Dir 128 Full Risk Assessment and Risk Management Plan (rarmp)

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1. 
   Summary of submissions from prescribed experts, agencies and authorities⁷
   

Advice received by the Regulator from prescribed experts, agencies and authorities on the consultation RARMP is summarised below. 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.

Abbreviations: GM: Genetically Modified; RARMP: Risk Assessment and Risk Management Plan.

Sub.No:	Summary of issues raised	Comment
1	Sees no problem with the application and has no comments on the RARMP.	Noted
2	Notes that the licence prohibits the use of material from the trials for human or animal consumption. Has no further comments on the licence application.	Noted.
3	Agrees with the overall conclusions of the RARMP and the proposed limits and controls.	Noted.
	The Regulator should consider further acknowledging uncertainty regarding potential for the introduced genes for abiotic stress tolerance and micronutrient uptake to result in increased survival of the GMOs or increases in toxicity or allergenicity, including in the summary table [Table 5].	Additional text has been added to the risk scenarios acknowledging uncertainty about the potential for improved persistence of the GM plants outside of the agricultural setting. Table 5 was not modified as this is a brief summary of the scenarios.
	This application involves a large number of lines, and suggests the Regulator consider the upper limits of what qualifies as a limited and controlled release.	This issue was considered as part of requirements under Section 50A of the Act, prior to preparation of a RARMP. The Regulator will continue to consider the appropriateness of limits and controls in determining if an application meets the requirements of section 50A.
	The Regulator should consider seeking information on the results of the trial to inform future applications for release of any of these GM lines, with respect to the potential risks to human health and the environment.	Chapter 3 lists additional information that may be required to assess future applications for larger scale trials, reduced containment measures or commercial release.
	The Regulator should consider clarifying the text in the RARMP regarding other government approvals, as approval for trials in South Australia would be required as part of the South Australian moratorium.	The South Australian moratorium on GM crops does not relate to protection of human health or the environment, and is a matter for the SA government and not the Regulator. Wording associated with the statement has been modified.
	Commends Table 5 in the RARMP as a useful device to summarise causal pathways	Noted.
4	Has no concerns regarding the potential for harm to humans or the environment, and accordingly has no objection to the granting of the licence for DIR 128.	Noted.
5	Given the biology and ecology of wheat and barley, and the limited scale and duration of the release, the environmental risks posed by the trial are likely to be low and manageable.	Noted.
	Both wheat and barley have been listed as minor weeds in Australia and California. The traits (including any stacking) may have the potential to enhance growth and survival of the GM wheat and barley and sexually compatible species in non-agricultural areas. Therefore, the RARMP (in particular Risk Scenarios 2, 4 and 6) could be improved by including more detailed discussion about this.	Additional text has been added to these risk scenarios to describe the uncertainty about whether the GM traits may increase the potential for persistence outside an agricultural setting.
	New sexually compatible species may be introduced into Australia in the future (eg perennial wheat). Even though there are only low rates of out-crossing, hybridisation between these new species and the GM plants may lead to weediness.	Risk scenarios 3 and 4 consider outcrossing to sexually compatible plants currently in the areas around the trial sites. There were no substantive risks identified, mainly due to the controls being proposed and the short duration of the trial. If new sexually compatible plants were introduced into Australia and were identified near the sites while the GMOs are growing, the licence conditions would minimise gene flow to these new species.
	Recommends more guidance on future data requirements, especially in regards to traits that may lead to weediness. Suggests the collection of a variety of data, including growths rates, plant morphology, seed dormancy and germination, disease resistance, head shattering, seed dispersal, seed longevity, and comparison with existing elite cultivars.	Chapter 3 lists additional information that may be required to assess future applications for larger scale trials, reduced containment measures or commercial release. Applicants/licence holders liaise with the OGTR about collection of appropriate data, and the DIR application forms provide guidance on the information required. Nevertheless, the applicant will be provided with these suggestions for data collection.
6	Supports the conclusion that DIR 128 poses negligible risks of harm to human health and the environment assuming that the below ambiguities are considered and rectified.	Noted.
	Paragraph 13 on page 3 of the RARMP states that visitors to the sites would be accompanied by authorised University of Adelaide staff. However, the licence allows any person to access a site as long as these persons are aware of the licence conditions.	Text in paragraph 13 has been modified to indicate that this is what the applicant proposes. However, the licence does not restrict access to sites but requires the licence holder to inform people of licence conditions prior to allowing them to conduct dealings with the GMOs.
	Paragraphs 59 and 60 of the RARMP mentions the locality Kunjin for one site but the locality is not mentioned for the other two sites.	The text of the RARMP has been amended to more clearly define the locations of the trial sites. Once GMOs are planted at a site, GPS coordinates will be posted on OGTR’s website.
	Paragraph 204 of the RARMP states that GM plant material must be destroyed if grown near other sexually compatible GM plants but the licence (condition 25) only states that the GM seed must not be used for future development. Suggest both statements refer to either plant material or seed.	Paragraph 204 (now paragraph 209 in the final RARMP) has been modified to indicate that seed must not be used for future development.