Summary of issues raised in submissions received from prescribed experts, agencies and authorities6 on the consultation RARMP for DIR 113


The Regulator received several submissions from prescribed experts, agencies and authorities on the consultation RARMP. All issues raised in submissions that related to risks to the health and safety of people and the environment were considered in the context of the currently available scientific evidence and were used in finalising the RARMP that formed the basis of the Regulator’s decision to issue the licence. Advice received is summarised below.

Abbreviations: Bt: Bacillus thuringiensis; CCI: Confidential Commercial Information; DIR: Dealings involving Intentional Release; GM: Genetically Modified; GMO: Genetically Modified Organism; OGTR: Office of the Gene Technology Regulator; RARMP: Risk Assessment and Risk Management Plan

Summary of issues raisedComments
Agrees with the overall conclusions of the RARMP.Noted.
Suggests that the technical summary of the RARMP (in addition to the licence conditions) should explicitly state that cotton used in the pollen trap must be treated in the same way as GM cotton.The Technical Summary has been modified to include this point.
Agrees that this dealing does not represent a risk to human health and the environment.Noted.
Suggests that the OGTR should consider including a requirement for licence holders to document any observed unusual incidents that occur during the trial.Licence condition 19 requires the licence holder to inform the Regulator if the licence holder becomes aware of any unintended effects of the dealings authorised by the licence.
Suggests that the OGTR should consider analysing the identified / unidentified risks that eventuated from previously approved DIR licences and publishing the results.The risk assessment process for this release considered risk assessments and monitoring reports from previous DIR licences involving similar GM traits.
Given the previous releases approved by the Regulator, along with the scale and the purpose of the proposed release, considers that the proposed licence conditions are appropriate.Noted.
Suggests that the field trial be used as an opportunity to acquire further data which reduces apparent uncertainty around potential toxicity to non-target species, especially in the case of ‘stacked’ traits.In Chapter 3, Section 4, of the RARMP it is stated that additional data on potential increases in toxicity to non-target invertebrates as a result of stacked insect resistance genes may be required to assess a large-scale or commercial release of the GM cotton varieties. OGTR has advised the licence holder that they should consider how this data could be collected.
The evidence supplied indicates that the proposed containment measures are adequate to minimise the risk of spread of the GMOs.Noted.
Suggests that landholders adjoining the trial site be advised of this application and the control processes involved.In Chapter 2 of the RARMP, Risk Scenarios 3 and 4 consider the likelihood of spread and persistence of the GMOs beyond the trial sites, or of interbreeding with cotton plants outside the trial sites. In the context of the limits and controls imposed by the licence conditions, these scenarios are assessed as posing negligible risks. Therefore, the Regulator has not imposed an additional licence condition requiring notification of landholders adjoining the trial sites. However Bayer and/or the site landholder may choose to inform adjacent landholders.
Satisfied with the conclusions of the draft RARMP. Considers that the proposed licence conditions would minimise the risk of gene transfer, weediness and toxicity to organisms to an acceptable level.Noted.
Points out that cotton has demonstrated long term survival in northern Australia and is classified as a minor to moderate weed, requiring control in a small number of locations. Cold stress is presented in the RARMP as an abiotic factor which could limit cotton weediness potential; however, this is unlikely to be a relevant factor in the north of Western Australia. In this area, it is possible that insect predation is a factor limiting cotton survival, and it is plausible that the genetic modifications for insect resistance may increase the weediness potential of the GM cotton. While it is agreed that the limited nature of the trial and the proposed controls will reduce the risks, it is recommended that the applicant should collect data on potential fitness advantages for these GM cotton varieties, particularly information about the effects of gene stacking on their potential weediness in suitable non-agricultural environments. This data would inform the risk assessment should the applicant seek approval for any larger scale or commercial release application of these GM cotton varieties.The RARMP states that the abiotic factors limiting cotton survival in Australia are cold stress, dry stress and soil suitability. Although the north of Western Australia would be warm enough to allow cotton persistence, none of the field trial sites are consistently wet enough to allow cotton persistence. A sentence has been added to Risk Scenario 3 in Chapter 2 of the RARMP to emphasise this point.
In the context of the locations, limits and controls of the current release, the potential persistence of these GM cotton varieties is considered to be limited by abiotic factors, and therefore modifications for insect resistance are not expected to increase weediness potential.
However, in the future the applicant may seek approval to release these GM cotton varieties in high rainfall areas of north-eastern Australia, where cotton has demonstrated naturalisation potential. The part of the RARMP which lists issues to be addressed for further releases (Chapter 3, Section 4) has been modified to include additional phenotypic characterisation of the GM cotton varieties, in particular of traits which may contribute to weediness. OGTR has advised the licence holder that they should consider how this data could be collected.
Suggests that to properly assess the risks posed by a commercial release of these cotton types, information would be required on the Australian insect toxicity range. The insect host ranges of the introduced Bt toxins are not fully described in the RARMP. Recommends that data about toxicity effects on Australian non-target species be collected from the trial.Available information on the relevant Bt proteins toxicity ranges has been summarised in brief in the CCI Attachment to the RARMP. The toxicity information has not been discussed in detail as this was not necessary for the purposes of risk assessment for the current limited and controlled release.
In Chapter 3, Section 4, of the RARMP it is stated that additional data on potential increases in toxicity to non-target invertebrates as a result of stacked insect resistance genes may be required to assess a large-scale or commercial release of the GM cotton varieties. OGTR has advised the licence holder that they should consider how this data could be collected.
There is some inconsistency in the use of the terms “type”, “variety” and “line” in the RARMP. If these terms are interchangeable, it is recommended that one of them should be used consistently. Otherwise, the definition of each term should be made explicit.The term “line” is used to mean GM cotton containing a single transformation event, and is defined at its first appearance. The general terms “type” and “variety” are interchangeable, and the RARMP has been modified to use only the term “variety”.



6Gene Technology Technical Advisory Committee, State and Territory Governments, Australian Government agencies, LGAs and the Minister for the Environment.