1. This chapter describes the parameters within which risks that may be posed to the health and safety of people or 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 organism(s) (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 agricultural practices. The parameters for the risk assessment context are summarised in Figure 1.
RISK ASSESSMENT CONTEXT |
|
| LEGISLATIVE REQUIREMENTS Gene Technology Act and Regulations Scope and boundaries of the risk assessment | |
| PROPOSED DEALINGS | PARENT ORGANISM |
| Proposed activities involving the GMO Proposed limits of the release Proposed control measures |
Origin and taxonomy Cultivation and use Biological characterisation Ecology |
| GMO | RECEIVING ENVIRONMENT |
| Introduced genes (genotype) Novel traits (phenotype) | Environmental conditions Agronomic practices Sexually compatible relatives Presence of similar genes |
| PREVIOUS RELEASES | |
Figure 1. Components of the context considered during the preparation of the risk assessment
2. For this application, establishing the risk assessment context includes consideration of:
- the legislative requirements (Section 2)
- the risk assessment methodology1
- the proposed dealings (Section 3)
- the parent organism (Section 4)
- the GMOs, nature and effect of the genetic modifications (Section 5)
- the receiving environment (Section 6)
- previous releases of these or other GMOs relevant to this application (Section 7).
1The risk assessment methodology used by the Regulator is outlined in more detail at Documents relating to the Risk Assessment process.