Environmental Risk Management Authority Decision
Application Number
NOC99002
Consideration Date
12 August 1999
Considered by
Genetically Modified Organism (GMO)
Standing Committee of the Authority
Date
24 August 1999
Application Details
Applicant
Category
Purpose
Application Received
Landcare Research
Import into Containment any New Organism [section 40(1)(a)]
To import into containment genetically modified potato tubers
expressing an antigen, to determine if possums develop an immune
response upon feeding, with the long term view to producing an
immunocontraceptive vaccine for management of the brushtail possum.
15 June 1999
Decision
The application is Approved with Controls.
The organism approved is: Solanum tuberosum L. (potato); Cultivar: Frito-Lay 1607; Line:
TH110; Binary vector: pTH110; Phenotype: potato expresses and accumulates the plantoptimised B-subunit of Escherichia coli (E. coli) heat-labile enterotoxin.
Application Process
The application was formally received on 15 June 1999. The application was stalled on 28
June 1999, whilst additional information was sought from the applicant. The application
was verified on 8 July 1999.
The application was not required under the Act to be 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),
comments from other government agencies (Ministry of Agriculture and Forestry and
Department of Conservation), and comment provided by the National Science Strategy
Committee (NSSC) for Possum and Bovine Tuberculosis Control.
Relevant Legislative Criteria
The matters considered in making this decision comprise those set out in sections 37, 44
and 45 of the Hazardous Substances and New Organisms Act 1996, and those relevant
matters in 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 Act, the Committee was satisfied that the
application was for one of the purposes specified in section 39(1) of the Act. The
Committee concluded that, importation into containment for feeding trials on possums
to determine whether the possums develop an immune response to a foreign antigen (the
plant-optimised B-subunit of E. coli heat-labile enterotoxin, sLT-B) delivered in
transgenic potato, constitutes an appropriate purpose under section 39(1)(h) of the Act
being Such other purposes as the Authority sees fit.
Ability to Escape Containment
In accordance with section 44(b) the Committee considered the ability of the organism,
Solanum tuberosum L. (line pH110), to escape from containment.
The applicant proposes to contain the genetically modified potato tubers, until used in a
designated 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 would also be used for the storage and analysis of animal
samples. The animal facility, to house possums to be used in the feeding trial, is also a
designated 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.
Taking into account the proposed containment regime the Committee was satisfied that
the organism (and possums to be used in the feeding trial) could be adequately contained
in the facilities described.
Self-sustaining Populations, Eradication and Adverse Effects
In reaching its decision the Committee considered the ability of Solanum tuberosum L. (line
pH110) to establish undesirable self-sustaining populations and the ease with which any
such populations could be eradicated [section 37(a) and (b)], in the event of any escape
from containment.
The Committee considered the likelihood of the establishment of a self-sustaining
population of genetically modified potatoes to be low given the fact that potatoes are not
considered to be fully naturalised and generally only form transient populations outside
of a cultivated environment. The Committee also noted that no potato populations exist
within the immediate vicinity of the containment facility with which the genetically
modified potato tubers could outcross.
The Committee therefore concluded, taking into account the ease of eradication of the
organism, that, the risk of the establishment of a self-sustaining population that could not
be eradicated was very low.
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The committee noted that the B-subunit of E. coli heat-labile enterotoxin (LT-B) is
derived from enterotoxigenic E. coli, which can cause diarrhoea, however the B-subunit
(LT-B) is not able to cause disease in the absence of the enzymatically active protein, LTA. The LT-B subunit when isolated from LT-A has been shown to elicit an immune
response without any symptoms of disease.
The Committee therefore concluded that the possibility of any adverse effects on the
New Zealand environment is very low, should any genetically modified potato tubers (or
possums that have consumed tubers) escape and establish.
Inseparable Organisms
In accordance with section 45(a)(ii) the Committee considered the effects of any
inseparable organisms.
The Committee noted that the genetically modified and unmodified potato tubers to be
used in this trial will be imported from the USA, and prior to shipment will have all soil
residues removed and be subject to phytosanitary certification by the Animal and Plant
Health Inspection Service (APHIS) of the United States Department of Agriculture
(USDA).
The Committee considered that the containment regime, including the destruction of all
potato tubers, and treatment and disposal of all possum excreta, would ensure that any
associated organisms would be contained.
Negligible Risk
Based on the consideration and analysis of adverse effects to the environment, and
public health, and taking into account the containment proposals, the Committee
considered that the risks associated with the importation into containment of the
organism Solanum tuberosum L. (line pH110) are negligible.
Benefits
The Committee considered the benefits of the importation into containment of Solanum
tuberosum L. (line pH110), and identified the primary benefit as being the increased
knowledge regarding the potential for this type of technology to be utilised to develop a
successful mechanism for biological control of possums (immunocontraceptive).
The Committee did recognise the uncertainty associated with the proposed research
outcomes in terms of the development of a mechanism for biological control of possums
via immunocontraception. However, the Committee noted that ongoing research,
including this programme, will contribute to reducing the uncertainty about the feasibility
of this mechanism of contraceptive delivery, and therefore the longer term benefits of
this line of research.
Conclusion
The Committee concluded that, taking account of the ability of the organism, Solanum
tuberosum L. (line pH110) (and possums that have consumed the organism), to escape
from containment as in section 44(b) of the Act, the beneficial effects of having the
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organism in containment outweighed the likely adverse effects of the organism and any
inseparable organisms, should the organism escape.
Having considered 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 additional controls could adequately contain the organism.
Controls
In order to satisfactorily address the matters detailed in the Third Schedule Part I
Containment Controls for Development and Field Testing of Genetically Modified Organisms1 of the
Act, the Authority’s approval of this application is subject to the following controls:
1.
1.1
To limit the likelihood of any accidental release of any organism or any
viable genetic material2:
Genetically modified potato tubers shall be stored until used in facility operated,
constructed, and maintained in accordance with the:
a)
MAF Regulatory Authority standard 154.02.17: Transitional Facility for Biological
Products; and
b) Australian New Zealand standard AS/NZS 2243.3:1995 Safety in Laboratories:
Part 3: (Microbiology), at Laboratory Physical Containment Level 2 (PC2).
1.2
The Animal Facility shall be operated, constructed, and maintained in accordance
with the:
a)
MAF Regulatory Authority standard 154.02.17: Transitional Facility for Biological
Products;
b) Australian New Zealand standard AS/NZS 2243.3:1995 Safety in Laboratories:
Part 3: (Microbiology), at Animal House Physical Containment Level 2 (PC2);
c) MAF Regulatory Authority/ERMA New Zealand (Animal Health and
Welfare) Standard 154.03.03: Containment Facilities for Vertebrate Laboratory
Animals; and
d) Animal Welfare Advisory Committee (AWAC) and National Animal Ethics
Advisory Committee (NAEAC) guidelines administered by MAF.
1.3
To ensure security, access to the containment facilities shall be subject to regular
surveillance by authorised personnel.
1.4
All possums in the feeding trial shall be individually identified by ear tags for
visible identification.
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
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1.5
The applicant shall maintain a register of the identity and fate of all possums in the
feeding trial.
1.6
The applicant shall maintain a register of all imported transgenic and unmodified
potato tubers with records of fate of all imported potato tubers.
1.7
All possums and potato tubers no longer required at the conclusion of the trial
shall be disposed of by incineration or autoclaving. Under no circumstances shall
imported potato tubers or possums involved in the feeding trial or parts thereof be
consumed.
1.8
All biological material (including unused/uneaten potatoes, potato peelings,
possums and possum faecal material) shall be disposed of by autoclaving or
incineration on-site, or off-site incineration in a MAF approved and Regional
Council licensed commercial incinerator. All material shall be transported between
the containment facility and commercial incinerator in secure containment to
prevent any unintended release of material. 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.
2.
2.1
3.
To exclude unauthorised people from the facility:
The applicant shall comply with the requirements contained in the standards listed
in control 1.1 and 1.2 relating to identification of entrances, numbers of and access
to entrances, and security requirements for the entrances and the facility.
To exclude other organisms from the facility and to control undesirable
and unwanted organisms within the facility:
3.1
The applicant shall comply with the requirements contained in the standards listed
in control 1.1 and 1.2 relating to exclusion of other organisms from the facility and
the control of undesirable and unwanted organisms within the facility.
4.
To prevent unintended release of the organism by experimenters working
with the organism:
4.1
The applicants shall comply with the requirements contained in the standards listed
in control 1.1 and 1.2 relating to the prevention of unintended release of the
organism by experimenters working with the organism.
5.
To control the effects of any accidental release or escape of an organism:
5.1
The applicants shall comply with the requirements contained in the standards listed
in control 1.1 and 1.2 relating to the provision of an eradication plan to deal with
any escaped organisms.
5.2
If for any reason a breach of containment (of either potato tubers or possums
involved in the trial) occurs the applicant shall notify the facility Supervisor3, the
3
An inspector appointed under the Biosecurity Act.
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Ministry of Agriculture and Forestry and ERMA New Zealand immediately the
event is noticed (and at least within 24 hours of the breach being detected).
6.
Inspection and monitoring requirements for containment facilities:
6.1
The applicant shall notify ERMA New Zealand of the date of importation of
genetically modified potato tubers and of the start date of the feeding trial.
6.2
The Authority or its authorised agent or properly authorised enforcement officers,
may inspect the facilities at any reasonable time.
6.3
The applicant shall provide a final report of the effectiveness of the containment
controls to the Authority at the completion of the research programme.
7.
7.1
Qualifications required of the persons responsible for implementing those
controls:
The applicant shall inform all personnel involved in the experiments of the
Authority’s controls.
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