ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Application Number
GMF98002
Date 4 March 1999
Consideration date
18 February 1999
Considered by
GMO Special Committee comprising: Professor Barry Scott
(Chair), Dr Oliver Sutherland and Dr Terry Lomax.
Application Details
Applicant
Date Application Received
Dr Kevin Davies, New Zealand Institute of Crop and Food Research,
Palmerston North
To field test, in the Wanganui-Manawatu Region, petunia genetically
modified for altered plant form or pigmentation, to assess field
performance of the vegetative plant.
14 August 1998
ERMA New Zealand Contact
Denise McDonald
Purpose:
Decision
The application is Approved with Controls.
The organisms approved are: Genetically modified Petunia auxilaris x (Petunia auxilaris x Petunia
hybrida) lines as detailed below. Common name: Mitchell Petunia (MP).
Binary Vectors
Original transformants
Approved lines to be used in field test
pLN38
38/MP/118 -maize Lc
1. 38/MP/118 self cross (LcLc)
2. 38/MP/118 x Mitchell
petunia (Lc+)
pLN70
70/MP/124-Agrobacterium rolC
3. 70/MP/124
pLN83
83/MP/231- Antirrhinum ros
4. 83/MP/231 x 38/MP/118
5. 38/MP/118 x 83/MP/231
6. 83/MP/231 self cross
Legislative Framework
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 and those relevant items in Part II of the Act. Pursuant to
section 45(1)(a)(i) of the Act, the Authority was satisfied that this application was for one of the
purposes specified in section 39(1) of the Act, being section 39(1)(b): Field testing any new
organism.
Consideration of the application followed the relevant provisions of the Hazardous Substances
and New Organisms (Methodology) Order 1998 (the Methodology).
Reasons for Decision
Adequacy of the Proposed Containment Regime
The Authority was satisfied that the containment procedures and management plan proposed by
the applicant can adequately contain the organism. Of particular importance are the:
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propagation of the petunia in a GMO containment greenhouse
location of field test site
daily monitoring to remove all flower buds
low total plant numbers
secure transportation to and from field test site, and
disposal of plant material.
The Authority noted that the containment procedures and management plan were modified
from the original application and reflected the concerns raised by submitters on the:
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potential for breach of containment via pollen and seed dispersal, and
potential for consequential adverse effects.
The Authority acknowledged the Department of Conservation’s advice that supervision of the
field test is critical and considers that daily monitoring and removal of buds is essential to the
containment of the field test, as petunia are known to come into flower very rapidly.
Self-sustaining Populations
The Authority was satisfied that provided the field test is operated in accordance with the
management plan and controls imposed by the Authority that the likelihood of escape of pollen
and seed is very low. The Authority noted that there is little information on the mechanism of
dispersal and transfer of petunia pollen and seeds, such as which organisms pollinate petunia and
how far the pollen can be dispersed. However, the Authority was satisfied that in the unlikely
event that any pollen, seed or vegetation propagules were to escape that it is extremely unlikely
that a self sustaining population could result. Petunias are not known to be weedy species and
are not known to form self-sustaining populations in New Zealand.
Horizontal Gene Transfer and Development of Antibiotic Resistance
The Committee also considered the likelihood of escape of transgenic genetic traits by horizontal
gene transfer to soil microorganisms and the development of resistance to the antibiotic
kanamycin (used as a marker gene in the transgenic petunia lines). The Committee concluded
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that for this application no new scientific information was submitted that would change its
position on these issues, as addressed in previous field test approvals: GMF98004, GMF98007,
GMF98008. Nor did the facts surrounding the application present new risks on these issues.
In these previous decisions the Authority commented on horizontal gene transfer and
established that while the scientific evidence available was inconclusive, horizontal gene transfer
from transgenic plants to soil micro-organisms is unlikely. With regards to the use of kanamycin
resistance genes the Authority considered, that any incremental antibiotic resistance resulting
from gene transfer from transgenic plants associated with the specific field tests identified, by
whatever means, would be unlikely to have any definable or material adverse consequences on
the environment or human health. The Committee agreed that these earlier conclusions also
apply in this instance.
Ngā Kaihautu Tikanga Taiao Report
The Committee noted the advice in the Ngā Kaihautu Tikanga Taiao report and encourages the
applicant to provide two further Rangitane Iwi Authorities (Tane Nui a Rangi o Manawatu and
Te Mauri o Rangitane) with information on the field test.
Negligible Risk
The Committee concluded that the risks of adverse effects associated with this field test are
negligible, based on consideration and analysis of the information provided, and taking into
account the application of risk management controls specified in this decision.
Benefits
The Committee found that the beneficial effects of having the organism in containment include
increased scientific knowledge of the phenotype and vegetative performance of the transgenic
lines under commercial growing conditions. The limited scope of the application, due to
prevention of flowering, has to some extent reduced the benefits, which would have otherwise
been available.
Conclusion
The Committee, having regard to the ability of the organism to escape from containment
[section 44(b)] concluded that the beneficial effects of having the organism in containment
outweighed the adverse effects of the organism and any inseparable organisms, should the
organism escape.
Having considered all the possible effects of the organism, in accordance with sections
45(1)(a)(ii) and (iii) of the Act, the Committee was satisfied that the proposed containment
regime and controls on approval imposed by the Committee could adequately contain the
organism.
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Controls
In order to provide for the matters detailed in Part I of the Third Schedule to the Act, Containment
Controls for Development and Field Testing of Genetically Modified Organisms, this application is approved
subject to the following controls:
1.
The plants shall be propagated in a GMO containment greenhouse operated in accordance
with PC2 level of containment of the Australian New Zealand Standard 2243.3:1995. The
facility shall be approved to meet any ERMA/MAF Containment Standards as applicable.
2.
Handling of genetically modified petunia seeds, cuttings and plants during propagation and
planting shall ensure that there is no spillage outside the containment greenhouse and the
field test site.
3.
All genetically modified petunia plant material shall be properly and adequately identified
at all times. Seedlings shall be transported to the field test site in sealed leak proof
containers packed into a second container of strong non-crushable material.
4.
ERMA New Zealand shall be informed, in writing, of the planting date prior to the
transfer of the genetically modified petunia plants to the field test site.
5.
The field test site shall be used solely for genetically modified petunias and non-modified
control petunia plants.
6.
Genetically modified plants not used in the field test shall be destroyed by autoclaving in a
PC1 containment facility (AS/NZ Standard 2243.3:1995).
7.
The field test site shall be located for ease of monitoring and to minimise damage caused
by floods, landslide etc.
8.
The field test shall consist of 6 genetically modified and 2 non-modified lines with no
more than 20 plants per line.
9.
The field test site shall be monitored daily to ensure that all flower buds are removed from
all plants (both genetically modified and non-modified controls) prior to the buds opening.
The plant material from the field test site shall be removed in a sealed, leak proof container
packed into a second container of strong non-crushable material and the plant material
shall be destroyed by autoclaving in a PC1 containment facility (AS/NZ Standard
2243.3:1995).
10.
Equipment used in the field testing of genetically modified petunias shall be thoroughly
cleaned at the field test site to prevent any viable genetically modified petunia material
leaving the field test site.
11.
During the field test the entire field (area 4651sq. m.) encompassing the planted area (42 sq
m) shall be monitored for any self sown or volunteer petunia plants. Any petunia plants
found shall be removed prior to flower bud formation, in a sealed leak proof container
packed into a second container of strong non-crushable material and destroyed by
autoclaving in a PC1 containment facility (AS/NZ Standard 2243.3:1995).
12.
On completion of the field test all plants shall be destroyed by herbicide application and
rotary hoeing.
13.
The field test planting site (area 42sq. m.) shall be monitored for at least 1 year following
completion of the field test and until no further seedlings appear. No petunia may be
planted on this 42 sq. m. site for 1 year following the trial. Seedlings shall be removed from
the field test site in a sealed leak proof container packed into a second container of strong
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non-crushable material and destroyed by autoclaving in a PC1 containment facility
(AS/NZ Standard 2243.3:1995).
14.
Only persons authorised by the applicant shall have access to the field test site, which shall
be secured at all times.
15.
Any container that is likely to contain viable genetically modified petunia material shall be
disposed of by incineration or autoclaving in a PC1 containment facility (AS/NZ Standard
2243.3:1995) to prevent the escape of genetically modified petunia.
16.
The applicant shall keep an inventory of petunia plant material removed and destroyed.
17.
Effective eradication measures as outlined in the Contingency Plan shall be implemented
following any breach of containment.
18.
The Authority or its authorised agent or properly authorised enforcement officers
(including inspectors appointed under the Biosecurity Act 1993), may inspect the facility at
any reasonable time.
19.
The applicant shall prepare and use a management plan to implement the controls
imposed by this approval. The plan shall specify the containment system and the post field
test regime for monitoring and destruction of the volunteers, as outlined in letter dated 18
December 1998, application question 15 and Application Attachment 3.
20.
The applicant shall ensure that all staff involved in the operation of the containment
greenhouse and field test are informed of these controls and the management plan.
21.
The applicant shall provide a report to ERMA New Zealand within four months of the
completion of the field test, including details of the outcomes of the field test and issues
relating to compliance with controls.
22.
Approval of the field test shall be for 3 months from date of planting at the field test site.
23.
For this application, controls 1-22 above, constitute the standard applicable to the
approval of a place, being the field test site, as a containment facility for the purposes of
section 39 of the Biosecurity Act 1993.
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