Summary of submissions from prescribed experts, agencies and authorities4
The Regulator received 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.
|Sub.||Summary of issues raised||Comment|
|1||As no materials from the GM safflower will be used for human food, has no comments on the licence application.||Noted.|
|2||Saffron thistle is a serious weed in the ACT, NSW and Victoria. Outcrossing between safflower and weedy relatives should be addressed in the RARMP.||As discussed in Chapters 1 and 2 of the RARMP, outcrossing between safflower and saffron thistle, or other weedy relatives present in Australia, produces hybrids that are sterile, and thus unable to spread or persist. In addition, licence conditions restrict outcrossing between safflower and weedy relatives by requiring that during flowering of GM safflower, any weedy relatives growing within 200 m of the trial site must be destroyed.|
|2||No real concerns about safety of the transgene.||Noted.|
|3||Some caution is needed when modifying biosynthetic pathways that could alter membrane lipids, possibly causing unintended pleiotropic effects. However, considers possible pleotropic effects are limited in this case.||The potential for unintended effects is discussed in Chapters 1 and 2 (risk scenarios 1 & 2) and areas of uncertainty relating to unintended effects are noted. However, it is concluded that negligible risks are posed in the context of the limits and controls of the release.|
|3||Agrees with the OGTR assessment that the proposed dealing poses negligible risk of harm to human health or the environment and considers that the licence has appropriate containment and isolation requirements||Noted.|
|4||Risk due to the small seed size of safflower, which could lead to loss during harvest or transport.||Loss of a small percentage of safflower seed during harvest is considered inevitable, as discussed in Chapters 2 and 3 of the RARMP. To minimise dispersal of seeds lost during harvest, licence conditions require that any areas where safflower seed may have fallen during harvest must be tilled within 14 days of the harvest in order to bury residual seed, then must be monitored for at least 12 months to destroy any volunteer safflower plants that emerge.|
The licence holder is required to transport safflower seed in accordance with the Regulator's Guidelines for the Transport, Storage and Disposal of GMOs. The guidelines set out measures for containment of GM seed during transport, and contingency plans for the unlikely event of a spill.
|4||Risk due to strong tendency of safflower to outcross - outcrossing rate of 0-100% (Claassen 1950). Bees can fly distances of >1 km. Is it possible to exclude bees from the trial site during flowering or to apply insecticide during flowering?||The paper cited (Claassen 1950) studied safflower cultivars grown in the United States in the 1940s. As discussed in Chapters 2 and 3 of the RARMP, modern safflower cultivars grown in Australia are >90%; self-pollinating, and the rates of bee-mediated cross-pollination drop off rapidly with distance. To manage the risk of gene flow, licence conditions require related species to be controlled within 200m of GM trial sites, and no other safflower crop may be grown within 600 m of the GM safflower. These measures are considered to be effective in managing gene flow. The suggested alternative control measures are not considered to be necessary to effectively manage risk and may not be practically feasible.|
|4||Are the trial sites in regions that are known to have weedy Carthamus? If so, can safflower pollinate these species to produce viable and fertile hybrids?||As discussed in Chapters 1 and 2 of the RARMP, weedy Carthamus species are widespread in Australia, so are likely to be present near the trial sites. However, outcrossing between safflower and weedy relatives present in Australia produces hybrids that are sterile, and thus unable to spread or persist. In addition, licence conditions restrict outcrossing between safflower and weedy relatives by requiring that during flowering of GM safflower, any related species growing within 200 m of the trial site must be destroyed.|
|5||Recommends that the Regulator further consider measures to limit seed dispersal, particularly by birds.||As discussed in Chapters 1 and 2 of the RARMP, safflower seeds that are eaten by birds are not viable when excreted. Information regarding potential bird-mediated seed dispersal by pathways other than consumption has been added to the RARMP. Licence conditions requiring deterrence of birds by bird scarers or bird netting are considered sufficient to minimise seed dispersal.|
|5||Recommends that the Regulator clarify the potential for the silencing construct to produce a protein.||The RARMP has been reworded for clarity.|
|5||Agrees with the overall conclusions of the RARMP.||Noted.|
|6||Satisfied with the conclusions of the draft RARMP.||Noted.|
|7||No concerns with the proposed trial given the conditions specified in the RARMP.||Noted.|
|8||Supports the application as the evidence supplied indicates that the genetic modifications are within the scope for this crop and would pose negligible risks.||Noted.|
|9||Supports approval of the licence on the terms indicated in the RARMP.||Noted.|
ReferencesClaassen, C.E. (1950). Natural and Controlled Crossing in Safflower, Carthamus tinctorius L. Agronomy Journal 42: 381-384
4Prescribed agencies include GTTAC, State and Territory Governments, relevant local governments, Australian Government agencies and the Minister for the Environment.