Operations of the Gene Technology
Regulator Annual Report 2013–14
The object of the Gene Technology Act 2000 is to protect the health and safety of people and to protect the environment by identifying risks posed
by, or as a result of, gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms.
ISBN: 978-1-74186-175-4
Online ISBN: 978-1-74186-176-1
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1
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Senator the Hon Fiona Nash
Assistant Minister for Health
Parliament House
Canberra ACT 2600
Dear Minister
I am pleased to present to you the Annual Report on the Operations of the Gene Technology Regulator covering the
period 1 July 2013 to 30 June 2014.
The annual report details the operations of the Gene Technology Regulator against the performance indicators for the
Office of the Gene Technology Regulator contained in Outcome 1, Population Health, of the Department of Health and
Ageing Portfolio Budget Statements for the period 1 July 2013 to 30 June 2014.
The annual report has been prepared in accordance with section 136(1) of the Gene Technology Act 2000 and the
guidelines approved by the Joint Committee of Public Accounts and Audit referred to in sections 63(2) and 70(2) of the
Public Service Act 1999.
Section 136(2) of the Gene Technology Act 2000 requires you to present this report to each house of Parliament within
15 sitting days of that house after the day you are given the report. The guidelines referred to in section 70(2) of the
Public Service Act 1999 require that this presentation occur on or before 31 October 2014.
Yours sincerely
Dr Robyn Cleland
Acting Gene Technology Regulator
19 September 2014
3
CONTACTS
Office of the Gene Technology Regulator
MDP 54 GPO Box 9848
Canberra ACT 2601 Australia
Level 1, Pharmacy Guild House
15 National Circuit
Barton ACT 2600
Telephone: 1800 181 030
Fax: (02) 6271 4202
Email: ogtr@health.gov.au
Website: www.ogtr.gov.au
ABN 15 862 053 538
Annual report web page <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1>.
Enquiries about the content of this report may be directed to the Business Management and Communications Section, Regulatory
Practice and Compliance Branch, Office of the Gene Technology Regulator.
4
OFFICE OF THE GENE TECHNOLOGY REGULATOR
Our vision
To be a trusted and respected regulator of gene technology safeguarding the Australian people and the environment.
Our mission
Dedicated to ensuring that genetically modified organisms are safely managed in Australia.
Our role
To protect the health and safety of people and the environment by identifying risks posed by, or as a result of, gene technology,
and by managing those risks through regulating certain dealings with genetically modified organisms.
Strategic objectives
To deliver efficient and effective regulation that protects people and the environment, and encompasses regulatory decisions and
activities (science, compliance, performance) that are evidence based, outcome focused, transparent, and consistent and
defensible.
To provide a safe, respectful and inclusive workplace that is productive and professionally rewarding.
To inform and engage effectively with our stakeholders so they understand and respect our decisions.
To ensure our governance arrangements are robust, exemplify best practice and fulfil all legal obligations.
Enabling strategies
Sound science
Effective compliance
Good governance
Capable, qualified staff
Clear communication
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 people
As at 30 June 2014, the Office of the Gene Technology Regulator comprised 53 scientific, legal, policy, professional and
administrative staff. We value our people and seek to attract and retain appropriately qualified and skilled people by providing an
environment that builds capability, motivates, inspires and supports.
Our valuesProfessional, transparent, accountable, proactive, collaborative, responsive, respectful,
inclusive, ethical.
ABOUT THIS REPORT
This annual report is prepared in accordance with the Requirements for Annual Reports as issued by the Department of the Prime
Minister and Cabinet and approved by the Joint Committee of Public Accounts and Audit under sections 63(2) and 70(2) of the
Public Service Act 1999.
The report is a formal accountability document that details the operations of the Gene Technology Regulator (the Regulator) during
2013–14 against deliverables and key performance indicators for the Office of the Gene Technology Regulator (OGTR) contained
in Outcome 1, Population Health, of the Department of Health and Ageing (the Department) 2013–14 Portfolio Budget Statement
(PBS).
This report describes the roles and responsibilities of the Regulator and the OGTR and provides readers with a useful and
informative picture of the OGTR’s performance over the past 12 months.
This report is arranged in four chapters and contains a number of appendices. The chapters are organised as follows:
Chapter 1 –Gene Technology Regulator’s review provides a summary of the OGTR’s activities over the past year, including major
5
achievements and the outlook for the coming year.
Chapter 2 – Corporate overview provides a brief description of the OGTR’s corporate governance arrangements and a summary of
performance against the reporting structure set out in the Department’s 2013–14 PBS.
Chapter 3 – Operational performance describes the OGTR’s achievements against the priorities for the reporting year. Deliverables
and performance targets achieved in the areas of assessments and approvals, monitoring and compliance, consultation with
stakeholders, and international relationships are discussed in detail along with other information on activities relating to the
Regulator’s statutory functions as prescribed by the Gene Technology Act 2000. Classes of dealings and authorisations outline the
types of dealings with genetically modified organisms (GMOs) defined by the Gene Technology Act 2000, the Gene Technology
Regulations 2001 and corresponding state and territory laws. A summary of classes of dealings, processes for authorisations and
statutory time frames are detailed in chapter three.
Chapter 4 – Management and accountability provides an overview of the OGTR’s resource management practices and its
adherence to Australian Government accountability principles.
The appendices provide a range of statistical and other information, including compliance with mandatory annual reporting
requirements. The appendices also contain detailed information on the history and structure of the gene technology regulatory
system and the types of GMO dealings and their assessment processes.
A glossary and alphabetical index are provided as aids to reader access and a list of requirements is provided to accord with the
Department of the Prime Minister and Cabinet’s Requirements for Annual Reports.
Note: The Department of Health 2013–14 Annual Report also contains information about the OGTR. This includes the OGTR
financial statements, which are consolidated into the Department’s financial statements.
Unless otherwise stated, all information provided in this report is sourced from the OGTR.
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CONTENTS
Operations of the Gene Technology Regulator Annual Report 2013–14
Contacts
Office of the Gene Technology Regulator
Our vision
Our mission
Our role
Our objective
Our people
Our values
About this report
Contents
CHAPTER 1 Gene Technology Regulator’s review
CHAPTER 2 Corporate overview
Corporate governance
Organisational structure
Gene Technology Regulator
Regulatory Practice and Compliance Branch
Evaluation Branch
Financial performance
Performance against PBS targets
CHAPTER 3 Operational performance
GMOs, dealings and authorisations
Time frames
Operational performance
Assessments and approvals
Licences for dealings involving intentional release
Licences for dealings not involving intentional release
Notifiable low-risk dealings
Dealings placed on the GMO Register
Emergency dealing determination
Accredited organisations
Certified physical containment facilities
Trend data for approval of main types of applications
Monitoring of genetically modified organisms
Compliance with the Gene Technology Act 2000
Consultation and provision of advice to stakeholders
Investigation of cost recovery for OGTR
International regulatory liaison
Other functions of the Gene Technology Regulator
CHAPTER 4 Management and accountability
Human resources
Work health and safety
Freedom of information
Purchasing
Assets management
Exempt contracts
Consultancies
Advertising and market research
Annual reporting requirements
Quarterly reporting requirements
National Disability Strategy
Ecologically sustainable development and environmental performance
APPENDIX 1 History and structure of the gene technology regulatory system
Development of the Gene Technology Act 2000
Governance arrangements
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Role of the Legislative and Governance Forum on Gene Technology
Coordination with prescribed agencies
APPENDIX 2 Types of applications, authorisations, monitoring and compliance
The GMO Register
Exempt dealings
Notifiable low-risk dealings
Licensed dealings
Dealings not involving intentional release
Dealings involving intentional release
Inadvertent dealings
The GMO Record
Accreditation and certification
Monitoring and compliance
APPENDIX 3 Membership of statutory committees and attendance at meetings
Gene Technology Technical Advisory Committee
GTTAC chair
GTTAC members 2011–14
Gene Technology Ethics and Community Consultative Committee
GTECCC chair
Remuneration and allowances for committee members
GTECCC members 2011–14
APPENDIX 4 Staff profile and training and development activities
Staff profile
Performance pay
Training and development
APPENDIX 5 Publications and guidance documents
Quarterly reports
APPENDIX 6 Stakeholder and public access to the OGTR
Website usage
Email address and free call number
APPENDIX 7 Presentations and meetings on gene technology in Australia
Glossary
List of requirements
Index
8
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CHAPTER 1 GENE TECHNOLOGY REGULATOR’S REVIEW
Gene Technology Regulator
2013-14 has been a year of challenges and opportunities for OGTR as we continue to fulfil our legislative obligations in
administering the national regulatory scheme for gene technology. Our Strategic Plan has guided our activities throughout the year
ensuring we focused on delivering efficient and effective regulation based on sound science, actively engaged and communicated
with our stakeholders, and maintained the highest standards of good governance and accountability.
The variety of genetically modified organisms (GMOs) seen in applications for environmental release continued to increase as
genetic modification is applied to new species and new traits are developed. This year, two new commercial varieties of cotton
were approved and field trials in canola, cotton, wheat, barley and safflower were authorised. In addition, a clinical trial of a
genetically modified (GM) vaccine for cholera was also approved (previously released under DIR 33) and an application for the
commercial release of a GM vaccine for poultry was received. We achieved our goal of 100 per cent of statutory decisions made on
time. These decisions were underpinned by comprehensive rigorous risk assessment and risk management plans based on robust
scientific evidence. We also met our target of monitoring a minimum of 20 per cent of field trial sites to ensure risks to people and
the environment are managed by maintaining a high level of compliance. As always, it has been through the efforts of our skilled,
productive and professional staff that we have been able to achieve this.
Efficient and effective regulation
This year saw the implementation phase of the 2013 revision of the Risk Analysis Framework (RAF), the document that describes
our approach to assessing and managing risks posed by work with GMOs. The revised RAF further articulates how we assess risks
posed by GMOs using frameworks already in place, such as the national weed risk assessment tool. We also focused on improving
our communication about such risks. Changes in our communication of scientific and regulatory decisions, to enhance clarity, have
been well received by our stakeholders.
Our Science Strategy 2013–18 was developed and launched. This document will guide us in maintaining and enhancing our
scientific and risk-analysis capability to meet current and future needs. The effective application of science to regulatory activities is
a critical part of our performance. The Science Strategy will also be important in continuing to build the professional capacity of our
staff.
The new Gene Technology Technical Advisory Committee was appointed for the 2014-17 triennium by the Assistant Minister. This
group of eminent scientists provides advice to the Regulator on licence applications and other scientific matters. Professor John
Rasko continued as chair of the committee. The retirement of the chair of the Gene Technology Ethics and Community
Consultative Committee, Dr Don Chalmers, marked the end of more than 12 years of service. Don has made an enormous
contribution to gene technology regulation both prior to the establishment of the regulatory scheme and as chair of a number of its
committees. He was the inaugural chair of what was then the Gene Technology Ethics Committee and was a pivotal contributor to
a number of papers produced by that committee.
Strong partnerships with other regulatory agencies are an important part of the national scheme regulating GMOs and in preventing
duplication of regulatory effort. The Regulator’s Forum and the Regulatory Science Network (RSN) provided valuable platforms for
engagement throughout the year. Risk communication was the focus of the RSN annual event this year, which served as a vehicle
for discussing operational approaches to stakeholder communication. Engagement through partnerships also occurred
internationally where OGTR had involvement in Organisation for Economic Cooperation and Development work facilitating
harmonisation of risk assessment and regulation of GMOs. In 2013–14 the Regulator signed an memorandum of understanding
with the International Centre for Genetic Engineering and Biotechnology to establish collaborative activities on risk assessment and
regulation of GMOs with a number of African GMO regulators.
The investigation of cost recovery of OGTR services by the Department of Health continued through 2013–14. The Department is
preparing a Regulation Impact Statement in line with current requirements. At OGTR we have continued to refine our internal
processes to deliver efficient services through initiatives such as electronic record keeping and process improvements.
The OGTR is responsible for the National Unintended Presence Strategy developed by the Australian Government to manage the
risk of unapproved GMOs in imported seed for sowing. In 2013–14 we worked with the departments of Agriculture, Environment
and Foreign Affairs to develop operational guidance to ensure communication and coordination between relevant agencies in the
event of an incident involving unapproved GMOs. This capacity-building work will continue through the next year to strengthen the
preventative strategy in place for managing risks of unapproved GMOs. In responding to the discovery in the United States of
America of unauthorised GM wheat in October 2013, the importance of a coordinated response was apparent.
10
Stakeholder engagement and risk communication
Guidance documents are produced in consultation with our stakeholders to assist them through the regulatory process and to
facilitate their understanding of regulatory requirements. The new, limited and controlled release application form finalised in
December 2013 clearly articulates the type of information required for different applications and provides a communication platform
for discussions between OGTR and applicants to ensure smooth progression and timely consideration of applications. This
document is the culmination of a significant amount of work by staff of OGTR in identifying only relevant information required to
underpin a rigorous risk assessment. The final document was also informed by detailed feedback from stakeholders.
Gene technology remains a contentious area and openness and transparency are critical in maintaining confidence in the
regulatory scheme. In 2013–14 work commenced on redevelopment of the OGTR website. Since the inception of OGTR, the
website has provided an important platform to engage with all of our stakeholders, from applicants to interested members of the
public. Analysis of the information we provide and consideration of our stakeholders’ needs led to recommendations to restructure
the website and organise regulatory guidance and ‘for information’ generic material into more logical groupings. The new structure
will align with feedback provided from stakeholders to make important information easier to find. These recommendations will be
implemented as the website is rebuilt over the next year.
Strategic engagement
OGTR is providing input to policymakers in the Department to give effect to the all Australian governments’ response to the 2011
Review of the Gene Technology Act 2000. The non-legislative recommendations accepted by governments and relevant to OGTR
have been implemented and will continue to inform our practice. In exploring opportunities to use new communication tools as
recommended by the review, OGTR used Twitter to tweet about the GM cholera vaccine. OGTR has actively participated in
providing technical advice to inform policy considerations regarding the other recommendations. A particular challenge is the issue
of definitional capture of new technologies. We will continue to be involved in discussions both within Australia and with
international counterparts around the world on this matter.
The Regulator administers a national scheme underpinned by an Intergovernmental Agreement and engagement with States and
Territories continued to be important in our regulatory practice. States and Territories provided useful risk assessment advice on
licence applications. The Regulator made a submission based on operational experience to Queensland’s review of its gene
technology legislation. It is pleasing to note that the Queensland government response will take forward a recommendation to
adopt a lock step approach to amending gene technology legislation, this approach has been enacted in NSW, the Northern
Territory and Tasmania. This approach offers many advantages for States and Territories.
Dr Joe Smith, the second Gene Technology Regulator, retired in March 2014. He was a great advocate of the nationally consistent
scheme for gene technology and actively engaged with reviews conducted by states and territories examining their approach to
legislation. It is appropriate to acknowledge his contribution to gene technology regulation in this area. His high level of integrity and
very personal concern for staff made the office a great place to work.
In moving into 2014–15, our Strategic Plan and Science Strategy will provide overarching guidance in how we go forward to deliver
on the government’s objectives for the regulation of gene technology. We will continue to use sound science, clear communication
and good governance to deliver efficient and effective regulation of gene technology that manages the risks posed by GMOs and
safeguards the Australian people and the environment.
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CHAPTER 2 CORPORATE OVERVIEW
This chapter provides an overview of the corporate governance arrangements for the Gene
Technology Regulator (the Regulator) and a description of the organisational structure of
the Office of the Gene Technology Regulator (OGTR). It also describes the OGTR’s human
resource management practices, and reports its performance against deliverables and key
performance indicators set out in Outcome 1, Population Health, of the Department of
Health and Ageing 2013–14 Portfolio Budget Statement (PBS).
CORPORATE GOVERNANCE
The Regulator is a statutory office holder with specific powers and functions under the Gene Technology Act 2000. In exercising
these functions, the Regulator is directly responsible to the Australian Parliament. During 2013–14, the Assistant Minister for Health
had portfolio responsibility for matters relating to the OGTR, which resides within the Australian Government Department of Health
(the Department). The Secretary of the Department provides staff to the OGTR under section 133 of the Gene Technology Act
2000.
The OGTR has an ongoing Head of Agreement in place with the Department to access a range of business management and
reporting services (information technology, financial reporting and accounting, human resources management, ministerial support
and property management). The cost of these services is reviewed annually.
The employment framework for the OGTR is the Public Service Act 1999, and staff are covered by the Department’s enterprise
agreement and governance policies and practices. These include application of appropriate ethical standards under the Australian
Public Service Values and Code of Conduct, and compliance with Australian Government freedom of information, privacy and work
health and safety legislation, the National Disability Strategy and workplace diversity policy.
The Financial Management and Accountability Act 1997 establishes the financial framework for OGTR governance. Integrity in
financial reporting is maintained through the internal audit arrangements of the service-level agreement with the Department. The
OGTR complies with the Commonwealth Fraud Control Guidelines as required by the Department.
OGTR internal policies and practices also cover the physical security and protection of confidential commercial information (CCI)
received from applicants in support of their applications.
The OGTR maintains its own business risk management plan, which senior OGTR staff review periodically.
ORGANISATIONAL STRUCTURE
The OGTR comprises an Evaluation Branch and a Regulatory Practice and Compliance Branch. Both branches include various
sections that focus on particular activities relating to regulation of gene technology (figure 1).
Figure 1: Organisational structure of the OGTR, 2013–14
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GENE TECHNOLOGY REGULATOR
The Regulator is an independent statutory office holder who administers the nationally consistent scheme for regulating gene
technology, comprised of the Gene Technology Act 2000 and corresponding state and territory laws.1 In administering the gene
technology regulatory system, the Regulator has specific responsibility to protect the health and safety of people, and to protect the
environment, by identifying risks posed by, or as a result of, gene technology, and by managing those risks through regulating
certain dealings with genetically modified organisms (GMOs).
After the retirement of Dr Joe Smith in March 2014, Dr Michael Dornbusch acted in the role as Regulator until June 2014 when Dr
Robyn Cleland commenced in the role.
Dr Cleland has extensive experience in regulatory agencies, including the OGTR, Food Standards Australia New Zealand and
Australian Pesticides and Veterinary Medicines Authority in corporate, risk management and scientific roles.
The legal section provides legal advice to the Regulator and the OGTR on the operation of Commonwealth, state and territory laws
affecting their functions, including setting licence conditions and handling CCI. It conducts training for OGTR staff on legal issues.
REGULATORY PRACTICE AND COMPLIANCE BRANCH
Mr Andrew Radanovich has been the acting Assistant Secretary Regulatory Practice and Compliance Branch since June 2014. Mr
Radanovich joined the OGTR in 2002 as an inspector and has managed the Compliance and Investigation Section since 2003.
Currently, as acting Assistant Secretary, he is responsible for regulatory practice policy, coordinating monitoring and compliance
activities, corporate business services, expert advisory committees, communication and international cooperation.
In partnership with the Department, the branch’s Business Management, Communications and Post Release Review Section
delivers administrative and financial reporting services. Other roles include account processing, financial planning, procurement,
human resource management, staff training and coordination, accommodation and property and asset management. The section
produces the annual and quarterly reports, staffs the free call 1800 181 030 number, coordinates responses to email enquiries to
<ogtr@health.gov.au> and manages the OGTR website. It has developed the Post Release Review Framework to guide ongoing
oversight of commercial or general-release GMOs.
1
See <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/legislation-2>.
13
The Compliance and Investigation Section conducts audits, reviews and investigations of organisations and individuals involved
with GMO dealings (including self-reported incidents and allegations made by third parties) to ensure that the dealings are
undertaken in accordance with the Gene Technology Act 2000.
The Monitoring Section monitors and inspects dealings with GMOs conducted at field trial sites and within contained facilities
certified by the Regulator. The aim of these activities is to ensure that dealings with GMOs comply with legislative obligations and
are consistent with the object of the Gene Technology Act 2000. In particular, the section focuses on maintaining compliance with
conditions of licences or other instruments and management of risks in relation to any potential breach of conditions.
The Regulatory Practice and Secretariat Section provides operational policy, information and coordination support for the OGTR,
including coordination of ministerial correspondence and briefings. It provides the contact point for Australian Government agencies
and other national and international organisations involved with regulating GMOs and coordinates input to international regulatory
harmonisation programs. It provides secretariat services to the Gene Technology Ethics and Community Consultative Committee
and the Gene Technology Technical Advisory Committee.
EVALUATION BRANCH
Dr Michael Dornbusch heads the Evaluation Branch. Dr Dornbusch first joined the OGTR in 2003 and managed the Plant
Evaluation Section from December 2006 until his appointment as Assistant Secretary in September 2009. Dr Dornbusch’s
responsibilities encompass managing evaluation of licence applications and other authorisations relating to dealings with GMOs
and other science-related projects that maintain and enhance the OGTR’s technical capabilities.
The Application and Licence Management Section receives and acknowledges all applications, processes accreditation and lowlevel certification applications, manages databases, reports on workflows and coordinates reviews of guidelines and application
procedures.
The Plant Evaluation Section prepares risk assessment and risk management plans (RARMPs) for dealings involving intentional
release (DIRs) of genetically modified (GM) plants into the environment, for the Regulator’s consideration and for consultation with
key stakeholders, including the public. The section gathers scientific data and produces reference documents to inform the risk
assessment process. It also provides technical advice to the Regulator, other sections of OGTR and stakeholders.
The Contained Dealings Evaluation Section prepares RARMPs for dealings not involving intentional release of GMOs into the
environment, also known as ‘contained dealings’, and non-plant DIR applications. The section provides advice to accredited
organisations and institutional biosafety committees on the classification of dealings with GMOs, and inspects and processes
certification applications for high-level and large-scale containment facilities.
The Science Cohort develops and manages science-related projects that affect the OGTR, including ongoing review and
implementation of the Risk Analysis Framework. It provides scientific advice, trains staff in risk analysis and provides input to
policies and processes associated with risk analysis. It also organises seminars and supports national and international input into
regulatory harmonisation programs, and oversees the OGTR library and reference manager database.
FINANCIAL PERFORMANCE
The Gene Technology Account is a Special Account for the purposes of the Financial Management and Accountability Act 1997.
The Special Account receives all moneys appropriated by the Parliament and makes payments for expenses the Regulator incurs
in performing these functions. The OGTR prepares accrual accounting financial statements in accordance with the Department of
Finance and Deregulation guidelines (that department was renamed the Department of Finance in September 2013). The
Australian National Audit Office performs an annual audit of these statements, which are then consolidated into the Department’s
financial statements for the year ended 30 June. The receipts and expenditure of the OGTR’s Special Account are shown in the
Department’s financial statements for the year ended 30 June.
The executive and section managers are responsible for ensuring appropriate use of resources. Under the OGTR’s organisational
structure, the Business Management, Communications and Post Release Review Section coordinates financial reporting and
management.
The 2013–14 federal budget measures for the OGTR are published in the Department’s 2013–14 PBS and are summarised in table
1.
Table 1: Australian Government funding for the OGTR, 2013–14 to 2017–18
2013–14 ($M)
Departmental
7.976
2014–15 ($M)
7.810
2015–16 ($M)
7.753
2016–17 ($M)
7.703
2017–18 ($M)
7.778
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PERFORMANCE AGAINST PBS TARGETS
The OGTR’s activities for 2013–14 are described on pages 62 to 64, under program 1.4 in Outcome 1, Population Health, of the
Department’s 2013–14 PBS.2 The key objective of this sub-program is to:
●
protect the health and safety of people and the environment by regulating dealings with genetically modified organisms.
The OGTR’s performance against deliverables and key performance indicators, as also reported in the Department’s 2013–14
annual report, is summarised in table 2.
Table 2: Deliverables, 2013–14
Qualitative deliverable: Implement changes to OGTR operations agreed by the all Australian governments’ response to
the Review of the Gene Technology Act 2000.
2013–14 reference point: Implementation completed within any agreed timeframes set in the response.
Result: Met.
In 2013–14, OGTR implemented operational recommendations from the 2011 Review of the Gene Technology Act 2000. This
included a range of activities to improve communication and consultation with regulated stakeholders and the public. Engagement
with stakeholders is an ongoing priority for OGTR.
Qualitative deliverable: Provide open, transparent and effective regulation of GMOs.
2013–14 reference point: Stakeholders, including the public, consulted on all assessments for proposed release of GMOs into the
environment.
Record of GMOs and maps of all field trial sites maintained and made publicly available on OGTR’s website.
Risk assessments and risk management plans prepared for all applications for licenced dealings.
Result: Met.
In 2013-14, the Regulator prepared comprehensive risk assessments and risk management plans and consulted with
stakeholders on seven GMO licence applications for intentional release into the environment (five field/clinical trials and two
general/commercial releases). The Regulator also prepared risk assessments and risk management plans for 10 licence
applications for work in contained facilities. The OGTR maintained a record of approved GMOs and maps of all field trial sites,
and made them available on the OGTR website.3
Qualitative KPI: Facilitate cooperation and prevent duplication in the implementation of GMO regulation.
2013–14 reference point: High degree of cooperation with relevant regulatory agencies.
Result: Met.
In 2013-14, the OGTR continued cooperative arrangements with other Australian Government regulators to enhance coordinated
decision making and avoid duplication in regulation of GMOs and genetically modified products .Quantitative deliverable
percentage of field trial sites and higher level containment facilities inspected.
2013–14 target: ≥20%
2013–14 actual: 40% and 25%
Result: Met.
In 2013–14, the OGTR inspected 40% of field trial sites to monitor compliance with licence conditions ensuring risks to human
health and the environment are minimised. Sites were inspected in the Australian Capital Territory, New South Wales, Victoria,
Queensland and Western Australia. Inspections included genetically modified canola, wheat, barley, cotton, sugarcane, banana,
safflower, and a clinical trial of genetically modified viral vaccines intended to provide protection against prostate cancer.
The OGTR also inspected 25% of higher level containment facilities to ensure compliance with certification conditions. These
inspections focused on the integrity of the physical structure of the facility and on the general laboratory practices followed.
.
Quantitative KPI: Percentage of licence decisions made within statutory time frames.
2
3
A copy of the 2011–12 PBS is available at <www.health.gov.au/internet/budget/publishing.nsf/Content/2009–10_Health_PBS>.
www.ogtr.gov.au
15
2013–14 target: 100%
2013–14 actual: 100%
Result: Met.
The Regulator made decisions on all licence applications within the applicable statutory time frames, as in previous reporting periods. There
were no appeals of decisions made under the gene technology legislation.
Qualitative KPI: Protect people and the environment through identification and management of risks from GMOs.
2013–14 reference point: High level of compliance with the gene technology legislation and no adverse effect on human health or
environment from GMOs
Result: Met.
Routine monitoring of the regulated community found a high level of compliance with the gene technology legislation.
16
CHAPTER 3 OPERATIONAL PERFORMANCE
As an introduction to operational activities, the first part of this chapter outlines the types
of dealings with genetically modified organisms (GMOs) that are defined by the Gene
Technology Act 2000, the Gene Technology Regulations 2001 and corresponding state and
territory laws.
It also provides a summary of classes of dealings, the process for authorisations and the statutory time frame for consideration of
each type of application and other statutory functions (such as certification and accreditation) that help the Regulator to manage
risks to health and safety of people and the environment. The second part of the chapter describes operational performance.
GMOS, DEALINGS AND AUTHORISATIONS
The Gene Technology Act 2000 defines a GMO as any organism that has been modified by gene technology, offspring derived
from such an organism, or anything declared as a GMO in the Regulations.
Section 10 of the Gene Technology Act defines ‘deal with’, in relation to a GMO, as:
(a) conduct experiments with the GMO
(b) make, develop or manufacture the GMO
(c) breed the GMO
(d) propagate the GMO
(e) use the GMO in the course of manufacture of a thing that is not the GMO
(f) grow, raise or culture the GMO
(g) import the GMO
(h) transport the GMO
(i) dispose of the GMO
and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of
paragraphs (a) to (i).
The Gene Technology Act forms the basis of a prohibitory scheme that makes dealing with a GMO a criminal offence unless, as
outlined in section 31, the dealing is:
●
an exempt dealing
●
a notifiable low risk dealing (NLRD)
●
authorised by a licence
●
included on the GMO Register
●
specified in an emergency dealing 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 involving routine laboratory techniques have been used safely for many years and represent minimal risk when performed in
accordance with the requirements of the Regulations.
Dealings authorised by a licence are further categorised into dealings not involving intentional release into the environment (DNIRs,
which are conducted in contained facilities), dealings involving intentional release into the environment (DIRs) and inadvertent
dealings.
For both DNIRs and DIRs the legislation requires the Regulator to prepare a risk assessment and risk management plan (RARMP)
as part of the process of making a decision on whether to issue or refuse a licence (sections 47 and 50 of the Gene Technology Act
2000 respectively). Part 5 of the Gene Technology Act also allows the Regulator to grant a temporary licence (no longer than 12
months) to a person who finds they are inadvertently dealing with an unlicensed GMO so that they can dispose of the GMO.
To be included on the GMO Register, the dealings with the GMO must first have been licensed by the Regulator and the Regulator
must be satisfied that there are minimal risks and that it is no longer necessary for people undertaking the dealings to be covered
by a licence.
The EDD provision in part 5A of the Gene Technology Act gives the Minister the power to expedite an approval of dealings with a
GMO in an emergency.
Table 3 provides a summary of the classes of dealings, outlining the authorisation requirements and the extent of management
conditions (such as containment in certified facilities).
17
The licensing system is centred on a rigorous process of risk assessment based on scientific evidence. For DIRs, the legislation
requires consultation with a wide range of experts, agencies and authorities, as well as the public. These include the Gene
Technology Technical Advisory Committee (GTTAC), state and territory governments, Australian Government agencies prescribed
in the Regulations, the Environment Minister, and relevant local councils.
The Regulator may, directly or on application, vary an issued licence or other instrument. Variations involve changes to conditions
applied to a licence or other instrument. The Regulator must not vary the licence unless satisfied that any risks posed by the
dealings proposed to be authorised by the licence as varied are able to be managed in such a way as to protect the health and
safety of people and the environment. The Regulator cannot vary a DNIR licence to authorise intentional release of a GMO into the
environment.
More information on the various classes of GMO dealings and their assessment process is in appendix 2 .4
An organisation undertaking dealings with GMOs authorised under a licence is required to be accredited by the Regulator.
Accreditation of organisations and certification of individual physical containment facilities helps to manage risks that may be
associated in dealings with GMOs (see also appendix 2).
Table 3: Classes of GMO dealings under the Gene Technology Act 2000
CATEGORY
LICENCE
CONTAINMENT
REQUIRED
DIR (except for
limited and controlled
releases)
Yes
Applications must be reviewed by IBC
Consultation on application
RARMP must be prepared
Consultation on RARMP and licence decision
by the Regulator
Containment measures may be required,
determined on a case-by-case basis, and
other licence conditions will apply
DIR (limited and
controlled)
Yes
Applications must be reviewed by IBC
RARMP must be prepared
Consultation on RARMP and licence decision
by the Regulator
Containment measures will be required
based on size/scope of release sought by
applicant and other licence conditions will
apply
DNIR
Yes
Applications must be assessed by IBC
RARMP must be prepared
Licence decision by the Regulator
Yes, PC2 (or higher) certified facilities
(usually)
EDD
No
Determination by Minister, subject to advice
of threat and utility of GMO from competent
authorities and risk assessment advice from
Regulator
Containment measures may be included in
EDD conditions
Exempt
No
Dealings classified as exempt are scheduled
in the Regulations
No intentional release to the environment
GMO Register
No, but must have been previously licensed,
and relevant information is reviewed by the
Regulator
Containment measures may be required
Inadvertent dealing
Yes
Licence decision by the Regulator only for
the purposes of disposal of the GMO
Containment and/or disposal measures will
apply
NLRD
No
Dealings are scheduled in Regulations
Conduct of NLRDs requires prior assessment
by IBC to confirm proper classification
Notified in annual report
Yes, PC1 or PC2 certified facilities (usually)
4
A complete listing of DNIR and DIR licence applications and approvals and NLRDs is at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gmorec-index-1>.
18
Notes: DIR = dealing involving intentional release of a GMO into the environment; DNIR = contained dealing with a GMO not involving intentional
release of the GMO into the environment; EDD = Emergency Dealing Determination; GMO = genetically modified organism; IBC = Institutional
Biosafety Committee; NLRD = notifiable low risk dealing; PC1(2) = physical containment level 1(2); RARMP = risk assessment and risk
management plan.
TIME FRAMES
Under section 43(3) of the Gene Technology Act, the Regulator must issue or refuse to issue a licence within a time limit prescribed
by the Regulations. Similarly, the Regulations prescribe a time frame for consideration of applications to accredit organisations and
to certify facilities. These statutory time frames are shown in table 4. They do not include weekends or public holidays in the
Australian Capital Territory or periods when the Regulator has sought more information from the applicant, including information to
resolve a confidential commercial information (CCI) claim, and cannot proceed with the decision-making process until that
information is provided. In these instances the statutory time frame clock is regarded as stopped (clock stop).
Table 4: Prescribed time frames
CATEGORY
TIME FRAME
Accreditation
90 working days (regulation 16)
Certification
90 working days (regulation 14)
DIR – limited and controlled, no significant risk
150 working days (regulation 8)
DIR – limited and controlled, significant risk
170 working days (regulation 8)
DIR (except for limited and controlled releases)
255 working days (regulation 8)
DNIR
90 working days (regulation 8)
Licence variation
90 working days (regulation 11A)
Notes: DIR = dealing involving intentional release of a GMO into the environment; DNIR = contained dealing with a GMO not involving intentional
release of the GMO into the environment.
OPERATIONAL PERFORMANCE
The second part of this chapter describes the Regulator’s achievements against Program 1.4 of Population Health, of the
Department of Health and Ageing 2013–14 Portfolio Budget Statements (PBS). It provides details of achievements on deliverables
and performance indicators in the key areas of:
●
assessments and approvals/authorisations under the Gene Technology Act 2000
●
monitoring of GMOs
●
compliance with the Gene Technology Act 2000
●
consultation with stakeholders
●
cooperation with relevant regulatory agencies
●
OGTR operational changes arising from the2013 all government response to the 2011 review of Gene Technology Act
2000.
ASSESSMENTS AND APPROVALS
Information on performance against deliverables and key performance indicators, as set out in the Department’s 2013–14 PBS, is
summarised in table 2.
In 2013–14 the OGTR received 472 applications and notifications as defined under the Gene Technology Act 2000 (table 5). Yearto-year fluctuations in the timing and volume of applications can be influenced by a range of factors, including research grant
funding cycles and seasonal agricultural factors, as well as changes to legislation.
LICENCES FOR DEALINGS INVOLVING INTENTIONAL RELEASE
DIR licence applications have a statutory time limit of up to 255 working days for making a decision, unless the application is for a
limited and controlled release. The statutory time limit for decisions on limited and controlled release applications is 150 working
days, or 170 working days if the proposed dealings may pose a significant risk to the health and safety of people or to the
environment.
19
During 2013–14 the Regulator issued seven DIR licences (table 6) and at 30 June 2014 was considering a further four licence
applications. Five of the DIR licences issued related to applications that were received before 1 July 2013. All licence decisions
were made within statutory time frames (table 2).
Five of the DIR licences issued in 2013–14 were for limited and controlled release (e.g. field trials or clinical trials) and two were for
commercial releases. While the majority of DIR applications related to crop plants with introduced traits intended to provide benefits
to agricultural production, two licences were issued for field trials of genetically modified (GM) plants, modified for altered oil
profiles, one of which was for nutritional enhancement and the other for industrial uses. One licence was issued for clinical testing
of a vaccine against cholera. Details of the trait categories are provided in table 6.
Of the seven DIR licences issued in 2013–14, five were issued to private companies, one to a government agency (CSIRO) and
one to a state agency (Victorian Department of Environment and Primary Industries). Of the 106 DIR licences issued since
commencement of the Gene Technology Act 2000, 56 (53 per cent) have been to private companies, 39 (37 per cent) to
government agencies and 11 (10 per cent) to universities (figure 2).
On 12 July 2013, a milestone was reached with the issuing of the 100th licence for dealings involving intentional release (DIR) of a
GMO. The Gene Technology Regulator approved DIR 120, an application for a field trial of a new type of cotton that has been
genetically modified for insect resistance and herbicide tolerance.
Table 5: Applications and notifications, 2013–14
Application type
Accreditation
CCI declaration for DIR
licence
CCI declaration for DNIR
licence
CCI declaration for NLRD
notification
CCI declaration for other
information
Certification
DIR licence
DNIR licence
Lifting suspension of
certification
NLRD notification
Surrender of accreditation
Surrender of certification
Surrender of DIR licence
Surrender of DNIR licence
Suspension of certification
Transfer of certification
Transfer of DNIR licence
Variation of accreditation
Variation of certification
Variation of DIR licence
Variation of DNIR licence
Total
ReceivedA
Withdrawn
ApprovedB
Ceased
considerationC
Refused
Under
considerationD
4
0
4
0
0
2
10
1
15
0
0
3
2
0
0
0
0
5
2
2
0
0
0
0
1
0
1
0
0
0
176
6
13
4
0
4
183
7
10
0
0
0
0
0
0
28
4
5
26
0
24
0
0
2
828
3
101
1
13
74
28
3
0
319
14
69
1693
n/a
0
5
0
1
1
0
1
1
5
3
4
32
n/a
5
94
1
12
71
27
4
0
338
21
71
888
n/a
0
0
0
0
0
0
0
0
0
1
0
1
n/a
0
0
0
0
0
0
0
0
0
0
0
0
n/a
0
34
1
2
2
1
0
0
41
2
14
146
Notes: CCI = confidential commercial information; DIR = dealing involving intentional release of a GMO into the environment; DNIR = contained dealing with a GMO not
involving intentional release of the GMO into the environment; NLRD = notifiable low risk dealing.
A
Includes variations initiated by the Regulator to four DIR licences and one certification.
B
Some applications reported as approved in this financial year were received in the previous financial year. Approved refers to issuing of a new or varied licence or other
instrument, consent to surrender of an instrument or to a declaration in relation to a CCI application.
C
Includes both ‘ceased consideration’ and ‘not considered’ under section 42 of the Gene Technology Act 2000.
D
Under consideration at 30 June 2014.
20
Table 6: DIR licences issued, 2013–14
DIR No.
Applicant
Parent
organism
Introduced trait
Type of
release
Received
Issued
DIR 118
Monsanto
Australia Limited
Cotton
(Gossypium
barbadense L.)
Herbicide
tolerance
Commercial
21-8-2012
16-8-2013
DIR 120
Monsanto
Australia Limited
Cotton
(Gossypium
hirsutum L.)
Insect resistance;
herbicide
tolerance
Limited and
controlled
7-12-2012
12-7-2013
DIR 121
CSIRO
Safflower
(Carthamus
tinctorius L.)
Altered oil profile
Limited and
controlled
21-12-2012
22-7-2013
DIR 122
Victorian
Government
Department of
Environment and
Primary Industries
Wheat (Triticum
aestivum L.)
Abiotic stress
tolerance; yield
Limited and
controlled
2-4-1013
31-10-2013
Limited and
controlled
18-4-2013
13-11-2013
Commercial
1-8-2013
19-6-2014
Limited and
controlled
3-9-2013
10-4-2014
DIR 123
Nuseed Pty Ltd
Canola (Brassica
napus L.)
DIR 124
Monsanto
Australia Limited
Cotton
(Gossypium
hirsutum L.)
PaxVax Aus Pty Ltd
Cholera
bacterium (Vibrio
cholera)
DIR 126
Composition—
food (human
nutrition);
composition—
animal nutrition;
selectable marker
Herbicide
tolerance; insect
resistance;
selectable
markers—
herbicide and
antibiotic;
reporter gene
expression
Vaccine attenuation,
Selectable marker
– mercury
resistance
21
Figure 2: DIR licences issued by organisation type since commencement of the Gene Technology Act 2000 (%)
0.6
0.5
0.4
0.3
0.2
0.1
0
53%
37%
10%
Company
Government
University
LICENCES FOR DEALINGS NOT INVOLVING INTENTIONAL RELEASE OF GMOS
DNIR licences authorise dealings with GMOs that are conducted in laboratories and other physical containment facilities and which
may pose risks that require management through the imposition of specific licence conditions. For DNIR licence applications, the
Regulator must make a decision within the statutory time frame of 90 working days.
In 2013–14, the Regulator issued 10 DNIR licences (see table 7). One of these licences (DNIR-532) incorporates two DNIR
applications issued as one licence. All approvals were made within the statutory time limit of 90 working days. The Regulator was
considering a further five DNIR applications at 30 June 2014. The types of GMO dealings authorised by DNIR licences issued in
2013–14 are research applications, the focus of which is shown in figure 3.
Table 7: DNIR licences issued, 2013–14
DNIR No.
Applicant
Title
Received
Issued
DNIR-524
Macfarlane Burnet
Institute for Medical
Research and Public
Health
Bat retroviruses
3-12-2012
22-10-2013
DNIR-532
University of New
South Wales
HCV founder virus
evolution: evolution and
vaccine targets
25-2-2013
4-7-2013
DNIR-535
Griffith University
Investigation of malaria
parasite proteins
29-4-2013
26-8-2013
DNIR-536
Ascend
Biopharmaceuticals Ltd
28-6-2013
29-10-2013
DNIR-537
CSIRO
Clinical study of the
efficacy and safety of
intra-tumoural injection
of ASN-002 in nodular
basal cell carcinoma
The molecular basis of
the pathogenicity of
Newcastle disease in
chickens
2-7-2013
2-12-2013
22
DNIR No.
Applicant
Title
Received
Issued
DNIR-539
Queensland University
of Technology
Development and use of
a banana streak virusbased virus vector to
investigate bananaFusarium interactions
Mouse model for studies
of B cells migration into
the eye
28-8-2013
6-1-2014
DNIR-540
Flinders University
26-8-2013
17-12-2013
DNIR-542
CSIRO
The molecular
determinants of
pathogenicity, tissue
tropism and
transmissibility of
influenza A virus.
HIV Biology of Latency
and Assembly
26-9-2013
30-1-2014
DNIR-543
University of New
South Wales
16-10-2013
21-2-2014
DNIR-546
Macquarie University
Investigation of the role
of glia in the control of
blood pressure
20-1-2014
28-5-2014
Figure 3: Research focus of DNIRs approved, 2013–14
Four DNIR licences were issued for the study of human pathogens and one DNIR licence authorised human clinical studies. Two
DNIR licences authorised dealings with viral vectors for research into human diseases. Two DNIR licences were issued for the
study of animal pathogens and one DNIR licence authorised the study of plant pathogens. Four DNIR applications were withdrawn
during the reporting period as the OGTR advised the applicant that the proposed dealings should be assessed as NLRDs. The
submission of these applications for the more highly scrutinised DNIR classification reflects the cautious approach of researchers
and accredited organisations.
Six of the 10 DNIR licences issued in 2013–14 were issued to publicly funded universities. One licence was issued to a private
company, one was issued a research institute and two were issued to a government agency (CSIRO) (figure 4).
23
Since the commencement of the scheme, 416 DNIR licences have been issued by the Regulator. As of June 2014, the majority of
DNIR licences issued by the Regulator have been to universities (figure 5).
Figure 4: Types of organisations that were issued DNIR licences in 2013–14
Figure 5: DNIR licences issued since commencement of the Gene Technology Act 2000
NOTIFIABLE LOW RISK DEALINGS
NLRDs are types of dealings that have been assessed, based on previous experience and current scientific knowledge, as posing
low risk. Dealings with GMOs classified as NLRDs are listed in the Regulations under Schedule 3, Part 1 (NLRDs appropriate for
PC1 facilities) and Schedule 3, Part 2 (NLRDs appropriate for PC2 (Part 2.1) and PC3 (Part 2.2) facilities). Conduct of NLRDs does
not require prior authorisation from the Regulator, but the dealings must have been assessed by an institutional biosecurity
24
committee (IBC) as meeting the NLRD classification, must be conducted in appropriate containment facilities and must comply with
other requirements specified in the Regulations. NLRDs must be notified to the Regulator annually. There is a five-year time limit
on the authority to conduct an NLRD.
The Regulator received 828 NLRD notifications during 2013–14. As in past years, notified NLRDs were predominantly for research
work. The types of organisations that notified NLRDs to the Regulator in 2013–14 is shown in figure 6.
Figure 6: Types of organisations that notified NLRDs in 2013–14
DEALINGS PLACED ON THE GMO REGISTER
The GMO Register is a list of dealings with GMOs that the Regulator is satisfied pose minimal risk to human health and safety and
the environment and can therefore be undertaken by anyone, subject to any specified conditions, without oversight of a licence
holder. Sections 78 and 79 of the Gene Technology Act 2000 allow the Regulator to place dealings with GMOs on the GMO
Register provided they have previously been licensed, pose minimal risks to people or the environment and are safe for anyone to
use without the need for a licence. Such determinations are disallowable legislative instruments and must be tabled in Parliament.
During 2013–14 the Regulator entered no new listings on the GMO Register, received no applications to place any dealings on the
GMO Register and had no applications under consideration.
EMERGENCY DEALING DETERMINATION
An EDD is a legislative instrument made by the Minister under section 72 of the Gene Technology Act 2000 to expedite approval of
dealings with a GMO in an emergency. The Regulator provides risk assessment and management advice to the Minister and
administers the EDD, including monitoring for compliance with any EDD conditions.
Further information about the process for making EDDs and EDDs issued under the Gene Technology Act is provided in appendix
2. Before making an EDD, the Minister must be satisfied that:
1.
there is an actual or imminent threat to the health and safety of people or the environment
2.
the dealings proposed to be specified in the EDD would, or would be likely to, adequately address the threat
3.
any risks posed by the dealings proposed to be specified in the EDD can be managed in such a way as to protect the
health and safety of people and the environment.
In relation to (1) the threat and (2) addressing the threat, the Minister must have received advice from the Commonwealth Chief
Medical Officer, the Commonwealth Chief Veterinary Officer or the Commonwealth Chief Plant Protection Officer. In relation to (3)
management of risks, the Minister must have received advice from the Regulator. The states and territories must also have been
consulted. EDDs can only be made to have effect for up to six months but may be extended by the Minister for additional periods of
up to six months at a time, subject to similar requirements as outlined above for making the EDD.
Under the Gene Technology Act, the Regulator has powers to monitor compliance with the conditions of the EDD.
25
During 2013–14 the Regulator did not receive any requests for advice in relation to making any EDDs, no EDDs were made and
none were in effect.
To date, one EDD has been issued for the temporary authorisation of equine influenza vaccine. This was issued in September
2007, was extended once, and expired in September 2008.
ACCREDITED ORGANISATIONS
The Regulator requires organisations licensed to conduct work with GMOs to remain accredited. To achieve and retain
accreditation, the organisation must satisfy the Regulator that it has, or has access to, a properly constituted and resourced IBC
and complies with other requirements of the Regulator’s Guidelines for Accreditation of Organisations. For accreditation
applications the Regulator must make a decision within the statutory time frame of 90 working days.
At 30 June 2014, 162 organisations were accredited. There has been no significant change in the profile of the types of
organisations accredited by the Regulator. Figure 7 shows a high proportion (69 per cent) of accredited organisations are primarily
publicly funded. Figure 8 shows that accredited organisations are located in all Australian jurisdictions, as well as one based in the
United States of America.
Figure 7: Organisations accredited at 30 June 2014 by type of organisation
26
Figure 8: Organisations accredited at 30 June 2014 by location of headquarters
CERTIFIED PHYSICAL CONTAINMENT FACILITIES
For applications for certification of physical containment (PC) facilities in accordance with the Regulator’s Certification Guidelines,
the Regulator must make a decision within the statutory time frame of 90 working days.
PC facilities are classified according to levels of stringency of measures for containing GMOs. The classifications relate to the
structural integrity of buildings and equipment used as well as to the handling practices employed by those working in the facility.
PC level 1 (PC1) facilities are used to contain organisms posing the lowest risk to human health and the environment. PC level 4
(PC4) facilities provide the most secure and stringent containment conditions. The number of facilities certified as at 30 June 2014
is listed in table 8 by facility type and containment level.
During 2013–14, 183 certifications for PC facilities were issued (table 5).
OGTR-certified PC facilities are located in all Australian jurisdictions (figure 9).
Table 8: Number of facilities certified at 30 June 2014 by physical containment level and type
Facility type
PC2
PC3
Animal
244
4
Aquatic
28
Constant temperature room
49
Facility
PC1
266
Invertebrate
Laboratory
Large grazing animal
4
42
3
1142
28
47
Large scale
20
Plant
Total
PC4
172
313
1697
35
4
Note: This table excludes facilities for which the certifications were suspended (at the request of the certification holders) as at 30 June 2014.
27
Figure 9: Physical containment facilities certified at 30 June 2014 by location
Applications for certification of PC facilities in 2013–14 reflected the proportions of types of organisations involved in contained
dealings (NLRDs and DNIRs). Private companies submitted only approximately 9 per cent of the applications for certification in the
reporting year, compared with 12 per cent from government agencies, 3 per cent from health services/hospitals, 26 per cent from
research institutes and 50 per cent from universities.
TREND DATA FOR APPROVAL OF MAIN TYPES OF APPLICATIONS
Table 9: Trend data for approval of main types of applications, 2009–10 to 2013–14
Financial year
"approved"
Accredited
Certified
DIR
DNIR
NLRD
2009–10
2010–11
2011–12
2012–13
2013–14
8
182
8
18
629
7
171
6
14
553
5
207
6
11
553
8
199
4
10
677
4
183
7
10*
828
* This includes issuing of one DNIR licence that incorporated two DNIR applications.
Applications can be made to the Regulator under section 184 of the Gene Technology Act 2000 for specified information that has
not previously been made public to be declared CCI. The extent of CCI claims can be the subject of considerable discussion with
the applicant and may require the OGTR to independently verify what information is already in the public domain. The Gene
Technology Act does not assign a statutory time frame within which the Regulator must make a decision on CCI applications, and
the evaluation of a licence application may be paused if significant CCI claims need to be resolved. In 2013–14 the Regulator made
16 CCI declarations; decisions on eight CCI applications were pending at 30 June 2014.
Surrender of licences and certifications usually occurs when dealings have concluded. Before surrender is approved, the Regulator
must be satisfied that all conditions (such as post-harvest monitoring) have been met and that any required cleaning and/or
decommissioning of facilities has taken place. The OGTR received 118 surrender requests in 2013–14 and approved 112. The
approvals included 94 for surrender of certifications of facilities, 12 to surrender DNIR licences, five to surrender accreditations and
one to surrender a DIR licence.
The Regulator may initiate variations to instruments issued under the Gene Technology Act 2000 (licence, certification or
accreditation), and instrument holders may also apply to the Regulator for variations. Variations to licences range from minor
administrative changes (such as a change to contact details) to significant changes to dealings (such as a request to grow the GM
crop at an additional or new site). Variations may also include evaluation of changes arising from renovations to a certified facility or
new methods to handle GMOs.
28
The OGTR approved 430 variations in 2013-14.
MONITORING OF GENETICALLY MODIFIED ORGANISMS
This section provides information on the range of inspection activities the OGTR conducted during 2013–14. The Regulator’s
quarterly reports5 provide detailed information about the inspections.
Inspections of DIR licences
The OGTR strategy for conducting field-trial monitoring draws on accumulated operational experience of compliance risk profiling. 6
During 2013–14, 18 accredited organisations held the 55 DIR licences in force. Eight licences were for commercial release of
GMOs (seven for crops, one for a vaccine). None of these licences imposed conditions that necessitate monitoring. Of those
licences for limited and controlled release of a GMO, four were for vaccine trials, and 43 were for limited and controlled trials of GM
crop varieties. The OGTR inspected 15 of the 43 licences for limited and controlled trials of GM crop varieties. Each licence may
contain a number of trial sites. One inspection of a limited and controlled vaccine trial was undertaken.
Outcome of inspection activities
The OGTR’s operational objective is to monitor at least 20 per cent of all limited and controlled field-trial locations annually. A
further target within this operational benchmark is to inspect a minimum of 5 per cent of all limited and controlled field trial sites
during each quarter of the year. In 2013–14 the OGTR exceeded its operational benchmark and exceeded its quarterly objective.
At the beginning of 2013–14, 94 licensed field trial sites were operating, 25 of which were current and 69 of which were subject to
post-harvest monitoring conditions. The OGTR inspected 38 sites in 2013–14 (19 current and 20 post-harvest monitoring sites)
representing 40 per cent of total sites as of 1 July 2013, thereby exceeding the minimum target of 20 per cent of field trial sites
each year (table 2). A breakdown of the number and proportion of inspections is in table 10.
Table 10: Number and proportion of inspections performed in each quarter of 2013–14
Quarter
July–September
2013
October–
December 2013
January–March
2014
April–June 2014
Number and
proportion of current
sites inspected
Number and
proportion of PHM
sites inspected
3/25 (12%)
4/69 (6%)
3/31 (10%)
4/62 (6%)
5/49 (10%)
8/37 (21%)
7/61 (11%)
5/72 (7%)
GM crop field trial types
The DIR licences in force authorised the limited and controlled release of a range of crop and plant types including banana, barley,
canola, cotton, Indian mustard, maize, perennial ryegrass/tall fescue, safflower, sugarcane, wheat and white clover. Although
licences were in force, planting has not occurred in all cases. Canola was the most prevalent crop, collectively trialled at 31 sites.
The OGTR inspected 38 field-trial sites across seven crop types during 2013–14 (table 11).
5
6
Available from OGTR, or at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1>.
Find more detail from the Monitoring Protocol at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/mc-protocols-1>.
29
Table 11: Number of licensed DIR sites by crop type/parent organism at beginning and end of 2013–14 and number of inspections
conducted in 2013–14
Crop type / parent organism
Banana
Barley
Barley, wheat
Canola
Canola, Indian mustarda
Cotton
Maize
Perennial ryegrass
Perennial ryegrass, tall fescuea
Safflower
Sugarcane
Wheat
White clover
Total
Number of
DIR trial sites
at beginning
of 2013–14
Number of DIR trial sites at
end of 2013–14
Number of DIR trial
sites inspected in
2013–14
5
3
8
31
2
25
1
0
1
0
11
5
2
94
4
4
4
39
2
11
0
1
0
2
14
7
2
90
5
1
3
10
0
6
0
0
0
1
7
5
0
38
Notes: Some DIR licences authorise trials with two similar crop species. In this table, trial sites authorised under such licences are listed separately to
those relating to licences authorising single crop species.
Cycle and status of field trial sites
During each year the status of field trials of GM crops undergoes significant changes. New trials are planted and become subject to
licence conditions to manage dissemination of the GMO from the trial site. Other trials are harvested and enter a post-harvest
monitoring period. Monitoring of the trial site continues until the OGTR is satisfied that no further inspections are required to
manage persistence of the GMOs. The OGTR then signs off the site as having completed all necessary licence obligations.
Figure 11: Total number of field trial sites and their status throughout 2013–14*
Note: PHM = post-harvest monitoring.*
As a result of the issuing of the licence for DIR 124 for the commercial release of Bollgard®III and Bollgard®III x Roundup Ready
Flex® cotton, all DIR 101 field trial sites still subject to monitoring obligations were released from those obligations (i.e. ‘signed off’)
in late June 2014.
30
Location by jurisdiction
In 2013–14 the OGTR conducted inspections of field trial sites in all states and territories where field trials were undertaken (table
12).
Table 12: Number of field trial sites and OGTR inspections in 2013–14 by state and territory
Jurisdiction
Number of DIR trial sites at 1
July 2013
Australian Capital Territory
Number of field trial site
inspections in 2013–14
6
8
New South Wales
25
8
Northern Territory
2
2
21
12
South Australia
4
2
Tasmania
0
0
Victoria
19
4
Western Australia
17
2
Total
94
38
Queensland
Inspections of contained dealings
The monitoring program also encompasses dealings conducted in certified contained facilities under DNIR licences and NLRDs. As
part of these activities, a minimum of 20 per cent of higher-level PC facilities (PC4, PC3 and PC2 large-scale) are monitored
annually.
As well as examining the integrity of the physical structure of the facility, inspections cover the general work practices employed in
handling GMOs.
At 30 June 2014,162 accredited organisations held 2144 certification instruments for containment facilities. During 2013–14,
certified facilities operated by 21 accredited organisations were monitored. For the purposes of monitoring, certified facilities are
grouped into higher and lower containment types. PC4, PC3 and PC2 large-scale laboratories are categorised as higher-level
containment facilities and the remaining facility types are categorised as lower-level containment facilities. The OGTR conducted
51 inspections across the range of facility types (table 13). Of the 56 higher-level containment facilities that had certification
instruments in force at the beginning of 2013–14, 14 were inspected. This figure represented 25 per cent of higher-level
containment facilities and exceeded the minimum target of inspecting 20 per cent of such facilities each year (table 2).
In addition, 20 DNIR licences in force during 2013–14 were monitored.
Table 13: Number of inspections of certified facilities (by type) conducted during 2013–14
Containment type
Physical containment level and
facility type
Lower-level containment
facilities
PC2 Animal
Higher-level containment
facilities
Total
Number of
inspections
7
PC2 Invertebrate
PC2 Laboratory
PC2 Plant
PC2 Large scale
2
23
5
1
PC3 Animal
PC3 Laboratory
PC4 Facility
4
7
2
51
31
Inspections by state
Certified facilities are located in all Australian states and territories (figure 9). In 2013–14, monitoring activities were carried out in
each state and territory except the Australian Capital Territory and Tasmania (figure 12). The number of OGTR inspections of
facilities reflects, as far as practicable, the number of facilities in each state and territory.
Figure 12: Number of certified facility inspections in 2013–14 by state and territory
Inspections by organisation type
Of the five OGTR categories of applicant organisations, universities held the greatest number of certifications during 2013–14
(figure 13). The number of OGTR inspections of facilities in each organisation category reflects, as far as practicable, the number of
facilities present in each category (figure 14).
Figure 13: Distribution of certified facilities at 30 June 2014 by organisation type
Figure 14: Number of certified facility inspections in 2013–14 by organisation type
32
COMPLIANCE WITH THE GENE TECHNOLOGY ACT 2000
During 2013–14, the regulated community demonstrated a high level of compliance with gene technology legislation (table 2).
In conducting routine inspections, the OGTR found some inconsistencies between an event or state of affairs and the requirements
imposed by licence or certification conditions. Such inconsistencies are referred to here as non-compliances. Non-compliance is
not regarded as a breach of the Gene Technology Act 2000 unless, after investigation, it is proven to be so. Each incident of noncompliance was assessed according to established OGTR protocols and found to present negligible risk to human health and
safety or to the environment.7
The Regulator’s response to all non-compliance incidents is informed by the OGTR’s Non-Compliance Protocol, to ensure
consistent responses proportional to the risks posed to human health and safety or to the environment.8
This section provides a summary of the types of non-compliances found and the relevant actions implemented. The results and
findings of all OGTR inspections are reviewed and used to inform future monitoring activities and to continue improving accredited
organisations’ compliance with the Gene Technology Act 2000.
Non-compliances
During 2013–14, OGTR monitoring of DIR licences found two instances of non-compliance where flowering volunteers were
identified on post-harvest monitoring trial sites.
One instance of non-compliance was identified through monitoring of DNIR licences in 2013–14 where the licence holder had not
obtained signed statements from staff undertaking licenced dealings.
A number of minor non-compliances were also identified during routine monitoring of containment facilities (table 14). Noncompliances included issues such as lapsed/failure of equipment, structural defects and issues with work practices.
Table 14: Number of non-compliances identified in certified facilities during 2013–14 by non-compliance type
Nature of non-compliance
Equipment
Structure
Personal protective equipment
Transport
Waste disposal
Work practices
Number of non-compliances
5
3
0
0
0
1
In all instances the Regulator determined that findings of non-compliance presented negligible risk to human health and safety or to
the environment, were minor in nature, involved negligible or zero culpability and were resolved by reminders, education and/or
cooperative compliance.
7
8
These incidents are discussed in the Regulator’s quarterly reports, available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1>.
The protocol is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/mc-protocols-1>.
33
Compliance and investigations
The OGTR recognises that both compliance and enforcement mechanisms are necessary to provide an effective and flexible
regulatory system that enables the most appropriate response to a given issue or incident. The OGTR Compliance and
Investigation Section assess and manage contraventions of the Gene Technology Act 2000 through:
●
a program of practice reviews and audits, which apply investigation practices and performance audit techniques to identify
and prevent contraventions of legislation through cooperative capacity building of regulated stakeholders’ compliance
management arrangements
●
assessment of regulated-party annual reports and other information collected under the regulatory system
●
third-party reporting, including a high degree of cooperative self-reporting of compliance issues by regulated parties
●
feedback on continual improvement of OGTR regulatory specifications and arrangements
●
conducting investigations, which can draw on monitoring and any of the above compliance management activities.
The OGTR investigates all reported or detected contraventions of legislation it administers, in accordance with the OGTR
Compliance and Enforcement Policy.9 Investigations are initiated through a preliminary assessment of relevant facts and likely
impacts to decide on the likelihood that a contravention has occurred or is about to occur, its seriousness and its likely
consequences. Based on the outcome of this initial assessment and the relevant legislative provisions, the OGTR determines the
appropriate level, if any, of further investigation and response.
No investigations were required in the reporting period. The OGTR completed four audits (the Australian National University,
Austin Health, Murdoch University, and the University of Queensland) in 2013–14. It has also progressed four additional audits
and five practice reviews in 2013–14. Audits involve a comprehensive examination of an accredited organisation’s compliance
management arrangements. Practice reviews apply single compliance risk themes from audits to a number of review
participants to identify and resolve compliance management risks. The review themes assessed in 2013–14 were partnerships;
transport, storage and disposal; facilities and equipment notices, notifications and records; and people management. When
completed, these activities are reported in the Regulator’s quarterly reports to the Parliament of Australia.
National strategy for unintended presence of unapproved GMOs
In 2005 the Australian Government Biotechnology Ministerial Council endorsed a risk-based national strategy to manage the
unintended presence of unapproved GMOs in imported seeds for sowing. The strategy was developed by an interdepartmental
working group chaired by the then Biotechnology Australia and comprising the Department of Agriculture, Fisheries and Forestry10;
the Department of the Environment and Heritage;11 the Department of Foreign Affairs and Trade; the Department of Education,
Science and Training;12 the Department of Industry, Tourism and Resources;13 the Department of Health and Ageing14; Food
Standards Australia New Zealand (FSANZ); and the OGTR.
The OGTR is responsible for implementing the strategy. The strategy has six components (table 15) and employs a risk
management approach, with resources dedicated to the areas posing the highest likelihood of unintended presence. The focus to
date has been on seeds for sowing, which has been assessed as the highest priority.
In recent years the OGTR has worked with the Australian Seed Federation (ASF) to develop a voluntary auditing and testing
program of existing industry quality assurance measures and has assessed the effectiveness of the first stage of reviews
completed in 2007. No issues of concern were identified for the five companies that participated in the quality assurance reviews.
In 2009–10 the OGTR began quality assurance reviews of Australian and state government and industry breeding programs. No
issues of concern were identified for the six companies that participated in the quality assurance reviews conducted since this time.
In 2013–14 the OGTR continued to work with the Australian seed industry including presenting at the ASF annual conference. The
OGTR also presented at a GM lucerne symposium hosted by Lucerne Australia.
In March 2014 the OGTR engaged SGA Solutions to assist in the development of an internal decision-making framework for the
management of potential low-level presence (LLP) incidents, The project required development of realistic LLP scenarios to test the
decision framework and hosting of a workshop with Australian Government agencies, including the Department of Agriculture,
9
10
11
12
13
14
The policy is available at <www.ogtr.gov.au> via the links to Monitoring and Compliance.
Now the Department of Agriculture
Now the Department of the Environment
Now the Department of Education
Department of Industry
Now the Department of Health
34
Department of Foreign Affairs and Trade, Department of Environment, and FSANZ, to test the scenarios and decision framework.
Table 15: Components of national strategy for unintended presence of unapproved GMOs
COMPONENT
DESCRIPTION
Risk profiling—
identifying seed
imports posing the
highest likelihood of
unintended presence
The OGTR has established a memorandum of understanding with the Department
of Agriculture to access data on imports. Data on imported seeds for sowing,
together with information on overseas commercial production of GMOs and input
from the Department of Environment and other relevant agencies, was used to
identify 12 priority crops.
Quality assurance and
identity preservation
Industry uses quality assurance and identity preservation systems for seed quality
purposes. The OGTR has developed a program for auditing and testing industry
quality assurance systems that industry has agreed and adopted.
Industry’s laboratory
testing
The voluntary code of conduct refers to testing programs. Industry needs to be able
to assure itself that it is managing the risk of importing unapproved seeds.
Approvals/advance
risk assessments for
Australia’s regulatory
agencies
The OGTR has prepared GMO incident response documents for 12 crops identified
through risk profiling as having the highest likelihood of unintended presence in
imports of seeds for sowing (canola, cotton, maize, potato, tomato, papaya,
soybean, squash, alfalfa, grasses, rice and wheat). These documents will provide a
basis for rapid risk assessment and management actions should an unintended
presence of an unapproved GMO be detected.
Post-market detection
The OGTR recognises the legislative limitations of preventing unintended imports
of unapproved GMOs and has worked cooperatively with industry to develop a
voluntary code. The code aims to isolate risks as early as possible in the
commercial seed supply chain. This is supported by the standard OGTR practice of
investigating information about potential and possible incidents.
Enforcement action
In the event of detection of unapproved GMOs, appropriate responses would be
determined on a case-by-case risk management basis. The OGTR continues
engagement with Australian Government agencies, relevant industry organisations
and states and territories on this issue.
CONSULTATION AND PROVISION OF ADVICE TO STAKEHOLDERS
The Regulator’s functions, as prescribed by section 27 of the Gene Technology Act 2000, include:
●
issuing technical and procedural guidelines in relation to GMOs
●
providing advice to the Legislative and Governance Forum on Gene Technology (LGFGT 15) about:
o
the operations of the Regulator and the GTTAC
o
the effectiveness of the legislative framework for regulating GMOs, including in relation to possible amendments
of the legislation
●
providing information and advice to other regulatory agencies about GMOs and GM products
●
providing information and advice to the public about regulating GMOs.
Security Sensitive Biological Agents Regulatory Scheme
The National Health Security Act 2007 implements a scheme for regulating security sensitive biological agents (SSBAs). The SSBA
Regulatory Scheme effects recommendations agreed by the Council of Australian Governments (COAG). The Office of Health
Protection in the Department has responsibility for administering the National Health Security Act 2007. Because of the similarities
between elements of gene technology regulation and the SSBA Regulatory Scheme, inspectors from the OGTR undertake
inspections under the scheme, in line with COAG recommendations.
The Gene Technology Regulations 2001 were amended (the Gene Technology Amendment Regulations 2009) in April 2009 to
allow inspectors from the existing Gene Technology Regulatory Scheme to monitor laboratories and facilities handling the SSBA for
compliance with the National Health Security Act 2007.
The amendment enables payment to the Regulator for SSBA monitoring activities from the SSBA Regulatory Scheme funds. The
OGTR has worked with the Office of Health Protection to develop operational monitoring requirements. Inspection activities
15
The Act refers to the Ministerial Council. As part of reforms by COAG, on 11 February 2011, the former Gene Technology Ministerial Council became the Legislative
and Governance Forum on Gene Technology.
35
commenced early in 2009–10 and have continued throughout 2013–14.
Revised guidelines
In 2013–14, the Regulator issued the following revised guidelines:
●
Guidelines for Certification of a Physical Containment Level 2 Large Grazing Animal Facility Version 1.1 (effective from 12
February 2014).
Advice to the Legislative Governance Forum on Gene Technology
The LGFGT initiated an independent review of the Gene Technology Act 2000 in June 2011 and invited public submissions. The
Regulator provided a submission to the review. The report of the 2011 Independent Review of the Gene Technology Act 2000 was
made publicly available in December 2011. It concluded that the national scheme is effective and efficient and the regulatory
burden and compliance costs appear justifiable compared with the benefits achieved. It made a number of recommendations aimed
at improving the operation of the scheme.The LGFGT finalised an all-governments response to the review and to its
recommendations in July 2013. In 2013–14, the OGTR implemented operational recommendations from the 2011 Review of the
Gene Technology Act 2000. This included a range of activities to improve communication and consultation with regulated
stakeholders and the public, including targeted use of social media for consultation on a DIR application (see section on advice to
public), updated fact sheets in plain English available on the OGTR website, feedback from key regulated organisations and
members of the client register via a survey to inform the review of the OGTR website (see section on OGTR website), and ongoing
participation in relevant international forums (see section on international regulatory liaison). The OGTR also collaborated with
colleagues in the Department in relation to progressing review recommendations related to legislative changes.
Advice on GMOs and GM products
During 2013–14, the OGTR provided advice on the regulation of GMOs and GM products to other regulatory agencies and to the
public.
Advice to other regulatory agencies
To facilitate reciprocal exchange of information with the other product regulatory agencies on assessment and approval of GMOs
and GM products required by their respective legislation,16 the OGTR has developed memoranda of understanding with FSANZ,
the Therapeutic Goods Administration (TGA), Australian Pesticides and Veterinary Medicines Authority (APVMA) and the
Australian Quarantine and Inspection Service (now Department of Agriculture Biosecurity). In 2013–14 the OGTR progressed
reviews of several of these memoranda. The OGTR also provided input to a proposed overarching memorandum of understanding
between the Department of Health and the Department of Agriculture. The OGTR also has a memorandum of understanding with
the Department of the Environment, in relation to consultation with the Environment Minister on DIR licence applications prescribed
under the Gene Technology Act 2000.
In line with recommendations from the 2006 Statutory Review of the Gene Technology Act 2000, a Regulators’ Forum has been
established to promote and facilitate information sharing between these regulatory agencies and the Regulator. The forum met
three times in 2013–14, discussing a work program for enhancing overall regulatory effectiveness through improved cross-agency
collaboration. The Regulatory Science Network is linked to the Regulators’ Forum and has met regularly, organising an InterAgency Workshop on Science Communication in which OGTR staff participated.
Advice to the public
The Gene Technology Act 2000 requires the Regulator to maintain a record of GMO and GM product dealings (the GMO Record).
The GMO Record includes details of licences issued, information about NLRDs, GMO dealings included on the GMO Register,
EDDs and information about GM products approved by other Australian regulatory authorities. The GMO Record was maintained
and updated throughout 2013–14 to incorporate approvals of GMOs under the Gene Technology Act and GM product approvals
notified to the Regulator by other agencies. The general public can access the GMO Record freely on the OGTR website
<ogtr.gov.au>.
In 2013–14, the OGTR received a number of emails and phone calls from members of the public as a result of misinterpretation of
technical information in various social media channels regarding the licence application DIR 126 for a GM cholera vaccine. The
OGTR took immediate action to update the website with additional non-technical information. As a result of the increased public
interest, the Regulator also tweeted calls for submission on the RARMP for DIR 126 using the Department of Health Twitter handle
every alternate week during the six-week consultation period to enhance wider circulation of information and consultation with a
broader cross section of the community.
16
The OGTR maintains the GMO Record, as a source of public information on such approvals, on its website at
<www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gmoregister-1>. The Gene Technology Consequential Amendments Act 2000 provides for product regulators
FSANZ, TGA, the National Industrial Chemicals Notification and Assessment Scheme and APVMA to seek advice from the Regulator on GM products.
36
OGTR website and contact points
The OGTR maintains a comprehensive website <www.ogtr.gov.au> that includes extensive information on the regulatory system
and decisions made by the Regulator. This information includes a number of fact sheets on relevant issues and copies of the full
RARMPs for each licensed release of a GMO into the environment. The OGTR completed review of several fact sheets on the
website to improve their readability and provide plain English information to stakeholders and the public, The updated versions of
factsheets are uploaded on the OGTR website. Other new information for the public in 2013–14 included a plain English summary
of the Risk Analysis Framework document, and an OGTR assessment and rebuttal of a journal article reporting adverse effects
from GM feed.
In March 2014, the OGTR engaged Reading Room Australia Pty Ltd to refresh the website design and content, and improve
functionality and user experience. During this project, a targeted survey of key stakeholders was conducted to receive feedback on
the current website content, clarity of language, navigation, function, style, usability etc. The OGTR received constructive feedback
in response to the survey which then informed the website review and will guide future redevelopment of the website. A refreshed
new look OGTR website is planned to be launched in 2014–15.
Website use statistics are provided in appendix 6.
The OGTR also has a 1800 free call number (1800 181 030) and an email address <ogtr@health.gov.au> that provide points of
contact for members of the public and other interested parties. Assistance with specific questions and additional mechanisms for
public feedback are among the services provided by these facilities.
The OGTR maintains a client register, which is a list of individuals and organisations that have registered their interest in regulation
of gene technology. Members receive notifications of new applications for GMOs and licences issued for release of GMOs into the
environment, significant changes to gene technology legislation, and invitations to comment on consultation RARMPs developed
for each application to release a GMO into the environment. Approximately 472 individuals and organisations are listed on the
OGTR client register. To be included on the OGTR client register and receive notifications, interested people should contact the
OGTR.
During 2013–14 the Regulator and the OGTR participated in a range of presentations and meetings on gene technology to inform
users, the Australian community and stakeholders about the regulatory system (appendix 7).
Comments about the website from stakeholders
On the whole, those interviewed said they were quite happy with the content on the website, that it was quite comprehensive, some
improvements to design and navigation would be helpful.
The length of pages were a specific complaint by a third of interviewees.
Certification guidelines were considered easy to understand and to implement, and many said that the OGTR guidelines are
aligned well with other standards that they also need to adhere to, such as the Australian Quarantine and Inspection Service, and
this led to a positive view of OGTR as a regulator.
The availability of audit information and checklists were praised as well, but participants requested more how-to information on
auditing and certifying a facility, and clearer information available on the website. A common theme around certification was around
the “interpretation” of the guidelines as there are grey areas that often need consultation with the OGTR to clear up, although
recent guidelines have become clearer.
Perception of OGTR responses was very high, with responses considered to be very quick, any delays being indicated upfront and
the information received being professional and helpful. The OGTR appeared to be quite open to discussion and proactive to work
with, which further helped the overall perception of the organisation as transparent and consultative.
INVESTIGATION OF COST RECOVERY FOR OGTR
The Department of Health is investigating the feasibility of cost recovery for OGTR services. Following on from an activity-based
costing study of OGTR in the previous reporting period, in 2013–14 the Department conducted an economic analysis of the gene
technology sector to inform policy considerations. The Department has been preparing a draft regulatory impact statement on
potential costing models for consultation with the regulated community and other stakeholders during 2014–15.
INTERNATIONAL REGULATORY LIAISON
Under section 27 of the Gene Technology Act 2000 the Regulator’s functions include:
●
monitoring international practice in relation to regulation of GMOs
●
maintaining links with international organisations that regulate GMOs in countries outside Australia
●
promoting harmonisation of risk assessments relating to GMOs and GM products by regulatory agencies.
Active participation in international forums enables Australia to inform and influence developments in GMO regulation, based on the
Australian experience, and helps ensure Australia’s regulatory scheme takes account of best international practice. The Regulator
and the OGTR have established a significant international presence. Feedback from meetings indicates that the Australian gene
37
technology regulatory system is highly regarded.
In 2013–14 the OGTR actively engaged in international forums focusing on harmonising the risk assessment and regulation of
GMOs. This included contributing to development of guidance documents by groups under the OECD and the United Nations
Cartagena Protocol on Biosafety. In the OECD, Australia is represented on the Working Group on the Harmonisation of Regulatory
Oversight in Biotechnology by Dr Peter Thygesen of the OGTR. The OGTR coordinated Australia’s input to current projects,
including the guidance document on low-level presence in seeds and commodities, the guidance document on environmental
considerations, and the sub-working group on microorganisms. The OGTR also represented Australia as the lead for consensus
biology documents on sugarcane, eucalyptus and cowpea. The sugarcane document was finalised in November 2013. In February
2014, the OGTR also represented Australia at an OECD workshop on risk assessment of crops developed using new plant
breeding technologies, and presented on working group activities on biotechnology to the 51st session of Joint Meeting of the
Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology.
As part of the OGTR’s engagement with the UN Cartagena Protocol on Biosafety, Dr Paul Keese participated in an open-ended
online forum on risk assessment and risk management and on the Ad Hoc Technical Expert Group on Risk Assessment and Risk
Management.
In August 2013, the Regulator signed a Memorandum of Understanding with the International Centre for Genetic Engineering and
Biotechnology for establishing collaborative activities on risk assessment and regulation of GMOs with a number of African GMO
regulators to promote harmonisation, monitor international practice and maintain links with international organisations that regulate
GMOs.
In November 2013 the OGTR took advantage of the presence of a number of representatives from international regulatory
agencies in Australia to hold a workshop in Canberra with four international speakers to discuss international regulatory challenges
in gene technology. The workshop was attended by staff from the OGTR and other Australian government agencies with an
interest in gene technology regulation.
The OGTR also participated in Australian Government and international discussions around strategies for preventing and
managing possible low-level presence of GM crops and attending an Food and Agriculture Organization of the United States’
meeting on LLP. The OGTR continued to liaise with other Australian Government agencies in responding to the detection of
unauthorised GM wheat in the USA. The OGTR interacted with key regulatory counterparts in other countries through bilateral
discussions and participation in international forums in 2013–14. These activities included presentations, consultation and/or
involvement at:

●
●
●
●
●
●
●
●
●
●
Workshop on Biotechnology Commercialisation and Trade in APEC Economies – Biosafety regulatory Perspective,
September 2013, Kuala Lumpur, Malaysia
International Life Sciences Institute South Asia Biosafety Conference and Workshop, September 2013, Delhi, India
Biosafety Inspections Workshop, Kula Lumpur, Malaysia, October 2013
3rd Annual Conference of the Association for Biological Safety of Australia and New Zealand, Auckland, New Zealand,
November 2013
Workshop on International Regulatory Challenges in Gene Technology, Canberra, Australia, November 2013
Workshop on Genetic Basis of Unintended Effects in Modified Plants, Canadian Food Inspection Agency, January 2014,
Ottawa, Canada
OECD Workshop on Environmental Risk Assessment of Products Derived from Novel Plant Breeding Techniques,
February 2014, Paris, France
OECD Focus Session on Biotechnology during 51st Joint Meeting of the Chemicals Committee and the Working Party on
Chemicals, Pesticides and Biotechnology, February 2014, Paris, France
28th meeting of the OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology, February
2014, Paris, France
Technical Consultation on Low Levels of Genetically Modified Crops in International Food and Feed Trade, UN Food and
Agriculture Organisation, March 2014, Rome, Italy
European Commission workshop, The Global Pipeline of GM Crops: An Outlook for 2020, Seville, Spain, June 2014
OTHER FUNCTIONS OF THE GENE TECHNOLOGY REGULATOR
The Gene Technology Act 2000 requires the Regulator to undertake functions that contribute to the OGTR’s capacity to conduct
high-quality assessments based on regulatory best practice and relevant scientific data. Section 27 of the Gene Technology Act
provides for the Regulator to:
●
undertake or commission research in relation to risk assessment and the biosafety of GMOs
●
promote harmonisation of risk assessment relating to GMOs and GM products by regulatory agencies.
Promote harmonisation
The OGTR has continued liaison with other regulatory agencies and other Australian Government agencies on relevant issues.
Regulatory harmonisation and the need to address regulation of new and emerging technologies has been a focus both nationally
38
and internationally.
The OGTR participated in the following meetings:
●
●
●
FSANZ workshop on New Plant Breeding Techniques. Canberra, August 2013
LLP/Unintended Presence (UP) Australian Government Agency meeting, Canberra, October 2013
Regulatory Science Network, Science Communication Workshop, Canberra, November 2013.
Find a full list of OGTR activities at Australian meetings, forums and conferences in appendix 7 .
39
CHAPTER 4 MANAGEMENT AND ACCOUNTABILITY
The Office of the Gene Technology Regulator (OGTR)’s management and accountability
practices encompass human resources, work health and safety, and the Commonwealth
Disability Strategy. The OGTR also adheres to Australian Government purchasing and
assets management, contracting and consultancy policies, as well as advertising and
market research policies, and ecologically sustainable development. The Gene Technology
Regulator reports to the Parliament annually as well as quarterly, as required by legislation.
HUMAN RESOURCES
The OGTR has a workforce of 53 employees. Of these, 48 are ongoing employees and five are non-ongoing employees (appendix
4).
The terms and conditions for non-Senior Executive Service (SES) staff at the OGTR are covered by the Department of Health’s
(the Department’s) Enterprise Agreement 2011–2014, which was made under section 172 of the Fair Work Act 2009. This is a
principles-based agreement, with most detail on operation of conditions in supporting guidelines. It offers a range of non-salary
benefits, listed in table 16.
The OGTR continued to build a strong team culture in its 13th year of operation. A weekly all-staff Friday morning tea was a
successful way of keeping staff up to date on major issues and allowed opportunities for input, participation and feedback. Friday
was also promoted as casual dress day, and staff who took up this option were encouraged to contribute a gold coin for donations
to:
●
Cancer Council Australia
●
Children’s Medical Research Institute – ‘Jeans for Genes’
●
Autism Australia
●
Ovarian Cancer Australia
●
Salvation Army – Red Shield Appeal.
Feedback from the Department’s annual staff survey again indicated a high overall job satisfaction rate for OGTR staff. Survey
feedback was used to inform the OGTR People Action Strategy Plan for 2013–14.
The OGTR implemented measures to maintain staff skills and motivation through appropriate training and development and to
ensure recruitment was conducted in a timely manner.
Two Regulator’s Achievement Awards recognising outstanding staff achievement were awarded in 2013–14: a team award to Dr
Andrea Robold and Dr Brian Weir, Plant Evaluation Section, for their excellent work in finalising the revision of the licence
application form for limited and controlled release of genetically modified (GM) plants, including data requirements; and an
individual award to Dr Heidi Mitchell, Regulatory Practice & Secretariat Section, for sustained and high-quality briefing support to
the Regulator in response to a range of priority issues. Staff undertook 120 days (240 days in 2011–12 and 241 days in 2010–11)
of formal training during the year, in addition to orientation and induction training for all new starters.
OGTR staff are able to access professional development opportunities through the Department’s performance development
scheme. At the beginning of each 12-month cycle, each employee and manager agree on the key commitments the employee will
undertake and the performance measures and development requirements needed to complete the commitment.
In 2013–14 the OGTR conducted refresher training for the emergency control team, consisting of one floor warden, two fire
wardens and one first aid officer. Members of the emergency control team are self-nominated and on completion of the required
training receive an allowance in accordance with the Enterprise Agreement.
Table 16: Non-salary benefits
AGREEMENT
BENEFITS
Enterprise
Agreement
Access to negotiated discount registration or memberships fees to join a fitness or health club
Access to the employee assistance program
Award scheme
Eligibility for performance-based pay
Extended purchased leave
40
AGREEMENT
BENEFITS
Flexible working hours
Flexible working locations including, where appropriate, access to laptop computers, dial-in facilities and mobile phones
Flex time
Influenza and hepatitis B vaccinations for staff who are required to come into regular contact with members of the
community classified as at increased risk of exposure to influenza
Leave for compelling reasons and exceptional circumstances
Maternity and adoption leave
Parental leave
Pay-out of additional duty in certain circumstances
Recognition of travel time
Reimbursement of eyesight testing and eyewear costs prescribed specifically for use with screen-based equipment
Study assistance
Support for professional and personal development
SES
All of the above benefits except flex time
Airport lounge membership
Car parking
Home office equipment
Private use of motor vehicles or an allowance in lieu (not all officers)
In keeping with the OGTR’s objective of providing a supportive working environment, staff have access to departmental assistance
measures. These include financial support for eyesight testing, occupational health and safety workstation assessments, problemresolution procedures and an employee assistance program. The assistance program is a free, short-term, professional and
confidential counselling and advice service provided by OPTUM. OGTR staff and their immediate family members can use the
program.
As a family-friendly organisation, the OGTR has endeavoured to be responsive to employee needs and circumstances through
provision of flexible working arrangements in recognition of the importance of work–life balance. The OGTR has a high proportion
of part-time employees. Staff have also accessed extended maternity leave on half pay and the 48/52 provision that allows for
additional unpaid leave while averaging salary payments over the year.
WORK HEALTH AND SAFETY
The OGTR is committed to ensuring a safe and healthy work environment for all workers, including contractors and visitors,
consistent with the legislative requirements of the Work Health and Safety Act 2001 and the Safety, Rehabilitation and
Compensation Act 1988.
The OGTR actively supports injured and ill employees in their return to work and provides appropriate reasonable adjustment to
working environments to achieve this, including flexible working arrangements. The commitment to provide rehabilitation
assistance to injured and ill employees is supported by medical examinations to determine fitness for duty and workplace
rehabilitation assistance.
The OGTR has undertaken a number of activities to embed changes resulting from the introduction of the Work Health and
Safety Act on 1 January 2012. Training for ‘officers’, ‘workers’ and health and safety representatives and harassment contact
officer has been undertaken. An e-learning module is available for all staff, including contractors and consultants, and a Work
Health and Safety Act overview is available on the Department’s intranet site. Work health and safety risk management
identification strategies have been incorporated in business planning processes.
The Department undertook work on reviewing health and safety management arrangements, along with associated policies,
guidelines and business processes, in order to reflect the requirements of the Work Health and Safety Act.
Initiatives to ensure workers’ health, safety and welfare
The OGTR undertook a range of initiatives under its health and life strategy to increase the health and wellbeing of staff, encourage
work-life balance and reduce the rates of illness and injury.
The improving wellness and motivation in the workplace: reducing unplanned leave initiative focuses on supporting the
Department’s commitment to:
●
creating, promoting and maintaining a safe and healthy working environment
41
●
encouraging productive working relationships
●
promoting and encouraging behaviours in staff and managers to assist in the management and reduction of unscheduled
absence levels.
The initiative complements existing OGTR strategies and action plans aimed at promoting a positive work environment, preventing
illness and injury, optimising performance and managing workloads and work-life balance.
The OGTR provided the option of influenza vaccinations, at no cost, to all staff as part of the health and wellbeing strategy and
the Enterprise Agreement.
Health and safety outcomes
Information on health and safety outcomes (including the impact on injury rates of workers) achieved as a result of initiatives
mentioned above or previous initiatives is incorporated into the Department’s annual report figures.
Notifiable incidents
Statistics relating to any notifiable incidents of which the OGTR became aware during the year that arose from the conduct of
business or undertakings by the OGTR are incorporated into the Department’s annual report figures.
Investigations under Part 10 of the Work Health and Safety Act
No directions, notices or enforceable undertakings under the Occupational Health and Safety (Commonwealth Employment)
Amendment Act 2006 or the Work Health and Safety Act were served on the OGTR during the year.
Work health and safety inspections were undertaken at the OGTR premises in Barton during 2013–14 and no major health or
safety issues were identified.
Other work health and safety support included provision of training in first aid, emergency evacuation systems and fire safety
systems.
FREEDOM OF INFORMATION
Agencies subject to the Freedom of Information Act 1982 are required to publish information to the public as part of the Information
Publication Scheme (IPS). This requirement (in Part II of the Freedom of Information Act) has replaced the former requirement to
publish a section 8 statement in an annual report. Each agency must display on its website a plan showing what information it
publishes in accordance with the IPS requirements.17
Freedom of information procedures
From 1 November 2010 a number of changes arising from the Australian Information Commissioner Act 2010 and the Freedom of
Information Amendment (Reform) Act 2010 were implemented, including removal of an application fee and the first hour of
decision-making to be free.
To enable a prompt response and to help the OGTR meet its obligations under the Freedom of Information Act, applicants should
provide as much information as possible about the documents they are seeking. A telephone number or an email address should
also be included in case OGTR officers need clarification.
Freedom of information contact details
Enquiries about submitting a formal request under the Freedom of Information Act should initially be directed to the freedom of
information coordinator on 1800 181 030.
Formal requests should be sent to:
Freedom of Information Coordinator
Office of the Gene Technology Regulator
MDP 54
GPO Box 9848
Canberra ACT 2601
In accordance with the Electronic Transactions Act 1999, freedom of information requests may be emailed to
<ogtr@health.gov.au>.
The OGTR received one request for access under freedom of information legislation during the reporting period. The request was
finalised within the statutory time frames.
The Regulator is required by the Freedom of Information Act (section 11C) to publish a disclosure log on the OGTR website. The
17
The OGTR plan is at <http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ips-1>.
42
disclosure log lists information that has been released in response to a freedom of information access request. 18
PURCHASING
In 2013–14 the OGTR complied with the Australian Government’s purchasing policies as articulated in the Commonwealth
Procurement Guidelines.
ASSETS MANAGEMENT
The OGTR applies a whole-of-life asset management strategy that is consistent with the Department’s asset management
program. In March 2013 the OGTR undertook a stocktake of fixed and intangible assets, in accordance with Australian Accounting
Standard 136, Impairment of Assets. This confirmed the location and condition of the OGTR’s assets and ensured that the assets
are carried at a value above the recoverable amount.
EXEMPT CONTRACTS
No exempt contracts were awarded in 2013–14.
CONSULTANCIES
No contract for consultancies were awarded in 2013–14.
The OGTR’s policy on selecting and engaging consultants accords with the Commonwealth Procurement Rules. Value for money
is the core principle for selection, underpinned by a focus on encouraging competition, efficiency and effectiveness, ethical
practices and accountability and transparency.
The Department’s Chief Executive Instructions and Procedural Rules further support the core principles in the Commonwealth
Procurement Rules.
The OGTR contracts consultancy services to ensure the achievement of more efficient and effective delivery of regulation and
related outputs.
ADVERTISING AND MARKET RESEARCH
The OGTR incurred $24 473 in advertising costs during 2013–14 ($31 142 in 2012–13) Advertising was used primarily to invite the
public to comment on risk assessment and risk management plans for licence applications involving intentional release (table 18).
Table 18: Media advertising organisations engaged, 2013–14
Organisation
Service Provided
Paid $
ADCORP
Placing advertising regarding regulatory activities
16 655
ADCORP
Placing advertisements for recruitment of staff
7818
Note: Amounts listed are inclusive of goods and services tax.
ANNUAL REPORTING REQUIREMENTS
Section 136 of the Gene Technology Act 2000 requires the Regulator to prepare and provide an annual report to the Minister on
the Regulator’s operations during that year for tabling in the Australian Parliament.
The Annual Report on the Operations of the Gene Technology Regulator 2012–13 was tabled in Parliament on 30 October 2013.19
QUARTERLY REPORTING REQUIREMENTS
Section 136A(2) of the Gene Technology Act 2000 requires the Regulator to prepare and provide a quarterly report to the
Minister on the operations of the Regulator during that quarter for tabling in the Australian Parliament. The Gene Technology Act
requires the report to include information on:
18
19
●
genetically modified organism (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
Find details by viewing the log at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ips-plan#log>.
The report is available from the OGTR Information Officer or at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1>.
43
the quarter.
Appendix 5 lists the quarterly reports the OGTR published in 2013–14.20
NATIONAL DISABILITY STRATEGY
Since 1994, Commonwealth departments and agencies have reported on their performance as policy adviser, purchaser,
employer, regulator and provider under the Commonwealth Disability Strategy. In 2007–08, reporting on the employer role was
transferred to the Australian Public Service Commission’s State of the Service Report and the APS Statistical Bulletin. These
reports are available at <www.apsc.gov.au>. From 2010–11, departments and agencies have no longer been required to report
on these functions.
The Commonwealth Disability Strategy has been overtaken by a new National Disability Strategy, which sets out a 10-year national
policy framework for improving life for Australians with disability, their families and carers. A high-level report to track progress for
people with disability at a national level will be produced by the Standing Council on Community, Housing and Disability Services to
the Council of Australian Governments and will be available at <www.fahcsia.gov.au>. The Social Inclusion Measurement and
Reporting Strategy agreed by the Australian Government in December 2009 also includes some reporting on disability matters in
its regular How Australia is Faring report and, if appropriate, in strategic change indicators in agency annual reports. More detail on
social inclusion matters can be found at <www.socialinclusion.gov.au>.
ECOLOGICALLY SUSTAINABLE DEVELOPMENT AND ENVIRONMENTAL PERFORMANCE
The OGTR supports the Australian Government’s commitment to ecologically sustainable development principles and reports here
on its operations during 2013–14 against section 516A of the Environment Protection and Biodiversity Conservation Act 1999.
Section 516A(6)(a) – Legislation administered by the Regulator during 2013–14 that accords with
ecologically sustainable development principles
The Regulator administers the Gene Technology Act 2000, and corresponding state and territory legislation, which aims to protect
the health and safety of people and the environment by identifying risks posed by gene technology and managing those risks
through regulating dealings with GMOs.
Section 516(6)(b) – How the OGTR outcomes have contributed to ecologically sustainable
development during 2013–14
In 2013–14 the OGTR continued to support the Regulator in regulating activities involving live and viable GMOs. These activities
ranged from contained work in certified laboratories to releases of GMOs into the environment. The Regulator imposed licence
conditions to protect the environment and used statutory powers to monitor and enforce those conditions.
In 2013–14, the Regulator received 18 licence applications; seven were for dealings involving intentional release of a GMO into the
environment (DIRs) and 13 were for dealings not involving intentional release of a GMO into the environment (DNIRs). In addition,
the Regulator issued 17 licences to deal with GMOs, comprising seven DIRs and 10 DNIRs (this includes one DNIR application
that was approved and integrated with another DNIR application into a combined licence) (see chapter 3).
The OGTR submits a nil response to sections 516A(6)(c), (d) and (e).
20
These are also available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1> or as hard copy by contacting the OGTR Information Officer.
44
APPENDIX 1 HISTORY AND STRUCTURE OF THE GENE TECHNOLOGY REGULATORY
SYSTEM
This appendix provides a brief description of the development of the Gene Technology Act
2000, governance arrangements for the regulatory system and how gene technology is
regulated in Australia.
DEVELOPMENT OF THE GENE TECHNOLOGY ACT 2000
Voluntary oversight of gene technology in Australia began in the mid 1970s, primarily on the initiative of the Australian Academy of
Sciences, and later on that of the Australian Government. Significant advances in applications of gene technology and resulting
elevated community concern about genetically modified organisms (GMOs) led, in November 1998, to the cooperative process
between the state and territory governments and the Australian Government to establish a uniform national approach to regulating
gene technology. After wide consultation, the Gene Technology Act 2000 and Gene Technology Regulations 2001 came into effect
on 21 June 2001.
In establishing the regulatory scheme, governments sought to recognise and reach a balance between the potential of gene
technology to contribute to society, and community concerns over its development and deployment. The extensive consultation
conducted during development of the regulatory scheme reflected the emphasis placed on community input and participation in the
decision-making process and generated strong agreement about what should be included and excluded from the scope of the
legislation. Broad consensus was reached that the Gene Technology Regulator (the Regulator) should consider only gene
technology, and that other forms of genetic manipulation used in conventional breeding should be excluded from assessments.
Other matters considered to be out-of-scope, included trade and marketability, cost–benefit considerations, comparisons with
alternative technologies, intellectual property and human cloning.
This led to the object of the Gene Technology Act 2000 being defined as:
to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result
of gene technology, and by managing those risks through regulating certain dealings with GMOs.
The national regulatory system is underpinned by the intergovernmental Gene Technology Agreement. This agreement, signed by
all Australian jurisdictions, sets out the understanding between governments of the nationally consistent regulatory system and
commits the states and territories to pass corresponding laws.
GOVERNANCE ARRANGEMENTS
The Gene Technology Act 2000 and the Gene Technology Regulations 2001 and corresponding state and territory laws (table 19)
provide a nationally consistent system to regulate development and use of gene technology in Australia. The legislation establishes
the Regulator as an independent statutory office holder to administer the national scheme. Under the intergovernmental Gene
Technology Agreement, the states and territories have committed to maintaining corresponding legislation with the Commonwealth.
The Regulator is charged with performing functions and exercising powers under the Gene Technology Act and corresponding
legislation (figure 15).
While the Regulator must consider risks to human health and safety and the environment relating to dealings with GMOs, other
agencies have responsibility for regulating GMOs or genetically modified (GM) products as part of a broader or different mandate.
During development of the gene technology legislation, it was determined that the Regulator’s activities should form part of an
integrated legislative framework that also includes a number of other regulatory authorities with complementary responsibilities and
expertise (see figure 16). This arrangement both enhances coordinated decision-making and avoids duplication. The Gene
Technology Act was accompanied by consequential amendments of the other relevant Acts relating to requirements for reciprocal
request and provision of advice and exchange of information between the Regulator and other relevant regulatory agencies. These
requirements include the following:
21
●
the Regulator must consult Commonwealth regulatory agencies prescribed in the Regulations (see table 22) on all
licence applications for dealings involving the intentional release of GMOs to the environment
●
there are requirements for agencies21 regulating GM products22 to consult and/or notify the Regulator regarding
applications for registration of products that are GM or contain GMOs.
Therapeutic Goods Administration, Australian Pesticides and Veterinary Medicines Authority, National Industrial Chemicals Notification and Assessment Scheme,
Food Standards Australia New Zealand.
22
A thing (other than a GMO) derived or produced from a GMO.
45
These provisions support an adequate and timely flow of information between the agencies to inform assessments and decisions.
(Accordingly, where other agencies approve GM products, they seek advice from the Regulator and provide notification of their
decisions to the Regulator for inclusion on the GMO Record.)
Figure 15: Governance arrangements for the Gene Technology Regulator
Table 19: Legislation administered by the Gene Technology Regulator
JURISDICTION
TITLE OF ACT AND REGULATIONS*
Australian Capital Territory
Gene Technology Act 2003
Gene Technology Regulations 2004
Commonwealth
Gene Technology Act 2000
Gene Technology Regulations 2001
Guidelines for the Transport, Storage and Disposal of GMOs**
New South Wales
Gene Technology (New South Wales) Act 2003
Northern Territory
Gene Technology (Northern Territory) Act 2004
Queensland
Gene Technology Act 2001
Gene Technology Regulation 2002
South Australia
Gene Technology Act 2001
Gene Technology Regulations 2002
Tasmania
Gene Technology (Tasmania) Act 2012
Victoria
Gene Technology Act 2001
Gene Technology Regulations 2011
* New South Wales, Northern Territory and Tasmania do not have regulations, as their Acts automatically adopt any amendments to the Commonwealth Act and
Regulations.
**These guidelines are a legislative instrument issued by the Regulator under section 27(d) of the Gene Technology Act.
46
ROLE OF THE LEGISLATIVE AND GOVERNANCE FORUM ON GENE TECHNOLOGY
The Legislative and Governance Forum on Gene Technology (LGFGT) 23 provides oversight of the national regulatory scheme for
gene technology.
The LGFGT was established by the Council of Australian Governments (COAG) under clause 20 of the intergovernmental Gene
Technology Agreement and comprises a representative Minister from each state and territory. Its role is to provide policy guidance
for the operation of the Gene Technology Act 2000. In addition, the LGFGT approves appointment of the Regulator and the chairs
of the statutory advisory committees (appendix 3) and provides advice to the Australian Government Minister for Health on
appointment of committee members.
Section 21 of the Gene Technology Act provides for the LGFGT to issue policy principles on ethical issues related to dealings with
GMOs and recognition of areas designated under state law for the purpose of preserving the identity of either GM crops or non-GM
crops for marketing purposes. Policy principles are legislative instruments and the Regulator must not issue a licence if it would be
inconsistent with a policy principle. One policy principle has been issued to date.
Table 20: Policy principles issued to date
POLICY PRINCIPLE
DATE ISSUED
DATE EFFECTIVE
Gene Technology (Recognition of Designated Areas) Principle
2003
31 July 2003
5 September 2003
The LGFGT is supported by the Gene Technology Standing Committee, which is comprised of 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 legislation
One of the Regulator’s prescribed functions is to advise the LGFGT about the effectiveness of the legislative framework for
regulating GMOs, including possible amendments to legislation. Since their inception, the Gene Technology Act 2000 and
Regulations have been amended to:
23
●
improve the effectiveness and efficiency of the Regulations. Three sets of amendments to the Regulations have been
made: Amendment Regulations 2006 (as a result of the 2004–06 Regulator’s review), Amendment Regulations 2007
(consequential amendments due to the review of the Gene Technology Act) and Amendment Regulations 2011 (as a
result of the 2008–11 Regulator’s review). The Regulator’s reviews of the Regulations have focused on technical aspects,
particularly that the classification and requirements for the conduct of GMO dealings are commensurate with risk and up to
date with current scientific knowledge
●
improve the operation of the Gene Technology Act at the margins. These generally minor amendments included addition
of emergency powers to the Gene Technology Act that give the Minister the ability to expedite approval of a GMO in
emergencies. These amendments were made as a result of the 2005–06 Statutory Review of the Gene Technology Act
2000 and the Gene Technology Agreement (Gene Technology Amendment Act 2007 and Gene Technology Amendment
Regulations 2007)
●
confer on the Regulator the function of making available inspectors appointed under section 150 of the Gene Technology
Act to be appointed as inspectors under Part 3, Division 7 of the National Health Security Act 2007. These amendments
(Gene Technology Amendment Regulations 2009) were in line with COAG recommendations providing for OGTR
inspectors to undertake monitoring inspections under the Security Sensitive Biological Agents Regulatory Scheme.
Referred to as the Ministerial Council in the Gene Technology Act 2000, see <http://www.health.gov.au/internet/main/publishing.nsf/Content/gene-gtmc.htm>.
47
Table 21: Amendments to Commonwealth gene technology legislation
AMENDING LEGISLATION
CHANGE INFORMED BY:
Gene Technology
Amendment Regulations
2006
2004–06 Regulator’s review
SUMMARY OF CHANGES
Requirements for institutional biosecurity
committee (IBC) assessment, notification and
conduct of notifiable low risk dealings (NLRDs)
Classification of particular GMO dealings as
exempt, NLRD, licensable
Classification of particular techniques as not
gene technology, and particular organisms as
not GMOs
Licence application requirements detailed in
forms issued by the Regulator
Gene Technology
Amendment Act 2007
2005–06 Independent
Statutory Review of the
Gene Technology Act 2000
Capacity to authorise a GMO by an Emergency
Dealing Determination
Capacity to authorise disposal of GMOs by
inadvertent dealings licence
Specific requirements for assessment and
consultation on limited and controlled release
licence applications
Changes to application time frames
Gene Technology Ethics & Community
Consultative Committee replaces Gene
Technology Ethics Committee and Gene
Technology Community Consultative
Committee
Gene Technology
Amendment Regulations
2007
2005–06 Independent
Statutory Review of the
Gene Technology Act 2000
Annual notification of NLRDs
Changes to classification and containment
requirements of NLRDs
Exempt dealing requirements
Gene Technology
Amendment Regulations
2009
Council of Australian
Governments’
recommendations
Gene Technology
Amendment Regulations
2011
2008–11 Regulator’s review
OGTR inspectors may be appointed as
inspectors for the Security Sensitive Biological
Agents Regulatory Scheme
Clarification of requirements for IBC
assessment, notification, containment and
conduct of NLRDs, including Transport,
Sstorage and Disposal guidelines
Changes to classification of particular GMO
dealings as exempt, NLRD, licensable
COORDINATION WITH PRESCRIBED AGENCIES
Sometimes conduct of particular activities with a GMO requires approval from both the Regulator and another regulatory body, for
example, dealings with a human medicine that is a GMO. Some human medicines, such as some live GM vaccines, require a
licence from the Regulator as well as registration and assessment by the Therapeutic Goods Administration (TGA), which would
need to authorise its administration to people. Similarly, while the Regulator is responsible for approving release of GM insecticideor herbicide-tolerant plants into the environment, the Australian Pesticides and Veterinary Medicines Authority (APVMA), which is
responsible for regulating all agricultural chemicals, registers the insecticide product produced in the GM plant and/or approves
application of the herbicide to which the GM plants are tolerant.
Although the focus and responsibility of other agencies that regulate products involving GMOs or GM products are distinct from
those of the Regulator, where there is also regulation by another agency, the Regulator has a policy of aligning the decision-making
processes to the extent that it is practicable within the limits of the relevant legislation. The OGTR and other regulatory agencies
work together to ensure that thorough coordinated assessments of parallel applications are undertaken and, wherever possible,
that the timing of decisions by the agencies coincides.
There are also instances where there may be approvals by one regulator but not another, for example, Food Standards Australia
New Zealand (FSANZ) is asked to assess the safety of a GM product that will be imported for sale for human food where no
48
application has been (and may never be) submitted to the Regulator to grow the GMO in Australia from which the GM product is
derived. The respective roles of the various agencies that regulate GMOs or GM products, along with the relevant legislation, are
listed in table 22.
Table 22: Regulatory agencies in Australia with a role in regulating gene technology
GMO/GM
AGENCY
PORTFOLIO
SCOPE
RELEVANT LEGISLATION
GMO dealings
OGTR
Health
The OGTR underpins the national scheme for
regulating GMOs in Australia. It aims to protect
human health and safety and the environment
by identifying risks posed by or as a result of
gene technology and managing those risks by
regulating certain dealings with GMOs.
Gene Technology Act
2000
Medicines, medical
devices, blood and
tissues
TGA*
Health
The TGA administers legislation that provides a
national framework for regulating therapeutic
products in Australia and ensures their quality,
safety and efficacy.
Therapeutic Goods Act
1989
Food
FSANZ*
Health
FSANZ is responsible for the Australia New
Zealand Food Standards Code, which prohibits
use of food products produced using gene
technology in Australia unless there is specific
approval for sale of these foods following a
safety assessment. The code also contains
provisions for labelling GM foods.
Food Standards Australia
New Zealand Act 1991
Agricultural and
veterinary
chemicals
APVMA*
Agriculture
APVMA operates the national system that
evaluates, registers and regulates all
agricultural chemicals (including those that are,
or are used on, GM crops) and veterinary
therapeutic products. Assessments consider
human and environmental safety, product
efficacy (including insecticide and herbicide
resistance management) and trade issues
relating to residues.
Agricultural and
Veterinary Chemicals
(Code) Act 1994
PRODUCTS
Agricultural and
Veterinary Chemicals
Administration Act 1994
Industrial chemicals
National Industrial
Chemicals
Notification and
Assessment
Scheme
Health
NICNAS provides a national notification and
assessment scheme to protect the health of the
public, workers and the environment from the
harmful effects of industrial chemicals.
Industrial Chemicals
(Notification and
Assessment) Act 1989
Quarantine
Department of
Agriculture
Department of Agriculture Biosecurity regulates
importation into Australia of all animal, plant and
biological products that may pose a quarantine
pest and/or disease risk.
Quarantine Act 1908
Agriculture*
Imported Food Control
Act 1992
* Prescribed agencies in the Gene Technology Regulations that the Regulator must consult on applications for a dealing involving intentional release of a GMO into the
environment .
49
APPENDIX 2 TYPES OF APPLICATIONS, AUTHORISATIONS, MONITORING AND
COMPLIANCE
This appendix outlines the classes of dealings with genetically modified organisms (GMOs)
that are defined by the Gene Technology Act 2000, the Gene Technology Regulations 2001
and corresponding state and territory laws, as well as the procedures followed for each
type of application and other instruments that help the Gene Technology Regulator (the
Regulator) to manage risks to health and safety of people and the environment. It also
describes activities that the Office of the Gene Technology Regulator (OGTR) undertakes to
monitor dealings with GMOs for compliance with legislation, and actions it takes in
response to non-compliances.
THE GMO REGISTER
The GMO Register is a register provided by Part 6, Division 3 of the Gene Technology Act 2000.
The Regulator may make a determination to include dealings with GMOs on the GMO Register24 according to section 78 of the
Gene Technology Act. To be included on the GMO Register, the dealings must first have been authorised by a GMO licence.
Dealings will not be entered on the GMO Register until the Regulator is satisfied that the risks they pose are minimal and that it is
not necessary for anyone conducting them to be covered by a licence in order to protect the health and safety of people or the
environment. After inclusion on the GMO Register the dealings no longer require authorisation by a licence from the Regulator but
may still have conditions attached to their registration. One GMO dealing (for a colour-modified carnation) is currently on the GMO
Register.
EXEMPT DEALINGS
Exempt dealings are dealings with GMOs that have been assessed over time as posing negligible 25 risks to people or to the
environment. They comprise basic molecular biology techniques that are used extensively in laboratories worldwide. The criteria for
exempt dealings are specified in the Gene Technology Regulations (Schedule 2). Exempt dealings must not involve intentional
release into the environment but do not require a specified level of containment. Guidance on appropriate containment measures
for exempt dealings is provided on the OGTR website. If dealings fall within the classification in the Regulations for exempt
dealings, they do not require a case-by-case risk assessment. Examples of exempt dealings include dealings with:
●
an animal 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 gene must not be uncharacterised, be derived from a pathogenic organism or code for a
toxin).
NOTIFIABLE LOW RISK DEALINGS
Notifiable low risk dealings (NLRDs) are dealings with GMOs that have been assessed as posing negligible risks provided certain
management conditions are met. The Regulations specify the GMO dealings that are classified as NLRDs (Schedule 3, Part 1 and
Part 2) and requirements for undertaking NLRDs (Regulation 13). Such dealings may only be undertaken in a facility certified by
the Regulator at least to a specified physical containment level (usually PC1, PC2 or PC3 certified facilities) and of an appropriate
design for the kind of dealing undertaken. Conducting NLRDs requires prior assessment by an institutional biosafety committee
(IBC) to confirm that proposed dealings with GMOs are properly classified as NLRDs, that the facilities are of the appropriate
physical containment level and type and that personnel have the appropriate training or experience. Organisations must keep a
record of all current NLRDs and notify them in an annual report to the Regulator. NLRDs are included on the Record of GMO and
GM product dealings but do not require case-by-case risk assessment by the Regulator.
An example of an NLRD that may be conducted in PC1 facilities is dealing with GM laboratory guinea pigs, mice, rabbits or rats
where the genetic modification does not provide an advantage or the animal is not infectious. NLRDs that may be conducted in
24
It is important to note the difference between the GMO Record and the GMO Register. The GMO Register lists GMOs that no longer require a licence and will only
ever be a subset of dealings included on the GMO Record. The GMO Record is a comprehensive listing of all dealings with GMOs, including licensed dealings,
NLRDs and GM products.
25
The term ‘negligible’ is defined in chapter 3 of the Risk Analysis Framework and is used here for consistency.
50
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 (for example, the introduced gene
may encode a pathogenic determinant or may be an uncharacterised gene from a pathogen).
NLRDs involving micro-organisms classified as Risk Group 3 under standard AS/NZS 2243:3:2012 must be undertaken in facilities
certified to at least PC3 level and appropriate to the dealings.
LICENSED DEALINGS
Any dealing with a GMO not classified as exempt or as an NLRD, listed on the GMO Register, or authorised by an Emergency
Dealing Determination (EDD) must not be conducted unless licensed. The Regulator considers all licence applications on a caseby-case basis. The Regulator must consider whether the risks posed by the dealing can be managed in such a way as to protect
human health and safety and the environment. The Regulator must make a decision on whether to issue or refuse a licence to
allow a dealing and (if a licence is to be issued) the management conditions to be imposed to manage any risks.
The legislation sets out a series of actions that the Regulator must take in considering applications for licences both for contained
dealings (DNIRs) and those involving intentional release (DIRs). The Gene Technology Act 2000 details steps that must be taken in
assessing licence applications, and application forms detail the information an applicant must provide.
For both DNIRs and DIRs, the Regulator requires an applicant to identify risks that the dealings may pose to human health and
safety and the environment and any measures proposed to manage those risks. The organisation’s IBC must support the
application.
The Gene Technology Act requires the Regulator to prepare a risk assessment and risk management plan (RARMP) for both DNIR
and DIR applications. The risk assessment takes account of any risks to human health and safety and the environment posed by
the dealing, and the risk management plan determines how those risks can be managed. The Regulator uses information provided
in the application as well as other relevant scientific/technical knowledge.
The requirements of the legislation have been framed so as to place under greater scrutiny dealings that involve intentional release
of GMOs to the environment (DIRs). The Regulator may impose conditions on all licences. For example, for all DIRs determined to
be limited and controlled releases, measures will be imposed to restrict the persistence and spread of the GMO and its genetic
material. Non-compliance with conditions placed on licences issued under the Gene Technology Act is a criminal offence. For both
DNIR and DIR applications, the applicant must also provide information specified in the Gene Technology Act as to their suitability
to hold a licence. This includes any information on relevant convictions and on revocations or suspensions of licences under laws
relating to human health and safety or the environment. The Regulator also makes an assessment of the applicant’s capacity to
comply with licence conditions.
While the Gene Technology Act is highly prescriptive about the process to be followed in assessing licence applications, it is not
explicit in directing how the Regulator should undertake risk analyses. The Risk Analysis Framework was, therefore, developed to
provide guidance on how the Regulator and the OGTR should apply internationally recognised risk analysis practices in the context
of the legislation. The framework was applied to all licence applications processed during 2013–14.26
DEALINGS NOT INVOLVING INTENTIONAL RELEASE
DNIRs usually take place under specified physical containment conditions in certified facilities that minimise risks to human health
and the environment. The Gene Technology Act requires preparation of an RARMP for DNIR applications (section 47). The
application form specifies the information the Regulator requires.
The legislation provides that in relation to DNIR licences, the Regulator may consult the Gene Technology Technical Advisory
Committee (GTTAC), the states and territories, relevant Australian Government agencies and any person the Regulator considers
appropriate.
The Regulator considers the RARMP in deciding whether to issue a licence and in determining the licence conditions that should
be imposed (if a licence were to be issued). Typical licence conditions require the applicant to conduct the dealings in certified
facilities, to follow particular handling requirements (such as avoiding use of ‘sharps’ and using biosafety cabinets), to train and
supervise staff, to transport and dispose of the GMO appropriately, and to have, and if necessary implement, contingency plans.
The process required in respect of DNIR applications is shown in figure 16 and described below.
26
The Risk Analysis Framework is available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/riskassessments-1>.
51
Figure 16: DNIR assessment process
Application for
DNIR licence
Sufficient
information?
No
Reject
application
Yes
Prepare RARMP
Yes
Consultation?
No
Consultation
Finalise RARMP
Yes
Finalise licence
conditions
Issue
licence
Can the risks be
managed to protect people
and the environment?
No
Refuse to
issue licence
Stage 1 – The applicant must complete the DNIR application form and provide comprehensive information about the proposed
dealings with the GMO, including possible risks posed by the dealings and proposed ways in which each risk would be managed.
The applicant must ensure that all responses to the Regulator’s information requirements are supported by appropriate data and
literature citations.
Stage 2 – The IBC reviews the application and appends an evaluation report setting out its advice as to the completeness of the
application form. The IBC’s role is to ensure the quality of applications submitted to the Regulator. If there is not sufficient
information the application is rejected.
Stage 3 – Section 47 of the Gene Technology Act requires the Regulator to prepare an RARMP. The information provided in the
application is used to prepare the RARMP in relation to the proposed dealings.
The actual risk assessment process is, to some extent, shaped by the data requirements set out in the DNIR application form;
however, the Regulator can require submission of any data required to comprehensively identify and evaluate risks posed by the
dealing. The Regulator is specifically permitted by the legislation to seek and take into account any other relevant information such
as independent research, independent literature searches and the advice of any person or group. The Regulator may also request
more information from the applicant.
Preparation of risk assessment involves developing risk scenarios that describe how risks that may be posed by dealings with the
GMO could result in harm, identifying risks that require more detailed characterisation, and estimating the level of risk based on the
52
likelihood of the event occurring and the likely consequences of that occurrence. Risks are then evaluated to determine which ones
require treatment to protect people and the environment.
The risk management plan considers how risks to human health and safety or to the environment posed by the dealings with the
GMO that require management may be able to be managed. This then provides the basis for conditions that may be applied to the
licence. Draft conditions are included in the consultation version of the RARMP.
Stage 4 – The Regulator may consult experts, agencies, or authorities, about the RARMP, such as the GTTAC, the states and
territories, prescribed Australian Government agencies, the Environment Minister, and appropriate local government authorities.
Stage 5 – The Regulator makes the decision on whether to issue a licence and, if so, any conditions to be imposed. This decision
is based on the RARMP, having regard to any policy principles issued by the Legislative and Governance Forum on Gene
Technology (LGFGT). The Regulator must notify the applicant in writing that a licence decision has been made. The Regulator also
advises all experts, agencies and authorities that were consulted.
The statutory time frame allowed for consideration of a DNIR application is 90 days.
DEALINGS INVOLVING INTENTIONAL RELEASE
Although the legislation defines two types of DIR, ‘limited and controlled’ DIRs and other DIRs, the same application form is used
for all DIRs. The Regulator will, on a case-by-case basis, use information the applicant has submitted (as specified in the
application form) to determine if the application is a limited and controlled release application, and therefore which consultation
process and time frame under the Gene Technology Act apply for processing the application.
The Risk Analysis Framework outlines the approach taken to risk analysis and preparing RARMPs. The eight-stage process
adopted in respect of DIR applications is shown in figure 17 and described below.
53
Figure 17: DIR assessment process
Stage 1 – The applicant must complete the DIR application form and provide comprehensive information about the proposed
dealings with the GMO, including possible risks posed by the dealings and proposed ways in which each risk would be managed.
The applicant must ensure that all responses to the Regulator’s information requirements are supported by appropriate data and
literature citations. Wherever possible, quantitative data should be provided. It is expected that applicants will collect relevant data
during contained work and early trials to support applications for dealings involving intentional releases of GMOs.
Stage 2 – The IBC reviews the application and appends an evaluation report setting out its advice as to the completeness of the
application form. The IBC’s role is to ensure the quality of applications submitted to the Regulator.
Stage 3 – Section 50A of the Gene Technology Act allows the Regulator to make a determination on the application as to whether
it is for a limited and controlled release, which would follow a shorter process.
Section 50A(1) of the Gene Technology Act specifies limited and controlled release applications as applying, if the Regulator is
satisfied that:
●
the principal purpose of the application is to enable the licence holder, and persons covered by the licence, to conduct
experiments
●
the application proposes, in relation to any GMO in respect of which dealings are proposed to be authorised:
o
controls to restrict dissemination or persistence of the GMO and its genetic material into the environment
54
o
●
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 section 50(3).
Section 50A(2) of the Gene Technology Act describes the term ‘controls’ as including:
●
methods to restrict the dissemination or persistence of the GMO or its genetic material into 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, in relation to dealings with the GMO or its genetic material, with:
o
a code of practice issued under section 24, or
o
a technical or procedural guideline issued under section 27.
Section 50A(3) describes the term ‘limits’ as including the:
●
scope of the dealings with the GMO
●
scale of the dealings with the GMO
●
locations of the dealings with the GMO
●
duration of the dealings with the GMO
●
persons who are to be permitted to conduct the dealings with the GMO.
Stage 4 – A notification of application is sent out for all DIR applications to those on the OGTR mailing list and placed on the
website advising when the consultation RARMP is expected to be released for comment. This is not a requirement of the Gene
Technology Act, but increases the transparency of the regulatory system and aims to increase participation in the consultation
process.
The Regulator must provide a copy of the application (excluding any information that has been declared by the Regulator as, or
under consideration as, confidential commercial information) to anyone who requests a copy (section 54).
Stage 5 – The Regulator must seek advice on the application regarding matters relevant to preparation of the RARMP from the
GTTAC, the states and territories, prescribed Australian Government agencies, the Environment Minister, and appropriate local
government authorities (section 50). The Regulator usually consults local government authorities where the release is proposed to
occur. In addition, the Regulator routinely seeks advice from other relevant Australian Government agencies such as the
Department of Agriculture and the Department of Foreign Affairs and Trade. If the application is for a limited and controlled release,
this consultation stage is not required.
Stage 6 – Section 51 of the Gene Technology Act requires the Regulator to prepare an RARMP (consultation version) and to take
account of submissions received during any consultation on the application under section 50.
The actual risk assessment process is, to some extent, shaped by the data requirements set out in the DIR application form;
however, the Regulator can require submission of any data required to comprehensively identify and evaluate risks posed by the
dealing. The Regulator is specifically permitted by the legislation to seek and take into account any other relevant information such
as independent research, independent literature searches and the advice of any person or group. The Regulator may also request
more information from the applicant or hold a public hearing.
Preparation of the risk assessment involves developing risk scenarios that describe how risks that may be posed by the dealings
with the GMO could result in harm, identifying risks that require more detailed characterisation and estimating the level of risk
based on the likelihood of the event occurring and the likely consequences of that occurrence. Risks are then evaluated to
determine which ones require treatment to protect people and the environment.
The risk-management plan considers how risks to human health and safety or to the environment posed by dealings with the GMO
may be able to be managed. This then provides the basis for conditions that may be applied to the licence. Draft conditions are
included in the consultation version of the RARMP.
Stage 7 – Once the consultation version of the RARMP is prepared for a DIR application, the Regulator must determine whether
any of the proposed dealings pose a significant risk to the health and safety of people or to the environment. The minimum
consultation period specified in the Gene Technology Act is 50 days if the Regulator is satisfied that the dealings may pose a
significant risk to the health and safety of people or to the environment. If the Regulator considers that the proposed dealings do
not pose significant risks, a minimum 30-day consultation period is specified (section 52(2)).
The statutory time frame allowed for consideration of a DIR application, except for a limited and controlled release application, is
255 days. For a limited and controlled release application this time frame is either 170 days (for dealings that may pose a
55
significant risk) or 150 days (for dealings that do not pose a significant risk).
The Regulator is required to seek public comment on the consultation RARMP through advertisements in a national newspaper,
the Australian Government Gazette and notices on the Regulator’s website. In practice, the Regulator advertises more broadly,
including in metropolitan and regional newspapers and specialist interest publications, and will advise by mail or email all people
and organisations that have registered their interest in receiving such information through the OGTR mailing lists. Under section
52(3) of the Gene Technology Act, the Regulator must also seek advice on the RARMP from the expert groups, agencies and
authorities listed in table 22 (for consultation on the application).
The Regulator is required to consult with the Australian Government Environment Minister on DIR licence applications.
Stage 8 – The Regulator finalises the RARMP, taking into account the advice provided in relation to the consultation version of the
RARMP, in accordance with section 56(2) of the Gene Technology Act. The Regulator makes the decision on issuing the licence,
and any conditions to be imposed, based on the finalised RARMP, having regard to any policy principles issued by the LGFGT
(formerly the Gene Technology Ministerial Council). The Regulator must notify the applicant in writing that a licence decision has
been made. The Regulator also publishes the finalised RARMP on the OGTR website; advises all experts, agencies and authorities
that were consulted and people or organisations that made submissions; and notifies registered recipients on the OGTR mailing
list.
INADVERTENT DEALINGS
Part 5 of the Gene Technology Act allows the Regulator to grant a temporary licence (no longer than 12 months) to a person who
finds they are inadvertently dealing with an unlicensed GMO. The licence may be issued to the person for the purposes of
disposing of the GMO. There is no requirement to prepare a RARMP or consult in relation to inadvertent dealing applications, but
the Regulator must not issue a licence unless satisfied that the risks posed by the dealings can be managed in such a way as to
protect the health and safety of people and the environment.
Emergency dealing determinations
The EDD provision in Part 5A (sections 72A–E) of the Gene Technology Act gives the Minister the power to expedite approval of a
dealing with a GMO in an emergency. This recognises that situations may arise in which a rapid assessment of a proposed dealing
with a GMO may be needed. An EDD can only be made for a limited period (up to six months) but may be extended by the
Minister. Before making an EDD, the Minister must be satisfied that:
●
there is an actual or imminent threat to the health and safety of people or to the environment
●
the dealings proposed to be specified in the EDD would, or would be likely to, adequately address the threat
●
any risks posed by the dealings proposed to be specified in the EDD are able to be managed in such a way as to protect
the health and safety of people and the environment.
The Minister must receive advice from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer or the
Commonwealth Chief Plant Protection Officer that the proposed emergency dealing would address the threat; and from the
Regulator about managing risks. The states and territories must also be consulted.
In developing the risk assessment advice for the Minister, the Regulator will apply the principles embodied in the risk analysis
framework, but, noting the emergency context and need for a rapid assessment, there are no prescribed consultation requirements.
THE GMO RECORD
Section 138 of the Gene Technology Act requires the Regulator to maintain a Record of GMO and GM Product Dealings (the GMO
Record). The GMO Record includes details of licences issued (DNIR, DIR, inadvertent dealing), information about NLRDs, GMO
dealings included on the GMO Register, EDDs and information about GM products approved by other regulatory authorities. 27
The GMO Record is currently divided into separate sections:
27
●
notifiable low risk dealings
●
contained dealings – DNIR licences
●
intentional releases – DIR licences
●
inadvertent dealing licences
●
GMO Register
●
EDDs
The GMO Record can be viewed at <www.ogtr.gov.au/gmorec/index.htm>.
56
●
GM products – those used in food processing, therapeutics, and pesticides and veterinary medicines authorised by other
regulatory agencies.
ACCREDITATION AND CERTIFICATION
Accreditation of organisations and certification of individual physical containment facilities helps manage risks that may be
associated with dealings with GMOs.
The Regulator will require an organisation undertaking certain dealings with GMOs to be accredited. The process of accreditation
enables the Regulator to assess whether the organisation has the resources and the internal processes in place to enable it to
effectively oversee work with GMOs. Before an organisation can be accredited it must have established, or have access to, an
appropriately constituted IBC.
IBCs provide on-site scrutiny of low-risk contained dealings that do not require case-by-case consideration by the Regulator
through independent assessment of NLRD proposals pursuant to regulation 13B—and on behalf of their organisation ensuring
compliance with legislative requirements. IBCs are required to comprise a range of suitable experts and an independent person.
They provide a quality-assurance mechanism that reviews the information that applicants submit to the Regulator.
Certain dealings must only be undertaken in facilities that are certified by the Regulator. The legislation allows the Regulator to
certify physical containment facilities to ensure that appropriate standards are met for containment of GMOs and that trained and
competent staff are carrying out procedures and practices. Under the legislation, the Regulator has issued guidelines specifying the
requirements for certification of each type of facility (laboratory, plant and animal, etc) to physical containment levels 1, 2, 3 or 4,
which must be met before a facility can be certified. 28 All certified facilities must be inspected before certification and annually
thereafter (except those certified as a PC1 facility). The OGTR inspects all high-level facilities (large-scale PC2, PC3 and PC4)
before certification and re-certification.
MONITORING AND COMPLIANCE
The aim of OGTR monitoring and compliance activities is to ensure dealings with GMOs comply with legislative obligations and are
consistent with the object of the Gene Technology Act, bearing in mind that non-compliance with conditions placed on licences
issued under the Gene Technology Act is a criminal offence. The OGTR has adopted an operational philosophy that places strong
emphasis on helping accredited organisations and licence holders comply with their legislative obligations.
In particular, monitoring activities focus on managing dealings at field trial sites and within certified physical containment facilities to
ensure:
●
dissemination of a GMO and its genetic material is minimised
●
persistence of a GMO in the environment is managed
●
effective management of the GMO is maintained.
OGTR monitoring activities comprise the functions of routine monitoring, including making spot checks, assessing monitoring
findings and, where necessary, recommending corrective action and follow-up activities.
The OGTR Monitoring Section conducts routine monitoring visits to a minimum of 20 per cent of field trial sites each year. The
OGTR strategy for conducting field trial monitoring draws on accumulated operational experience of risk profiling in relation to
compliance. For example, OGTR field trial monitoring coincides, where possible, with periods or circumstances when noncompliance with licence conditions designed to limit the spread and persistence of GMOs or their genetic material is more likely to
occur (for example, during flowering and/or harvesting of GM crops).
The monitoring program for contained dealings involves inspecting DNIRs and the facilities in which those dealings are conducted,
as well as monitoring a minimum of 20 per cent of PC4, PC3 and PC2 large-scale facilities per year. These inspections focus on
the integrity of the physical structure of a facility and on the general laboratory practices followed in that facility, including the
practices followed for DNIRs and NLRDs.
OGTR compliance activities comprise reviews of potential compliance risks, audits, investigations and related enforcement
activities.
The OGTR may initiate practice reviews in response to observations made during monitoring activities or to follow-up incident
reports that may relate to non-compliance with licence conditions by accredited organisations. Their objective is to determine
whether licence conditions can be, and are being, effectively implemented. An accredited organisation may seek a practice review
to assess the effectiveness of systems that its IBCs use to ensure that dealings are being conducted in accordance with the Gene
Technology Act.
28
The Guidelines for Certifications of Physical Containment Facilities are available at <www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/forms-guidelines-1>.
57
The OGTR or an accredited organisation can initiate an audit entailing documentary evidence, observations and/or assessments of
procedures and practices. These activities are conducted to:
●
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 non-compliance with the Gene Technology Act and corresponding state or territory
laws with the aim of gathering evidence. Such investigations are not restricted to purely criminal aspects—in the wider context they
may include advice on detected flaws and vulnerability in policies, practices and procedures. An investigation may be initiated as a
consequence of OGTR monitoring, self-reporting by an accredited organisation or third-party reporting.
58
APPENDIX 3 MEMBERSHIP OF STATUTORY COMMITTEES AND ATTENDANCE AT
MEETINGS
The Gene Technology Act 2000 establishes two statutory committees to provide advice to the Gene Technology Regulator (the
Regulator) and the Legislative and Governance Forum on Gene Technology (LGFGT). These are the:
●
Gene Technology Technical Advisory Committee (GTTAC)
●
Gene Technology Ethics and Community Consultative Committee (GTECCC).
The 2011–14, memberships of GTTAC and GTECCC expired on 31 January 2014. The Assistant Minister for Health, Senator the
Hon. Fiona Nash, appointed 19 members to GTTAC that commenced in February 2014, including a mix of new and ongoing
members. The 2011–14 membership of GTECCC, with the exception of the cross-member with the Australian Health Ethics
Committee (AHEC), expired on 31 January 2014. The appointment process for the new membership of GTECCC was still ongoing
at 30 June 2014.Videoconferences represent an important and efficient option for conducting committee meetings, especially on
discrete agendas, given reduced travel requirements for members and reduced costs. During 2013–14, GTTAC continued to make
use of the videoconference network established by the Department of Health, meeting twice by videoconference.
GENE TECHNOLOGY TECHNICAL ADVISORY COMMITTEE
GTTAC’s functions, as set out in section 101 of the Gene Technology Act, are to provide scientific and technical advice, at the
request of the Regulator or the LGFGT, on genetically modified organisms (GMOs); genetically modified (GM) products;
applications made under the Gene Technology Act; the biosafety aspects of gene technology; and the need for policy principles,
policy guidelines, codes of practice, and technical and procedural guidelines in relation to GMOs and GM products and the content
of such principles and codes.
The Regulator must seek GTTAC’s advice on the Risk Assessment and Risk Management Plan (RARMP) for all licence
applications for dealings involving intentional release (DIR) and may seek advice on other applications. The Regulator must also
seek GTTAC’s advice during the preparation of the RARMP for all DIR applications which are not assessed as limited and
controlled under section 50A of the Gene Technology Act. In 2013–14 the Regulator sought advice from GTTAC on seven DIR
applications, including for the limited and controlled release of GM canola and GM wheat and/or barley, a clinical trial of a GM
vaccine against cholera, and three commercial releases (GM cotton, GM canola and a GM vaccine to protect chickens against
pathogenic Escherichia coli). GTTAC met four times during 2013–14, twice face-to-face and twice by videoconference (table 23).
Communiqués from GTTAC meetings, which provide an overview of key matters discussed and resolutions, are published on the
OGTR website29 and in the Regulator’s quarterly reports to Parliament.
Table 23: Attendance at GTTAC meetings, 2013–14
Meeting date
No of GTTAC members in attendance
17 September 2013 (videoconference)
18
18 December 2013
14
20 February 2014
16
21 May 2014 (videoconference)
15
GTTAC CHAIR
Professor John Rasko AO BSc (Med), MBBS(Hons), PhD, MAICD, FFSc (RCPA), FRCPA, FRACP has relevant skills and
experience in molecular biology, virology, risk assessment, clinical medicine, biochemistry, animal biology and immunology.
Professor Rasko is an Australian pioneer in the application of adult stem cells and genetic therapy. He directs the Department of
Cell and Molecular Therapies at Royal Prince Alfred Hospital and heads the Gene and Stem Cell Therapy Program at the
Centenary Institute, University of Sydney. Professor Rasko is a clinical haematologist, pathologist and scientist with a productive
track record in gene and stem cell therapy, experimental haematology and molecular biology. In more than 150 publications he
has contributed to the understanding of stem cells and blood cells, gene-transfer technologies, cancer, human kidney disorders
and non-coding RNAs.
Professor Rasko’s contributions to scientific organisations include being co-founder (2000) and past-president (2003–05) of the
29
At <http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gttaccomm-1>.
59
Australasian Gene Therapy Society; vice president of the International Society for Cellular Therapy (ISCT) (2008–12) and founder
(2009) of ISCT-Australia; chair of the Advisory Committee on Biologicals (Therapeutic Goods Administration); scientific advisory
committees and board member for philanthropic foundations; and a member of several ethics committees. He is the recipient of
national (distinguished fellow award at The Royal College of Pathologists of Australasia; Eric Susman Prize for 2011 from The
Royal Australasian College of Physicians; Roche medal from the Australian Society for Biochemistry and Molecular Biology) and
international awards in recognition of his commitment to excellence in medical research, including appointment as an Officer of the
Order of Australia in June 2012 for distinguished service to biomedical research in the field of gene and cell therapy as a clinician.
Professor Rasko previously served as a GTTAC member (2001–03 and 2004–07) and as chair (2008–10 and 2011–14).
GTTAC MEMBERS 2011–14
Table 24: Members of GTTAC at 30 June 2014
Dr Jason Able
Senior lecturer in plant breeding and Durum Breeding Australia Southern Node Leader,
School of Agriculture, Food & Wine, University of Adelaide (South Australia)
Emeritus Professor Craig Atkins
Senior Honorary Research Fellow, School of Plant Biology, University of Western Australia
(Western Australia)
Professor Ross Barnard
Biotechnology Program Director, School of Chemistry and Molecular Biosciences, University
of Queensland (Queensland)
Professor Jacqueline Batley
ARC Future Fellow; School of Plant Biology, University of Western Australia (WA)
Professor Gabrielle Belz
Laboratory Head, Division of Molecular Immunology, Walter and Eliza Hall Institute of
Medical Research, Melbourne (Victoria)
Dr Graham Bonnett
Research Director, CSIRO Agriculture Flagship (Queensland)
Ms Laura Fell
Poultry meat farmer, McLaren Vale (South Australia)
Professor Ian Godwin
Professor in Plant Molecular Genetics, School of Agriculture and Food Sciences, University
of Queensland (Queensland)
Associate Professor John Hayball
School of Pharmacy and Medical Sciences, University of South Australia (South Australia)
Dr Rodney Mahon
Honorary Fellow, CSIRO Land & Water Flagship (Australian Capital Territory)
Dr Michael Michael
Laboratory Head, Flinders Centre for Innovation in Cancer, Flinders Medical Centre (South
Australia)
Dr Gabrielle O’Sullivan
Executive Officer and Member, Institutional Biosafety Committee, Royal Prince Alfred
Hospital (New South Wales)
Associate Professor Marie Ranson
School of Biological Sciences, University of Wollongong (New South Wales)
Professor John Rasko AO (chair)
Director, Cell and Molecular Therapies, Royal Prince Alfred Hospital; and Program Head Centenary
Institute (New South Wales)
Dr Kelly Shaw
Senior consultant KP Health (Tasmania)
Professor Kevin Smith
Professor Plant Breeding, University of Melbourne (Victoria)
Associate Professor Jason Smythe
Senior Business Development Manager, Faculty of Medicine, Monash University; and
Adjunct Associate Professor, Faculty of Science and Engineering, La Trobe University
(Victoria)
Dr Diane Webster
Chair, Swinburne Biosafety Committee; Affiliate Research Fellow, School of Biological
Sciences, Monash University; National Convenor, Women in Science Enquiry Network
(Victoria)
Professor Paul Young
Professor of Virology and Head of School, School of Chemistry and Molecular Biosciences,
University of Queensland (Queensland)
60
GENE TECHNOLOGY ETHICS AND COMMUNITY CONSULTATIVE COMMITTEE
GTECCC’s functions are set out in section 107 of the Gene Technology Act. They are to provide advice, at the request of the
Regulator or the LGFGT, on ethical issues relating to gene technology and on matters of general concern relating to GMOs;
community consultation and risk communication regarding licence applications for DIR; and the need for policy principles, policy
guidelines, codes of practice, technical and procedural guidelines relating to GMOs and GM products and the content of such
principles and codes.
The 2011–14 membership of GTECCC expired on 31 January 2014, with the exception of the cross-member with the AHEC,
Professor Susan Dodds. Professor Dodds was appointed to GTECCC in March 2013 with her term to expire at the end of the
current AHEC triennium, on 30 June 2015. The appointment process for the remaining members of GTECCC for the 2014–17
triennium is ongoing.
The previous GTECCC did not meet between July 2013 and its expiry in January 2014. During this period, GTECCC continued to
maintain a watching brief on developments and reports regarding synthetic biology. On 31 October 2013 the GTECCC-AHEC cross
member, Professor Susan Dodds, attended an AHEC meeting and advised AHEC members of GTECCC’s interest in the issue of
‘dual-use’ research. A report from this AHEC meeting was provided to GTECCC members.
Communiqués from GTECCC meetings, which provide an overview of key matters discussed and resolutions, are published on the
OGTR website and in the Regulator’s quarterly reports to Parliament.
OUTGOING GTECCC CHAIR
Professor Donald Chalmers LLB, LLM retired after 12 years of service as chair of GTECCC; the former Gene Technology Ethics
Committee (GTEC; 2001–07); and the former Gene Technology Community Consultative Committee (GTCCC; 2006–07).
Professor Chalmers has had an exemplary career and he brought significant expertise and experience to his role as committee
chair. He is Professor of Law and Director of the Centre for Law and Genetics at the University of Tasmania (UTAS), a Foundation
Fellow of the Australian Academy of Law and former Dean of the UTAS Faculty of Law.
Professor Chalmers has authored or contributed to numerous government reports, books on various aspects of law and major
legal treatises. He is the recipient of a number of Australian Research Council and National Health and Medical Research
Council (NHMRC) grants to research legal and ethical implications of developments in genetics and he has had significant
involvement with many committees dealing with health, medical research and genetics. Professor Chalmers was chair of AHEC
(1994 to 2000); deputy chair of the NHMRC Embryo Research Licensing Committee (2003–12); a member of the NHMRC
Human Genetics Advisory Committee (2006–09); chair of the Australian Red Cross Human Research Ethics Committee (2000–
10); and board member of the Australian Institute of Family Studies (1998 to 2006).
Professor Chalmers was Law Reform Commissioner in Tasmania (1991–97). In 1985 he chaired the Tasmanian Inquiry into
Artificial Conception and in 1995 he chaired the Commonwealth Ministerial Review of the National Institutional Ethics Committee
System. He is also active and respected internationally and is the deputy chair of the international Human Genome Organisation
Ethics Committee; chair of the International Cancer Genome Consortium Access committee; and a member of the Scientific
Review Panel of Genome Canada (2004–09).
Professor Chalmers’s leadership of GTECCC and its predecessor advisory committees was highly regarded. He actively fostered
interactions with GTTAC and AHEC and under his guidance the committees consistently provided high-quality, considered advice
to the Regulator and produced respected and valuable guidance documents. These documents have strengthened the gene
technology regulatory system and enhanced its credibility.
Most significant is The National Framework of Ethical Principles in Gene Technology 2012 (the Framework), which provides a
national reference point for promoting ethical conduct in gene technology. Professor Chalmers has made a significant contribution
to the Australian gene technology regulatory scheme. His long and active involvement started prior to the establishment of the
national legislative scheme, and included membership of the Commonwealth Biotechnology Advisory Council (1999 to 2002).His
comprehensive knowledge and understanding of health law, genetics and research ethics greatly benefitted the gene technology
advisory committees.
REMUNERATION AND ALLOWANCES FOR COMMITTEE MEMBERS
The Remuneration Tribunal is an independent statutory body that determines the remuneration and allowances for all members of
OGTR committees. Committee members are part-time office holders for the purposes of the Remuneration Tribunal and are paid
in accordance with the current determination for part-time office holders.30
30
More information is available at <www.remtribunal.gov.au>.
61
GTECCC MEMBERS 2011–14
Table 26: Members of GTECCC at 30 June 2014
Professor Susan Dodds
Dean of the Faculty of Arts and Professor of Philosophy, University of Tasmania (Tasmania)
62
APPENDIX 4 STAFF PROFILE AND TRAINING AND DEVELOPMENT ACTIVITIES
This appendix provides information on Australian Public Service (APS) staff employed by the
OGTR in 2013–14 under the Public Service Act 1999.
Tables 27 to 30 provide details on staff numbers and aggregated information on salary, performance pay and non-salary benefits
provided to staff during the year under the Department of Health Enterprise Agreement 2011–2014 and Individual Flexibility
Arrangement.
Tables 31 to 33 show the staff training and development activities conducted in 2013–14.
STAFF PROFILE
Table 27: OGTR staff numbers by classification and contract type at 30 June 2014
Headcount by contract
Nomina
l
classific
ation
REMUNERATIO
N TRIBUNAL
EA
IFA
Section 24
Total
1
HOPO
1
SES 1
2
EL2
2
6
EL1
6
13
13
LEGAL 2
1
1
APS6
21
21
APS5
6
6
APS4
1
1
APS3
2
2
1
Total
43
7
2
53
Table 28: OGTR staff numbers by gender at 30 June 2014
Headcount by gender and
employee group
Employee group
Ongoing
Non-ongoing
Total
Female
Male
23
3
26
Total
25
2
27
48
5
53
Table 29: Number of employee commencements and cessations in financial year 2013–14
Commencements and cessation
2013–14
Action
Hiring employees
Termination
Total
Female
Male
3
4
7
Total
2
3
5
5
7
12
63
PERFORMANCE PAY
Most performance payments made in 2013–14 related to assessments for the 2012–13 cycle. Due to the small numbers of staff at
the SES level, details for SES and non-SES staff have been combined (table 29). Payments have been aggregated to preserve
employees’ privacy. The OGTR makes performance bonus payments available to staff working under a current Individual Flexibility
Arrangement or via individual determination under section 24(1) of the Public Service Act 1999. Determinations are produced
following negotiations with the staff member and the Department of Health (the Department) regarding terms and conditions of
employment.
Table 30: SES and non-SES bonus payments, 1 July 2013 to 30 June 2014
LEVEL
SES Band 1 and non-SES staff
NUMBER
AGGREGATED AMOUNT
9
$75,464.94
TRAINING AND DEVELOPMENT
During 2013–14, OGTR Legal Officer Alceo Turello conducted introductory and ongoing training for OGTR staff on legal issues
(table 31). The Science Cohort Section conducted training on risk assessments (table 32).
Table 31: Internal legal issue training presentations, 2013–14
Date
Topic
July 2013
GM in Australian Litigation
July 2013
Marsh v Baxter Injunction
August 2013
Developments in US GM Alfalfa Litigation
September 2013
Use of Social Media by Commonwealth Employees
January 2014
Non-compliance Responses and Accountability
February 2014
Confidential Commercial Information
March 2014
Information Issues—Privacy and Freedom of Information
March 2014
Code of Conduct Expectations
May 2014
Marsh v Baxter: the defendant's case
May 2014
NZ Zinc finger Case
June 2014
Marsh v Baxter: the Outcome
Table 32: Other internal training presentations, 2013–14
Date
Topic
May 2014
Risk perception parts 1 and 2
March 2014
RAF 2013 training for newcomers
February 2014
Weed risk assessment methodology for GM plants
August 2013
RAF 2013 training parts 1 and 2
The OGTR Forum provides a venue where, in addition to presentations by visiting experts, current information is shared among
staff on topics such as scientific and risk assessment issues, summaries of recent conferences and feedback from international
meetings. A range of OGTR staff and guest speakers made presentations at the OGTR Forum in 2013–14 (table 33).
64
Table 33: Presentations at OGTR Forum, 2013–14
Date
Topic
Speaker
June 2014
The program for Biosafety Systems (PBS): strategies and achievements in Asian and
African partner countries
Mr John Komen
April 2014
Developing modified oils in GM crops
Dr Allan Green, CSIRO
Feedback from OECD meeting on regulatory oversight of biotechnology and
workshop on new plant breeding technologies
Drs Peter Thygesen and Heidi
Mitchell
March 2014
Weed risk and climate change
Dr Darren Kriticos, CSIRO
February 2014
Unintended effects in GMOs: feedback from Canadian workshop
Dr Paul Keese
Bee pollination behaviour
Drs Saul Cunningham and
Lucas Garibaldi, CSIRO
December 2012
Public attitudes to GMOs
Dr Craig Cormick, CSIRO
November 2012
Feedback from Malaysian biosafety workshop
Dr Andrew Berry
October 2012
An African approach to biosafety regulation
Dr Paul Keese
Grains Research and Development Corporation (GRDC)
Dr Juan Juttner, GRDC
Feedback from south Asia biosafety conference
Dr Michael Dornbusch
September 2013
Feedback from APEC workshop on biosafety regulatory perspectives
Dr Joe Smith
August 2013
The International Centre for Genetic Engineering and Biotechnology (ICGEB)
Mr Decio Ripandelli, ICGEB
New genes for new environments
Mr Leigh Smith, DAFWA
Contained Dealings Evaluation Section
Drs Maryanne Shoobridge,
Anuj Srivastava and Jeremy
Turner
Overview of NICNAS and its approach to risk analysis
Dr Daniella Leonte, NICNAS
Feedback from APEC meeting
Dr Robyn Cleland
Overview of Master of Biotechnology (Plant Biotechnology) program at the
University of Adelaide
Prof Diane Mather, University
of Adelaide
July 2013
65
APPENDIX 5 PUBLICATIONS AND GUIDANCE DOCUMENTS
All the documents listed in this appendix were published during 2013–14. Copies are available at <www.ogtr.gov.au>. Paper copies
of certain publications are also available from the OGTR Information Officer.
QUARTERLY REPORTS
Quarterly report for the period 1 April 2013 to 30 June 2013
Quarterly report for the period 1 July 2013 to 30 September 2013
Quarterly report for the period 1 October 2013 to 31 December 2013
66
APPENDIX 6 STAKEHOLDER AND PUBLIC ACCESS TO THE OGTR
The OGTR facilitates accredited agency, stakeholder and public access to its services through a website, an email address and a
free call 1800 number.
WEBSITE USAGE
Table 34 lists the successful hits on the OGTR website. The most requested information sheets and website pages are listed
below.
Table 34: Website activity, 2013–14 and 2012–13
MONTH
HITS
VISITS
2013–14
2012012–13–13
2013–14
2012012–132–13
July
273 687
171 408
32 138
26 398
August
293 963
189 026
32 470
29 584
September
279 727
232 123
35 968
31 954
October
313 268
203 339
37 916
36 148
November
467 408
225 267
58 815
38 152
December
311 184
196 392
44 002
29 320
January
309 920
209 492
42 465
28 981
February
302 530
260 162
40 179
28 574
March
355 648
300 105
52 266
33 262
April
301 751
283 807
54 838
35 311
May
304 748
289 502
46 199
35 733
June
310 009
291 249
41 754
34 133
The most popular pages viewed on the OGTR website during 2013–14 were as follows.










DIR 126—Clinical trial of a genetically modified vaccine against cholera—PaxVax Australia Pty Ltd
Maps of trial sites
What's new
Guidelines and forms for certification of physical containment facilities
List of applications and licences for Dealings involving Intentional Release (DIR) of GMOs into the environment
Record of GMOs and GM product dealings
About the OGTR
List of genetically modified product approvals
Guidelines
Fact sheets
The most popular downloaded documents in 2013–14 were:

Risk Analysis Framework

the biology of Saccharum spp (sugarcane)

the biology of Gossypium hirsutum L. and Gossypium barbadeuse L. (cotton)

the biology of Ananas comosus var. comosus (pineapple)

the biology and Ecology of Rice (Oryza sativa L.) in Australia

the biology of Carica papaya L. (papaya, pawpaw, paw paw)

DIR 126—Receipt of licence application (DIR 126) from PaxVax Australia Pty Ltd for a clinical trial of a GM cholera vaccine
67



The biology of Zea mays L. ssp mays (maize or corn)
PC2 laboratory guidelines
the biology of hybrid tea rose (Rosa x hybrida).
EMAIL ADDRESS AND FREE CALL NUMBER
The 1800 number and the OGTR email address <ogtr@health.gov.au> are points of contact for members of the public and other
interested parties. Assistance with specific questions and additional mechanisms for public feedback are among the services that
the 1800 line and email facilities provide. While there were some peaks in usage of the 1800 number, there was a slight decline in
usage of the email address compared with the previous year (table 35).
Table 35: Email and free call 1800 number activity, 2013–14 and 2012–13
MONTH
EMAILS
1800 NUMBER
2013–14
2012–132012–13
2013–14
2012–132012–13
July
106
83
72
96
August
70
104
35
85
September
82
76
89
89
October
99
98
73
101
November
196
84
210
75
December
98
63
95
66
January
88
79
n/a*
66
February
92
74
n/a*
100
March
171
66
n/a*
95
April
83
91
n/a*
110
May
71
238
n/a*
125
June
75
202
n/a*
92
Total
1231
1258
1100
*due to change of suppliers these figures were not available for these periods.
The Monitoring Section maintains an email inbox to facilitate efficient communication with accredited organisations. The inbox
provides a central point through which accredited organisations can contact the section with queries, legislative notifications and
self-reporting of non-compliances. The Monitoring Section email inbox ensures that all communications are answered efficiently
while staff are away from the office. The inbox received 1044 emails during 2013–14 (823 in 2012–13).
The Regulatory Practice and Secretariat Section maintains an email inbox to facilitate efficient communication between advisory
committee members and secretariat staff. The inbox ensures that secretariat staff answer all communications in a timely manner.
The inbox received 1148 emails during 2013–14 (1361 in 2012–13).
The Contained Dealings Evaluation Section maintains an email inbox to provide a central point for efficient coordination of
responses to queries relating to classification of GMO dealings, high-level facility certification requirements and GMO licences. The
inbox received330 emails during 2013–14 (423 in 2012–13).
The Application and Licence Management Section maintains an email inbox to provide a central, shared communication point to
allow efficient coordination of responses to correspondence and queries about applications the section has received. The inbox
received 2306 emails during 2013–14 (3235 in 2012–13).
The OGTR welcomes feedback on ways to improve provision of information on gene technology regulation.
68
APPENDIX 7 PRESENTATIONS AND MEETINGS ON GENE TECHNOLOGY IN AUSTRALIA
The Regulator and OGTR staff regularly attend and present papers to meetings, forums and conferences in Australia.
Table 36: Presentations and representations made in Australia, 2013–14
DATE
EVENT
LOCATION
July 2013
Regulators’ Forum
Canberra
July 2013
Australian Society for Microbiology annual meeting 2013
Adelaide
August 2013
Food Standards Australia New Zealand workshop on new
plant breeding techniques
Canberra
September 2013
Meeting of South Australian IBCs
September 2013
InterDrought IV Conference
Perth
September 2013
Biosecurity course at the Australian National University
Canberra
September 2013
Society for Risk Analysis—Australia and New Zealand
Conference
Canberra
September 2013
Australian Seed Federation 2013 Convention
Gold Coast
October 2013
Seminar given to students as part of a tertiary
biotechnology course at Australian National University
Canberra
October 2013
Department of Industry biomass-based industries working Canberra
group meeting
October 2013
Low Level Presence (LLP)/Unintended Presence (UP)
Australian Government agency meeting
Canberra
November 2013
Australasian Environmental Law Enforcement and
Regulators Network Conference
Melbourne
November 2013
Department of Agriculture’s 'Let's Talk Genes' Forum
Canberra
November 2013
Regulatory Science Network Risk Communication
Workshop
Canberra
November 2013
CropLife National Members’ Forum
Canberra
November 2013
AusBiotech Agriculture and Food Biotechnology
Symposium
Brisbane
November 2013
Lucerne Australian Symposium 2013
Keith, South Australia
February 2014
Presented at the Regulatory Science Network meeting
Canberra
February 2014
CropLife meeting—LLP, AHTEG, Review response
Canberra
March 2014
Canberra Biological Weapons Convention & Chemical
Weapons Convention IDC – Department of Foreign
Affairs and Trade
Canberra
March 2014
Presentation to Therapeutic Goods Administration
Canberra
May 2014
CSIRO Biosecurity Futures Workshop
Canberra
69
GLOSSARY
The terms described in this glossary are important to understanding this report; they do not, however, substitute for the definitions
of terms relevant to the operation of the gene technology regulatory system contained in section 10 of the Gene Technology Act
2000.
Accredited organisation
an organisation that is accredited under section 92 of the Gene Technology Act 2000
Agreement
the inter-governmental Gene Technology Agreement that all Australian jurisdictions signed in 2001 that
underpins the nationally consistent regulatory framework for gene technology
APS
Australian Public Service
APVMA
Australian Pesticides and Veterinary Medicines Authority
CCI
confidential commercial information declared under section 185 of the Gene Technology Act 2000
Certification Guidelines
Guidelines for Certification of a Physical Containment Facility
Collective Agreement
a collective agreement for staff of the Department of Health and Ageing 2007–11
Clock stop
the period during which the statutory time limit for making a decision on an application is suspended—usually
because evaluation cannot proceed until additional information requested from an applicant is received
COAG
Council of Australian Governments
Contained dealing
see DNIR
CSIRO
Commonwealth Scientific and Industrial Research Organisation
Dealing
to ‘deal with’ a GMO is defined in section 10 of the Gene Technology Act 2000 and includes (but is not limited
to) experiment with, manufacture, breed, propagate, grow, culture, import, transport and dispose of a GMO, and
to possess, supply or use a GMO in the course of any of these
Department
Australian Government Department of Health
DIR
a dealing involving intentional release of a GMO into the environment (for example, field trial or commercial
release)
DNIR
a contained dealing with a GMO not involving intentional release of the GMO into the environment (for example,
experiments in a certified facility such as a laboratory)
EDD
Emergency Dealing Determination
FSANZ
Food Standards Australia New Zealand
GM
genetically modified
GM product
a thing (other than a GMO) derived or produced from a GMO
GMO
genetically modified organism
GMO Record
Record of GMO and GM product dealings
GST
goods and services tax
GTCCC
Gene Technology Community Consultative Committee
GTEC
Gene Technology Ethics Committee
GTECCC
Gene Technology Ethics and Community Consultative Committee
GTSC
Gene Technology Standing Committee
GTTAC
Gene Technology Technical Advisory Committee
IBC
institutional biosafety committee
Incident
a self-reported event that may constitute a non-compliance with regulatory requirements and a public health or
70
Accredited organisation
an organisation that is accredited under section 92 of the Gene Technology Act 2000
environment risk
KPI
key performance indicator
LGFGT
Legislative and Governance Forum on Gene
LLP
low level presence
MOU
memorandum of understanding
NHMRC
National Health and Medical Research Council
NICNAS
National Industrial Chemicals Notification and Assessment Scheme
NLRD
notifiable low-risk dealing (for example, plant or tissue culture work undertaken in a certified physical
containment facility)
OECD
Organisation for Economic Co-operation and Development
OGTR
Office of the Gene Technology Regulator
PBS
Portfolio Budget Statement
PC1/PC2/PC3/PC4
physical containment (PC) levels of facilities certified by the Regulator
PHM
post-harvest monitoring
Physical containment facility
a building or place certified by the Regulator to a specified containment level under section 84 of the Gene
Technology Act 2000
RAF
Risk Assessment Framework
RARMP
risk assessment and risk management plan
Regulations
Gene Technology Regulations 2001
Regulator
Gene Technology Regulator
RSN
Regulatory Science Network
SSBA
security sensitive biological agents
TGA
Therapeutic Goods Administration
TSD Guidelines
Guidelines for the Transport, Storage and Disposal of GMOs
Volunteer
regrowth of plant from seed that has remained on a site after a trial has been completed
WHO
World Health Organization
71
LIST OF REQUIREMENTS
31∗
Ref
Part of report
8(3) & A.4
Letter of transmittal
Table of contents
Index
Glossary
Contact officer(s)
Internet home page address and internet
address for report
A.5
A.5
A.5
A.5
A.5
9
9(2)
9(2)
9(2)
9(3)
10(1)
10(1)
10(2)
10(3)
11(1)
11(2)
11(2)
11(2)
Review by departmental secretary
Summary of significant issues and
developments
Overview of department’s performance and
financial results
Outlook for following year
Significant issues and developments –
portfolio
Mandatory
Suggested
Role and functions
Organisational structure
Outcome and programme structure
Where outcome and programme structures
differ from PBSs/Portfolio Additional
Estimates Statements (PAES) or other
portfolio statements accompanying any other
additional appropriation bills (other portfolio
statements), details of variation and reasons
for change
Portfolio structure
Mandatory
Mandatory
Mandatory
Mandatory
Review of performance during the year in
relation to programmes and contribution to
outcomes
Actual performance in relation to
deliverables and KPIs set out in PBSs/PAES
or other portfolio statements
Where performance targets differ from the
PBS/PAES, details of both former and new
targets, and reasons for the change
Narrative discussion and analysis of
Mandatory
Suggested
Suggested
Portfolio
departments
(suggested)
Departmental
overview
10(1)
11
Requireme
nt
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Review by
Secretary
9(1)
10
Description
Portfolio
departments
(mandatory)
Report on
performance
Mandatory
Mandatory
Mandatory
* The reference is to the location of the item in the requirements – e.g. ‘A.4’ refers to the fourth item in
Attachment A.
31
72
31∗
Ref
Part of report
performance
Trend information
Significant changes in nature of principal
functions/services
Performance of purchaser/provider
arrangements
11(2)
11(3)
11(3)
11(3)
Factors, events or trends influencing
departmental performance
Contribution of risk management in
achieving objectives
Performance against service charter
customer service standards, complaints data,
and the department’s response to complaints
Discussion and analysis of the department’s
financial performance
Discussion of any significant changes in
financial results from the prior year, from
budget, or anticipated to have a significant
impact on future operations
Agency resource statement and summary
resource tables by outcomes
11(3)
11(4)
11(5)
11(6)
11(7)
12
Description
Requireme
nt
Mandatory
Suggested
If
applicable
(suggested)
Suggested
Suggested
If
applicable
(mandatory)
Mandatory
Mandatory
Mandatory
Management
and
accountability
Corporate
governance
12(1)
Agency heads are required to certify that
their agency complies with the
‘Commonwealth Fraud Control Guidelines’
Statement of the main corporate governance
practices in place
Names of the senior executive and their
responsibilities
Senior management committees and their
roles
Corporate and operational plans and
associated performance reporting and review
Internal audit arrangements including
approach adopted to identifying areas of
significant financial or operational risk and
arrangements to manage those risks
Policy and practices on the establishment
and maintenance of appropriate ethical
standards
How nature and amount of remuneration for
senior executive service officers is
determined
12(2)
12(3)
12(3)
12(3)
12(3)
12(3)
12(3)
Mandatory
Mandatory
Suggested
Suggested
Suggested
Suggested
Suggested
Suggested
External
scrutiny
73
31∗
Ref
Part of report
12(4)
Description
Significant developments in external
scrutiny
Judicial decisions and decisions of
administrative tribunals and by the
Australian Information Commissioner
Reports by the Auditor-General, a
Parliamentary Committee. the
Commonwealth Ombudsman or an agency
capability review
12(4)
12(4)
Requireme
nt
Mandatory
Mandatory
Mandatory
Management of
human
resources
12(5)
12(6)
12(6)
12(6)
12(6)
12(6)
12(7)
12(8)
12(9) & B
12(10)-(11)
Assets
management
12(12)
Purchasing
12(13)-(22)
Consultants
Assessment of effectiveness in managing
and developing human resources to achieve
departmental objectives
Workforce planning, staff retention and
turnover
Impact and features of enterprise or
collective agreements, individual flexibility
arrangements (IFAs), determinations,
common law contracts and Australian
Workplace Agreements (AWAs)
Training and development undertaken and
its impact
Work health and safety performance
Productivity gains
Statistics on staffing
Enterprise or collective agreements, IFAs,
determinations, common law contracts and
AWAs
Performance pay
Assessment of effectiveness of assets
management
Assessment of purchasing against core
policies and principles
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
Suggested
Suggested
Suggested
Suggested
Suggested
Mandatory
Mandatory
Mandatory
If
applicable
(mandatory)
Mandatory
Mandatory
74
31∗
Part of report
Description
12(23)
Australian
National Audit
Office access
clauses
Exempt
contracts
Financial
statements
Other
mandatory
information
Absence of provisions in contracts allowing
access by the Auditor-General
Ref
12(24)
13
14(1) & C.1
14(1) & C.2
14(1) & C.3
14(1)
14(2) & D.1
14(3) & D.2
14(4) & D.3
14(5)
E
F
Requireme
nt
Mandatory
Contracts exempted from publication in
AusTender
Financial statements
Mandatory
Work health and safety (Schedule 2, Part 4
of the Work Health and Safety Act 2011)
Advertising and market research (section
311A of the Commonwealth Electoral Act
1918) and statement on advertising
campaigns
Ecologically sustainable development and
environmental performance (section 516A of
the Environment Protection and Biodiversity
Conservation Act 1999)
Compliance with the agency’s obligations
under the Carer Recognition Act 2010
Mandatory
Grant programmes
Disability reporting—explicit and
transparent reference to agency-level
information available through other
reporting mechanisms
Information Publication Scheme statement
Correction of material errors in previous
annual report
Agency resource statements and resources
for outcomes
List of requirements
Mandatory
Mandatory
Mandatory
If
applicable
(mandatory)
Mandatory
Mandatory
Mandatory
If
applicable
(mandatory)
Mandatory
Mandatory
* Refer to the Department of Health and Ageing 2013–14 annual report.
75