ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 12 September 2005 and 23 August 2007
18 December 2003
GMF03001
Application code:
Application category: Field Test in Containment any Genetically Modified Organism under
the Hazardous Substances and New Organisms (HSNO) Act 1996
New Zealand Institute for Crop & Food Research Limited
Applicant:
To field test onions modified for tolerance to the herbicide glyphosate,
Purpose:
and to evaluate their environmental impact; herbicide tolerance;
agronomic performance; development as cultivars and equivalency to
non-genetically modified onions.
3 June 2003
Date received:
3 – 5 November 2003
Hearing date:
18 December 2003
Decision date:
Special Committee of the Environmental Risk Management Authority
Considered by:
Summary of Decision
1. The application to field test the following organism is approved with
controls (specified in Appendix 1) having been considered in accordance with
the relevant provisions of the Hazardous Substances and New Organisms
(HSNO) Act 1996 and of the HSNO (Methodology) Order 1998:
Onions (Allium cepa L.) modified with one or two insertion events of a
construct from one of three pMON series plasmids* containing (between the
right and left T-DNA borders):
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a promoter derived from a plant virus;*
a sequence encoding the leader sequence from one of two specified
plant heat shock proteins;*
a sequence encoding a chloroplast transit peptide from a plant
species;*
a synthetic EPSPS gene, conferring tolerance to herbicide glyphosate,
based on the CP4 EPSPS gene from Agrobacterium strain CP4; and
a 3’ untranslated region1 from a plant gene.*
* Specified in Appendix 2; confidential information.
This region contains signals for the termination of transcription. 3’indicates the location of this region
on the DNA molecule.
1
2. The controls attached to the approval are set out in Appendix 1, attached. The
controls provide for the adequate containment of the organism, and for the
management of any risks. In particular the controls provide for:
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the specification of the field trial site (the field trial containment
facility), being a location in the region around Lincoln, and the control
and securing of the facility in regard to the entry and exit of biological
material and of people;
limitation of the duration of the approval to ten years;
the scope of the field trial programme including the number of
genetically modified onions grown and other matters;
disposal of onion plant material;
removal of all onions from the field before flowering (and thus pollen
transfer) can occur;
a prohibition against ingestion of the onions by people; and
monitoring and inspections both during the field trial and after its
completion.
3. In considering the application the three non-negligible risks (or costs) were
considered to be the risk of potential pollen contamination of other produce,
unanticipated effects due to the incomplete characterization of the genetically
modified onions, and the opportunity cost of not funding more beneficial
research.
4. The principal benefit was considered to be that of scientific and other
knowledge generated by the field trial. Other significant benefits included the
provision of a platform for research into environmental effects and a
contribution to the retention of scientific expertise in New Zealand.
5. Concerns raised by Māori were considered to be adequately ameliorated by
the controls set regarding kaitiaki functions and receipt of reports.
6. The benefits were considered to outweigh the risks and costs. However,
uncertainty was a significant factor in considering both elements.
7. Other means of achieving the research objectives were considered, but this did
not provide any reason to decline the application.
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Full Decision
1
1.1
Application Process
Legislative criteria for application
1.1.1.1 The application was lodged pursuant to section 40(1)(c) of the Hazardous
Substances and New Organisms Act (HSNO) Act 1996 (the Act). The decision was
made in accordance with section 45 of that Act taking into account additional
matters to be considered under sections 37, 44 and 44A, and matters relevant to the
purpose of the Act, as specified under Part II of the Act. Unless otherwise stated,
references to section numbers in this decision refer to sections of the Act.
1.1.1.2 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 12 (dealing with assessment of risks) and 13 (dealing
with assessment of costs and benefits). Unless otherwise stated, references to clauses
in this decision refer to clauses of the Methodology.
1.2 Receipt of application
1.2.1.1 The application was formally received on 3 June 2003. Staff of ERMA New Zealand
reviewed the application and it was considered that it did not contain sufficient
information for it to proceed. The applicant was informed of the further information
requirements, by written notice, within ten working-days of application receipt.
Consideration was given to the ability of the applicant to provide further relevant
information, as required in section 52(1) of the Act. The Minister for the
Environment was notified on 3 July 2003 in accordance with section 53(4)(a) of the
Act. The revised application was received on 4 July 2003.
1.3 Special Committee
1.3.1.1 In accordance with section 19(2)(b) of the Act and clause 43 of the First Schedule to
the Act the New Zealand Environmental Risk Management Authority (the
Authority) appointed a Special Committee on 28 August 2003 to consider the
application. The Authority delegated to the Committee all necessary powers to
determine the application. The Committee comprised: members of the Authority,
Professor Colin Mantell (Chair), Dr Lin Roberts, Dr Manuka Henare, and external
member, Professor Clive Ronson (expert in microbial and plant molecular genetics).
References to the Committee in the remainder of this decision mean the Special
Committee appointed to undertake the consideration.
1.4 Public notification
1.4.1.1 The application was publicly notified on 10 July 2003 in accordance with section
53(1)(d) of the Act 1996. Notification was made in accordance with clause 7 of the
Methodology and the method of public notification was that determined by the
Authority pursuant to section 53A of the HSNO Act 1996. An alert notice was
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printed in The Dominion, The New Zealand Herald, The Press and The Otago Daily
Times on 16 July 2003.
1.5 Submissions
1.5.1.1 Public submissions closed on 20 August 2003. Submissions conforming to section
54(2) of the Act were received from 1933 parties, of which 427 indicated that they
wished to be heard at a hearing. The names of all submitters are available on request
from the Wellington office of ERMA New Zealand.
1.6 Consultation with government departments
1.6.1.1 In accordance with section 53(4) of the Act and clause 5 of the Methodology, and
for the purpose of section 58(1)(c) of the Act, various government departments and
other agencies were notified of the receipt of the application. A submission was
received from the Department of Conservation (DoC) and comment was received
from the Ministry of Agriculture and Forestry (MAF).
1.7 Experts
1.7.1.1 In accordance with section 58(1)(a) of the Act and clauses 17 and 18 of the
Methodology the Committee, following notification to the applicant of its intention,
appointed two experts to review the information provided with the application and to
provide advice on matters relating to onion agronomy and weed management. The
information sought included onion cropping management practices, crop
physiology, herbicide usage, pests and control methods, and location and size of
export markets. The experts consulted were Mr Richard Wood and Dr Anis Rahman.
Each consultant provided a written report to the Committee2 and Mr Richard Wood
attended the hearing as provided for in clause 19 of the Methodology.
1.7.1.2 In addition, the application and the Evaluation and Review (E&R) Report prepared
by the project team, consisting of Agency3 staff, were reviewed by Dr Mike Pearson
(expert in viral diseases of plants) of the School of Biological Sciences at the
University of Auckland. The section of the E&R Report that dealt with horizontal
gene transfer4 was reviewed by Associate Professor Kaare Nielsen (one of the
world's foremost experts on horizontal gene transfer) of the Department of
Pharmacy, Faculty of Medicine, University of Tromso and the Norwegian Institute
of Gene Ecology in Norway. These reviews assessed the scientific robustness of the
E&R Report, providing minor suggestions which were incorporated prior to the
release of the E&R Report.
1.8 Information available for the consideration
1.8.1.1 The information available for the consideration comprised:
2
Appendices 6 and 7 of the Evaluation and Review Report on GMF03001.
The Agency refers to the staff of ERMA New Zealand.
4
Section 9.7 E&R Report on GMF03001.
3
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the application submitted by the applicant (including confidential
information);
the Evaluation and Review (E&R) Report prepared by the Agency (including
the reports from Mr Richard Wood and Dr Anis Rahman, and comments
from MAF and DoC);
the report from the ERMA Māori advisory committee, Ngā Kaihautū
Tikanga Taiao;
further information obtained from the applicant;
information and evidence contained in submissions;
information and evidence presented to the Committee by representatives of
Te Rūnanga o Ngai Tahu and Te Taumutu; and
information from field trials of similar genetically modified onions
conducted in the United States of America (supplied to the Committee in
confidence and discussed in closed session at the hearing).
1.8.1.2 The project team requested further information from the applicant on the 6th of
August 2003 as provided for in section 58 of the Act. The applicant responded to
this request on 18 August 2003. A second request for information under section 58
of the Act was sent to the applicant on 21 August 2003 and was responded to on 25
August 2003. Reports from two agronomic experts were requested in accordance
with section 58 of the Act. These were received on 3 October 2003.
1.9 Hearing
1.9.1.1 The Authority arranged the holding of a public hearing5 in Christchurch between the
3rd and 5th of November 2003. Christchurch was selected as a venue by the
Committee on 5th September 2003 based on an analysis of likely attendance by
submitters made by Agency staff and the fact that Christchurch is the closest main
centre to the location of the field trial. The Committee accepts that this location
created difficulties for those submitters from other regions wishing to attend;
however, this would be true of any venue. Christchurch was the preferred venue for
facilitating the participation of those parties with a greater potential to be affected by
the field trial due to the proximity of those parties to the field trial site.
1.9.1.2 It was necessary to convene a hearing outside of the 30 working-day period from the
close of submissions provided for in section 59(1)(d) of the Act because of
constraints on the availability of the Committee members and because the reports
from the agronomic experts could not be received within that time limit. A letter
requesting consent to the waiver of the requirement to convene a hearing within 30
working days of the close of the public submission period was sent to the applicant
on 29 August 2003. The applicant declined to consent and the Authority determined
that as information had been requested under section 58(1) of the Act a hearing
could not be scheduled within the statutory time limit. Section 58(3) of the Act
provides that the Authority may postpone the hearing until requested information
has been received.
5
Section 60 of the Act and clause 2(2)(b) of the Methodology.
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1.9.1.3 Submissions were presented to the Committee at the hearing by the persons listed
below. In addition the Committee invited members of Te Rūnanga o Ngai Tahu and
Te Taumutu (the two Rūnanga that assert mana whenua over the land on which the
field trial is to be undertaken) to attend the hearing and to provide further
information on, inter alia, the effects on the relationship of Māori and their culture
and traditions with taonga.
1.9.1.4 Presentations were made at the hearing by the following persons:
For the applicant:
 Michael Garbett (Counsel)
 Colin Eady (Scientist, Crop & Food Research)
 Tony Conner (Scientist, Crop & Food Research)
 Maureen O’Callaghan (Scientist, AgResearch)
For the Agency:
 Andrew Allen (Project Leader)
For Ngā Kaihautū Tikanga Taiao:6
 Mere Roberts
For Te Rūnanga o Ngai Tahu:
 Edward Ellison
For Te Taumutu Rūnanga:
 Hirini Matunga
For submitters:
 Tim Allen Jenkins
 Susie Lees
 Claire Bleakley
 Jan Gerritsen
 David Williams
 Wendy McGuinness
 Steve Abel
 Elvira Dommisse
 Duncan Currie
 Hugh Frith
 Hugh Ritchie
 Peter Silcock
 Bob Crowder
 Dennis Enright
 Rudolf Jarosewitsch
 Jen Crawford
6
Ngā Kaihautū Tikanga Taiao has been formally established as a Māori advisory committee under section 24A
of the Act, to advise the Authority on how to take account of issues of concern to Māori (particularly in
relation to sections 6(d) and 8 of the Act).
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Francis Wevers
Kirsteen Britten
Ryan Garland
Suzanne Blyth
Lois Griffiths
Deborah Tsavousis
Irinka Britnell
Michael Britnell
Charles Drace
John Christie
Paul de Spa
Blair Anderson
Melanie White
John Bentham
1.9.1.5 At the request of the Committee (in accordance with clause 19 of the Methodology)
Richard Wood (consultant) was present at the hearing. Other project team members
present included Kevin Currie, Fleur François and Linda Robinson.
2 Consideration
2.1 Summary of the application
2.1.1.1 The application is for approval to field test in containment onions genetically
modified for tolerance to the herbicide glyphosate. The purpose was described in
various ways at different stages in the process. In the lodged application the purpose
was described as being to evaluate the genetically modified onions’ environmental
impact, herbicide tolerance, agronomic performance, development as cultivars and
equivalency to non-genetically modified onions.
2.1.1.2 In Dr Eady’s opening submission at the hearing, two purposes of the research were
described. Firstly, the provision of a resource for the study of environmental impacts
of genetic modification. Secondly, to identify and produce quality herbicide resistant
onion lines.
2.1.1.3 In the applicant’s closing submission the aims of the research were described as:
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to field test genetically modified onions to assess:
o phenotypic variation;
o the performance of onions in natural soil; and
o the development of onions in natural weather conditions;
to enable Crop & Food to contribute to international collaborative research;
to develop the breeding lines for conditional release;
to assess onions themselves for glyphosate resistance and equivalency to
control onions in field conditions; and
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to provide a platform for associated research into:
o developing botanical files;
o investigating impacts on non-target soil biota; and
o measuring persistence of DNA sequences at the field trial site.
2.1.1.4 The genetically modified onions that are the subject of this approval have been, or
are in the process of being, developed by Crop & Food Research Limited at Lincoln,
in accordance with an approval granted under the Act by the Crop & Food Lincoln
Institutional Biological Safety Committee (IBSC) under delegated authority from
the Authority. The development approval (GMD001339) and associated controls
applies to the genetically modified onions under all circumstances other than those
covered by this decision (GMF03001). The Committee notes that the development
approval covers a wider range of organisms than are approved in this decision. The
development approval does not permit field testing and therefore this approval
enables only the onions, described on page one of this decision, to be field tested in
accordance with the controls listed in Appendix 1. These organisms are otherwise
subject to the controls set by the development approval (GMD001339).
2.1.1.5 The unmodified onion material used to develop these genetically modified onions
consists of a range of onion germplasm lines. There are currently 28 distinct
transgenic lines developed and others to be developed. This material is genetically
modified by one or two insertion events of one of three related genetic constructs
consisting of a promoter derived from a plant virus, a sequence encoding a leader
sequence derived from one of two plant heat shock proteins, a sequence encoding a
chloroplast transit peptide sequence derived from a plant species, a synthetic EPSPS
gene, conferring tolerance to herbicide glyphosate, based on the CP4 EPSPS gene
from Agrobacterium strain CP4, and a 3’ untranslated region from a plant gene. The
construct was inserted into the onion genome by Agrobacterium- mediated
transformation using one of three pMON7 series plasmid vectors which contain the
above construct and other vector sequences that were not transferred into the onion.
2.1.1.6 The field trial involves planting trial plots of up to 2560 genetically modified onion
seedlings at any one time, plus control seedlings, into a field site in Canterbury for
growing into bulbs and removal prior to flowering. Initially discrete onion lines will
be tested in small scale plots of 40 plants. Selected lines will then be tested in large
scale plots of 240 plants. Testing shall be conducted within a containment facility
registered with MAF in accordance with section 39 of the Biosecurity Act 1993 and
in accordance with the controls specified in this decision.
2.2 Sequence of the consideration
2.2.1.1 In accordance with clause 8 of the Methodology the Committee considered the
information provided from the sources listed above. The approach adopted by the
Committee was to look sequentially at identification, assessment and the combined
evaluation of risks and of costs and benefits. Identification of potential risks and
costs took into account the matters in clauses 9 and 10 of the Methodology.
Interposed with this were the consideration of the proposed management regime,
7
Plasmid named after the original developer, Monsanto.
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and the ability of the organisms to escape and form self-sustaining populations.
Controls were considered in relation to the identified risks and those risks identified
as significant were assessed (clause 12). Costs and benefits were assessed in
accordance with clause 13 of the Methodology.
2.2.1.2 Risk characteristics were then established, in accordance with clause 33 of the
Methodology. Finally, taking account of the risk characteristics established in
accordance with clause 33 of the Methodology, the combined impact of risks, costs
and benefits was evaluated in accordance with clause 34.
2.2.2 Purpose of application
2.2.2.1 The Committee are satisfied that the purpose of this application is to field test any
new organism (section 39(1)(b) of the Act).
2.3 Identification of the significant risks and costs of the
organism
2.3.1.1 Significant risks and costs identified for assessment and evaluation were as follows,
following clauses 9 and 10 of the Methodology, which incorporate sections 5, 6 and
8 of the Act.
2.3.1.2 In accordance with sections 5 and 6 of the Act and clause 9 of the Methodology, the
Committee categorised the potential adverse effects of this application under the
headings of biological and physical environment, human health and safety, the
relationship of Māori and their culture and traditions with taonga, and social and
economic issues.
2.3.1.3 The following potential adverse effects were identified under each category. The
potential adverse effects include those that might arise from the transfer of genetic
elements (section 44A(2)(c) of the Act).
2.3.2 Potential adverse effects on biological and physical environment
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Potential for glyphosate-tolerant onions to become weeds.
Potential for selective pressure to exacerbate glyphosate-tolerant weed
problems.
Potential for gene flow of the herbicide tolerance gene from GM onions to
other weedy plant species.
Potential for gene flow from genetically modified onions to relatives to alter
biodiversity.
Potential of GM onions to be harmful to beneficial, native or valued
organisms.
Potential for adverse effects resulting from organisms associated with
genetically modified onions being transferred outside of the containment
structure.
Potential for adverse environmental effects from glyphosate use.
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2.3.3 Potential adverse effects on human health and safety
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Potential for the GM onions to be allergenic or toxic to humans.
Potential for adverse effects on human health from glyphosate use.
Potential for the development of antibiotic resistant pathogenic bacteria
through the horizontal transfer of antibiotic resistance genes from GM onions
to bacteria.
2.3.4 Potential adverse effects on the relationship of Māori and their culture
and traditions with taonga
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Potential for the disruption/alteration of whakapapa (including the mauri and
tapu inherent within) to affect Māori cultural values, physical and
metaphysical well-being.
Potential effect on the kaitiakitanga of Māori caused by gene flow and
contamination of land and water.
Potential breach of Te Tiriti o Waitangi/the Treaty of Waitangi caused by
inability to protect taonga (tangible and intangible).
2.3.5 Potential adverse economic and social effects
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Potential effects of pollen drift from GM onions to other crops and honey.
Diversion of research money from more useful research.
Public rejection / abhorrence of genetic engineering of food crops and of use
of taxpayer funded research to develop GM foods.
Contribution to dominance of agriculture by multinational companies.
Costs to exporters of a detrimental effect on ‘clean green image’.
2.3.6 Potential effects resulting from the transfer of any genetic elements to
other organisms in or around the site of the field test
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Adverse effects arising from horizontal transfer of genetic material to other
organisms.
2.3.7 Potential unanticipated adverse effects due to the genetic modification
process
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Potential for unanticipated adverse effects.
Potential to create new viruses due to the presence of viral promoters.
2.4 Identification of the potential benefits of the
organisms:
2.4.1.1 Potential benefits of the field testing of the organisms that were identified for
assessment and evaluation, following clauses 9 and 10 of the Methodology, which
incorporates sections 5, 6 and 8 of the HSNO Act, were as follows:
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Development of knowledge and experience by Crop & Food Research Ltd
scientists.
Provision of a platform for related research to occur.
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The development of lines of genetically modified onions which are patented
by Crop & Food Research Limited.
Continued funding for Crop & Food Research Ltd from New Zealand and
overseas sources contributing to ongoing research and employment.
Assisting with retention of scientific skills as intellectual capital within New
Zealand.
2.5 Proposed containment and controls and their
adequacy
2.5.1.1 The Committee considered the adequacy of containment for the purpose of section
45(1)(a)(iii) of the Act, and the magnitude and probability of the risks, costs and
benefits at the same time and in an integrated fashion. This is because the former
interact with the latter and this is recognised in clause 12(d) of the Methodology and
in section 45(1)(a)(ii) of the Act. For convenience in setting out the decision, the
adequacy of containment is discussed first. This discussion includes options and
proposals for managing risks.8
2.5.1.2 In accordance with sections 37 and 44 of the Act and clauses 10(e) and (f) of the
Methodology, the Committee has considered the ability of the organism(s) or any
heritable material to escape containment and to establish an undesirable selfsustaining population, and the ease with which these could be eradicated if such
populations were established. Other matters relating to controls were also
considered.
2.5.2 Ability to adequately contain the organism
2.5.2.1 The field trial would be conducted in accordance with the MAF/ERMA New
Zealand Standard 155.04.09: Containment Facilities for New Organisms (including
genetically modified organisms) of Plant Species (the Plant Containment Standard)
(control 1.6). This Standard stipulates that no plants, viable or heritable plant
material9 may be removed from the field trial site except under conditions specified
by the Authority in the containment controls (controls 1.4, 1.14 and 1.18).
2.5.2.2 For clarity of separation from other Allium plants, the Committee requires a ten
metre separation distance surrounding the field trial containment facility to be
maintained clear of Allium species belonging to the cepa group (control 6.3).
2.5.2.3 The Committee has identified and assessed the following pathways by which the
genetically modified onions may escape from containment:
Removal of onions by unauthorised persons
2.5.2.4 Given the high profile of field trials of genetically modified plants there is a risk of
sabotage associated with this trial which could lead to genetically modified onion
8
Clause 12(d) of the Methodology.
Heritable material is defined in section 2 Act and in this context means onion reproductive structures
and bulbs.
9
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material being unlawfully taken out of containment. This is the reason for keeping
the detailed location of the field trial site confidential.
2.5.2.5 In order to address this issue, control 2.1 requires access to the field trial site to be
restricted to persons authorised by the facility Operator. Fences must separate the
field trial containment facility from land to which there is unrestricted public access
and gates must be locked outside of normal working hours.
Loss from containment during transit
2.5.2.6 Onion plants could potentially be lost from containment during transit between the
field trial site and the containment plant house or laboratories. The Committee
consider that it is likely that all plant material could be recovered from the site of
any spillage. To assist any such recovery, an inventory of individual plants (the
number of plants or parts thereof in each transgenic line transported) shall be made
prior to transfer from the PC2 containment plant house to the field trial site or from
the field trial site to the PC2 containment plant house (control 1.14).
2.5.2.7 Adherence to the Plant Containment Standard (sections 4.5 and 4.6) requirements
for transfer and transport of plants or viable plant material will reduce the risk of
loss during transit. In addition, the Committee has imposed the following controls
that address the movement of genetically modified onions between the field trial site
and the containment plant house with the aim of minimising the likelihood of losses
occurring during transit. Control 1.12 requires transfer of genetically modified
onions to and from the field trial containment facility to be in secure containers to
prevent spillage. The register of plants, required by section 4.8 of the Plant
Containment Standard (155.04.09) and by control 1.13, would ensure that in the
event of loss in transit, it would be possible to check exactly what was lost and
whether all lost material was recovered. Control 1.14 (an inventory to be used
during all transits of plants) is a measure to ensure that any such losses would be
detected.
2.5.2.8 Onion seedlings and bulbs may be transported between the field trial containment
facility and the PC2 containment plant house under this approval, but not seed
(control 7.5). This is to reduce the likelihood of loss of seed in transit (in the event
of spillage) or of non-germinated seed in the soil.
2.5.2.9 The Committee considers that the above measures make it highly improbable that
there will be any loss from containment of any genetically modified onions during
transit.
Unintentional removal by human activity
2.5.2.10 Handling errors by workers and displacement of onion material by machinery or
equipment could lead to an escape from the containment facility of the genetically
modified onion and controls have been set to address this possibility.
2.5.2.11 The applicant proposes to perform all planting and harvesting of the GM onions by
hand in order to reduce the likelihood of escape of genetically modified onion
material through that material becoming attached to machinery or equipment. If
machinery is operated on the site, workers shall check it prior to leaving the site to
ensure that no onion material or soil is inadvertently being removed (control 4.1).
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Additionally, the Operator, or a person so authorised by the Operator, shall be
present if heavy machinery is used within ten metres of any genetically modified
onions in the field trial containment facility (control 4.2).
2.5.2.12 The Committee considers that the experience of the staff involved with the field trial
would mean that loss from containment through inadvertent human error is
improbable provided that all inexperienced or temporary staff are adequately
supervised. Therefore controls 4.3 and 4.4 require all personnel involved in the
handling of the organisms to be informed of the Authority’s controls and that
training of personnel working in the containment facility shall be in accordance with
section 3.4 of the Plant Containment Standard (155.04.09).
2.5.2.13 The plant register (control 1.13) and the monitoring regime (control 6.4) would
provide a mechanism by which losses would be detected. Control 5.2 requires the
attempted retrieval of any lost material immediately after the losses are detected.
2.5.2.14 Given the above measures the Committee considers that it is very unlikely that there
will be any loss from containment of the organism through unintentional handling
errors by workers.
Irrigation system failure
2.5.2.15 Flooding could occur through a burst irrigation pipe with the resultant displacement
of GM plants off-site. The Committee view this particular pathway of escape as
improbable because such events would be easily observed by workers operating
irrigation systems on the site and retrieval of any displaced onion plants could be
undertaken. The register of all plants in the field trial site (control 1.13) would
provide a means of ensuring that all GM plants were accounted for following such
an event.
Removal or destruction of heritable material
2.5.2.16 Heritable material of onion consists of seeds, pollen, top sets and bulbs. Pollen and
seed are addressed below. Onion bulbs may potentially escape containment by
failure to remove them following the field trial. Given the experience of Crop &
Food Research Ltd staff, this is a highly improbable scenario; nevertheless, three
controls address this issue. First, control 1.18 requires all genetically modified
onions to be removed from the field trial containment facility after their first
growing season. Secondly, controls 6.6 and 6.7 require visual inspection of the site
following removal of the onions each growing season and at the completion of the
trial. Monitoring of the site at one-monthly intervals for, and removal of, any
heritable material including volunteer onion plants after the field testing has been
completed is also required. This monitoring shall continue for one year following
the removal of any onion plant found in the field trial containment facility. The
monitoring frequency of one month has been stipulated on the basis of the time it
takes for onion plants to bolt. A crop rotation has been specified (control 5.5) which
requires the planting of potatoes or a green manure crop following the removal of
onions. A green manure crop is one grown for the purpose of replenishing soil and is
incorporated into the soil rather than harvested. In the third year of the rotation the
soil shall be left fallow. This is because the Committee is of the view that volunteer
onion plants will be more easily detected in a potato or other uniform crop than in a
fallow field.
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2.5.2.17 An approval under section 45 of the Act to field test a new organism in containment,
if the new organism is a genetically modified organism, must include controls to
ensure that, after the end of the field test the organism and any heritable material
from the organism is removed or destroyed (section 45A(2)(a) of the Act). The
Committee may also include controls to ensure that, after the end of the field test
and after heritable material is removed or destroyed, some or all of the genetic
elements remaining from the organism are removed or destroyed (section 45A(2)(b)
of the Act).
2.5.2.18 The issue of removing any heritable material is addressed by removal of all heritable
material at the end of each growing season (control 1.18) and inspection of the site
for any heritable material left behind (controls 6.6 and 6.7). The issue of genetic
elements remaining from the genetically modified onions is addressed by leaving
any remaining genetic elements to break down or become inactive at the site and
monitoring to detect and remove any subsequent re-growth or seedling germination
(control 6.7).
2.5.2.19 In addition, all bulbs and above ground vegetative material from the genetically
modified onions and from all non-genetically modified onions used as experimental
controls in the field trial, that are not retained for research purposes or transferred to
collaborators under lawful approvals, must be destroyed by autoclaving (controls 1.4
and 1.15 ).
2.5.2.20 The field trial plots are to be surrounded by buffer rows of differently coloured
onions for the purposes of experimental design. A separation distance of 30
centimetres between the buffer rows and the experimental plots is designed to
minimise any possibility of genetically modified root material being removed along
with the buffer onions. The onions from these buffer rows must be composted
(control 7.6).
Movement of pollen or seed
2.5.2.21 Escape of pollen from the field trial is addressed by mechanisms to prevent pollen
production. The removal of all bulbs after the first season of growth (control 1.18)
means that the genetically modified onion plants are not likely to produce flowers
because onions are biennial plants that normally only flower in the second year of
growth. However, some plants may produce flowers early (bolting) within the first
year of growth. The interval from the appearance of a flower head in the neck of an
onion plant until flower opening is approximately 4 weeks. Therefore, no plant
belonging to the genus Allium shall be allowed to flower in the field trial
containment facility (control 1.11). Weekly monitoring is required, while genetically
modified onions are in the field trial containment facility, to ensure that all
reproductive structures that may appear are identified and removed (control 6.4).
2.5.2.22 The Committee considers that these measures would mean that it is very likely that
the Operator would identify and remove all flowering structures from the GM
onions in advance of pollen or seed being dispersed.
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Removal of plant material by animals (e.g. rodents, escaped stock, birds)
2.5.2.23 The Committee heard and read evidence that suggested that vertebrate animals such
as rabbits and birds (such as pukeko) may interfere with the field trial and
potentially breach containment through displacement of onion plant material.
2.5.2.24 Information about potential animal interactions with the field trial was presented to
the Committee from submitters and onion agronomist Mr Richard Wood. Rabbits,
hares and birds were identified as animals that may feed on growing onion crops.
Although no certainty of the presence of pukeko was established, the Committee
was told of pukeko hoarding apples, which is consistent with their scavenging and
opportunistic feeding habits.
2.5.2.25 Larger animals are likely to be effectively excluded from the field trial site by fences
(required by control 2.1) and it is unlikely wandering stock could gain access to the
field trial site. Control 3.1 requires grazing animals to be excluded from the field
trial containment facility and control 3.2 requires the Operator of the facility to
monitor for signs of pest damage or interference in addition to the vermin control
measures required by section 4.9 of the Plant Containment Standard.
2.5.2.26 The genetically modified onion seedlings planted in the field trial shall be covered
with net cloches until the plants are well established in order to prevent accidental
removal by physical elements such as wind, and to act as a deterrent to interference
by biological elements such as birds and other animals (control 1.17).
2.5.2.27 The Committee concludes that given the above measures, it is very unlikely that
birds or large animals will remove onion plant material from the field trial site.
There is uncertainty concerning whether the proposed site is free of rodents and
whether rodents may remove onion plant material and if so whether that material
could regenerate. However, in accordance with clause 29 of the Methodology this
uncertainty is not considered to be significant. The Committee considers that the
eating of onion plant material by rodents or other small animals would not provide a
pathway for escape of the onion and that it would be very unlikely that sufficient
material to regenerate a plant would be carried by such animals.
Loss from the site by forces of nature, (e.g. wind, flooding)
2.5.2.28 Covering of the seedlings in the initial stages of them being planted out by net
cloches (control 1.17) may also reduce the probability of them being blown away by
wind. The Committee considers that it is very unlikely that forces of nature, such as
wind, fire, or flooding, would cause an escape of genetically modified onions.
However, a control is imposed to counter unintended/accidental dispersal by forces
of nature of genetically modified onion plants from the field trial site. It addresses
this issue by prohibiting the location of the genetically modified onions from any
area within ten metres of any open water drains (control 1.10).
2.5.3 Other containment controls
Duration of the approval
2.5.3.1 The Committee considers that the risks posed by this field trial are unlikely to
change over time provided that the field trial is conducted in accordance with this
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approval and with the controls imposed by this decision. Therefore the Committee
has determined that the duration of the approval shall be for ten years from the date
of this decision (control 1.8), which it considers to be sufficient time for the
applicant to carry out the work proposed.
Monitoring and inspection
2.5.3.2 Agency staff will receive a field trial plan for each year with details of plantings to
be undertaken and will check these plans for conformity to controls 1.16 and 7.7
(control 7.3).
2.5.3.3 Notification of planting and harvesting shall be provided to MAF and to ERMA
New Zealand prior to the event (controls 7.3 and 7.4). This is for the purposes of
coordinating inspections by the Supervisor who will inspect at planting and
harvesting in accordance with the applicable Containment Facility Standard.10 Other
inspections shall be at times specified in the applicable Standard and this may
include unannounced inspections (control Error! Reference source not found.).
Annual reports on field trial
2.5.3.4 For the purpose of assisting the work of the Agency in monitoring the field trial an
annual report shall be sent to ERMA New Zealand and Ngā Kaihautū Tikanga Taiao
(control 7.8). In order to recognize and provide for the role of Te Rūnanga o Ngai
Tahu and Te Taumutu Rūnanga as ngā kaitiaki in the region, the Operator of the
field trial containment facility shall ensure that regular reports and updates are
provided to those parties at a minimum of once a year (control 7.8). The regularity
and nature of reporting will be agreed between the parties annually and reported to
ERMA New Zealand and Ngā Kaihautū Tikanga Taiao.
Final report following trial
2.5.3.5 On completion of the field trial full reports are to be provided to the Agency, Ngā
Kaihautū Tikanga Taiao, Te Rūnanga o Ngai Tahu and Te Taumutu Rūnanga, and if
requested representatives will meet to discuss the outcomes of the research (control
7.9).
Maximum number of GM onion plants
2.5.3.6 A number of different genetically modified lines will be field tested. These lines are
derived from a range of onion germplasm lines which will all undergo the genetic
modification detailed in section 2.1.1 above. As the exact number of lines to be
tested in any one year is not yet determined a maximum number of genetically
modified onion plants that can be held in the field trial containment facility at any
one time has been set (control 7.7). This limit of 2700 individual genetically
modified plants has been determined taking into account the applicant’s
experimental design.
Duty to report any matters relevant to management of trial
2.5.3.7 Control 7.10 requires the Operator of the containment facility to inform the
Supervisor and ERMA New Zealand of any matters that may affect the long term
10
Currently inspection frequency is stated in section 6.4.1 of the Plant Containment Standard (March
2003: 155.04.09).
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management of the field trial. The purpose of this control is to assist the relevant
authorities with ongoing monitoring of the field trial.
2.5.4 Ability of organism to escape and to establish an undesirable selfsustaining population
2.5.4.1 In accordance with sections 44 and 37 of the Act, the Committee considered the
ability of the organisms to escape and to establish an undesirable self-sustaining
population should there be a loss from containment, and the ease with which such a
population could be eradicated.
2.5.4.2 The possible sources of a self-sustaining population of onions are bulbs left in the
ground after harvest or escaped organisms establishing and reproducing. An escaped
onion plant would have the potential to produce pollen (which may disperse and
hybridise with other plants) and seeds. The controls detailed in Appendix 1,
incorporate measures to prevent either of these potential sources from occurring.
2.5.4.3 The Committee accepts that the ability of genetically modified onions to escape (or
to be lost from containment) and to form a self-sustaining population is poor based
on the containment measures and the characteristics of the onions, in particular their
slow growth rate and susceptibility to weed competition. The Committee also
considers that the genetic modification is unlikely to contribute to the onion
becoming weedy and establishing an undesirable self-sustaining population.
2.5.4.4 None of the wild relatives of Allium cepa present in New Zealand or non-A. cepa
cultivated Alliums are known to hybridise and produce fertile offspring with the
onion, therefore, it is very unlikely that any escaped genetically modified onions
would form a self-sustaining population by outcrossing to wild or cultivated
relatives. Insect-mediated pollination of other onions of the same species in the
vicinity of a flowering escape would be a possible mechanism for the transgene to
spread, and for the formation of a new organism. The risk of this occurrence is
assessed below (section 2.6.2). However, the Committee is unaware of any reports
of self-sustaining populations of onions originating from onions currently grown in
New Zealand.
2.5.4.5 Based on the above matters, the Committee concludes that it would be improbable
that, if it escaped from containment, the genetically modified onion would form an
undesirable self-sustaining population.
2.5.5 Ease of eradication of an undesirable self-sustaining population
2.5.5.1 The eradication of an undesirable self-sustaining population of these genetically
modified onions would be straightforward. Any broad spectrum herbicide, other
than glyphosate (e.g. amitrole or MCPA) could effectively eliminate such a
population.
2.5.5.2 If a self-sustaining population did establish, the identification of this could be
difficult as it would require specific testing for the transgenic construct used in the
field trial. One way of identifying that onions found outside of containment were
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these genetically modified onions would be to spray with glyphosate. The applicant
refers to being able to use molecular methods to test onions for the presence of the
transgene which could be uniquely identified. This would provide evidence for any
unauthorised use of the applicant’s intellectual property. Molecular identification of
the organism could be used to show that an onion found outside of the containment
facility had originated from the field trial.
2.6 Assessment of the potential risks and costs of the
organism
2.6.1 Approach and coverage
2.6.1.1 The risks and costs assessed below are those identified as potentially significant,
having regard for those matters set out in clauses 9 and 10 of the Methodology.
Risks were considered in terms of the requirements of clause 12 of the
Methodology, including especially the assessment of consequences and
probabilities, the impact of uncertainty and the impact of risk management. Costs
were considered in terms of clause 13 of the Methodology. Evidence available to the
Committee was evaluated in accordance with clause 25 of the Methodology.
2.6.1.2 For each risk the Committee have addressed the following considerations, as set out
in the Methodology, as far as is reasonably practicable considering the particular
nature of each risk.






The nature of the adverse effect (clause 12(a)).
An assessment and evaluation of likelihood and consequence (clause 12(b)).
Where possible, an assessment of the level of risk as a combination of the
likelihood of occurrence and the magnitude of the adverse effect (clause
12(c)).
The risk management proposals and their effect on both the risk and the
uncertainty associated with the risk (clause 12(d)).
An assessment of what all the effects of the organism should the organism
escape containment, (section 45).
An explicit consideration of the uncertainty bounds on the estimates (clause
12(e)). How uncertainty affects the assessment of the risk (clause 25 scientific and technical uncertainty, clause 29 - materiality of uncertainty,
and clause 30 - need for caution where not resolved).
2.6.1.3 A “cost” is defined in the Methodology as “the value of a particular adverse effect
expressed in monetary or non-monetary terms”. Each risk will have an associated
cost, which is the reason for linking costs and risks together. The Methodology and
the Act both call for consideration of monetary and non-monetary costs (clause 13
and section 9). In most field trial cases, the direct costs are those associated with
conducting the trial and will accrue to the applicant. Consideration of costs includes:


Whether the cost is monetary or non-monetary (clause 13(a)).
An estimate of the magnitude of the cost (clause 13(b)).
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
The distributional effects over time, space and groups in the community
(clause 13(c)).
2.6.1.4 Explicit consideration of the uncertainty associated with the estimate (clause 25
scientific and technical uncertainty, clause 29 materiality of uncertainty and clause
30 need for caution where not resolved) may also be required.
2.6.1.5 The assessments set out below apply to those risks identified in section 2.3 of this
decision.
2.6.2 Potential adverse effects on the biological and physical environment
Potential for glyphosate-tolerant onions to become weeds
2.6.2.1 Cultivated onion has characteristics that make it unlikely to become a weed such as
its slow growth habit, biennial growth pattern and long history of domestication.
Expression of the glyphosate-tolerant trait would not result in the onion becoming an
uncontrollable weed even if the genetically modified onions were to escape from
containment. Any escaped onions could be readily eradicated by application of an
alternative herbicide and the desirability of this approach would depend on whether
genetically modified onion populations occurred on cultivated or waste land.
2.6.2.2 Therefore the Committee finds that it is highly improbable that glyphosate-tolerant
onions would become established as weeds, and the environmental impact would be
minimal. The proposed controls further reduce the likelihood of genetically
modified onions becoming weeds by reducing the likelihood of escape to a very low
level. The overall risk is thus considered to be negligible.
Potential for selective pressure to exacerbate glyphosate-tolerant weed
problems
2.6.2.3 The Committee accepts the evidence that some plant species are already present in
New Zealand that vary in their natural tolerance to glyphosate, such as clover, and
that given the current usage of glyphosate in New Zealand, selective pressure
favouring more glyphosate-tolerant varieties is likely to already be present.
2.6.2.4 The risk of a selective pressure from the use of glyphosate during the trial causing
glyphosate-tolerant plant species to become weeds was considered. Such weeds may
appear as a result of plants that are currently resistant to glyphosate benefiting from
the removal of competing (glyphosate-sensitive) species. Alternatively, mutations
may cause previously glyphosate-sensitive weed species to become resistant to the
herbicide. Therefore there are two aspects to this issue, firstly, whether glyphosate
resistant plants will occur, and secondly, whether such plants may become weeds or,
if already weeds, whether control of them will become more difficult.
2.6.2.5 In the context of current usage of glyphosate in the New Zealand environment, any
effect from the proposed use, in small garden sized plots, would be an insignificant
addition to any selective pressure that already exists. In addition the crop rotation
practices that are to be employed will reduce to a very low level the likelihood of
glyphosate-tolerant mutants becoming a problem.
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2.6.2.6 Therefore, the Committee find that it is highly improbable that the use of glyphosate
during the field trial will cause glyphosate-tolerant weeds to occur and that the risk
is negligible.
2.6.2.7 The Committee notes that alternative herbicides are available to control glyphosatetolerant weeds and that these alternative chemicals may have adverse environmental
effects and involve costs to persons responsible for weed control. However, given
the Committee’s findings on the low likelihood of glyphosate-tolerant weeds
developing and given the scale of the field trial, this risk is also negligible.
Potential for gene flow of the herbicide tolerance gene from genetically
modified onions to other weedy plant species
2.6.2.8 The potential for gene flow from genetically modified onions to related species
raises the risks of producing weeds or other crop plants that are tolerant to
glyphosate. The mechanism by which this could potentially occur is through pollen
transfer, by wind or insect, and hybridisation with other plants, resulting in a transfer
of the transgene conferring resistance to glyphosate. The potential for horizontal
gene transfer to other organisms is discussed below in section 2.6.6 of this decision.
2.6.2.9 Creation of glyphosate tolerance by this mechanism is highly improbable because of
the controls prohibiting and preventing flowering of the genetically modified onions
in the field trial (controls 1.11, 6.4 and 7.5). Even if flowering occurred, glyphosate
tolerant weeds could not result unless successful gene flow to wild or weedy
relatives of onion produced fertile hybrids. The presence of wild or weedy relatives
of onion is prohibited by controls 6.3 and 6.5. Even if wild or weedy relatives were
present within the vicinity of the field trial, fertile interspecific hybrids are unlikely
to be formed between these species and the genetically modified onions. Glyphosate
tolerant volunteer onions or weeds could be removed, if located and identified, by
spraying with an alternative herbicide or by hand weeding.
2.6.2.10 The Committee concludes that it is highly improbable that the glyphosate tolerance
trait would spread to weedy relatives as a result of gene flow and that, if this
occurred, the impact would be minimal because of the options available for control
of such plants. This risk is thus negligible.
Potential for gene flow from genetically modified onions to alter biodiversity
2.6.2.11 Gene flow from the genetically modified onions to other plants might result in an
altered biodiversity, through hybridisation with and/or outcompeting other related
species in the environment.
2.6.2.12 Conditions required for these effects to occur are:





pollen drift from the genetically modified onions;
plants present nearby to receive that pollen;
those plants must be in a state receptive to pollen;
those plants must be compatible enough to form a fertile hybrid containing the
transgene; and
the resultant hybrid must have a selective advantage.
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2.6.2.13 The containment measures imposed by this decision will make it highly improbable
that gene flow through cross-pollination to plants related to onions will occur. This
is because of the measures to prevent the genetically modified onions flowering.
2.6.2.14 In the section above, on containment, the measures to be adopted to prevent pollen
being produced by the onion plants in the field trial are discussed. Briefly, the two
measures are first, limiting the trial to first-year onion plants only (by exclusion of
second-year bulbs), and secondly, requiring the removal of any reproductive
structures that may appear (controls 1.11 and 7.5).
2.6.2.15 The Committee considers that pollen production can be prevented by excluding the
second-year onion bulbs from the field trial (control 7.5). Bulbs will be removed
from the field trial containment facility at the end of the first year for flowering and
seed production in a contained PC2 plant house (control 1.18). The possibility of
bolting (early flowering) is recognised as a potential pathway for the accidental
release of pollen. This is to be managed by weekly monitoring for and removal of
plants exhibiting flowering structures before pollen can be released (controls 1.11
and 6.4).
2.6.2.16 The Committee accepts that there are no native plants closely related to or able to
hybridise with the onion in New Zealand. Therefore, in the highly improbable event
of pollen escape, there are three potential pathways by which gene flow may occur:



from genetically modified onions to unmodified onion crops;
from genetically modified onions to cultivated relatives; and
from genetically modified onions to wild relatives of onion.
2.6.2.17 If gene flow to non- genetically modified onion crops did occur, the magnitude of
the environmental effect would be minimal because it is expected that the
transferred trait would only affect susceptibility of the onion to a single type of
herbicide (the issue of glyphosate-tolerant onions causing a weed problem is
discussed above). The Committee recognises that while the environmental effect of
such gene flow may be minimal, there are potential adverse economic effects for
other growers and these are considered below under economic and social issues.
2.6.2.18 The Committee accepts the evidence summarised in the E&R Report11 and finds that
even if the genetically modified onions were to produce pollen and even if related
cultivated Allium species, such as garlic and chives, were present and receptive to
pollen from the onions at the field trial site, the production of fertile hybrids by gene
flow from the genetically modified onions to cultivated Allium species would be
highly improbable and hence the risk is negligible.
2.6.2.19 The risk resulting from gene flow to wild relatives of onion would be from new
“fitter” hybrids becoming established or replacing non-modified plants, growing in
new places and changing ecological balances. Based on information from
hybridisation studies of Allium species, there are a number of isolation barriers that
prevent crossing between different Allium species. It is therefore unlikely that A.
cepa can cross with any of the four related wild species present in New Zealand,
including A triquetrum (three-cornered garlic) and A. vineale (wild garlic) which do
exhibit weedy characteristics in New Zealand. For this risk to eventuate, not only
11
Section 9.2.1 paragraphs 51 and 52.
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must hybridisation occur but the hybrids produced must obtain a fitness advantage
over the wild-type plant. For the genetically modified onions to pose any greater risk
than non-transgenic onions, which have been grown in Canterbury previously, the
herbicide resistance trait would need to confer a competitive advantage. This is
unlikely because, in the wild environment, glyphosate is not likely to be used.
2.6.2.20 Based on the evidence before the Committee, it is concluded that even if wild or
weedy onion relatives were present within the vicinity of the field trial, fertile
interspecific hybrids are unlikely to be formed between these species and the
genetically modified onions. Glyphosate resistant volunteer onions or weeds in the
containment facility would be easily identified and could then be removed by
spraying with an alternative herbicide. The risk is accordingly negligible.
Potential of genetically modified onions to be harmful to beneficial, native or
valued organisms
2.6.2.21 The risk to beneficial, native or valued organisms that will be exposed to the
genetically modified onions includes direct health effects on individual organisms
(ranging from pukeko to insects and soil invertebrates) and population level effects.
2.6.2.22 The Committee accepts the evidence in the E&R Report12 and finds that while
beneficial, native or valued organisms may be exposed to transgenic protein and
DNA produced by genetically modified onions, there is no evidence to suggest that
the CP4 EPSPS protein or the genetically modified onions will cause adverse effects
to those organisms at the population level.
2.6.2.23 The CP4 EPSPS protein expressed in the transgenic onions is derived from a soil
bacterium and EPSPS is commonly encountered in nature where it is expressed by
non-genetically modified plants and microorganisms. EPSPS protein is not toxic or
allergenic to livestock or wildlife and there is no expectation that this protein will
have adverse effects.
2.6.2.24 The CP4 EPSPS enzyme has been subjected to various safety assessments13. The
enzyme does not show amino acid homology to known allergens or mammalian
toxins, is readily inactivated by heat or mild acidic conditions and has been shown to
be readily degraded in an in vitro digestibility assay. Therefore, it is highly
improbable that the genetically modified onions would display oral toxicity to
animals. There is a small degree of uncertainty associated with this assessment
because these studies have not been performed on EPSPS protein derived from these
transgenic onions and the level of novel protein expression in transgenic onions is
unknown. However, previous food safety studies of CP4 EPSPS protein expressed
in other transgenic plants suggest that it is improbable that CP4 EPSPS expressed by
transgenic onions would be toxic to animals.
2.6.2.25 This risk is accordingly considered to be negligible.
12
13
Section 9.2.1 paragraphs 54 to 66
Section 9.3.1 of the E&R Report on GMF03001
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Potential for adverse effects resulting from organisms associated with
genetically modified onions being transferred outside of the containment
structure
2.6.2.26 The Committee considered the risk of a transfer from the containment plant house to
the field trial containment facility of other organisms associated with the transgenic
onions. In particular the genetically modified Agrobacterium that is used in the
development of the genetically modified onions has the potential to remain
associated with the plants and to be released into the environment. A step in the
development process is specifically designed to kill the associated bacteria by
applying the antibiotic Timentin®. The Committee accepts that this treatment will
kill most but not necessarily all of the genetically modified Agrobacterium present
on the modified onion material. Further measures to decrease the likelihood of this
occurring are the propagation of seedlings from seed which can be collected without
coming into contact with the media in which the transformed plants are growing.
2.6.2.27 The Committee has considered the nature of the risk of accidental release of
genetically modified Agrobacterium associated with the genetically modified onion
and finds that, if this were to occur, the effect would be insignificant because the
genetic construct used in the development of the onions can only have limited
impact. The Committee therefore consider this risk to be negligible and not
requiring specific management.
Potential for adverse environmental effects from glyphosate use
(i) Incidence of Fusarium disease
2.6.2.28 The reports available to the Committee of an increase in Fusarium resulting from
the use of herbicides on crops and consequent incidence of fungal disease problems
do not contain conclusive evidence. The reports presented to the Committee were
preliminary reports from non-peer reviewed literature and are therefore treated with
caution. The adverse effect which could result from increased environmental levels
of the pathogenic fungi Fusarium would be a potential increase in the incidence of
Fusarium disease affecting subsequent crops. The probability of this occurring
cannot be deduced from the evidence presented to the Committee.
2.6.2.29 However, if such effects were to occur within this field trial the scale and magnitude
of such an effect would be minor and not sufficient to warrant consideration of
management options. In terms of clause 29 of the Methodology the uncertainty
relating to Fusarium is not considered to be material to this application. However,
the Committee considers that the potential effect of this onion on microbial
communities (including Fusarium) is one area of uncertainty that the proposed
research into environmental effects associated with this field trial may be able to
address and the opportunity to do so should be taken.
(ii) Other potential effects of glyphosate use
2.6.2.30 Other potential effects of glyphosate use in the environment were raised by
submitters and many cited the recently published results of the UK Farmscale study
to evaluate the effects of herbicide resistant genetically modified crops on farmland
wildlife. The study found direct links between farm herbicide use patterns and the
abundance of weeds and insects (bees, butterflies, beetles etc) in these crops, with
potential impact on native birdlife dependent on weed seed or insects for food.
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While noting that most New Zealand native birds are much less dependent on
farmland for food and habitat than their UK counterparts, the Committee considered
the study provides a useful methodology for assessing the impact of farm practice,
including use of agrichemicals, on insect and plant biodiversity which could be
useful in assessing impacts of proposed herbicide application regimes.
2.6.2.31 Given the small scale of the field trial, the Committee accepts that glyphosate use at
the field trial site is very unlikely to have permanent or long term adverse effects on
biodiversity. Any potential environmental effects would be minimal and limited to
the field trial site, and therefore, the risk is negligible.
2.6.3 Potential adverse effects on human health and safety
Potential for the genetically modified onions to be allergenic or toxic to humans
2.6.3.1 In the unlikely event of ingestion of the genetically modified onions, it is unlikely
that the transgenic onions will be allergenic or toxic to humans. There is a degree of
uncertainty associated with this assessment because toxicity and allergenic studies
have not been performed on the transgenic onions and the level of foreign protein
expression in the genetically modified onions has not been determined. Therefore,
due to this uncertainty, consumption of genetically modified onions is prohibited
(control 5.4). Given the low likelihood of consumption of onions and the prohibition
on consumption, this risk is considered to be negligible.
Potential for adverse effects on human health from glyphosate use
2.6.3.2 Submitters expressed a concern that the herbicide tolerance technology used in the
genetically modified onions may lead to increased amounts of glyphosate use and
that this herbicide itself may have adverse effects on human health. However, the
Committee finds that there are no significant effects from the use of glyphosate on
this field trial site that are relevant to this consideration because, due to the scale of
the field trial, it is highly improbable that adverse human health effects would result
from glyphosate applications at the field trial site. Given the current usage of
glyphosate in New Zealand, the risk posed by this field trial to human health by
glyphosate is negligible and any costs resulting from this would be insignificant.
2.6.3.3 The larger question of glyphosate residues on food crops would only arise if and
when a release application was made. The Committee found that such questions
were relevant to the consideration of what value to place on potential benefits that
may come from this research (refer to section 2.7.4 below).
Potential for the development of antibiotic resistant pathogenic bacteria
2.6.3.4 The risk of the development of antibiotic resistant pathogenic bacteria through the
horizontal transfer of antibiotic resistance genes from genetically modified onions to
bacteria was raised in submissions. There are antibiotic resistance genes on the
plasmid vectors used to transform the onions but these are located outside of the left
and right T-DNA borders. There is a very low likelihood of transfer of these genes
into the modified onions. However, this approval excludes any genetically modified
onion that carries a construct containing an antibiotic resistance gene (refer to
description of approved organisms, section 2.1.1 above).
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2.6.3.5 The Committee considered that verification that the modified onion lines do not
contain the antibiotic resistance genes should be required before these lines were the
subject of a release application and it has set a control requiring molecular
characterisation of the lines selected for larger scale field testing to prove the
absence of vector derived genes from outside of the T-DNA borders. Control 1.16
(III) requires the Operator to verify by molecular analysis that transgenic parental
lines used in large scale trial plots do not contain vector DNA sequences from
outside of the left and right T-DNA borders from plasmids used in development.
2.6.3.6 Considering the low likelihood of the onions containing antibiotic resistance genes,
the risk associated with this trait transferring to pathogenic bacteria is considered to
be negligible and any cost would be insignificant.
2.6.4 Potential adverse effects on the relationship of Māori and their culture
and traditions with taonga
2.6.4.1 The need to take account of the relationship between Māori and their culture and
traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna
and other taonga is set out in section 6(d) of the Act and in clause 9(c)(iv) of the
Methodology. Section 8 of the Act requires the Authority to take into account the
principles of the Treaty of Waitangi.
2.6.4.2 The risks of adverse effects to aspects of tikanga Māori which is generally
considered a taonga and critical to the survival of Māori culture and tradition
(specifically the principles of whakapapa and kaitiakitanga) have been well
described in the E&R Report on this application14. The Committee also heard oral
evidence during the hearing from the two principal Māori groups concerned with
this application, Te Rūnanga o Ngai Tahu and Te Taumutu. (Both Rūnanga assert
mana whenua over the land on which the field trial is to be undertaken but the latter
to a greater extent as the field trial is to take place in the region around Lincoln.).
The Committee accepts that this evidence indicates concerns about the unknown
ways in which the genetically modified onion field trial might have an effect on
whakapapa and kaitiakitanga.
2.6.4.3 Uncertainties about these effects will be ameliorated by proposals to develop a
relationship between Crop & Food Research Ltd and Te Rūnanga o Ngai Tahu and
Te Taumutu based on the sharing of information. In addition the intended
relationship will also reflect Te Tiriti o Waitangi/the Treaty of Waitangi obligations
of Ngai Tahu and Te Taumutu Rūnanga in terms of the protection of their taonga,
and as ngā kaitiaki in the region.
2.6.4.4 The Committee recommends and endorses the proposed engagement between the
approval holder and Te Rūnanga o Ngai Tahu and Te Taumutu Rūnanga for ongoing
consultation throughout the duration of the field trial in the form of the performance
of kaitiaki functions (control 7.1) and receipt of reports (controls 7.8 and 7.9).
2.6.4.5 Both Te Rūnanga o Ngai Tahu and Te Taumutu Rūnanga have indicated a
willingness to participate in a consultative group. The Committee endorses this
14
Section 8.5.1 of the E&R Report on GMF03001.
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proposal and recognises that it would be appropriate to also involve Ngā Kaihautū
Tikanga Taiao and the Federation of Māori Authorities (FOMA) in such a
consultative group in order to ensure broader Māori participation (control 7.2).
Control 7.2 seeks to ensure that Crop & Food Research Ltd continue to consult
broadly with Māori about the issues involved with the genetic modification of food,
and the knowledge generated from the trial that may benefit the ongoing
development of understanding amongst Maori of the cultural implications of genetic
modification.
2.6.4.6 The measures adopted will, in the Committee’s view, ameliorate impacts to a
sufficient degree that they can be considered to be a negligible risk.
2.6.5 Potential adverse economic and social effects
Potential effects of pollen drift from GM onions to other crops and honey
2.6.5.1 Potential economic consequences flowing from pollen-mediated gene flow to nongenetically modified onions include the potential costs to onion growers and honey
producers arising from contamination of produce. These costs may include
destruction of onion crops contaminated by escaped onion pollen/seed, and in the
case of organic growers, certification could be forfeited or sources of certified seed
affected. The economic consequences could be very serious and concern was
expressed by submitters about the unavailability of insurance to cover such events.
2.6.5.2 The potential costs flowing from these effects are mostly measured in monetary
units but the Committee acknowledges that there would be non-monetary human
costs also. Monetary costs associated with replacing crops and loss of organic
certification would be limited to the area in which actual contamination occurred,
though as organic farms near Lincoln appear currently to be the only source of
certified organic onion seed, then there may also be impact on organic growers
elsewhere in the country. There was some uncertainty about how far pollen could
spread but the upper limit of such uncertainty indicates that contamination would be
limited to the region around Lincoln. For organic growers the costs could be
ongoing as it may take up to three years to recover lost certification. Consequences
could be significant for growers or honey producers located very close to the field
trial but this would likely be only a small number of individuals. The Committee
considers that these costs would be moderate to high.
2.6.5.3 Individuals who were directly affected may suffer not only a monetary cost but also
a sense of personal grievance that could not easily be compensated. Another
potential effect which is recognised as affecting the populace as a whole, if an
escape of pollen occurred, is a loss of trust in the regulatory system.
2.6.5.4 The Committee have noted the new section 124G of the Act, which provides that an
applicant is liable for loss or damage caused by failing to comply with controls. Part
7A also introduces substantial penalties and other orders for non-compliance, which
can be sought by an enforcement agency.
2.6.5.5 As the consequential costs are potentially moderate to high, the management of this
risk has been carefully considered. The Committee is confident that the containment
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measures15 will be successful. The Committee concludes that there is a very low
likelihood of pollen contamination of other produce16 i.e. that to a very high level of
probability, drift of pollen from the genetically modified onions will not occur.
However, because of the potential consequences, the overall risk is considered to be
very low rather than negligible.
Diversion of research money from more useful research
2.6.5.6 The Committee heard and read evidence about the range of fungal, insect and weed
problems facing major onion growers, which has lead to onions receiving intensive
applications of fungicides, pesticides and herbicides. Cultivation practices, use of
nitrogen fertilisers, especially on winter crops, and the intensive spray regimes have
led to degradation of the soil resource, runoff, leaching, and contamination of soil
and groundwater, raising questions about the sustainability of conventional onion
growing practices and the need for a more systems-based approach to tackling the
suite of problems these growers face.
2.6.5.7 Current weed control of onion crops uses a combination of selective herbicides,
usually a combination of residual herbicides and short-lived contact herbicides,
matched against the weed species present. The long term goal of the current
application is the production of onion cultivars that can be grown with reduced
numbers and volumes of herbicide applications.
2.6.5.8 Whether or not the research succeeds will become clear in due course. In
considering the current application, to field test genetically modified onions in
containment, such downstream effects were only considered in the context of how
likely it was that the research will deliver significant downstream benefits which is a
factor in determining the value/benefit of the proposed research. The Committee’s
assessment of potential benefits is outlined below in section 2.7 of this decision.
2.6.5.9 In accordance with section 6(e) of the Act, which requires the Committee to take
into account the economic and related benefits and costs of using a new organism,
the Committee considers that allocation of research funds to this line of research
means an opportunity cost is incurred through funds not being available for other,
potentially more useful, areas of research. The issue of the lost opportunity to do
other more valuable research is not an issue that has been previously considered by
the Authority. It has been considered by the Decision-making Committee in this
case because it was an issue that was strongly featured in submissions and
discussions at the hearing.
2.6.5.10 Other areas of research that could potentially have received this funding include
non-genetic modification research related to onions, including systems based
research (which examines the suite of problems facing onion growers), research into
higher priority problems in onion growing, research into alternative weed control
methods (other than this method based on herbicide resistance), and genetic
modification research into onions and other crops which does not involve the use of
herbicide resistance.
15
16
Refer to Appendix 1.
Refer to section 2.6.2 above.
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2.6.5.11 The majority of submitters expressed a preference for investing in sustainable
agricultural methods such as organic and integrated pest management (including
non-chemical based weed control) to find ways of reducing chemical use in farming,
over genetic manipulation. With reference specifically to weed control, Dr Rahman
reviewed a range of non-chemical methods of weed control, but noted that none of
them currently represent a practical viable option for large scale commercial onion
production.17 Both experts, consulted by the Agency on this application, noted that
the herbicides in current use were not “mainly toxic and persistent” as described by
the applicant, and Mr Wood noted that there has been a progressive reduction in the
toxicity of the herbicides used in onions over recent years as ongoing herbicide
research is making more short lived specific herbicides of lower toxicity available.
2.6.5.12 As noted above, conventional large scale onion growers are facing a suite of interrelated problems, problems which “are not easily solved as complex agronomic,
economic and social factors are involved.”18 Addressing one of these problems
(weed control) in isolation, without considering the complex interplay of factors
which are making conventionally grown onions so vulnerable to attack by fungi
(especially white rot) and insect pests (especially thrips), may do little to improve
the overall sustainability of crop production as the major problems may not be
affected, or may even be exacerbated (e.g. by removing refuges for natural enemies).
2.6.5.13 The Committee also heard a range of evidence concerning the likelihood that
glyphosate resistant crops do actually reduce the volume of herbicides used. The
Committee did not explore this issue in detail but did hear and read of enough
studies to consider, as the Royal Commission on Genetic Modification had
previously done, that the long term benefits of this technology are uncertain.
2.6.5.14 The Committee noted that Federated Farmers supported the application and that the
New Zealand Vegetable and Potato Growers Federation gave it qualified support.
2.6.5.15 To some people research towards chemical dependant (albeit reduced) weed control
is inherently less valuable than research into non-chemical based weed control. To
others any research aimed at reducing chemical usage is highly valuable.
2.6.5.16 It is not clear to the Committee that genetic modification for herbicide tolerance is a
priority for research funds among all potential areas of onion related research and
therefore, pursuing this strand of research does represent an opportunity cost in
terms of New Zealand agricultural and horticultural research priorities. The
uncertainty about the long term environmental benefits of herbicide-tolerance
technology invites the conclusion that this is not soundly based use of research
funding. This decision under the HSNO Act should thus not be seen as an
endorsement of the decision to fund this research.
2.6.5.17 The Committee concludes that this research is uncertain in terms of its potential to
yield economic or environmental benefits, relative to other possible research
investments. The uncertainty is sufficient to conclude that this is a non-negligible
risk, but the risk is nevertheless considered to be low.
17
Appendix 7 E&R Report on GMF03001.
Holland, P and Rahman, A (1999) Review of trends in Agricultural pesticide use in New Zealand.
MAF Policy Technical Paper 99/11.
18
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Public rejection / abhorrence of genetic engineering of food crops and of use of
taxpayer funded research to develop genetically modified foods
2.6.5.18 Section 5(b) of the HSNO Act requires the Authority to recognise and provide for
the maintenance and enhancement of the capacity of people and communities to
provide for their own economic, social, and cultural wellbeing.
2.6.5.19 Many submitters expressed opposition to the field trial citing a range of concerns
including:




protecting consumer choice over genetically modified food crops;
whether public money should be spent on genetically modified food crop
research;
potential adverse health effects; and
potential adverse environmental effects.
2.6.5.20 The Committee received many opinions that the proposed field trial was a waste of
time and money developing genetically modified food which would not find a
market and which represented unacceptable risks. Many submitters felt that
approving this field trial would encourage further investment in these technologies
and thus advance the introduction of genetically modified crops into the food
production systems of New Zealand. This advancement was seen to be opposed to
the ontological response of many submitters who simply do not want to have
genetically engineered crops present in New Zealand, and particularly objected to
the spending of their taxpayer money on genetically modified food crop research.
2.6.5.21 The Committee acknowledges the concerns of submitters and recognizes that many
of them will be disappointed with the approval of this application. However,
insufficient linkage was demonstrated to show any significant potential adverse
effect on the capacity of people and communities to provide for their own economic,
social and cultural wellbeing arising from this field trial and the risk is therefore
assessed as negligible.
Contribution to dominance of agriculture by multinational companies
2.6.5.22 A concern expressed by submitters was that, as an international seed company is
involved in development of the genetically modified onions, the work will assist the
dominance of agricultural seed markets by large multinational companies with
adverse effects resulting. It can conversely be argued that market benefits for New
Zealand might arise from such collaboration.
2.6.5.23 Whatever the merits of the arguments, the Committee's view is that any market
dominance effects arising from this field trial will be insignificant, both because of
its limited scale and duration and because it will not in itself lead to marketed
products. The risk is thus considered to be negligible.
Costs to exporters of a detrimental effect on the ‘clean green image’
2.6.5.24 Many submissions referred to a detrimental effect on New Zealand’s “clean green
image”. The Committee accepts that this “image” is being used as a marketing tool
both for the sale of New Zealand produce overseas and in advertising aimed at
attracting tourists.
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2.6.5.25 However, no evidence presented to the Committee established a link between the
proposed onion field trial and a fall in the value of this marketing tool. No evidence
indicated that previous similar small scale field trials of genetically modified plants
(e.g. potato, tamarillo, canola, maize) have caused any damage to New Zealand’s
“clean green” environmental image. This field trial is to be in containment and no
marketing of these genetically modified onions can occur under this approval.
2.6.5.26 Therefore, the Committee finds that the risk of an adverse effect on the “clean green
image” marketing tool occurring as a result of this field trial, considering both
likelihood of the effect occurring and the magnitude of the effect if it should occur,
is negligible.
2.6.6 Potential effects resulting from the transfer of any genetic elements to
other organisms in or around the site of the field test
2.6.6.1 The Committee has considered the risk of potential effects resulting from the
transfer of any genetic elements to other organisms in or around the site of the field
trial. The transfer of genetic elements through normal sexual reproduction has been
addressed above under the heading gene flow, however, there may be other
mechanisms by which genetic elements may be transferred between organisms.
These mechanisms are referred to as horizontal gene transfer (HGT). The possible
pathways by which HGT from genetically modified onions might occur include:





from genetically modified onions to soil bacteria, mycorrhizal fungi and other
microorganisms (particularly in the rhizosphere);
from genetically modified onions to pathogens that infect onions;
from genetically modified onions to invertebrates that may feed on onions;
from genetically modified onions to bacteria in the gut of organisms that might
feed on the onions (including human); and
from genetically modified onions to vertebrate (including human) cells in the
digestive tract.
2.6.6.2 The Committee considers that HGT of the EPSPS genetic construct from genetically
modified onions in all of the above scenarios is theoretically possible but, based on
current knowledge including previous studies in the laboratory and in the field, such
events are improbable. Further, because glyphosate tolerance is not considered to
provide a selective advantage in the event of transfer to soil bacteria, fungal or viral
pathogens, it is considered unlikely that the HGT of the CP4 EPSPS gene will result
in the gene becoming established in the population. Measured soil concentrations of
glyphosate generally do not exceed 5 mg/kg dw soil even at application rates as high
as 9 kg glyphosate/ha19 and at standard application rates, glyphosate would not be
expected to reach concentrations which would adversely affect soil microbial
function. In addition, many soil bacteria possess the ability to degrade glyphosate.
Therefore, even if the glyphosate-tolerance trait was transferred to a soil
microorganism, it is improbable that it would confer a selective advantage on that
organism. The potential consequence of HGT to vertebrates or invertebrates is also
considered to be insignificant.
19
Giesy et al (2000) Ecotoxicological risk assessment for Roundup Herbicide Reviews of
Environmental Contamination and Toxicology 167:35-120.
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2.6.6.3 Therefore the Committee agrees with the assessment of the E&R Report20 that the
occurrence of HGT is improbable and any consequence insignificant, but
acknowledges there is a degree of uncertainty. The risk of adverse effects resulting
from HGT of the EPSPS genetic construct from genetically modified onions in this
field trial is considered to be negligible.
2.6.7 Unanticipated effects due to the genetic modification process
(i)
Potential for unanticipated effects
2.6.7.1 Unanticipated effects may potentially occur within the genetically modified plants as
a result of the genetic modification process. Random insertion of genes into the
genomic DNA may, in addition to the intended effect (which, here, is to confer
glyphosate tolerance), result in unexpected shifts in metabolic pathways leading to
alterations in concentrations of nutrients and secondary metabolites or, in theory,
even to the formation of new toxins.
2.6.7.2 Analysis of the DNA sequence of the transgene flanking regions may establish
whether the insertion has taken place within or in proximity to an endogenous gene
and may give an indication of potential unanticipated effects. Analysis of the
integrated transgene in planta will also yield information on whether any genetic
rearrangements occurred during the transformation process.
2.6.7.3 Characterisation of the CP4 EPSPS protein expressed in planta will yield
information concerning whether the expected protein is produced correctly.
Molecular and compositional analysis and field testing of genetically modified
onions are the only ways by which to identify unanticipated adverse or positive
effects of the genetically modified onions and to reduce uncertainty in this area.
2.6.7.4 The applicant intends to undertake various molecular characterisation analyses on
the transformed onion lines in parallel with the field trial but carried out under the
development approval GMD001339. The object of these analyses is to determine the
location of the insertion of the CP4 EPSPS gene and the number of copies that are
inserted into each modified line. The Committee wish to limit the uncertainty of
effects due to the genetic modification by restricting this approval to genetically
modified onion lines that contain no more than two insertion events (control
1.16(II)). Only genetically modified onion lines containing one or two insertion
events shall be field tested and only lines with one insertion event shall be used in
the larger scale trial plots.
2.6.7.5 Due to the potential exposure of other organisms at the field trial containment
facility to the genetically modified onions the Committee considered that the
residual uncertainty due to potential effects from the genetic modification is
significant and accordingly the risk is assessed as very low rather than negligible.
(ii)
Potential to create new viruses due to the presence of viral promoters
2.6.7.6 The Committee heard evidence of concerns held by some submitters that, as a
promoter originally derived from a plant virus was used in the genetic construct
inserted into the onion, new viruses could be produced. A promoter sequence by
20
Refer to section 9.7.1.81 of the E&R Report.
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itself is not pathogenic. A promoter sequence does not encode a protein product. It
contains sequences that allow transcription factors and the RNA polymerase enzyme
to bind and initiate transcription of the downstream gene.
2.6.7.7 The promoter sequences used in the genetically modified onions21 have been used in
research for many years without reports of other viruses acquiring them and onions
are not infected by the viral species from which the promoter sequences were
derived. The promoter itself has no ability for independent movement or infection,
although if multiple copies of it occur in a genome there is the possibility of
recombination occurring between them. However, the potential for this to occur is
no greater for promoter sequences than for other homologous sequences within the
plant genome. Such recombination is very unlikely to result in the generation of a
new virus if an existing virus was not involved in the recombination. If a virus
acquired the promoter it is improbable that a new pathogen would develop since the
host range or pathogenicity of the virus is very unlikely to be affected by a promoter
– such features are associated with the genes that the virus expresses.
2.6.7.8 Therefore the Committee considers that this risk is negligible.
2.7 Assessment of beneficial effects
2.7.1 Approach and coverage
2.7.1.1 The beneficial effects assessed below are those identified as potentially significant,
having regard for those matters set out in clauses 9 and 10 of the Methodology. A
“benefit” is defined in the Methodology as “the value of a particular positive effect
expressed in monetary or non-monetary terms”. Benefits were considered in terms
of the requirements of clause 13 of the Methodology, including especially the
assessment of the nature of the beneficial effect (whether monetary or nonmonetary), the magnitude or expected value of the benefit (including the uncertainty
bounds on the value), and the distributional effect of the benefit.
2.7.1.2 The benefits assessed below are those identified in section 2.4 (above) of this
decision. The Committee notes that this list is somewhat narrower than the list of
benefits originally cited in the application which included potential long-term
benefits that may result from the application of the technology currently under
development (e.g. projected savings on herbicide costs for growers and reductions in
overall herbicide usage in the environment). This field trial is only one step in the
process from research to commercialisation. While the potential downstream
benefits are relevant to an assessment of the value of the development of these
genetically modified onions (see section 2.7.4 below), the Committee considers that
the significant benefits that warrant further assessment are those that will accrue
directly from this field trial.
2.7.1.3 Consideration of benefits includes:

an estimate of the magnitude of the benefit (clause 13(b));
21
Specific identity was supplied to the Committee in confidence on the ground of prejudice to the
commercial position of the supplier.
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


where relevant an assessment of the likelihood of occurrence (clause 13(b));
whether the benefit is monetary or non-monetary (clause 13(a)); and
the distributional effects over times, space and groups in the community
(clause 13(c)).
2.7.1.4 Explicit consideration of the uncertainty associated with the estimate (clause 29
(materiality of uncertainty) and clause 30 (need for caution where not resolved))
may also be required.
2.7.2 Development of knowledge and experience by Crop & Food Research
Limited scientists
2.7.2.1 The principal benefit to be derived from the field trial is the scientific knowledge
expected to be gained. This knowledge will be gained in the areas of:







phenotypic variation exhibited by genetically modified onion lines;
the effectiveness of herbicide regime for weed control in plots of glyphosatetolerant onions;
the tolerance of the modified onions to glyphosate herbicide;
information on potential herbicide savings through the use of this technology;
agronomic performance of new transgenic onion lines;
biological behaviour of genetically modified onions; and
effects of genetically modified onions on the environment.
2.7.2.2 The Committee notes that while valuable information would be obtained on some
aspects, information on other aspects will be limited due to the small size and scale
of the field trial. Scientific knowledge is primarily a non-monetary benefit.
2.7.2.3 One of the more significant questions to be addressed is whether this technology
(genetic modification for herbicide tolerance) is likely to be a way of improving the
sustainability of onion cropping practices. This is a long term question and this field
trial is an early step in the process of addressing this. The Committee heard a range
of opinion on potential for herbicide reductions from the use of glyphosate-tolerant
onions and this varied from the applicant’s claims of up to 80% to the agronomic
consultant’s estimates of 38% to 50%. The Committee considers that the applicant’s
evidence (based on the practices of only one grower with higher than average
herbicide usage) is likely to be an optimistic estimate. The Committee also notes that
the small scale of the trials and the fact that seedlings will be planted (in contrast to
standard commercial practice of plantings seeds) limits how realistic the estimates of
potential herbicide savings will be.
2.7.2.4 The Committee also noted that the goal of the research was to offer an alternative to
growers. Whether this was then taken up by the industry (and lead to actual
reductions in herbicide use) can only be speculative at this stage.
2.7.2.5 Whereas this information will primarily benefit Crop & Food Research Limited,
there may be an indirect public benefit when papers are published describing the
research and its results.22
22
Clause 13(c) of the Methodology.
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2.7.2.6 On balance, the Committee considers the benefit (beneficial effect) and its value in
this area to be at least moderate, but subject to considerable uncertainty.
2.7.3 Provision of a platform for related research to occur
2.7.3.1 The applicant, at the hearing, identified the following research which could
potentially be done in conjunction with the proposed field trial:
(a) developing the botanical files concept for Allium;
(b) investigating the impacts on non-target soil biota, including microbes and
invertebrates; and
(c) measuring the persistence of DNA sequences at the field site.
2.7.3.2 The Committee heard evidence of preliminary research that was conducted during a
previous field trial of genetically modified potato involving investigations into the
composition of culturable bacterial and fungal communities associated with the
transgenic plants in the field. It is anticipated that similar studies may be undertaken
during this field trial. The science personnel involved in the onion field trial would
not be performing much of this research work. Rather it was expected that other
groups would carry out some work using existing funding and that additional
funding may be sought to carry out specific research projects while the onion field
trial was occurring. This is why the applicant did not provide specific details of what
research would be done and how it would be done.
2.7.3.3 Although developing the botanical files concept for Allium species does not require
a field trial in order to be done, the field testing and potential future release of
genetically modified onions provides the justification for developing a botanical file
for Allium species.
2.7.3.4 The Committee noted that research into the impacts of the genetically modified
onions and associated herbicide regime on non-target soil biota is likely to require
large sample sizes to obtain meaningful data. In addition, sampling is likely to
require destruction of the sampled onions. No details of proposed samplings were
provided to the Committee by the applicant and it was not clear to the Committee
whether it would be possible to obtain meaningful data, especially given the small
scale of the trial coupled to the uncertain funding availability. Therefore the
Committee was unable to assess the size of this proposed benefit but considered
there was considerable uncertainty as to the likelihood of it being realized.
Nevertheless, the Committee recognizes that this trial provides an opportunity for
soil biota research that would not otherwise exist, in particular for the conduct of
experimental work on the impact of transgenic plants and associated practices such
as herbicide applications on the soil biota.
2.7.3.5 The Committee noted that the objective of determining the persistence of DNA
sequences at the field trial site addresses an area of current uncertainty and is likely
to yield worthwhile data. Although no details of the planned experimental design
were provided to the Committee, the Committee envisages that the experiments will
follow the persistence of transgene DNA released from decaying plant material such
as roots, left after the bulbs and above-ground material have been removed.
2.7.3.6 The applicant indicated in the original application that sampling for HGT
assessment at the field test site may be done by other research groups, but this work
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was not identified by the applicant at the hearing. However, the Committee
considers that it is unlikely any meaningful data on HGT would be obtained from
this trial as the transgene, CP4 EPSPS, is unsuitable for this purpose.
2.7.3.7 In order to prevent interference with any associated research on impacts of the
genetically modified onions on soil biota and DNA persistence that may be done,
control 5.5 prohibits the growing of any other genetically modified crop in areas
within the field trial containment facility, previously used for growing genetically
modified onions, for the duration of the trial.
2.7.3.8 As with the scientific knowledge discussed above (section 2.7.2.) any information
gained from related research will be a non-monetary benefit primarily for the
researchers concerned and for the public domain once published. Having taken
account of the uncertainty in this area the Committee consider that the expected
value of the proposed environmental impact research is low to moderate.
2.7.4 The development of lines of genetically modified onions which are
patented by Crop & Food Research Limited
2.7.4.1 The applicant explained that one of the underlying rationales for this line of research
is the goal of producing onion cultivars that may be grown successfully with a weed
management regime that uses a pre-sowing application of a residual herbicide
followed by glyphosate herbicide sprays as an alternative to current practices. If this
research proves successful it may lead to an opportunity for onion growers to reduce
the number and possibly volume of herbicides used, at least in the short term.
2.7.4.2 The Committee considered it was very likely that the field trial would allow the
applicant to assess the genetically modified onions for phenotypic variation and to
gain information on the performance of the onions in natural soil under natural
weather conditions. Information will also be gained on the glyphosate tolerance of
the onions under field conditions and their growth equivalency to control onions.
2.7.4.3 Therefore, a potential benefit of the field trial is that it allows the selection of onion
lines which perform well in the field, for potential further commercial development.
Patenting of selected lines would represent an asset and potentially a monetary
benefit for Crop & Food Research Ltd. The value of this asset is currently
speculative because of many uncertainty factors including:



how effective the herbicide savings would be;
current consumer resistance to genetically modified food products that may
limit or reduce potential markets; and
whether the technology will be adopted by industry.
2.7.4.4 The Committee heard evidence about the potential for this technology to enable
onion growers to reduce the volume and toxicity of herbicide usage in onion
growing should the genetically modified onions be grown, and on the likelihood that
genetically modified onions will be attractive to growers, allowing these savings to
be realized.
2.7.4.5 The evidence before the Committee indicated that the applicant had probably
overstated both the levels of current herbicide usage and potential savings possible
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with this technology. The Committee also noted that evidence on the long term
environmental benefits from the use of this technology in other crops overseas was
not clear.
2.7.4.6 The effectiveness of the technology is only one factor in translating the potential
savings into real environmental benefit. Other factors would also influence adoption
of the technology by growers including market responses to genetically modified
foods in our main onion markets (currently Europe (56.5%) and Japan (22.7%), both
markets which have over recent years expressed significant aversion to GM foods),
and the cost of patented genetically modified seed.
2.7.4.7 However, given that it will be many years before these lines may become
marketable cultivars and that consumer attitudes and cost structures may change
during that period and the uncertainty about the possible production benefits of the
cultivars, it was not possible to predict the likely level of uptake of genetically
modified cultivars by growers and thus the value of any new cultivars to Crop &
Food Research Ltd and to the New Zealand onion industry.
2.7.4.8 Taking account of uncertainty, this benefit was considered to be low.
2.7.5 Continued funding for Crop & Food Research Limited from New Zealand
and overseas sources contributing to ongoing research and
employment
2.7.5.1 The funding the research has attracted, and potentially will continue to attract, will
enable the direct employment of scientific research staff. Other investment in
equipment may also be possible. Funding is drawn from both Crop & Food Research
Limited’s New Zealand sourced funding streams and extra from overseas
collaborators. Employment is of benefit both to those employed and to the
community as a whole and the contribution from the overseas collaborator is
expected to lead to a net increase of employment.
2.7.5.2 The Committee accepts that other, non-monetary, benefits may also flow from
international collaboration with Seminis Vegetable Seeds (e.g. contributing to
keeping New Zealand at the forefront of genetic modification technology in
Alliums). It is accepted that the continuation of funding from that source depends on
Crop & Food Research Ltd being able to carry out research such as that described
here.
2.7.5.3 In this light the Committee considers that only the funding from Seminis Vegetable
Seeds should be seen as additional and contributing to a net increase in employment.
Notwithstanding the potential non-monetary benefits recognized by the Committee,
the value of this benefit overall is assessed as low.
2.7.6 Assisting with retention of scientific skills as intellectual capital within
New Zealand
2.7.6.1 Any nation depending on a knowledge-based economic future and especially a
country with significant dependence on agricultural and horticultural industries
needs to have scientific centres that attract and retain scientists of international
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calibre and to be leading developmental and applied research. It is a benefit to retain
people with internationally recognised scientific expertise in New Zealand. It is
possible that other problems or opportunities will arise, now or in the future, which
can most effectively be addressed using genetic modification techniques and in that
situation it would be useful to have those skills in the country, or at least sufficient
skills to be able to identify the value of genetic modification in delivering the
solution and to quickly set up capacity for genetic modification research. Crop and
Food Research Limited’s international standing in this type of research is an asset
for New Zealand and contributes to the attraction and retention of high calibre
scientists. This is a combination of monetary and non-monetary benefit.
2.7.6.2 While the argument is accepted, it is difficult to assess the significance of this
particular project to the retention of scientific skills. The benefit of assisting with the
retention of scientific skills is assessed as being low to moderate.
2.8 Alternative methods of achieving the research
objective
2.8.1.1 Section 44A(2)(b) of the Act requires the Authority to take into account any
alternative method of achieving the research objective that has fewer adverse effects
than the field trial on human health and safety, and the environment, in particular
ecosystems and their constituent parts.
2.8.1.2 The Committee has taken the closing submission to the public hearing as the most
up to date and thus appropriate statement of the applicant’s research objectives.
These objectives can be conveniently analysed in two groups as set out below.
Group 1
Development of onion lines by field testing for
performance, in natural weather and soil conditions
(phenotype, equivalency and glyphosate tolerance).
2.8.1.3 The Committee is of the view that field testing of onion lines for evaluation as
potential for commercial cultivar development is most appropriately done by
conducting a field trial. It was suggested by submitters that trials could be done
overseas as an alternative. However, the Committee accepts that potential New
Zealand cultivars need to be field tested in New Zealand conditions.
Group 2
Providing a platform for others to do environmental
impact research.
2.8.1.4 The Committee has noted some uncertainty about the potential for meaningful
information on the environmental impacts of growing genetically modified onions to
be obtained given the limitations of scale inherent in this field trial (section 2.7.3
above). However, for the purpose of conducting environmental impacts in a field
situation, plants must be placed into the field, so it is doubtful if any alternative
means could be found other than a field trial to do the work.
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2.8.1.5 As well as identifying other means of achieving the research objectives, those other
means must have fewer adverse effects. Given the generally low level of risk
associated with the proposed field trial, it is felt to be unlikely that risk would be a
factor in preferring other approaches.
2.8.1.6 The Committee’s view is thus that the proposed approach is broadly appropriate to
achieving the research objectives and that the adverse effects are sufficiently low for
this not to be material in looking at objectives. There is thus no reason under section
44A(2)(b) of the Act to decline the application.
2.9 Establishment of the approach to risk in the light of
risk characteristics
2.9.1.1 Clause 33 of the Methodology requires the Authority to have regard for the extent to
which a specified set of risk characteristics exist when considering applications. The
intention of this provision is to provide a route for determining how cautious or risk
averse the Authority should be in weighing up risks and costs against benefits. In the
case of the present application, the relevance of clause 33 is much reduced because
the application is “in containment” and it has already been concluded that the
containment provisions and other controls will reduce most biological and physical
risks to a low level.
2.9.1.2 In relation to the biological and physical risks considered (and the risks to human
health), the containment measures limit the extent to which exposure to the risks is
involuntary. The potential risks to which individuals may be involuntarily exposed is
mainly limited to pollen escape from containment and therefore this approval is
subject to controls that satisfy the Committee that no pollen will be present.
2.9.1.3 The duration of the approval is limited and none of the significant risks identified
are considered to persist over time. It is also considered that the risks are not subject
to uncontrollable spread nor are they likely to have effects extending beyond the
immediate location of incidence. Given the nature of the risks identified, it is
considered that they are not irreversible.
2.9.1.4 There is some degree of understanding by the general public of the risks posed by
the potential spread of pollen to other crops and the mechanism to prevent this
occurrence is easily understood. However, there is little experience of how the
adverse effects of such an occurrence might be managed. It is likely that other risks
are not well understood by the general public.
2.9.1.5 The Committee therefore have determined that a cautious approach to containment
is warranted and this is reflected in the controls to which this approval is subject.
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2.10 Overall evaluation of risks, costs and benefits and of
the adequacy of containment
2.10.1 Combining and weighing of risks, costs and benefits
2.10.1.1 The overall evaluation of risks and costs (incorporating adverse effects) and benefits
(incorporating beneficial or positive effects) set out below was carried out having
regard to clauses 22 and 34 of the Methodology, and in accordance with the tests in
clause 27 of the methodology and section 45 of the Act. Clause 27 of the
Methodology is the appropriate reference for weighing costs, risks and benefits
because (as indicated below) the aggregate risks and costs are not negligible, and
thus must be explicitly weighed against benefits.
2.10.1.2 In combining risks and costs in accordance with clause 34 of the Methodology, the
Committee was unable to find common units of measurement and neither was there
a dominant risk. All of the non-negligible risks and costs were thus considered in
combination including:



the risk of pollen contamination of other produce;
unanticipated effects due to the lack of characterization of the genetically
modified onions; and
the opportunity cost of not funding more beneficial research.
2.10.1.3 In the case of the first risk, there is a very low likelihood of pollen contamination
occurring because of controls to prevent flowering. The risk is, however, nonnegligible (assessed as very low) because of the potential economic and other
consequences for organic and other growers. In the case of the second risk, the risk
is assessed as very low because of uncertainty about unexpected shifts in metabolic
pathways as a result of the random insertion of genes into the genome of the
genetically modified onions. The opportunity cost of not funding more beneficial
research is considered by the Committee to be non-negligible because of uncertainty
as to whether herbicide tolerance will prove to be a useful option in addressing the
problems of onion growing. However, the risk is assessed as low because of
uncertainty about the relative value of alternative research programmes in advance
of their implementation.
2.10.1.4 Other risks and costs considered but found to be negligible were those associated
with other effects on the biological and physical environment, effects on human
health and safety, those arising from Māori issues and concerns, and those
associated with other economic and social issues. In making these assessments the
Committee considered both the impact of containment and other controls, and the
implications of the failure of controls. In aggregate, costs and risks were considered
to be low.
2.10.1.5 In combining benefits in accordance with clause 34 the Committee was again unable
to find common units of measurement which could be used, principally because of
the lack of quantitative data. However, the dominant benefit was found to be the
scientific and other knowledge created by carrying out the research which was the
purpose of the field trial and this was assessed as moderate. Other benefits assessed
as being low or low to moderate, included the provision of a platform for related
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research, the development of patentable lines of genetically modified onions, local
employment and a contribution to the retention of scientific skills in New Zealand.
2.10.1.6 The benefits, risks and costs were then weighed up in accordance with clause 27 of
the Methodology. While the dominant benefit of obtaining scientific and other
knowledge was subject to considerable uncertainty it was considered to be
sufficiently significant, even taking account of the uncertainty, to outweigh the
combined risks and costs of the application.
2.10.2 Adequacy of containment
2.10.2.1 Section 45 of the Act requires the Committee to be satisfied that the genetically
modified organisms can be adequately contained. The committee considered all of
the controls finally proposed, as set out in Appendix 1, and did so in the context both
of preventing the escape of the organisms and effectively managing any risks.
2.10.2.2 The Committee also determined that controls were in place as required by section
45A(2)(a) of the Act, but that no specific controls were required to deal with genetic
elements, as set out in section 45A(2)(b) of the Act. The Committee confirmed that
controls were in place as required by clause 6A of the Third Schedule to the Act.
2.10.2.3 Having regard to all of the above, the Committee was satisfied that the genetically
modified onions would be adequately contained.
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3 Decision
1. Pursuant to section 45(1)(a)(i) of the Act, the Committee is satisfied that this
application is for one of the purposes specified in section 39(1) of the Act, being
section(s) 39(1)(b): Field testing any new organism.
2. Having considered all the possible effects in accordance with sections 45(1)(a)(ii) and
section 44A(2)(c) and pursuant to clause 27 of the Methodology, and based on
consideration and analysis of the information provided and taking into account the
application of risk management controls specified in this decision, the view of the
Committee is that the risks (or costs) of adverse effects associated with the field
testing in containment of the following organism are outweighed by the benefits of
conducting the research:
Onions (Allium cepa L.) modified with one or two insertion events of a
construct from one of three pMON series plasmids* containing (between the
right and left T-DNA borders):





a promoter derived from a plant virus;*
a sequence encoding the leader sequence from one of two specified
plant heat shock proteins;*
a sequence encoding a chloroplast transit peptide from a plant
species;*
a synthetic EPSPS gene, conferring tolerance to herbicide glyphosate,
based on the CP4 EPSPS gene from Agrobacterium strain CP4; and
a 3’ untranslated region23 from a plant gene.*
* Specified in Appendix 2; Confidential information.
3. The Committee is satisfied that the proposed containment regime, as set out in
Appendix 1, will adequately contain the organism as required by section 45(1)(a)(iii)
of the Act. The Committee is also satisfied that the specific requirements set out in
section 45A(2) and clause 6A of the Third Schedule to the Act are met by the
controls.
4. In accordance with section 44A(2)(b) of the Act the Committee is satisfied that there
are no alternative methods of achieving the research objectives that have fewer
adverse effects, and that there is no basis under this section for declining the
application.
5. In accordance with clause 36(2)(b) of the Methodology the Committee records that, in
reaching this conclusion, it has applied the balancing tests in section 45 of the Act and
clause 27 of the Methodology and has relied in particular on the criteria set out in the
following sections of the Act:
 section 44 additional matters to be considered;
 section 45 determination of application;
 section 44A additional matters to be considered for field test;
This region contains signals for the termination of transcription. 3’indicates the location of this
region on the DNA molecule.
23
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

section 45A controls required for all field tests;
clause 6A of the Third Schedule-inspection and monitoring.
6. The Committee has also applied the following criteria in the Methodology:











clause 9 - equivalent of sections 5, 6 and 8;
clause 10 - equivalent of sections 36 and 37;
clause 12 – evaluation of assessment of risks;
clause 13 – evaluation of assessment of costs and benefits;
clause 21 – the decision accords with the requirements of the Act and
regulations;
clause 22 – the evaluation of risks, costs and benefits – relevant
considerations;
clause 24 – the use of recognised risk identification, assessment, evaluation
and management techniques;
clause 25 – the evaluation of risks;
clause 27 - the risks and costs are outweighed by benefits;
clause 33 – the risk characteristics; and
clause 34 – the aggregation and comparison of risks, costs and benefits.
7. The application for field testing of the onions (Allium cepa L.) modified with the CP4
EPSPS gene conferring tolerance to herbicide glyphosate is thus approved, with
controls, as set out in Appendix 1.
_____________________
Professor Colin Mantell
_______________
Date: 18 December 2003
Chairperson of Special Committee
Approval code: GMF000040
Amendments:
12 September 2005; control 7.5 amended to remove the restriction on the use of onion seed
by omitting the words “seed or” and adding the words “Genetically modified onion
seeds used must be securely fastened inside lengths of seed tape greater than 1m in
length.” Controls 1.12, 1.13, 1.14, 1.17 and 6.4 amended accordingly to clarify that
references to “seedlings” now also includes seeds.
12 September 2005; control 4.1 amended to change requirement to clean all visible soil off
equipment and footwear used on the field test site by omitting the words “residual soil
and onion material” and substituting the words “traces of onion material, and soil
potentially harbouring onion material.”
12 September 2005; control 6.4 amended to remove requirement to record the fate of those
onion seeds or seedlings sown that do not establish by adding the words “A record of
non-established material shall be kept and;” “established (fourth true leaf stage);” and
“(This means the Operator will record the numbers planted out, the numbers that do not
establish and the fate of only those that are established).”
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12 September 2005; control 7.6 amended to allow the use of alternative species in buffer
rows by adding the words “or non Allium plant material may be planted as an
alternative buffer row” and “other plant material can be removed and composted or
ploughed back into the soil.”
12 September 2005; controls 7.8 and 7.9 amended to remove the requirement for the Operator
to provide reports to the proposed Māori consultative group by omitting the words “and
to the proposed Māori consultative group referred to in control 7.2.”
_____________________
Date: 12 September 2005
Dr Kieran Elborough
Chair GMO Standing Committee
Amendment: November 2006
Changes to controls:
 Addition of footnotes to the containment facility references and the Australian/New
Zealand containment facility references to “future proof” the decision
 Standardise the wording of the breach of containment control
 Replacement of the control regarding inspection of facilities by the Authority, its
agent or enforcement officers with the standard control
____________________________
Dr Kieran Elborough
Chair, GMO Standing Committee
Environmental Risk Management Authority Decision: GMF03001
Date: 23 August 2007
Page 43 of 53
Appendix 1; 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, the approved organisms are subject to the controls set out below. In this
text references to providing information or reports to ERMA New Zealand shall mean
the Chief Executive of ERMA New Zealand or any other person nominated by the
Chief Executive for this purpose. The terms Operator and Supervisor have the
meanings given in the MAF/ERMA New Zealand Standard 155.04.09: Containment
Facilities for New Organisms (including genetically modified organisms) of Plant
Species.
1
To limit the likelihood of any accidental release of any organism or any
viable genetic material
Containment facility
1.1
Responsibility for conduct of the field trial shall be held by an Operator approved in
accordance with section 40 of the Biosecurity Act 1993, and the Operator shall be
responsible for ensuring that these controls are complied with.
1.2
The field testing of genetically modified onions shall be carried out in a field trial
containment facility registered by the Ministry of Agriculture and Forestry (MAF)
under the Biosecurity Act 1993, in accordance with the MAF/ERMA New Zealand
Standard 155.04.0924: Containment Facilities for New Organisms (including
genetically modified organisms) of Plant Species.
1.3
The boundaries of the containment facility, being the area of land set aside for the field
trial, shall be marked by a permanent feature (or GPS location details) and shall be
fixed for the duration of the field trial. The boundaries shall be so fixed that the
Operator has a legal right of control over the management of the whole of the facility
and an area surrounding the facility to a distance of ten metres.
1.4
All genetically modified onions may only be removed from the field trial containment
facility in order to be destroyed, or to be returned to the laboratory and plant house
containment facilities used for the development of these organisms, or for transfer to
collaborators under lawful approvals. Following transfer to another containment facility
the genetically modified onions shall be subject to the controls of development
approval GMD001339 for these organisms. Destruction must be by autoclaving at a
sufficient temperature and under such conditions as to ensure that all biological
material is rendered non-viable i.e. unable to grow or to reproduce. All references in the
24
Any reference to this standard in these controls refers to any subsequent version approved or
endorsed by ERMA New Zealand.
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remainder of these controls to being “destroyed” or to “destruction” shall have this
meaning.
1.5
ERMA New Zealand shall be sent a copy of the MAF registration certificate for the
field trial containment facility once registered.
1.6
The field trial containment facility shall be operated and maintained in accordance
with:
(a)
the MAF/ERMA New Zealand Standard (March 2003: 155.04.0924):
Containment Facilities for New Organisms (including genetically
modified organisms) of Plant Species (the Plant Containment
Standard), (or equivalent future versions) so far as it relates to field
trials; and
(b)
all of the controls set by the Committee in this decision.
1.7
The Crop & Food Research Limited containment facility manual shall be updated to
implement the controls imposed by this decision in accordance with the Plant
Containment Standard (155.04.0924). The contingency plan set out in this manual shall
include measures to manage any accidental release of plants outside the facilities, or
any other emergency, and a procedure to identify and recover any genetically modified
plant material.
1.8
The duration of the field trial shall be limited to the period between the date on which
this approval is granted and the expiry of ten years from that date.
1.9
The field trial containment facility shall continue to be managed and registered as a
containment facility for a period of one year following the later event of either the
completion of the field trial or any re-growth or germination of onions detected in
accordance with control 6.7.
1.10 The site of the field trial containment facility shall be that identified in the confidential
information supplied with the application. Genetically modified onions shall not be
planted within ten metres of open water drains.
1.11 No plant belonging to the genus Allium shall be allowed to flower in the field trial
containment facility. Any plant of the genus Allium displaying a sexual reproductive
structure (pipe) in the field trial containment facility shall be removed as soon as the
pipe is observed and dealt with as set out in control 1.4.
1.12 Genetically modified onion seedlings or seeds securely fastened inside seed tape shall
be transferred from the containment plant house to the field trial containment facility in
secure containers, which must include packaging in closed non-crushable boxes and
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transport in an enclosed vehicle if one is necessary for transportation. Harvested onions
shall be transported from the field trial containment facility to the containment plant
house, or for destruction in accordance with control 1.4, in secure closed containers to
prevent spill. All such transfers of plants or viable plant material shall require written
authority from the Supervisor of the field trial containment facility.
Register of Plants
1.13 A Register of onion seed or seedlings taken out of PC2 containment for planting in the
field trial shall be maintained. This Register incorporates and extends the requirements
of Section 4.8.2 of the Plant Standard (155.04.0924). The following records shall be
made for each seed or seedling:

the identity of the onion line (species, unique identifier for line and details of
genetic modification including number of transgene insertion events (where
known), or for F1 hybrids the identification of parental lines with their
number of insertion events);

the identity of the person responsible for the plant(s);

the date of planting;

the date of transfer of plant(s) or viable plant material to another facility and
the identity of the receiving facility;

the date of receipt of plant(s) or viable plant material from another facility;
and

the date and method of final disposal of plant(s).
1.14 An inventory of genetically modified onion plants or seeds taken out of PC2
containment structures and transferred to the field trial containment facility (and from
the field trial containment facility to the containment plant house or for destruction)
shall be checked on arrival to ensure that no plants or seeds are lost in transit and that
no genetically modified onions are planted outside the field trial containment facility.
1.15 All bulbs and above-ground vegetative material from the genetically modified onions
and from all non-genetically modified onions used as experimental controls25 not
retained for research purposes or transferred to collaborators under lawful approvals,
shall be destroyed immediately following removal from the field trial containment
facility. At the conclusion of the field trial or in the event of premature ending of the
trial or upon the expiry of this approval all onion material shall be removed from the
25
This control does not apply to the buffer rows of onions. For controls applicable to buffers refer to
control 7.6.
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field trial containment facility and the site shall be monitored in accordance with
control 6.7.
Specification of plants to be field tested
1.16 The Operator, before removal of plants from the containment plant house for field
testing of genetically modified onions specified in section 3 of this decision, shall
verify to ERMA New Zealand in writing that:
I. The genetic constructs and genetically modified plant tissue have been
developed in accordance with approval GMD001339 under section 42 of the
Act.
II. The genes, promoters and transformation events are those specified in section 1
of this decision and that the onion line to be tested contains only one or two
insertion events of the CP4 EPSPS gene and only lines with one insertion event
shall be used in the larger scale trial plots.
III. Molecular analysis of the transgenic parental lines used in the large scale trial
plots has demonstrated the absence of vector-derived genes outside of the left
and right T-DNA borders.
1.17 Onion seedlings or seeds planted in the field trial containment facility shall be covered
with net cloches until the plants are well established and rooted. The net cloches should
be of a design and appropriately positioned so the likelihood of birds removing the
seeds or seedlings is negligible.
1.18 Genetically modified onions, and all heritable material26 derived from them, shall be
removed from the field trial containment facility no later than the end of the first
growing season after planting.
2
2.1
To exclude unauthorised people from the facility
At all times only persons authorised by the Operator, or approved by the Operator and
accompanied by a person authorised by the Operator, shall have access to the field trial
containment facility and the Operator shall maintain measures to discourage
unauthorised access to the site that include:
a) a fence between the field trial containment facility and any land to which there
is unrestricted public access. Any gates to the facility may be unlocked
whenever personnel are on the site and shall be locked outside of normal
working hours.
b) A record of all persons authorised to access the field trial containment facility
shall be maintained and be available for inspection by the facility Supervisor.
26
Heritable material is defined in section 2 Act and, as discussed in section 2.5.2, in this context means
reproductive structures and bulbs.
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c) A log of all persons accessing the field trial containment facility who are not
named as authorised persons shall be maintained and be available for
inspection by the facility Supervisor.
3
To exclude other organisms from the facility and to control undesirable
and unwanted organisms within the facility
3.1
Domestic grazing animals shall be excluded from the field trial containment facility.
3.2
The Operator shall monitor the site for signs of pest damage or interference with the
genetically modified onions. All instances of damage or interference shall be recorded
in the field trial log required by control 6.8, together with a record of action taken to
prevent or minimise future damage or interference.
4
To prevent unintended release of the organism by experimenters working
with the organism
4.1
All equipment and footwear used in the field trial containment facility shall be cleaned
of all visible traces of onion material, and soil potentially harbouring onion material, in
the field trial containment facility, after each use.
4.2
No heavy machinery (tractors etc.) shall be used within ten metres of any genetically
modified onions in the field trial containment facility unless in the presence of the
Operator of the containment facility or of a person authorised to supervise that
machinery by the Operator.
4.3
The Operator of the containment facility or his/her nominee shall inform all personnel
involved in handling the genetically modified onions of the controls attached to this
approval.
4.4
The training of personnel working in the facility shall be in compliance with the Plant
Containment Standard (155.04.0924).
5
To control the effects of any accidental release or escape of an organism
5.1
Operation of the containment facility shall comply with the requirements of the
standards listed in control 1.6 relating to controlling the effects of any accidental
release or escape of an organism.
5.2
In the event of any potential or actual breach of containment leading to the removal of
the genetically modified plants involved in the field trial, the contingency plan for the
retrieval or destruction of any viable material of the organism that has escaped shall be
implemented immediately. The Operator shall make all reasonable efforts to recover
the plants and verify that retrieved plants are transgenic onion plants. If retrieved plants
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cannot be replanted in the field trial containment facility then they shall be either
transferred to the containment plant house or destroyed.
5.3
If a breach of containment occurs, the facility operator must ensure that the MAF
Inspector responsible for supervision of the facility has received notification of the
breach within 24 hours.
5.4
No transgenic onions or experimental control onions, or parts thereof, nor any other
food crops grown in those parts of the field trial containment facility used in the past
two years for growing genetically modified onions, shall under any circumstances be
offered for sale or consumed by any person, whether or not connected or associated
with Crop and Food Research Limited.
5.5
The area within the field trial containment facility used for growing genetically
modified onions shall be subject to the following crop rotation for each planting (no
genetically modified crops other than onions shall be used):
Year 1
Year 2
Year 3
Genetically Modified Onions
Potatoes or green manure crop
Fallow
Note: Green manure crop is a plant crop which is not harvested and is incorporated
into the soil. Fallow means cultivated soil not sown.
6
Controls addressing inspection and monitoring requirements, including
any inspection required before, during and after the field trial
6.1
The operation of the field trial containment facility shall comply with the requirements
contained in the Plant Containment Standard (155.04.09) relating to the inspection and
monitoring requirements for the containment facility.
6.2
The inspection and monitoring requirements for containment facilities shall be in
compliance with the standards listed in control 1.2.
6.3
Prior to planting of any genetically modified onions in the field trial containment
facility and on each occasion that planting of a plot occurs, the facility and an area of
ten metres surrounding it shall be inspected, by Crop & Food Research Limited
personnel familiar with Allium species, for the presence of any plants belonging to the
cepa group of the genus Allium, which, if found, shall be removed.
6.4
During the period when genetically modified onions are present in the field trial
containment facility, the facility and area of ten metres surrounding it shall be
monitored every week by Crop & Food Research Limited personnel familiar with the
development of reproductive structures in Allium species. A log of each monitoring
visit, recording the date, all Allium plants with pipes found, and any action taken in
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respect of those plants shall be maintained. Records of every transgenic onion seed or
plant planted out shall be verified from the original numbers. A record of nonestablished material shall be kept and the fate of any established (fourth true leaf stage)
plants that die during the trial or are removed from the field trial containment facility
shall be recorded. If a discrepancy is found, the MAF Supervisor and ERMA New
Zealand shall be informed immediately and their directions followed. (This means the
Operator will record the numbers planted out, the numbers that do not establish and the
fate of only those that are established).
6.5
In addition, the weekly inspection of the containment facility and surrounding area
(control 6.4) shall monitor for non-trial Allium plants of the cepa group. All non-trial
Allium plants of the cepa group found shall be removed and destroyed. A log of all such
plants found shall be recorded. This log shall be available for inspection by the facility
Supervisor.
6.6
Following removal of each planting of genetically modified onions and non-transgenic
trial onions, the site shall be inspected to verify that all reproductive structures and
bulbs are removed or destroyed in accordance with control 1.4. A record of this
verification will be made available for inspection by the Supervisor.
6.7
The entire field trial containment facility shall remain registered and be monitored to
detect any re-growth or seedling germination (volunteer), for a period of one year
following the later of the removal of either all trial onion plants or of any volunteer that
is subsequently found. If any volunteer plants of Allium cepa are found in the field trial
containment facility, these shall be removed and destroyed. Monitoring shall be
performed monthly. A log of these monitoring events shall be maintained and it shall
record the date, any Allium cepa plants found and any action taken.
6.8
A log shall be maintained that records any security monitoring of the field trial site, all
instances of unauthorised interference with the field trial site, all breaches of
containment and actions taken in respect of those breaches.
6.9
Logs of all monitoring and inspection undertaken on the field trial containment facility
and surrounding area (including that required by the above controls 6.4, 6.5, 6.6, 6.7,
and 6.8) shall be maintained and available for inspection by the facility Supervisor.
This is additional to the requirements of section 4.12 of the Plant Standard (155.04.09).
7
7.1
Additional controls
The applicant shall formally recognise the role of Te Rūnanga o Ngai Tahu and Te
Taumutu Rūnanga as ngā kaitiaki in the region of the field trial. This will include the
applicant seeking the prior agreement (i.e. before the commencement of the project) of
Te Rūnanga o Ngai Tahu and Te Taumutu Rūnanga about the nature and extent of
those kaitiaki responsibilities and obligations, and providing every reasonable
opportunity for agreed activities to be undertaken at the appropriate times.
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7.2
The applicant shall make all reasonable attempts to approach Te Rūnanga o Ngai Tahu,
Te Taumutu Rūnanga, Ngā Kaihautū Tikanga Taiao and the Federation of Māori
Authorities (FOMA) with the intention of forming a Māori consultative group. The
membership and terms of reference of any such group may be defined by the applicant
in consultation with the Māori parties involved
7.3
The Operator shall supply both ERMA New Zealand and MAF the final field trial plan
for each year with a list of all lines to be tested, the number of plants and the proposed
planting dates. This notification must be provided at least seven days prior to the
genetically modified onions being moved onto the field trial containment facility27.
7.4
The Operator shall notify the facility Supervisor and ERMA New Zealand of the
intended dates of harvesting and removal of the genetically modified onions from the
field trial site. This notification must be made at least seven days prior to the removal
from the field trial containment facility28.
7.5
Genetically modified onion seedlings field tested must be in their first year of growth.
No second-year bulbs of the genetically modified onions shall be used in the field trial.
Genetically modified onion seeds used must be securely fastened inside lengths of seed
tape greater than 1m in length.
7.6
Buffer row onions shall differ from the genetically modified onions planted at the
containment facility in a readily observable phenotypic character such as bulb colour,
or non-Allium plant material may be planted as an alternative buffer row. A separation
distance of 30 centimetres shall be maintained between the buffer rows and the
experimental plots. Following removal of buffer row onions from the soil the bulbs
shall be composted, other plant material can be removed and composted or ploughed
back into the soil.
7.7
The maximum number of genetically modified plants in the field trial shall not exceed
2700 at any one time over the period of the approval.
7.8
A comprehensive report on the progress and the outcome of the field trial shall be
provided to ERMA New Zealand, to Ngā Kaihautū Tikanga Taiao, to Te Rūnanga o
Ngai Tahu, and to Te Taumutu Rūnanga, by 30 June of each year during the approval
period. This shall include information on:
a)
b)
the continuing viability of the project;
any incident of interference with the field trial (whether or not a containment
breach occurred), the method of managing the incident and the outcome
resulting from this incident;
27
In accordance with the Plant Standard (section 6.4.1) the Supervisor shall inspect the facility at
planting.
28
In accordance with the Plant Standard (section 6.4.1) the Supervisor shall inspect the facility at
harvest.
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c)
d)
a record of trial activities in the preceding year;
the research done (including that on environmental effects) and any outcomes
of the research;
what unanticipated events were observed;
a plan of activities for the coming year;
a statement on compliance with each of these controls; and
records of any onion plants displaying pipes found.
e)
f)
g)
h)
Any confidential information included in this report should be clearly indicated.
7.9
At the end of the field trial a comprehensive report on the outcome of the field trial
shall be provided to ERMA New Zealand, to Ngā Kaihautū Tikanga Taiao, to Ngai
Tahu, and to Te Taumutu. The report shall be provided within three months of the
earlier of either the last genetically modified onion being removed from the field trial
site (in the event of the field trial being discontinued) or of the final date determined by
this decision for the duration of the field trial. This report shall include:
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Information that in the applicant’s view will assist the Authority with future
considerations.
Results of investigations into the effects of genetically modified plants on the
environment.
Information on whether the potential benefits of the field trial were actually
realised.
Information on what environmental impacts occurred.
Information on what unanticipated events were observed.
Comments on the appropriateness of the Authority’s controls.
Comment on how effectively the relationship with Ngai Tahu, Te Taumutu,
and Ngā Kaihautū Tikanga Taiao was maintained.
Any other information considered by the Operator to be of interest to the
Authority, to Ngai Tahu, to Te Taumutu, and to Ngā Kaihautū Tikanga Taiao.
7.10 The Operator shall promptly inform the facility Supervisor and ERMA New Zealand of
any matters which may affect the long term management of the field trial including:


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changes in the principal investigator responsible for the field trial;
any changes within or external to Crop & Food Research Limited that may
affect the management of the trials;
any event or circumstance that would affect the capacity of Crop & Food
Research Limited to meet the requirements of the Authority’s controls; and
changes in the use or ownership of the land on which the containment facility
is located and the area immediately surrounding the facility.
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Appendix 2; confidential information
Note: This Appendix, containing details of the origins of the genetic constructs, is
held in a confidential file at the Wellington office of ERMA New Zealand. This
information was supplied to the Committee for consideration, in confidence.
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