principles issued to date

POLICY PRINCIPLE DATE ISSUED DATE EFFECTIVE

Gene Technology (Recognition of Designated Areas) Principle 2003

31 July 2003 5 September 2003

The LGFGT is supported by the Gene Technology Standing Committee, which is comprised of of ficials (with relevant technical expertise) representing each state and territory.

To separate the Regulator’s responsibilities relating to implementing the Gene Technology Act from those for developing policy relating to the Gene Technology Act itself, the Department of Health provides the secretariat for the LGFGT and the standing committee.

23 Referred to as the Ministerial Council in the Gene Technology Act 2000, see .

78 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

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

• improve the effectiveness and efficiency of the Regulations. Three sets of amendments to the Regulations have been made: Amendment Regulations 2006 (as a result of the 2004-06 Regulator’s review), Amendment Regulations 2007 (consequential amendments due to the review of the Gene Technology Act) and Amendment Regulations 2011 (as a result of the 2008-11 Regulator’s review). The Regulator’s reviews of the Regulations have focused on technical aspects, particularly that the classification and requirements for the conduct of GMO dealings are commensurate with risk and up to date with current scientific knowledge

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

• confer on the Regulator the function of making available inspectors appointed under section 150 of the Gene Technology Act to be appointed as inspectors under Part 3, Division 7 of the National Health Security Act 2007. These amendments (Gene Technology Amendment Regulations 2009) were in line with COAG recommendations providing for OGTR inspectors to undertake monitoring inspections under the Security Sensitive Biological Agents Regulatory Scheme.

APPENDIX 1 79

Table 21: Amendments to Commonwealth gene technology legislation

AMENDING LEGISLATION

CHANGE INFORMED BY:

SUMMARY OF CHANGES

Gene Technology Amendment Regulations 2006

2004-06 Regulator’s review Requirements for institutional biosecurity committee (IBC) assessment, notification and

conduct of notifiable low risk dealings (NLRDs)

Classification of particular GMO dealings as exempt, NLRD, licensable

Classification of particular techniques as not gene technology, and particular organisms as not GMOs

Licence application requirements detailed in forms issued by the Regulator

Gene Technology Amendment Act 2007

2005-06 Independent Statutory Review of the Gene Technology Act 2000

Capacity to authorise a GMO by an Emergency Dealing Determination

Capacity to authorise disposal of GMOs by inadvertent dealings licence

Specific requirements for assessment and consultation on limited and controlled release licence applications

Changes to application time frames

Gene Technology Ethics & Community Consultative Committee replaces Gene Technology Ethics Committee and Gene Technology Community Consultative Committee

Gene Technology Amendment Regulations 2007

2005-06 Independent Statutory Review of the Gene Technology Act 2000

Annual notification of NLRDs

Changes to classification and containment requirements of NLRDs

Exempt dealing requirements

80 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

AMENDING LEGISLATION

CHANGE INFORMED BY:

SUMMARY OF CHANGES

Gene Technology Amendment Regulations 2009

Council of Australian Governments’ recommendations

OGTR inspectors may be appointed as inspectors for the Security Sensitive Biological Agents Regulatory Scheme

Gene Technology Amendment Regulations 2011

2008-11 Regulator’s review Clarification of requirements for IBC assessment, notification, containment and

conduct of NLRDs, including Transport, Sstorage and Disposal guidelines

Changes to classification of particular GMO dealings as exempt, NLRD, licensable

COORDINATION WITH PRESCRIBED AGENCIES

Sometimes conduct of particular activities with a GMO requires approval from both the Regulator and another regulatory body, for example, dealings with a human medicine that is a GMO. Some human medicines, such as some live GM vaccines, require a licence from the Regulator as well as registration and assessment by the Therapeutic Goods Administration (TGA), which would need to authorise its administration to people. Similarly, while the Regulator is responsible for approving release of GM insecticide- or herbicide-tolerant plants into the environment, the Australian Pesticides and Veterinary Medicines Authority (APVMA), which is responsible for regulating all agricultural chemicals, registers the insecticide product produced in the GM plant and/or approves application of the herbicide to which the GM plants are tolerant.

Although the focus and responsibility of other agencies that regulate products involving GMOs or GM products are distinct from those of the Regulator, where there is also regulation by another agency, the Regulator has a policy of aligning the decision-making processes to the extent that it is practicable within the limits of the relevant legislation. The OGTR and other regulatory agencies work together to ensure that thorough coordinated assessments of parallel applications are undertaken and, wherever possible, that the timing of decisions by the agencies coincides.

There are also instances where there may be approvals by one regulator but not another, for example, Food Standards Australia New Zealand (FSANZ) is asked to assess the safety of a GM product that will be imported for sale for human food where no application has been (and may never be) submitted to the Regulator to grow the GMO in Australia from which the GM product is derived. The respective roles of the various agencies that regulate GMOs or GM products, along with the relevant legislation, are listed in table 22.

APPENDIX 1 81

Table 22: Regulatory agencies in Australia with a role in regulating gene technology GMO/GM PRODUCTS AGENCY PORTFOLIO SCOPE RELEVANT

LEGISLATION

GMO dealings OGTR Health The OGTR underpins the national scheme for

regulating GMOs in Australia. It 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* Health The 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* Health FSANZ is responsible for the Australia New

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

Food Standards Australia New Zealand Act 1991

Agricultural and veterinary chemicals APVMA* Agriculture 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

82 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

GMO/GM PRODUCTS

AGENCY PORTFOLIO SCOPE RELEVANT

LEGISLATION

Industrial chemicals National Industrial Chemicals Notification and Assessment Scheme

Health 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 Department of

Agriculture*

Agriculture Department of Agriculture Biosecurity 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

* Prescribed agencies in the Gene Technology Regulations that the Regulator must consult on applications for a dealing involving intentional release of a GMO into the environment .

APPENDIX 2 83

APPENDIX 2 TYPES OF APPLICATIONS, AUTHORISATIONS, MONITORING AND COMPLIANCE

This appendix outlines the classes of dealings with genetically

modified organisms (GMOs) that are defined by the Gene Technology

Act 2000, the Gene Technology Regulations 2001 and corresponding

state and territory laws, as well as the procedures followed for each

type of application and other instruments that help the Gene

Technology Regulator (the Regulator) to manage risks to health and

safety of people and the environment. It also describes activities that

the Office of the Gene Technology Regulator (OGTR) undertakes to

monitor dealings with GMOs for compliance with legislation, and

actions it takes in response to non-compliances.

THE GMO REGISTER The GMO Register is a register provided by Part 6, Division 3 of the Gene Technology Act 2000.

The Regulator may make a determination to include dealings with GMOs on the GMO Register24 according to section 78 of the Gene Technology Act. To be included on the GMO Register, the dealings must first have been authorised by a GMO licence. Dealings will not be entered on the GMO Register until the Regulator is satisfied that the risks they pose are minimal and that it is not necessary for anyone conducting them to be covered by a licence in order to protect the health and safety of people or the environment. After inclusion on the GMO Register the dealings 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.

24 It is impor tant 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 in-cluded on the GMO Record. The GMO Record is a comprehensive listing of all dealings with GMOs, including licensed dealings, NLRDs and GM products.

84 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

EXEMPT DEALINGS Exempt dealings are dealings with GMOs that have been assessed over time as posing negligible25 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 Gene Technology 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 int o which genetically modified (GM) somatic cells have been introduced, where the introduced somatic cells do not produce infectious agents

• small v olumes (less than 25 litres) of an approved host/vector system into which low-risk genetic material has been introduced (for example, the gene must not be uncharacterised, be derived from a pathogenic organism or code for a toxin).

NOTIFIABLE LOW RISK DEALINGS Notifiable low risk dealings (NLRDs) 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 Part 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, PC2 or PC3 certified facilities) and of an appropriate design for the kind of dealing undertaken. Conducting NLRDs requires prior assessment by an institutional biosafety committee (IBC) to confirm that proposed dealings with GMOs are properly classified as NLRDs, that the facilities are of the appropriate physical containment level and type and that personnel have the appropriate training or experience. Organisations must keep a record of all current NLRDs and notify them in an annual report to the Regulator. NLRDs are included on the Record of GMO and GM product dealings but do not require case-by-case risk assessment by the Regulator.

An example of an NLRD that may be conducted in PC1 facilities is dealing with GM laboratory guinea pigs, mice, rabbits or rats where the genetic modification does not provide an advantage or the animal is not infectious. NLRDs that may be conducted in PC2 facilities include dealings with:

• a GM animal (other than a GM labor atory guinea pig, mouse, rabbit, rat or roundworm (Caenorhabditis elegans)), including invertebrates

• a GM plant

• an appr oved host/vector system that does not meet the criteria for an exempt dealing (for example, the introduced gene may encode a pathogenic determinant or may be an uncharacterised gene from a pathogen).

25 T he term ‘negligible’ is defined in chapter 3 of the Risk Analysis Framework and is used here for consistency.

APPENDIX 2 85

NLRDs involving micro-organisms classified as Risk Group 3 under standard AS/NZS 2243:3:2012 must be undertaken in facilities certified to at least PC3 level and appropriate to the dealings.

LICENSED DEALINGS Any dealing with a GMO not classified as exempt or as an NLRD, listed on the GMO Register, or authorised by an Emergency Dealing Determination (EDD) 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 or refuse a licence to allow a dealing and (if a licence is to be issued) the management conditions to be imposed to manage any risks.

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

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

The Gene Technology Act requires the Regulator to prepare a risk assessment and risk management plan (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 Regulator uses information provided in the application as well as other relevant scientific/ technical knowledge.

The requirements of the legislation have been framed so as to place under greater scrutiny dealings that involve intentional release of GMOs to the environment (DIRs). The Regulator may impose conditions on all licences. For example, for all DIRs determined to be limited and controlled releases, measures will be imposed to restrict the persistence and spread of the GMO and its genetic material. Non-compliance with conditions placed on licences issued under the Gene Technology Act is a criminal offence. For both DNIR and DIR applications, the applicant must also provide information specified in the Gene Technology Act as to their suitability to hold a licence. This includes any information on relevant convictions and on revocations or suspensions of licences under laws relating to human health and safety or the environment. The Regulator also makes an assessment of the applicant’s capacity to comply with licence conditions.

While the Gene Technology 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 practices in the context of the legislation. The framework was applied to all licence applications processed during 2013-14.26

26 The Risk Analysis Framework is available at .

86 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

DEALINGS NOT INVOLVING INTENTIONAL RELEASE DNIRs usually take place under specified physical containment conditions in certified facilities that minimise risks to human health and the environment. The Gene Technology Act requires preparation of an 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 the Gene Technology Technical Advisory Committee (GTTAC), the states and territories, relevant Australian Government agencies and any 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.

APPENDIX 2 87

The process required in respect of DNIR applications is shown in figure 16 and described below.

Figure 16: DNIR assessment process

Sufficient information?

Prepare RARMP

Finalise licence conditions

Consultation

Finalise RARMP

Application for

DNR licence

Consultation?

Can the risk be managed to protect people and the environment

Reject application

Refuse to issue license

Issue licence

YES

YES

YES

NO

NO

NO

88 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Stage 1 - The applicant must complete the DNIR application form and provide comprehensive information about the proposed dealings with the GMO, including possible risks posed by the dealings and proposed ways in which each risk would be managed. The applicant must ensure that all responses to the Regulator’s information requirements are supported by appropriate data and literature citations.

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. If there is not sufficient information the application is rejected.

Stage 3 - Section 47 of the Gene Technology Act requires the Regulator to prepare an RARMP. The information provided in the application is used to prepare the RARMP in relation to the proposed dealings.

The actual risk assessment process is, to some extent, shaped by the data requirements set out in the DNIR 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.

Preparation of risk assessment involves developing risk scenarios that describe how risks that may be posed by 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 ones require treatment 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 dealings 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. Draft conditions are included in the consultation version of the RARMP.

Stage 4 - The Regulator may consult experts, agencies, or authorities, about the RARMP, such as the GTTAC, the states and territories, prescribed Australian Government agencies, the Environment Minister, and appropriate local government authorities.

Stage 5 - The Regulator makes the decision on whether to issue a licence and, if so, any conditions to be imposed. This decision is based on the RARMP, having regard to any policy principles issued by the Legislative and Governance Forum on Gene Technology (LGFGT). The Regulator must notify the applicant in writing that a licence decision has been made. The Regulator also advises all experts, agencies and authorities that were consulted.

The statutory time frame allowed for consideration of a DNIR application is 90 days.

APPENDIX 2 89

DEALINGS INVOLVING INTENTIONAL RELEASE Although the legislation defines two types of DIR, ‘limited and controlled’ DIRs and other DIRs, the same application form is used for all DIRs. The Regulator will, on a case-by-case basis, use information the applicant has submitted (as specified in the application form) to determine if the application is a limited and controlled release application, and therefore which consultation process and time frame under the Gene Technology Act apply for processing the application.

The Risk Analysis Framework outlines the approach taken to risk analysis and preparing RARMPs. The eight-stage process adopted in respect of DIR applications is shown in figure 17 and described below.

90 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Figure 17: DIR assessment process

Consultation minimum 30 working days

Sufficient information?

Is the release limited & controlled?

Do the

dealings pose a significant risk?

Seek advice

Finalise licence conditions

Consultation minimum 50 working days

Finalise RARMP

Prepare

consultation RARMP

Application for

DIR licence

Can the risk be managed to protect people and the environment

Reject application

Refuse to issue license

Issue licence

YES

YES

YES

YES

NO

NO

NO

NO

APPENDIX 2 91

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

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

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

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

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

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

o contr ols to restrict dissemination or persistence of the GMO and its genetic material into the environment

o limits on the pr oposed release of the GMO

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

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

• methods t o restrict the dissemination or persistence of the GMO or its genetic material into the environment

• methods f or disposal of the GMO or its genetic material

• dat a collection, including studies to be conducted about the GMO or its genetic material

• the geogr aphic area in which the proposed dealings with the GMO or its genetic material may occur

• compliance , in relation to dealings with the GMO or its genetic material, with:

o a code of pr actice issued under section 24, or

o a t echnical or procedural guideline issued under section 27.

92 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

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

• scope of the dealings with the GMO

• scale of the dealings with the GMO

• locations of the dealings with the GMO

• dur ation of the dealings with the GMO

• persons who ar e to be permitted to conduct the dealings with the GMO.

Stage 4 - A notification of application is sent out for all DIR applications to those on the OGTR mailing list and placed on the website advising when the consultation RARMP is expected to be released for comment. This is not a requirement of the Gene Technology Act, 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 that has been declared by the Regulator as, or under consideration as, confidential commercial information) to anyone who requests a copy (section 54).

Stage 5 - The Regulator must seek advice on the application regarding matters relevant to preparation of the RARMP from the GTTAC, the states and territories, prescribed Australian Government agencies, the Environment Minister, and appropriate local government authorities (section 50). 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 and the Department of Foreign Affairs and Trade. If the application is for a limited and controlled release, this consultation stage is not required.

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

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 ones require treatment to protect people and the environment.

APPENDIX 2 93

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

Stage 7 - Once the consultation version of the RARMP is prepared for a DIR application, the Regulator must determine whether any of the proposed dealings pose a significant risk to the health and safety of people or to the environment. The minimum consultation period specified in the Gene Technology Act 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 time frame 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 time frame 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, the Australian Government Gazette and notices on the Regulator’s website. In practice, the Regulator advertises more broadly, including in metropolitan and regional newspapers and specialist interest publications, and will advise by mail or email all people and organisations that have registered their interest in receiving such information through the OGTR mailing lists. Under section 52(3) of the Gene Technology Act, the Regulator must also seek advice on the RARMP from the expert groups, agencies and authorities listed in table 22 (for consultation on the application).

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

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

INADVERTENT DEALINGS Part 5 of the Gene Technology 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 a way as to protect the health and safety of people and the environment.

94 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Emergency dealing determinations The EDD provision in Part 5A (sections 72A-E) of the Gene Technology Act gives the Minister 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:

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

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

• an y 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 from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer or the Commonwealth Chief Plant Protection Officer that the proposed emergency dealing would address the threat; and from the Regulator about managing risks. 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, noting the emergency context and need for a rapid assessment, there are no prescribed consultation requirements.

THE GMO RECORD Section 138 of the Gene Technology Act requires the Regulator to maintain a Record of GMO and GM Product Dealings (the GMO Record). The GMO Record includes details of licences issued (DNIR, DIR, inadvertent dealing), information about NLRDs, GMO dealings included on the GMO Register, EDDs and information about GM products approved by other regulatory authorities.27

The GMO Record is currently divided into separate sections:

• notifiable lo w risk dealings

• cont ained dealings - DNIR licences

• int entional releases - DIR licences

• inadv ertent dealing licences

• GMO Regist er

• EDDs

• GM pr oducts - those used in food processing, therapeutics, and pesticides and veterinary medicines authorised by other regulatory agencies.

27 T he GMO Record can be viewed at .

APPENDIX 2 95

ACCREDITATION AND CERTIFICATION Accreditation of organisations and certification of individual physical containment facilities helps manage risks 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 whether 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 through independent assessment of NLRD proposals pursuant to regulation 13B—and on behalf of their organisation ensuring compliance with legislative requirements. IBCs are required to comprise a range of suitable experts and an independent person. They provide a quality-assurance mechanism that reviews the information that applicants submit to the Regulator.

Certain dealings must only be undertaken in facilities that are certified by the Regulator. The legislation allows the Regulator to certify physical containment facilities to ensure that appropriate standards are met for containment of GMOs and that trained and competent staff are carrying out procedures and practices. Under the legislation, the Regulator has issued guidelines specifying the requirements for certification of each type of facility (laboratory, plant and animal, etc) to physical containment levels 1, 2, 3 or 4, which must be met before a facility can be certified. 28 All certified facilities must be inspected before certification and annually thereafter (except those certified as a PC1 facility). The OGTR inspects all high-level facilities (large-scale PC2, PC3 and PC4) before certification and re-certification.

MONITORING AND COMPLIANCE The aim of OGTR monitoring and compliance activities is to ensure dealings with GMOs comply with legislative obligations and are consistent with the object of the Gene Technology Act, bearing in mind that non-compliance with conditions placed on licences issued under the Gene Technology 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 mat erial is minimised

• persist ence of a GMO in the environment is managed

• ef fective management of the GMO is maintained.

28 T he Guidelines for Certifications of Physical Containment Facilities are available at .

96 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

OGTR monitoring activities comprise the functions of routine monitoring, including making spot checks, assessing 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 GMOs or their genetic material is more likely to occur (for example, during flowering and/or harvesting of GM crops).

The monitoring program for contained dealings involves inspecting DNIRs and the facilities in which those dealings are conducted, as well as monitoring a minimum of 20 per cent of PC4, PC3 and PC2 large-scale facilities per year. These inspections focus on the integrity of the physical structure of a facility and on the general laboratory practices followed in that facility, including the 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 whether licence conditions can be, and are being, effectively implemented. An accredited organisation may seek a practice review to assess the effectiveness of systems that its IBCs use to ensure that dealings are being conducted in accordance with the Gene Technology Act.

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

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

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

• suggest impr ovements to procedures and practices where appropriate.

An investigation is an inquiry into a suspected non-compliance with the Gene Technology 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 third-party reporting.

APPENDIX 3 97

APPENDIX 3 MEMBERSHIP OF STATUTORY COMMITTEES AND ATTENDANCE AT MEETINGS

The Gene Technology Act 2000 establishes two statutory committees to provide advice to the Gene Technology Regulator (the Regulator) and the Legislative and Governance Forum on Gene Technology (LGFGT). These are the:

• Gene T echnology Technical Advisory Committee (GTTAC)

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

The 2011-14 memberships of GTTAC and GTECCC expired on 31 January 2014. The Assistant Minister for Health, Senator the Hon. Fiona Nash, appointed 19 members to GTTAC that commenced in February 2014, including a mix of new and ongoing members. The 2011-14 membership of GTECCC, with the exception of the cross-member with the Australian Health Ethics Committee (AHEC), expired on 31 January 2014. The appointment process for the new membership of GTECCC was still ongoing at 30 June 2014.

Video conferences represent an important and efficient option for conducting committee meetings, especially on discrete agendas, given reduced travel requirements for members and reduced costs. During 2013-14, GTTAC continued to make use of the video conference network established by the Department of Health, meeting twice by video conference.

GENE TECHNOLOGY TECHNICAL ADVISORY COMMITTEE GTTAC’s functions, as set out in section 101 of the Gene Technology Act, are to provide scientific and technical advice, at the request of the Regulator or the LGFGT, on genetically modified organisms (GMOs); genetically modified (GM) products; applications made under the Gene Technology Act; the biosafety aspects of gene technology; and the need for policy principles, policy guidelines, codes of practice, and technical and procedural guidelines in relation to GMOs and GM products and the content of such principles and codes.

The Regulator must seek GTTAC’s advice on the Risk Assessment and Risk Management Plan (RARMP) for all licence applications for dealings involving intentional release (DIR) and may seek advice on other applications. The Regulator must also seek GTTAC’s advice during the preparation of the RARMP for all DIR applications which are not assessed as limited and controlled under section 50A of the Gene Technology Act. In 2013-14 the Regulator sought advice from GTTAC on seven DIR applications, including for the limited and controlled release of GM canola and GM wheat and/or barley, a clinical trial of a GM vaccine against cholera, and three commercial releases (GM cotton, GM canola and a GM vaccine to protect chickens against pathogenic Escherichia coli). GTTAC met four times during 2013-14, twice face-to-face and twice by videoconference (table 23).

98 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Communiqués from GTTAC meetings, which provide an overview of key matters discussed and resolutions, are published on the OGTR website29 and in the Regulator’s quarterly reports to Parliament.

Table 23: Attendance at GTTAC meetings, 2013-14

Meeting date No of GTTAC members in attendance

17 September 2013 (video conference) 18

18 December 2013 14

20 February 2014 16

21 May 2014 (videoconference) 15

GTTAC CHAIR Professor John Rasko AO BSc (Med), MBBS(Hons), PhD, MAICD, FFSc (RCPA), FRCPA, FRACP has relevant skills and experience in molecular biology, virology, risk assessment, clinical medicine, biochemistry, animal biology and immunology.

Professor Rasko is an Australian pioneer in the application of adult stem cells and genetic therapy. He directs the Department of Cell and Molecular Therapies at Royal Prince Alfred Hospital and heads the Gene and Stem Cell Therapy Program at the Centenary Institute, University of Sydney. Professor Rasko is a clinical haematologist, pathologist and scientist with a productive track record in gene and stem cell therapy, experimental haematology and molecular biology. In more than 150 publications he has contributed to the understanding of stem cells and blood cells, gene-transfer technologies, cancer, human kidney disorders and non-coding RNAs.

Professor Rasko’s contributions to scientific organisations include being co-founder (2000) and past-president (2003-05) of the Australasian Gene Therapy Society; vice president of the International Society for Cellular Therapy (ISCT) (2008-12) and founder (2009) of ISCT-Australia; chair of the Advisory Committee on Biologicals (Therapeutic Goods Administration); scientific advisory committees and board member for philanthropic foundations; and a member of several ethics committees. He is the recipient of national (distinguished fellow award at The Royal College of Pathologists of Australasia; Eric Susman Prize for 2011 from The Royal Australasian College of Physicians; Roche medal from the Australian Society for Biochemistry and Molecular Biology) and international awards in recognition of his commitment to excellence in medical research, including appointment as an Officer of the Order of Australia in June 2012 for distinguished service to biomedical research in the field of gene and cell therapy as a clinician.

Professor Rasko previously served as a GTTAC member (2001-03 and 2004-07) and as chair

(2008-10 and 2011-14).

29 At .

APPENDIX 3 99

GTTAC MEMBERS 2011-14 Table 24: Members of GTTAC at 30 June 2014

Dr Jason Able Senior lecturer in plant breeding and Durum Breeding Australia Southern Node Leader, School of Agriculture, Food & Wine, University of Adelaide (South Australia)

Emeritus Professor Craig Atkins Senior Honorary Research Fellow, School of Plant Biology, University of Western Australia (Western Australia)

Professor Ross Barnard Biotechnology Program Director, School of Chemistry and Molecular Biosciences, University of Queensland (Queensland)

Professor Jacqueline Batley ARC Future Fellow; School of Plant Biology, University of Western Australia (WA)

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

Dr Graham Bonnett Research Director, CSIRO Agriculture Flagship (Queensland)

Ms Laura Fell Poultry meat farmer, McLaren Vale (South Australia)

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

Associate Professor John Hayball School of Pharmacy and Medical Sciences, University of South Australia (South Australia)

Dr Rodney Mahon Honorary Fellow, CSIRO Land & Water Flagship (Australian Capital Territory)

Dr Michael Michael Laboratory Head, Flinders Centre for Innovation in Cancer, Flinders Medical Centre (South Australia)

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

Associate Professor Marie Ranson School of Biological Sciences, University of Wollongong (New South Wales)

Professor John Rasko AO (chair) Director, Cell and Molecular Therapies, Royal Prince Alfred Hospital; and Program Head Centenary Institute (New South

Wales)

Dr Kelly Shaw Senior consultant KP Health (Tasmania)

100 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Professor Kevin Smith Professor Plant Breeding, University of Melbourne (Victoria)

Associate Professor Jason Smythe Senior Business Development Manager, Faculty of Medicine, Monash University; and Adjunct Associate Professor, Faculty of

Science and Engineering, La Trobe University (Victoria)

Dr Diane Webster Chair, Swinburne Biosafety Committee; Affiliate Research Fellow, School of Biological Sciences, Monash University; National Convenor, Women in Science Enquiry Network (Victoria)

Professor Paul Young Professor of Virology and Head of School, School of Chemistry and Molecular Biosciences, University of Queensland (Queensland)

GENE TECHNOLOGY ETHICS AND COMMUNITY CONSULTATIVE COMMITTEE

GTECCC’s functions are set out in section 107 of the Gene Technology Act. They are to provide advice, at the request of the Regulator or the LGFGT, on ethical issues relating to gene technology and on matters of general concern relating to GMOs; community consultation and risk communication regarding licence applications for DIR; 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.

The 2011-14 membership of GTECCC expired on 31 January 2014, with the exception of the cross-member with the AHEC, Professor Susan Dodds. Professor Dodds was appointed to GTECCC in March 2013 with her term to expire at the end of the current AHEC triennium, on 30 June 2015. The appointment process for the remaining members of GTECCC for the 2014-17 triennium is ongoing.

The previous GTECCC did not meet between July 2013 and its expiry in January 2014. During this period, GTECCC continued to maintain a watching brief on developments and reports regarding synthetic biology. On 31 October 2013 the GTECCC-AHEC cross member, Professor Susan Dodds, attended an AHEC meeting and advised AHEC members of GTECCC’s interest in the issue of ‘dual-use’ research. A report from this AHEC meeting was provided to GTECCC members.

Communiqués from GTECCC meetings, which provide an overview of key matters discussed and resolutions, are published on the OGTR website and in the Regulator’s quarterly reports to Parliament.

APPENDIX 3 101

OUTGOING GTECCC CHAIR Professor Donald Chalmers LLB, LLM retired after 12 years of service as chair of GTECCC; the former Gene Technology Ethics Committee (GTEC; 2001-07); and the former Gene Technology Community Consultative Committee (GTCCC; 2006-07).

Professor Chalmers has had an exemplary career and he brought significant expertise and experience to his role as committee chair. He is Professor of Law and Director of the Centre for Law and Genetics at the University of Tasmania (UTAS), a Foundation Fellow of the Australian Academy of Law and former Dean of the UTAS Faculty of Law.

Professor Chalmers has authored or contributed to numerous government reports, books on various aspects of law and major legal treatises. He is the recipient of a number of Australian Research Council and National Health and Medical Research Council (NHMRC) grants to research legal and ethical implications of developments in genetics and he has had significant involvement with many committees dealing with health, medical research and genetics. Professor Chalmers was chair of AHEC (1994 to 2000); deputy chair of the NHMRC Embryo Research Licensing Committee (2003-12); a member of the NHMRC Human Genetics Advisory Committee (2006-09); chair of the Australian Red Cross Human Research Ethics Committee (2000-10); and board member of the Australian Institute of Family Studies (1998 to 2006).

Professor Chalmers was Law Reform Commissioner in Tasmania (1991-97). In 1985 he chaired the Tasmanian Inquiry into Artificial Conception and in 1995 he chaired the Commonwealth Ministerial Review of the National Institutional Ethics Committee System. He is also active and respected internationally and is the deputy chair of the international Human Genome Organisation Ethics Committee; chair of the International Cancer Genome Consortium Access committee; and a member of the Scientific Review Panel of Genome Canada (2004-09).

Professor Chalmers’s leadership of GTECCC and its predecessor advisory committees was highly regarded. He actively fostered interactions with GTTAC and AHEC and under his guidance the committees consistently provided high-quality, considered advice to the Regulator and produced respected and valuable guidance documents. These documents have strengthened the gene technology regulatory system and enhanced its credibility.

Most significant is The National Framework of Ethical Principles in Gene Technology 2012 (the Framework), which provides a national reference point for promoting ethical conduct in gene technology. Professor Chalmers has made a significant contribution to the Australian gene technology regulatory scheme. His long and active involvement started prior to the establishment of the national legislative scheme, and included membership of the Commonwealth Biotechnology Advisory Council (1999 to 2002).His comprehensive knowledge and understanding of health law, genetics and research ethics greatly benefitted the gene technology advisory committees.

102 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

REMUNERATION AND ALLOWANCES FOR COMMITTEE MEMBERS The 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. 30

GTECCC MEMBERS 2011-14 Table 26: Members of GTECCC at 30 June 2014

Professor Susan Dodds Dean of the Faculty of Arts and Professor of Philosophy, University of Tasmania (Tasmania)

30 More information is available at .

APPENDIX 4 103

APPENDIX 4 STAFF PROFILE AND TRAINING AND DEVELOPMENT ACTIVITIES

This appendix provides information on Australian Public Service (APS)

staff employed by the OGTR in 2013-14 under the Public Service

Act 1999.

Tables 27 to 30 provide details on staff numbers and aggregated information on salary, performance pay and non-salary benefits provided to staff during the year under the Department of Health Enterprise Agreement 2011-2014 and Individual Flexibility Arrangement.

Tables 31 to 33 show the staff training and development activities conducted in 2013-14.

104 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

STAFF PROFILE Table 27: OGTR staff numbers by classification and contract type at 30 June 2014

Headcount by contract

Nominal classification EA IFA Section

24

REMUNERATION TRIBUNAL

Total

HOPO 1 1

SES 1 2 2

EL2 6 6

EL1 13 13

LEGAL 2 1 1

APS6 21 21

APS5 6 6

APS4 1 1

APS3 2 2

Total 43 6 2 1 53

APPENDIX 4 105

Table 28: OGTR staff numbers by gender at 30 June 2014

Headcount by gender and employee group

Employee group Female Male Total

Ongoing 23 25 48

Non-ongoing 3 2 5

Total 26 27 53

Table 29: Number of employee commencements and cessations in financial year 2013-14

Commencements and cessation 2013-14

Action Female Male Total

Hiring employees 3 2 5

Termination 4 3 7

Total 7 5 12

PERFORMANCE PAY Most performance payments made in 2013-14 related to assessments for the 2012-13 cycle. Due to the small numbers of staff at the SES level, details for SES and non-SES staff have been combined (table 29). Payments have been aggregated to preserve employees’ privacy. The OGTR makes performance bonus payments available to staff working under a current Individual Flexibility Arrangement or via individual determination under section 24(1) of the Public Service Act 1999. Determinations are produced following negotiations with the staff member and the Department of Health (the Department) regarding terms and conditions of employment.

Table 30: SES and non-SES bonus payments, 1 July 2013 to 30 June 2014

LEVEL NUMBER AGGREGATED AMOUNT

SES Band 1 and non-SES staff 9 $75,464.94

106 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

TRAINING AND DEVELOPMENT During 2013-14, OGTR Legal Officer Alceo Turello conducted introductory and ongoing training for OGTR staff on legal issues (table 31). The Science Cohort Section conducted training on risk assessments (table 32).

Table 31: Internal legal issue training presentations, 2013-14

Date Topic

July 2013 GM in Australian Litigation

July 2013 Marsh v Baxter Injunction

August 2013 Developments in US GM Alfalfa Litigation

September 2013 Use of Social Media by Commonwealth

Employees

January 2014 Non-compliance Responses and

Accountability

February 2014 Confidential Commercial Information

March 2014 Information Issues—Privacy and Freedom

of Information

March 2014 Code of Conduct Expectations

May 2014 Marsh v Baxter: the defendant’s case

May 2014 NZ Zinc finger Case

June 2014 Marsh v Baxter: the Outcome

APPENDIX 4 107

Table 32: Other internal training presentations, 2013-14

Date Topic

May 2014 Risk perception parts 1 and 2

March 2014 RAF 2013 training for newcomers

February 2014 Weed risk assessment methodology for GM plants

August 2013 RAF 2013 training parts 1 and 2

The OGTR Forum provides a venue where, in addition to presentations by visiting experts, curr ent information is shared among staff on topics such as scientific and risk assessment

issues, summaries of recent conferences and feedback from international meetings. A range of OGTR staff and guest speakers made presentations at the OGTR Forum in 2013-14 (table 33).

Table 33: Presentations at OGTR Forum, 2013-14

Date Topic Speaker

June 2014 The program for Biosafety

Systems (PBS): strategies and achievements in Asian and African partner countries

Mr John Komen

April 2014 Developing modified oils in

GM crops

Dr Allan Green, CSIRO

Feedback from OECD meeting on regulatory oversight of biotechnology and workshop on new plant breeding technologies

Drs Peter Thygesen and Heidi Mitchell

March 2014 Weed risk and climate

change

Dr Darren Kriticos, CSIRO

February 2014 Unintended effects in

GMOs: feedback from Canadian workshop

Dr Paul Keese

Bee pollination behaviour Drs Saul Cunningham and Lucas Garibaldi, CSIRO

108 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Date Topic Speaker

December 2012 Public attitudes to GMOs Dr Craig Cormick, CSIRO

November 2012 Feedback from Malaysian

biosafety workshop

Dr Andrew Berry

October 2012 An African approach to

biosafety regulation

Dr Paul Keese

Grains Research and Development Corporation (GRDC)

Dr Juan Juttner, GRDC

Feedback from south Asia biosafety conference Dr Michael Dornbusch

September 2013 Feedback from APEC

workshop on biosafety regulatory perspectives

Dr Joe Smith

August 2013 The International Centre for

Genetic Engineering and Biotechnology (ICGEB)

Mr Decio Ripandelli, ICGEB

New genes for new environments

Mr Leigh Smith, DAFWA

Contained Dealings Evaluation Section

Drs Maryanne Shoobridge, Anuj Srivastava and Jeremy Turner

Overview of NICNAS and its approach to risk analysis Dr Daniella Leonte, NICNAS

July 2013 Feedback from APEC

meeting

Dr Robyn Cleland

Overview of Master of Biotechnology (Plant Biotechnology) program at the University of Adelaide

Prof Diane Mather, University of Adelaide

APPENDIX 5 109

APPENDIX 5 PUBLICATIONS AND GUIDANCE DOCUMENTS

All the documents listed in this appendix were published during 2013-14. Copies are available at . Paper copies of certain publications are also available from the OGTR Information Officer.

QUARTERLY REPORTS Quarterly report for the period 1 April 2013 to 30 June 2013 Quarterly report for the period 1 July 2013 to 30 September 2013 Quarterly report for the period 1 October 2013 to 31 December 2013

110 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

APPENDIX 6 STAKEHOLDER AND PUBLIC ACCESS TO THE OGTR

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

WEBSITE USAGE Table 34 lists the successful hits on the OGTR website. The most requested information sheets and website pages are listed below.

Table 34: Website activity, 2013-14 and 2012-13

MONTH HITS VISITS

2013-14 2012-13 2013-14 2012-13

July 273 687 171 408 32 138 26 398

August 293 963 189 026 32 470 29 584

September 279 727 232 123 35 968 31 954

October 313 268 203 339 37 916 36 148

November 467 408 225 267 58 815 38 152

December 311 184 196 392 44 002 29 320

January 309 920 209 492 42 465 28 981

February 302 530 260 162 40 179 28 574

March 355 648 300 105 52 266 33 262

April 301 751 283 807 54 838 35 311

May 304 748 289 502 46 199 35 733

June 310 009 291 249 41 754 34 133

APPENDIX 6 111

The most popular pages viewed on the OGTR website during 2013-14 were as follows.

• DIR 126—Clinical trial of a genetically modified vaccine against c holera—PaxVax Australia Pty Ltd

• Maps of trial sites

• What’s new

• Guidelines and forms f or certification of physical containment facilities

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

• Record of GMOs and GM product dealings

• About the OGTR

• List of genetically modified product appr ovals

• Guidelines

• Fact sheets

The most popular downloaded documents in 2013-14 were:

• Risk Analysis Fr amework

• the biology of Saccharum spp (sugarcane)

• the biology of Gossypium hirsutum L. and Gossypium barbadeuse L. (cotton)

• the biology of Ananas comosus var. comosus (pineapple)

• the biology and Ecology of Rice (Oryza sativa L.) in Australia

• the biology of Carica papaya L. (papaya, pawpaw, paw paw)

• DIR 126—Receipt of licence application (DIR 126) from P axVax Australia Pty Ltd for a clinical trial of a GM cholera vaccine

• The biology of Zea mays L. ssp mays (maize or corn)

• PC2 laborat ory guidelines

• the biology of hybrid t ea rose (Rosa x hybrida).

EMAIL ADDRESS AND FREE CALL NUMBER The 1800 number and the OGTR email address 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 the services that the 1800 line and email facilities provide. While there were some peaks in usage of the 1800 number, there was a slight decline in usage of the email address compared with the previous year (table 35).

112 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Table 35: Email and free call 1800 number activity, 2013-14 and 2012-13

MONTH EMAILS 1800 NUMBER

2013-14 2012-13 2013-14 2012-13

July 106 83 72 96

August 70 104 35 85

September 82 76 89 89

October 99 98 73 101

November 196 84 210 75

December 98 63 95 66

January 88 79 n/a* 66

February 92 74 n/a* 100

March 171 66 n/a* 95

April 83 91 n/a* 110

May 71 238 n/a* 125

June 75 202 n/a* 92

Total 1231 1258 1100

*due to change of suppliers these figures were not available for these periods.

The Monitoring Section maintains an email inbox to facilitate efficient communication with accredited organisations. The inbox provides a central point through which accredited organisations can contact the section with queries, legislative notifications and self-reporting of non-compliances. The Monitoring Section email inbox ensures that all communications are answered efficiently while staff are away from the office. The inbox received 1044 emails during 2013-14 (823 in 2012-13).

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 1148 emails during 2013-14 (1361 in 2012-13).

APPENDIX 6 113

The Contained Dealings Evaluation Section maintains an email inbox to provide a central point for efficient coordination of responses to queries relating to classification of GMO dealings, high-level facility certification requirements and GMO licences. The inbox received 330 emails during 2013-14 (423 in 2012-13).

The Application and Licence Management Section maintains an email inbox to provide a central, shared communication point to allow efficient coordination of responses to correspondence and queries about applications the section has received. The inbox received 2306 emails during 2013-14 (3235 in 2012-13).

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

114 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

APPENDIX 7 PRESENTATIONS AND MEETINGS ON GENE TECHNOLOGY IN AUSTRALIA

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

Table 36: Presentations and representations made in Australia, 2013-14

DATE EVENT LOCATION

July 2013 Regulators’ Forum Canberra

July 2013 Australian Society for Microbiology annual meeting 2013 Adelaide

August 2013 Food Standards Australia New Zealand workshop on new plant breeding techniques

Canberra

September 2013 Meeting of South Australian IBCs

September 2013 InterDrought IV Conference Perth

September 2013 Biosecurity course at the Australian National University Canberra

September 2013 Society for Risk Analysis—Australia and New Zealand Conference Canberra

September 2013 Australian Seed Federation 2013 Convention Gold Coast

October 2013 Seminar given to students as part of a tertiary biotechnology course at Australian National University

Canberra

October 2013 Department of Industry biomass-based industries working group meeting

Canberra

October 2013 Low Level Presence (LLP)/Unintended Presence (UP) Australian Government agency meeting

Canberra

APPENDIX 7 115

DATE EVENT LOCATION

November 2013 Australasian Environmental Law Enforcement and Regulators Network Conference

Melbourne

November 2013 Department of Agriculture’s ‘Let’s Talk Genes’ Forum Canberra

November 2013 Regulatory Science Network Risk Communication Workshop Canberra

November 2013 CropLife National Members’ Forum Canberra

November 2013 AusBiotech Agriculture and Food Biotechnology Symposium Brisbane

November 2013 Lucerne Australian Symposium 2013 Keith, South Australia

February 2014 Presented at the Regulatory Science Network meeting Canberra

February 2014 CropLife meeting—LLP, AHTEG, Review response Canberra

March 2014 Canberra Biological Weapons Convention & Chemical Weapons Convention IDC - Department of Foreign Affairs and Trade

Canberra

March 2014 Presentation to Therapeutic Goods Administration Canberra

May 2014 CSIRO Biosecurity Futures Workshop Canberra

116 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

GLOSSARY

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

Accredited organisation

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

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

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

Certification Guidelines

Guidelines for Certification of a Physical Containment Facility

Collective Agreement

a collective agreement for staff of the Department of Health and Ageing 2007-11

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

COAG Council of Australian Governments

Contained dealing

see DNIR

CSIRO Commonwealth Scientific and Industrial Research Organisation

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

Department Australian Government Department of Health

APPENDIX 7 117

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

FSANZ Food Standards Australia New Zealand

GM genetically modified

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

GMO genetically modified organism

GMO Record Record of GMO and GM product dealings

GST goods and services tax

GTCCC Gene Technology Community Consultative Committee

GTEC Gene Technology Ethics Committee

GTECCC Gene Technology Ethics and Community Consultative Committee

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

KPI key performance indicator

LGFGT Legislative and Governance Forum on Gene

LLP low level presence

MOU memorandum of understanding

NHMRC National Health and Medical Research Council

NICNAS National Industrial Chemicals Notification and Assessment Scheme

118 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

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

OECD Organisation for Economic Co-operation and Development

OGTR Office of the Gene Technology Regulator

PBS Portfolio Budget Statement

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

PHM post-harvest monitoring

Physical containment facility

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

RAF Risk Assessment Framework

RARMP risk assessment and risk management plan

Regulations Gene Technology Regulations 2001

Regulator Gene Technology Regulator

RSN Regulatory Science Network

SSBA security sensitive biological agents

TGA Therapeutic Goods Administration

TSD Guidelines Guidelines for the Transport, Storage and Disposal of GMOs

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

WHO World Health Organization

31

APPENDIX 7 119

LIST OF REQUIREMENTS31

PART OF REPORT DESCRIPTION PAGE

Letter of transmittal 3

Table of contents 9-11

Index 123-136

Glossary 116-118

Contact officer(s) 67

Internet home page address and internet address for report 4

Review by secretary Review by departmental secretary 13-15

Summary of significant issues and developments

13-15

Overview of department’s performance and financial results 20-23

Outlook for following year 15

Significant issues and developments— portfolio

Departmental overview

Role and functions 5, 16-17, 74

Organisational structure 17

Outcome and program structure 21-23

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

16, 81-82

31 The reference is to the location of the item in the requirements - e.g. ‘A.4’ refers to the fourth item in Attachment A.

120 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

PART OF REPORT DESCRIPTION PAGE

Portfolio structure 16, 81-82

Report on performance

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

24-63

Actual performance in relation to deliverables and KPIs set out in PBSs/PAES or other portfolio statements

21-23

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 24-63

Trend information 44

Significant changes in nature of principal functions/services 13-15, 78

Performance of purchaser/provider arrangements

n/a

Factors, events or trends influencing departmental performance 13-15, 73-79

Contribution of risk management in achieving objectives

13

Social inclusion outcomes 71

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

110-113

Discussion and analysis of the department’s financial performance 1 *

Discussion of any significant changes from the prior year, from budget or anticipated to have a significant impact on future operations*

Agency Resource Statement and summary resource tables by outcomes *

121

PART OF REPORT DESCRIPTION PAGE

Management and accountability

Corporate governance

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

*17

Statement of the main corporate governance practices in place 16-17, 74-75

Names of the senior executive and their responsibilities 18-19

Senior management committees and their roles 97-102

Corporate and operational planning and associated performance reporting and review

13-15

Approach adopted to identifying areas of significant financial or operational risk 13

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

16, 100

How nature and amount of remuneration for SES officers is determined* 105

External Scrutiny Significant developments in external scrutiny n/a

Judicial decisions and decisions of administrative tribunals

n/a

Reports by the Auditor-General, a parliamentary committee or the Commonwealth Ombudsman

*

Management of human Resources Assessment of effectiveness in managing and developing human resources to

achieve departmental objectives*

64-65

Workforce planning, staff turnover and retention 64-65, 105

122 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

PART OF REPORT DESCRIPTION PAGE

Impact and features of enterprise or collective agreements, individual flexibility arrangements (IFAs), determinations, common law contracts and Australian workplace agreements (AWAs)

64-65, 105

Training and development undertaken and its impact 65, 106-108

Work health and safety performance 67-68

Productivity gains n/a

Statistics on staffing 104-105

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

64-65, 105

Performance pay 105

Assets management Assessment of effectiveness of assets management 70

Purchasing Consultants

Assessment of purchasing against core policies and principles 69

The annual report must include a 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). The annual report must include a statement noting that information on contracts and consultancies is available through the AusTender website

70

Australian National Audit Office access clauses

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

Exempt contracts Contracts exempt from the AusTender 70

123

PART OF REPORT DESCRIPTION PAGE

Financial statements Financial statements *

Other mandatory information Work health and safety (Schedule 2, Part 4 of the Work Health and Safety Act 2011)

64-65

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

70

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

72

Compliance with the agency’s obligations under the Carer Recognition Act 2010 *

Grant programs n/a

Disability reporting—explicit and transparent reference to agency-level information available through other reporting mechanisms

71

Information Publication Scheme statement 57

Correction of material errors in previous annual report n/a

List of requirements 119_123

1 Refer to the Department of Health and Ageing 2013-14 annual report.

124 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

INDEX

A abbreviations and acronyms, 116-118

accountability see management and accountability

accredited organisations, 41-42

monitoring and inspections, 45

number, 41

process, 41

time frame for decisions, 28, 41

trend data, 44

achievements, 13-15

activities for 2013-14, 13-15

activity-based costing study, 60

address and contact details, 4

free call number, 60, 111-113

freedom of information, 69

advertising and market research, 70

advice on GMOs and GM products, 58-59

advice to prescribed agencies, 58-59, 80

advisory committees, 97-102

meeting attendance, 97-102

membership, 97-102

remuneration and allowances, 102

agencies see regulatory agencies

annual report, 7-8, 71

appeals against Regulator decisions, 23

application form, new, 14, 65

applications and notifications, 29-32

number, 29

time frame for decisions, 28

trend data, 44

APS Values and Code of Conduct, 16

assessments and approvals, 25, 29, 53-54, 59

125

processes for, 86-93

assets management, 70

Assistant Minister for Health, 14, 16, 97

audits

external, 53-54

internal, 17

of regulated parties, 96

Australian National Audit Office (ANAO), 20

Australian Pesticides and Veterinary Medicines Authority (APVMA), 58, 80-81

Australian Seed Federation, 54

authorisations, classes of, 83

awards and recognition, staff, 65

B banana, 23, 36, 46

barley, 23, 46

bilateral arrangements, 62

biosafety and risk assessment, 57, 62

bonuses see performance pay

breaches, 19

breeding programs, reviews of, 55

budget, 20

Business Risk Management Plan, 17

C canola, 23, 33, 46, 56

Cartagena Protocol on Biosafety, 61

certification guidelines, revised, 57

certified physical containment facilities, 42-44, 95

applications, 31-32, 44

classification of, 42

exempt dealings, 84

guidelines, 57

location by jurisdiction, 43

monitoring and inspection, 48-51

non-compliance, 52-53

notifiable low risk dealings (NLRDs), 25, 39

126 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

number, 42

by organisation type, 43

time frames for decisions on, 28, 42

trend data, 44

variations, 26, 44

Chalmers, Prof. Donald, 14, 101

chickens, 38, 97

cholera, 34, 59

classes of GMO dealings, 27-28, 83-86, 89, 93

classifications of staff, 104

Cleland, Dr Robyn, 18

client register, 60

clinical trials, 23, 97

clock stop, 28, 116

clover, white, 46

code of conduct see APS Values and Code of Conduct

commercial release of GMOs, 13, 45, 47

committees see advisory committees

Commonwealth Fraud Control Guidelines, 17

communication products and activities, 59, 110-115

Compliance and Investigation Section of OGTR, 18-19, 53-54

compliance management, 52-56

conferences see meetings and forums

confidential commercial information (CCI), 31

number of declarations, 38

consultancies, 70

consultation and engagement 14-15, 57-60

government agencies, 14-15, 63

local councils, 25, 88, 92

Minister for the Environment, 25, 49, 88, 92

prescribed agencies, 14-15, 80-82

public, 14-15, 59, 110-113

regulated parties, 14-15

regulatory agencies, 14-15, 62-63

states and territories, 14-15

contact details see address and contact details

127

contained facilities see certified physical containment facilities

corporate governance, 16-17

corporate overview, 16-23

corresponding legislation, state and territory, 73-74

cost recovery investigation, 60

cotton, 23, 30, 33-34, 46, 47, 97

crops, field trial, 46

inspections, 45-48

cross-agency collaboration, 59

CSIRO, 30, 33, 36, 37, 116

D data requirements, 88, 91-92

databases, 19

dealings 83-96

classes of, 28, 84-93

definition, 24

licensed, 29-32

see also dealings involving intentional release (DIRs); dealings not involving intentional release (DNIRs); Emergency Dealing Determinations (EDDs); exempt dealings; inadvertent dealings; notifiable low risk dealings (NLRDs)

dealings involving intentional release (DIRs), 29-35, 89-93

applications and notifications, 29-32

assessment process, 90

licences issued, 29-30, 33-35

location by jurisdiction, 48

monitoring and inspection, 45

non-compliance, 52

by organisation type, 35

time frames for decisions on, 28, 29

trend data, 44

dealings not involving intentional release (DNIRs), 35-38, 86-88

applications, 31-32

assessment process, 87

licences issued, 36-38

monitoring and inspection, 52

by organisation type, 38

128 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

research focus of, 37

time frames for decision on, 28

trend data, 38, 44

dealings placed on GMO Register, 40

deliverables, 22-23

Department of Agriculture, 55, 56, 58, 82, 92

Department of Foreign Affairs and Trade, 54, 55, 92

Department of Health, 16, 58, 59, 60

Department of Health and Ageing, 54

Department of Industry, Tourism and Resources, 54

Department of the Environment, 55, 56

departmental assistance measures, 67

disability, people with, 71

disease research, 36, 37

disposal of GMOs see Guidelines for the Transport, Storage and Disposal of GMOs

diversity, workplace, 16

Dodds, Professor Susan, 100

Dornbusch, Dr Michael, 18, 19

E e-learning module, 67

ecologically sustainable development, 72

email contacts, 111-112

emergency control team, internal, 65

Emergency Dealing Determinations (EDDs), 40, 94

number, 40

employees see staff

employment framework, 16

enterprise agreement, 16, 64, 66, 103

environmental performance, 21, 72

equine influenza vaccine, 40

ethical standards, 16

eucalypts, 61

Evaluation Branch of OGTR, 19-20

exempt contracts, 70

exempt dealings, 84

129

containment guidelines, 57

expenses, 20

F fact sheets, 16, 59

feedback mechanisms, 59-60

female staff, 105

field trial sites 22, 45-48

change of status, 47

crop types at, 46

location by jurisdiction, 48

monitoring and inspection, 13, 19, 23, 45-48, 96

number, 47

financial framework, 16-17

Financial Management and Accountability Act 1997, 17, 20

financial performance, 20

financial reporting, 20

financial statements, 20

flexible working arrangements, 66, 67

Food Standards Australia New Zealand (FSANZ), 54, 58, 63, 75, 81

forums see meetings and forums

fraud control, 17

free call number, 111-112

freedom of information, 16, 68-69

functions and role, 62-63

funding, 20

G gender of staff, 105

Gene Technology Account, 20

Gene Technology Act 2000, 16, 18, 52, 73-74, 78

amendment and review, 22, 58, 78-79

contraventions, 53-54

convictions, 26

dealings under, 24-28

development of, 73

and GMO Record, 59

130 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

and GMO Register, 25, 83

investigations, 53-54

licensed dealings under, 24-28, 35, 38

non-compliance, 52-53

object, 73

provision of advice under, 57-60

Regulator’s functions under, 57, 61, 62

reporting requirements under, 71

variation of instruments under, 44

Gene Technology Agreement, 73, 74, 78

Gene Technology Ethics and Community Consultative Committee (GTECCC), 100

chair, 101

membership, 102

Gene Technology Regulator, 5-6, 18, 74-76

review 2013-14, 13-15

Gene Technology Technical Advisory Committee (GTTAC), 97-98

chair, 98

membership, 99

genetically modified organisms (GMOs) and GM products

advice on, 58-59

definition, 26

see also crops, field trial; monitoring and inspection; risk assessment and management

glossary, 116-118

GM wheat, unlicensed see wheat

GMO Record, 94

GMO Register, 83

dealings placed on, 40

governance arrangements, 16-17, 74-76

government funding, 20

guidance documents, 109

guide to annual report, 7-8, 71

Guidelines for the Accreditation of Organisations, 41

Guidelines for the Transport, Storage and Disposal of GMOs, 76

guidelines, revised, 57

131

H harmonisation activities, 61, 62, 63

Head of Agreement, 16

health and safety see work health and safety

highlights for 2012-13, 13-15

human clinical studies, 37

human pathogens studies, 37

human resources see staff

I inadvertent dealings, 93

independent reviews, 58

Indian mustard, 46

information technology see website

injuries and accidents, 68

inspection see monitoring and inspection

institutional biosafety committees (IBCs), 27, 79, 80, 88, 91, 95

international engagement, 61-62

investigations, 53-54, 96

K key performance indicators, 21-24

L Legal Section of OGTR, 18

Legislative and Governance Forum on Gene Technology (LGFGT), 77-80

advice to, 58

legislative framework, 16, 18, 20, 74, 78

legislative review and amendment, 58, 78-80

licences see applications and authorisations

licensed dealings, 29-38, 83 see also dealings involving intentional release (DIRs); dealings not involving intentional release (DNIRs); notifiable low risk dealings (NLRDs)

limited and controlled release, 27, 89, 91, 97

time frames for decisions on, 28, 93

list of requirements, 119-123

local councils, consultation with, 25, 88, 92

132 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

M maize, 46, 56

male staff, 105

management and accountability, 64-72

market research see advertising and market research

maternity leave, staff, 67

meetings and forums, 107-108, 114-115

meetings of advisory committees, 98, 100

memoranda of understanding, 14, 56, 58

Minister for Health and Ageing, 40, 77, 94

Minister for the Environment, 16, 75, 93

ministerial correspondence and briefings, 19

mission statement, 5

monitoring and inspection, 45-51, 95-96

field trials, 45-48

targets, 23, 45, 48

N National Disability Strategy, 71

National Health Security Act 2007, 57

national strategy for unintended presence of unapproved GMOs, 54-56

non-compliance, 52-53

contained facilities, 52-53

non-salary benefits, 66

notifiable incidents, 68

notifiable low risk dealings (NLRDs), 39, 84-85

containment guidelines, 42, 84

notification of, 31

number, 39

by organisation type, 39

trend data, 44

number of staff, 104

O objective, 6

occupational health and safety, 67-68

1800 free call number, 111-112

133

online resources, 110-111

operational performance, 24-63

organisational structure, 17

organisations, accreditation of, 41-42, 95

organisations, inspections by, 45-50

outcome, 22-23

outlook, 13-15

overview, 13-15

P papaya, 56

pathogens studies, 37

perennial ryegrass/tall fescue, 46

performance against deliverables, 22-23

performance highlights, 22-23

performance pay, 105

performance, operational, 24-63

physical containment facilities see certified physical containment facilities

physical containment guidelines, 42, 84

pineapple, 111

policy principles on dealings with GMOs, 77, 97, 100

portfolio membership, 16

practice reviews of regulated parties, 53, 54, 96

prescribed agencies, 81-82

consultation and engagement, 14-15, 80

prescribed time frames, 28

presentations see meetings and forums

privacy, 16

procurement, 69

program, 21-23

prostate cancer vaccine, 23

public consultation and engagement, 14-15, 59

Public Service Act 1999, 3, 16, 103

publications and guidance, 109

purchasing, 69

134 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

Q quality assurance audits and reviews, 54-56

quantitative deliverables, 21-23

quarterly reporting, 71

R Radanovich, Andrew, 18

Rasko, Professor John, 98

regulated parties, consultation and engagement, 14-15

Regulator’s Achievement Award for staff, 65

Regulator’s review, 13-15

Regulators’ Forum, 59

regulatory agencies, consultation and engagement, 14-15, 62-63

regulatory framework, 16-17, 57-58, 74, 78

regulatory harmonisation, 61, 62, 63

Regulatory Practice and Compliance Branch of OGTR, 18-19, 53-54

Regulatory Science Network, 59, 63

remuneration and allowances, advisory committees, 102

reporting lines, 16-17

reporting requirements, 71, 119-123

research

dealings involving intentional release (DIRs), 29-35

dealings not involving intentional release (DNIRs), 35, 37

notifiable low risk dealings, 39

resource management and use, 20

retention of staff, 64-67, 105

reviews see independent reviews

revised guidelines, 57

Risk Analysis Framework (RAF), 13, 85, 89

risk analysis workshop, 61

risk assessment and management, 55-56, 61, 62, 72, 84-85, 87-88, 90-94

risk assessment and risk management plans (RARMPs), 20, 25, 27, 70, 85, 88

role and functions, 5, 62-63

S safflower, 23, 33, 46

secretariat services, 19

135

security, 17

Security Sensitive Biological Agents Regulatory Scheme, 57

seeds, imported, 54, 56

self-reporting by regulated parties, 53, 96, 112

seminars see meetings and forums

service level agreements, 17

Smith, Dr Joe, 15

social inclusion measures, 15

staff, 64-67, 103-108

classifications, 105

flexible working arrangements, 67

gender, 105

maternity and unpaid leave, 67

non-salary benefits, 66

number, 6, 104-105

profile, 103-108

retention, 6, 105

satisfaction survey, 65

training and development, 106-108

work health and safety, 67-68

work-life balance, 67

stakeholder consultation and engagement, 14-15, 57-60, 110-113

states and territories

consultation and engagement, 14-15, 40, 56, 86, 88, 92, 94

contained facilities in, 43

corresponding legislation, 74

inspections in, 47-50

statutory committees see advisory committees

structure see organisational structure

sugarcane, 23, 46, 61

surrender of licences and certification, 32, 44

T tall fescue/perennial ryegrass, 46

Therapeutic Goods Administration (TGA), 58, 75, 80, 81

time frames, prescribed, 28

136 OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14

training and development, staff, 106

transparency, 15, 70

transport of GMOs see Guidelines for the Transport, Storage and Disposal of GMOs

U unintended presence of unapproved GMOs, 54-56

unlicensed GMOs, 25, 93

unplanned leave, 67

V vaccinations, staff, 66, 68

vaccine studies, 29, 45

inspection of facilities, 23

values, 6

variations of licences, 26, 32, 44

time frames for decisions on, 28

vision statement, 5

W website, 15, 59-60

freedom of information disclosure log, 69

information on, 59

usage, 110-111

weed risk assessments, 13

wheat, 23, 33, 46, 56, 97

unauthorised plants in US, 62

white clover, 46

work health and safety

in contained facilities, 52

staff, 67-68

Work Health and Safety Act investigations, 68

work-life balance, staff, 67

workplace diversity, 16

workshops see meetings and forums

Y year ahead, 15

www.ogtr.gov.au

All information in this publication is correct as at October 2014 10873 October 2014

OPERATIONS OF THE GENE TECHNOLOGY REGULATOR ANNUAL REPORT 2013-14