136. The limits and controls proposed in the application were important in establishing the context for the risk assessment and in reaching the conclusion that the risks posed to people and the environment are negligible. Therefore, to maintain the risk context, licence conditions have been imposed to limit the release to the proposed size, locations and duration, and to restrict the spread and persistence of the GMOs and their genetic material in the environment. The licence conditions imposed are summarised in this Chapter.
3.1 Licence conditions to limit and control the release
3.1.1 Consideration of limits and controls proposed by CSIRO
137. Sections 3.1 and 3.2 of Chapter 1 provide details of the limits and controls proposed by CSIRO in their application. These are discussed in the three risk scenarios characterised for the proposed release in Chapter 2. Many of these proposed control measures are considered standard for GM crop trials and have been imposed by the Regulator in previous DIR licences. The appropriateness of these controls is considered further below.
138. The duration of the field trial would be confined to three growing seasons, with one trial site during the first growing season and up to three trial sites during the second and third growing seasons, with a maximum area of 1 ha per site. The small size and short duration of the trial would limit the potential exposure of humans, vertebrates and other organisms to the GMOs (Risk Scenario 1).
139. Only authorised personnel with appropriate training would be permitted to deal with the GMOs. This measure would limit the potential exposure of humans to the GMOs (Risk Scenario 1).
140. The applicant proposes, in line with a standard DIR licence condition, that trial sites be located at least 50 m from natural waterways to minimise the chance of viable plant material being washed away from the site. An additional licence condition has been included requiring immediate notification of any extreme weather conditions affecting the trial sites during the release. This will allow control measures to be taken to minimise dispersal of GM safflower outside the proposed trial sites (Risk Scenario 2).
141. The applicant proposes to grow both GM safflower and non-GM safflower in the trial sites. As non-GM safflower may be mingled with or fertilised by GM safflower, a standard licence condition requires that non-GM safflower plants grown in a trial site must be treated as if they are GMOs.
142. At one trial site, the applicant proposes to minimise bird access to the GMOs by covering the site with bird netting. At the two other trial sites, the applicant proposes to control bird predation of the GMOs by the use of commercial bird scarers. As discussed in Risk Scenario 2, birds are unlikely to disperse viable GM safflower seeds either by consumption or by external adhesion. Therefore, measures to deter birds, rather than completely exclude them, are considered sufficient to both limit exposure of wildlife to the GMOs (Risk Scenario 1) and control potential dispersal of GMOs outside the trial sites (Risk Scenario 2). A licence condition requires that for the period from 14 days after commencement of flowering of the GMOs in a trial site until the site has been cleaned, the trial site must be either:
- covered with bird netting, which must be maintained in a state adequate to deter birds; or
- equipped with bird scarers that are expected to deter the main seed-eating bird species present in the vicinity of the trial site.
144. The applicant proposes to surround each trial site with a 10 m monitoring zone, which is either free of vegetation or planted with vegetation mown to a height of less than 10 cm. This would serve three purposes:
- to avoid attracting or harbouring rodents (Risk Scenarios 1 and 2)
- to facilitate detection of naturalised safflower plants or weedy related species that might hybridise with GM safflower (Risk Scenario 3)
- to facilitate detection of GM plant material that has been dispersed during sowing or harvesting (Risk Scenario 2).
146. The applicant proposes that the monitoring zone would be surrounded with a 190 m isolation zone, and while the GMOs are flowering in a trial site, both the monitoring and isolation zones would be inspected every 35 days for the presence of safflower or related species. Although safflower requires at least 45 days to develop from its inconspicuous rosette stage to flowering (GRDC 2010), there is little information available on the rate of development of weedy Carthamus species present in Australia, and it is conceivable that in favourable conditions they could develop to flowering in less than 35 days. A higher frequency of inspection is appropriate to deal with this uncertainty. A licence condition requires that for the period from 14 days prior to the expected commencement of flowering of any GMOs in a trial site, until after all GMOs have finished flowering, the monitoring and isolation zones must be inspected every 14 days for the presence of safflower or related species, and any plants discovered must be destroyed prior to flowering. These measures will minimise gene flow to naturalised safflower or related weedy species (Risk Scenario 3).
147. The applicant proposes to ensure that no other safflower crops are grown within 400 m of the trial sites. Commercial safflower cultivars are predominantly self-pollinated, and the limited publications available suggest that the incidence of bee-mediated pollination drops rapidly with distance. The international guidelines for production of basic safflower seed recommend an exclusion distance of 400 m from other safflower cultivars to produce high purity seed (OECD 2013). However, at this exclusion distance there could still be very low levels of cross-pollination that are acceptable for growers, and there is a lack of scientific studies addressing efficacy of exclusion distances for safflower. In these circumstances of uncertainty, it is considered appropriate to increase the exclusion distance by a safety factor. For a Canadian field trial of GM safflower in 2011, the Canadian Food Inspection Agency (see CFIA website) required that GM safflower plants be reproductively isolated from other safflower plants by 800 m, and from safflower seed production by 1600 m. However, the GM safflower in the Canadian trial expressed a pharmaceutical compound that could potentially have adverse effects on humans or animals if ingested, whereas GM safflower with the trait of increased levels of oleic acid is not expected to be toxic or allergenic (Risk Scenario 1). In Risk Scenario 3, it was noted that pollen flow might occur not only to a safflower crop, but also to safflower volunteers if these grow in abundance in the year after planting of a safflower crop. Based on these considerations, a licence condition states that GM safflower must not be grown within 600 m of either a safflower crop that is not a part of the field trial, or an area that was planted in the previous 12 months to a safflower crop that was not a part of the field trial. The 600 m exclusion distance would be a combination of a 10 m monitoring zone, a 190 m isolation zone and a 400 m exclusion zone. This condition will minimise gene flow to other safflower plants (Risk Scenario 3).
148. The applicant proposes to harvest the seed by hand, or using either a single row harvester or small plot harvester. Avoiding the use of large mechanical harvesters would limit the potential for dispersal of GM material during harvesting (Risk Scenario 2). A condition specifying these harvesting methods is included in the licence.
149. In line with a standard licence condition, the applicant proposes to clean equipment used with the GMOs on-site before use for any other purpose. This would minimise dispersal of GM material by humans (Risk Scenario 2).
150. The applicant proposes to clean the trial sites and adjacent areas after harvest by incorporating plant material into the soil. During sowing and harvesting, plant material could be scattered into the area immediately surrounding the trial, so there is potential for residual seed to be present in both the trial site and the monitoring zone. In Risk Scenario 2 it was noted that during the period between harvest and cleaning, residual seed on the soil surface would be susceptible to dispersal by animal predation, water runoff after rainfall, or strong winds. Therefore, it is appropriate to require that cleaning occurs shortly after harvest. A licence condition requires that GMO planting areas and their associated monitoring zones must be cleaned by ploughing plant material into the soil within 14 days after harvest of the GMOs.
151. The applicant proposes regular watering of the trial site post-harvest, to promote germination of residual seed. Due to the low dormancy of safflower seeds (Chapter 1, Section 4), one irrigation is considered sufficient to manage survival and persistence of viable safflower seeds in the soil (Risk Scenario 2). A licence condition requires that GMO planting areas and their associated monitoring zones must be irrigated at least once post-harvest.
152. The applicant proposes post-harvest monitoring of the trial site and any areas used to clean equipment for 24 months, destroying any volunteer safflower plants detected before flowering. The proposed frequency of inspections is monthly, or if no volunteers are found during six consecutive inspections, reduced to once per three months. As safflower has low dormancy, with buried seeds reported to have no viability beyond one year (Mcpherson et al. 2009b), it is considered unnecessary to inspect the trial sites for as long as two years. Licence conditions require post-harvest monitoring and destruction of volunteers at least once every 35 days for at least twelve months, and until no volunteers are found for at least six months. Records must be kept of monitoring activities and findings, including number and location of volunteers, which will allow the Regulator to assess the ongoing suitability of these measures and provide additional information for future assessments.
153. The applicant proposes that harvested seeds not required for further experimentation may be disposed of by burial at a depth of >1m . Due to the low dormancy of safflower, this will be an effective method of destruction, and it will manage persistence of viable safflower seed (Risk Scenario 2). A licence condition includes deep burial as an approved method of destruction.
154. In line with a standard licence condition, the applicant proposes that all transport and storage of GM plant material would comply with the Regulator’s Guidelines for the transport, storage and disposal of GMOs, available on the OGTR website. These protocols for the handling of GMOs would minimise exposure of people and other organisms to the GMOs (Risk Scenario 1), and dispersal of GMOs into the environment (Risk Scenario 2) during transport.
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155. The applicant proposes that experimental analysis of the GM plant materials would take place in certified PC2 facilities, or that seed oil composition analysis would occur at the CSIRO Animal, Food and Health Sciences Werribee facility, which is not certified. Seeds would be rendered non-viable by crushing and/or oil extraction prior to transport to the Werribee facility. A licence condition states that experiments may take place in a planting site, at the CSIRO Animal, Food and Health Sciences Werribee facility in the case of non-viable GM plant material, or in another facility approved in writing by the Regulator. Experiments with the GMOs or GM plant material may be conducted in certified physical containment facilities as Notifiable Low Risk Dealings (NLRDs) in accordance with all appropriate requirements of the Gene Technology Regulations 2001, and therefore this activity is not covered in the licence.
156. It was noted in Chapter 2 that unexpected effects of genetic modification could potentially lead to increased toxicity or allergenicity (Risk Scenario 1) or increased weediness (Risk Scenario 2). A standard licence condition requires the applicant to notify the OGTR of any unintended effects of the dealing authorised by the licence.
157. The applicant does not propose using any of the GM plant material for human or animal consumption, and the GM safflower has not been assessed for food use by FSANZ. Therefore a condition in the licence prohibits material from the trial from being used for human food or animal feed.
3.1.2 Summary of licence conditions to be implemented to limit and control the release
158. A number of licence conditions have been imposed to limit and control the proposed release, based on the above considerations. These include requirements to:
- limit the duration of the field trial to three growing seasons
- limit the field trial to one site of up to 1 ha during the first growing season, and three sites of up to 1 ha each during the second and third growing seasons
- locate trial sites at least 50 m from natural waterways
- ensure that no other safflower crops are grown within 600 m of the trial sites
- surround each site with a 10 m monitoring zone maintained in a manner that does not attract or harbour rodents
- while the GM safflower is flowering, inspect areas within 200 m of the trial sites and destroy any safflower or related species
- use bird netting or bird scarers to deter birds
- control rodents
- harvest GM safflower separately to other crops or trials
- clean equipment prior to removal from the site
- destroy all plant materials not required for testing or future trials
- promote germination of residual seed by post-harvest tillage and irrigation
- monitor for at least 12 months after harvest, and until no volunteer safflower plants are detected for at least 6 consecutive months, and destroy any safflower plants before flowering
- transport and store GM material in accordance with the Regulator’s guidelines
- not allow GM plant material or products to be used for human food or animal feed.
3.2 Other risk management considerations
159. All DIR licences issued by the Regulator contain a number of conditions that relate to general risk management. These include conditions relating to:
- applicant suitability
- contingency plans
- identification of the persons or classes of persons covered by the licence
- reporting structures
- a requirement that the applicant allows access to the trial sites and other places for the purpose of monitoring or auditing.
3.2.1 Applicant suitability
160. 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 capacity of the applicant to meet the conditions of the licence.
162. The licence includes a requirement for the licence holder to inform the Regulator of any circumstances that would affect their suitability.
163. In addition, any applicant organisation must have access to a properly constituted Institutional Biosafety Committee and be an accredited organisation under the Act.
3.2.2 Contingency plan
164. CSIRO is required to submit a contingency plan to the Regulator before conducting any dealings with the GMOs under this licence. This plan must detail measures to be undertaken in the event of any unintended presence of the GM safflower lines outside of the permitted areas.
165. 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 modifications in a recipient organism. This instrument is required before conducting dealings with the GMOs.
3.2.3 Identification of the persons or classes of persons covered by the licence
166. 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. Prior to conducting any dealings with the GMOs under this licence, CSIRO is also required to provide a list of people and organisations who will be covered by the licence, or the function or position where names are not known at the time.
3.2.4 Reporting requirements
167. 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.
- expected and actual dates of planting
- details of areas planted to the GMOs
- expected dates of flowering
- expected and actual dates of harvest
- actual dates of cleaning after harvest
- details of inspection activities.
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169. 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 site.
170. 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.
171. In cases of non-compliance with licence conditions, the Regulator may instigate an investigation to determine the nature and extent of non-compliance. The Act provides 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.