ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Controls amended under S67A on 10 June 2002
Application Number
GMF98007
Hearing Date
12 November 1998
Considered by
The Authority
Original Decision
22 December 1998
Application Details
Application Code:
Prime Contact:
Purpose:
Date Application Received
GMF98007
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 bacterial soft rots, 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: Iwa; Binary vectors:
pSHIVA, pBINPMgA-D, and pBINPLys; Phenotype: resistant to Erwinia carotovora, bacterial
soft rot.
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. Pursuant to 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 clauses 29-33.
Field Test of Genetically Modified Organisms yet to be Developed
The Authority noted that the application sought approval to field test some lines 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 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 and 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:
i.
the ability of the organism to hybridise, or to establish a self-sustaining
population, and the possibility of an escape generating antibiotic resistance in
other species; and
ii.
the likelihood of adverse effects (including toxicity and allergenicity) on non-target
organisms resulting from the consumption or absorption of the peptides
expressed in the potato lines.
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 over 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 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 an 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 extremely 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-organism is
unlikely.
Toxicity and Allergenicity of Peptides (Magainin 2 and Cecropin B)
In response to points raised in submissions, the Authority considered the potential toxicity
and allergenicity of the peptides magainin 2 and cecropin B in the event of their
consumption or absorption by other organisms. The organisms of particular concern are soil
micro-organisms, and people who may ingest potato material.
As regards their possible toxicity to other organisms in the soil, either within or outside the
containment location, eg in consequence of un-harvested tubers rotting in the soil, the
Authority noted that as the peptides are soluble in water, they could disperse from these
isolated loci. However, at the same time, they are likely to be inactivated by protolytic
enzymes abundant in the soil environment, and therefore are likely to be destroyed before
being transported any distance from their source.
In the context of the proposed small-scale field test the Authority did not regard the risk of
detrimental impact on other soil organisms as a material threat to the ecosystem of which the
containment location forms a part.
Nonetheless, this is a matter which the applicant is able to monitor, and the Authority has
therefore included as a control on this approval that the mobility of the magainin 2 and
cecropin B peptides expressed by the tubers and their consequential impact on the
surrounding soil organisms be monitored during the field test. The monitoring is to be
conducted within the buffer zone of the containment location.
Further, it noted that scientific data on this point, and on the likely life of peptides in the soil
would need to be addressed in the event that the applicant sought approval for the general
release of transgenic potatoes containing these peptides
As regards the ingestion of peptides by humans, the Authority noted that the available
scientific data on their toxicity to mammals was not extensive. However, several research
papers note that magainins and cecropins have low toxicity to eukaryotic cells in general. No
testing has been undertaken by the applicant although it is expected that this will be
addressed as part of the field testing, and such data will be critical to any application for
general release.
There is considerably more data regarding the potential allergenicity of peptides such as
these. In brief both magainan 2 and cecropin B are molecules which in themselves are too
small to generate an allergenic response if ingested. However, they could conjugate to form
entities that may produce an allergenic response, but the likelihood of this happening in the
gut following human ingestion is very low. Moreover, even if antibodies were induced, the
individual would have to mount a strong enough immune response for an adverse effect to
occur. This is an area in which considerable research is continuing.
While the available data at this point is uncertain, the direction of the data is that serious
toxic or allergenic effects are unlikely to result from the human ingestion of magainin 2 and
cecropin B. However, the data is uncertain, and the Authority is required in terms of section 7
of the Act to take into account the need for caution in managing potential adverse effects.
In this regard the Authority referenced clauses 29-33 of the Hazardous Substances and New
Organisms (Methodology) Order 1998 (the Methodology), dealing respectively with the
treatment of uncertainty, and factors affecting the Authority’s approach to risk.
Clause 31 of the Methodology provides that where the uncertainty arises from an absence of
information or inconclusive information the Authority may request the applicant to provide
further information. This was done in the present case, and the content of that further
information is reflected in this decision.
Clause 29 of the Methodology provides that where the Authority encounters scientific and
technical uncertainty relating to the potential adverse effects of an organism it should first
determine the materiality and significance to the application of that uncertainty.
The Authority considered both the likelihood of the peptides escaping from containment,
and the likelihood of their ingestion by humans, and concluded that by any comparative
reckoning the probabilities of either occurrence are very low, given the control conditions
relating to the containment location and management plan.
Given the direction of the available evidence that ingestion of magainin 2 and cecropin B by
humans is unlikely to have serious toxic or allergenic effects, the Authority concluded that
the uncertainty was not material to the application.
Clause 33 of the Methodology lists the risk characteristics to which the Authority must have
regard in determining its approach to risk. The Authority concluded that the risks associated
with the human ingestion of peptides in context of the field test proposed can be regarded as
voluntary, contained in time, not subject to uncontrollable spread and understood by the
persons likely to be in a position to take the risks (staff with access to the containment
location).
Overall, the Authority concluded that the scientific uncertainty associated with the toxicity
and allergenicity of magainin 2 and cecropin B should not be detrimental to the application,
provided additional control measures are introduced. These encompass taking steps to
ensure that unauthorised persons do not enter the containment location, and a requirement
not only that harvesting should be conducted by hand, but that the harvest process should
be repeated at each harvest to minimise the number of tubers remaining in the ground.
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 soft rot under normal growing conditions. At 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 and 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 transgene is expressed and showing efficacy by growth indices of soft rot
bacteria in green house grown plants;
1.5
the lines exhibit the expected characteristics; and
1.6
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 is to 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 monitor in the buffer zone for the potential for the peptides
magainin 2 and cecropin B to move from the containment location and their effect on
soil organisms. To achieve this, the applicant shall prepare and implement a sampling
and analysis programme that shall specify what samples will be obtained (eg soil, biota
and/or moisture samples); where the samples will be collected (location and depth),
the sensitivity of the analytical methods (eg at least ½ the inhibitory concentration,
IC50, for the most sensitive soil organisms). The applicant shall also prepare and
implement a programme to determine the effects these peptides have on soil
organisms. This programme will include the identification of appropriate sentinel
species, and the methods to determine the effects of the peptides on these organisms.
These programmes should be submitted to ERMA New Zealand prior to
implementation.
25.
The applicant shall:
25.1
Advise the Authority of planting dates.
25.2
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:
25.2.1 progress and outcomes of the field test; and
25.2.2 extent of compliance with the above conditions (including any
incidents of escape of transgenic potato from containment).
26.
25.3
Provide a final report at the conclusion of the approval period, by 30 June
2002/03.
25.4
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.
For this application, controls 1-25 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.)
Cultivar:
Iwa.
Genetic modifications:
The introduced DNA in the transgenic potato plants shall
comprise only one of following three DNA segments: the
modified T-DNA that is carried on any one of the binary
vectors pSHIVA, pBINPMgA-D, pBINPLys.
A chimeric gene conferring kanamycin resistance to plant cells
consisting of the coding region of neomycin
phosphotransferase II from the bacterial transposon Tn5.