ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Date signed: 21 December 2001
Application code
GMC01007
Application
category
To import into containment any new organism under section
40(1)(a) of the Hazardous Substances and New Organisms (HSNO)
Act 1996
Applicant
AgResearch, Grasslands, Palmerston North
Purpose
To import into containment two knockout modifications of genetically
modified endophyte (Neotyphodium sp. strain Lp1) to study the roles
and activities of ergovaline biosynthesis and closely related metabolites
Date received
19 November 2001
Consideration date
19 December 2001
Considered by
The Genetically Modified Organisms Standing Committee of the
Environmental Risk Management Authority (the Authority)
Summary of Decision
The application to import into containment two knockout genetic modifications of the
endophyte Neotyphodium sp. strain Lp1 is approved, with controls (as listed in Annex 1 of
this decision) having been considered in accordance with the relevant provisions of the HSNO
Act and the HSNO (Methodology) Order 1988.
The organisms have been given the following unique identification codes for the ERMA New
Zealand Organism Register:

Neotyphodium sp., strain Lp1, dmaW-knockout

Neotyphodium sp., strain Lp1, IpsA-knockout
The two Neotyphodium sp., strain Lp1 isolates to be imported have been specifically modified
by homologous recombination to disable either a peptide synthetase gene (IpsA) or a
dimethylallyltryptophan gene (dmaW). Both of these genes are considered essential for the
production of ergovaline by the endophyte in ryegrass. These genes are disrupted by the
hygromycin phosphotransferase gene derived from Escherichia coli.
The endophytes will be imported in the form of pure cultures (suitable for preparing for
inoculation into new host plants), and in planta, ie within their symbiotic host plant, perennial
ryegrass Lolium perene L. (Family: Graminae; Tribe: Poaeae).
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 section 44, and matters relevant to the purpose of the Act, as specified under
Part II of the HSNO Act. Unless otherwise stated, references to section numbers in this
decision refer to sections of the HSNO Act.
Consideration of the application followed the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (the Methodology), as specified
in more detail below. Unless otherwise stated, references to clause numbers in this decision
refer to clauses of the Methodology.
Application Process
Application receipt
The application was formally received 19 November 2001. The organisms are defined as low
risk (category B) under the HSNO Low Risk Modifications Regulations 1998 and therefore
application receipt was not publicly notified, according to ERMA New Zealand policy.
In accordance with clauses 2(2)(e) and 5 of the Methodology and section 58(c) of the HSNO
Act the Department of Conservation (DoC) and Ministry of Agriculture and Forestry (MAF)
Biosecurity Authority were sent a copy of the application and provided comment for the
consideration process.
Information available for consideration
An Evaluation and Review (E&R) Report was prepared by ERMA New Zealand to assist and
support the Committee's decision-making. The E&R Report consolidated and evaluated the
relevant information in a format and sequence consistent with the decision-making
requirements of the HSNO Act and of the Methodology. Recognised techniques were used in
identifying, assessing, and evaluating the relevant information, as required under clause 24 of
the Methodology. Techniques for identifying and preparing information on risks, costs and
benefits were based on internal procedures as specified in the ERMA New Zealand Technical
Guide publications.
The documents available for the evaluation and review of the application by ERMA New
Zealand included the application; copies of key references cited in the application; copies of
the Containment Manuals for the AgResearch Plant Molecular Genetics Laboratory and
Glasshouse (Grasslands, Palmerston North site); and comments from the Department of
Conservation. MAF Biosecurity Authority did not have any specific comments on this
application.
Decision making Committee
The application was considered by the Genetically Modified Organism Standing Committee
of the Authority, appointed in accordance with section 19(2)(b) of the HSNO Act. The
Committee comprised the following members: Mrs Jill White (Chair), Mrs Helen Hughes and
Ms Jane Lancaster.
Environmental Risk Management Authority Decision: Application GMC01007
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Purpose of the Application
The purpose of the application is to use the two knockout genetic modifications of
Neotyphodium sp. strain Lp1, to study the comparative production of ergot alkaloids and
related metabolites by the genetically modified and unmodified endophytes, to improve
understanding of endophyte secondary metabolism, insect pest protection and risks of animal
toxicosis.
In accordance with section 45(1)(a)(i) of the HSNO Act, the Committee determined that the
purpose was appropriate under section 39(1)(h): Such other purposes as the Authority thinks
fit.
Consideration approach and sequence
In accordance with clause 24 of the Methodology, the approach adopted by the Committee
was to look sequentially at identification, assessment and evaluation of risks, costs and
benefits. The decision-making process is described in more detail in the following sections,
with reference to legislative requirements under the HSNO Act and Methodology.
Identification of the risks, costs and benefits
The Committee conducted an identification of potential risks, costs and benefits related to the
application, based on the requirements of the HSNO Act and the HSNO (Methodology)
Order. Risks, costs and benefits were categorised in terms of their area of impact on:

Environment

Human health and safety

Māori culture

Economy
Identification of risks
The Committee recognised the following potential risks associated with the application in
accordance with the Methodology clauses 9(a) and (c) (as specified in section 5 of the E&R
Report):
Risks to the environment

Risks associated with horizontal gene transfer to other organisms (including
hybridisation with other plant fungi).

Risks associated with the importation of plant diseases with the live perennial
ryegrass.

Risks associated with development of endophytes with enhanced toxicity to grazing
animals.

Risks of enhanced weediness of perennial ryegrass infected with genetically
modified endophytes.
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Risks to human health and safety

Risks to human health and safety, through allegenicity or toxicity of the genetically
modified endophytes.
Risks to Māori culture

Risks to relationship of Māori and their culture and traditions with taonga associated
with the importation and use of genetically modifed endophytes, including potential
feeding trials involving native or valued fauna.
Risks to the economy
Refer to costs associated with the application, below.
Identification of benefits and costs
The Committee recognised the following potential benefits and costs associated with the
application, in accordance with the Methodology clauses 9, 10, 13, and 14 and section 6(e) of
the HSNO Act (as specified in section 7.4 of the E&R Report):

Maintaining international standing and leadership in Neotyphodium endophyte
research.

The applicant’s ability to attract funding and indirect support, for example through
international collaboration, for their research.

Improved knowledge of the impact of ergovaline biosynthesis disruption upon other
aspects of the endophyte-grass symbiosis.

Development of endophytes with benefits for animal health and improved pasture
productivity in New Zealand.

Costs to the agricultural industry if perennial ryegrass containing the genetically
modified endophytes escaped and established a self-sustaining population.
Adequacy of the proposed containment
In assessing risks, the adequacy of the containment regime was considered (section
45(1)(a)(iii) of the HSNO Act) in relation to the ability of the organisms to escape
containment; form self-sustaining populations, and the ease of eradication of any such
populations (sections 37 and 44). Risk management techniques were considered in relation to
the identified risks (clause 24).
Ability to escape containment
The Committee considers that the organisms to be imported would, if developed in New
Zealand, meet the characteristics of Category B experiments under the HSNO (Low-Risk
Genetic Modification) Regulations 1998. Experiments are thus required to be conducted, and
the genetically modified organisms contained, under Physical Containment Level 2 (PC2)
laboratory and plant house conditions, as specified under the Australian/New Zealand
Standard AS/NZS 2243.3:1995 Safety in Laboratories: Part 3: Microbiology (refer to Controls
1.1 and 1.2 in Annex 1 of this decision).
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The Committee notes that the perennial ryegrass plants containing modified endophytes will
be maintained in the AgResearch Plant Breeding and Genomics Containment Glasshouses in
Palmerston North (MAF reference code 3255). These glasshouses are registered under joint
MAF Biosecurity Authority/ERMA New Zealand Containment Standard 154.04.09 (plant
house) and meet PC2 requirements.
The Committee also notes that the modified endophytes will be cultured, manipulated,
inoculated into ryegrass seedlings, harvested and extracted in the AgResearch Plant Molecular
Genetics Laboratory in Palmerston North (MAF reference code 482). This laboratory is
registered at PC2 under joint MAF Biosecurity Authority/ERMA New Zealand Containment
Standards 154.02.17 (transitional facilities for biological products), and 154.03.02
(microorganisms).
The Committee notes that procedures are set out to prevent accidental removal of plant
material outside the glasshouse on personal clothing, in AgResearch's glasshouse containment
manual. However, the Committee notes the absence of specific reference to accidental
removal of genetically modified material on clothing, in AgResearch's microorganism facility
containment manual. The Committee has added, therefore, an additional control to reduce the
risk of accidental removal from containment on clothing of seeds or other plant material
containing modified endophytes (refer to Control 1.8, Annex 1 of this decision). Additional
Controls 1.3 to 1.7 inclusive (refer to Annex 1 of this decision) relate to plant handling
practices and are also intended to reduce risks of escape from containment of genetically
modified material.
The applicant signalled an intention to evaluate the effects of genetic modifications on plants
in feeding trials involving contained insects and other invertebrate microfauna (such as mites
and nematodes). However, the applicant states that the detail of these trials is yet to be
defined. In the absence from the application of a description of the feeding trials, the
Committee imposes an additional control requiring details of the feeding trials to be approved
by the Authority before the trials commence (refer to Control 1.9, Annex 1 of this decision).
The Committee also imposes other additional controls to minimise risks of escape of
genetically modified material from containment during, or as a consequence of feeding trials,
should the feeding trials be conducted (refer to Controls 1.10 to 1.12, Annex 1 of this
decision).
Furthermore, the Committee excludes native invertebrates and all vertebrates (ie native or
exotic) from use in any feeding trials. Should the applicant wish to include such organisms in
feeding trials, a Grounds for Reassessment request (under section 62(1) of the HSNO Act)
would need to be submitted to ERMA New Zealand, and any consequent Reassessment
application (under section 63(1) of the HSNO Act) approved by the Authority (refer to
additional Controls 1.13 and 1.14, Annex 1 of this decision).
The Committee considers that with the containment controls it has imposed (refer to Annex 1
of this decision), it is very unlikely for viable genetically modified endophyte (including seeds
or plants containing endophyte) to escape or be removed inadvertently from containment.
The Committee requires the applicant to submit a report to ERMA New Zealand, by 31
December 2004, describing any unanticipated adverse effects associated with the genetically
modified endophytes (refer to additional Control 8.2, Annex 1 of this decision).
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Ability of the organisms to establish an undesirable self-sustaining population
and ease of eradication
In accordance with sections 44 and 37 of the HSNO Act, the Authority considered the ability
of the organisms to establish undesirable self-sustaining populations, should they escape from
containment, and the ease with which such populations could be eradicated. In evaluating
these matters the Committee took into account the nature of the organisms (clause 22 of the
Methodology).
The Committee concurs with the E&R Report (section 6.21), that if the modified endophyte
material alone escaped, it is very unlikely to survive in nature, and very unlikely to infect
suitable host plants and establish a self-sustaining population. If viable plant material
containing viable modified endophyte escaped, then it may be equally likely or unlikely for
plants containing the endophyte to establish, depending on whether or not the viable plant
material settles in a location suitable for establishment. The magnitude of the effects would be
minimal or minor, as any increased adverse effects on livestock or increased weedy ability
would be likely to be able to be rapidly noticed and infected patches of grass could be
removed or destroyed. However, the Committee also noted that if seeds or viable plant
material established then it is likely that it would not be able to be detected if no adverse
effects occurred or loss from containment was not noticed. Therefore, the containment
controls associated with this approval are to ensure that inadvertent loss of material from
containment is very unlikely.
Assessment of risks
The Committee concluded that taking into account the containment controls imposed in this
decision, the application poses negligible risks. In reaching this conclusion, the Committee
gave particular regard (under clauses 9, 10 and 12 of the Methodology) to:
Risks to the environment
The Committee considers that it is very unlikely that adverse environmental effects would
result from having the genetically modified endophytes in containment (based on the
assessment provided in section 7.1 of the E&R Report). It is expected that the modified
endophytes would exhibit less toxicity than the unmodified parental strains, although there is
uncertainty associated with this because the effect of disruption in the metabolic pathway has
not yet been well studied. The work proposed by the applicant would reduce this uncertainty.
The Committee also noted the expectation of the applicant that plants containing modified
endophyte with reduced insect feeding ability may be less able to establish and so be very
unlikely to have increased weediness. The Committee considers that there is uncertainty
associated with this, but that research proposed by the applicant will reduce this uncertainty,
and so long as the plant material infected with the endophyte remains in containment it is very
unlikely for adverse effects on the environment due to altered weedy potential to occur.
It is also considered very unlikely, due to the controlled and contained nature of the
experiments that escape from containment and/or adverse effects on the environment would
result from horizontal gene transfer since both fungal, plant, and animal material is to be
contained at all times, and viable genetically modified material destroyed when no longer
required.
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The Committee considered the potential for importation of plant diseases when plant material
containing the genetically modified endophyte is imported. As required under the Biosecurity
Act normal phytosanitary and quarantine procedures are required during importation. As such
the Committee considers that the risks associated with importation of plants containing
genetically modified endophyte are very unlikely to be different from those associated with
importation of other viable plant or fungal material.
The Committee considers it unlikely that adverse effects on native or valued flora and fauna
would occur if the modified endophytes established outside containment, although there will
be uncertainty associated with this until the effects of the modified ryegrass endophytes are
tested by the proposed research. As noted above, increased adverse effects on livestock are
likely to be able to be rapidly detected and infected plants could be removed or destroyed.
Therefore the Committee considers that the magnitude of any adverse effects on native or
valued flora and fauna would be minimal or minor in the event of escape from containment.
Risks to human health and safety
The Committee considers that it is very unlikely that the import and use of genetically
modified endophytes would have any adverse effects on human health and safety (based on
the assessment provided in section 7.2 of the E&R Report). In the very unlikely event that
adverse effects were realised, they would probably be local (ie limited to research staff) and
treatable, so that the magnitude of effect would be minimal.
Risks to Māori culture
The Committee considers the import and use of the genetically modified endophytes is very
unlikely to have any adverse effects on Māori and their taonga (based on the assessment
provided in section 7.3 of the E&R Report).
The Committee notes that feeding trials involving insects and other invertebrate microfauna
may be conducted in the future (refer to E&R Report sections 6.10 and 6.11). The Committee
considers that if native invertebrates (such as grass grub beetles or larvae) are to be used in
feeding studies, the applicant should consult with local hapu on this issue during the research
planning stage. As noted above, the Committee considers that native invertebrates should be
excluded from any approval given at this stage. Consequently, if the applicant wishes to
include native invertebrates in any future feeding trials, a Grounds for Reassessment request
would need to be submitted to ERMA New Zealand (refer to additional Control 1.13, Annex
1 of this decision). It would be appropriate to provide results of consultation with local Māori
groups in any application for reassessment. Similarly, a Grounds for Reassessment request
would be required for any proposed feeding trials that involve either native or exotic
vertebrates (refer to Control 1.14, Annex 1 of this decision).
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Assessment of benefits and costs
Benefits1 that may arise from the application (regarding matters set out in clauses 9 and 10 of
the Methodology) were assessed and considered in terms of clauses 13 and 14. The
Committee concurs with the assessment provided in section 7.4 of the E&R Report, that the
primary benefit of the importation of the genetically modified endophytes is likely to be the
increase in scientific knowledge (non-monetary). An objective of the research is to improve
knowledge of the impact of ergovaline biosynthesis disruption upon other aspects of the
endophyte-grass symbiosis. Longer-term objectives include development of improved
endophyte strains, which the applicant states could have major benefits for animal health and
improved pasture productivity in New Zealand. The Committee notes the uncertain nature of
such potential long-term benefits.
The Committee considers that economic costs in the event of escape of the genetically
modified material are very unlikely and would have minimal or minor impacts, based on the
assessment provided in sections 7.1 and 7.4 of the E&R Report.
The Committee considers that the primary benefits associated with this application are likely
to be non-monetary and that no additional costs2 are likely to be imposed on third parties.
Overall evaluation of risks, costs and benefits
In accordance with clauses 21 and 36(2)(b) of the Methodology, the Committee records that
the following criteria in the HSNO Act and Methodology have been particularly relied on:
1
The Committee has considered the application in the context of the purpose and
principles of the HSNO Act (sections 4 - 8 inclusive of the HSNO Act).
2
Pursuant to section 45(1)(a)(i) of the HSNO Act, the Committee is satisfied that this
application is for one of the purposes specified in section 39(1) of the Act, being section
39(1)(h): Such other purposes the Authority sees fit.
3
In evaluating risks, costs and benefits the following information has been taken into
account (in accordance with clause 22 of the Methodology): (i) the nature and
characteristics of the organism, (ii) the applicant's assessments and risk management
proposals, and (iii) the Evaluation and Review (E&R) Report provided for ERMA New
Zealand (which was collated using a recognised risk management process in accordance
with clause 24 of the Methodology).
4
The Committee has recognised and taken into account hazards and areas of impact as
listed in clauses 9 and 10 of the Methodology, particularly in relation to evaluating
adverse and beneficial effects on the environment, human health, economy and Māori
culture.
5
The Committee has taken into account the characteristics of risks, costs and benefits in
accordance with clauses 12, 13 and 34 of the Methodology, particularly in relation to the
nature, likelihood, magnitude and spread of adverse and beneficial effects.
A “benefit” is defined in regulation 2 of the Methodology Order as “the value of a particular positive effect
expressed in monetary or non-monetary terms”.
1
A “cost” is defined in regulation 2 of the Methodology Order as “the value of a particular adverse effect
expressed in monetary or non-monetary terms”.
2
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6
The degree of uncertainty attached to scientific evidence relating to risks has been
considered in accordance with clause 25 of the Methodology.
7
In its approach to risk, the Committee had regard to the risk characteristics set down in
clause 33 of the Methodology, and concluded that none of the characteristics listed in
clause 33(a) – (e) applied to this application.
8
The Committee is satisfied that the organisms can be adequately contained (sections
45(1)(a)(iii) and 44(b) of the HSNO Act), under the controls required by this decision
(refer to Annex 1). In relation to the additional matters to be considered under section 37
of the HSNO Act, the Committee considers that it is very unlikely for viable genetically
modified endophyte (including seeds or plants containing endophyte) to escape or be
removed inadvertently from containment and form a self-sustaining population.
However, the Committee notes that eradication, while technically feasible, would depend
on the ability to detect any breach of containment and the subsequent location of any selfsustaining population.
9
The Committee has formed the view that risks associated with the application are
negligible. In noting the above conclusion that the organisms can be adequately contained
under the controls required by this decision, the Committee considers the benefits
associated with the importation and use of the organisms in containment outweigh the
costs. The Committee has therefore considered this application in terms of clause 26 of
the Methodology. In reaching this conclusion, the Committee considered all the possible
beneficial and adverse effects of the organisms (and any inseparable organisms) in
accordance with sections 45(1)(a)(ii) and (iii) of the HSNO Act.
Decision
The application for importation into containment of two knockout modifications of
genetically modified endophyte (Neotyphodium sp. strain Lp1) is thus approved in
accordance with section 45(a) of the HSNO Act. As required under section 45(2) the approval
is subject to controls (as listed in Annex 1 of this decision).
The Committee accepts the advice from ERMA New Zealand (refer to E&R Report, section
6.18) that it would be appropriate to impose a three-year time limit on this approval.
Accordingly, approval to import, in terms of this decision, is valid until 31 December 2004
(refer to additional Control 8.1, Annex 1).
Mrs Jill White
Chair, Decision-making Committee of the Authority
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Date
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Annex 1: Controls required by this approval
In order to satisfactorily address the matters detailed in the Third Schedule Part I:
Containment controls for importing, developing or field testing of genetically modified
organisms3 of the HSNO Act, and other matters in order to give effect to the purpose of the
HSNO Act (section 45(2)), 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 material4:
1.1
The person responsible for a particular research area 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 facility in which the organisms are maintained shall be registered by
the Ministry of Agriculture and Forestry (MAF) Biosecurity Authority in accordance
with the MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.02
(Containment Facilities for Microorganisms), at microorganism Physical Containment
Level 2 (PC2); and MAF/ERMA New Zealand Standard 155.04.09 (Containment
Facilities for New organisms (including genetically modified organisms) of plant
species), at plant house Physical Containment Level 2 (PC2), and the additional controls
of the Authority. The construction and operation of the containment facilities (‘the
facility’) in which the organisms are maintained, shall be in accordance with the
relevant standards listed above.
Additional controls relating to plant handling:
1.3
Plants containing the genetically modified endophytes shall be clearly labelled.
1.4
All plants containing genetically modified endophyte shall be monitored weekly during
the flowering season to check for development of reproductive structures.
1.5
Prior to flower maturation the reproductive structures shall be removed or the plants or
reproductive structures securely covered with an appropriate material to ensure that
escape of pollen and seeds does not occur.
1.6
Seeds and other plant material required for further analysis shall be collected and
securely stored and transported in sealed containers.
1.7
Soil, containers or dishes in which plants containing genetically modified endophytes
are grown, and surfaces which may have been exposed to seeds or plants containing
modified endophytes shall be sterilised after use.
1.8
Laboratory coats without pockets are to be worn by all people within containment
facilities containing genetically modified endophytes. These coats are to be removed
and left within the containment area by people leaving the containment facilities.
3
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.
4
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,
e.g. when organisms or parts thereof are sublethally damaged by being frozen, dried, heated, or affected by
chemical.
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Additional controls relating to invertebrate feeding trials:
1.9
Procedures to be followed in invertebrate feeding trails, including identity and numbers
of invertebrates to be used, shall be submitted to ERMA New Zealand. Any such trials
cannot commence without written approval from the Authority (refer also to control
1.13 regarding native invertebrates).
1.10 In the event that invertebrate feeding trials are conducted on the genetically modified
material: the test invertebrates, genetically modified fungi, and plant material containing
genetically modified fungi shall be securely contained in registered containment
facilities [154.03.02 (microorganism) or 155.04.09 (plant house)] in an appropriate
manner such that the organisms are unable to escape.
1.11 After the feeding trials, invertebrates shall be released or disposed of in such a manner
that prevents release of viable genetically modified endophyte from containment. This
shall include a prohibition on removing live invertebrates from the containment facility
until they have spent at least 24 hours on a diet of non-genetically modified food.
1.12 All biological material no longer required (including unused/uneaten endophyte and
endophyte-infected plant material) shall be disposed of by autoclaving or incineration
on site.
1.13 Native invertebrates are excluded from use in any feeding trials involving genetically
modified material associated with this approval. In the event that the applicant wishes to
include native invertebrates in feeding trials, a Grounds for Reassessment request would
need to be submitted to ERMA New Zealand (under section 62(1) of the HSNO Act)
seeking such approval.
1.14 Vertebrates are excluded from use in any feeding trials involving genetically modified
material associated with this approval. In the event that the applicant wishes to include
vertebrates in feeding trials, a Grounds for Reassessment request would need to be
submitted to ERMA New Zealand (under section 62(1) of the HSNO Act) seeking such
approval.
2
To exclude unauthorised people from the facility:
2.1
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.2 relating to the identification of
entrances, numbers of and access to entrances and security requirements for the
entrances and the facility.
3
To exclude other organisms from the facility and to control undesirable and
unwanted organisms within the facility:
3.1
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.2 relating to the 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
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.2 relating to the prevention of
unintended release of the organisms by experimenters working with the organisms.
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5
To control the effects of any accidental release or escape of an organism:
5.1
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.2 relating to controlling the effects of
any accidental release or escape of an organism.
5.1
If for any reason a breach of containment occurs, the facility Supervisor5, MAF
Biosecurity Authority and ERMA New Zealand shall be notified immediately the event
is noticed (and at least within 24 hours of the breach being detected).
5.2
In the event of any breach of containment of the organisms, the contingency plan for the
attempted retrieval or destruction of any viable material of the organism that has
escaped shall be implemented immediately. The contingency plan shall be included in
the containment manual in accordance with the requirements of standards listed in
control 1.2.
6
Inspection and monitoring requirements for containment facilities:
6.1
The operation of the containment facilities shall comply with the requirements
contained in the standards listed in control 1.2 relating to the inspection and monitoring
requirements for containment facilities.
6.2
The Authority, or its authorised agent or properly authorised enforcement officers, may
inspect the facilities at any reasonable time.
6.3
The containment manual shall be updated, as necessary, to address the implementation
of the controls imposed by this approval, in accordance with the Standards listed in
control 1.2.
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 1.2.
8
Other matters:
Additional controls:
8.1
This import approval is valid until 31 December 2004. At this time, any genetically
modified endophyte material already imported can continue to be held in containment
under the controls specified in this approval.
8.2
On, or before, 31 December 2004 a report shall be submitted to ERMA New Zealand by
the applicant, describing whether or not any unanticipated adverse effects associated
with the genetically modified endophytes were observed. Any such effects shall be
described along with inferences about their cause and any actions taken to manage the
adverse effects.
5
An inspector appointed under the Biosecurity Act.
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