ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Controls amended under S67A on 10 June 2002
Application Number
GMF98008
Hearing Date
12 November 1998
Considered by
The Authority
Original Decision
22 December 1998
Application Details
Application Code
Applicant
Purpose
Date Application Received
GMF98008
New Zealand Institute of Crop & Food Research Ltd
To field test, in the Canterbury region over 5 years, potato cultivars
genetically modified for increased resistance to potato tuber moth, to
evaluate resistance and yield performance of individual lines.
14 August 1998
ERMA New Zealand Contact
Elizabeth Beale
Decision
The application is Approved with Controls.
The organism approved is: Solanum tuberosum L. (potato); Cultivar: various (refer to attached
schedule); Binary vectors: pART27G, pART27G7, pART27G10, pART27G14, and
pART1AcB; Phenotype: resistant to Lepidoptera (moths), specifically potato tuber moth
(Phthorimaea operculella).
Legislative Framework
The application was lodged pursuant to section 40 of the Act, and determined in accordance
with section 45 and the additional matters contained in sections 37 and 44 and those relevant
items in Part II of the Act. In accordance with section 45(1)(a)(i) of the Act, the Authority was
satisfied that this application was for one of the purposes specified in section 39(1) of the Act,
being section 39(1)(b): Field testing any new organism.
Consideration of the application followed the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (the Methodology), 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).
Field Test of Genetically Modified Organisms yet to be Developed
The Authority noted that the application sought approval to field test some lines of certain
cultivars which have yet to be developed. Development of those further lines will require
approval prior to field testing, under section 39(1)(a) of the Act, which may be sought either
from an Institutional Biological Safety Committee (IBSC) or from the Authority.
The Authority concluded that it could in this instance grant approval for field testing the yet
to be developed lines. This conclusion was made on the basis that the characteristics of the
organisms yet to be developed can be identified through the detailed specification of the
genetic modifications, and by reference to the lines already developed from the Iwa and
other cultivars detailed in this application.
Requirements of the applicant in this regard are specified in the first control set out at the
conclusion of this decision.
Issues Considered in Decision Making
In reaching a decision on the application the Authority considered, inter alia:

the adequacy of the proposed containment location within which the field test is to be
conducted;

the likelihood of escape from the containment location including the possibility of
horizontal gene transfer; and

the risks to the environment and the health and safety of people in the event of an
escape including, in particular, the ability of the organism to hybridise, or to establish a
self-sustaining population, and the possibility of an escape generating resistance in
other species to the Bacillus thuringiensis (Bt) toxin or the antibiotic, kanamycin.
Adequacy of the Proposed Containment Location
The Authority was satisfied with the containment procedures and management plan put
forward by the applicant as regards supervision, size of plots, transportation of potatoes in
secure sacks, disposal of tubers by autoclaving or incineration, but has required certain
changes regarding harvesting, removal of foliage, the buffer zone and isolation distance.
The Authority considered the possibilities for escape from the containment location by
mechanisms including the dispersal of pollen by wind, bees and other insects; the dispersal
of seed and unintentional loss of seed and heritable material, including tubers; and loss by
deliberate theft.
Potato flowers are primarily self-pollinating with little nectar and therefore the risk of
effective cross-pollination by bees or other insects has an extremely low probability. In
addition, evidence given at the hearing suggests that sexual reproduction in potatoes occurs
most readily early in the day when temperatures are lower, but when pollinating insects are
least active, so that the window of opportunity for cross-pollination is narrow.
The transgenic potatoes are to be planted later than the non-transgenic potatoes and will
correspondingly flower later, thus securing effective temporal containment relative to any
non-transgenic potato crops grown in the vicinity of the containment location.
As regards heritable material, the Authority noted that escape via wind-borne pollen was
unlikely given the inclusion in the management plan of three buffer rows of non-transgenic
plants, and an isolation distance of 50 metres between the containment location and any
other non-transgenic potato crop. Evidence given at the hearing indicated that crosspollination occurs rarely within a potato crop, and that effective cross-pollination of potato
has not been established at distances greater than six metres. However the Authority
considered greater safety would be ensured if the buffer rows occupied a zone of not less
than six metres width and that the proposed 50 metre isolation distance should be
maintained from the outer edge of the buffer zone.
The Authority considered the probability of escape via seed also to be extremely low as all
berries developing on transgenic plants are to be removed.
Hybridisation
Ngā Kaihautu Tikanga Taiao had raised the possibility of native flora valued by Māori,
particularly poroporo (Solanum laciniatum), being adversely affected as a result of possible
hybridisation by transgenic potato plants. The Authority considered the likelihood of
hybridisation by transgenic potato pollen of all other Solanum species in New Zealand.
Unpublished data included in the application indicated that appropriate tests have been
undertaken and that no hybridisation resulted for all the species tested, including poroporo.
The Authority concluded from this evidence that such hybridisation was highly unlikely.
Self-sustaining Populations
Sections 37(a) and (b) of the Hazardous Substances and New Organisms Act 1996 require the
Authority to consider the ability of the organism to establish an undesirable self-sustaining
population, in the event of escape from containment, and the ease with which such a
population could be eradicated.
To be potentially self-sustaining, the transgenic potatoes would need to exhibit evidence of a
rapid and high rate of reproduction, an ability to disperse reproductive parts widely, and a
tolerance of a wide range of climatic and soil conditions. The principal undesirable
characteristic is weediness.
Non-transgenic potatoes have not demonstrated a potential to establish self-sustaining
populations, and there is no reason to assume that transgenic potatoes would be different.
Nor do potatoes manifest weedy characteristics in New Zealand. The Authority concluded
that the probability of the organism escaping from containment is extemely low, and its
potential then to establish an undesirable self-sustaining population even more so.
The Authority was also satisfied that should such a population establish it could be
eradicated by the use of common herbicides, eg amitrole, glyphosate or MCPA.
Horizontal Gene Transfer
In considering the likelihood of escape of genetic material by horizontal gene transfer to soil
micro-organisms, the Authority noted that while the scientific evidence available is
inconclusive, horizontal gene transfer from transgenic plants to soil micro-organisms is
unlikely. Moreover, because Bacillus thuringiensis is already widespread in the natural soil
environment, horizontal transfer of the toxin gene to soil micro-organisms, particularly in
the context of the proposed small-scale field test, is extremely unlikely to have any definable
or material impact.
Development of Bt Resistance
The Authority considered the possibility of the development of resistance within populations
of Lepidotera (specifically the potato tuber moth) to the cry proteins derived from the soil
bacterium Bacillus thuringiensis, and any adverse effects on beneficial organisms, specifically
insects, which may occur as a result of consuming the toxin.
Based on the available scientific evidence the Authority concluded that the probability of
Lepidoptera populations developing resistance to cry proteins, in the context of the proposed
small-scale field test, was very low. Moreover, the origin of any resistance developed would
be difficult to determine because of the current use of Bt toxin as an organic insecticide.
In addition the Authority considered that any adverse effects on populations of beneficial
organisms, such as ladybirds and lacewings, would in the context of the proposed field test
be insignificant.
Development of Antibiotic Resistance
The Authority considered whether the kanamycin resistance marker gene might by various
means be introduced into the human genome, resulting in the development of resistance to
the antibiotic kanamycin, which is used (though not widely) to treat certain human diseases.
The Authority concluded that the probability of such introduction into the human genome
was extremely low.
In addition, the Authority noted that the gene for kanamycin resistance encodes an enzyme,
neomycin phosphotransferase, which confers resistance by modifying the specific antibiotic.
The genes which confer such resistance are common throughout soil micro-organisms, and
occur even in the micro-organisms of the human gut.
Because such resistance is already widespread, the Authority considered that any incremental
resistance resulting from gene transfer from transgenic potato plants associated with this
field test, by whatever means, would be unlikely to have any definable or material adverse
consequences on the environment or human health.
Negligible Risk
The Authority concluded, based on consideration and analysis of the information provided,
and taking into account the application of risk management controls specified in this
decision, that the risks of adverse effects associated with this field test are negligible.
Benefits
The application is to undertake field tests in containment of certain lines of defined potato
cultivars developed under laboratory and glasshouse conditions to determine their resistance
to potato tuber moth under normal growing conditions. A this point the benefits from the
research, when completed, for potato growers and more generally for New Zealand have still
to be established. The issue for the Authority therefore was whether there was benefit to be
gained from completing the research in terms of the scientific knowledge it will generate
relative to the risks of conducting the field test in containment under the control conditions
imposed. The Authority 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.
Conclusion
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.
Controls
In order to provide for the matters detailed in Part I of the Third Schedule to the Act,
Containment Controls for Development and Field Testing of Genetically Modified Organisms, this
application is approved subject to the following controls:
1.
The applicant before planting any genetically modified potato line or lines, not yet
developed, shall obtain development approval and provide a declaration to the
Authority verifying that:
1.1
the line has been developed in accordance with an approval under section 39(1)(a)
of the Act;
1.2
the line is one of those listed in the attached schedule;
1.3
the line contains the transgene (verified by methods including, but not limited
to, the Polymerase Chain Reaction (PCR) or Southern hybridisation analysis);
1.4
the lines exhibit the expected characteristics; and
1.5
the lines do not exhibit any undesirable traits.
2.
The trial site shall be on land owned and operated by the institute. The inspector
nominated by MAF and the Chief Executive of the Authority shall be notified prior
to any location changes and these changes shall be within the general vicinity
identified in the application and be related to information available to the Authority
at the time the decision was signed.
3.
At all times only authorised persons shall have access to the containment location (the
farm), and only specified personnel shall have knowledge of the location of the trial
site.
3.1
The trial site is to be monitored daily (on weekdays) for interference other than by
authorised personnel.
3.2
The gates of the containment location shall be locked from 6pm to 8am on weekdays,
with key access outside of these times controlled by the farm manager.
4.
Transgenic potatoes shall be isolated from other potato crops not associated with the
field test by at least 50 metres from the outside edge of the buffer zone.
5.
The containment location shall be bounded by a buffer zone at least six metres wide
and containing a minimum of three buffer rows of non-transgenic potatoes.
6.
All transgenic potato material shall be properly and adequately identified at all times.
7.
Handling of transgenic potato tubers/plants during planting is to ensure that there is
no spillage outside the containment location.
8.
Immediate and effective measures shall be taken to limit any spread of transgenic
potato tubers and seed from the containment location.
9.
Equipment used in the field testing of transgenic potatoes shall be thoroughly cleaned
at the containment location to prevent any viable transgenic potato material leaving
the containment location.
10.
To prevent unintended/accidental release of transgenic seed from the containment
location, all berries on transgenic potatoes shall be collected before ripening and
destroyed (by incineration or autoclaving), or maintained under containment, at least at
PC1 containment according to AS/NZS 2243.3:1995.
11.
All tubers from transgenic plants and any volunteers shall be harvested by hand and
removed from the containment location in securely tied bags. The containment
location being harvested shall be dug over again within one week to ensure that no
transgenic tubers remain.
12.
Any object or material that is likely to contain viable transgenic potato propagules shall
be disposed of in such a manner (by incineration or autoclaving) as to prevent
unintended release.
13.
Tubers from transgenic potatoes shall be stored in containment (at least at PC1
containment according to AS/NZS 2243.3:1995) or destroyed (by incineration or
autoclaving) and ERMA New Zealand notified in writing within 10 working days of
the event occurring.
14.
All other vegetative material, including foliage and roots, from the transgenic plants
shall be collected and destroyed by autoclaving or incineration.
15.
Transgenic potato material and seeds shall be bioassayed in at least PC1 containment
in accordance with AS/NZS 2243.3:1995.
16.
The containment location shall be left fallow for at least three years after the
completion of the field test as per control 21.
17.
The Authority or its authorised agent or properly authorised enforcement officers,
may inspect the containment location at any reasonable time.
18.
The applicant shall inform all staff involved in the operation and management of the
field test of the conditions and controls applicable to this field test.
19.
The applicant shall ensure adequate training of all personnel involved in the field test.
20.
The applicant shall adhere to the Trial Design and Experimental Plan as detailed in the
application, and shall modify the Plan by inclusion of additional controls.
Monitoring and Reporting Requirements
21.
The containment location shall be monitored for a minimum of three years for
presence of volunteer transgenic potatoes, and subsequently for 12 months beyond the
appearance and removal of any volunteers. Volunteer tubers/plants shall be destroyed
(by incineration or autoclaving) prior to flower buds forming on the plants.
22.
The applicant shall monitor the buffer zone and the isolation zone for any volunteer
potato plants, and test any appearing by the Polymerase Chain Reaction (PCR), for
presence of the transgenes. This shall be recorded and reported to the Authority.
23.
The applicant shall keep an inventory of all material harvested and destroyed.
24.
The applicant shall:
24.1 Advise the Authority of planting dates.
24.2 Provide a report to the Authority at the conclusion of each seasons field tests,
within four months of the end of each season or at any other time if requested
by the Authority or ERMA New Zealand, including detail of the:
24.2.1
24.2.2
progress and outcomes of the field test; and
extent of compliance with the above conditions (including any
incidents of escape of transgenic potato from containment).
24.3 Provide a final report at the conclusion of the approval period, by 30 June
2002/03.
24.4 Provide an annual report to the Authority recording the results of post-trial
monitoring, for a minimum of three years or until no further volunteers appear.
25.
For this application, controls 1-24 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.
Schedule
Parent Plant:
Potato (Solanum tuberosum L.)
Cultivars:
Iwa, Ilam Hardy, Rua, Russet Burbank, Kaimai, Karaka, Red
Rascal, Kiwitea, White Delight, Driver, Everest, Pacific,
Dawn, Fraser, Crop 13-Crop 23, V394 and Vtn62-33-3.
Genetic modifications:
The introduced DNA in the transgenic potato plants shall
comprise only one of following five DNA segments: the
modified T-DNA that is carried on any one of the binary
vectors pART27G, pART27G7, pART27G10, pART27G14
or pART1AcB.
A chimeric gene conferring kanamycin resistance to plant cells
consisting of the coding region of neomycin
phosphotransferase II from the bacterial transposon Tn5.