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

LEGISLATIVE REQUIREMENTS
Gene Technology Act and Regulations
Scope and boundaries of the risk assessment
RISK ASSESSMENT METHODOLOGY
PROPOSED DEALINGSPARENT ORGANISM
Proposed activities involving the GMO
Proposed limits of the release
Proposed control measures
Origin and taxonomy
Cultivation and use
Biological characterisation
Ecology
GMORECEIVING ENVIRONMENT
Introduced genes (genotype)
Novel traits (phenotype)
Environmental conditions
Agronomic practices
Sexually compatible relatives
PREVIOUS RELEASESPresence of similar genes
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 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.