201. Licence conditions are imposed to control the dissemination and persistence of the GMOs and their genetic material in the environment and limit the release to the size, location and duration requested by the applicant. Both of these considerations were important in establishing the context for the risk assessment and in reaching the conclusion that the risks posed to people and environment are negligible. The conditions are detailed in the licence and summarised in Section 4.1.2.
4.1 Licence conditions
4.1.1 Consideration of limits and controls proposed by CSIRO
202. Sections 3.2 and 3.3 of Chapter 1 provide details of the limits and controls proposed by CSIRO in their application, and discussed in the events characterised for the release in Chapter 2. The appropriateness of these limits and controls are considered further below.203. The permitted dealings are confined to one site of 1 ha, on CSIRO-controlled land at Ginninderra Experimental Station in the ACT. Only staff with appropriate training will be allowed access to the site. Additionally, the applicant does not intend to use any of the GM plant material as human food or animal feed, with the exception of rat and pig nutritional trials, from which no material will enter the human food or animal feed supply. Furthermore, the duration of the release will be limited to three years. These measures will limit the potential exposure of humans and vertebrates to the GMOs (Event 1) and the potential for the GM wheat lines to persist or to establish outside the proposed release site (Event 3).
204. The applicant’s proposal to limit gene flow from the GM wheat (Event 4) included surrounding the release site with a 10 m wide herbicide-treated area, a 200 m zone in which no other wheat plants are to be grown, and a 500 m zone in which no wheat breeding lines would be cultivated (Figure 2). The applicant proposed to heavily graze the area immediately around the herbicide-treated zone to limit the growth of species related to wheat, and to inspect for and destroy them if detected close to the time of the GM wheat lines flowering. The applicant proposed an exception to the 200 m wheat isolation zone for two other limited and controlled releases of GM wheat at the site, which are currently being evaluated by the OGTR. The applicant states that pollen movement between trials would be restricted by a 2 m wide buffer of non-GM wheat surrounding the area of the site planted to each of the proposed releases.
205. Differences in pollen flow have been observed between different pollen flow studies in wheat. A number of variables, particularly pollen source size, climatic conditions and the difficulty of detecting rare events, could influence the accuracy and reproducibility of these measurements. Low rates of outcrossing occur up to 100 m from the pollen source (reviewed by OGTR 2008), and very low rates of outcrossing have been recorded up to 2.75 km from the pollen source (Matus-Cadiz et al. 2007).
206. Field trial releases of GM wheat in Canada require a 30 m isolation distance between the GM plants and other wheat plants, while in the United States the isolation distance is 20 feet (approximately 6.1 m) (USDA-APHIS 1994; Canadian Food Inspection Agency 2006). In the European Union, various GM wheat field trials have been approved, requiring border plantings of non-GM wheat or other plants ranging up to 30 m wide and isolation distances from other wheat ranging from 2 to 50 m (European Commission Directorate General for the Environment 2009).
207. In Australia, requirements for basic and certified wheat seed production are aligned with OECD rules (Australian Seeds Authority Ltd. 2006). OECD rules (OECD 2008) stipulate a maximum acceptable level of off-types or other cultivars of the same species of 0.1% for basic seed and 0.3% for certified seed. Seed crops of self-fertilising cereals are required to be separated from other cereal crops by a barrier or space sufficient to prevent seed mixture during harvest. Similarly, the United States Federal Seed Act Regulations does not specify an isolation distance for wheat used for seed production. However, for hybrid seed production (where the phenotype may be variable and determination of contamination levels is difficult) a distance of 300 feet (approximately 100 m) is required for the US and 25–100 m for the OECD (Code of Federal Regulations 2006; OECD 2008).
208. The applicant proposed to maintain a 500 m isolation zone to separate the GM wheat lines from cultivation of wheat breeding lines. If gene flow to a breeding line were to occur, and the breeding line was to eventually become commercially successful, this could lead to increased propagation and dispersal of the GMOs. However, on the basis of the scientific literature on gene flow, international containment measures for GM wheat trials, and the rules for producing basic and certified seed, a 200 m isolation zone clear of other wheat plants is considered adequate to minimise gene flow from the GM wheat plants to other wheat plants (including breeding lines) or other sexually compatible species outside the release site (Event 4 and Event 5) and is therefore imposed as a licence condition.
209. An exception to the 200 m wheat isolation zone is proposed for cultivation of GM wheat lines of proposed releases DIR 093 and DIR 094, should these releases be approved, and cross-pollination could occur between them. There is very limited evidence for the effectiveness of a physical barrier such as wheat plants for decreasing pollen movement. However, physical separation of each release proposed to occur at the site will strongly reduce pollen flow, ensure separation of the different trials is maintained during extreme weather, and prevent mixing of seed at harvest. For these reasons, and in parallel with the requirements for Australian wheat seed production, a buffer zone of at least 2 m surrounding each trial (giving a total of 4 m between two adjacent trials) is imposed as a licence condition to limit potential cross-pollination between different GM wheat releases (Event 4). It is required that, if the buffer zone is planted with non-GM wheat, these plants are prevented from setting seed. This measure will reduce potential dispersal outside the buffer zone of seed from non-GM wheat plants which may carry the transgenes as a result of cross-pollination from the GM wheat lines.
201. The applicant proposed that the licence be structured such that different areas of land planted with GMOs within the 1 ha fenced area could be independently signed off, allowing their use for other purposes while the GMOs are cultivated in other areas within the fence. The imposed licence conditions allow for this to occur, and include restrictions upon how land within the fenced area may be used. Important in accommodating this proposal was consideration of how it affected containment of the GMOs. Previous wheat licences require that the monitoring zone surrounding a trial location be monitored for volunteers after harvest, and signed off with the trial location. However, in allowing multiple trial locations to occur within the same monitoring zone (subject to approval of DIRs 093 and 094), post-harvest monitoring requirements must be relative to individual trial locations.
211. In determining post-harvest monitoring requirements, it is important to consider the potential dispersal of grain during sowing and harvesting (mechanical dispersal). This is most likely to result in dispersal of grain into the area immediately around the trial, including the buffer zone. It is considered unlikely that mechanical dispersal of grain would occur over the distance of more than 4 m separating different trial sites. However, the potential for mechanical dispersal of grain from plantings adjacent to the fence into the monitoring zone is limited by only a 2 m width of buffer zone. To reduce the possibility of mechanical dispersal from the trial location into the monitoring zone (which is not required to be monitored for volunteers after harvest), the imposed licence conditions include a requirement to surround the GM wheat lines by a buffer zone of at least 4 m where they are cultivated adjacent to the fence.
212. The applicant proposed to surround the trial with a 1.8 m high deer-mesh fence, the bottom 0.85 m of which also consists of rabbit mesh, around the perimeter of which they will conduct rodent baiting and trapping at 10 m intervals. These measures will aid in excluding grazing livestock and in reducing the size of the rodent population which may have access to the GM wheat lines. As viable seed may remain on the soil surface after harvest, a licence condition is imposed requiring rodent reduction measures to continue after harvest and until all remaining seeds have been incorporated into the soil through post harvest tillage. Additionally the 10 m herbicide-treated zone will serve as a measure to control rodent activity at the proposed release site (Event 3). Whilst there are differing reports regarding the average territory size of mice, the use of reduced vegetation has been shown to help reduce rodent numbers in agricultural settings. This will limit the potential exposure of vertebrates to the GMOs (Event 1) and the potential dispersal of the GMOs (Event 3).
213. Although the applicant has proposed to include rabbit mesh in the lower half of the fence, this has not been imposed as a licence condition because seed dispersal by rabbits is not expected. Rabbits prefer soft, green, lush grass (Myers & Poole 1963), and evidence suggests that viable wheat seeds are unlikely to pass through the digestive system of rabbits (see Event 3). Therefore, a rabbit-proof fence has not been imposed as a licence condition.
214. The applicant has proposed to cover the planted areas of the site with small mesh bird-proof netting to prevent access to the GM wheat plants by birds, and so limit the potential for dispersal of the GM wheat lines by birds. The possibility of dispersal of GM plant materials by birds was considered in detail in the RARMP for DIR 071/2006 which is available from the OGTR or from the website and is discussed in The Biology of Triticum aestivum L. em Thell. (Bread Wheat) (OGTR 2008). To briefly summarise, bird damage has been reported for wheat crops although birds appear to prefer softer plant parts, and are more likely to eat wheat or grain on site rather than carry it elsewhere for storage or consumption. However, there are no reports on the ability of birds such as cockatoos and galahs, which are known to consume loose seeds found on the soil surface following harvest, to disperse viable seeds. Reports of seed dispersal via birds are generally confined to fruit-eating birds which consume succulent fruits and berries and then disseminate the undigested seeds at considerable distances (McAtee 1947; Barnea et al. 1991; VanDer Wall et al. 2005), rather than grain-eating birds which intentionally consume seed grains including wheat and barley (Diaz 1990; Thompson et al. 1991). The thin seed coats of the wheat cultivars used in this trial will promote digestion of the seeds during passage through bird and animal intestines and therefore dispersal of viable GM wheat seed is likely to be low. For this reason there is no requirement to deter birds with bird-proof netting.
215. The applicant has stated that the trial site will be at least 1000 metres from the nearest waterway. A standard DIR licence condition is imposed requiring the trial site to be located at least 50 metres from a natural waterway which will limit the dispersal of viable GM plant material in the event of flooding (Event 3).
216. The applicant has proposed a number of measures to minimise the persistence of any GM wheat plants and seeds in the seed bank at the proposed release site after harvest of the proposed trial (Event 2). These measures include treating harvested areas to encourage germination of seed dropped at harvest with three cycles of irrigation followed by herbicide treatment to destroy volunteer wheat plants, at monthly intervals. Plant material remaining at the site after harvest will be ploughed in at an unspecified time after harvest. The applicant has also proposed to monitor the proposed release site for 24 months after harvest or until the site has been clear of any volunteers for one growing season, which runs from early June to early February. All volunteers will be destroyed before flowering by herbicide application.
217. The loss of seed at harvest is estimated to range between 0.8 and 6%, depending upon factors including the harvest machinery used, the genetic tendency of a variety to shed seed and weather conditions (reviewed byAnderson & Soper 2003). The applicant has proposed to harvest the GM wheat plants with a hand-operated plot harvester. Wicks et al. (2000) reported that small plot headers are less efficient than commercial harvesters, so self-sown wheat may be a greater problem under experimental conditions.
218. Cereal grains require an after-ripening period before germination can occur, which takes up to seven months depending upon genetic background and environmental conditions (reviewed byAnderson & Soper 2003). The process of after-ripening is favoured by hot dry conditions, which can be facilitated in the field by retaining any seed remaining after harvest on the soil surface prior to irrigation (Pickett 1993) Although the time required for after-ripening of the GM wheat lines under the expected field conditions is unknown, retention of dropped seed on the soil surface until irrigation treatment is imposed as a licence condition. Following after-ripening, the persistence of seed depends on several factors which contribute to seed dormancy: cultivar genetics, environmental conditions during seed formation, crop nutrition, environmental conditions after shedding, and field treatment (reviewed by Anderson & Soper 2003). Viable wheat seeds persist in the soil for longer periods in dry than in moist conditions, and wheat seeds present as un-threshed ears have longer dormancy than loose seeds (Komatsuzaki & Endo 1996). Shallow tillage after harvest, combined with irrigation, will germinate much of the grain dropped at harvest (Ogg & Parker 2000), while deep tillage encourages burial-induced dormancy (reviewed by Anderson & Soper 2003). Shallow tillage concurrent with irrigation would also serve to enable degradation of the plant material remaining at the site after harvest.
219. There is high variability in volunteer wheat emergence, and various field studies report volunteer emergence up to two years following harvest (reviewed by Anderson & Soper 2003). A Canadian field study of spring wheat persistence reported low levels of volunteer germination three years after wheat seeds were dropped in test plots (Harker et al. 2005). However, the relevance of these results to Australian field conditions is questionable, because of the harsh winter conditions in the western Canadian field sites studied. It is thought that dormancy of cereals is reduced in warmer temperatures (reviewed by Pickett 1989), and so dormancy is expected to be reduced in Australian field conditions compared to western Canada. Further, there is evidence that the proposed irrigation and cultivation treatments are effective in promoting germination of wheat seed, which will remove seed from the soil seed bank.
220. It is considered that three irrigations, combined with an appropriate tillage regime, and monitoring for and destruction of volunteers for at least 24 months would effectively reduce survival and persistence of viable wheat seeds in the soil. The imposed licence conditions require that initial irrigation should take place within 60 days of harvest to encourage surface seed to germinate. Two further irrigations will be required at intervals of at least 28 days, concurrent with tillage to the original sowing depth, with the last irrigation occurring during the final six months of the monitoring period. These treatments will further promote germination by ensuring any remaining seeds are exposed to sufficient moisture and placed at an appropriate depth for germination and will also encourage the microbial decomposition of any residual seed. As viable wheat seeds are expected to persist in soil for periods of up to 24 months in Australian conditions, post harvest monitoring of the release site for at least 24 months after harvest with no volunteers observed in the most recent six months, needs to be completed before an application that inspection conditions no longer apply can be made to the Regulator. These measures will minimise the persistence of the GMOs in the environment (Event 2).
221. The applicant proposes to plant break crops after the GMOs are harvested each year, to help remediate the soil and prevent the build up of disease. The crops proposed are lucerne (Medicago sativa) and forage brassica (Brassica campestris), and they would be planted after the post-harvest irrigation and subsequent treatment with a non-selective herbicide. The break crop would be grown for up to four months before being ploughed back into the soil. During growth of the break crops, the site would be treated with herbicides selective for grasses, thereby destroying any volunteer wheat plants present. It is further specified in the imposed licence conditions that the selective herbicide be used such that any volunteers are destroyed before flowering.
222. Although, as indicated above, volunteer wheat plants would be destroyed before flowering, their presence may go undetected in the break crop. This could affect the ability to sign off the site, as it would be unlikely that the Regulator could be satisfied that no volunteers had been observed at the site if the break crop was grown in the six month period prior to an application for sign off.
223. The applicant states that they aim to avoid replanting areas of the trial site from season to season to avoid build-up of soil disease. They state that if replanting should be necessary it will be restricted to areas of the site utilised in the first season for replanting in the third season, and only with GMOs from the same release as the initial planting. This measure is imposed as a licence condition, to the effect that areas of the site utilised by DIR 092 may not be replanted with GMOs released under any other proposed release. The applicant proposed that there be no restriction on the specific GM wheat line planted in season three onto season one plots, if the plots have been free of volunteers for the six months before season three planting. If volunteers occur, the applicant proposes to restrict season three planting to the same GM wheat line planted in season one in that plot. However, only low levels of volunteers are expected to persist on the season one plots to the time of season three planting, given imposed licence conditions to require treatments of the site to encourage volunteer germination. Therefore, it is considered unnecessary to restrict the lines of DIR 092 which may be replanted in season three on the basis of volunteer occurrence.
224. Non-GM wheat will be planted amongst the GM wheat at the site (refer to Chapter 1, Section 3.1 for details). As there is a possibility of viable GM material being present in the non-GM plants, a licence condition has been imposed requiring these non-GM plants to be treated as the GMOs and therefore subject to all the same licence conditions. This will limit the dispersal of viable GM plant material (Event 3).
225. The applicant has stated that any plant material taken off-site for experimental analysis will be transported according to the Regulator’s Guidelines for the transport of GMOs. The applicant proposed to mill some of the harvested grain to flour in a PC2 facility, and unless grain or flour is to be stored for future experiments it will be destroyed by autoclaving after analysis. These are standard protocols for the handling of GMOs to minimize exposure of the GMOs to human and other organisms (Event 1), dispersal into the environment (Event 3), and gene flow/transfer (Events 4 and 5).
4.1.2 Summary of measures imposed by the Regulator to limit and control the release
226. A number of licence conditions have been imposed to limit and control the release, which are described in detail in the licence. These include requirements to:- conduct the release on a total area of up to 1 ha at one site in the ACT, between July 2009 and June 2012
- establish a 10 m zone around the trial site that is free of any related species and is maintained in a manner that does not attract or harbour rodents
- maintain an isolation zone of at least 200 m around each trial site free of any sexually compatible species, with the exception of other GM wheat lines approved for release by the Regulator
- separate the GM wheat trial from any other GM wheat trial by at least a 4 m
- enclose the trial site with a 1.8 m high livestock-proof fence with lockable gates
- conduct rodent baiting and/or trapping in and around each trial site
- locate the trial site more than 50 m away from natural waterways
- harvest the GM wheat plant material separately from other crops
- destroy all plant materials not required for further analysis or future trials
- contain, transport and store material from the GMOs in accordance with the Regulator’s guidelines
- not permit any GM wheat plant material to be used in human food or animal feed, with the exception of rat and pig nutritional experiments, from which no material is to enter the human food or animal feed supply
- gain approval for the proposed rat and pig nutritional studies from the CSIRO Human Nutrition Animal Ethics Committee before products derived from the GMOs are used in such studies
- clean the sites and equipment used on the sites following harvest
- apply measures to promote germination of any wheat seeds that may be present in the soil after harvest, including three irrigation cycles, with the last irrigation occurring during the final 6 months of the monitoring period
- post-harvest monitoring of the site for at least 24 months and destroy any wheat plants that may grow until no volunteers are detected for a continuous 6 month period.
4.1.3 Measures to control other activities associated with the trial
227. The Regulator has issued guidelines and policies for the transport and supply of GMOs (Guidelines for the transport of GMOs; Policy on transport and supply of GMOs). Licence conditions based on these guidelines and policies have been imposed regarding transportation and storage, and to control possession, use or disposal of the GMOs for the purposes of, or in the course of, the authorised dealings.228. Conditions applying to the conduct of experimental analyses are also included in the licence conditions.
4.2 Other risk management considerations
229. All DIR licences issued by the Regulator contain a number of general conditions that relate to general risk management. These include, for example:- applicant suitability
- contingency plans
- identification of the persons or classes of persons covered by the licence
- reporting structures, including a requirement to inform the Regulator if the applicant becomes aware of any additional information about risks to the health and safety of people or the environment
- a requirement that the applicant allows access to the trial sites by the Regulator, or persons authorised by the Regulator, for the purpose of monitoring or auditing.
4.2.1 Applicant suitability
230. In making a decision whether or not to issue a licence, the Regulator must have regard to the suitability of the applicant to hold a licence. Under section 58 of the Act matters that the Regulator must take into account include:- any relevant convictions of the applicant (both individuals and the body corporate)
- any revocation or suspension of a relevant licence or permit held by the applicant under a law of the Commonwealth, a State or a foreign country
- the applicant's history of compliance with previous approved dealings
- the capacity of the applicant to meet the conditions of the licence.
232. The licence includes a requirement for the licence holder to inform the Regulator of any circumstances that would affect their suitability or their capacity to meet the conditions of the licence.
233. CSIRO must continue to have access to a properly constituted Institutional Biosafety Committee and be an accredited organisation under the Act.
4.2.2 Contingency plan
234. CSIRO is required to submit a contingency plan to the Regulator within 30 days of the issue date of the licence. This plan would detail measures to be undertaken in the event of any unintended presence of the GM wheat lines outside of the permitted areas.235. CSIRO is also required to provide a method to the Regulator for the reliable detection of the presence of the GMOs and the introduced genetic materials in a recipient organism. This instrument is required within 30 days of the issue date of the licence.
4.2.3 Identification of the persons or classes of persons covered by the licence
236. The persons covered by the licence are the licence holder and employees, agents or contractors of the licence holder and other persons who are, or have been, engaged or otherwise authorised by the licence holder to undertake any activity in connection with the dealings authorised by the licence.4.2.4 Reporting structures
237. The licence obliges the licence holder to immediately report any of the following to the Regulator:- any additional information regarding risks to the health and safety of people or the environment associated with the trial
- any contraventions of the licence by persons covered by the licence
- any unintended effects of the trial.
239. A number of written notices are also required under the licence that assist the OGTR in designing and implementing a monitoring program for all licensed dealings. The notices include:
- expected and actual dates of planting
- expected and actual dates of commencement of flowering
- expected and actual dates of harvest and cleaning after harvest.
4.2.5 Monitoring for Compliance
240. The Act stipulates, as a condition of every licence, that a person who is authorised by the licence to deal with a GMO, and who is required to comply with a condition of the licence, must allow inspectors and other persons authorised by the Regulator to enter premises where a dealing is being undertaken for the purpose of monitoring or auditing the dealing. Post-release monitoring continues until the Regulator is satisfied that all the GMOs resulting from the authorised dealings have been removed from the release sites.241. If monitoring activities identify changes in the risks associated with the authorised dealings, the Regulator may also vary licence conditions, or if necessary, suspend or cancel the licence.
242. In cases of non-compliance with licence conditions, the Regulator may instigate an investigation to determine the nature and extent of non-compliance. These include the provision for criminal sanctions of large fines and/or imprisonment for failing to abide by the legislation, conditions of the licence or directions from the Regulator, especially where significant damage to health and safety of people or the environment could result.