APPENDIX 1 History and structure of the gene technology regulatory system Development of the Gene Technology Act 2000 Governance arrangements 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 Email address and free call number APPENDIX 7 Presentations and meetings on gene technology in Australia Glossary List of requirements Index CHAPTER 1 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
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, 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 Part of report Description 8(3) & A.4 Letter of transmittal Mandatory A.5 Table of contents Mandatory A.5 Index Mandatory A.5 Glossary Mandatory A.5 Contact officer(s) Mandatory A.5 Internet home page address and internet address for report Mandatory 9 Review by Secretary 9(1) Review by departmental secretary Mandatory 9(2) Summary of significant issues and developments Suggested 9(2) Overview of department’s performance and financial results Suggested 9(2) Outlook for following year Suggested
9(3) Significant issues and developments – portfolio Portfolio departments (suggested) 10 Departmental overview 10(1) Role and functions Mandatory 10(1) Organisational structure Mandatory 10(1) Outcome and programme structure Mandatory 10(2) 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 Mandatory 10(3) Portfolio structure Portfolio departments (mandatory) 11 Report on performance 11(1) Review of performance during the year in relation to programmes and contribution to outcomes Mandatory 11(2) Actual performance in relation to deliverables and KPIs set out in PBSs/PAES or other portfolio statements Mandatory 11(2) Where performance targets differ from the PBS/PAES, details of both former and new targets, and reasons for the change Mandatory 11(2) Narrative discussion and analysis of performance Mandatory 11(2) information Mandatory 11(3) Significant changes in nature of principal functions/services Suggested 11(3) Performance of purchaser/provider arrangements If applicable (suggested) 11(3) Factors, events or trends influencing departmental performance Suggested 11(3) Contribution of risk management in achieving objectives Suggested 11(4) Performance against service charter customer service standards, complaints data, and the department’s response to complaints If applicable (mandatory) 11(5) Discussion and analysis of the department’s financial performance Mandatory 11(6) Discussion of any significant changes in financial results from the year, from budget, or anticipated to have a significant impact on future operations Mandatory
the Environment Protection and Biodiversity Conservation Act 1999) 14(1) Compliance with the agency’s obligations under the Carer Recognition Act 2010 If applicable (mandatory) 14(2) & D.1 Grant programmes Mandatory 14(3) & D.2 Disability reporting—explicit and transparent reference to information available through other reporting mechanisms Mandatory 14(4) & D.3 Information Publication Scheme statement Mandatory 14(5) Correction of material errors in previous annual report If applicable (mandatory) E Agency resource statements and resources for outcomes Mandatory F List of requirements Mandatory * to the Department of Health and Ageing 2013–14 annual report.