Abbreviations APVMA Australian Pesticides and Veterinary Medicines Authority Avr avirulence bp Base pair CaMV Cauliflower mosaic virus CCI Confidential Commercial Information ced-9 Cell death abnormality gene9 DBFC Darwin Banana Farming Company DIR Dealings involving Intentional Release DNA Deoxyribonucleic acid Foc Fusarium oxysporum forma specialis (f. sp) cubense Foc TR4 Fusarium oxysporum forma specialis (f. sp) cubense (Foc) tropical race 4 (TR4) FSANZ Food Standards Australia New Zealand GM Genetically modified GMO Genetically modified organism ha Hectare HR Hypersensitive response km Kilometres LGA Local Government Area m Metres NBS-LRR nucleotide binding site-leucine rich repeat NLRD Notifiable Low Risk Dealing nptII Neomycin phospotransferase II gene NSW New South Wales NT Northern Territory OGTR Office of the Gene Technology Regulator PCD Programmed cell death PC2 Physical Containment level 2 QLD Queensland QUT Queensland University of Technology R gene Gene conferring resistance to a particular pathogen RARMP Risk Assessment and Risk Management Plan Regulations Gene Technology Regulations 2001 Regulator Gene Technology Regulator RGA2 NBS-LRR type resistance gene TEV Tobacco etch virus the Act The Gene Technology Act 2000 TR4 Tropical race 4 WA Western Australia
details of inspection activities. Monitoring for compliance The Act stipulates, as a condition of every licence, that a person who is authorised by the licence to deal with a GMO, and who is required to comply with a condition of the licence, must allow inspectors and other persons authorised by the Regulator to enter premises where a dealing is being undertaken for the purpose of monitoring or auditing the dealing. Post-release monitoring continues until the Regulator is satisfied that all the GMOs resulting from the authorised dealings have been removed from the release site. If monitoring activities identify changes in the risks associated with the authorised dealings, the Regulator may also vary licence conditions, or if necessary, suspend or cancel the licence. In cases of non-compliance with licence conditions, the Regulator may instigate an investigation to determine the nature and extent of non-compliance. The Act provides for criminal sanctions of large fines and/or imprisonment for failing to abide by the legislation, conditions of the licence or directions from the Regulator, especially where significant damage to health and safety of people or the environment could result. Issues to be addressed for future releases Additional information has been identified that may be required to assess an application for a commercial release of these GM banana lines, or to justify a reduction in limits and controls. This includes: additional molecular and biochemical characterisation of the GM banana lines, particularly with respect to potential for increased toxicity and allergenicity, and additional phenotypic characterisation of the GM banana lines, particularly with respect to traits which may contribute to weediness. Conclusions of the consultation RARMP The RARMP concludes that the proposed limited and controlled release of GM banana poses negligible risks to the health and safety of people or the environment as a result of gene technology, and that these negligible risks do not require specific risk treatment measures. However, conditions have been imposed to limit the release to the proposed size, location and duration, and to restrict the spread and persistence of the GMOs and their genetic material in the environment, as these were important considerations in establishing the context for assessing the risks.