Table 3: Prescribed timeframes for applications Category Timeframe (working days) Accreditation 90 (r. 16) Certification 90 (r. 14) DIR—limited and controlled, no significant risk 150 (r. 8) DIR—limited and controlled, significant risk 170 (r. 8) DIR—except for limited and controlled releases 255 (r. 8) DNIR 90 (r. 8) Licence variation 90 (r. 11A) DIR = dealing involving intentional release of a genetically modified organism into the environment; DNIR = contained dealing with a genetically modified organism not involving intentional release into the environment; r = regulation Operational achievements This section describes the achievements of delivering national gene technology regulation and performance against Outcome 7 (Health Infrastructure, Regulation, Safety and Quality) of the 2015–16 Department of Health PBS. It provides details of achievements on deliverables and performance indicators in the key of: assessments and authorisations under the Act monitoring of GMOs compliance with the Act consultation with stakeholders cooperation with relevant regulatory agencies operational changes arising from the 2013 response by all Australian governments to the 2011 review of the Act. Assessments and approvals Information on performance against deliverables and key performance indicators, as set out in the 2015–16 Department of Health PBS, is summarised in the second part of this chapter. In 2015–16, the OGTR received 1571 applications and notifications, as defined under the Act (Table 4). The timing and volume of applications each year can be influenced by a range of factors, including research grant funding cycles, seasonal agricultural factors and changes to legislation. Table 4: Applications and notifications, 2015–16 Application type Received Withdrawn Approveda Refused Ceased considerationb Under considerationc Accreditation 3 0 4 1 0 0 CCI declaration for DIR licence 7 0 4 0 0 8 CCI declaration for DNIR licence 1 0 0 0 0 5
improve the operation of the Gene Technology Act. These generally minor amendments included addition of emergency powers to the Act that give the minister the ability to expedite approval of a GMO in emergencies. The amendments were made as a result of the 2005–06 statutory review of the Act and the Gene Technology Agreement (Gene Technology Amendment Act 2007 and Gene Technology Amendment Regulations 2007). The Gene Technology Amendment Act 2015 implemented five recommendations of the LGFGT’s 2011 independent review of the Gene Technology Act, agreed by the LGFGT in 2013. The amendments commenced on 11 March 2016. Table 20: Amendments to Commonwealth gene technology legislation Amending legislation Change informed by Summary of changes Gene Technology Amendment Regulations 2006 2004–06 Regulator’s review Changes to requirements for IBC assessment, notification and conduct of Changes to classification of particular GMO dealings as exempt, NLRD or licensable Changes to classification of particular techniques as not gene technology, and particular organisms as not GMOs Licence application requirements detailed in forms issued by the Regulator Gene Technology Amendment Act 2007 2005–06 independent statutory review of the Gene Technology Act 2000 Capacity to authorise a GMO by an emergency dealing determination Capacity to authorise disposal of GMOs by an inadvertent dealings licence Specific requirements for assessment and consultation on limited and controlled release licence applications Changes to application timeframes Replacement of Gene Technology Ethics Committee and Gene Technology Community Consultative Committee by Gene Technology Ethics and Community Consultative Committee Gene Technology Amendment Regulations 2007 2005–06 independent statutory review of the Gene Technology Act 2000 Annual notification of Changes to classification and containment requirements for NLRDs Changes to exempt dealing requirements Gene Technology Amendment Regulations 2009 Council of Australian Governments’ recommendations Capacity for OGTR inspectors to be appointed as inspectors for Security Sensitive Biological Agents Regulatory Scheme Gene Technology Amendment Regulations 2011 2008–11 Regulator’s review Clarification of requirements for IBC assessment, notification, containment and conduct of NLRDs, including transport, storage and disposal guidelines Changes to classification of particular GMO dealings as exempt, NLRD or licensable Gene Technology Amendment Act 2015 2011 independent review of the Gene Technology Act 2000 Minor and technical amendments