4. In accordance with section 50A of the Gene Technology Act 2000 (the Act), this application is considered to be a limited and controlled release application, as its principal purpose is to enable the applicant to conduct experiments and the applicant has proposed limits on the size, locations and duration of the release, as well as controls to restrict the spread and persistence of the GMOs and their genetic material in the environment. Therefore, the Gene Technology Regulator (the Regulator) was not required to consult with prescribed experts, agencies and authorities before preparation of the Risk Assessment and Risk Management Plan (RARMP; see section 50 of the Act).

5. Section 51 of the Act and regulation 9A of the Regulations outline the matters the Regulator must take into account in preparing a RARMP.

6. Section 52 of the Act requires the Regulator to seek comment on the RARMP from the States and Territories, the Gene Technology Technical Advisory Committee, Commonwealth authorities or agencies prescribed in the Regulations, the Minister for the Environment, relevant local council(s), and the public. The advice from the prescribed experts, agencies and authorities and how it was taken into account is summarised in Appendix A. No public submissions were received.

7. The Risk Analysis Framework (OGTR 2009) explains the Regulator’s approach to the preparation of RARMPs in accordance with the legislative requirements. Additionally, there are a number of operational policies and guidelines developed by the Office of the Gene Technology Regulator (OGTR) that are relevant to DIR licences. These documents are available from the OGTR website.

8. Any dealings conducted under a licence issued by the Regulator may also be subject to regulation by other Australian government agencies that regulate GMOs or GM products, including Food Standards Australia New Zealand (FSANZ), Australian Pesticides and Veterinary Medicines Authority (APVMA), Therapeutic Goods Administration, National Industrial Chemicals Notification and Assessment Scheme and Department of Agriculture, Fisheries and Forestry (DAFF) Biosecurity (formerly Australian Quarantine and Inspection Service). These dealings may also be subject to the operation of State legislation declaring areas to be GM, GM free, or both, for marketing purposes.