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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
ANNUAL REPORT
2014–15
www.ogtr.gov.auAll information in this publication is correct as at October 2015
OPERATIO
NS OF THE G
ENE TECHNOLO
GY REG
ULATOR ANNUAL REPO
RT 2014-15
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The object of the Gene Technology Act 2000 is to protect the health and safety of people, and to protect the environment, by identifying risks posed by, or as a result of, gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms.
ISSN: 2205-4502 (online)ISSN: 1833-6264 (print)
PAPER-BASED PUBLICATIONS© Commonwealth of Australia 2015This 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 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 [email protected].
INTERNET SITES© Commonwealth of Australia 2015This 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 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 [email protected].
CONTACTS
Office of the Gene Technology Regulator MDP 54 GPO Box 9848 Canberra ACT 2601 Australia Level 1, Pharmacy Guild House 15 National Circuit Barton ACT 2600
Telephone: 1800 181 030 Fax: (02) 6271 4202 Email: [email protected] Website: www.ogtr.gov.au
ABN 15 862 053 538
Annual report webpage: www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1
Inquiries 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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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 I A N N U A L R E P O R T 2 0 1 4 – 1 5 iii
Senator the Hon Fiona Nash
Minister for Rural 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 2014 to 30 June 2015.
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 7 (Health Infrastructure, Regulation, Safety and Quality)
of the Department of Health Portfolio Budget Statements for the period 1 July 2014
to 30 June 2015.
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 2015.
Yours sincerely
Dr Robyn Cleland
Acting Gene Technology Regulator
6 October 2015
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Summary of OGTR performance
LegislationGene Technology Act 2000 and corresponding state and territory legislation
ObjectTo protect people and the environment from risks posed by genetically modified organisms
Governance
Finance Gene Technology Special Account $7.81m
PBS targets Met
Statutory timeframes 96%
Monitoring targets Exceeded
Shared services Extensive use
Staff 43
Breakdown of staffing levels 1 Holder of Public Office; 2 SES B1; 21 EL staff 23 APS staff
Statutory work
Limited and controlled DIR 5
Commercial DIR 2
DNIR 10
Certifications 89
Variations 324
New NLRDs 842
Compliance No risks to people or the environment; 1 audit, 4 practice reviews
Statutory Committees
GTTAC 2 face to face meetings, 2 V/C
GTECCC Appointment process ongoing
Other Activities
Stakeholder engagement 6th National Institutional Biosafety Committee Forum
Consultation On every risk assessment and risk management plan
TransparencyAll decisions included on the GMO Record (website)
Website upgrade
Harmonisation
ISBGMO meeting, Cape Town, South Africa
Three joint inspections of certified labs with the Department of Agriculture
OECD – Eucalyptus and Cowpea consensus biology documents
Deregulation
Streamlining data requirements to support limited and controlled DIR applications
GT Act Technical Amendments
International assessments Incorporated where available, work ongoing
ProjectsHorizon scanning report
Public attitudes to gene technology survey
Recent reviews 2011 Review of the Gene Technology Act
Key external stakeholdersCompanies, universities, research institutes, health services, State and Territory governments, other regulatory agencies, other C’wth departments, NGOs, industry peak bodies, the public
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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 I A N N U A L R E P O R T 2 0 1 4 – 1 5 v
CONTENTSOffice of the Gene Technology Regulator vii
About this report ix
1 Gene Technology Regulator’s review 1
Annual report 2
Stakeholder engagement 3
Deregulation 3
National harmonisation 4
International harmonisation and capacity building 5
2 Corporate overview 7
Corporate governance 8
Organisational structure 9
Gene Technology Regulator 10
Regulatory Practice and Compliance Branch 11
Evaluation Branch 12
Financial performance 13
Performance against PBS targets 14
3 Operational performance 17
Statutory functions and regulatory processes 18
Operational achievements 23
4 Management and accountability 59
Human resources 60
Work health and safety 63
Freedom of information 65
Purchasing 66
Assets management 66
Exempt contracts 66
Consultancies 66
Advertising and market research 67
Annual reporting requirements 67
Quarterly reporting requirements 67
National Disability Strategy 68
Ecologically sustainable development and environmental performance 68
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Appendix 1 History and structure of the gene technology regulatory system 72
Appendix 2 Application types, authorisations, and monitoring and compliance 82
Appendix 3 Presentations and meetings on gene technology in Australia 99
Appendix 4 Stakeholder and public access to the OGTR 100
Appendix 5 Staff profile, and training and development activities 104
Appendix 6 Publications 108
Appendix 7 Membership of statutory committees and attendance at meetings 109
Glossary and shortened forms 114
List of requirements 116
Index 121
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viiO 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 I A N N U A L R E P O R T 2 0 1 4 – 1 5
OFFICE OF THE GENE TECHNOLOGY REGULATOR Our visionTo be a trusted and respected regulator of gene technology safeguarding the
Australian people and the environment.
Our missionDedicated to ensuring that genetically modified organisms are safely managed in
Australia.
Our roleTo protect the health and safety of people and the environment by identifying risks
posed by, or as a result of, gene technology, and by managing those risks through
regulating certain dealings with 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.
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Enabling strategies• Sound science
• Effective compliance
• Good governance
• Capable, qualified staff
• Clear communication
Outcomes• A high-performing 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.
• Regulatory decisions that are transparent, consistent, defensible and
evidence based.
• People that are skilled, productive and professional.
• A cooperative and compliant regulated community that engages with the
regulatory system.
Our peopleAs at 30 June 2015, the Office of the Gene Technology Regulator comprised 50
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 valuesProfessional, transparent, accountable, proactive, collaborative, responsive,
respectful, inclusive, ethical.
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ixO 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 I A N N U A L R E P O R T 2 0 1 4 – 1 5
ABOUT THIS REPORT This annual report is prepared in accordance with Requirements for annual reports,
issued by the Department of the Prime Minister and Cabinet, and approved by the
Joint Committee of Public Accounts and Audit under ss. 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 2014–15 against deliverables and
key performance indicators for the Office of the Gene Technology Regulator (OGTR);
these are contained in Outcome 7 (Health Infrastructure, Regulation, Safety and
Quality) of the 2014–15 Health Portfolio Budget Statements.
This report describes the roles and responsibilities of the Regulator and the OGTR. It
provides readers with a picture of the OGTR’s performance over the past 12 months.
The report contains four chapters and a number of appendixes. The chapters are
organised as follows:
• Chapter 1, ‘Gene Technology Regulator’s review’, summarises 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 2014–15 Health Portfolio
Budget Statements.
• Chapter 3, ‘Operational performance’, describes the OGTR’s achievements
against the priorities for 2014–15. It discusses deliverables and
performance targets achieved for assessments and approvals, monitoring
and compliance, consultation with stakeholders, and international
relationships. The chapter also provides information on other activities
relating to the Regulator’s statutory functions, as prescribed by the
Gene Technology Act 2000. Classes of dealings with genetically modified
organisms (GMOs) are defined in the Gene Technology Act 2000, the
Gene Technology Regulations 2001, and corresponding state and territory
laws. This chapter summarises the classes of GMO dealings, processes for
authorisations and statutory timeframes.
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• Chapter 4, ‘Management and accountability’, provides an overview of the OGTR’s
resource management practices and adherence to Australian Government
accountability principles.
The appendixes provide a range of statistical and other information, including
information needed for compliance with annual reporting requirements. The
appendixes also contain detailed information on the history and structure of the gene
technology regulatory system, types of GMO dealings and the assessment processes.
Note: The 2014–15 annual report of the Australian Government Department of
Health 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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CHAPTER 1GENE TECHNOLOGY REGULATOR’S REVIEW
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Annual reportThis year has been a busy one for the Office of the Gene
Technology Regulator (OGTR) as we worked to fulfil our
legislative responsibilities in administering the national
regulatory scheme for gene technology. Our strategic plan
and science strategy have guided our activities to ensure
that we deliver efficient and effective regulation that is
based on sound science, that we communicate openly and
transparently with our stakeholders, and that we deliver the
highest standards of accountability and governance.
We have had more applications for environmental releases this year than since
the early days of the regulatory scheme. Comprehensive risk assessments and risk
management plans were prepared, and stakeholders were consulted, on nine
licence applications for intentional release of genetically modified organisms (GMOs)
into the environment: six field trials, a clinical trial, a commercial genetically modified
(GM) canola and a commercial GM vaccine for poultry.
We have also had a greater variety of application types, particularly in the area of
human and animal therapeutics. This year saw the first approval of a commercial
licence for a GM animal vaccine. Increased numbers of applications have been
submitted for GM human therapeutics, and this has contributed to a significant
increase in the number of commercial applications received. Five such applications
are currently under consideration—the largest number that the OGTR has ever had
at one time. In addition, I have approved 10 GMO licence applications for work
in contained facilities based on the risk assessments and risk management plans
prepared by the office.
During 2014–15, the OGTR maintained its active approach to monitoring for
compliance with requirements that ensure that risks to human health and the
environment are minimised. The OGTR inspected 44% of field trial sites to monitor
compliance with licence conditions and found high levels of compliance by licence
holders. Sites were inspected in New South Wales, the Northern Territory, Queensland,
Victoria and Western Australia. Inspections included GM canola, wheat, barley,
cotton, sugarcane, banana and safflower.
The OGTR also inspected 29% 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.
Again, high levels of compliance by licence holders were found.
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As part of the Australian Government Department of Health, the OGTR has been
involved in the review of the portfolio’s function and efficiency, and will be part of
the implementation of recommendations of the review. We have also been active
in supporting government priorities in relation to deregulation, and national and
international harmonisation.
Stakeholder engagementOne of our major achievements this year was hosting a successful Institutional
Biosafety Committee (IBC) Forum in April 2015. This biennial event was opened by
our portfolio minister, Senator the Honourable Fiona Nash. Professor Fiona Wood was
the keynote speaker, and her presentation inspired all of us to aim for greatness.
The IBCs, which provide in-house expertise and oversight within organisations, are
important partners in the regulatory scheme. IBCs have consistently indicated that the
forums help them to share knowledge, regulatory approaches and strategies across
organisations, which assists compliance with regulatory requirements. Although the
program mainly focused on GMOs in contained facilities, a new addition this year was
a workshop on applications for release of GM plants into the environment. Participants
found this valuable, and it will become part of these events in the future.
Another milestone was the launch of our new website, a major platform for OGTR
communication activity. The site has been redesigned to be more intuitive and easy
to navigate, and to provide information users need ‘at their fingertips’. Feedback from
external users so far has been positive.
DeregulationDeregulation is an opportunity to improve our regulatory practice to ensure risk-
based regulation—in which the level of regulatory oversight is proportionate to the
level of risk posed by the activity—and to assist stakeholders’ understanding of,
and compliance with, the regulatory scheme. In responding to the government’s
deregulation agenda, the OGTR has continued to focus on improving our processes
and procedures. The draft of a new commercial release application form was
circulated to our stakeholders for consultation. This form aims to streamline and clarify
data requirements, to guide applicants in providing information to support their
application. Feedback was positive and will be incorporated into the final version.
The Gene Technology Act Amendment Bill 2015 was tabled in parliament during the
winter sitting. This Bill will give effect to minor and technical amendments that were
agreed to in the 2013 response by all governments to the 2011 review of the
Gene Technology Act 2000. The OGTR supported the process leading to introduction
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of the Bill, and we are looking forward to implementing the deregulatory changes in
the Bill when it comes into effect.
In response to the Australian Government’s Industry, Innovation and Competitiveness
Agenda, the OGTR continued to investigate how international standards and
assessments might be further incorporated into our processes. Because of different
regulatory approaches and diverse perspectives on the technology, there are
no international standards for approvals of work with GMOs. However, the Gene
Technology Regulator currently uses data from international approvals and trusted risk
assessments, where available, to support decision making on licence applications.
Involvement in the consultations that led to the Australian Government’s Regulator
Performance Framework and Community of Practice to support best-practice
regulation have provided an opportunity to examine how we measure our
performance. Although not subject to the framework (because the regulatory scheme
comprises state and territory legislation as well as Commonwealth legislation), we
examined our performance measures to ensure that they align with the principles
underpinning the framework and to ensure that we use regulatory best practice.
It is clear that the regulatory scheme for gene technology was developed using
the principles of best-practice regulation, consistent with those of the Regulator
Performance Framework.
National harmonisationThe OGTR has strong relationships across government, particularly with sister
regulatory agencies. Bilateral arrangements with other Australian Government
regulators continued to support timely, efficient and comprehensive assessment
of GMOs and GM products. The OGTR partnered with the Australian Government
Department of Agriculture to pursue efficiencies that may be generated through
joint inspections of laboratory facilities. Three initial joint inspections were
conducted during 2014–15, and further opportunities were identified to minimise
the regulatory burden on organisations that are subject to related requirements of
both organisations.
Another significant harmonisation activity was chairing the Regulatory Science
Network, a very active group that encompasses regulators from various portfolios. The
network’s focus during the year was on science as evidence for regulatory decision
making, participation in the current review of Australian Standard AS/NZS 2243.3
(Safety in laboratories: microbiological safety and containment), and adapting the
Post-border Weed Risk Management Protocol1 tool in our risk assessment and risk
1 www.saiglobal.com/pdftemp/previews/osh/as/misc/handbook/hb294-2006.pdf
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management plans. This protocol articulates risk criteria that are applicable to GMOs
as well as to plants, and supports adoption of common national protection goals.
International harmonisation and capacity buildingAs the national regulatory body for GMOs in Australia, the OGTR is actively involved in
a number of international efforts to harmonise regulatory oversight of work with GMOs.
The OGTR is a trusted source of guidance on risk assessment for countries seeking
practical approaches to regulating GMOs.
Two officers from the OGTR were involved in organising, and presented at, the
13th International Symposium on the Biosafety of GMOs in November 2014 in
Cape Town, South Africa. This pre-eminent biennial conference was attended by
academic researchers, regulators and other interested groups. It provided a unique
concentration of expertise and perspectives to inform science-based risk assessment,
and encourage the exchange of ideas and innovations for best-practice regulation.
Other international activities this year included ongoing input to the Organisation
for Economic Co-operation and Development Working Group on the Harmonisation
of Regulatory Oversight in Biotechnology. Significant input to this working group by
Australia resulted in the declassification of a biology document on eucalypts, fruitful
visits to the OGTR by two regulatory officials from Ghana, and hosting by the OGTR
of a delegation from India. The OGTR also contributed to Australian engagement in
the United Nations Convention on Biological Diversity (CBD) and the United Nations
Cartagena Protocol on Biosafety, both of which had their biennial meetings in 2014.
OGTR scientific staff participated in an expert online forum on synthetic biology
established by the CBD. The regulation of new technologies, including synthetic
biology, continues to be an issue internationally and for the OGTR.
In closing, I would like to thank the staff of the OGTR for their efforts and dedication
in fulfilling our statutory requirements, and their contribution to the work of the office
throughout an exceptionally busy year. Without their hard work and commitment, the
achievements presented in this annual report would not have been possible.
As we look forward to 2015–16, we will be guided by the Department of Health
Corporate Plan and Behaviours in Action. We will continue to use the enabling
strategies in our strategic plan of sound science, effective compliance, good
governance, capable and qualified staff, and clear communication to protect the
health and safety of people and the environment.
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CHAPTER 2CORPORATE OVERVIEW
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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 7 (Health Infrastructure, Regulation, Safety and Quality) of the 2014–15 Health Portfolio Budget Statements (PBS).
Corporate governanceThe Regulator is a statutory office holder with specific powers and functions under
the Gene Technology Act 2000 (see Appendix 1 for background about the Act and
its governance). In exercising these functions, the Regulator is directly responsible
to the Australian Parliament. During 2014–15, the Assistant Minister for Health had
portfolio responsibility for matters relating to the OGTR, which is part of the Australian
Government Department of Health. The Secretary of the department provides staff
to the OGTR under s. 133 of the Act; these staff are funded by the Gene Technology
Special Account to provide administrative and scientific support to the Regulator.
The OGTR has an ongoing head of agreement in place with the department to
access a range of business management and reporting services, through both the
Shared Services Centre and directly. The services covered are 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. 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; compliance with Australian
Government freedom of information, privacy, and work health and safety legislation;
and compliance with the National Disability Strategy and Australian Government
workplace diversity policy.
The Public Governance, Performance and Accountability Act 2013 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 2011, as required by the department.
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OGTR internal policies and practices also cover the physical security and protection
of confidential commercial information received from applicants in support of their
applications.
The OGTR maintains its own business risk management plan, which senior OGTR staff
review periodically.
Organisational structureThe OGTR comprises an Evaluation Branch, and a Regulatory Practice and
Compliance Branch. Both branches include a number of sections that focus on
particular activities relating to regulation of gene technology (Figure 1).
Figure 1: Organisational structure of the OGTR, 2014–15
Gene Technology
Regulator
Regulatory Practice and Compliance Branch
Business Management, Communication and Post Release Review
Compliance and Investigation
Monitoring
Regulatory Practice and Secretariat
Application Entry Point
Contained Dealings Evaluation
Plant Evaluation
Science Cohort
Evaluation Branch
Legal
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In August 2014, the Evaluation Branch was restructured: the responsibility of
assessing and managing low-level certifications was moved from the Application
and Licence Management Section to the Contained Dealings Evaluation Section.
The Application and Licence Management Section was then renamed the
Application Entry Point Section.
Gene Technology RegulatorThe Regulator is an independent statutory office holder who administers the nationally
consistent scheme for regulating gene technology, comprising the Gene Technology
Act 2000, and corresponding state and territory laws.2 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).
Dr Robyn Cleland was the acting Regulator for most of the reporting period.
Dr Cleland has extensive experience in corporate, risk management and scientific
roles in regulatory agencies, including the OGTR, Food Standards Australia New
Zealand, and the Australian Pesticides and Veterinary Medicines Authority.
The Legal Section provides legal advice to the Regulator and the OGTR on the
operation of Commonwealth, state and territory laws affecting their functions,
including setting licence conditions and handling confidential commercial
information. It trains OGTR staff on legal issues.
2 www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/legislation-2
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Regulatory Practice and Compliance BranchMr Andrew Radanovich has been the acting Assistant Secretary, Regulatory Practice
and Compliance Branch, since May 2015. 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, coordination of monitoring and compliance activities, corporate business
services, expert advisory committees, communication and international cooperation.
In partnership with the department, the branch’s Business Management,
Communication 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 freecall (1800 181 030) number, coordinates
responses to email inquiries (to [email protected]) and manages the OGTR website.
It has developed the Post Release Review Framework to guide ongoing oversight of
GMOs that have been released commercially or as general releases.
The Compliance and Investigation Section audits, reviews and investigates
organisations and individuals involved in 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.
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. In particular, the section
focuses on maintaining compliance with conditions of licences or other instruments,
and managing 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 is the contact point for other Australian
Government agencies, and other national and international organisations
involved in 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.
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Evaluation BranchMr William Tucker has been the acting Assistant Secretary, Evaluation Branch, since
May 2015. Mr Tucker first joined the OGTR in 2002. He managed the Contained
Dealings Evaluation Section from August 2014, and the Plant Evaluation Section
between 2010 and 2014. Mr Tucker’s responsibilities encompass managing
evaluation of licence applications and other authorisations relating to dealings with
GMOs, and other science-related projects that maintain and improve the OGTR’s
technical capabilities.
The Application Entry Point Section receives and acknowledges all applications,
processes accreditation applications, manages databases and reports on workflows.
The Contained Dealings Evaluation Section prepares risk assessment and risk
management plans (RARMPs) in response to applications for dealings not involving
intentional release of GMOs into the environment (DNIRs)—also known as ‘contained
dealings’—and applications for non-plant dealings involving intentional release (DIR).
The section provides advice to accredited organisations and Institutional Biosafety
Committees on the classification of dealings with GMOs, and inspects and processes
applications for certification of high-level and large-scale containment facilities. As
of August 2014, the section also processes applications for certification of lower-level
facilities and coordinates reviews of certification guidelines.
The Plant Evaluation Section prepares RARMPs in response to DIR applications
for genetically modified (GM) plants, 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 the
OGTR and stakeholders.
The Science Cohort develops and manages science-related projects, 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, supports national
and international input into regulatory harmonisation programs, and oversees the
OGTR library.
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Financial performanceThe Gene Technology Account is a Special Account for the purposes of the Public
Governance, Performance and Accountability Act 2013. The Special Account receives
all moneys appropriated by parliament and makes payments for expenses the
Regulator incurs in performing its functions. The OGTR prepares accrual accounting
financial statements in accordance with Department of Finance guidelines. The
Australian National Audit Office audits these statements each year, and the
statements are then consolidated into the financial statements of the department 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,
Communication and Post Release Review Section coordinates financial reporting and
management.
The 2014–15 federal budget measures for the OGTR are published in the department’s
2014–15 PBS and are summarised in Table 1.
Table 1: Australian Government funding for the OGTR, 2014–15 to 2018–19
2014–15 ($ million)
2015–16 ($ million)
2016–17 ($ million)
2017–18 ($ million)
2018–19 ($ million)
Departmental 7.810 7.730 7.656 7.707 7.760
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14
Performance against PBS targetsThe OGTR’s activities for 2014–15 are described under Program 7.7 in Outcome 7
(Health Infrastructure, Regulation, Safety and Quality) of the 2014–15 Health PBS.3
The key objective of the subprogram relating to gene technology regulation is to
‘protect the health and safety of people and the environment by regulating work with
genetically modified organisms’.
The OGTR’s performance against deliverables and key performance indicators, which
is also reported in the department’s 2014–15 annual report, is summarised below.
Qualitative deliverable: Progress improvements to OGTR operations recommended by all Australian governments’ response to the review of the Gene Technology Act 2000
2014–15 reference points:
• Implementation completed within agreed timeframes.
• Progress agreed minor and technical amendments to increase flexibility and
reduce regulatory burden.
Result: Met
In 2014–15, the OGTR undertook a range of activities to improve communication and
consultation with regulated stakeholders and the public. In particular, the OGTR
significantly rebuilt its website, taking into account feedback from stakeholders, and
continued to use social media tools to disseminate information. The department
made minor and technical amendments to the Gene Technology Amendment Bill
2015, which was introduced into parliament in June 2015.
Qualitative deliverable: Provide effective regulation of GMOs that is open and transparent
2014–15 reference points:
• RARMPs prepared for all applications for licensed dealings.
• Stakeholders, including the public, consulted on all assessments for
proposed release of GMOs into the environment.
• Record of GMO dealings and maps of all field trial sites maintained and
made publicly available on the OGTR website.
Result: Met
In 2014–15, the Regulator prepared comprehensive RARMPs for, and consulted
with stakeholders on, nine GMO licence applications for intentional release into
the environment: six field trials, one clinical trial, a commercial GM canola and a
commercial GM vaccine for poultry. The Regulator also prepared RARMPs for
3 A copy of the 2014–15 PBS is available at http://www.cancerscreening.gov.au/internet/budget/publishing.nsf/
Content/2014-2015_Health_PBS
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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.4
Quantitative deliverable: Percentage of field trial sites and higher-level containment facilities inspected
2014–15 target: ≥20%
2014–15 actual: 44% (field trial sites) and 29% (higher-level containment facilities)
Result: Met
In 2014–15, the OGTR inspected 44% of field trial sites to monitor compliance with
licence conditions that ensure that risks to human health and the environment
are minimised. Sites were inspected in New South Wales, the Northern Territory,
Queensland, Victoria and Western Australia. Inspections included GM canola, wheat,
barley, cotton, sugarcane, banana and safflower.
The OGTR also inspected 29% 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.
Qualitative indicator: Protect people and the environment through identification and management of risks from GMOs
2014–15 reference points:
• Comprehensive and effective risk assessment and risk management
of GMOs.
• High level of compliance with the gene technology legislation, and no
adverse effect on human health or the environment from authorised GMOs.
Result: Met
Routine monitoring of the regulated community found a high level of compliance with
the gene technology legislation.
4 www.ogtr.gov.au
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Qualitative indicator: Facilitate cooperation and provision of advice between relevant regulatory agencies with responsibilities for GMOs and/or genetically modified products
2014–15 reference point:
• High degree of cooperation with relevant regulatory agencies and provision
of timely advice.
Result: Met
In 2014–15, the OGTR continued cooperative arrangements with other Australian
Government regulators to improve coordinated decision making, and avoid
duplication in regulation of GMOs and GM products.
The OGTR engaged in international forums relevant to GMO regulation, including the
Organisation for Economic Co-operation and Development Working Group on the
Harmonisation of Regulatory Oversight in Biotechnology and the 13th International
Symposium on the Biosafety of GMOs. Regulators from other countries continued to
seek input from the OGTR because the Australian scheme is considered a model for
robust, practical and efficient regulation of GMOs. The OGTR also provided technical
support to Australian engagement in the 2014 meetings of the United Nations
Convention on Biological Diversity and the United Nations Cartagena Protocol on
Biosafety.
Quantitative indicator: Percentage of licence decisions made within statutory timeframes
2014–15 target: 100%
2014–15 actual: 95%
Result: Substantially met
The Regulator made decisions on all but one licence application within the
applicable statutory timeframes. The decision on one application was made 19 days
after the statutory timeframe as a result of an unavoidable delay in publication of the
mandatory gazettal notice for consultation. There were no appeals of decisions made
under the gene technology legislation.
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CHAPTER 3OPERATIONAL PERFORMANCE
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18
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 summarises classes of dealings, the process for authorisations and the statutory timeframe for consideration of each type of application. Other statutory functions, such as certification and accreditation, that help the Gene Technology Regulator (the Regulator) manage risks to the health and safety of people and the environment are also described.
The second part of the chapter describes operational performance in relation to
these activities and to performance indicators in Outcome 7 (Health Infrastructure,
Regulation, Safety and Quality) of the 2014–15 Health Portfolio Budget Statements (PBS).
Statutory functions and regulatory processesGMOs, dealings and authorisationsThe Gene Technology Act defines a GMO as any organism that has been modified by
gene technology, offspring derived from such an organism, or anything declared as a
GMO in the Regulations.
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, produce or manufacture the GMO
(c) breed the GMO
(d) propagate the GMO
(e) use the GMO in the course of manufacture of a thing that is not the GMO
(f) grow, raise or culture the GMO
(g) import the GMO
(h) transport the GMO
(i) dispose of the GMO
and includes the possession, supply or use of the GMO for the purposes of, or in the
course of, a dealing mentioned in any of paragraphs (a) to (i).
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The Gene Technology Act forms the basis of a prohibitory scheme that makes dealing
with a GMO a criminal offence unless, as outlined in s. 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 determination (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 involve routine laboratory techniques that have been used safely for many
years and pose 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 (ss. 47 and 50 of the Gene Technology
Act, respectively). Part 5 of the Act also allows the Regulator to grant a temporary
licence (no longer than 12 months) to a person who finds that 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. The Regulator must be satisfied that the risks associated
with the dealing are minimal 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 2 summarises the classes of dealings, their authorisation requirements and the
extent of containment required to conduct the dealing.
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Table 2: Categories of GMO dealings under the Gene Technology Act 2000
Category Authorisation requirements Containment
DIR (except for limited and controlled releases)
Licence required
Review of applications by IBC
Consultation on application
Preparation of RARMP
Consultation on RARMP and licence decision by Regulator
Containment measures may be required, determined case by case, and other licence conditions will apply
DIR (limited and controlled releases)
Licence required
Review of applications by IBC
Preparation of RARMP
Consultation on RARMP and licence decision by Regulator
Containment measures will be required, based on size and scope of release sought by applicant, and other licence conditions will apply
DNIR
Licence required
Review of applications by IBC
Preparation of RARMP
Licence decision by Regulator
Usually PC2 (or higher)-certified facilities
EDD
Licence not required
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
ExemptLicence not required
Dealings classified as exempt are scheduled in the Regulations
No intentional release to the environment
GMO Register
Licence not required
Dealings must have been previously licensed
Review of relevant information by Regulator
Containment measures may be required
Inadvertent dealing
Licence required
Licence decision by Regulator only for the purposes of disposal of the GMO
Containment and/or disposal measures will apply
NLRD
Licence not required
Dealings classified as NLRDs are scheduled in Regulations
Conduct of NLRDs requires prior assessment by IBC to confirm proper classification
Notified in annual report
Usually PC1- or PC2-certified facilities
DIR = dealing involving intentional release of a GMO into the environment; DNIR = contained dealing with a GMO not involving intentional release 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
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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, state and territory governments, Australian
Government agencies prescribed in the Regulations, the Minister for the Environment,
and relevant local councils.
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 a licence unless satisfied that any risks posed
by the dealings to be varied are able to be managed 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
processes is in Appendix 2.5
An organisation undertaking dealings with GMOs authorised under a licence must
be accredited by the Regulator. Accreditation of organisations and certification
of individual physical containment facilities helps to manage risks that may be
associated with dealings involving GMOs (see also Appendix 2).
5 Complete lists of DNIR and DIR licence applications and approvals, and NLRD, at http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gmorec-index-1
Inspecting a GM cotton field trial site in Queensland
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Category Timeframe (working days)
Accreditation 90 (r. 16)
Certification 90 (r. 14)
DIR—limited and controlled, no significant risk 150 (r. 8)
DIR—limited and controlled, significant risk 170 (r. 8)
DIR—except for limited and controlled releases 255 (r. 8)
DNIR 90 (r. 8)
Licence variation 90 (r. 11A)
DIR = dealing involving intentional release of a genetically modified organism into the environment; DNIR = contained dealing with a genetically modified organism not involving intentional release into the environment; r = regulation
TimeframesUnder s. 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. The Regulations also
prescribe a timeframe for consideration of applications to accredit organisations
and to certify facilities. These statutory timeframes are shown in Table 3. They do not
include weekends or public holidays in the Australian Capital Territory. They also
do not include periods when the Regulator has sought more information from the
applicant, including information to resolve a confidential commercial information
(CCI) claim. The decision-making process cannot proceed until the information is
provided. In these instances, the statutory timeframe clock is regarded as stopped.
Table 3: Prescribed timeframes for applications
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23O 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 I A N N U A L R E P O R T 2 0 1 4 – 1 5
Operational achievements This section describes the Regulator’s achievements against Outcome 7 (Health
Infrastructure, Regulation, Safety and Quality) of the 2014–15 Health PBS. It provides
details of achievements on deliverables and performance indicators in the key
areas of:
• assessments and authorisations under the Gene Technology Act
• monitoring of GMOs
• compliance with the Gene Technology Act
• consultation with stakeholders
• cooperation with relevant regulatory agencies
• Office of the Gene Technology Regulator (OGTR) operational changes
arising from the 2013 response by all Australian governments to the 2011
review of the Gene Technology Act.
Assessments and approvalsInformation on performance against deliverables and key performance indicators, as
set out in the 2014–15 Health PBS, is summarised in Chapter 2.
In 2014–15, the OGTR received 1553 applications and notifications, as defined under
the Gene Technology Act (Table 4). The timing and volume of applications each year
can be influenced by a range of factors, including research grant funding cycles,
seasonal agricultural factors and changes to legislation.
Inspecting a GM sugarcane field trial site in Queensland
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Table 4: Applications and notifications, 2014–15
Application type Received Withdrawn Approveda Refused Ceased considerationb
Under considerationc
Accreditation 10 0 10 0 0 2
CCI declaration for DIR licence 7 1 4 0 0 5
CCI declaration for DNIR licence 0 0 1 0 0 4
CCI declaration for NLRD notification 0 0 0 0 0 0
CCI declaration for other information 0 0 0 0 0 0
Certification 83 2 89 0 0 20
DIR licence 10 0 7 0 0 7
DNIR licence 9 0 11d 0 0 3
Lifting suspension of certification 35 0 36 0 0 1
NLRD notification 842 1 na na na na
Surrender of accreditation 5 0 4 0 0 1
Surrender of certification 94 1 122 0 0 5
Surrender of DIR licence 12 0 13 0 0 0
Surrender of DNIR licence 5 1 5 0 0 1
Suspension of certification 39 1 40 0 0 0
Transfer of certification 11 0 10 0 0 2
Transfer of DNIR licence 3 0 1 0 0 2
Variation of accreditation 0 0 0 0 0 0
Variation of certificatione 313 5 252 0 0 97
Variation of DIR licencee 12 1 9 1 0 3
Variation of DNIR licence 63 0 63 0 0 14
Total 1553 13 677 1 0 167
CCI = confidential commercial information; DIR = dealing involving intentional release of a genetically modified organism into the environment; DNIR = contained dealing with a genetically modified organism not involving intentional release into the environment; na = not applicable; NLRD = notifiable low risk dealinga ‘Approved’ refers to issuing of a new or varied licence or other instrument, consent to surrender an instrument, or a declaration in relation to a CCI application. Some applications reported as approved in 2014–15 were received in the previous financial year.b Includes both ‘ceased consideration’ and ‘not considered’ under s. 42 of the Gene Technology Act 2000c Under consideration at 30 June 2015d Includes two applications that were approved but incorporated into a single licencee Includes variations initiated by the Regulator to four DIR licences and one certification
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Licences for dealings involving intentional release of GMOsDecisions on DIR licence applications have a statutory time limit of 255 working days,
unless the application is for a limited and controlled release. The statutory time limit for
decisions on applications for limited and controlled release 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.
The Regulator issued seven DIR licences during 2014–15 (Table 5) and was considering
a further seven licence applications at 30 June 2015. Four of the DIR licences issued
related to applications that were received before 1 July 2014.
Six of the seven licence decisions were made within statutory timeframes (see
Chapter 2). One licence decision was not made within the statutory timeframe
because of a delay—outside the Regulator’s control—in gazettal of the mandatory
consultation notice. To meet statutory consultation requirements, the decision was
made 19 days after the statutory timeframe. There were no appeals of decisions made
under the gene technology legislation.
Five of the DIR licences issued in 2014–15 were for limited and controlled release
(e.g. field trials or clinical trials), and two were for commercial releases. All of the
limited and controlled release licences and one commercial release licence related
to crop plants with a variety of introduced traits. The other commercial release licence
was for a vaccine for chickens. Details of the traits introduced into the organisms for
release are provided in Table 5.
Of the seven DIR licences issued in 2014–15, four were issued to private companies,
one to a government agency (CSIRO) and two to universities (Table 5). Of the 113 DIR
licences issued since commencement of the Gene Technology Act, 60 (53%) have
been to private companies, 40 (35%) to government agencies and 13 (12%)
to universities (Figure 2).
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26
Table 5: DIR licences issued, 2014–15
Figure 2: Types of organisations issued with DIR licences since commencement of the Gene Technology Act 2000
DIR no. ApplicantCrop type
(parent organism)
Introduced trait
Type of release Received Issued
DIR-125
Zoetis Australia Research &
Manufacturing Pty Ltd
Escherichia coli
Vaccine—attenuation Commercial 23 Jul 2013 18 Dec 2014
DIR-127 Monsanto Australia Limited Canola Herbicide
tolerance Commercial 10 Dec 2013 21 Nov 2014
DIR-128 University of Adelaide
Wheat and barley
Abiotic stress tolerance;
nutrient uptake
Limited and controlled 26 Nov 2013 4 Aug 2014
DIR-129 Sugar Research Australia Limited Sugarcane Herbicide
toleranceLimited and controlled 27 Mar 2014 24 Oct 2014
DIR-130 Murdoch University Wheat Improved
grain qualityLimited and controlled 1 Jul 2014 3 Mar 2015
DIR-131 CSIRO Safflower Altered oil profile
Limited and controlled 17 Jul 2014 17 Feb 2015
DIR-133Bayer
CropScience Pty Ltd
Cotton
Insect resistance; herbicide tolerance
Limited and controlled 26 Sep 2014 11 May 2015
DIR = dealing involving intentional release of a genetically modified organism into the environment
0
10
20
30
40
50
60
UniversityGovernmentCompany
Perc
en
tag
e o
f lic
en
ce
s
53% 35% 12%
DIR = dealing involving intentional release of a genetically modified organism into the environment
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Licences for dealings not involving intentional release of GMOsDNIR licences authorise dealings with GMOs that are conducted in laboratories and
other physical containment facilities, and may pose risks that require management
through specific licence conditions. For DNIR licence applications, the Regulator must
make a decision within the statutory timeframe of 90 working days.
In 2014–15, the Regulator issued 10 DNIR licences (see Table 6). One of these
(DNIR-547) incorporated two DNIR applications issued as one licence. All approvals
were made within the statutory time limit. The Regulator was considering a further
three DNIR applications at 30 June 2015.
The types of GMO dealings authorised by DNIR licences issued in 2014–15 are research
applications, the focus of which is shown in Figure 3.
Table 6: DNIR licences issued, 2014–15
DNIR no. Applicant Title Received Issued
DNIR-538University of New
South WalesHIV biology 22 Jul 2013 4 Jul 2014
DNIR-547
Zoetis Australia Research &
Manufacturing Pty Ltd
Evaluation of toxin expression in Pichia pastoris and Chinese hamster (Cricetulus
griseus) ovary cells 8 Apr 2014 14 Aug 2014
DNIR-549Tréidlia Biovet
Pty LtdManufacture of foot rot vaccine for sheep
and goats9 May 2014 12 Sep 2014
DNIR-550
Harry Perkins Institute of Medical Research
Generation of fluorescent lentiviral transduced tumour cell lines
6 Jun 2014 2 Oct 2014
DNIR-551Monash University
Human immunodeficiency virus antiviral development
28 Jul 2014 2 Dec 2014
DNIR-552University of
Western SydneyUse of N11 murine microglia for drug
discovery14 Aug 2014 19 Dec 2014
DNIR-553Australian National University
Assessing HIV vaccine efficacy 13 Aug 2014 3 Dec 2014
DNIR-554
QIMR Berghofer Medical Research Institute
Production and clinical trial of a genetically modified Plasmodium falciparum blood
stage vaccine9 Sep 2014 17 Feb 2015
DNIR-555 Griffith UniversityNew studies on the virulence and
physiology of Burkholderia pseudomallei 4 Nov 2014 11 Jun 2015
DNIR-556Monash University
Factors controlling developmental transitions in the fungus Candida albicans 2 Dec 2014 17 Apr 2015
DNIR = contained dealing with a genetically modified organism not involving intentional release into the environment
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28
Figure 3: Research focus of DNIRs approved, 2014–15
Figure 4: Types of organisations issued with DNIR licences since commencement of the Gene Technology Act 2000
Of the 10 DNIR licences issued in 2014–15, 5 authorised the development of potential
vaccines to treat or prevent disease in humans and animals, 3 authorised research into the
ways in which pathogens cause disease in humans, and 2 authorised research into the
function of genes thought to be involved in cancer and in the production of toxins.
Two of the DNIR licences issues in 2014–15 were issued to private companies, two to research
institutes and six to universities. The types of organisations to which DNIR licences have been
issued since commencement of the Gene Technology Act 2000 are shown in Figure 4.
0
5
10
15
20
25
30
35
40
UniversityResearch institute
Health service/hospital
GovernmentCompany
Perc
en
tag
e o
f lic
en
ce
s
15% 13% 15% 17% 40%
0
10
20
30
40
50
PathogenesisGene function/expression
Treatment/prevention
Perc
en
tag
e o
f lic
en
ce
s
50% 20% 30%
DNIR = contained dealing with a genetically modified organism not involving intentional release into the environment
DNIR = contained dealing with a genetically modified organism not involving intentional release into the environment
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Notifiable low risk dealingsNLRDs are 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
Biosafety 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. Authority to
conduct an NLRD has a five-year time limit.
The Regulator received 842 NLRD notifications during 2014–15. As in past years, notified
NLRDs were predominantly for research work. The types of organisations that notified
NLRDs to the Regulator in 2014–15 are shown in Figure 5.
Figure 5: Types of organisations that notified NLRDs in 2014–15
0
10
20
30
40
50
60
UniversityResearch institute
Health service/hospital
GovernmentCompany
Perc
en
tag
e o
f NLR
Ds
1% 8% 7% 29% 55%
NLRD = notifiable low risk dealing
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Dealings placed on GMO RegisterThe GMO Register is a list of dealings with GMOs that the Regulator is satisfied pose
minimal risk to human health and safety or 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 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 undertake without the need for a licence. Such determinations are disallowable
legislative instruments and must be tabled in parliament.
During 2014–15, the Regulator entered no new listings on the register, received
no applications to place dealings on the register and had no applications
under consideration.
Emergency dealing determinationAn EDD is a legislative instrument made by the minister under s. 72 of the Gene
Technology Act to expedite approval of dealings with a GMO in an emergency. The
Regulator provides risk assessment and risk management advice to the minister, and
administers the EDD, including monitoring for compliance with any EDD conditions.
Before making an EDD, the minister must be satisfied that:
• there is an actual or imminent threat to the health and safety of people or
the environment
• the dealings proposed to be specified in the EDD would, or would be likely to,
adequately address the threat
• any risks posed by the proposed dealings can be managed to protect the
health and safety of people, and the environment.
In relation to the first two points (the threat and addressing the threat), the minister
must receive advice from the Commonwealth Chief Medical Officer, Chief Veterinary
Officer or Chief Plant Protection Officer. In relation to the third point (management of
risks), the minister must receive advice from the Regulator. The states and territories
must also be consulted. EDDs 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 to those applying when the EDD is made.
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Under the Gene Technology Act, the Regulator has powers to monitor compliance
with the conditions of the EDD.
Appendix 2 provides further information about the process for making EDDs, and EDDs
issued under the Gene Technology Act.
During 2014–15, the Regulator did not receive any requests for advice in relation to
making 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.
Accreditation of organisationsThe Regulator requires organisations licensed to 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. The Regulator must make a decision on accreditation applications
within the statutory timeframe of 90 working days.
At 30 June 2015, 168 organisations were accredited. Accredited organisations are
located in all Australian jurisdictions; one is based in the United States of America
(Figure 6). The profile of the types of organisations accredited by the Regulator
has not changed significantly: a large proportion (69%) are primarily publicly
funded (Figure 7).
Figure 6: Organisations accredited at 30 June 2015, by location of headquarters
0
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USAWAVicTasSAQldNTNSWACT
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5% 28% 2% 16% 10% 1% 29% 8% 1%
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Figure 7: Organisations accredited at 30 June 2015, by type of organisation
Certification of physical containment facilitiesIn accordance with the Regulations, the Regulator must make a decision about
applications for certification of physical containment facilities within the statutory
timeframe of 90 working days.
Physical containment facilities are classified according to how stringent the measures
are for containing GMOs. The classifications relate to the structural integrity of
buildings and equipment, and to the handling practices used by people working in
the facility. Physical containment level 1 (PC1) facilities are used to contain organisms
posing the lowest risk to human health and the environment. PC level 4 (PC4) facilities
provide the most secure and stringent containment conditions. The number of
facilities certified at 30 June 2015 is listed in Table 7 by facility type and containment
level.
During 2014–15, 89 certifications for physical containment facilities were
approved (Table 4).
0
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15
20
25
30
35
UniversityResearch institute
Health service/hospital
GovernmentCompany
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31% 14% 14% 20% 21%
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The organisations issued these certifications reflected the types of organisations
involved in contained dealings (NLRDs and DNIRs). This is to be expected because
most NLRDs and DNIRs are conducted in certified facilities. Private companies
received approximately 4% of certification approvals in 2014–15, government agencies
22%, health services and hospitals 2%, research institutes 22% and universities 49%.
OGTR-certified physical containment facilities are located in all Australian
jurisdictions (Figure 8).
Table 7: Number of facilities certified at 30 June 2015
Containment level
Facility type PC1 PC2 PC3 PC4
Animal 249 5
Aquatic 27
Constant temperature room 48
Facilitya 268 5
Invertebrate 48 3
Laboratory 1090 28
Large grazing animal 45 2
Large scale 20
Plant 170
Total 313 1654 36 5
PC = physical containmenta PC1 and PC4 facilities are not categorised into types.Note: This table excludes facilities for which the certifications were suspended (at the request of the certification holders) as at 30 June 2015.
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Figure 8: Physical containment facilities certified at 30 June 2015, by location
Trend data for approval of main types of applicationsThe number of accreditations issued rose in 2014–15 (Table 8).
The total number of accredited organisations at 30 June 2015 was 168, up from 162 on
30 June 2014.
The number of certification approvals fell to 89, less than in any previous year. This in
part reflects a move towards organisations having large, multiroom facilities, rather
than a larger number of separate certifications. The number of current certifications
dropped by 41 during the reporting year.
Numbers of DIR and DNIR applications were the same as in 2013–14. The number of NLRDs
notified was slightly more than in 2013–14, and was the highest number in any year.
0
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15
20
25
30
35
WAVicTasSAQldNTNSWACT
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6% 20% 1% 17% 12% 1% 35% 8%
Inspecting a PC2 laboratory in Queensland.
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Table 8: Trend data for approval of main types of applications, 2010–11 to 2014–15
DIR = dealing involving intentional release of a genetically modified organism (GMO) into the environment; DNIR = contained dealing with a GMO not involving intentional release into the environment; NLRD = notifiable low risk dealinga ‘Approval’ for DNIR refers to the number of licences issued. This can differ from the total number of applications approved when two or more applications are integrated into a single licence. b Correction to the number (10) reported in the 2013–14 report. Three applications were approved and incorporated into a single licence.c Two applications were approved and incorporated into a single licence.
Secondary applications
Confidential commercial information
Applications can be made to the Regulator under s. 184 of the Gene Technology Act
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 Act does not assign a statutory timeframe for the
Regulator’s decision on CCI applications, and the evaluation of a licence application
may be paused if significant CCI claims need to be resolved.
In 2014–15, the Regulator made five CCI declarations; decisions on nine CCI
applications were pending at 30 June 2015.
Surrenders
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 decommissioning of facilities have taken place.
The OGTR received 116 surrender requests in 2014–15 and approved 144: 122 for
surrender of certifications of facilities, 13 for surrender of DIR licences, 5 for surrender of
DNIR licences and 4 for surrender of accreditations.
Application type
2010–11 2011–12 2012–13 2013–14 2014–15
Accreditation 7 5 8 4 10
Certification 171 207 199 183 89
DIR 6 6 4 7 7
DNIRa 14 11 8b 10c 10c
NLRD 553 553 677 828 842
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Variations
The Regulator may initiate variations to instruments issued under the Gene
Technology Act (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 genetically modified [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 for handling GMOs.
The Regulator approved 324 variations in 2014–15.
Monitoring genetically modified organismsThis section provides information on the OGTR’s range of inspection activities during
2014–15. The Regulator’s quarterly reports6 provide detailed information about the
inspections.
Inspections of DIR licences
The OGTR strategy for field trial monitoring draws on accumulated operational
experience of compliance risk profiling.7
During 2014–15, 19 accredited organisations held the 60 DIR licences in force—11 for
commercial release of GMOs (9 for crops and 2 for vaccines), and 49 for limited and
controlled release of GMOs (47 for crops and 2 for vaccines). None of the commercial
release licences imposed conditions that necessitated monitoring. The OGTR
inspected 14 of the 47 licences for limited and controlled trials of GM crop varieties
(which might include a number of trial sites for each licence). One limited and
controlled vaccine trial was inspected.
Outcome of inspection activities
The OGTR’s operational objective is to monitor at least 20% of all field trial locations of
limited and controlled releases each year (see Chapter 2). A further target within this
operational benchmark is to inspect a minimum of 5% of all field trial sites for limited
and controlled releases during each quarter of the year.
6 Available from the OGTR, or at www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1
7 Details are provided in the Monitoring protocol (www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/mc-
protocols-1).
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In 2014–15, the OGTR exceeded both its operational benchmark and its quarterly
objective. At the beginning of 2014–15, 90 licensed field trial sites were operating, 33 of
which were current and 57 of which were subject to post-harvest monitoring conditions.
The OGTR inspected 42 sites in 2014–15 (21 current and 21 post-harvest monitoring sites),
representing 47% of total sites as of 1 July 2015, thereby exceeding the target of 20% of
field trial sites each year. A breakdown of the number and proportion of sites inspected
in 2014–15 is in Table 9.
The number of sites and number inspected over the past five years (2010–15) is in
Figure 9.
Table 9: Number and proportion of DIR field trial site inspections in each quarter of 2014–15
Figure 9: Number of sites and number inspected each year, 2010–11 to 2014–15
Number and proportion of sites inspected
Quarter Current sites Post-harvest monitoring sites
July–September 2014 5/33 (15%) 4/57 (7%)
October–December 2014 3/36 (8%) 9/56 (16%)
January–March 2015 6/39 (15%) 4/49 (8%)
April–June 2015 7/30 (23%) 4/55 (7%)
0
20
40
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100
2014–152013–142012–132011–122010–11
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Sites at the start of the financial year Sites inspected
DIR = dealing involving intentional release of a genetically modified organism (GMO) into the environment
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Types of GM crops inspected
DIR licences in force authorised the limited and controlled release of a range of GM
crop and plant types: banana, barley, canola, Indian mustard, cotton, narrow-leafed
lupin, perennial ryegrass, safflower, sugarcane, wheat and white clover. Although
licences were in force, planting has not occurred in all cases. Canola was the most
prevalent GM crop, trialled at 41 sites.
The OGTR inspected 42 field trial sites across seven crop types during 2014–15
(Table 10).
Table 10: Number of licensed DIR trial sites at beginning and end of 2014–15, and number
inspected in 2014–15, by crop type
DIR = dealing involving intentional release of a genetically modified organism into the environmentNote: Some DIR licences authorise trials with two similar crop species. In this table, trial sites authorised under such licences are listed separately from trial sites authorised under a licence for a single crop species.
Crop type (parent organism)No. trial sites on
1 July 2014No. trial sites on
30 June 2015No. trial sites
inspected
Banana 4 3 4
Barley 3 3 0
Barley, wheat 5 6 5
Canola 39 36 17
Canola, Indian mustard 2 0 0
Cotton 11 21 9
Perennial ryegrass 1 1 0
Safflower 2 2 2
Sugarcane 14 20 4
Wheat 7 6 1
White clover 2 2 0
Total 90 100 42
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Cycle and status of field trial sites
During each year, the status of field trials of GM crops undergoes significant
changes. When new trials are planted, they 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 trial sites continues until
the OGTR is satisfied that no further inspections are required to manage persistence
of the GMO. The OGTR then signs off the site as having completed all necessary
licence obligations.
Figure 10 shows the change during 2014–15 in the numbers of current field trial sites
and field trial sites subject to post-harvest monitoring.
Figure 10: Total number of DIR field trial sites and their status during 2014–15
20
40
60
80
100
120
Jul 15
Jun 15
May 15
Apr 15
Mar 15
Feb 15
Jan 15
Dec 14
Nov 14
Oct 14
Sep 14
Aug 14
Jul 14
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Total sites
Post-harvest monitoring sites
Current sites
Inspecting a GM safflower field trial site in Western Australia
DIR = dealing involving intentional release of a genetically modified organism (GMO) into the environment
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Locations of field trial site inspections
In 2014–15, the OGTR inspected field trial sites in all states and territories where field
trials were undertaken (Table 11).
Table 11: Number of DIR field trial sites and OGTR inspections in 2014–15, by state and territory
Inspections of contained dealings
The monitoring program also encompasses dealings conducted in certified
containment facilities under DNIR licences and NLRDs. For monitoring purposes,
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.
At least 20% of higher-level physical containment facilities are monitored annually (see
Chapter 2). As well as examining the integrity of the physical structure of the facility,
inspections cover the general work practices used in handling GMOs.
At 30 June 2015, 142 organisations held 2008 certification instruments for containment
facilities. During 2014–15, the OGTR inspected 44 facilities across the range of facility
types (Table 12). Of the 58 higher-level containment facilities that had certification
instruments in force at the beginning of 2014–15, 17 were inspected. This figure
represents 29% of higher-level containment facilities and exceeds the minimum target
of inspecting 20% of such facilities each year.
In addition, 17 DNIR licences in force during 2014–15 were monitored.
Jurisdiction No. trial sites at 1 July 2014 No. field trial site inspections in 2014–15
Australian Capital Territory 5 0
New South Wales 18 5
Northern Territory 2 4
Queensland 18 9
South Australia 4 0
Tasmania 0 0
Victoria 23 10
Western Australia 20 14
Total 90 42
DIR = dealing involving intentional release of a genetically modified organism (GMO) into the environment
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Table 12: Number of inspections of certified facilities (by type) conducted during 2014–15
PC = physical containment
Locations of facility inspections
Certified facilities are located in all Australian states and territories (Figure 8).
In 2014–15, monitoring activities took place in each state and territory except the
Northern Territory, South Australia and Western Australia (Figure 11). The number of
OGTR inspections of facilities reflects, as far as practicable, the number of facilities in
each state and territory.
Containment type PC level and facility type No. of inspections
Lower level PC2 Animal 4
PC2 Laboratory 20
PC2 Plant 3
Higher level PC2 Large scale 1
PC3 Animal 1
PC3 Invertebrate 2
PC3 Laboratory 11
PC4 Facility 2
Total 44
Inspecting a GM banana field trail site in the Northern Territory
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Figure 11: Number of certified facility inspections in 2014–15, by state and territory
Types of organisation inspected
Of the five OGTR categories of applicant organisations, universities held the largest
number of certifications during 2014–15 (Figure 12). The number of OGTR inspections
of facilities (Figure 13) reflects, as far as practicable, the number of facilities present in
each organisation category.
Figure 12: Distribution of certified facilities at 30 June 2015, by organisation type
0
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Figure 13: Number of certified facility inspections in 2014–15, by organisation type
Compliance with the Gene Technology Act 2000
During 2014–15, the regulated community demonstrated a high level of compliance
with the gene technology legislation (see Chapter 2).
During routine inspections, the OGTR found some inconsistencies with the
requirements imposed by licence or certification conditions. Such inconsistencies are
referred to as noncompliances. Noncompliance is not regarded as a breach of the
Gene Technology Act unless, after investigation, it is proven to be so.
The Regulator’s response to all noncompliance incidents is informed by the OGTR
compliance and enforcement policy, to ensure consistent responses that are
proportionate to the risks posed to human health and safety or to the environment.8
This section provides a summary of the types of noncompliance found and the
actions implemented. The results and findings of all OGTR inspections are reviewed
and used to inform future monitoring activities, and to improve accredited
organisations’ compliance with the Gene Technology Act.
8 www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/CompEnforcementPolicy09-htm
0
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1 16 0 1 26
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Noncompliances
During 2014–15, OGTR monitoring of DIR licences found three instances of
noncompliance with licence conditions—sections of a pollen trap were not at the
same growth stage as the planting area, and related species were planted in the
isolation zone while GMOs were growing.
Seven instances of noncompliance were identified through monitoring of DNIR
licences. These included the licence holder not obtaining signed statements from staff
undertaking licensed dealings, a copy of the licence not being made available inside
a certified facility where licensed dealings could take place and licensed dealings
taking place in a facility not listed on the licence.
A number of minor noncompliances were also identified during routine monitoring of
containment facilities (Table 13). They included structural defects, lack of adequate
personal protective equipment and issues with work practices.
Table 13: Number of minor noncompliances identified in certified facilities during 2014–15,
by noncompliance type
Each incident of noncompliance was assessed according to established OGTR
protocols and found to present negligible risk to human health and safety or to the
environment, to be minor in nature, and to involve negligible or zero culpability.9
The noncompliances were resolved by reminders, education and/or cooperative
compliance.
9 These incidents are discussed in the Regulator’s quarterly reports (www.ogtr.gov.au/internet/ogtr/publishing.
nsf/Content/reports-1).
Nature of noncompliance Number
Equipment 0
Personal protective equipment 1
Structure 4
Transport 0
Waste disposal 0
Work practices 3
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Compliance and investigations
The OGTR recognises that both compliance mechanisms and enforcement
mechanisms are necessary to provide an effective and flexible regulatory system
that enables the most appropriate response to a given issue or incident. The OGTR
Compliance and Investigation Section assesses and manages contraventions of the
Gene Technology Act through:
• a program of practice reviews and audits, which apply investigation
practices and performance audit techniques to identify and prevent
contraventions of legislation through cooperative capacity building of
regulated stakeholders’ compliance management arrangements
• assessment of the annual reports of regulated parties and other information
collected under the regulatory system
• third-party reporting, including a high degree of cooperative self-reporting of
compliance issues by regulated parties
• feedback on OGTR regulatory specifications and arrangements, which
allows continual improvement
• investigations, which can draw on monitoring activities and any of the above
compliance management activities.
Investigations are initiated through a preliminary assessment of relevant facts and
likely impacts, which indicate the likelihood that a contravention has occurred (or is
about to occur), its seriousness and its likely consequences. Based on the outcome of
Confirming GPS coordinates of a post-harvest GM canola site in Western Australia
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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 one
audit of the Department of Agriculture and Food Western Australia in 2014–15. It
also progressed another audit and four practice reviews in 2014–15. Audits involve
a comprehensive examination of an accredited organisation’s compliance with
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 2014–15 were partnerships, shared
facilities and dealings; facilities, equipment, people management and instructions;
and records, notices and notifications. When completed, these activities are reported
in the Regulator’s quarterly reports to the Australian Parliament.
National strategy for unintended presence of unapproved GMOs
The OGTR is responsible for implementing a risk-based national strategy to manage
the unintended presence of unapproved GMOs in seeds imported for sowing in
Australia. The strategy was developed in 2005 by an interdepartmental working
group chaired by the then Biotechnology Australia and comprising the Department
of Agriculture, Fisheries and Forestry;10 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 Ageing;14 Food Standards Australia New Zealand (FSANZ);
and the OGTR.
The strategy has six components (Table 14). It uses a risk management approach,
with resources dedicated to the areas posing the highest likelihood of unintended
presence of GMOs.
The OGTR has worked with the Australian Seed Federation to develop a voluntary
auditing and testing program of existing industry quality assurance measures. No
issues of concern have been identified for the organisations that have participated in
the quality assurance reviews.
In 2014–15, the OGTR continued to engage with other government departments,
including the Australian Government Department of Agriculture, regarding low-level
10 Now the Department of Agriculture
11 Now the Department of the Environment
12 Now the Department of Education
13 Now the Department of Industry
14 Now the Department of Health
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presence of unapproved GMOs. The OGTR also continued to liaise with the Australian
Seed Federation and the seed industry to raise awareness of management of
potential incidents involving low-level presence of GMOs, and to ensure their ongoing
voluntary cooperation and action regarding this issue.
Table 14: 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
seeds imported for sowing, together with information on overseas
commercial production of GMOs, and input from the Department of
the Environment and other relevant agencies, were 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 to and adopted.
Industry laboratory
testing
The voluntary code of conduct (see below) refers to testing
programs. Industry needs to be able to assure itself that it is
managing the risk of importing unapproved seeds.
Approvals and
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.
These are canola, cotton, maize, potato, tomato, papaya, soybean,
squash, alfalfa, grasses, rice and wheat. The 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 limitations of legislation in preventing
unintended imports of unapproved GMOs and has worked
cooperatively with industry to develop a voluntary code of conduct.
The code aims to identify 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 engages with Australian Government
agencies, relevant industry organisations, and states and territories
on this issue.
DNIR = genetically modified organism; OGTR = Ofice of the Gene Technology Regulator
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Consultation and provision of advice to stakeholdersThe Regulator’s functions, as prescribed by s. 27 of the Gene Technology Act, include:
• issuing technical and procedural guidelines in relation to GMOs
• providing advice to the Legislative and Governance Forum on Gene
Technology (LGFGT15) about
- the operations of the Regulator and the Gene Technology Technical Advisory
Committee
- 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, which is administered by the department’s
Office of Health Protection, provides for a scheme for regulating security sensitive
biological agents (SSBAs). The SSBA Regulatory Scheme effects recommendations
agreed by the Council of Australian Governments (COAG). Because of 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 in April 2009 (through
the Gene Technology Amendment Regulations 2009) to allow inspectors from the
existing gene technology regulatory scheme to monitor laboratories and facilities
handling SSBAs for compliance with the National Health Security Act. The amendment
enables payment to the Regulator for SSBA monitoring activities from 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 continued during 2014–15.
15 The Act refers to the Ministerial Council. As part of reforms by the Council of Australian Governments, on
11 February 2011, the former Gene Technology Ministerial Council became the Legislative and Governance
Forum on Gene Technology.
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Certification guidelines
The Regulator did not consult on, or issue, any revised guidelines in 2014–15.
However, the Regulator has discussed with the Department of Agriculture the potential
for further harmonisation between their respective certification schemes.
This includes the potential for further alignment of the Regulator’s guidelines with the
Department of Agriculture’s requirements for quarantine facilities, and with
the relevant Australian standard.
OGTR staff have also jointly inspected facilities with Department of Agriculture auditors
to learn more about each other’s practices and processes, to determine whether this
could also be an area of harmonisation.
DIR application form
The Regulator consulted on a new draft DIR application form for commercial release
of GMOs. The new streamlined application form provides guidance for applicants
and clarifies data requirements, with the aim of improving the application process
and reducing regulatory impacts for DIR applicants.
National Institutional Biosafety Committee Forum
The sixth National IBC Forum was held in Canberra on 29–30 April 2015 at the National
Gallery of Australia. Representatives of IBCs and accredited organisations from most
states and territories attended, with 141 delegates from 77 organisations. The forum
was opened by the Assistant Minister for Health, Senator the Hon. Fiona Nash. The
keynote address was given by the Director of the Burns Service of Western Australia,
Professor Fiona Wood AM. Guest speakers and panel members from organisations
and IBCs, together with OGTR staff, contributed to an engaging and well-received
program. Major topics for discussion included the steps being taken by the OGTR
towards regulatory harmonisation, and regulatory issues relating to emerging
technologies.
For the first time, the IBC Forum program included a half-day plant DIR workshop
presented by OGTR staff. The workshop provided information about licence variations
and what constitutes CCI, and discussed the proposed new DIR application form
and proformas for monitoring inspections. It was attended by approximately 40
stakeholders with an interest in releases of GM plants.
The IBC Forum built on the positive outcomes of past events. It provides an important
opportunity for feedback and exchange of information between IBCs and the OGTR,
enhancing regulation of gene technology. The forum also allows IBCs to share
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experiences and learn from each other. IBCs are important partners in the regulatory
scheme, providing in-house expertise and oversight within organisations. IBCs have
consistently indicated that the forum helps them to share knowledge, regulatory
approaches and strategies across organisations, which assists compliance with
regulatory requirements.
Other forums
During 2014–15, 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.
The OGTR participated in the following meetings:
• Regulator’s forum meeting, Canberra, August and December 2014, and April
2015
• Regulatory Science Network meetings, Canberra, September and November
2014, and March 2015
• Australian Pesticides and Veterinary Medicines Authority (APVMA)
Nanotechnology Regulation Symposium, Canberra, October 2014
• Public Sector Regulators: Better Regulation, Better Regulators, Melbourne,
October 2014
Inspecting a storage facility in New South Wales
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• Regulatory Science Network annual event, ‘Doing more with less: how
science can contribute to smart regulation’, Canberra, November 2014
• CSIRO Futures Forum, Canberra, November 2014
• Regulator’s Community of Practice meeting, Canberra, December 2014 and
June 2015.
Appendix 3 lists OGTR activities at Australian meetings, forums and conferences.
Legislative and Governance Forum on Gene Technology
In 2014–15, the OGTR continued to implement recommendations agreed by the
LGFGT in 2013 from its 2011 independent review of the Gene Technology Act.
These included a range of operational activities to improve communication
and consultation with regulated stakeholders and the public—for example, the
sixth National IBC Forum, targeted use of social media for consultation on a DIR
application, and ongoing participation in relevant international forums (see
‘International regulatory liaison’, below).
The OGTR worked with the Office of Parliamentary Counsel to complete drafting of
the Gene Technology Amendment Bill 2015, which implements five agreed minor and
technical recommendations from the 2011 review. In collaboration with colleagues
in the department, the OGTR consulted the Gene Technology Standing Committee
and the LGFGT on the draft Bill, and a special majority (i.e. two-thirds of jurisdictions)
agreed to the Bill. The Bill was introduced to the House of Representatives in June 2015.
The proposed changes do not alter the policy intent of the regulatory scheme, but will
reduce regulatory impact for the regulated community.
Advice on GMOs and GM products
During 2014–15, the OGTR provided advice on the regulation of GMOs and GM
products to other regulatory agencies and the public.
Advice to other regulatory agencies
To facilitate reciprocal exchange of information with other product regulatory agencies
on assessment and approval of GMOs and GM products, the OGTR has developed
memorandums of understanding (MOUs) with FSANZ, the Therapeutic Goods Administration,
the APVMA and the Australian Quarantine and Inspection Service (now the Department
of Agriculture). In 2014–15, the OGTR progressed review of the MOU with the Department
of Agriculture, and provided input to a proposed overarching MOU between the
Department of Health and the Department of Agriculture. The OGTR also has an MOU
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with the Department of the Environment in relation to consultation with the Minister for the
Environment on DIR licence applications, as prescribed by the Gene Technology Act.
In line with recommendations from the 2006 statutory review of the Gene Technology
Act, a Regulators’ Forum was established to facilitate information sharing between these
other regulatory agencies and the Regulator. The forum met three times in 2014–15,
discussing a work program for improving overall regulatory effectiveness through greater
cross-agency collaboration.
The Regulatory Science Network, which is linked to the Regulators’ Forum, held its annual
symposium in Canberra in November 2014, with the title ‘Doing more with less: how
science can contribute to smart regulation’. The OGTR won the inaugural award for Most
Scientifically Innovative Regulatory Agency/Department.
Advice to the public
The Gene Technology Act requires the Regulator to maintain a record of dealings with
GMOs and GM products (the GMO Record), which can be accessed by the public.16 The
GMO Record contains information on licences issued, NLRDs, GMO dealings included on
the GMO Register, EDDs and GM product approvals notified by other Australian regulatory
authorities. The GMO Record was maintained and updated with new authorisations issued
during 2014–15.
OGTR website and contact points
The OGTR maintains a comprehensive website17 that provides 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.
In March 2014, the OGTR engaged Reading Room Australia Pty Ltd to refresh the website
design and content, and improve functionality and user experience. A targeted survey
of key stakeholders provided constructive feedback on the website content, clarity of
language, navigation, function, style, usability and so on.
The feedback informed the website review and guided the redevelopment of the website. A
refreshed, new-look website was launched in March 2015, and feedback from external users
so far has been positive.
16 The OGTR maintains the GMO Record as a source of public information on such approvals on its website
(www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gmorec-index-1). The Gene Technology Consequential Amendments Act 2000 provides for product regulators—FSANZ, the Therapeutic Goods Administration, the
National Industrial Chemicals Notification and Assessment Scheme, and the APVMA—to seek advice from the
Regulator on GM products.
17 www.ogtr.gov.au
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Appendix 4 provides statistics on website use.
The OGTR has a 1800 freecall number and an email address18 that provide points of
contact for members of the public and other interested parties. Assistance with specific
questions and other mechanisms for public feedback are among the services provided.
The OGTR maintains a client register: a list of individuals and organisations that
have registered their interest in regulation of gene technology. Members receive
notifications of new applications for GMOs, licences issued for release of GMOs into
the environment, and significant changes to gene technology legislation. They are
also invited to comment on consultation RARMPs for applications to release GMOs
into the environment. The OGTR client register has 413 individuals and organisations
listed. To be included on the OGTR client register and receive notifications, interested
people should contact the OGTR.
Investigation of cost recovery for the OGTRThe department is investigating the feasibility of cost recovery for OGTR services.
Following an activity-based costing study of the OGTR in the previous reporting period,
in 2014–15 the department conducted an economic analysis of the gene technology
sector to inform policy considerations. The department is preparing a draft regulatory
impact statement on potential costing models for consultation with the regulated
community and other stakeholders during 2015–16.
International regulatory liaisonUnder s. 27 of the Gene Technology Act, the Regulator’s functions include:
• monitoring international practice in relation to regulation of GMOs
• maintaining links with international organisations that regulate GMOs
• promoting harmonisation of risk assessments relating to GMOs and
GM products by regulatory agencies.
Active participation in international forums ensures that Australia’s regulatory scheme
takes account of developments in GMO regulation and science. Feedback from
meetings continues to indicate that the Australian gene technology regulatory
system is highly regarded. International engagement also enables Australia to inform
international best practice based on its practical experience of administering efficient
and effective GMO regulation.
18 Freecall number: 1800 181 030, email: [email protected]
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In 2014–15, OGTR engagement included participation in multilateral forums, including
the Organisation for Economic Co-operation and Development (OECD) Working
Group on the Harmonisation of Regulatory Oversight in Biotechnology (WGHROB) and
the United Nations (UN) Cartagena Protocol on Biosafety, participation in international
symposiums and bilateral engagement with regulators from other countries.
The OGTR provides input and advice on GMO regulation to other Australian agencies
to support their international engagement—for example, Australian responses
to notifications by other countries about changes to regulation (including GMO
regulation) under the World Trade Organization Agreement on the Application of
Sanitary and Phytosanitary Measures (SPS Agreement).
The OGTR continued to engage in international forums on harmonising the risk
assessment and regulation of GMOs. The OGTR leads Australian representation on,
and coordinates Australian input to, the OECD WGHROB. The WGHROB develops
scientific guidance to support risk assessment of GMOs, including consensus biology
documents.19 The OGTR led development of the Consensus document on the
biology of Eucalyptus spp.,20 which was declassified in 2014, and is leading work
on the biology of cowpea. The OGTR also contributed to projects on environmental
considerations for environmental assessment of transgenic plants, new plant breeding
techniques (NPBTs), sorghum, tomato and microalgae.
The OGTR is responsible for entering Australian commercial approvals of GMOs
onto the OECD BioTrack Product Database21 and the UN Biosafety Clearing-House.22
The OGTR is the national focal point for the UN Cartagena Protocol on Biosafety
and coordinates Australian engagement in activities under the protocol, such as
submissions on particular issues. The biennial meetings of the UN Cartagena Protocol
on Biosafety and the parent convention—the UN Convention on Biological Diversity
(CBD)—took place in September–October 2014; the OGTR provided technical support
to Australian delegations to both meetings.
An OGTR officer, Dr Paul Keese, continued to serve on the Biosafety Protocol’s Ad
Hoc Technical Expert Group on Risk Assessment and Risk Management, as well as
providing input into draft guidance on risk assessment, and participating in an open-
ended online forum on risk assessment and risk management. The OGTR coordinated
19 www.oecd.org/science/biotrack/
consensusdocumentsfortheworkonharmonisationofregulatoryoversightinbiotechnology.htm
20 www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2014)27&doclanguage=en
21 www2.oecd.org/biotech
22 https://bch.cbd.int
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the preparation of a submission to the Biosafety Protocol on socioeconomic
considerations, and OGTR officers participated in an online forum on this topic. The
CBD is considering synthetic biology in the context of potential risks to biodiversity,
and its relationship to modern biotechnology and the Biosafety Protocol. The
OGTR provided input to the Australian submissions on this issue, and OGTR officers
participated in an expert online forum on synthetic biology in 2015.
In 2012, the OGTR entered into an MOU with the UN International Centre for Genetic
Engineering and Biotechnology (ICGEB) to provide input to a training program
for officials from sub-Saharan Africa about biosafety regulation. In 2014–15, the
OGTR hosted regulatory officials from Ghana and continued to provide input to
ICGEB activities, including development of a postgraduate biosafety program in
collaboration with the University of Melbourne.
The OGTR continued its engagement with the International Society for Biosafety
Research. This included contributing to the organisation of, and participating in, the
13th International Symposium for Biosafety of GMOs (ISBGMO), held in November
2014 in Cape Town, South Africa. ISBGMO occurs every two years and is an important
forum for regulators and scientists to discuss developments in biosafety.
OGTR international engagement in 2014–15 included consideration of low-level
presence of unapproved GMOs and NPBTs. The OGTR participated in a conference
on NPBTs arranged by the International Life Sciences Institute in India in October 2014,
and a Japanese delegation visited the OGTR in December 2014 to discuss NPBTs. The
OGTR also participated in Australian Government and international discussions about
strategies for preventing and managing low-level presence of unapproved GM crops.
In 2014–15, the OGTR analysed the GMO regulatory systems of other countries. This
was in response to the Australian Government initiative to identify opportunities
for Australia to achieve efficiencies by adopting standards and/or assessments
undertaken by other countries. The OGTR will continue to remain informed about
GMO regulation internationally, and to adopt or adapt relevant approaches by other
countries, to ensure that the Australian system is efficient and effective (as required by
s. 4A of the Gene Technology Act).
The OGTR interacted with key regulatory counterparts in other countries through
participation in international forums in 2014–15, including:
• the International Association of Plant Biotechnology Congress, Melbourne,
August 2014
• the International Conference on New Plant Breeding Molecular Technologies,
Jaipur, India, October 2014
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• a workshop organised by CSIRO, and sponsored by the OECD, on removing
barriers to the uptake of GM animals as a sustainable solution to food
security and safety, Geelong, October 2014
• the International Symposium for Biosafety of GMOs, Cape Town, South Africa,
November 2014
• the Association of Biosafety for Australia and New Zealand Annual
Conference, Sydney, November 2014.
In 2014–15, the OGTR continued to receive requests from regulators in other countries
to visit Australia and learn about the Australian approach to GMO regulation. This
represents continuation of a trend over the past few years. Feedback from these visits
indicates that the OGTR’s approach to risk analysis and regulation is held in high
regard as scientifically rigorous, practical and effective.
Visits by international delegations to the OGTR in 2014–15 were:
• a visit by a Japanese delegation to discuss NPBTs, December 2014
• a visit by a delegation from the Republic of Korea to learn about
GMO regulation in Australia, March 2015
• a visit from a regulatory official from Ghana, August 2014
• a visit by a delegation of seven regulatory officials from India,
December 2014.
Other functions of the Gene Technology RegulatorUnder s. 27 of the Gene Technology Act, functions of the Regulator include:
• undertaking or commissioning research in relation to risk assessment and
the biosafety of GMOs
• promoting harmonisation of risk assessment relating to GMOs and GM
products by regulatory agencies.
These functions maintain the OGTR’s capacity to conduct high-quality assessments
based on regulatory best practice and relevant scientific data.
Research commissioned by the Regulator
The Regulator commissioned the following two research projects in 2014–15:
• ‘Gene technology in Australia: a situational analysis’—desktop analysis by
Susannah Tymms. This research provided a succinct overview of the state of
the gene technology operating environment in Australia.
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• ‘Community attitudes to gene technology’—research involving a survey
conducted by the organisation ‘instinct and reason’.23 This study explored
current awareness, attitudes, beliefs, perceptions and understanding relating
to general science and technology, and particularly to biotechnology,
including specific applications and controllers of gene technology.
Over recent years, a number of surveys of community attitudes towards
biotechnology have gauged the state of Australian public awareness,
identified knowledge gaps, and tracked changes in awareness and
attitudes. The findings have been used to develop strategies to engage
with the community on these issues, including increasing public awareness
of developments in emerging technologies. This study continues to track
community attitudes and behaviours. Information from the study will be used
to inform communication activities.
Promote harmonisation
The OGTR has continued to liaise 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, have been a focus both
nationally and internationally.
The OGTR has participated in a number of meetings with the Department of
Agriculture to explore opportunities to reduce the regulatory burden on stakeholders
subject to joint oversight (i.e. stakeholders who have facilities that are both certified by
the OGTR and approved by the Department of Agriculture). One of the outcomes of
these meetings is a pilot project to assess potential benefits to stakeholders from joint
inspections by the OGTR and the Department of Agriculture. In 2014–15, the agencies
jointly inspected three facilities in the ACT and Queensland. This pilot project will
continue in 2015–16.
23 http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-other
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CHAPTER 4MANAGEMENT AND ACCOUNTABILITY
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The management and accountability practices of the Office of the Gene Technology Regulator (OGTR) encompass human resources, work health and safety, and the Commonwealth Disability Strategy. The OGTR adheres to Australian Government policies for purchasing and assets management, contracting and consultancy, advertising and market research, and ecologically sustainable development. The Gene Technology Regulator (the Regulator) reports to parliament annually and quarterly, as required by legislation.
Human resourcesThe OGTR has a workforce of 50 employees. Of these, 46 are ongoing employees and
4 are non-ongoing employees (Appendix 5).
The terms and conditions for non–Senior Executive Service staff at the OGTR are
covered by the Department of Health’s Enterprise Agreement 2011–14, which was
made under s. 172 of the Fair Work Act 2009. This is a principles-based agreement,
with most of the detail on operation of conditions provided in supporting guidelines. It
offers a range of nonsalary benefits, listed in Table 15.
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Table 15: Nonsalary benefits
SES = Senior Executive Service
Agreement Benefits
Enterprise Agreement Access to negotiated discount registration or membership fees to
join a fitness or health club
Access to the employee assistance program
Award scheme
Eligibility for performance-based pay
Access to 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 who
have 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)
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The OGTR continued to build a strong team culture in its 14th year of operation. A
weekly all-staff Friday morning tea was a successful way of keeping staff up to date
on major issues, and provided 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 the Olivia Lambert Foundation,
Autism Australia and the Cancer Council.
The OGTR implemented measures to maintain staff skills and motivation through
appropriate training and development, and to ensure that recruitment occurred in a
timely manner.
Dr Kylie Tattersall was awarded the Regulator’s Achievement Award for 2014 for her
inclusiveness, perseverance and outstanding qualities as a manager. Kylie was a
longstanding member of the OGTR staff, and her depth of knowledge and experience
made an enormous contribution to the work of the office. She recently left the OGTR to
take up a position at the Australian Pesticides and Veterinary Medicines Authority.
Staff undertook 100 days of formal training during the year (compared with 120 days
in 2013–14 and 240 days in 2012–13). This was in addition to orientation and induction
training for all new starters.
OGTR staff can access professional development opportunities through the
department’s performance development scheme. At the beginning of each
12-month cycle, all employees and their managers agree on key commitments for the
employee’s professional development, and the associated performance measures
and development requirements.
In 2014–15, refresher training was given to the emergency control team, comprising
one floor warden and two fire wardens. Members of the emergency control team are
self-nominated. On completion of the required training, they receive an allowance in
accordance with the Enterprise Agreement.
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, workstation assessments, problem resolution procedures
and an employee assistance program. The employee 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 by providing flexible working arrangements, in
recognition of the importance of work–life balance. The OGTR has a high proportion of
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part-time employees. Staff have accessed extended maternity leave on half pay, and
the 48/52 provision, which provides additional unpaid leave while averaging salary
payments during the year.
Feedback from the department’s annual staff survey again indicated high overall
job satisfaction for OGTR staff. Survey feedback was used to inform the OGTR People
Strategy Action Plan for 2014–15.
Work health and safetyThe 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 2011 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 providing rehabilitation
assistance to injured and ill employees is supported by medical examinations to
determine fitness for duty and the need for workplace rehabilitation assistance.
Initiatives to ensure workers’ health, safety and welfare The department’s Improving Wellness and Motivation in the Workplace: Reducing
Unplanned Leave initiative supports the department’s commitment to:
• creating, promoting and maintaining a safe and healthy working
environment
• encouraging productive working relationships
• promoting and encouraging behaviours in staff and managers to assist in
the management and reduction of levels of unscheduled absence.
The initiative complements existing OGTR strategies and action plans aimed at
promoting a positive work environment, increasing the health and wellbeing of staff,
reducing rates of 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 People Strategy Action Plan 2010–2015 and the Enterprise Agreement.
The OGTR has implemented changes resulting from the introduction of the Work
Health and Safety Act on 1 January 2012. Training has been conducted for ‘officers’,
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‘workers’, health and safety representatives, and a harassment contact officer. An
e-learning module is available for all staff, including contractors and consultants,
and an overview of the Work Health and Safety Act is available on the department’s
intranet site. Strategies for identification and management of work health and safety
risks have been incorporated into business planning processes.
The department has reviewed health and safety management arrangements,
along with associated policies, guidelines and business processes, to reflect the
requirements of the Work Health and Safety Act.
Staff of the Contained Dealings Evaluation Section undertook driver training, as they
are required to drive in capital cities when inspecting facilities. Staff of the Monitoring,
and Compliance and Investigation sections also undertook this training, as well as
four-wheel-drive training. Staff from these sections are required to drive in all states
and territories of Australia, including in country areas, on unfamiliar roads (tar and
gravel) and under a range of conditions (such as rain and low visibility).
Monitoring, and Compliance and Investigation staff members were issued with
branded uniforms appropriate to the type of inspections—field sites or contained
facilities—being conducted.
Other work health and safety support included provision of training in first aid,
emergency evacuation systems and fire safety systems.
Health and safety outcomes Information on health and safety outcomes (including impacts on injury rates
of workers) relating to the initiatives mentioned above or to previous initiatives is
incorporated into the department’s annual report.
Notifiable incidents Statistics relating to any notifiable incidents that arose from the conduct of business
or undertakings by the OGTR of which the OGTR became aware during the year are
incorporated into the department’s annual report figures.
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Investigations under Part 10 of the Work Health and Safety ActNo 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.
Regular work health and safety inspections were undertaken at the OGTR premises in
Barton during 2014–15. No major health or safety issues were identified.
Freedom of informationAgencies subject to the Freedom of Information Act 1982 are required to publish
information for 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 IPS requirements.24
Freedom of information proceduresFrom 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 no cost for the
first hour of decision making.
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
Inquiries about submitting a formal request under the Freedom of Information Act
should initially be directed to the Freedom of Information Coordinator on (freecall)
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
24 The OGTR plan is at http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ips-1
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In accordance with the Electronic Transactions Act 1999, freedom of information
requests may be emailed to [email protected].
The OGTR received three requests for access under freedom of information
legislation during the reporting period. The requests were finalised within the statutory
timeframes.
The Regulator is required by the Freedom of Information Act (s. 11C) to publish a
disclosure log on the OGTR website. The disclosure log25 lists information that has been
released in response to a freedom of information request.
PurchasingIn 2014–15, the OGTR complied with the Australian Government’s purchasing policies,
as articulated in the Commonwealth Procurement Rules.
Assets managementThe OGTR applies a whole-of-life asset management strategy that is consistent with
the department’s asset management program. In April 2015, 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 contractsNo exempt contracts were awarded in 2014–15.
ConsultanciesThe OGTR contracts consultancy services to ensure the achievement of more efficient
and effective delivery of regulation and related outputs.
No contracts for consultancies were awarded in 2014–15.
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.
25 www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ips-plan#log
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The department’s Accountable Authority Instructions and Procedural Rules supports
the core principles in the Commonwealth procurement rules.
Advertising and market researchThe OGTR incurred $18 073 in advertising costs during 2014–15 ($24 473 in 2013–14)
(Table 16). Advertising was used primarily to invite the public to comment on risk
assessment and risk management plans for licence applications involving intentional
release of genetically modified organism (GMOs) into the environment, as required
under s. 52 of the Gene Technology Act 2000.
Table 16: Media advertising organisations engaged, 2014–15
Organisation Service provided Paid
Mitchell and Partners Placing advertisements regarding regulatory activities $18 073
Note: Amount listed includes goods and services tax.
Annual reporting requirementsSection 136 of the Gene Technology Act requires the Regulator to prepare and
provide an annual report to the minister on the Regulator’s operations during the year
for tabling in the Australian Parliament.
Annual report 2013–14: operations of the Gene Technology Regulator was tabled in
parliament on 20 October 2014.26
Quarterly reporting requirementsSection 136A(2) of the Gene Technology Act requires the Regulator to prepare and
provide a quarterly report to the minister on the operations of the Regulator during the
quarter for tabling in the Australian Parliament. The Gene Technology Act requires the
report to include information on:
• GMO licences issued during the quarter
• any breaches of conditions of a GMO licence that have come to the
Regulator’s attention during the quarter
• auditing and monitoring of dealings with GMOs under the Gene Technology
Act by the Regulator or an inspector during the quarter.
26 The report is available from the OGTR Information Officer or at www.ogtr.gov.au/internet/ogtr/publishing.nsf/
Content/reports-1
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Appendix 6 lists the quarterly reports the OGTR published in 2014–15.27
National Disability StrategySince 1994, Australian Government departments and agencies have reported on their
performance as policy adviser, purchaser, employer, regulator and provider under
the Commonwealth Disability Strategy. In 2007–08, reporting on the employer role was
transferred to the Australian Public Service Commission’s State of the service report
and the APS Statistical Bulletin.28 From 2010–11, departments and agencies have no
longer been required to report on these functions.
The Commonwealth Disability Strategy has been superseded by the National
Disability Strategy 2010–2020, which sets out a 10-year national policy framework to
improve the lives of people with disability, promote participation and create a more
inclusive society. A high-level two-yearly report will track progress against each of the
six outcome areas of the strategy and present a picture of how people with disability
are faring. The first of these reports will be available in late 2014.29
Ecologically sustainable development and environmental performanceThe OGTR supports the Australian Government’s commitment to ecologically
sustainable development principles, and reports here on its operations during 2014–15
against s. 516A of the Environment Protection and Biodiversity Conservation Act 1999.
Section 516A(6)(a)—Legislation administered by the Regulator during 2014–15 that accords with ecologically sustainable development principlesThe Regulator administers the Gene Technology Act, and corresponding state and
territory legislation, which aim 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.
27 These reports are available from the OGTR Information Officer or at http://www.ogtr.gov.au/internet/ogtr/
publishing.nsf/Content/reports-1
28 www.apsc.gov.au
29 www.dss.gov.au
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Section 516(6)(b)—How OGTR outcomes have contributed to ecologically sustainable development during 2014–15In 2014–15, 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 these conditions.
In 2014–15, the Regulator received 19 licence applications; 10 were for dealings
involving intentional release of a GMO into the environment (DIRs) and nine were for
dealings not involving intentional release of a GMO into the environment (DNIRs). The
Regulator issued 17 licences to deal with GMOs, comprising 7 DIRs and 10 DNIRs (see
Chapter 3).
The OGTR submits a nil response to ss. 516A(6)(c), (d) and (e).
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APPENDICES
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APPENDIX 1 HISTORY AND STRUCTURE OF THE GENE TECHNOLOGY REGULATORY SYSTEM
This appendix briefly describes 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 2000Voluntary oversight of gene technology in Australia began in the mid-1970s,
primarily on the initiative of the Australian Academy of Science and later 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 a 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 the 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. Extensive consultation
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.
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This led to the object of the Gene Technology Act being defined as:
to protect the health and safety of people, and to protect the environment,
by identifying risks posed by or as a result of gene technology, and by
managing those risks through regulating certain dealings with GMOs.
The 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.
Governance arrangementsThe Gene Technology Act, the Gene Technology Regulations, and corresponding
state and territory laws (Table 17) 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 14).
Although 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 includes a number of other regulatory authorities with
complementary responsibilities and expertise (see Figure 14). This arrangement both
supports coordinated decision making and avoids duplication. The Gene Technology
Act was accompanied by consequential amendments to 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 Regulator must consult Australian Government regulatory agencies
prescribed in the Regulations (see Table 20) on all licence applications for
dealings involving the intentional release of GMOs into the environment.
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• Agencies30 regulating GM products31 are required 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. 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.
Figure 14: Governance arrangements for the Gene Technology Regulator
30 Therapeutic Goods Administration, Australian Pesticides and Veterinary Medicines Authority, National Industrial
Chemicals Notification and Assessment Scheme, Food Standards Australia New Zealand
31 A GM product is a thing (other than a GMO) derived or produced from a GMO.
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 DOATGA NICNASAPVMA Local
councils
GTTAC
GTECCC
Gene Technology Regulator
Office of the Gene Technology
Regulator
Governance Consultation Advice
Technical Regulatory Consultation
Prov
ide
ad
vic
e a
t th
e
req
ue
st o
f th
e L
eg
isla
tive
a
nd
Gov
ern
an
ce
Fo
rum
or
the
Re
gu
lato
r
APVMA = Australian Pesticides and Veterinary Medicines Authority; FSANZ = Food Standards Australia New Zealand; GTTAC = Gene Technology Technical Advisory Committee; GTECCC = Gene Technology Ethics and Community Consultative Committee; NICNAS = National Industrial Chemicals Notification and Assessment Scheme; DOA = Department of Agriculture; TGA = Therapeutic Goods Administration
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Table 17: Legislation administered by the Gene Technology Regulator
a New South Wales, the Northern Territory and Tasmania do not have regulations, as their Acts automatically adopt any amendments to the Commonwealth Act and Regulations.
b These guidelines are a legislative instrument issued by the Regulator under s. 27(d) of the Gene Technology Act.
Legislative and Governance Forum on Gene Technology The Legislative and Governance Forum on Gene Technology (LGFGT)32 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. It comprises
a representative minister from each state and territory. Its role is to provide policy
guidance for the operation of the Gene Technology Act. In addition, the LGFGT
approves appointment of the Regulator and the chairs of the statutory advisory
committees (see Appendix 7), and provides advice to the Australian Government
minister responsible for gene technology regulation (the Assistant Minister for Health)
on appointment of committee members.
32 Referred to as the Ministerial Council in the Gene Technology Act 2000 (see www.health.gov.au/internet/
main/publishing.nsf/Content/gene-gtmc.htm).
Jurisdiction Acts and Regulationsa
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 GMOsb
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
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Section 21 of the Gene Technology Act provides for the LGFGT to issue policy
principles on ethical issues relating 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 18).
Table 18: Policy principles issued at 30 June 2015
The LGFGT is supported by the Gene Technology Standing Committee, which
comprises officials (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.
Changes to gene technology legislationOne 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 Act and the Regulations have
been amended (Table 19) 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 following 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
Policy principle Date issued Date effective
Gene Technology (Recognition of Designated Areas) Principle 2003 31 July 2003 5 September 2003
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• improve the operation of the Gene Technology Act. 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. The amendments were made as a result of
the 2005–06 statutory review of the Gene Technology Act and the Gene
Technology Agreement (Gene Technology Amendment Act 2007 and Gene
Technology Amendment Regulations 2007). Amendments to implement five
recommendations of the LGFGT’s 2011 independent review of the Gene
Technology Act, agreed by the LGFGT in 2013, were introduced in the House
of Representatives in June 2015. Passage and commencement of the Gene
Technology Amendment Bill 2015 is anticipated in 2015–16
• allow the Regulator to make available inspectors appointed under s. 150
of the Gene Technology Act 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.
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Amending legislation
Change informed by Summary of changes
Gene
Technology
Amendment
Regulations
2006
2004–06
Regulator’s review
• Changes to requirements for IBC assessment,
notification and conduct of NLRDs
• Changes to classification of particular GMO
dealings as exempt, NLRD or licensable
• Changes to 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 an
inadvertent dealings licence
• Specific requirements for assessment and
consultation on limited and controlled release
licence applications
• Changes to application timeframes
• Replacement of Gene Technology Ethics
Committee and Gene Technology Community
Consultative Committee by Gene Technology Ethics
and 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 for NLRDs
• Changes to exempt dealing requirements
Gene
Technology
Amendment
Regulations
2009
Council of
Australian
Governments’
recommendations
• Capacity for OGTR inspectors to be appointed as
inspectors for 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, storage and disposal guidelines
• Changes to classification of particular GMO
dealings as exempt, NLRD or licensable
Table 19: Amendments to Commonwealth gene technology legislation
GMO = genetically modified organism; IBC = Institutional Biosafety Committee; NLRD = notifiable low risk dealing; OGTR = Office of the Gene Technology Regulator
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Coordination with prescribed agenciesConduct of activities with a GMO sometimes requires approval from both the
Regulator and another regulatory body—for example, dealings with a human
medicine that is a GMO. Some human medicines (e.g. live GM vaccines) require both
a licence from the Regulator and registration and assessment by the Therapeutic
Goods Administration, which authorises administration of the vaccine to people.
Similarly, while the Regulator is responsible for approving release of GM animal
vaccines and GM insecticide- or herbicide-tolerant plants into the environment,
the Australian Pesticides and Veterinary Medicines Authority, which is responsible
for regulating all agricultural and veterinary chemicals, registers the vaccine or the
insecticide product produced in the GM plant and approves application of the
herbicide to which the GM plants are tolerant.
Although these other agencies have a different focus and responsibility from those of
the Regulator, 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 parallel applications are
thoroughly assessed in a coordinated way and that, wherever possible, the timing of
decisions by the agencies coincides.
In other instances, approval is required from one regulatory agency but not another.
For example, Food Standards Australia New Zealand assesses the safety of a GM
product that will be imported for sale as a human food, where no application has
been (and may never be) submitted to the Regulator to grow in Australia the GMO
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 20.
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Table 20: Regulatory agencies in Australia with a role in regulating gene technology
GMO, GM product or activity
Agency Portfolio ScopeRelevant
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
TGAa 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 FSANZa 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
Standard 1.5.2—Food produced using gene technology
Agricultural
and
veterinary
chemicals
APVMAa Agriculture The 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 Act 1994
Agricultural and Veterinary Chemicals (Administration) Act 1992
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APVMA = Australian Pesticides and Veterinary Medicines Authority; FSANZ = Food Standards Australia New Zealand; GM = genetically modified; GMO = genetically modified organism; NICNAS = National Industrial Chemicals Notification and Assessment Scheme; OGTR = Office of the Gene Technology Regulator; TGA = Therapeutic Goods Administrationa 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
GMO, GM product or activity
Agency Portfolio ScopeRelevant
legislation
Industrial
chemicals
NICNAS 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
Agriculturea
Agriculture Department of Agriculture Biosecurity regulates importation into Australia of all animal, plant and biological products that may pose a quarantine pest or disease risk.
Quarantine Act 1908
Imported Food Control Act 1992
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APPENDIX 2 APPLICATION TYPES, AUTHORISATIONS, AND MONITORING AND COMPLIANCE
This appendix describes:
• 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
• the procedures followed for each type of application and other instruments that help the Gene Technology Regulator (the Regulator) manage risks to the health and safety of people, and the environment
• 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 noncompliances.
GMO RegisterThe GMO Register is provided for by Part 6, Division 3 of the Gene Technology Act. The
Regulator may make a determination to include dealings with GMOs on the GMO
Register33 according to s. 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
33 It is important to note the difference between the GMO Record and the GMO Register. The GMO Register lists
GMOs that no longer require a licence and is a subset of dealings included on the GMO Record. The GMO
Record is a comprehensive listing of all dealings with GMOs, including licensed dealings, NLRDs and GM
products.
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covered by a licence 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.
Types of dealingsExempt dealingsExempt dealings are dealings with GMOs that have been assessed over time as
posing negligible34 risks to people or 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 of a GMO into the environment
but do not require a case-by-case risk assessment or a specified level of containment.
Guidance on appropriate containment measures for exempt dealings is provided on
the OGTR website.
Examples of exempt dealings are dealings with:
• an animal into which genetically modified (GM) somatic cells have
been introduced, where the introduced somatic cells do not produce
infectious agents
• small volumes (less than 25 litres) of an approved host–vector system
into which low risk genetic material has been introduced—for example,
the introduced DNA must not encode an uncharacterised gene from a
pathogen, an entire viral genome or a toxin.
Notifiable low risk dealingsNotifiable low risk dealings (NLRDs) are dealings with GMOs that have been assessed
as posing negligible risks provided that 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 (r. 13). Such dealings may only be
undertaken in a facility certified by the Regulator to a specified physical containment
level (usually PC1, PC2 or PC3) 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 the proposed dealings are properly classified as
34 The term ‘negligible’ is defined in Chapter 3 of the Risk Analysis Framework and is used here for consistency.
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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 GMO Record (see below) but do not require
case-by-case risk assessment by the Regulator.
An example of an NLRD that may be conducted in PC1 facilities is working with GM
laboratory guinea pigs, mice, rabbits or rats where the genetic modification does not
provide an advantage and has not made the animal infectious.
NLRDs that may be conducted in PC2 facilities include dealings with:
• a GM animal (other than a GM laboratory guinea pig, mouse, rabbit, rat or
roundworm [Caenorhabditis elegans]), including invertebrates
• a GM plant
• an approved host–vector system that does not meet the criteria for an
exempt dealing (e.g. the introduced DNA may encode a pathogenic
determinant or may be an uncharacterised gene from a pathogen).
NLRDs involving microorganisms classified as Risk Group 3 under Australian
Standard AS/NZS 2243:3:2012 (Safety in laboratories: microbiological safety and
containment) must be undertaken in facilities certified to at least PC3 level and
appropriate to the dealings.
Licensed dealingsAny dealing with a GMO not classified as exempt, 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 case
by case. 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. If a licence is to be issued, the Regulator must decide on 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 for contained dealings (DNIRs) and for intentional release
of GMOs into the environment (DIRs). The Gene Technology Act 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,
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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 these risks can be
managed. The Regulator uses information provided in the application, as well as
other relevant scientific and technical knowledge. The requirements of the legislation
have been framed to place DIRs under greater scrutiny than DNIRs.
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.
For both DNIR and DIR applications, the applicant must provide information about
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 assesses the applicant’s capacity
to comply with licence conditions. Noncompliance with conditions placed on
licences issued under the Gene Technology Act is a criminal offence.
Although 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 2014–15.35
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 (s. 47) requires preparation of an RARMP for DNIR applications. 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
35 The Risk Analysis Framework is available at http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/risk-
analysis-framework
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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. Typical licence
conditions require the applicant to conduct the dealings in certified facilities, to
follow particular handling requirements (such as avoiding use of ‘sharps’ and using
biosafety cabinets), to train and supervise staff, to transport and dispose of the GMO
appropriately, and to have, and if necessary implement, contingency plans.
The process for assessing DNIR applications is shown in Figure 15. The statutory
timeframe for consideration of a DNIR application is 90 days.
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Figure 15: DNIR assessment process
Sufficient information?
Prepare RARMP
Finalise licence conditions
Consultation
Finalise RARMP
Application for
DNIR licence
Consultation?
Can the risk be managed to
protect people and the environment?
Reject application
Refuse to issue licence
Issue licence
YES
YES
YES
NO
NO
NO
DNIR = contained dealing with a genetically modified organism not involving intentional release into the environment; RARMP = risk assessment and risk management plans.
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The application process comprises five stages, as descibed below.
Stage 1
The applicant completes the DNIR application form and provides comprehensive
information about the proposed dealings with the GMO, including possible risks
posed by the dealings and 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 on the completeness of the application. The IBC’s role is to ensure the quality
of applications submitted to the Regulator. If insufficient information has been
provided, 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.
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 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.
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 may be managed. This provides the basis for conditions that may
be applied to the licence. Draft conditions are included in the consultation version of
the RARMP.
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Stage 4
The Regulator may consult experts, agencies or authorities about the RARMP.
These include GTTAC, the states and territories, prescribed Australian Government
agencies, the Minister for the Environment, and appropriate local government
authorities. The Regulator finalises the RARMP, considering the advice provided.
Stage 5
The Regulator decides 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.
Dealings involving intentional release
The legislation defines two types of DIR: limited and controlled DIRs, and other DIRs.
Currently, two application forms are available: one for limited and controlled DIR
applications involving GM plants, and another for all other applications. A specific
application form for commercial release of GM plants is under development. The
Regulator will, on a case-by-case basis, use information that the applicant has
provided on the application form to determine whether the release should be
assessed as a limited and controlled release. This decision will determine which
consultation process and timeframe under the Gene Technology Act will apply for
processing the application.
The Risk Analysis Framework outlines the approach taken to risk analysis and
preparing RARMPs. The assessment process for DIR applications is shown in Figure 16.
The statutory timeframe allowed for consideration of a DIR application, except for a
limited and controlled release application, is 255 days. For a limited and controlled
release application, this timeframe is either 170 days (for dealings that may pose a
significant risk) or 150 days (for dealings that do not pose a significant risk).
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Figure 16: 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 licence
Issue licence
YES
YES
YES
YES
NO
NO
NO
NO
DIR = dealing involving intentional release of a genetically modified organism into the environment; RARMP = risk assessment and risk management plans.
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The application process comprises eight stages, as described below.
Stage 1
The applicant completes the DIR application form and provides comprehensive
information about the proposed dealings with the GMO, including possible risks
posed by the dealings and 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 on the completeness of the application. 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 determine whether
the application is for a limited and controlled release, which follows a shorter process.
Section 50A(1) of the Gene Technology Act specifies that an application is a limited
and controlled release application if the Regulator is satisfied that:
• the principal purpose of the application is to enable the licence holder, and
people covered by the licence, to conduct experiments
• the application proposes
- controls to restrict dissemination or persistence of the GMO and its genetic
material in the environment
- limits on the proposed release of the GMO
• the controls and limits are of such a kind that it is appropriate not to seek the
advice referred to in s. 50(3).
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Section 50A(2) of the Gene Technology Act describes ‘controls’ as including:
• methods to restrict the dissemination or persistence of the GMO or its
genetic material in the environment
• methods for disposal of the GMO or its genetic material
• data collection, including studies to be conducted about the GMO or its
genetic material
• the geographic area in which the proposed dealings with the GMO or its
genetic material may occur
• compliance with
- a code of practice issued under s. 24, or
- a technical or procedural guideline issued under s. 27.
Section 50A(3) describes ‘limits’ as including the:
• scope of the dealings
• scale of the dealings
• locations of the dealings
• duration of the dealings
• people who are permitted to conduct the dealings.
Stage 4
A notification of application is sent out 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 to anyone who requests it
(s. 54). This excludes any information that has been declared by the Regulator as
(or is under consideration as) confidential commercial information.
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Stage 5
The Regulator must seek advice on the application regarding matters relevant to
preparation of the RARMP from GTTAC, the states and territories, prescribed Australian
Government agencies, the Minister for the Environment, and appropriate local
government authorities (s. 50). The Regulator usually consults local government
authorities in the area where the release is proposed to occur. In addition, the
Regulator routinely seeks advice from 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 s. 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 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.
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.
The risk management plan considers how risks to human health and safety or to the
environment may be managed. This provides the basis for conditions that may be
applied to the licence. Draft conditions are included in the consultation version of
the RARMP.
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Stage 7
Once the consultation version of the RARMP is prepared, 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 (s. 52(2)).
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 special-interest publications.
All people and organisations that have registered their interest in receiving such
information are advised by mail or email. Under s. 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 20 (for consultation on the application).
The Regulator is required to consult with the Australian Government Minister for the
Environment on DIR licence applications.
Stage 8
The Regulator finalises the RARMP, considering advice provided in response to
the consultation version of the RARMP, in accordance with s. 56(2) of the Gene
Technology Act. The Regulator decides whether to issue 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.
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Inadvertent dealingsPart 5 of the Gene Technology Act allows the Regulator to grant a temporary licence
(for no longer than 12 months) to a person who finds that 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 an 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
to protect the health and safety of people, and the environment.
Emergency dealing determinationsThe EDD provision in Part 5A (ss. 72A–E) of the Gene Technology Act gives the minister
the power to expedite approval of a dealing with a GMO in an emergency, when 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 this may be extended by the
minister. Before making an EDD, the minister must be satisfied that:
• there is an actual or imminent threat to the health and safety of people or
to the environment
• the proposed dealings would, or would be likely to, adequately address
the threat
• any risks posed by the dealings are able to be managed to protect the
health and safety of people, and the environment.
The minister must receive advice from the Commonwealth’s Chief Medical Officer,
Chief Veterinary Officer or 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. Because of the
emergency context and the need for a rapid assessment, there are no prescribed
consultation requirements.
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GMO RecordSection 138 of the Gene Technology Act requires the Regulator to maintain a Record
of GMO and GM Product Dealings (the GMO Record). The GMO Record36 contains
information on licences issued (DNIRs, DIRs, inadvertent dealings), NLRDs, GMO
dealings included on the GMO Register, EDDs and GM products approved by other
regulatory authorities.
The GMO Record is currently divided into separate sections:
• NLRDs
• contained dealings—DNIR licences
• intentional releases—DIR licences
• inadvertent dealing licences
• GMO Register
• EDDs
• GM products—those used in food processing, therapeutics, and pesticides
and veterinary medicines authorised by other regulatory agencies and
notified to the Regulator.
Accreditation and certificationAccreditation of organisations and certification of individual physical containment
facilities help to manage risks that may be associated with dealings with GMOs.
The Regulator requires organisations undertaking certain dealings with GMOs to be
accredited. The process of accreditation enables the Regulator to assess whether
the organisation has the resources and internal processes 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 (under r. 13B). On behalf of their organisation, they ensure compliance
with legislative requirements. IBCs 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.
36 www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gmorec-index-1
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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, animal, etc.) to physical
containment levels 1, 2, 3 or 4, which must be met before a facility can be certified.37
All certified facilities must be inspected before certification and annually thereafter
(except PC1 facilities). The OGTR inspects all high-level facilities (PC3, PC4 and large-
scale PC2) before certification and recertification.
Monitoring and complianceThe aim of OGTR monitoring and compliance activities is to ensure that dealings
with GMOs comply with legislative obligations and are consistent with the object
of the Gene Technology Act. Noncompliance 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.
Monitoring activities focus on managing dealings at field trial sites and within certified
physical containment facilities to ensure that:
• dissemination of a GMO and its genetic material is minimised
• persistence of a GMO in the environment is managed
• effective management of the GMO is maintained.
OGTR monitoring activities comprise routine monitoring (including spot checks),
assessing monitoring findings and, where necessary, recommending corrective action
and follow-up activities.
The OGTR Monitoring Section makes routine monitoring visits to at least 20% of field
trial sites each year. The OGTR strategy for 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
noncompliance with licence conditions designed to limit the spread and persistence
of GMOs or their genetic material is more likely to occur (e.g. during flowering or
harvesting of GM crops).
37 http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/certifications-1
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The monitoring program for contained dealings involves inspecting DNIRs and the
facilities in which these dealings are conducted, as well as monitoring at least 20%
of PC4, PC3 and large-scale PC2 facilities every year. These inspections focus on
the integrity of the physical structure of the facility and on the general laboratory
practices followed in the 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 relating to noncompliance with
licence conditions by accredited organisations. The objective for practice reviews
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, to:
• verify 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 procedures and practices provide mechanisms to identify
and resolve emerging risks
• suggest improvements to procedures and practices, where appropriate.
An investigation is an inquiry into a suspected noncompliance with the Gene
Technology Act, and corresponding state or territory laws, with the aim of gathering
evidence. Such investigations are not restricted to criminal aspects—in the wider
context, they may include advice on detected flaws and vulnerabilities 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.
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APPENDIX 3 PRESENTATIONS AND MEETINGS ON GENE TECHNOLOGY IN AUSTRALIA
The Regulator and staff from the Office of the Gene Technology Regulator regularly attend and present papers to meetings, forums and conferences in Australia.
Presentations made in 2014–15 are listed in Table 21.
Table 21: Presentations and representations in Australia by the Regulator and OGTR staff, 2014–15
Date Event Location
August 2014Crawford Fund Conference—Ethics, Efficiency and Food
SecurityCanberra
August 2014 International Association of Plant Biotechnology Congress Melbourne
August 2014 Australian Seed Federation Conference Albury
September 2014 ComBio 2014 Canberra
September 2014Lecture to biosecurity students at Australian National
UniversityCanberra
September 2014Risk Communication and Outrage Management workshop
by Professor Peter SandmanCanberra
October 2014Workshop on removing barriers to the uptake of GM animals
as a sustainable solution to food security and safetyGeelong
October 2014Lecture to undergraduate students at Australian National
UniversityCanberra
October 2014 AusBiotech 2014 national conference Gold Coast
October 2014 15th Australasian Plant Breeding Conference Melbourne
October 2014Australian Pesticides and Veterinary Medicines Authority
Nanotechnology Regulation SymposiumCanberra
November 2014Association of Biosafety for Australia and New Zealand
Annual ConferenceSydney
March 2015University of Queensland Occupational Health and Safety
Forum 2015Brisbane
April 2015 Genome editing workshop at University of Adelaide Adelaide
April 2015 Sixth National Institutional Biosafety Committee Forum Canberra
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APPENDIX 4 STAKEHOLDER AND PUBLIC ACCESS TO THE OGTR
The Office of the Gene Technology Regulator (OGTR) facilitates access by accredited agencies, stakeholders and the public to its services through a website, an email address and a freecall 1800 number.
Website usageTable 22 lists the successful hits on the OGTR website. The most requested information
sheets and website pages are listed below.
Table 22: Website activity, 2014–15 and 2013–14
Hits Visits
Month 2014–15 2013–14 2014–15 2013–14
July 364 258 273 687 47 668 32 138
August 346 769 293 963 41 995 32 470
September 298 832 279 727 40 593 35 968
October 317 372 313 268 43 785 37 916
November 301 821 467 408 45 986 58 815
December 266 678 311 184 42 876 44 002
January 288 424 309 920 41 086 42 465
February 313 950 302 530 44 574 40 179
March 424 186 355 648 47 392 52 266
April 313 641 301 751 44 087 54 838
May 365 655 304 748 47 535 46 199
June 280 956 310 009 38 911 41 754
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The most popular pages viewed on the OGTR website during 2014–15 were, in
descending order:
• maps of trial sites
• guidelines and forms for certification of physical containment facilities
• list of applications and licences for dealings involving intentional release
(DIR) of genetically modified organisms (GMOs) into the environment
• list of genetically modified (GM) product approvals
• what’s new
• Record of GMOs and GM Product Dealings
• legislation
• about the OGTR
• Gene Technology Amendment Regulations 2011
• risk assessment references.
The most popular downloaded documents in 2014–15 were:
• Risk Analysis Framework
• The biology of the Saccharum spp. (sugarcane)
• The biology of Musa L. (banana)
• The biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton)
• The biology and ecology of rice (Oryza sativa L.) in Australia
• The biology of Ananas comosus var. comosus (pineapple)
• The biology of Zea mays L. ssp. mays (maize or corn)
• The biology of Carica papaya L. (papaya, pawpaw, paw paw)
• The biology of hybrid tea rose (Rosa × hybrida)
• PC2 laboratory guidelines.
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Email address and freecall numberThe 1800 number and the OGTR email address ([email protected]) are points of
contact for members of the public and other interested parties. Assistance with
specific questions and advice on additional mechanisms for public feedback are
among the services that the 1800 line and email facilities provide. Use of the email
address declined compared with the previous year (Table 23).
Table 23: Email and freecall 1800 number activity, 2014–15 and 2013–14
na = not available, as a result of change of suppliers
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 noncompliances. The Monitoring Section email inbox ensures
that all communications are answered efficiently while staff are away from the office.
The inbox received 1115 emails during 2014–15 (1044 in 2013–14).
Emails 1800 number
Month 2014–15 2013–14 2014–15 2013–14
July 64 106 78 72
August 66 70 65 35
September 89 82 75 89
October 73 99 55 73
November 61 196 63 210
December 52 98 46 95
January 50 88 46 na
February 69 92 60 na
March 135 171 50 na
April 98 83 100 na
May 45 71 60 na
June 41 75 73 na
Total 843 1231 771 na
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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 790 emails during 2014–15 (1148 in 2013–14).
The Contained Dealings Evaluation Section maintains an email inbox to provide
efficient coordination of responses to queries relating to classification of GMO
dealings, certification requirements and GMO licences. The inbox received 578 emails
during 2014–15 (330 in 2013–14).
The Application Entry Point Section maintains an email inbox to provide a central,
shared communication point, allowing efficient coordination of responses to
correspondence and queries about applications the section has received. The inbox
received 1881 emails during 2014–15 (2306 in 2013–14).
The OGTR welcomes feedback on ways to improve provision of information about
gene technology regulation.
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APPENDIX 5 STAFF PROFILE, AND TRAINING AND DEVELOPMENT ACTIVITIESThis appendix provides information on Australian Public Service staff employed by the Office of the Gene Technology Regulator (OGTR) in 2014–15 under the Public Service Act 1999.
Tables 24–27 provide details on staff numbers, and aggregated information on
salary, performance pay and nonsalary benefits provided to staff during 2014–15
under the Department of Health Enterprise Agreement 2011–2014 and Individual
Flexibility Arrangement.
Tables 28 and 29 show the staff training and development activities conducted in 2014–15.
Staff profileTable 24: OGTR staff numbers, by classification and contract type, 30 June 2015
Number of staff
Nominal classification
EA IFASection 24 of Public Service
Act
Remuneration Tribunal
Total
Holder of Public
Office1 1
SES 1 2 1 3
EL2 4 4 8
EL1 12 12
Legal 2 1 1
APS6 20 20
APS5 3 3
APS4
APS3 2 2
Total 41 7 1 1 50
APS = Australian Public Service; EA = Enterprise Agreement; EL = executive level; IFA = Individual Flexibility
Arrangement; SES = Senior Executive Service
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Table 25: OGTR staff numbers by gender, 30 June 2015
Number of staff
Employee group Female Male Total
Ongoing 25 21 46
Non-ongoing 2 2 4
Total 27 23 50
Table 26: Number of employee commencements and cessations in 2014–15
Number of staff
Action Female Male Total
Hiring 4 1 5
Termination 3 2 5
Total 7 3 10
Performance payThe OGTR makes performance bonus payments available to staff working under a
current Individual Flexibility Arrangement or via individual determination under
s. 24(1) of the Public Service Act 1999. Determinations follow negotiations with the staff
member and the department regarding terms and conditions of employment.
Most performance payments made in 2014–15 related to assessments for 2013–14.
Because of the small numbers of staff at the Senior Executive Service (SES) level,
details for SES and non-SES staff have been combined (Table 27). Payments have
been aggregated to preserve employees’ privacy. Performance pay has ceased for
Executive Level 2 and SES staff members for the 2014–15 financial year.
Table 27: SES and non-SES bonus payments, 2014–15
Level Number of staff Aggregated amount
SES Band 1 and non-SES staff 10 $83 308.68
SES = Senior Executive Service
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Training and developmentDuring 2014–15, OGTR Legal Officer Alceo Turello conducted introductory and ongoing
training for OGTR staff on legal issues (Table 28).
Table 28: Internal training presentations on legal issues, 2014–15
Date Topic
July 2014
Marsh v Baxter—the decision
The Sustainability Council of New Zealand Trust v The
Environmental Protection Authority
August 2014 Which legislation applies? Legal status and jurisdiction
October 2014Legislative instruments and the Gene Technology
Regulations 2001
November 2014 Licence conditions as works in progress
February 2015Legal status and compliance with licence conditions—who is
obliged to comply?
March 2015 Administrative law fundamentals
April 2015Information disclosure
The Gene Technology Act for Indian delegation
May 2015 The Gene Technology Act for starters
June 2015 Providing information and advice
The OGTR Forum provides a venue where presentations are made by visiting
experts, and staff share current information on 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
2014–15 (Table 29).
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Table 29: Presentations at the OGTR Forum, 2014–15
Date Topic Speaker
July 2014
Regulation of pesticides: advances and contestability
Dr Les Davies, APVMA
Feedback from international workshop on the global pipeline of GM crops
Will Tucker
Feedback from international meeting on risk assessment and risk management under the Cartagena Protocol on Biosafety
Dr Paul Keese
August 2014Biosafety implementation in Ghana
Prof Kwabena Bosompem
October 2014Outlook questions and answers
Andrew Keal
November 2014
Feedback from international conference on new plant breeding molecular technologies
Dr Michael Dornbusch
Sugarcane seed and seedling physiology: knowledge to support environmental risk assessment for GM deployment
Dr Johann Pierre and Dr Graham Bonnett, CSIRO
December 2014
Biosafety regulatory framework in India
Dr Ranjini Warrier and Dr SR Rao
Feedback from international symposium on biosafety of GMOs
Dr Alison Wardrop and Dr Paul Keese
January 2015New opportunities in distance learning
Acting Professor Andrew Drinnan, University of Melbourne
February 2015Environmental safety assessment in Korea
Professor Soon-Ki Park
April 2015Introduction to Bayesian networks
Dr Brian Weir
June 2015GMO regulatory system in Ghana
Eric Amaning Okoree
APVMA = Australian Pesticides and Veterinary Medicines Authority; GM = genetically modified; GMO = genetically
modified organism
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APPENDIX 6 Publications
Documents published during 2014–1538 were:
• Operations of the Gene Technology Regulator: quarterly report
1 April to 30 June 2014
• Operations of the Gene Technology Regulator: quarterly report
1 July – 30 September 2014
• Operations of the Gene Technology Regulator: quarterly report
1 October – 31 December 2014
• Operations of the Gene Technology Regulator: quarterly report
1 January – 31 March 2015.
38 Copies are available at www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1. Paper copies of
some publications are also available from the OGTR Information Officer.
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APPENDIX 7 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 Technology Technical Advisory Committee (GTTAC)
• Gene Technology Ethics and Community Consultative Committee (GTECCC).
Gene Technology Technical Advisory CommitteeGTTAC’s functions, as set out in s. 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 that are
not assessed as limited and controlled under s. 50A of the Gene Technology Act.
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In 2014–15, the Regulator sought advice from GTTAC on nine DIR applications,
including for the limited and controlled release of GM sugarcane, GM wheat and GM
safflower. GTTAC met four times during 2014–15: twice in face-to-face meetings and
twice by videoconference (Table 30). Communiqués from GTTAC meetings, which
provide an overview of key matters discussed and resolutions, are published on the
Office of the Gene Technology Regulator (OGTR) website39 and in the Regulator’s
quarterly reports to parliament.
Table 30: Attendance at GTTAC meetings, 2014–15
Meeting date Number of GTTAC members attending
24 September 2014 16
18 December 2014 17
29 January 2015 16
8 April 2015 18
GTTAC chairProfessor 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 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. He is an Australian pioneer in the
application of adult stem cells and genetic therapy. 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 noncoding RNAs.
39 www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gttaccomm-1
GTTAC = Gene Technology Technical Advisory Committee
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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 (2008–12) of the International Society for Cellular Therapy (ISCT) and
founder (2009) of ISCT-Australia, chair of the Advisory Committee on Biologicals
(Therapeutic Goods Administration), a member of scientific advisory committees,
a board member for philanthropic foundations and a member of several ethics
committees. He is the recipient of national awards (Distinguished Fellow Award of
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. Professor Rasko was appointed 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).
GTTAC members 2014–17The current members of GTTAC (Table 31) were appointed in February 2014 by the
Assistant Minister for Health, Senator the Hon. Fiona Nash.
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Table 31: Members of GTTAC at 30 June 2015
Dr Jason AbleSenior Lecturer in Plant Breeding; Southern Node Leader, Durum Breeding Australia, School of Agriculture, Food and 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 BarnardBiotechnology 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 (Western Australia)
Professor Gabrielle BelzLaboratory Head, Division of Molecular Immunology, Walter and Eliza Hall Institute of Medical Research (Victoria)
Dr Graham Bonnett Research Director, CSIRO Agriculture Flagship (Queensland)
Ms Laura Fell Poultry meat farmer, McLaren Vale (South Australia)
Professor Ian GodwinProfessor 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 MahonHonorary Fellow, CSIRO Land and Water Flagship (Australian Capital Territory)
Dr Michael MichaelLaboratory Head, Flinders Centre for Innovation in Cancer, Flinders Medical Centre (South Australia)
Dr Gabrielle O’SullivanExecutive Officer and member, Institutional Biosafety Committee, Royal Prince Alfred Hospital (New South Wales)
Professor Marie RansonSchool of Biological Sciences, University of Wollongong (New South Wales)
Professor John Rasko AO (chair)
Director, Cell and Molecular Therapies, Royal Prince Alfred Hospital; Program Head, Centenary Institute (New South Wales)
Dr Kelly Shaw Senior consultant, KP Health (Tasmania)
Professor Kevin Smith Professor of Plant Breeding, University of Melbourne (Victoria)
Associate Professor Jason Smythe
Senior Business Development Manager, Faculty of Medicine, Monash University; Adjunct Associate Professor, Faculty of Science and Engineering, La Trobe University (Victoria)
Dr Diane WebsterChair, Swinburne Biosafety Committee; Affiliate Research Fellow, School of Biological Sciences, Monash University; National Convenor, Women in Science Enquiry Network (Victoria)
Professor Paul YoungProfessor of Virology and Head of School, School of Chemistry and Molecular Biosciences, University of Queensland (Queensland)
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Gene Technology Ethics and Community Consultative CommitteeGTECCC’s functions are set out in s. 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 matters of general concern
relating to GMOs
• community consultation and risk communication regarding licence
applications for DIRs
• the need for policy principles, policy guidelines, codes of practice, and
technical and procedural guidelines relating to GMOs and GM products,
and the content of such principles and codes.
Consultation of the Regulator with GTECCC on licence applications is not a
statutory requirement.
The term of most members of GTECCC expired in January 2014, and the appointment
process for a new membership of GTECCC was still in progress at 30 June 2015.
Professor Susan Dodds was appointed to GTECCC in March 2013 as the cross-member
with the Australian Health Ethics Committee (AHEC). Her term on GTECCC expired with
the expiry of her AHEC term on 30 June 2015.
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. No meetings were held in 2014–15.
Remuneration and allowances for committee membersThe Remuneration Tribunal is an independent statutory body that determines the
remuneration and allowances for all members of OGTR committees. Committee
members are part-time office holders for the purposes of the Remuneration Tribunal
and are paid in accordance with the current determination for part-time office
holders.40
40 More information is available at www.remtribunal.gov.au.
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GLOSSARY AND SHORTENED FORMSThe terms described in this glossary are important to understanding this report;
however, they do not substitute for the definitions of terms relevant to the operation of
the gene technology regulatory system in s. 10 of the Gene Technology Act 2000.
accredited organisationan organisation that is accredited under s. 92 of the Gene Technology Act 2000
APVMA Australian Pesticides and Veterinary Medicines Authority
CCIconfidential commercial information declared under s. 185 of the Gene Technology Act 2000
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 s. 10 of the Gene Technology Act 2000. It includes 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 activities.
department Australian Government Department of Health
DIRa dealing involving intentional release of a GMO into the environment (e.g. field trial or commercial release)
DNIRa contained dealing with a GMO not involving intentional release of the GMO into the environment (e.g. experiments in a certified facility such as a laboratory)
EDD emergency dealing determination
FSANZ Food Standards Australia New Zealand
Gene Technology Agreement
an intergovernmental agreement that all Australian jurisdictions signed in 2001, which underpins the nationally consistent regulatory framework for gene technology
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
GTECCCGene Technology Ethics and Community Consultative Committee
GTTAC Gene Technology Technical Advisory Committee
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IBC Institutional Biosafety Committee
incidenta self-reported event that may constitute a noncompliance with regulatory requirements and a risk to public health or the environment
LGFGT Legislative and Governance Forum on Gene Technology
MOU memorandum of understanding
NLRDnotifiable low risk dealing (e.g. 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 Statements
PC1, PC2, PC3, PC4 physical containment levels of facilities certified by the Regulator
physical containment facility
a building or place certified by the Regulator to a specified containment level under s. 84 of the Gene Technology Act 2000
RARMP risk assessment and risk management plan
Regulations Gene Technology Regulations 2001
Regulator Gene Technology Regulator
TGA Therapeutic Goods Administration
UN United Nations
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LIST OF REQUIREMENTSRefa Part of report Description Requirement
8(3) & A.4 iii Letter of transmittal Mandatory
A.5 v–vi Table of contents Mandatory
A.5 121–128 Index Mandatory
A.5 114 Glossary Mandatory
A.5 ii Contact officer(s) Mandatory
A.5 iiInternet home page address and
internet address for reportMandatory
9 Review by Secretary
9(1) 1–6 Review by departmental secretary Mandatory
9(2) iv, 2–6Summary of significant issues and
developmentsSuggested
9(2) * 13–16Overview of department’s
performance and financial resultsSuggested
9(2) 6 Outlook for following year Suggested
9(3)Significant issues and
developments—portfolio
Portfolio
departments—
suggested
10 Departmental overview
10(1)vii, 18–23,
56–57Role and functions Mandatory
10(1) 9–10 Organisational structure Mandatory
10(1) 23–58 Outcome and program structure Mandatory
10(2) 14–16
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
Mandatory
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Refa Part of report Description Requirement
11(6) *
Discussion of any significant changes
in financial results from the prior
year, from budget or anticipated to
have a significant impact on future
operations
Mandatory
11(7) 14–16
Agency resource statement and
summary resource tables by
outcomes
Mandatory
12 Management and accountability
Corporate governance
12(1) * 8
Agency heads are required to certify
their agency’s actions in dealing with
fraud
Mandatory
12(2) 8–9Statement of the main corporate
governance practices in placeMandatory
12(3)Names of the senior executive and
their responsibilitiesSuggested
12(3)Senior management committees and
their rolesSuggested
12(3)
Corporate and operational plans and
associated performance reporting
and review
Suggested
12(3)
Internal audit arrangements including
approach adopted to identifying
areas of significant financial or
operational risk and arrangements to
manage those risks
Suggested
12(3)
Policy and practices on the
establishment and maintenance of
appropriate ethical standards
Suggested
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Refa Part of report Description Requirement
External scrutiny
12(4) naSignificant developments in external
scrutinyMandatory
12(4) na
Judicial decisions and decisions of
administrative tribunals and by the
Australian Information Commissioner
Mandatory
12(4) *
Reports by the Auditor-General,
a Parliamentary Committee, the
Commonwealth Ombudsman or an
agency capability review
Mandatory
Management of human resources
12(5) 62–63
Assessment of effectiveness in
managing and developing human
resources to achieve departmental
objectives
Mandatory
12(6)Workforce planning, staff retention
and turnoverSuggested
12(6)
Impact and features of enterprise
or collective agreements, IFAs,
determinations, common law
contracts and AWAs
Suggested
12(6)Training and development
undertaken and its impactSuggested
12(6) Work health and safety performance Suggested
12(6) Productivity gains Suggested
12(7) 104–105 Statistics on staffing Mandatory
12(8) na Statistics on employees who identify
as IndigenousMandatory
12(9) 60–63, 104
Enterprise or collective agreements,
IFAs, determinations, common law
contracts and AWAs
Mandatory
12(10) & B 105 Performance pay Mandatory
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Refa Part of report Description Requirement
12(11)–(12)Assets
management
Assessment of effectiveness of assets
management
If applicable,
mandatory
12(13) PurchasingAssessment of purchasing against
core policies and principlesMandatory
12(14)–(23) Consultants
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.
Mandatory
12(24)
Australian
National
Audit Office
Access
Clauses—na
Absence of provisions in contracts
allowing access by the Auditor-
General
Mandatory
12(25)
Exempt
contracts—
na
Contracts exempted from publication
in AusTenderMandatory
12(26)–(28)Small
business
Procurement initiatives to support
small businessMandatory
13*Financial
statementsFinancial statements
Mandatory
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Refa Part of report Description Requirement
Other mandatory information
14(1) & C.1 63–65
Work health and safety (Schedule 2,
Part 4 of the Work Health and Safety
Act 2011)
Mandatory
14(1) & C.2 67
Advertising and market research
(section 311A of the Commonwealth
Electoral Act 1918) and statement on
advertising campaigns
Mandatory
14(1) & C.3 68–69
Ecologically sustainable development
and environmental performance
(section 516A of the Environment
Protection and Biodiversity
Conservation Act 1999)
Mandatory
14(1) *
Compliance with the agency’s
obligations under the Carer
Recognition Act 2010
If applicable,
mandatory
14(2) & D.1 na Grant programs Mandatory
14(3) & D.2 *
Disability reporting—explicit and
transparent reference to agency level
information available through other
reporting mechanisms
Mandatory
14(4) & D.3 65Information Publication Scheme
statementMandatory
14(5) 35Correction of material errors in
previous annual report
If applicable,
mandatory
E *Agency Resource Statements and
Resources for Outcomes Mandatory
F 116–120 List of requirements Mandatory
AWA = Australian Workplace Agreement; IFA = Individual Flexibility Arrangement; na = not applicable; PAES = Portfolio
Additional Estimates Statements; PBS = Portfolio Budget Statementsa The reference is to the location of the item in the requirements—for example, ‘A.4’ refers to the fourth item in Attachment A.
* Refer to the Department of Health 2014–15 annual report
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INDEXPage number conventions: ‘f’ refers to figures, ‘p’ refers to photographs, ‘t’ refers to tablesaccountability see management and accountabilityaccreditation of organisations, 21, 31–32, 96–97
application timeframe, 22tnumber of applications, 24tprocesses for, 31surrender of accreditation, 35trend data, 34, 35tvariations to accreditation, 36
accredited organisations, 21, 31f, 32fachievements against Outcome 7 (Health Infrastructure, Regulation, Safety and Quality), 23–47advertising and market research, 67, 67tagencies see regulatory agenciesAgricultural and Veterinary Chemicals Act 1994, 80tAgricultural and Veterinary Chemicals (Administration) Act 1992, 80tAgricultural and Veterinary Chemicals (Code) Act 1994, 80tanimal disease prevention, 2, 28, 79applicants see organisationsApplication Entry Point Section, 9f, 12applications and notifications, 23, 24t see also under dealings involving intentional release (DIRs);
dealings not involving intentional release (DNIRs)assessments and approvals of applications and notifications, 23–24, 24tassets management, 66Assistant Secretary, Evaluation Branch, 12Assistant Secretary, Regulatory Practice and Compliance Branch, 11audit, internal, 13Australian Information Commissioner Act 2010, 65Australian National Audit Office (ANAO), 13Australian Pesticides and Veterinary Medicines Authority (APVMA), 51Australian Public Service Values and Code of Conduct, 8Australian Quarantine and Inspection Service, 51Australian Seed Federation, 46, 47Australian Standard AS/NZS 2243.3 (Safety in laboratories: microbiological safety and
containment) review, 4
banana (GM), 2, 15, 38t, 41pbarley (GM), 2, 15, 26t, 38tBiotechnology Australia, 46Business Management, Communication and Post Release Review Section, 9f, 11, 13
cancer research, 28canola (GM), 2, 15, 26t, 38tcertification guidelines, 49certification of containment facilities, 32–34 see also containment facilities
application timeframe, 22t
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number of applications, 24ttrend data, 34, 35t
chicken vaccine (GM) application, 2, 25Cleland, Dr Robyn
review by, 1–5role, 10
client register, 53code of conduct see APS Values and Code of Conductcommercial releases, iv, 2, 3, 14, 25, 26t, 36, 49, 54 see also confidential commercial informationcommittees see statutory committeescommunication and consultation, 14, 48–53, 100–103
email and feecall number activities, 102tCompliance and Investigation Section, 9f, 11, 45, 64compliance with the Gene Technology Act 2000, 43–46, 98confidential commercial information (CCI), 9, 22, 35consultancies, 66–67consultation and communication, 14, 48–53, 100–103contact details, ii, 52–53
freedom of information, 65–66Contained Dealings Evaluation Section, 9f, 12, 64containment facilities
certification, 32–34containment levels/types, 32, 33t, 40, 41tinspections, 2, 4, 15, 40–43locations, 41, 42fnumber of certification approvals, 24t, 32, 33t, 34f
cooperation with other regulatory agencies, 5, 16corporate governance, 8–9corporate overview, 7–16cost recovery investigation, 53cotton (GM), 2, 15, 21p, 26t, 38tCouncil of Australian Governments (COAG), 48crop plants (GM), 25, 26t
inspection of field trials, 38, 38tCSIRO, 25, 26t, 51, 56
dealings, 18–22 see also dealings involving intentional release (DIR); dealings not involving intentional release (DNIRs); dealings placed on GMO Register; emergency dealing determinations (EDDs); exempt dealings; notifiable low risk dealings (NLRDs)
assessments and approvals of applications and notifications, 23–24, 24tcategories of dealings, 19, 20t, 83–95
dealings involving intentional release (DIRs), 2, 19, 20t, 21, 89–94application process, 91–94application timeframe, 22t, 25assessment process, 90finspection of field trials, 36–40licences issued, 25, 26tnew draft application form, 49number of applications, 24tplant workshop on, 49trend data, 35t
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dealings not involving intentional release (DNIRs), 19, 20t, 21, 27–28, 85–89application process, 88–89application timeframe, 22t, 27assessment process, 87finspection of containment facilities, 40–43licences issued, 27t, 28, 28fnumber of applications, 24ttrend data, 35t
dealings placed on GMO Register, 19, 20t, 30, 52, 82–83, 84, 86Department of Agriculture, 46–47, 47t, 49, 51
partnership, 5regulatory harmonisation, 57scope in regulatory process, 80t–81t
Department of Agriculture, Fisheries and Forestry, 46Department of Education, 46Department of Education, Science and Training, 46Department of Foreign Affairs and Trade, 46Department of Health, 3, 8, 46, 51
scope in regulatory process, 80t–81tDepartment of Health and Ageing, 46Department of Industry, 46Department of Industry, Tourism and Resources, 46Department of the Environment, 46, 47tDepartment of the Environment and Heritage, 46deregulation, 3
ecologically sustainable development, 68–69Electronic Transactions Act 1999, 65–66emergency dealing determinations (EDDs), 19, 20t, 30–31, 95employee assistance program, 62employees see staffEnterprise Agreement, 61tEnvironment Protection and Biodiversity Conservation Act 1999, 68–69environmental release applications see dealings involving intentional release (DIR)equine influenza vaccine, 31ethical standards, 8Evaluation Branch, 9, 9f, 10, 12exempt contracts, 66exempt dealings, 19, 20t, 83
Fair Work Act 2009, 60female staff, 105tfield trials
crop types, 38, 38tinspections, 2, 15, 36–43locations, 40, 40tmonitoring of cycle and status, 39, 39f
financial performance, 13financial reporting, 8, 13financial statements, x, 13
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Food Standards Australia New Zealand Act 1991, 80tFood Standards Australia New Zealand (FSANZ), 46, 51, 74f, 80t, 114forums see meetings and forumsfreedom of information, 65–66Freedom of Information Act 1982, 65Freedom of Information Amendment (Reform) Act 2010, 65functions see rolefunding, 13t
Gene Technology Act 2000, ii, iii, iv, ix, 8, 10, 11, 23, 75t, 80tamendments to, 76–77, 78tapplication types, 82–98compliance with, 43, 45–46dealings with GMOs defined, 18–22development of the Act, 72–73noncompliance incidents, 44, 44tresponse to the review of, 4, 14, 51, 52, 76, 78ts. 4A, 55s. 21 (policy), 76s. 27 (international regulatory liaison), 53–56s. 27 (research and harmonisation), 56s. 43(3), 22s. 52 (advertising and market research), 67s. 72 (emergency dealing determination), 30–31s. 78 and s. 79 (GMO Register), 30, 52s. 136 (reporting), 67s. 136A(2), 67–68s. 184 (confidential commercial information), 35statutory committees, 109–113variations to licences, certifications and accreditations, 36
Gene Technology Act Amendment Bill 2015, 4, 51Gene Technology Ethics and Community Consultative Committee (GTECCC), 11, 109–112, 113Gene Technology Regulations 2001 (the Regulations), ix
amendment, 48application timeframes, 22, 22tdefinition of GMO, 18
Gene Technology Regulator (the Regulator)review by, 1–5role, 10
Gene Technology Technical Advisory Committee (GTTAC), 11, 21, 109–112genetically modified organisms (GMOs) see also containment facilities; field trials
dealings see under dealingsdefined, 18environmental release applications, 2, 23, 24t, 25–26, 27–28, 69monitoring and inspections, 36–43, 97–98national strategy to manage the unintended presence of unapproved GMOs in imported
seeds, 46–47performance against deliverable, 14
glossary, 114–115GMO Record, 52, 96
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GMO Register, 19, 20t, 30, 52, 82–83governance, iv, 8–9, 73–75, 74f
health and safety see work health and safetyhistory of the gene technology regulatory system, 72–81human disease prevention, 2, 27t, 28, 79human resources, 60–63
Imported Food Control Act 1992, 81tImproving Wellness and Motivation in the Workplace: Reducing Unplanned Leave initiative, 63inadvertent dealings, 19, 20t, 95Industrial Chemicals (Notification and Assessment) Act 1989, 81tIndustry, Innovation and Competitiveness Agenda (Australian Government), 4inspection of containment facilities, 2, 15, 40–43
number of inspections, 41t, 42f, 43fpartnership with Department of Agriculture, 4
inspection of DIR licences, 36–40inspection of field trial sites, 2, 15, 36–43
number and proportion of sites, 37f, 37tnumbers by crop, 38tnumbers by location, 39fstatus of sites, 39f
Institutional Biosafety Committee (IBC), 29national forum, 3, 49
international regulatory liaison, 4, 5, 16, 53–56International Society for Biosafety Research, 55International Symposium on the Biosafety of GMOs (ISBGMO), 5, 16, 55, 56
laboratory dealings see dealings not involving intentional release (DNIRs)Legal Section, 9f, 10legislation, 75t, 78t, 80t see also Gene Technology Act 2000Legislative and Governance Forum on Gene Technology (LGFGT), 51, 75–78licences see applications and notificationslicensed dealings, 20t, 21, 84–94 see also dealings involving intentional release (DIR); dealings not
involving intentional release (DNIRs); inadvertent dealingslimited and controlled release applications, iv, 20t, 22t, 25, 26t, 36, 38, 89 see also dealings
involving intentional release (DIR)list of requirements, 116–120local councils, 21
male staff, 105tmanagement and accountability, 59–69meetings and forums, 2, 49–50, 50–51, 99, 99t, 107t
international, 55–56Minister for the Environment, 21, 52mission statement, viimonitoring and inspections of GMOs, 36–43, 97–98 see also inspection of containment facilities;
inspection of field trialsMonitoring Section, 9f, 11, 64National Disability Strategy, 68
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National Health Security Act 2007, 48National Industrial Chemicals Notification and Assessment Scheme, 81tNational Institutional Biosafety Committee Forum, 2, 49–50national relationships with other regulatory agencies, 5, 16national strategy to manage the unintended presence of unapproved GMOs in imported seeds,
46–47noncompliance with the Gene Technology Act 2000, 44–46
numbers, 43tnotifiable incidents, 64notifiable low risk dealings (NLRDs), iv, 19, 20t, 29, 83–84, 96
inspection of containment facilities, 40–43monitoring, 40number of applications, 24ttrend data, 34, 35ttypes of organisations, 29f
notifications and applications, 23, 24t
objectives, vii, 14Occupational Health and Safety (Commonwealth Employment) Amendment Act 2006, 65Organisation for Economic Co-operation and Development (OECD)
Biotrack Product Database, 54Working Group on the Harmonisation of Regulatory Oversight in Biotechnology (WGHROB), 5,
16, 54organisations
accredited, 21, 31f, 32fissued with certifications for containment facilities, 33, 42fissued with licences, 26f, 27t, 28, 28fnotifications of low risk dealings, 29, 29f
Outcome 7 (Health Infrastructure, Regulation, Safety and Quality), iii, ix, 14achievements against, 23–47
outcomes, viiiinspection of field trials, 36–37work health and safety, 64
pathogen disease development, 28People Strategy Action Plan 2010–2015, 63perennial ryegrass (GM), 38tperformance
against deliverables and key performance indicators, 14–16financial, 13operational, 17–57summary, iv
physical containment facilities see containment facilitiesPlant Evaluation Section, 9f, 12Post Release Review Framework, 11Post-border Weed Risk Management Protocol tool, 5poultry vaccine (GM) application, 2, 25public access to OGTR, 52–53, 100–103 see also communication and consultationpublic awareness of GMOs, 57Public Governance, Performance and Accountability Act 2013, 8, 13
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127O 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 I A N N U A L R E P O R T 2 0 1 4 – 1 5
public interactions, 52–53Public Service Act 1999, iii, ix, 8publications, 67–68, 108purchasing, 66
Quarantine Act 1908, 81tquarterly reporting, 67–68, 108
Radanovich, Mr Andrew, 11Regulator Performance Framework and Community of Practice (Australian Government), 4Regulator’s Achievement Award for 2014, 62regulatory agencies, 21, 57, 80t–81tregulatory harmonisation, 80t–81tRegulatory Practice and Compliance Branch, 9, 9f, 11Regulatory Practice and Secretariat Section, 9f, 11regulatory processes, 18–22Regulatory Science Network, 5, 52reporting requirements of OGTR, 67–68research applications (DNIR licences), 27, 28fresearch commissioned by the Regulator, 56–57risk assessment and management of GMOs, 15risk assessment and risk management plans (RARMPs), 12, 14–15, 19, 20t, 95
access to, 52, 53dealings involving intentional release (DIR), 89, 90f, 92, 93, 94, 109dealings not involving intentional release (DNIRs), 85, 86, 87f, 88, 89
risk management plan (OGTR), 9role, vii, 48
Safety, Rehabilitation and Compensation Act 1988, 63safflower (GM), 2, 15, 26t, 38t, 39pScience Cohort, 9f, 12science strategy, 2Security Sensitive Biological Agents Regulatory Scheme, 48security sensitive biological agents (SSBAs), 48seed industry issues, 46–47staff, viii
nonsalary benefits, 61tnumbers, 60performance pay, 105, 105tprofile, 104, 104t, 105ttraining and development, 62, 64, 106t, 107t
stakeholder engagement, 3, 100–103consultation and communication, 14, 48–53
states and territories, 10, 21, 68accredited organisations, 31fcertified physical containment facilities, 34flegislation, 75tlocations of containment facilities, 41, 42flocations of field trials, 40, 40t
statutory committees, iv
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128
Gene Technology Ethics and Community Consultative Committee (GTECCC), 11, 113Gene Technology Technical Advisory Committee (GTTAC), 11, 21, 109–111, 112t
statutory functions, iv, 18–22strategic plan, 2strategies, viiistructure of OGTR, 9–10, 9fstructure of the gene technology regulatory system, 72–81sugarcane (GM), 2, 15, 23p, 26t, 38tsurrenders of licences and certifications, 24t, 35
Tattersall, Dr Kylie, 62temporary licence, 19Therapeutic Goods Act 1989, 80tTherapeutic Goods Administration, 51, 74f, 80ttimeframes for licence applications, 22, 22t, 25, 27training and development, staff, 62, 64, 106t, 107tTucker, Mr William, 12
unintended presence of unapproved GMOs, 46–47, 55United Nations (UN)
Biosafety Clearing-House, 54Cartagena Protocol on Biosafety, 5, 16, 54–55Convention on Biological Diversity (CBD), 5, 16, 54–55International Centre for Genetic Engineering and Biotechnology (ICGEB), 55
vaccine development, 28, 31, 36, 79values, viiivariations of licences, 21, 24t, 36
application timeframe, 22tnumbers, iv, 24t, 36
variations to licences, certifications and accreditations, 35vision statement, vii
website, ii, 3, 11, 52–53, 100–101, 100tdisclosure log, 66
wheat (GM), 2, 15, 26t, 38twhite clover (GM), 38twork health and safety, 63–65Work Health and Safety Act 2011, 63, 64
investigations under Part 10, 65
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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
ANNUAL REPORT
2014–15
www.ogtr.gov.auAll information in this publication is correct as at October 2015
OPERATIO
NS OF THE G
ENE TECHNOLO
GY REG
ULATOR ANNUAL REPO
RT 2014-15
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