251. Licence conditions are imposed to control the dissemination and persistence of the GMOs and their genetic material in the environment and to limit the release to the size and locations 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 4.1.3.
4.1 Licence conditions
4.1.1 Consideration of limits proposed by BSES
252. Section 3.2 of Chapter 1 provides details of the limits proposed by BSES in their application, which are discussed in the events characterised for the release in Chapter 2. The appropriateness of these limits is considered further below.
253. The permitted dealings are confined to a maximum total area of 21 ha over six BSES stations, across five LGAs in Queensland. The applicant has proposed a fifteen year duration for this limited and controlled release. The previous releases of sugarcane under other DIR licences have been for much shorter terms, reflecting the 12-18 month cropping cycle of sugarcane. As discussed in Chapter 2 there is uncertainty relating to a number of the events arising from possible changes to the context of the trial over this time period. This may impact on the conclusions of the current risk assessment.
254. Agricultural practices may change leading to increased flowering of commercial cane or the introduction of varieties which flower in cooler regions. There is uncertainty surrounding the potential for gene flow in sugarcane as, until recently there was little research in this important area. As this research develops, this could alter the assessment of the potential for gene flow.
255. Over the longer term climate change may impact on the proposed release. It has been predicted that CO2 levels are likely to double by 2050, with a 1.3-2˚C increase in temperature for Bundaberg (da Silva et al. 2008), suggesting that there would be a change in both CO2 levels and temperature over the 15 year term of the licence. This could lead to altered distribution of sexually compatible relatives, or altered flowering times of these plants, thus synchronising flowering of sexually compatible plants in the proposed trial sites where it is currently disparate. Experiments in which sugarcane was grown under double the current atmospheric level of CO2 showed yield increases of 14% for the first harvest and 24% for ratoon crops (da Silva et al. 2008). The increase in the relative growth rates of crops from setts or from ratoons may lead to altered agricultural practices, with more ratooning than currently practised. The planting window for cane may also be altered with more planting in the winter period (SRDC 2007) and thus an altered flowering period. The increased temperature may also lead to an increase in pests and diseases, or the introduction of new pests to the region (SRDC 2007), which would necessitate altered agricultural practices, or the introduction of new varieties. Current predictions of the effects of climate change on Queensland include predictions of increased rainfall intensity and more intense tropical storms in some areas, particularly north Queensland (Queensland Government EPA 2008). If this eventuates then the proposed trial locations may become more likely to flood, which could increase the likelihood of dispersal of the GM sugarcane plant material.
256. This is an early stage field trial so very little is known about these GM lines and how they would behave under field conditions. It is strongly anticipated that within the 15 year time-scale proposed for the release there will be substantial advances in scientific understanding of the introduced genes and the genes targeted for silencing by the introduced RNAi constructs, particularly for those genes which are currently very poorly understood. In addition, further knowledge would come from evaluation of the GM sugarcane lines in the early stages of the proposed release (in field, clonal and progeny assessment trials of the GM sugarcane lines, before crossing is carried out). Such information would greatly reduce uncertainty by informing future risk assessments of the toxicity and allergenicity of the GM sugarcane (Event 1), the extent to which the genetic modifications may improve survival of the GM sugarcane lines (Event 2), the extent to which the GM sugarcane may disperse (Event 3) and cross with other sugarcane (Event 4) or sexually compatible species (Event 5), and unintended effects of the genetic modifications (Event 7).
257. Given the early stage nature of the proposed release, there are numerous areas of uncertainty including potential changes in the context within which risks have been assessed. Therefore, the imposed licence conditions limit the release to six years, rather than the 15 years proposed by the applicant.
4.1.2 Consideration of controls proposed by BSES
258. Section 3.3 of Chapter 1 provides details of the controls proposed by BSES in their application, which are discussed in the events characterised for the release in Chapter 2. The appropriateness of these controls is considered further below.
259. Only staff with appropriate training would be allowed access to the trial sites. Additionally, the applicant does not intend to use any of the GM plant material as human food or animal feed. These measures would limit the potential exposure of humans and vertebrates to the GMOs (Event 1) and the potential for the GM sugarcane plants to persist or to establish outside the proposed release sites (Event 3).
260. The trial sites would be located more than 50 m from the nearest natural waterways on land which has minimal risk of flooding (information provided by the applicant), which would reduce the likelihood of plant material being washed away from the sites (Event 3).
261. The applicant has proposed to test the GM sugarcane plants for A. tumefaciens and only release those that do not contain the bacterium. The extent to which Agrobacterium persists in GM sugarcane is unclear. The applicant proposes to transfer GM sugarcane plants from tissue culture directly to seedling benches at BSES stations on which field plantings would be carried out. Given the large number of lines proposed for release and the short time between transformation and release, PCR testing is considered to be an important control to reduce the likelihood of Agrobacterium-mediated gene flow (Event 8), and so is included as an imposed licence condition.
262. There are no published studies of gene flow in sugarcane. Sugarcane pollen is thought to be produced in limited quantities and have low viability. Sugarcane has strong daylength and temperature requirements for flowering and viable pollen production, which effectively limit the production of significant amounts of viable seed to areas of Queensland north of the Burdekin river. The environmental conditions required for seed germination and establishment are also only found in north Queensland. The germination of seed and establishment of seedlings is limited by factors such as humidity, temperature, low intrinsic competitive ability, nutrient availability, pests and diseases and other environmental factors that normally limit the spread and persistence of sugarcane plants in Australia.
263. At the field sites, the applicant intends to surround the GM sugarcane with a guard row of non-GM sugarcane. The guard row would be separated from the nearest non-GM sugarcane by a 6 m isolation zone free of sexually compatible species. Such separation would help prevent inadvertent mixing of cane at harvest. In addition, the applicant has proposed further measures to reduce the likelihood of inadvertent harvesting of GM sugarcane, including marking field plantings with star pickets, signing GM plantings and informing and training staff on harvest and handling of GM sugarcane. Separation of GM from non-GM sugarcane with a guard row and isolation zone is considered an effective enough measure to reduce the likelihood of inadvertent harvesting of GM sugarcane, and so the further measures proposed by the applicant have not been imposed as licence conditions.
264. The applicant has proposed to cultivate GM sugarcane plants on seedling benches prior to planting in the field, using areas set aside at each BSES station at which field planting would occur. Non-GM sugarcane plants would also be cultivated in these facilities. The applicant proposes to keep GM and non-GM plants on separate benches, and barcode label the GM material. In order to reduce the potential dispersal of potted GM sugarcane plants by workers unaware of restrictions on their movement, the imposed licence conditions include a requirement to clearly label GM plants as being GM, and to sign benches containing GM material to indicate they hold GM plants.
265. In crossing facilities the applicant proposed to colour- and barcode label GM sugarcane and maintain GM sugarcane in clearly signed areas separate to areas used for non-GM sugarcane. These measures to reduce the potential for inadvertent mixture of GM and non-GM material have been included as licence requirements.
266. The applicant intends to contain flowering in those regions where environmental conditions are suitable for flowering, viable pollen production, seed germination and seedling survival (ie at the proposed crossing facilities at BSES Meringa and Southern). In crossing facilities the applicant proposes to separate GM and non-GM sugarcane, inspect GM sugarcane for signs of flowering three times per week in the period when the plants are likely to flower, and enclose GM sugarcane inflorescences in pollen lanterns prior to spikelet opening. This inspection frequency is considered appropriate for experienced sugarcane breeders to predict the onset of spikelet opening. The applicant describes the pollen lanterns as being impermeable to pollen, based upon the results of Skinner (1959). Skinner tested various materials for the ability to allow cross-pollination of an enclosed male sterile flower by nearby pollen-producing inflorescences. The applicant also proposes measures to control gene flow in the event that open spikelets are detected on the GM sugarcane before pollen lanterns are applied: open spikelets on the GM sugarcane would be removed and destroyed then the inflorescence enclosed in a pollen lantern, and nearby non-GM sugarcane would be subject to the same measures to ensure no seed is set as a result of pollination outside pollen lanterns. These measures would reduce the potential for pollen flow (Events 4 and 5) and have been included as licence requirements.
267. The applicant has stated that any plant material taken off-site for experimental analysis and planting material moved between BSES stations would be transported according to the Regulator’s Guidelines for the Transport of GMOs. These are standard protocols for the handling of GMOs to minimize exposure of humans and other organisms to the GMOs, dispersal into the environment, and gene flow/transfer. The applicant has proposed to transport sugarcane stems within BSES stations tied down in covered trailers. Sugarcane stems are considered propagative plant material, as they can potentially give rise to new sugarcane plants. The Regulator’s transport guidelines require that viable or propagative GM material be enclosed by a primary and secondary unbreakable container when being transported, to minimise the risk of dispersal of GMOs. Displacement of stem pieces from trailers during transport could potentially lead to unintended establishment of GM sugarcane plants, thus increasing human and animal exposure to the GMOs (Event 1), allowing dispersal of the GM sugarcane (Event 2), and potentially enabling gene flow (Events 4 and 5). For these reasons, the requirement to transport all GM sugarcane material to and from trial sites according to the Regulator’s Guidelines is imposed as a licence condition.
268. The applicant has proposed to destroy any viable GM plant material after final harvest by either burning, mulching or by herbicide treatment (Event 3). Similar disposal and/or destruction methods have been used previously for GM sugarcane under the licences for DIR 019/2002, DIR 051/2004 and DIR 070/2006 and are used in the industry as standard destruction methods (OGTR 2008b). This would minimise exposure to the GM plant material (Event 1) and limit the likelihood of spread and persistence (Event 2). However, it has also been proposed that stalks may be harvested and left to rot in the field, generally when these have been hand harvested. As discussed in Event 3 there is the potential for dispersal of viable cane pieces by animals and extreme weather conditions. Harvesting and leaving to rot in the field is not considered an acceptable method of destruction, and is not included as a condition in the licence.
269. The applicant has proposed to monitor the field release sites for 12 months post harvest and destroy any volunteer GM sugarcane, ensuring the sites are free of any volunteer sugarcane for a continuous period of at least six months. Sugarcane seed has little dormancy (Simpson 1990), and stem pieces capable of giving rise to new plants are not expected to remain viable over long periods, so this time period is considered appropriate for minimising the persistence of the GMOs in the environment (Event 2), potential for dispersal (Event 3) and gene flow (Events 4 and 5). A requirement to monitor the field release sites monthly for at least 12 months and until no volunteers have been detected for 6 months is included as a condition in the licence.
4.1.3 Summary of measures imposed by the Regulator to limit and control the release
270. 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:
- limit the release to six years
- surround the field trial sites with one guard row of non-GM sugarcane and a further isolation zone of at least 6 m
- separate GM sugarcane material from non-GM material when propagating seedlings or setts on seedling benches, and clearly identifying GM material
- separate GM from non-GM sugarcane in crossing facilities (glasshouses, pot holding areas, photoperiod glasshouses and crossing shed) and clearly identify GM material
- monitor GM sugarcane in photoperiod facilities for spikelet opening three times weekly and enclose inflorescences in pollen lanterns for controlled crossing, and destroy open spikelets not enclosed in pollen lanterns
- locate the field trial sites at least 50 m away from natural waterways
- harvest and process the GM sugarcane separately from any other sugarcane
- carry out analysis of plant materials only at the BSES stations or in PC2 laboratories
- destroy all plant materials not required for experimentation or propagation
- after cleaning of sites, monitor for and destroy any GM sugarcane that may grow for at least 12 months, and until no volunteers have been detected at the sites for a continuous 6 month period
- transport the GM plant materials in accordance with the Regulator’s transportation guidelines
- not allow the GM plant material or products to be used for human food or animal feed.
271. 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.
272. onditions applying to the conduct of experimental analyses are also included in the licence conditions.
4.2 Other risk management considerations
273. 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.
274. 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.
275. On the basis of information submitted by the applicant and records held by the OGTR, the Regulator considers BSES suitable to hold a licence.
276. The licence conditions include 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.
277. BSES must continue to have access to a properly constituted Institutional Biosafety Committee and be an accredited organisation under the Act.
4.2.2 Contingency plans
278. BSES 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 sugarcane lines outside of the permitted areas.
279. BSES 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
280. 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
281. 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.
283. A number of written notices are also be required under the licence that assist the OGTR in designing and implementing a monitoring program for all licensed dealings. The notices would 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.
284. 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.
285. 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.
286. 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.