148. Licence conditions have been imposed to restrict the spread and persistence of the GMOs and their genetic material in the environment and limit the release to the size, locations and duration proposed in the application. 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 this Chapter.

3.1 Licence conditions to limit and control the release

3.1.1 Consideration of limits and controls proposed by Bayer


149. Sections 3.2 and 3.3 of Chapter 1 provide details of the limits and controls proposed by Bayer in their application. These are discussed in the six risk scenarios characterised for the proposed release in Chapter 2. Many of these proposed control measures are considered standard GM cotton licence conditions and have been imposed by the Regulator in previous DIR licences. The appropriateness of these controls is considered further below.

150. The release would be limited to up to 6 sites per year in the LGAs of Narrabri, NSW, Wyndham-East Kimberley, WA, and Central Highlands, Qld. The duration of the release would be limited to three years and the maximum cumulative area of the release would be 78 ha. Only staff with appropriate training would be allowed to deal with the GMOs. GM plant material will not be permitted to enter commercial human or animal food supply chains. These measures will minimise the potential exposure of humans and other organisms to the GMOs (risk scenarios 1 and 2) and the potential for the GM cotton to be dispersed outside the trial limits (risk scenario 3).

151. Each site would be surrounded by a 20 m wide pollen trap or a 3 km exclusion zone, the latter in combination with a 100 m monitoring zone, to restrict gene flow from the GM cottons. As discussed in the The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2008), cotton is predominantly self-pollinating, with the highest level of outcrossing occurring between adjacent rows. Outcrossing is rare beyond 20 m (Llewellyn et al. 2007), and a 20 m pollen trap of non-GM cotton or GM cotton approved under commercial licences DIR 062/2005 and DIR 066/2006 would minimise gene transfer to sexually compatible plants outside the trial (risk scenario 4).

152. As an alternative to a 20 m pollen trap, a 3 km exclusion zone in combination with a 100 m monitoring zone immediately surrounding a trial site was proposed. The exclusion zone would be free of intentionally planted (GM and non-GM) cotton. The monitoring zone would be inspected every 30 days while the cotton plants are being grown at the trial site and kept free of flowering cotton plants. In the RARMP prepared for DIR 081/2007, the literature regarding outcrossing rates over heterogenous terrain was reviewed. In addition, the suitability of the combination of these controls was assessed and found acceptable to restrict vertical gene transfer from GM cotton trial sites to other (GM and non-GM) cotton.

153. The applicant has proposed to locate the trial sites more than 50 m from the nearest waterway which would minimise the chance of viable plant material being washed away from the site. This is a standard DIR licence condition. In addition, licence conditions have been imposed requiring immediate notification of any extreme weather conditions affecting the site during the proposed release, and cleaning of areas where GM plant material has been dispersed. These measures will minimise likelihood for the GM cotton to be dispersed outside the release sites (risk scenario 3).

154. The applicant has proposed that the GM cotton would be harvested and ginned separately from other cotton crops to prevent mixing. All equipment used in connection with cultivating the GM cotton will be cleaned on site prior to removal. An additional licence condition has been imposed requiring that any gin used for the GM cotton must be cleaned immediately following its use and before any other cotton crop is ginned. These measures are expected to limit the potential exposure of humans and other vertebrates to the GMOs (risk scenario 1) and the potential for the GM cotton to be dispersed outside the release sites (risk scenario 3).

155. After the GM cottons have been harvested, the applicant has proposed to destroy all remaining plant material not required for further testing, and to clean the sites and all equipment used. As discussed in the The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2008), cotton seeds have low dormancy levels and do not generally form a viable seed bank. However, dormancy can be induced in cotton seeds by low soil temperature and/or soil moisture. The applicant proposes at least one post-harvest cultivation (followed by an irrigation event) of the trial sites and pollen traps to promote cotton seed germination and minimise the persistence of a GM cotton seed bank. A licence condition has been imposed requiring this cultivation to occur in the spring or summer following the harvest, so that soil temperature will be suitable for cotton seed germination. The licence requires that each trial site would be monitored post-harvest at least every two months for a minimum of twelve months and until the site has been clear of volunteers for at least six months. These measures will limit the persistence of the GM cotton in the environment (risk scenario 3).

156. 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, Storage and Disposal of GMOs. These are standard protocols for the handling of GMOs to minimise exposure of people and other organisms to the GMOs (risk scenarios 1 and 2), dispersal into the environment (risk scenario 3), and gene transfer (risk scenario 4).

3.1.2 Summary of measures imposed by the Regulator to limit and control the release


157. 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 release to a total cumulative area of 78 ha in three LGAs between May 2012 and May 2015.
  • restrict gene flow via pollen from field trial sites using one of the following measures:
    1. surround the trial site with a 100 m monitoring zone and maintain a 3 km isolation distance between the site and intentionally planted cotton crops, or
    2. surround the trial site by a 20 m pollen trap of non-GM cotton or commercially approved GM cotton, and treating the pollen trap plants in the same way as the GMOs
  • harvest and gin all cotton plant material separately from other cotton crops
  • clean all equipment used in connection with the cotton plant material
  • after harvest, destroy all cotton plant material not required for further analysis or future planting
  • after cleaning of sites, apply measures to promote germination of any cotton seeds that may be present in the soil
  • after cleaning of sites, monitor for and destroy any GM cotton that may grow for at least 12 months, and until no volunteers are observed for a continuous 6 month period
  • transport and store the GM plant material in accordance with the Regulator’s guidelines or other specific conditions
  • not allow GM plant material or products to be used for human food or animal feed.
158. Research with the GMOs or GM plant material may be conducted in certified physical containment facilities as Notifiable Low Risk Dealings (NLRD) in accordance with all applicable requirements of the Gene Technology Regulations 2001, and therefore this activity is not covered in the licence.

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 licence holder 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.
161. On the basis of information submitted by the applicant and records held by the OGTR, the Regulator considers Bayer suitable to hold a licence.

162. 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.

163. Bayer must continue to have access to a properly constituted Institutional Biosafety Committee and be an accredited organisation under the Act.

3.2.2 Contingency plan


164. Bayer is required to submit a contingency plan to the Regulator within 30 days of the issue date of the licence. This plan must detail measures to be undertaken in the event of any unintended presence of the GM cotton outside of the permitted areas.

165. Bayer 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.

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 growing the GMOs, Bayer is also required to provide a list of people and organisations who will be covered, 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.
168. A number of written notices are also required under the licence that assist the Regulator in designing and implementing a monitoring program for all licensed dealings. The notices include:
    • locations of trial sites
    • expected and actual dates of planting
    • details of areas planted to the GMOs
    • expected dates of flowering
    • expected and actual dates of harvest and cleaning after harvest
    • details of inspection activities.

3.2.5 Monitoring for Compliance


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.