4.1 Regulatory scheme and the role of the Gene Technology RegulatorAll dealings with GMOs require authorisation under the Gene Technology Act 2000 (the GT Act). (See Appendix 1.) The objective of the GT Act is “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 GMOs”. The Gene Technology Regulator (the Regulator) administers the national regulatory system established by the Act.
The Office of the Gene Technology Regulator (OGTR) provides administrative support to the Regulator in the performance of his functions. The Regulator, supported by the OGTR, is responsible for assessing and issuing licences for dealings with GMOs, accrediting organisations undertaking gene technology, and certifying facilities. Requirements for ensuring risk management and monitoring all dealings with GMOs and, where licensed, any intentional release are variously provided through the GT Act, the Regulations, Guidelines issued by the Regulator, and conditions imposed through licences, certification of facilities and accreditation of organisations.
The Regulator’s approach to undertaking risk assessments of dealings with GMOs is set out in the Risk Analysis Framework (the RAF) (OGTR 2009). The RAF deals with how long-term and short-term impacts of dealings with GMOs should be assessed and the way that dealings should be managed according to identified best scientific practices.
The RAF acknowledges the importance of considering ethical dimensions of risk assessment and notes that OGTR’s risk analysis process should be consistent with the principles outlined by GTECCC. When the RAF was revised and updated in 2007, specific reference was made to the ethical issues of safeguards where data is lacking, scientific uncertainty, environmental impacts and the “precautionary principle” as defined in the GT Act, namely that “where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation”.
4.2 The Gene Technology Ethics and Community Consultative CommitteeThe GTECCC is a statutory advisory committee established under section 106 of the GT Act to advise both the Gene Technology Regulator and Legislative and Governance Forum on Gene Technology. The GTECCC continues to provide advice to the Regulator on ethical issues relating to gene technology, the need for, and content of, policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons, and codes of practice in relation to ethics.
In this role, GTECCC developed the National Framework 2012 to provide a national reference point to promote the ethical conduct of dealings with gene technology consistent with the objectives of the GT Act.
The opinions expressed in this discussion paper represent the views of the GTECCC and do not necessarily reflect those held by the Office of the Gene Technology Regulator (OGTR) that provides the Secretariat to the Committee.
Figure 1. Australian system for regulation of gene technology
APVMA: Australian Pesticides and Veterinary Medicines Authority
DAFF Biosecurity: Department of Agriculture, Fisheries and Forestry Biosecurity (formerly Australian Quarantine & Inspection Service)
FSANZ: Food Standards Australia New Zealand
GTTAC: Gene Technology Technical Advisory Committee
GTECCC: Gene Technology Community Consultative Committee
NICNAS: National Industrial Chemicals Notification and Assessment Scheme
Regulated Community: accredited organisations and Institutional Biosafety Committees (IBCs)
TGA: Therapeutic Goods Administration
4.3 National Framework 2006The National Framework 2012 builds on the principles laid down in the National Framework for the Development of Ethical Principles in Gene Technology 2006 (National Framework 2006). The National Framework 2006 was developed by the former Gene Technology Ethics Committee (GTEC) – now the Gene Technology Ethics and Community Consultative Committee (GTECCC) – to provide guidance on the ethical issues relating to gene technology under the GT Act (see section 107). The National Framework 2006 was consistent with international standards at the time and acknowledged the emergence and development of environmental ethics that underpin gene technology. This includes the care and protection of the environment and natural ecosystems, respect for biodiversity, the precautionary approach, and encouraging sustainability.
GTECCC reviewed the National Framework 2006 in 2009–10 through an independent national survey2. Survey responses identified a need to strengthen the application of the principles in the National Framework 2006 and provide better promotion of its use. The survey gave support to the National Framework as a means to encourage ethical conduct in gene technology — in particular where it related to human health, the environment, genetically modified organisms and products. Based on these results, GTECCC decided to publish this new National Framework 2012, reflecting feedback from the survey as well as international instruments and developments, changes to the regulatory context and community attitudes. The National Framework 2012 provides ethical guidance which can be used by regulated entities, and which they can be encouraged to refer.
2An online survey of regulated and non-regulated stakeholders was conducted by ORIMA Research Pty Ltd in March–April 2010: Survey of Regulated and Non-Regulated Clients to Inform the Review of the National Framework for the Development of Ethical Principles in Gene Technology.