1. This chapter describes the parameters within which risks that may be posed to the health and safety of people and the environment by the proposed release are assessed. These include the scope and boundaries for the evaluation process required by the gene technology legislation, details of the intended dealings, the genetically modified organisms (GMO(s)) and parent organism(s), previous approvals and releases of the same or similar GMO(s) in Australia or overseas, environmental considerations and relevant horticultural practices. The parameters for the risk assessment context are summarised in Figure 1.
RISK ASSESSMENT CONTEXT
Gene Technology Act and Regulations
Scope and boundaries of the risk assessment
|RISK ASSESSMENT METHODOLOGY|
|PROPOSED DEALINGS||PARENT ORGANISM|
|Proposed activities involving the GMO
Proposed limits of the release
Proposed control measures
|Origin and taxonomy|
Cultivation and use
|Introduced genes (genotype)|
Novel traits (phenotype)
Sexually compatible relatives
|PREVIOUS RELEASES||Presence of similar genes|
2. For this application, establishing the risk assessment context includes consideration of:
- the legislative requirements (Section 2)
- the risk assessment methodology6
- the proposed dealings (Section 3)
- the parent organism (Section 4)
- the GMO, nature and effect of the genetic modification (Section 5)
- the receiving environment (Section 6)
- previous releases of this or other GMOs relevant to this application (Section 7).
6The risk assessment methodology used by the Regulator is outlined in more detail on the OGTR website - documents relating to the Risk Assessment process.