336. Uncertainty is an intrinsic property of risk and is present in all aspects of risk analysis, including risk assessment, risk management and risk communication. Both dimensions of risk (ie consequence and likelihood) are always uncertain to some degree.

337. Uncertainty in risk assessments can arise from incomplete knowledge or inherent biological variability1 For commercial/general releases, where there may not be limits and controls to restrict the spread and persistence of the GMOs and their genetic material in the environment, uncertainty may be addressed through post release review (see Chapter 3, Section 4).

338. InVigor® x Roundup Ready® canola has been approved by the Regulator for limited and controlled release (field trials) under licences DIR 069/2006 and DIR 104. These licences also authorised the release of several other lines of GM canola as well as lines of GM Indian mustard (Brassica juncea). In the DIR 069/2006 and DIR 104 RARMPs, information was identified as requiring possible consideration if Bayer were to submit an application for a larger scale release of the GMOs. The information identified that is relevant to the GM canola lines can be categorised as follows:

    • additional molecular and biochemical characterisation of the GM canola and Indian mustard lines (eg genotypic stability, and expression levels of the introduced genes)
    • data on the potential toxicity of plant material from the GM canola and Indian mustard lines including levels of known endogenous toxins
    • phenotypic characterisation of the GM canola and Indian mustard lines, particularly with respect to traits that may contribute to biotic or abiotic stress tolerance, weediness (eg germination and reproductive capacity) or persistence (eg seed dormancy)
    • the level of pollen mediated gene flow between both canola and Indian mustard and related species in Australia

339. Bayer has submitted five reports characterising the InVigor® x Roundup Ready® canola proposed for commercialisation in Australia in relation to the first three points listed above. These have been discussed in Chapter 1.

340. No new data on the level of pollen mediated gene flow between canola and related plants in Australia was provided by the applicant. However, the uncertainty noted in the RARMP for DIR 104 was associated with the potential for pollen-mediated gene flow from GM Indian mustard plants, rather than from the GM canola. Information on gene flow from canola is available in published literature, and the potential for gene flow between canola and sexually related plants is discussed in Risk Scenario 4.

341. For all commercial or long-term releases uncertainty exists in relation to changes in the context surrounding the release. The risk assessment has been prepared in the context of current agricultural practices, climate and weather patterns, and the conclusions are appropriate in this context, however, over time if these were to change then the appropriateness of these conclusions is less certain.

342. The level of uncertainty about InVigor® x Roundup Ready® canola is considered to be low given the now several years of growing the parental GM canola lines in Australia and overseas, eg in Canada and the USA.

1A more detailed discussion is contained in the Regulator’s Risk Analysis Framework available at the OGTR website or via Free call 1800 181 030.