ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Hearing Date
10 August 1999
Date
21 October 1999
Considered by
Genetically Modified Organisms Standing Committee of the
Authority appointed under section 19(2)(b) of the Hazardous
Substances and New Organisms Act 1996.
Application Details
Application Codes
Applicant
Purpose
Date Application Received
GMF98005/GMC99001
Pioneer New Zealand Limited
To import and field test in containment genetically modified herbicide
tolerant maize for breeding purposes, in the Waikato Region.
23 September 1998
ERMA New Zealand Contact
Denise McDonald
Application Codes
Applicant
Purpose
Date Application Received
GMF98006/GMC99002
Pioneer New Zealand Limited
To import and field test in containment genetically modified insect
resistant maize for breeding purposes, in the Waikato Region.
23 September 1998
ERMA New Zealand Contact
Denise McDonald
Decision
The applications are Approved with Controls.
The organisms approved are:
1. Zea mays (maize) line T25. Produced using plasmid p35S/Ac containing a synthetic version of
the phosphinothricin acetyltransferase gene (PAT) isolated from the soil bacterium
Streptomyces viridochromogenes conferring tolerance to glufosinate-ammonium herbicide.
2. Zea mays (maize) line MON810. Produced using plasmids PV-ZMBK07 and PB-ZMGT10
containing the cry1A(b) gene for expression of an insect control protein (Cry1A(b)) derived
from the common soil bacterium Bacillus thuringiensis subsp. kurstaki (Bt) conferring resistance
to lepidopteran insects.
Application Process
The application was formally received on 23 September 1998, and verified on 25 September
1998.
The application was publicly notified on 26 September 1998 in The Dominion, The New
Zealand Herald, The Press and The Otago Daily Times.
Public submissions closed on 9 November 1998. Ten submissions were received for GMF98005
and nine for GMF98006.
In undertaking the review and evaluation of the application ERMA New Zealand identified a
number of deficiencies in the application. Further information was sought from the applicant on:

claims regarding pollen dispersal and lack of insect interest in pollen

the field test management and harvesting procedures

additional information on the financial benefits to New Zealand associated with the
proposal.
The applicant also provided information on the research into the effects of Bt pollen on
Monarch caterpillars.
The documents available for the evaluation and review of the application by ERMA New
Zealand included: the application, public submissions received, additional information as
identified above, public submissions, comment from the Department of Conservation and an
external scientific review (of the application only) undertaken by Associate Professor Clive
Ronson.
The application was determined by the Genetically Modified Organisms Standing Committee of
the Authority appointed in accordance with section 19(2)(b) of the Hazardous Substances and
New Organisms Act 1996. The Committee comprised members of the Authority: Professor
Barry Scott (Chairman), Helen Hughes, Bill Falconer, Dr Oliver Sutherland and Professor Colin
Mantell.
Summary of Hearing Proceedings
A public hearing was held on 10 August 1999 in Wellington.
Presentations
Presentations were made to the Genetically Modified Organisms Standing Committee by the
following parties:
For the applicant:
Rex Oliver
Tracey Rood
Research Associate, Pioneer New Zealand Inc.
Pioneer Hi-Bred International Inc.
For ERMA New Zealand:
Denise McDonald
Project Leader, ERMA New Zealand
For Ngā Kaihautu Tikanga Taiao1:
Ngā Kaihautu Tikanga Taiao has been formally established under clause 42 of the First Schedule to the Hazardous
Substances and New Organisms Act 1996, as a Māori advisory committee, 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).
1
Page 2 of 15
Murray Parsons
Ngā Kaihautu Tikanga Taiao
Submitters:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Berylla Berylla
Susie Lees
Oraina Jones
Mary Anne Howard-Clarke2
Alan Fricker
Tony Martin
Seager Mason
Sue Kedgely
David Treadwell
Phillida Bunkle
Rick Warham
Jon Muller
Jennifer Jane
Tricia Allen
Ian Melrose
Paul Butler
Private
Private
Private
R.A.G.E and Witness to Berylla Berylla
Witness for RAGE and Berylla Berylla
Witness for RAGE and Berylla Berylla
Witness for Oraina Jones
Witness for RAGE and Berylla Berylla
Witness for RAGE and Berylla Berylla
Witness for RAGE and Berylla Berylla
Witness for RAGE and Berylla Berylla
Witness for RAGE and Berylla Berylla
Witness for RAGE and Berylla Berylla
Witness for RAGE and Berylla Berylla
Witness for RAGE and Berylla Berylla
Witness for RAGE and Berylla Berylla
Subsequent to the hearing further information was sought by the committee. Additional
information received and considered by the committee included:

Further information on the status of international approvals of the maize

Information on the Bt toxin content in the insect resistant maize

Information on the potential for research to be carried out during the trials

Further information on security measures proposed by the applicant.
The information detailed above was forwarded to parties3 to the application for their
information.
Relevant Legislative Criteria
The application was lodged pursuant to section 40 of the Hazardous Substances and New
Organisms Act 1996, and determined in accordance with section 45 and the additional matters
contained in sections 37 and 44. The relevant items in Part II of the Act of particular significance
were: The maintenance and enhancement of the capacity of people and communities to provide for their own
economic, social, and cultural wellbeing and for the reasonably foreseeable needs of future generations section
5(b), and The relationship of Māori and their culture and traditions with their ancestral lands, water, sites,
waahi tapu, valued flora and fauna, and other taonga, section 6(d).
Consideration of the application followed the relevant provisions of the Hazardous Substances
and New Organisms (Methodology) Order 1998 (the Methodology).
2
Submitter to application GMF98005 only.
Parties: Including submitters, the applicant and relevant Government agencies from whom comment on the
application was received.
3
Page 3 of 15
The Applications
The applications are for approval both to import seed into containment and perform two
seasons of small scale field tests of herbicide tolerant and insect resistant maize at Pukekohe, in
the Waikato region. As each application to field test also includes a requirement to gain approval
to import the transgenic seed into containment the codes GMC99001 and GMC99002 have also
been assigned to applications GMF98005 and GMF98006. This takes into account the separate
approvals required to both import the seed and field test the maize in containment. The approval
for import and field testing of maize lines T25 and MON810 is covered by this decision and the
attached set of controls.
The trials are for the purpose of increasing inbred seed and developing hybrid seed containing a
PAT gene conferring herbicide tolerance or a Bt toxin gene for insect resistance. The seed is to
be exported to France following each harvest for further testing and evaluation of the new lines
created.
Scope of the Applications
The seed will be imported into New Zealand and held in storage until planting at Pioneer’s seed
storage facility, Pukekohe. The seed storage facility, seed processing facility and trial site will be
containment facilities for the purposes of the Biosecurity Act 1993, with controls imposed to
prevent dispersal of genetic material from the trial site. A maximum of 0.4 of a hectare is to be
planted in transgenic maize for both seasons.
The production of inbred and hybrid seed by hand pollination involves the collection, in paper
bags, of pollen from transgenic plants, which is then transferred to non-transgenic plants. At
harvest the resulting ears are collected and transferred, in secure bags, to Pioneer’s seed
processing facility. Here the kernels of corn are removed from the ear and packaged for export
to France.
Key Issues
The Committee’s consideration of the application encompassed, inter alia:
1.
2.
The adequacy of the proposed containment regime, including the:
i.
Ability of the organism to escape from containment
ii.
Ability of the organism to establish a self-sustaining population
iii.
Ease of eradication of any population established.
Effects of the organism (risks to the environment and human health and safety), including:
i.
Risks to the environment and public health
ii.
Risks to the relationship of Mäori and their culture and traditions with their ancestral
lands, water, sites, waahi tapu, valued flora and fauna, and other taonga
iii.
Long-term unanticipated environmental and health effects.
Specific risks to the environment and human health and safety considered, included:
i.
Horizontal gene transfer.
Page 4 of 15
3.
ii.
Potential risks from use of the cauliflower mosaic virus promoter (CaMV)
iii.
Development of resistance to the Bacillus thuringiensis toxin
iv.
Transfer of antibiotic resistance
v.
Effects on non-target organisms
vi.
Effects from the disposal of plant material.
In addition the Committee considered, risks to:
i.
4.
The maintenance and enhancement of the capacity of people and communities to
provide for their own economic, social, and cultural wellbeing and for the reasonably
foreseeable needs of future generations.
The Committee also considered the economic and related benefits to be derived from the
use of the organisms.
Adequacy of the Proposed Containment Regime
The Committee’s consideration of the adequacy of the proposed containment regime
encompassed, inter alia:
i.
the ability of the organism to escape from containment
ii.
the ability of the organism to establish a self-sustaining population, and
iii.
the ease of eradication of any population established.
The ability of the organism to escape from containment
In considering the ability of the organism to escape from containment, the Committee
considered the following specific points:
i.
breach of containment through dispersal of pollen
Maize is a wind pollinated crop and the pollen is not known to be dispersed by insects. The
applications state that the pollen remains viable for a period of up to 30 minutes and the crop
will be at least 400m from other maize crops in the vicinity of these trials, which is double the
OECD required isolation distance to achieve variety purity.
The applicant has proposed and this decision requires that the pollen tassels be secured in
weatherproof paper bags prior to pollen formation. The collected pollen is transferred to the
recipient non transgenic maize and secured with the paper bag. New bags are secured over the
transgenic donor plants to ensure no remaining pollen escapes.
The Committee considered that should pollen bags be damaged and pollen dispersed from the
site, the 400m isolation distance (minimum) from other maize crops, the presence of a shelter
belt, and the limited period of viability of the pollen would make it highly unlikely that any pollen
could successfully pollinate maize outside the trial site.
ii.
breach of containment through dispersal of seed
All transgenic maize ears will be contained within the weatherproof paper bags, which are only
removed at harvest. This ensures that the transgenic ears are readily identifiable and makes it
Page 5 of 15
unlikely that any rodents or birds could distribute the seeds. The applicant also notes that in 12
years of using the bagging technique for performing hand pollinations no bags have been
damaged.
At the completion of the hand pollination procedure and prior to the formation of viable seed all
transgenic plants will be destroyed onsite by mulching and burial.
The Committee was satisfied, subject to the controls imposed in this decision, that the
containment regime could adequately contain maize as a part of these field tests.
iii.
breach of containment following deliberate action
The Committee considered the risk of sabotage, and the potential for such action to breach the
proposed containment measures. It concluded that several factors would reduce, though not
eliminate the vulnerability of the field test site to acts of sabotage. These included the location of
the site, its enclosure by a tall shelterbelt, its lack of visibility from the road, and the location of
the landowner's dwelling beside the access to site from the road.
The greatest risks from deliberate breach of the containment measures would arise during the
period of pollen production and viability. However, were such a breach to occur it does not
follow that pollen would necessarily be distributed from the trial site and cross pollinate nonmodified maize, particularly given the limited viability of such pollen. The Committee concluded
that the likelihood of escape from the trial site due to an act of sabotage, and of cross pollination
with unmodified maize was negligible.
The ability of the organism to establish a self-sustaining population and the
ease of eradication
To be potentially self-sustaining an organism has to establish populations in the uncontrolled
environment. But to establish widely the transgenic maize would need to exhibit evidence of a
rapid and high rate of reproduction, an ability to disperse reproductive parts widely, and a
tolerance of a wide range of climatic and soil conditions. The principal undesirable characteristic
is weediness.
The Committee noted that the biology of maize shows that the species does not possess the
weedy potential. The seed does not remain dormant in the soil, the seed has no self-dispersal
mechanisms due to the non-shattering aspect of maize cobs and also any seed consumed by
animals would be broken down in the digestive tract. Therefore, maize requires human
intervention to be disseminated. Maize is also a highly cultivated crop and any seedlings that may
establish would be unlikely to survive due to their poor competitive ability.
According to the information provided in the application no additional traits, other than
herbicide tolerance and insect resistance, are conferred to the maize lines T25 and MON810 due
to their modifications. These traits are unlikely to enable the modified maize to establish selfsustaining populations in natural habitats. In addition, these traits would not be an advantage to
the crops in New Zealand as glufosinate herbicides are not generally used on conventional maize
crops and no lepidopteran pests of maize of significance exist in New Zealand.
In the event of maize pollen escaping from the paper bags, being wind dispersed beyond 400
metres, remaining viable and crossing with non-modified maize it would be unlikely to establish
a self-sustaining population due to the traits described above. Also there are no wild relatives of
maize that transgenic maize can cross with in New Zealand.
Page 6 of 15
The characteristics of maize and its additional traits indicate that there is a very low likelihood
that maize from these field tests could establish self-sustaining populations due to seed or pollen
dispersal.
The ease of eradication of any population that established
The Committee considered that any seed that did remain in the soil at the trial site and
germinated the following season could be easily identified and destroyed by hand weeding,
mechanical cultivation or treatment with a non-glufosinate herbicide (as required by the post
harvest monitoring controls). Volunteers that may germinate, resulting from the unlikely event
that transgenic seed or pollen is dispersed from the trial site, would be unlikely to be identified or
eradicated.
However, the characteristics of maize make it unlikely that populations of escaped maize could
establish.
Effects of the Organism (Risks to the Environment and
Human Health and Safety)
In considering the effects of the organism, the Committee took into account the following
matters:
1. Risks to the environment and public health.
2. The relationship of Māori and their culture and traditions with their ancestral lands, water,
sites, waahi tapu, valued flora and fauna, and other taonga.
3. Long-term unanticipated environmental and health effects
Risk to the Environment and Public Health
For any effects on the environment to be realised as a result of this containment application, the
organism or its genetic material must first escape into the uncontrolled environment. The
principal issue to be considered therefore is whether the escape of such material is possible and
whether controls can be imposed that would effectively prevent the organism and its genetic
material from escaping containment.
Specifically the Committee considered the following issues:
i.
Possibility of horizontal gene transfer
The Committee has previously addressed the risk of horizontal gene transfer from plants to soil
microbes in decisions GMF98004, GMF98007 and GMF98008. The Committee noted in these
decisions that while the scientific evidence available is inconclusive, horizontal gene transfer
from transgenic plants to soil microorganisms is unlikely.
Specifically in relation to the use of the Bt toxin gene the Committee noted in decision
GMF98008 (insect resistant potatoes) that Bacillus thuringiensis is already widespread in the natural
soil environment, and horizontal transfer of the toxin gene to soil microorganisms, particularly in
the context of the proposed small-scale field test, is extremely unlikely to have any definable or
material impact.
The Committee considers that no new information has arisen that causes the Committee to
reassess its position on this issue.
Page 7 of 15
ii.
Potential risks from use of the cauliflower mosaic virus promoter (CaMV)
In its previous decisions involving organisms containing the CaMV promoter (ie. GMF98007
and GMF98008) the Committee has not commented on the safety or otherwise of its use.
Submitters on both the maize field test applications raised concerns that the CaMV promoter
could recombine with gut bacteria. Although there is no intent by the applicant or potential from
this approval for the maize to be consumed by animals or humans the Committee noted that to
date there is no evidence that the CaMV promoter, which has been widely used for many years,
has any risk associated with its use.
iii.
Development of resistance to the Bacillus thuringiensis (Cry1A(b)) toxin and
adequacy of refugia
The Committee considered the possibility of the development of resistance within populations
of Lepidoptera to the Cry1A(b) proteins expressed in the plants, and any adverse effects on
beneficial organisms, specifically insects, which may occur as a result of consuming the toxin.
Based on the available scientific evidence, the Committee concluded that the probability of
lepidopteran populations developing resistance to Cry1A(b) proteins, in the context of the
proposed small-scale field test, was very low. Moreover, the origin of any resistance developed
would be difficult to determine because of the current use of Bt toxins as an organic insecticide.
The Committee considered the recent laboratory study by Huang et al. (1999)4. The results in
this study appear to show that resistance to a commercial formulation of Bacillus thuringiensis toxin
(Dipel ES) is dominant in the European corn borer. This is in contrast to findings for other
insect pests. This suggests that where resistance to Bt toxin is dominant, new strategies may be
needed to prevent emergence of resistance in the insect population, as the success of a refugia
strategy depends on Bt toxin resistance being recessive. The Committee also noted that Dipel
ES, the Bt toxin tested by Huang et al. (1999) contains at least three Bt toxins compared to a
single toxin in Bt maize.
The Committee also considered laboratory results using the cotton pest, pink bollworm moths
by Liu et al (1999)5 which indicate that a resistant strain of larvae on Bt cotton takes longer to
develop than susceptible larvae on non-Bt cotton. This developmental asynchrony favours nonrandom mating and could reduce the expected benefits of the refuge strategy.
In the context of the insect resistant application, considered here, the Committee is satisfied that
the potential for emergence of Bt toxin resistance in insects located at the trial site is still very
low given the small size of the Bt maize plot (approximately 0.2 hectare).
iv.
Development of antibiotic resistance
Based on the information provided by the applicant maize line T25 contains a truncated
ampicillin resistance gene and line MON810 totally lacks antibiotic resistance genes. The
Committee therefore considered that any potential for transfer of antibiotic resistance was not an
issue.
v.
Effects on non-target organisms
Huang F, Buschman L L, Higgins R A, and McGaughey W H 1999: Inheritance of resistance to Bacillus thuringiensis
toxin (Dipel ES) in the European corn borer. Science 284: 965-67.
5 Yong-Biao Liu, Bruce E. Tabashnik, T. J. Dennehy, A. L. Patin, A. C. Bartlett 1999. Development time and
resistance to Bt crops. Nature 400: 519.
4
Page 8 of 15
From the available evidence the Committee noted that the PAT gene responsible for glufosinate
ammonium tolerance in maize line T25, has not been known to affect population levels of
interacting organisms. The Committee, taking this into account along with the small scale of this
trial, considered that the maize line T25 is not likely to have any negative impacts on other
organisms.
In assessing the effect of maize line MON810 the Committee considered evidence including the
reported negative effects of genetically modified Bt maize pollen on monarch butterflies (Danaus
plexippus) by Losey et al. (1999)6 and on beneficial organisms through secondary poisoning.
The Committee considers that further work will be needed to evaluate the long term implications
in natural situations of the results of these studies. In relation to this field test the potential
impact on Monarch butterflies or other organisms from any escape of Bt pollen is estimated to
be insignificant relative to other causes of mortality to them.
In addition, the Committee considered that any adverse effects on populations of beneficial nonlepidopteran organisms, such as ladybirds and lacewings, would be insignificant in the context of
a small scale field test.
In considering the information available the Committee noted that there are no known adverse
health effects from the human consumption of processed transgenic maize from lines T25 or
MON810. The Committee reviewed the international status of approvals to release maize lines
T25 and MON810 for food and commercial growing and noted that approvals to import grain
have been given by the United States, European Union, United Kingdom, Canada and Japan.
Both lines are approved to be commercially grown in countries including the United States,
Canada and European Union. The Committee noted that individual countries in the European
Union are reviewing release approvals and that Austria and Luxembourg have not approved the
growing of genetically modified maize.
vi.
Effects from the disposal of plant material following harvest
The applications proposed that the transgenic plant material will be cultivated into the soil and
buried at the trial site following the hand pollination procedure. The Committee considered
whether the incorporation into the soil of the plant material containing Bt toxin may have any
negative effect on soil microorganisms.
Information, with supporting data provided in confidence, was supplied by the applicant. This
information assured the Committee that the Cry1A(b) protein, as a component of post harvest
Bt maize, breaks down rapidly both on the ground surface and in the soil.
The Committee concluded that the controls imposed in this decision would minimise the
likelihood of an escape of the organism, and thereby minimise the likelihood of any possible
adverse effects on the environment and public health.
Risk to the Relationship of Mäori Culture and Traditions with
Taonga
Ngä Kaihautü Tikanga Taiao’s audit of applications GMF98005 and GMF98006 directed the
Committee to their concern about the possibility of transgenic pollen crossing with varieties of
Zea mays used by Mäori for producing the food känga wai, känga kopuwai or känga pirau
6
Losey J E, Rayor L S, and Carter M E 1999: Transgenic pollen harms monarch larvae. Nature 399: 214.
Page 9 of 15
(fermented corn). Ngä Kaihautü Tikanga Taiao noted that their concern relates more to any
release of genetically modified maize.
The Committee notes that the containment controls will minimise the likelihood of any possible
risks to the relationship of Mäori culture and traditions with taonga due to dispersal of transgenic
maize pollen and seed.
Long-term unanticipated environmental and health effects
The Committee received submissions expressing concerns that the processes and consequences
of genetic modification are insufficiently established for the applicant to be able to assure that
that there will be no unanticipated long term adverse effects on either the environment or
human health.
These submissions covered several grounds:

the uncertainty of genetic modification as a science obliged the Authority to take a
precautionary approach under the Act;

the possibility of escape during the field test period, or of crossing with non-modified
maize following release would jeopardise New Zealand’s expanding organic agricultural
and horticultural industries, its ‘clean green’ image, and its biodiversity;

the possibility of long term adverse effects materialising well into the future had to be
taken into account in considering the well-being of future generations.
In terms of the Act the Committee can consider these kinds of issue in relation to, either:

the requirement under section 5(b) 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 well-being and for the reasonably foreseeable needs of future
generations (though this provision is directed more to the long term sustainability of the
environment than to the management of long term adverse impacts on human health); or

the requirement under section 7 Act to take account of the need for caution in managing
adverse effects where there is scientific and technical uncertainty about those effects.
The Authority does not dismiss any of the concerns expressed. However, concerns regarding
scientific uncertainty, and potential long term adverse impacts on future generations are more
relevant to release applications than to an application for small scale contained field tests. There
may be some scientific uncertainty regarding the potential consequences of the genetic
modifications proposed in the present applications, but this will not result in adverse
consequences for the environment, human health, or future generations while the field tests are
undertaken in containment. The caution required of the Committee relates to the adequacy of
the containment conditions and management regime. In this regard the Committee considers the
risks to be negligible for current and future generations alike.
The Authority considers however, that the applicant should take note of the concerns expressed,
and be prepared to address them in the event that an application is made to release the
genetically modified maize, or products or material derived from them.
Page 10 of 15
At that time the possibility of long term adverse consequences can be expected to be more
determinative. This decision relates only to the proposed small scale contained field tests, and
should not be taken as any commentary on the safety of any products which may be derived
from genetically modified maize.
Benefits
The purpose of the applications is to develop new lines of transgenic maize for export to France
for further testing. Because of the nature of the purpose the Committee considered that the
benefits to New Zealand from this trial are minimal. However the Committee considers that the
annual income for the trials for Pioneer is not insubstantial at $600,000. The Committee notes
that Pioneer New Zealand Inc. is a well established New Zealand company providing
employment for 25 staff over summer and that by carrying out these trials is able to maintain
crucial business relationships with their international parent company.
During the trials information will be collected by Pioneer New Zealand Inc. on: unexpected
morphological differences between transgenics and non-transgenics; diseases occurring at the
site; and the occurrence of beneficial and non-target insects and predators at the site, that may be
of benefit to the assessment of field tests in the future.
The Committee wishes to emphasise that field tests like these should incorporate such a research
component, so that the results are available for the evaluation of any future field test and release
applications.
Risks, Costs and Benefits
In terms of clause 26 of the Methodology the Authority may, taking into account the measures
available for risk management, approve an application where an organism poses negligible risks
to the environment and human health and safety if it is evident that the benefits of the organism
outweigh the costs.
Where this is not the case, then under clause 27 the Authority must take into account the extent
to which the risks and costs associated with the organism may be outweighed by the benefits.
The Committee considers that the benefits of these trials are limited but that such organisations
should be permitted to proceed with their business activities where there is negligible risk to the
environment and human health and safety.
Conclusion
Pursuant to section 45(1)(a)(i) of the Act, the Committee was satisfied that the applications are
for one of the purposes specified in section 39(1) of the Act, being section 39(1)(b): Field testing
any new organism.
Having considered all the possible effects of the organism, in accordance with sections
45(1)(a)(ii) and (iii) of the Act, the Committee is of the view based on consideration and analysis
of the information provided, and taking into account the application of risk management
controls specified in this decision, that the risks of adverse effects associated with the field
testing of transgenic maize lines T25 and MON810, are outweighed by the beneficial effects of
having the organism in containment.
The Committee is satisfied that the proposed containment regime imposed will adequately
contain the organism.
Page 11 of 15
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 applications to import
into containment and field test in containment are approved subject to the following controls:
1.
To limit the likelihood of any accidental release of any organism or any viable
genetic material7:
Import into Containment (Seed Storage and Processing)
1.1
Prior to planting, export and during processing the seed shall be maintained in
containment facilities8 operated in compliance with the MAF Standard 152.04.03F Requirements for Holding and Process Facilities (Class: Transitional Facilities) for
Uncleared Risk Goods.
1.2
Transgenic maize seed shall be imported and transported in accordance with the Packaging
Instruction No. 650 of the International Air Transport Association (IATA) Dangerous
Goods Regulations. All containers used must be clearly labelled with the name, address,
and phone number of both the sender and the recipient. During storage, the transgenic
maize seed shall be kept separate from all other seed stock at all times. The seed packets
shall not be opened and shall remain at the seed storage containment facilities in Pukekohe
until the time of planting.
1.3
Any handling of the transgenic maize seed packets must be carried out in a separately
designated area within the containment facility. The seeds shall not be removed from the
individual packets until time of planting and shall be transported to the trial site in clearly
labelled leak proof containers packed into a second container made of strong noncrushable material.
1.4
All inlets and outlets to the containment facility shall be secured to prevent ingress of seed
feeding animals to the facility.
1.5
At all times only persons authorised by the applicant shall have access to the seed storage
and processing containment facilities.
1.6
All transgenic maize material shall be properly and adequately identified at all times.
1.7
Any residual material associated with the imported transgenic maize seed (packaging
material etc.) shall be destroyed in a manner (preferably by incineration) to prevent
unintended release of transgenic seed into the environment.
1.8
After drying of the harvested maize ears and removal of the kernels the ears shall be
disposed of daily, by incineration.
Viable Genetic Material is biological material that can be resuscitated to grow into tissues or organisms. It can be
defined to mean biological material capable of growth even though resuscitation procedures may be required, eg
when organisms or parts thereof are sublethally damaged by being frozen, dried, heated, or affected by chemical.
8 The containment facilities referred to in controls 1.1 to 1.11 are the seed storage facility and the seed processing
facility.
7
Page 12 of 15
1.9
ERMA New Zealand and the facility Supervisor9 shall be informed in writing prior to
removal of transgenic maize seed from the containment facilities for planting and export.
1.10 The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the containment facilities at any reasonable time.
1.11 All equipment and clothing used in the offsite processing of transgenic maize shall be
thoroughly cleaned to prevent any viable transgenic maize material escaping.
Field Test in Containment
1.12 The trial shall be located at the site identified in the application and shall be used solely for
the proposed field tests of transgenic maize involving maize lines T25, MON810 and nonmodified maize.
1.13 The method of handling the transgenic maize seeds during planting and transport shall
ensure that there is no spillage outside the trial site.
1.14 All imported seed not used in the field tests shall be exported or destroyed by incineration.
1.15 Maize pollen tassels on transgenic plants shall be fully contained within secure
weatherproof bags prior to pollen production.
1.16 Immediately following the removal of the bags containing collected pollen the transgenic
tassels shall be secured with a new bag to prevent the dispersal of any remaining pollen.
1.17 At the completion of hand pollination the transgenic plants shall be destroyed by
mechanical mulching and burial.
1.18 At the time of hand pollination the ears on the non-transgenic recipient plants shall be
secured with the weatherproof bags.
1.19 All ears produced by hand pollination shall be hand harvested and transported to the
drying facility in secure bags to ensure no transgenic material is dispersed.
1.20 Following harvest the non-transgenic plants shall be mulched, the field rotary hoed, and
deep ploughed to ensure plant material is destroyed and buried.
1.21 All transgenic seed produced shall be exported or destroyed by incineration.
1.22 The applicant shall adhere to the trial design and experimental procedures as detailed in
the application, except as otherwise required by these controls.
1.23 At all times only persons authorised by the applicant shall have access to the trial site.
1.24 Any object or material that is likely to contain viable transgenic maize shall be disposed of
by incineration or autoclaving, to prevent unintended release.
1.25 No transgenic plant material from the trial site shall be used for animal feed or for human
consumption or removed from the trial site (except for ears, with kernels for processing).
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An inspector appointed under the Biosecurity Act.
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1.26 The applicant shall ensure that the bags on tassels are monitored for bird or rodent
damage and any damage detected shall be remedied to prevent pollen escape.
2.
To exclude unauthorised people from the facility10:
2.1
The trial site shall be monitored for interference other than by authorised personnel. This
shall include monitoring of the trial site both while workers are on site and after-hours, the
procedure for which shall be detailed in the management plan.
3.
To exclude other organisms from the facility and to control undesirable and
unwanted organisms within the facility:
3.1
The applicant shall discourage seed feeding animals having access to transgenic maize seed
after sowing and during germination by the use of rodent baits and bird scares.
4.
To prevent unintended release of the organism by experimenters working with
the organism:
4.1
Equipment and clothing used in the field testing of transgenic maize shall be thoroughly
cleaned at the trial site to prevent any viable transgenic maize material leaving the trial site.
5.
To control the effects of any accidental release or escape of an organism:
5.1
The applicant shall include in the management plan, the procedures to be implemented in
the event of the loss of containment of any transgenic material. The eradication procedure
shall ensure that no viable transgenic maize material remains in the environment.
5.2
If for any reason a breach of containment occurs or an event that is likely to be in the
public interest, e.g. destruction of transgenic material, the applicant shall notify the facility
Supervisor and ERMA New Zealand immediately the event is noticed (and at least within
24 hours of the breach being detected).
5.3
The applicant shall maintain a minimum isolation distance of at least 400m between the
transgenic maize field tests and any non-modified maize not involved in the trials.
6.
Inspection and monitoring requirements for containment facilities:
6.1
The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the trial site at any reasonable time.
6.2
The trial site shall be monitored for at least 1 year following each of the two seasons, from
the date the plants are mulched following harvest. Any volunteer plants shall be destroyed
by manual or chemical means prior to reproductive structures forming.
6.3
The applicant shall:
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(i)
maintain a register of all transgenic maize material imported, harvested, destroyed,
and exported. The register shall record dates, the identity of the plants and methods
of disposal.
(ii)
advise ERMA New Zealand and the facility Supervisor in writing of sowing, harvest
and export of seed dates.
The containment facility for controls 1.13 to 7.2 is the field trial site.
Page 14 of 15
(iii)
provide a comprehensive report to ERMA New Zealand within four months of the
harvest and export of the transgenic seed or at any other time if requested by ERMA
New Zealand detailing progress and outcomes of the field tests, and extent of
compliance with the controls.
(iv)
provide reports to ERMA New Zealand within four months of the completion of
each 1-year monitoring period on the monitoring activities and occurrence of
volunteers.
7.
Implementation of Controls:
7.1
The applicant shall inform all personnel involved in the field tests of genetically modified
maize of the controls imposed in this decision.
7.2
The applicant shall prepare and use a management plan to implement the controls
imposed by this approval, to be approved by ERMA New Zealand and MAF. The plan
shall specify the containment system at the seed storage facility, at the trial site and for offsite processing. It shall also include the post field test monitoring regime and the
destruction of volunteers as required by these controls and defined in the applications and
the additional information.
Note: For the purposes of this approval the controls 1.12-7.2 above shall constitute the standard applicable to the
approval of a place as a containment facility for the purposes of section 39 of the Biosecurity Act 1993.
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