Application Number
Hearing Date
Consideration Date
Considered by
GMF98004
11 November 1998
20 November 1998
The Authority
Date 26 November 1998
Application Code
Applicant
Purpose
Date Application Received
GMF98004
Kimihia Research Centre
To field test, in the Canterbury region, genetically modified sugar beet, to evaluate agronomically important characteristics.
13 August 1998
ERMA New Zealand Contact Elizabeth Beale
The application is Approved with Controls.
The organism approved is:
Beta vulgaris vulgaris (sugar beet); designation of transformed line: T120-7, category: HT
(herbicide tolerant), phenotype: phosphinothricin resistant, construct: pOCA18/Ac.
The matters considered in making this decision comprise those set out in sections 37, 44 and
45 of the Act, and those relevant items in Part II of the Act.
Consideration of the application followed the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (the Methodology), but with particular regard to clause 8 (information appropriate to the scale and significance of the risks, costs and benefits) and clause 26 (applications where the risks are negligible).
In hearing evidence on this application general issues were raised in relation to genetically modified organisms (GMOs) including whether a decision on this application should be influenced by the broader question of the acceptability of GMOs within New Zealand. The
Hazardous Substances and New Organisms Act 1996 provides for applications to be either approved or declined on a case by case basis on the criteria set out in the Act. A decision regarding acceptability of GMOs in general would need to be made by Parliament, and

implemented by an amendment to the Act. It is therefore the Authority’s view that addressing this general issue is inappropriate to the consideration of this application to field test genetically modified sugar beet.
In accordance with section 45(1)(a)(i) of the Act, the Authority was satisfied that this application is for one of the purposes specified in section 39(1) of the Act, being section
39(1)(b): Field testing any new organism.
In reaching its decision the Authority considered the ability of the organism to establish an undesirable self-sustaining population and the ease with which such a population could be eradicated [section 37(a) and (b)]. In considering these items the Authority was satisfied that the likelihood of the establishment of a self-sustaining population was low. The Authority was also satisfied that should such a population establish it could be eradicated.
In reaching this conclusion the Authority considered the mechanisms for any escape to occur, including: removal of seed prior to germination by birds, pollen/seed spread as a result of failure to remove bolters, and unintentional loss of seed/heritable material.
The Authority was satisfied that the likelihood of escape via birds, pollen and unintentional loss is low provided the trial is operated in accordance with the management plan and controls imposed by the Authority. In considering these mechanisms the Authority was satisfied that birds are unlikely to remove buried seed from the ground, all bolters will be removed prior to flower buds opening (and hence prevent pollen dispersal), and that all appropriate measures will be taken to prevent unintended release beyond the trial site.
The Authority also considered the likelihood of escape of transgenic genetic traits by horizontal gene transfer to soil micro-organisms. The Authority concluded that, while the scientific evidence available is limited, horizontal gene transfer as a result of this field trial is unlikely to occur. The Authority also concluded that if horizontal transfer did occur, the genetic constructs involved in the transgenic sugar beet would be unlikely to cause significant adverse effects.
Based on the available evidence the Authority considered that, given the unlikely event of any escape from containment, the development of resistance to the herbicide Buster © , by species in the genus Beta with which the sugar beet might hybridise, would not constitute a significant adverse effect. In the event of any escape the Authority noted that transgenic sugar beet remains susceptible to a range of common herbicides including Roundup ©
Granstar ©
and
. The Authority also noted the fact that the PAT gene product acts to catalyse the break down of specific chemical components and does not itself have any toxic properties.
In addition, the weight of scientific evidence suggests that, should it occur, the development of resistance to the antibiotic kanamycin, which is not widely used as a treatment for human disease, would not constitute a significant adverse effect.
The Authority therefore formed the view that the risks associated with this field test are negligible.
The Authority finds that the direct benefits identified in undertaking this field test in containment include, but are not limited to, the commercial return to the applicant, the

experience to be gained in handling GMOs and the value of the applicant’s relationship with its overseas client.
The Authority, having regard to the ability of the organism to escape from containment
[section 44(b)], concluded that the beneficial effects of having the organism in containment outweighed the adverse effects of the organism and any inseparable organisms, should the organism escape.
Having considered all the possible effects of the organism, in accordance with sections
45(1)(a)(ii) and (iii) of the Act, the Authority was satisfied that the proposed containment regime and additional controls on approval imposed by the Authority could adequately contain the organism.
In order to provide for the matters detailed in the Third Schedule Part I Containment Controls for
Development and Field Testing of Genetically Modified Organisms of the Act, the Authority’s approval of this application is subject to the following controls:
1.
The applicant shall advise the Authority of any sale of the trial site within three years of completion of the trial, and shall require the purchaser to comply with controls 11 and
12 below.
2.
The trial site is to be located so as to avoid the possibility of damage caused by floods, landslide and other natural hazards.
3.
The trial site is to be used solely for the trial of transgenic sugar beet. Entrances are to be secured and the trial site is to be monitored for interference other than by authorised personnel.
4.
At all times only authorised persons are to have access to the trial site.
5.
Transgenic sugar beet is to be isolated by at least 100 metres from the nearest nontransgenic sugar beet.
6.
All transgenic sugar beet material is to be properly and adequately identified at all times.
Transgenic sugar beet plants and/or any heritable material shall not be transported from the trial site.
7.
Handling of transgenic sugar beet seed during the sowing operation shall ensure that there is no spillage outside the field trial site.
8.
Equipment used in the field testing of transgenic sugar beet shall be thoroughly cleaned at the trial site to prevent any viable transgenic sugar beet material leaving the trial site.
9.
The applicant shall monitor the trial site at least every seven days and identify and destroy all bolters (seed stalks) prior to flower buds maturing to ensure that there is no flowering or pollen production.

10.
The applicant shall prevent seed-eaters having access to transgenic sugar beet seed prior to germination and prevent herbivores having access to transgenic sugar beet plants, during the trial period.
11.
The applicant shall identify and destroy any seedlings which germinate within 100 metres of the trial site, during the field trial, and for a minimum of 3 years following completion of the trial or until no further seeds germinate.
12.
The applicant shall, following completion of the trial identify and destroy any seedlings which germinate within the site for a minimum of 3 years or until no further seeds germinate.
13.
Any object or material that is likely to contain viable transgenic sugar beet, including any unused seed, is to be disposed of by incineration or autoclaving so as to prevent unintended release.
14.
All biological material related to this field trial must be destroyed by application of herbicide and rotary hoed within 12 months of the sowing date, or by 31 December
2000, whichever is first.
15.
The Authority or its authorised agent or properly authorised enforcement officers, may inspect the trial site at any reasonable time.
16.
The applicant is to inform all staff involved in the operation and management of the field trial of the conditions and controls applicable to this field trial.
17.
The applicant is required to ensure adequate training of all personnel involved in the field trial.
18.
The field trial is to be managed according to the regime set out in the management plan and the application .
Monitoring and Reporting Requirements
19.
The applicant shall: i.
advise the Authority of the sowing date; ii.
advise the Authority at first emergence of the beets, including an estimate of the number of plants that germinated; iii.
advise the Authority of the date the first bolters appear; iv.
advise the Authority of the date following final count of bolters and the mid-
March application of herbicide to kill the crops; v.
provide a report to the Authority at the conclusion of the field trial, by 30 th June
1999 (or 2000), or at any other time if requested by the Authority or ERMA
New Zealand, including detail of the:
 the conduct and outcomes of the field trial; and

 extent of compliance with the above conditions (including any incidents of escape of the transgenic sugar beet from containment). vi.
provide an annual report to the Authority by 30 th June recording the results of posttrial monitoring, for a minimum of 3 years or until no further seeds germinate.
20.
For this application, controls 1-19 above, constitute the standard applicable to the approval of a place as a containment facility for the purposes of section 39 of the
Biosecurity Act 1993.