ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under S67A on 16 November 2001 and 13 November 2006 and 22 August 2007
Original Decision 27 March 2001
Application code
GMC00020
Application type
To import into containment a genetically modified organism under
section 40(1)(a) of the Hazardous Substances and New Organisms
(HSNO) Act.
Applicant
Landcare Research Ltd (Lincoln)
Purpose
To import into containment genetically modified carrots and potatoes
expressing possum contraceptive antigens, to determine if possums show
an immune response upon feeding that is sufficient to affect their
fertility, with the view to producing a new method for management of
the brushtail possum.
Date received
21 December 2000.
Consideration period
9-14 March 2001.
Considered by
A Committee of the GMO New Organisms Standing Committee of the
Environmental Risk Management Authority (the Authority).
Decision
The application to import genetically modified carrots and potatoes into containment is
approved subject to controls in accordance with sections 45(1)(a) and 45(2) of the Hazardous
Substances and New Organism Act 1996.
The approved organisms are:
Daucus carota sativus L. (carrot); Cultivar Nanco as modified by pTH110 containing the plant
optimised B subunit of Escherichia coli heat labile enterotoxin LT-B.
Daucus carota sativus L. (carrot); Cultivar Nanco as modified by pGPTV-pAW4 containing
possum [Trichosurus vulpecula (Kerr, 1792)] zona pellucida protein (ZP3).
Daucus carota sativus L. (carrot) Cultivar Nanco as modified by pGPTV-pAW4 A2 containing a
truncated version of the ZP3 gene and the A2 region of the E.coli heat labile enterotoxin subunit
A (LT-A).
Daucus carota sativus L. (carrot) Cultivar Nanco as modified by pGPTV-pAW6 containing the LTB gene and ZP3 gene.
Solanum tuberosum L. (potato) as modified by pTH110 containing the plant optimised B subunit
of Escherichia coli (E. coli) heat labile enterotoxin LT-B.
Solanum tuberosum L. (potato) as modified by pGPTV-pAW4 containing possum zona pellucida
protein (ZP3).
Solanum tuberosum L. (potato) Cultivar Frito Lay 1607 as modified by pGPTV-pAW6 containing
the LT-B gene and ZP3 gene.
Solanum tuberosum L. (potato) Cultivar Frito Lay 1607 as modified by pGPTV-pAW4 A2 a
truncated version of the ZP3 gene and the A2 region of the E.coli heat labile enterotoxin subunit
A (LT-A).
Application process
The application was formally received on 21 December 2000, and stalled for further information,
which was received and verified on 29 January 2001. The application was not publicly notified.
The documents available for the evaluation and review of the application by ERMA New
Zealand included the application, appendices (including copies of all literature cited) and
comments from the Department of Conservation.
The application was considered by a Committee of the Genetically Modified Organisms Standing
Committee of the Authority appointed in accordance with section 19(2)(b) of the HSNO Act
1996. The Committee comprised the following members: Mrs Helen Hughes (Chair) Professor
Colin Mantell, and Ms Prue Kapua
Relevant legislative criteria
The application was lodged pursuant to section 40(1)(a) of the HSNO Act. The decision was
determined in accordance with section 45, taking into account additional matters to be
considered under sections 37 and 44 and matters relevant to the purpose of the Act, as specified
under Part II of the Act.
Consideration of the application followed the relevant provisions of the Hazardous Substances
and New Organisms (Methodology) Order 1998, but with particular regard to clauses 8 (dealing
with the scale and significance of the risks, costs and benefits) and 26 (dealing with applications
where the risks are negligible).
Reasons for the decision
Purpose
In accordance with section 45(1)(a)(i) of the HSNO Act 1996 the Committee considers that the
application to import into containment genetically modified carrots and potatoes to assess
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responses in possums to the contraceptive protein ZP3 and immune response enhancer (sLT-B),
constitutes an appropriate purpose under section 39(1)(h) of the Act 1996: Such other purposes as the
Authority thinks fit.
Inseparable organisms
The Committee considered the effects of any inseparable organisms in accordance with section
45(a)(ii) of the HSNO Act and noted that the genetically modified carrots and potatoes would be
developed using high health cultivars which will be free from other organisms. The potatoes and
carrots will also be washed and scrubbed before shipment and required to meet phytosanitary
certification by Animal and Plant Health Inspection Service (APHIS), therefore contamination
with other organisms is very unlikely. Should any inseparable organisms be imported, it is very
unlikely they would escape containment under the specified containment controls imposed in this
decision.
Ability to escape containment
The Committee has considered the ability of the organism to escape from containment in
accordance with section 44(b) of the HSNO Act.
The Committee notes that the applicant currently stores genetically modified potatoes in their
facility approved under MAF Regulatory Authority standard 154.02.17: Transitional Facility for
Biological Products; that meets PC2 standards as described in the Australia/New Zealand
(AS/NZS) Standard: 2243.3:1995 Safety in Laboratories: Part 3: (Microbiology). This facility will
also be used for the storage and analysis of animal samples.
The Committee further requires the genetically modified carrots and potatoes to be maintained in
a 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 155.04.09:
Containment Facilities for New Organisms (including genetically modified organisms) of Plant
Species.
The Committee considered the potential for genetically modified and non-genetically modified
material to get mixed up and the possible removal of the genetically modified potatoes and
carrots from the containment facility by personnel either by accident or design. The Committee
has proposed containment controls to minimise any accidental removal of any carrots or
potatoes. These controls include appropriate labelling to avoid confusion during storage, ensuring
all modified and non-modified material is stored in a lockable unit, keeping a register of the
identity and fate of the possums and modified and non-modified carrots and potatoes,
requirements for disposal of all biological material and adequate time before possums can be kept
in the outdoor pens after eating modified carrots and potatoes, and has limited the quantities to
be imported to further reduce the possibility of accidental mix up of genetically modified and non
genetically modified carrots and potatoes.
The animal facility for housing possums to be used in the feeding trial is also designated a
Transitional Facility for Biological Products meeting PC2 standards as described in AS/NZS
2243.3:1995, in addition to the MAF Regulatory Authority/ERMA New Zealand (Animal Health
and Welfare) Standard 154.03.03: Containment Facilities for Vertebrate Laboratory Animals.
The Committee considered the ability of the possums to escape from the outdoor pens where the
possums will be kept for natural breeding. The Committee concluded that the likelihood of
genetic material from transgenic carrots or potatoes being taken up by the possum genome is
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unlikely, and therefore the possums once released into the outdoor pens can not be classed as
new organisms and therefore specific containment controls do not appear necessary.
The Committee also considered the ways in which the genetically modified carrots and potatoes
may escape from containment, which included transfer of genetic material to organisms and
deficiencies in the containment facility. The Committee considers that in view of the limited
duration of exposure to possums through their diet that the likelihood of antibiotic resistance
developing is very low.
The Committee is satisfied that it is very unlikely genetically modified carrots or potatoes would
escape from containment, taking into account the laboratory procedures proposed by the
applicant and the containment controls imposed in this decision.
Ability to form self-sustaining populations
The Committee also considered the ability of the organisms to establish a self-sustaining
population and the ease with which any such populations could be eradicated were considered in
accordance with sections 37(a) and (b) of the Act.
The Committee noted from the ERMA New Zealand Evaluation and Review report that the
applicant proposes to bring the genetically modified and unmodified carrots and potatoes in a
freeze-dried form, however the applicant actually proposes to bring the modified material in a
raw form, and if freeze drying proves successful, it may be bought in a freeze dried form in the
future. The Committee considered the ability of both types to form self-sustaining populations.
The Committee considered the possibility of hybridisation occurring, but concluded that viable
material would have to escape containment, grow or be grown, flower and produce pollen within
dispersal range of appropriate non-modified plants, and the hybrids would need to reproduce and
survive successfully. Carrots do not re-grow from their taproots and all potato peelings that
contain eyes or bud material are to be incinerated. The Committee considered that the
likelihood of both types to form self-sustaining populations is unlikely.
The Committee notes that the applicant is required to implement procedures for the retrieval or
destruction of any viable material of the organism that has breached containment, as part of the
facility approval, and as detailed in the Landcare Research (Lincoln) containment manual.
The Committee concludes that the genetically modified organisms are very unlikely to escape
containment, taking into account the laboratory procedures proposed by the applicant and the
containment controls imposed in this decision. Should the organisms breach containment they
are unlikely to establish self-sustaining populations in the uncontrolled environment.
Adverse effects
The Committee further considered the potential adverse effects in accordance with section
45(a)(ii) of the HSNO Act 1996.
Effects on the Environment
The Committee notes from above (refer to sections: Ability to escape containment and Ability to
form a self-sustaining population) the effects on fauna, flora and the ecosystem in the unlikely
event of escape from containment are likely to be negligible.
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Effects on Human Health
The Committee considered the potential risks on human health including: allergenicity of carrot
and potato pollen (if organisms formed a self-sustaining population), toxicity of genetically
modified carrots and potatoes following consumption by humans, transfer of antibiotic resistance
genes to humans, and the potential risk of the ZP3 protein causing contraceptive effects to
human females.
The Committee concluded the risks of consumption to humans of genetically modified carrots
and potatoes including the transfer of antibiotic resistance genes, allergenicity and toxicity are
low.
Effects on the relationship of Māori with their taonga
The Committee considered the potential adverse effects associated with the organisms on the
relationship of Māori and their culture and traditions with their ancestral lands, water, sites, wāhi
tapu, valued flora and fauna, and other taonga.
The Committee considers that adverse effects on Māori and their culture and traditions are
unlikely, based on the fact that no genes from humans or native flora and fauna would be
involved in the research, and that the genetically modified organisms would be used in
containment. In the unlikely event that the organisms breached containment, the Committee
considers it would be very unlikely for these organisms to pose risks to native or valued flora or
fauna or otherwise adversely affect the environment or Māori culture.
Negligible risk
Based on the consideration and analysis of adverse effects to the environment, public health, and
Māori culture and, taking into account the containment controls imposed in this decision, the
Committee considers risks associated with the importation of genetically modified carrots and
potatoes into containment are negligible. The Committee has therefore considered this
application in terms of clause 26 of the Methodology.
Costs and benefits
The Committee considers that the primary benefit of the importation would be the increased
knowledge gained from plant-expressed antigens as a delivery system for biological control of
possums in the future. However the Committee noted that before this could be developed, the
specificity of the antigen would need to be determined.
The Committee is satisfied that costs are unlikely to accrue to parties other than the applicant.
Conclusion
Having considered the possible effects of the organisms in accordance with sections 45(1)(a)(ii)
and (iii) of the HSNO Act, the Committee is satisfied that the proposed containment regime and
additional controls will adequately contain the organisms.
The Committee concludes that, taking account of the ability of the organism to escape from
containment (refer section 44(b) of the HSNO Act 1996), the beneficial effects of having the
organisms in containment outweigh the likely adverse effects of the organisms and any
inseparable organisms, should the organisms escape.
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The application to import into containment genetically modified carrots and potatoes, is thus
granted in accordance with section 45(1)(a) of the HSNO Act. As required under section 45(a)(b)
the approval is subject to containment controls, as specified below.
Containment controls
In order to satisfactorily address the matters detailed in the Third Schedule Part I Containment
Controls for Development, Importations or Field Testing of Genetically Modified Organisms1 of the Act, the
Authority’s approval of this application is subject to the following controls:
1.
To limit the likelihood of any accidental release of any organism or any viable
genetic material2:
1.1
The person responsible for the feeding trials and/or the person responsible for the
operation of the containment facility shall inform all personnel involved in the handling
of the organisms of the Authority’s controls.
1.2
The containment facilities shall be approved by Ministry of Agriculture and Forestry
(MAF) in accordance with the MAF Biosecurity Authority/ERMA New Zealand
Standards 154.03.033, Containment Facilities for Vertebrate Laboratory Animals and 155.04.093
Containment Facilities for New Organisms (including genetically modified organisms) of Plant species
and the controls of the Authority.
1.3
The construction and operation of the containment facilities (‘the facility’) in which the
organisms are maintained, shall be in accordance with the:
a)
MAF Biosecurity Authority/ERMA New Zealand Standard 155.04.093: Containment
Facilities for New Organisms (including genetically modified organisms) of Plant species, at Laboratory
Physical Containment Level 2 (PC2);
b)
Australian New Zealand Standard AS/NZS 2243.3:19953 Safety in Laboratories: Part 3:
(Microbiology), at Laboratory Physical Containment Level 2 (PC2);
c)
MAF Regulatory Authority/ERMA New Zealand (Animal Health and Welfare) Standard
154.03.033: Containment Facilities for Vertebrate Laboratory Animals; animal house physical
containment level 2 (PC2) and
d)
Animal Welfare Advisory Committee (AWAC) and National Animal Ethics Advisory
Committee (NAEAC) guidelines administered by MAF.
Additional Controls
1.4
To ensure security, access to the containment facilities shall be subject to regular
surveillance by authorised personnel.
Bold headings refer to Matters to be Addressed by Containment Controls for Development and Field Testing of Genetically
Modified Organisms, specified in the Third Schedule of the HSNO Act 1996.
1
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.
2
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA
New Zealand
3
Environmental Risk Management Authority Decision: Application GMC00020
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1.5
Appropriate labelling to avoid confusion during storage and use shall be clearly and
separately identify all genetically modified and non-modified carrots and potatoes.
1.6
All genetically modified and unmodified carrots and potatoes shall be stored in a labelled,
lockable storage unit including the refrigerator(s).
1.7
All possums in the feeding trial shall be individually identified by ear tags and tattoos for
visible identification.
1.8
All possums shall be kept for at least 16 days in the containment facility after the last dose
of genetically modified carrots or potatoes has been given before being transferred to the
outdoor pens.
1.9
The total amount of genetically modified carrots and potatoes to be imported at any one
time shall be up to 10kg per transformation group4, and up to 10kg per transformation
group of non-transformed carrots and potatoes.
1.10
The applicant shall maintain a register of the identity and fate of all possums in the
feeding trial as well as of all imported modified and unmodified carrot taproots and
potato tubers.
1.11
All biological material (including unused/uneaten potatoes and carrots, peelings, possums
and possum faecal material) shall be disposed of by autoclaving or incineration on site, or
off-site in a MAF approved and Regional Council licensed commercial incinerator in
secure containment to prevent any unintended release from containment. Transportation
shall be undertaken by drivers trained in the handling of dangerous goods (Hazard class
6.2). Possum urine shall be chemically treated (sterilised) prior to disposal.
1.12
All possums, potato tubers and carrot taproots no longer required at the conclusion of
the trial shall be disposed of by incineration or autoclaving. Under no circumstances shall
imported potato tubers, carrot taproots or possums involved in the feeding trial or parts
thereof be removed from containment or be consumed.
4
Transformation groups are:
Daucus carota sativus L. (carrot); Cultivar Nanco as modified by pTH110
Daucus carota sativus L. (carrot); Cultivar Nanco as modified by pGPTV-pAW4
Daucus carota sativus L. (carrot) Cultivar Nanco as modified by pGPTV-pAW4-A2
Daucus carota sativus L. (carrot) Cultivar Nanco as modified by pGPTV-pAW6
Solanum tuberosum L. (potato) as modified by pTH110
Solanum tuberosum L. (potato) as modified by pGPTV-pAW4
Solanum tuberosum L. (potato) Cultivar Frito-Lay 1607 as modified by pGPTV-pAW6
Solanum tuberosum L. (potato) Cultivar Frito-Lay 1607 as modified by pGPTV-pAW4-A2
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2.
To exclude unauthorised people from the facility:
2.1
The identification of entrances, numbers of and access to entrances, and security
requirements for the entrances and the facility shall be in compliance with the
requirements of the standards listed in control 1.3.
3.
To exclude other organisms from the facility and to control undesirable and
unwanted organisms within the facility:
3.1
The exclusion of other organisms from the facility and the control of undesirable and
unwanted organisms within the facility shall be in compliance with the standards listed in
control 1.3.
4.
To prevent unintended release of the organism by experimenters working with
the organism:
4.1
The prevention of unintended release of the organism by experimenters working with the
organism shall be in compliance with the standards listed in control 1.3.
5.
To control the effects of any accidental release or escape of an organism:
5.1
Control of the effects of any accidental release or escape of an organism shall be in
compliance with the standards listed in control 1.3.
5.2
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.
5.3
In the event of any breach of containment the contingency plan for the attempted
retrieval or destruction of any viable material of the organisms that have escaped shall be
implemented immediately. The contingency plan for carrots, potatoes and possums shall
be included in the containment manual in accordance with MAF/ERMA New Zealand
Standard 155.04.093: Containment Facilities for New Organisms (including genetically
modified organisms) of Plant species and MAF Regulatory Authority/ERMA New
Zealand (Animal Health and Welfare) Standard 154.03.033: Containment Facilities for
Vertebrate Laboratory Animals.
6.
Inspection and monitoring requirements for containment facilities:
6.1
The inspection and monitoring requirements for containment facilities shall be in
compliance with the standards listed in control 1.3.
6.2
The applicant shall notify ERMA New Zealand of the date and quantity of each import
of genetically modified and non-modified potato tubers and carrot taproots and of the
start date of the feeding trial.
6.3
The containment manuals shall be updated, as necessary, to address the implementation
of the controls imposed by this approval, in accordance with the standards listed in
control 1.3.
7.
Qualifications required of the persons responsible for implementing those
controls:
7.1
The training of personnel working in the facility shall be in compliance with the
standards listed in control 1.3.
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Signed on behalf of the Authority
Mrs Helen Hughes
Chair GMO Standing Committee
Date: 27 March 2001
Amendment: 16 November 2001
Amend control 1.3(c) by adding “animal house containment level 2 (PC2).
Mrs Helen Hughes Chair
Chair GMO Standing Committee
Date: 16 November 2001
Amendment: October 2006
GMC00020 decision amended to remove controls 6.4 requiring the applicant to provide a report
to ERMA New Zealand in each December on compliance with the controls outlined in this
approval, with particular reference to the topics listed in section 4.12 of the MAF/ERMA New
Zealand Standard 155.04.09: Containment Facilities for New Organisms (including genetically
modified organisms) of Plant species and section 4.10 of the MAF Regulatory Authority/ERMA
New Zealand (Animal Health and Welfare) Standard 154.03.03: Containment Facilities for
Vertebrate Laboratory Animals and 6.5 requiring the applicant to shall provide a final report of
the effectiveness of the containment controls to the Authority at the completion of the research
programme.
Dr Kieran Elborough
Chair GMO Standing Committee
Date: 13 November 2006
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
 Removal of the control regarding inspection of facilities by the Authority, its agent or
enforcement officers
____________________________
Dr Kieran Elborough
Chair, GMO Standing Committee
Environmental Risk Management Authority Decision: Application GMC00020
Date: 22 August 2007
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