ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under s67A on 01 February 2005 and 22 August 2007
Date Signed: 23 June 2004
Application code:
GMD03105
Application category:
Develop in Containment any New Organism under the
Hazardous Substances and New Organisms (HSNO) Act
1996
Applicant:
AgResearch Limited
Private Bag 3123
HAMILTON 2001
Applicant contact:
Allan Nixon
Purpose:
To ascertain in containment, the functions of genes
associated with growth of hair and skeletal and cardiac
muscle, by altering the expression of those genes in
animal cells and tissues using replication-deficient viral
vectors.
Date application received
26 April 2004
Consideration date:
8 June 2004
Considered by:
Committee of the Authority
1
Summary of Decision
The application to develop in containment the organisms as listed in Table 1: has been
approved with controls, having been considered in accordance with the relevant
provisions of the Hazardous Substances and New Organisms Act 1996 (the HSNO
Act) and the HSNO (Methodology) Order 1998 (the Methodology).
Table 1: Approved organisms
Host Organism
modified by the
vector and Donor
DNA on the right
Vector and Donor DNA
Homo sapiens cell
lines (293 derivatives,
911, PER.C6)
(GMD03105)
Modified by recombinant mammalian expression plasmids and retroviral
(including lentiviral) or adenoviral plasmids containing genetic material1
from sheep, cattle, human2 or mouse involved in cell survival, cell
proliferation, cell differentiation/maturation and development of muscle,
skin and hair including:
Mus musculus cell
lines (NIH 3T3
derivatives)
(GMD03105)
1. growth factors
2. developmental regulators
3. hormone receptors
4. cell adhesion molecules
5. cell survival and cell cycle associated genes
6. transcription factors
7. other genes involved in regulating the cell proliferation,
differentiation, survival or development of muscle, skin and hair.
Colourimetric and fluorescent reporter genes
Selectable markers
The cDNA sequences described above may have regulatory or
localisation sequences fused to them such as:

Protein tags including histidine (His), FLAG, V5 epitope and Lumio
hexameric protein tag.

Promoters including CMV, UbC, MMLV 5’LTR, keratin 14,
myostatin, myosin light chain, muscle creatine kinase, RSV, U6

Regulatory elements/systems including polyadenylation signals,
internal ribosomal entry sites, recombination sites, ecdysone
regulated system, tetracycline regulated system.

Other commercially available promoter or regulatory elements.
1
sense cDNAs, sense constructs containing nucleotide substitution or deletions (to determine
functional domains), antisense and RNA interference sequences
2
Non-Māori only
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Host Organism
modified by the
vector and Donor
DNA on the right
Mus musculus cell
lines (primary and
immortalised)
(GMD03105)
Vector and Donor DNA
Modified by retroviral (including lentiviral) or adenoviral vectors containing
genetic material3 from sheep, cattle, human or mouse involved in cell
survival, cell proliferation, cell differentiation/maturation and development
of muscle, skin and hair including:
1. growth factors
2. developmental regulators
Homo sapiens cell
lines (primary and
immortalised)
(GMD03105)
3. hormone receptors
4. cell adhesion molecules
5. cell survival and cell cycle associated genes
Ovis aries cell lines
(primary and
immortalised)
(GMD03105)
6. transcription factors
7. other genes involved in regulating the cell proliferation,
differentiation, survival or development of muscle, skin and hair.
Rattus norvegicus cell
lines (primary and
immortalised)
(GMD03105)
Colourimetric and fluorescent reporter genes
Bos taurus cell lines
(primary and
immortalised)
(GMD03105)

Protein tags including histidine (His), FLAG, V5 epitope and Lumio
hexameric protein tag.

Promoters including CMV, UbC, MMLV 5’LTR, keratin 14,
myostatin, myosin light chain, muscle creatine kinase, RSV, U6

Regulatory elements/systems including polyadenylation signals,
internal ribosomal entry sites, recombination sites, ecdysone
regulated system, tetracycline regulated system.

Other commercially available promoter or regulatory elements.
Cricetulus griseus cell
lines (primary and
immortalised)
(GMD03105)
Selectable markers
The cDNA sequences described above may have regulatory or
localisation sequences fused to them such as:
Coturnix japonica cell
lines (primary and
immortalised)
(GMD03105)
Mus musculus
(GMD03105)
Rattus norvegicus
(GMD03105)
3
sense cDNAs, sense constructs containing nucleotide substitution or deletions (to determine
functional domains), antisense and RNA interference sequences.
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This application was required to be considered by the Authority as it included
developments that were considered “not low-risk” genetic modifications (clause 1(e)
of the Schedule of the HSNO (Low-Risk Genetic Modification) Regulations 2003)
involving “viral vectors whose host range includes human cells and that contain one
or more inserted nucleic acid sequence(s) coding for a product that can lead to
uncontrolled mammalian cellular proliferation or be toxic to mammalian cells, or
both”.
2
Legislative Criteria for Application
The application was lodged pursuant to section 40(1)(b) of the HSNO Act. The
decision was determined in accordance with section 45, and matters relevant to the
purpose of the HSNO Act, as specified under Part II of that 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 Methodology,
with particular regard to clauses 12 (dealing with assessment of risks) and 13 (dealing
with assessment of costs and benefits). Unless otherwise stated, references to clause
numbers in this decision refer to clauses of the Methodology.
Application Process
Application GMD03105 was formally received and verified on 26th April 2004 as
having adequate information for processing.
In accordance with section 58(c) of the HSNO Act and clause 5 of the Methodology
the Department of Conservation (DoC) and Ministry of Agriculture and Forestry
(MAF) were invited to comment on this application. There were no comments from
MAF. The response of DoC was included in Appendix 2 of the Evaluation and
Review (E&R) report.
Information Available for Consideration
The documents available for the consideration of the application by ERMA New
Zealand were:

Application GMD03105: develop within a containment structure any
genetically modified organism (other than by rapid assessment). The
application also included appendices.

E&R Report prepared by the Agency to assist and support the Committee's
decision-making.

Comments from DoC on the application.
The Committee considered the application and supporting information. The
Committee considered that the application was extremely comprehensive.
Recognised techniques were used in identifying, assessing, and evaluating the
relevant information, as required under clause 24 of the Methodology. Techniques for
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identifying and preparing information on risks, costs and benefits were based on
internal procedures as specified in the ERMA New Zealand Technical Guide
publications.
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 and clause 43 of the First Schedule. That Committee comprised the
following members: Associate Professor Marie Dziadek (Chair) and Dr Max
Suckling.
3
Sequence of the Consideration
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. Interposed with this was the consideration of the adequacy of
the proposed containment regime, and the ability of the organism to escape and to
form a self-sustaining population. Management techniques were considered in relation
to the identified risks (clause 24) and those risks identified as significant were
assessed (clause 12). Costs and benefits were assessed in accordance with clause 13 of
the Methodology.
Finally, taking account of the risk characteristics established in accordance with
clause 33 of the Methodology, the combined impact of risks, costs and benefits was
evaluated in accordance with clause 34.
Purpose of the Application
AgResearch Limited sought approval “to ascertain in containment, the functions of
genes associated with growth of hair and skeletal and cardiac muscle, by altering the
expression of those genes in animal cells and tissues using replication-deficient viral
vectors.”
In accordance with section 45(1)(a)(i) of the HSNO Act, the Committee determined
that the purpose was appropriate under 39(1)(a) of the HSNO Act: The development
of any genetically modified organism.
The Sequence of Steps in the Consideration
In accordance with clause 24 of the Methodology, the approach to the consideration
adopted by the Committee was to first examine the scope of the application, and the
range of organisms applied for, then to look sequentially at the identification,
assessment and evaluation of risks, costs and benefits. Qualitative scales used by the
Committee to measure likelihood and magnitude of risks, costs and benefits were
provided in Appendix 3 of the E&R report.
In assessing risks and costs, issues affecting the adequacy of the containment regime
and the potential for population establishment and population eradication were
considered (as required by sections 37 and 44 of the HSNO Act and clause 10(e) of
the Methodology). The containment regime was considered in the context of a risk
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management regime for controlling the identified risks and costs (clauses 12(d) and
24). In doing so, the Committee set controls to satisfactorily provide for the matters in
the Third Schedule (Part I) of the HSNO Act. It was then considered whether or not
there were any residual risks that required further consideration.
Benefits associated with this application were considered in accordance with clauses
9, 10, 13 and 14 of the Methodology and section 6(e) of the HSNO Act.
Scope of Application and Organism Description
The scope of the organisms subject to the approval is limited to that described above
in Table 1: Approved organisms.
This approval covers several stages of a development, resulting in the development of
genetically modified cell lines and rodents. These stages are:

Generation of recombinant adenoviral and retroviral (including lentiviral) vectors
in Homo sapiens and Mus musculus cell lines (PC2, Schedule 1(e) under HSNO
(Low-Risk Genetic Modification) Regulations 2003).

Genetic modification of mammalian and avian cell lines with adenoviral and
lentiviral vectors (PC2, Schedule 1(e) under HSNO (Low-Risk Genetic
Modification) Regulations 2003).

Genetic modification of rodents with adenoviral and lentiviral vectors (PC2,
Schedule 1(e) under HSNO (Low-Risk Genetic Modification) Regulations 2003).
The Committee noted the wide scope of donor DNA and acknowledged that there
would be some unknown genes used. The Committee considered that the risk was
minimised by using a step-wise approach of in vitro and then in vivo techniques.
The Committee noted the use of “any other commercially available promoter or
regulatory elements/systems yet to be developed”. The Committee considered that
commercially developed elements or systems would not notably change the overall
risk profile of the application.
The Committee noted that there was no intent to generate any germ-line genetic
changes in the rodents.
The Committee noted that the applicant was planning on using primary human cell
lines. However, these would be imported and not created in New Zealand.
4
Identification of potential adverse effects
The Committee identified risks and costs related to the application in accordance with
clauses 9 and 10 of the Methodology, which incorporate sections 5, 6, 8 and 43 of the
HSNO Act.
The Committee considered section 4 (Identification of potential risks, costs and
benefits) of the E&R report when carrying out the identification of potential adverse
and beneficial effects (risks, costs and benefits). The Committee did not identify any
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other potential adverse effects other than those outlined in section 4 of the E&R
report.
Adverse environmental effects
The Committee records that risks to the environment were considered, in accordance
with clauses 9(a)-9(c) and 10 of the Methodology. The Committee accepts the
conclusions reached in the E&R Report that the development and use of the
organisms in containment is very unlikely to pose significant risks to the environment.
The Committee considered that risks to the environment discussed within the E&R
report to be negligible and no further consideration of these aspects was warranted.
Māori and their culture and traditions
The Committee considered the potential adverse Māori cultural effects and noted
sections 4.1 and 6.40 – 6.46 of the E&R Report. The Committee considered the
potential cultural effects in accordance with clauses 9(b) and 9(c)(iv) of the
Methodology and sections 5(b), 6(d) and 8 of the HSNO Act.
The Committee noted that the applicant had undertaken consultation with Ngāti
Wairere and Te Kotuku Whenua consultants and as a result of the consultation, no
unresolved issues remained. The Committee accepts the conclusions reached in the
E&R Report that potential risks to the whakapapa, mauri and tapu of native or valued
fauna caused by the regeneration, escape and transfer of recombinant viral vectors
would be minimal in magnitude and highly improbable in likelihood. The Committee
considered the risks posed to Māori to be negligible. Therefore, no further
consideration of these effects was warranted.
Adverse effects on human health and safety
The Committee identified that adverse health effects on human health and safety due
to occupational exposure was a potentially significant adverse effect in accordance
with clauses 9 and 10 of the Methodology and is further discussed in section 6 of this
decision document.
Adverse effects to society and the community
The Committee considered that no adverse effects to society and community were
identified that were not more comprehensively covered in other sections of the
consideration. Therefore, no further consideration of these aspects was warranted.
Adverse effects on the economy
The Committee records that adverse effects on the economy were considered in
accordance with clauses 9(a)-9(c) and 10 of the Methodology. The Committee accepts
the conclusions reached in the E&R Report, that risk of these adverse effects is
negligible; therefore, no further consideration of these aspects was warranted.
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5
Adequacy of the Proposed Containment Regime
In assessing risks and costs, the Committee considered issues affecting the adequacy
of the containment regime (in accordance with section 45(1)(a) of the HSNO Act); the
potential for population establishment and population eradication (sections 37 and 44
of the HSNO Act and clauses 10(e) and 10(f) of the Methodology); and other matters
in order to give effect to the purpose of the HSNO Act (section 45(2)(b)). Risk
management techniques were used in relation to the identified risks and costs (clauses
12(d) and 24 of the Methodology). As such, the assessment of risks and costs (refer to
section 7 of this decision) was taken into account in setting the containment
requirements that are discussed in this section.
Ability to adequately contain the organism
In considering the ability of the organism to escape from containment, the Committee
considered the:
i.
biological characteristics of the organism
ii. potential pathways for escape of the organism from the containment
facility
iii. proposed containment regime
iv. ability of the organism to establish a self-sustaining population.
The controls imposed by this approval (as specified in Appendix 1) address the
matters detailed in the Third Schedule Part I of the HSNO Act: Matters to be
addressed by containment controls for importing, developing or field testing of
genetically modified organisms under the Act. Additional controls to give effect to the
purpose of the HSNO Act have also been included. These controls incorporate the
requirement for managing risks and costs (under clauses 12(d) and 24 of the
Methodology) posed by the genetically modified viral vectors, cell lines and rodents
subject to this approval. The controls have been imposed to ensure that exposure of
laboratory workers and other persons, and the outside environment, to risks and costs
posed by the organisms is negligible.
The Committee examined the information supplied by the applicant explaining how
operation of the facility worked while work with viral vectors was being undertaken.
Procedures to be followed included, vectors would be separated temporally and the
same work would be conducted in series for each viral vector type with
decontamination procedures between. The Committee agreed that the applicant’s
procedures in place for the operation of the PC2 laboratory were satisfactory and only
temporal separation was necessary as the applicant was not intending to work with
more than one viral vector at a time. The Committee noted that the applicant was
planning on manufacturing the recombinant viruses, purifying and then storing them
in a freezer. Therefore, the Committee considered it highly improbable that
recombination could occur between different viral vectors and did not require the
applicant to monitor for undesired recombination events
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Ability of Organism to Establish a Self-sustaining Population and the
Ease of Eradication
In accordance with sections 44 and 37 of the HSNO Act the Committee considered
the ability of the organism to establish undesirable self-sustaining populations, should
it escape from containment and the ease with which such populations could be
eradicated.
The Committee considers that with the containment controls it has imposed (refer to
Appendix 1 of this decision); it is highly improbable for the cell lines or rodents
modified with viral vectors to escape or to be removed inadvertently from the
containment facility and to establish self-sustaining populations.
6
Assessment of the Risks, Costs and Benefits
The potential risks and costs assessed here are those identified as significant, having
regard for those matters set out in clauses 9 and 10 of the Methodology. Risks were
considered in terms of the requirements of clause 12 of the Methodology, including
the assessment of consequences and probabilities, the impact of uncertainty and the
impact of risk management. Costs were considered in terms of clause 13 of the
Methodology.
The evidence available was scientific in nature and was considered in terms of clause
25(1) of the Methodology. This evidence comprised principally that provided by the
applicant and additional evidence set out in the E&R Report.
In section 4 above, the Committee identified a potentially significant adverse effect on
human health and safety from viral vectors infecting laboratory workers via accidental
injection or inhalation of aerosols. What follows is the assessment of those adverse
effects.
Potential adverse effects to human health and safety
The Committee considered the adverse health and safety effects due to occupational
exposure in accordance with clauses 12, 13 and 14 of the Methodology. The degree of
uncertainty attached to the evidence is taken into account, as required under clauses
25(1), 29, 30, 32 and 33 of the Methodology.
The Committee considered the E&R report (sections 6.19 to 6.35) to contain an
excellent analysis of the potential adverse effects on human health and safety resulting
from occupational exposure to recombinant viral vectors. The Committee considers
that in the event of an inadvertent injection of viral particles, the low viral titre and the
replication defective nature of the virus used in this study, will limit the effects to a
minimum and the infection will be localised to the injection site. Further, the
Committee noted that a person experienced with the use of viruses or recombinant
viral vectors shall maintain oversight of the experiments, and shall organise training
for staff in best practice procedures for risk reduction (additional control 8.1,
Appendix 1 of this document).
The Committee agrees with the E&R report (section 5.13) that the oversight of the
experiments proposed in this application by a scientist experienced with the use of
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recombinant viral vectors will reduce the occupational health risk to staff (additional
control 8.1, Appendix 1 of this document).
The Committee agreed with the E&R report (section 5.21) that the use of a class II
biological safety cabinet as mentioned in additional control 8.2 (see Appendix 1 of
this document) should minimise the risk to laboratory workers.
The Committee agreed with the E&R report (section 5.42-5.44) that in order to
minimise the risk of accidental colonisation of workers with infected cell lines,
laboratory workers should not infect cultures of their own cells, nor, as a general rule,
those of their immediate family or other members of the laboratory (additional control
8.3 , Appendix 1 of this document).The Committee agreed with the E&R report
(section 5.50) that it will be highly improbable laboratory personnel will be infected
during this work if there is strict adherence to the containment standards and
additional controls. Therefore, taking in account the controls (particularly the
additional controls) they considered that the risk of potential adverse effect to human
health and safety as a result of occupational exposure to recombinant viral vectors to
be negligible.
Assessment of Costs
A “cost” is defined in clause 2 of the Methodology as “the value of a particular
adverse effect expressed in monetary or non-monetary terms”. The Committee did not
identify any costs that would be incurred by the approval of the application other than
those to the applicant.
Assessment of benefits (beneficial effects)
The Committee agreed with the E&R report and identified the following benefits
associated with the application, in accordance with the Methodology clauses 9, 10, 13
and 14, and section 6(e) of the HSNO Act:
The Committee considered that the direct benefits of this application are those of
gains in scientific knowledge and scientific reputation and standing for the
researchers. The Committee considered that these benefits are very likely to occur
based on the applicant’s track record in securing grants and funding and their
publications in top-tier peer-reviewed scientific journals. Also, the Committee
considered that these benefits will be shared between the applicant, who may secure
international collaborations or attract grant funding as a result, and the greater
scientific community when the results of the research are published and become
available in the public domain. However, the Committee note that these benefits are
research-based and the outcomes cannot be defined with a great deal of certainty.
The Committee considers that potentially the research could have significant nonmonetary benefits for human health in the long-term if the applicant was able to
develop novel therapeutic strategies for treatment or, to enhance recovery from
muscle or skin disorders. The diseases the researchers are attempting to develop
therapy strategies for are serious diseases and any scientific breakthrough that
contributed to some type of therapy to alleviate these conditions would be of major
benefit to the community. However, the Committee notes that there is a large degree
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of uncertainty surrounding expected long-term non-monetary benefits, as it depends
on how successful the research is and on a number of other factors.
The Committee noted that potentially the research could have significant nonmonetary benefits for animal welfare in the long-term if they were able to develop
products that maintain healthy muscle mass and improve distribution of the fleece in
farm animals (section 6.50 of the E&R report). The Committee noted there is a large
degree of uncertainty surrounding these potential long-term benefits and that there
was insufficient information at this stage in the research to determine the likelihood or
magnitude of such long-term benefits.
7
Establishment of the Approach to Risk in the Light of
Risk Characteristics
Clause 33 of the Methodology requires the Authority to have regard to the extent to
which a specified set of risk characteristics exist when considering applications. This
provision provides a route for determining how cautious or risk averse the Authority
should be in weighing up risks and costs against benefits. In the present application,
clause 33 is influenced by the application being “in containment” and the conclusion
drawn is that the containment provisions and other controls will reduce most
biological and physical risks to a low level.
In relation to the biological and physical risks considered, the containment measures
limit the extent to which exposure to the risks is involuntary. Given the Committee's
finding that the risk of this occurring is highly improbable, the extent to which these
risk characteristics are present does not warrant caution additional to that required by
section 7 of the Act.
8
Other matters
The Committee considered that no other matters were relevant in setting controls
outside the Third Schedule, in order to give effect to the purpose of the HSNO Act (in
accordance with section 45(2)(b)).
9
International and related matters
The Committee considered there were no international obligations relevant to this
approval in accordance with clause 9(c)(vi) of the Methodology and section 6(f) of the
HSNO Act.
10
Overall Evaluation of Risk, Costs and Benefits
In reaching its decision on this application, the Committee records that the following
criteria in the HSNO Act and the Methodology have been particularly relied on (in
accordance with clauses 21 and 36(2)(b) of the Methodology):
The application has been considered in the context of the purpose and principles of
the HSNO Act (sections 4-8 inclusive).
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Pursuant to section 45(1)(a)(i) of the HSNO Act, the Committee is satisfied that the
purpose of the application falls under section 39(1)(a): the development of any
genetically modified organism.
In accordance with section 45 of the HSNO Act, and clauses 9, 10 and 12 of the
Methodology, the Committee concluded that each of the risks and costs was
negligible taking into account the containment regime and the controls. Thus, the
Committee considered the application under clause 26 of the Methodology.
A number of potentially significant risks are considered to be negligible, after taking
account of the organism description and the impact of containment and other controls
set out in Appendix 1.
As assessed earlier in this document the benefits are largely scientific. While these
benefits are very likely to exist, their magnitude may range from minimal to moderate
depending on the success of the research and the scientific value of the research
results. The Committee noted that potentially the benefits could include positive
outcomes for both human health and animal welfare product development. The
Committee noted that these benefits were potentially significant depending on the
outcome of the research. However, the Committee considered that it that there was
insufficient information at this stage in the research to determine the likelihood or
magnitude of such long-term benefits. The Committee then considered whether, given
the organism description and the containment and controls proposed, the benefits
outweigh the significant risks and costs. The Committee’s view is that the benefits do
outweigh the costs and risks.
The Committee is satisfied that the cell lines and rodents transduced with recombinant
viral vectors can be adequately contained (sections 45(1)(a)(iii) and 44(b) of the
HSNO Act), by the controls required in this decision (refer to Appendix 1).
In accordance with clause 36(2)(b) of the Methodology, the Committee records that in
reaching this conclusion, it has applied the balancing tests in section 45 of the HSNO
Act.
11
Decision
1. Pursuant to section 45(1)(a)(i) of the Hazardous Substances and New
Organisms Act 1996, 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)(a):
the development of any genetically modified organism.
Having considered all the possible effects in accordance with sections
45(1)(a)(ii) and 44 and pursuant to clause 26 of the Methodology, and based
on consideration and analysis of the information provided and taking into
account the application of risk management controls specified in this decision,
the view of the Committee is that the risks (or costs) of adverse effects
associated with the development in containment of the organisms listed in
table 1 are outweighed by the benefits.
2. The Committee is satisfied that the proposed containment regime, as set out in
Appendix 1, will adequately contain the organism as required by section
45(1)(a)(iii) of the Hazardous Substances and New Organisms Act 1996.
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3. In accordance with clause 36(2)(b) of the Methodology the Committee records
that, in reaching this conclusion, it has applied the balancing tests in section 45
of the Hazardous Substances and New Organisms Act 1996 and clause 26 of
the Methodology and has relied in particular on the criteria set out in the
following sections of the Act:
 section 44 additional matters to be considered;
 section 45 determination of application;
 section 37 additional matters to be considered;
 The Third Schedule-Part I matters to be addressed by containment
controls developing of genetically modified organisms.
4. The Committee has also applied the following criteria in the Methodology:
clause 9 - equivalent of sections 5, 6 and 8;
clause 10 - equivalent of sections 36 and 37;
clause 12 – evaluation of assessment of risks;
clause 13 – evaluation of assessment of costs and benefits;
clause 21 – the decision accords with the requirements of the Hazardous
Substances and New Organisms Act 1996 and Regulations;
clause 22 – the evaluation of risks, costs and benefits – relevant
considerations;
clause 24 – the use of recognised risk identification, assessment, evaluation
and management techniques;
clause 25 – the evaluation of risks;
clause 26 - the risks and costs are negligible and outweighed by the benefits;
clause 33 – the risk characteristics; and
clause 34 – the aggregation and comparison of risks, costs and benefits.
5. The application for development in containment of organisms described in
table 1 is thus approved, with controls, as set out in Appendix 1.
Associate Professor Marie Dziadek
Chair of Decision-making Committee
Date: 23 June 2004
Organism approval codes: GMD003193 - GMD003202
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Amendment: February 2005
Amended to correct a technical error in the controls by adding the ‘MAF Biosecurity
Authority/ERMA New Zealand Standard 154.03.03: Containment Facilities for
Vertebrate Laboratory Animals’ and by altering subsequent references to containment
standards in the controls so that both standards that are relevant to this approval apply.
Associate Professor Marie Dziadek
Chair of Decision-making Committee
Date: 1 February 2005
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
____________________________
Date: 22 August 2007
Dr Kieran Elborough
Chair, GMO Standing Committee
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Appendix 1: Controls
In order to satisfactorily address the matters detailed in the Third Schedule Part I:
Matters to be Addressed by Containment Controls for Development and Field Testing
of Genetically Modified Organisms4of the Act, and other matters in order to give
effect to the purpose of the Act (section 45(2)), the approved organism is subject to
the following controls:
1
To limit the likelihood of any accidental release of any organism
or any viable genetic material5 :
1.1
The person responsible for a particular research area and/or the person
responsible for the operation of the containment facilities (‘the facility’) shall
inform all personnel involved in the handling of the organisms of the
Authority’s controls.
1.2
For the work with mammalian cell lines and production of viral vectors the
containment facilities shall be approved by Ministry of Agriculture and
Forestry (MAF), in accordance with the MAF Biosecurity Authority/ERMA
New Zealand Standard 154.03.026: Containment Facilities for
Microorganisms Physical containment level 2 (PC2) and the controls set out
by Authority.
1.3
For the work with the transgenic rodents the containment facilities shall be
approved by Ministry of Agriculture and Forestry (MAF), in accordance with
the MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.036:
Containment Facilities for Vertebrate Laboratory Animals Physical
containment level 2 (PC2) and the controls set out by Authority.
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 1.2 and 1.3 of this
document.
3
To exclude other organisms from the facility and to control
undesirable and unwanted organisms within the facility:
4
Bold headings refer to matters to be addressed by containment controls for new organisms excluding
genetically modified organisms, specified in the Third Schedule (Part II) of the HSNO Act 1996.
5
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 sub lethally damaged by being
frozen, dried, heated, or affected by chemical.
6
Any reference to this standard in these controls refers to any subsequent version approved or endorsed
by ERMA New Zealand
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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 1.2 and 1.3 of this document.
4
To prevent unintended release of the organism by experimenters
working with the organism:
4.1
The prevention of unintended release of the organisms by experimenters
working with the organisms shall be in compliance with the standards listed in
control 1.2 and 1.3 of this document.
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 the organisms
shall be in compliance with the standards listed in control 1.2 and 1.3 of this
document.
5.2
In the event of any breach7 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 shall
be included in the containment manual in accordance with standards listed in
control 1.2 and 1.3 of this document.
5.3
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.
6
Inspection and monitoring requirements for containment facilities:
6.1
The inspection and monitoring requirements for the containment facilities
shall be in compliance with the standards listed in control 1.2 and 1.3 of this
document.
6.2
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 1.2 and 1.3 of this document.
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 and 1.3 of this document.
For the purposes of these controls a ‘breach of containment’ means any interference with the
containment facility or any non-compliance with Authority’s controls whether an approved organism
escapes from containment or not.
7
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8
Additional Controls
8.1
A scientist experienced with the use of recombinant viral vectors shall at all
times maintain oversight of the experiments, and shall provide training to staff
in best practice procedures for risk reduction.
8.2
A biological safety cabinet of class II shall be used for all experiments
requiring PC2 containment where the handling of viral vectors may result in
the production of aerosols.
8.3
Under no circumstances should investigators be infecting cultures of their own
cells, or of their immediate relatives, or those of other staff of the laboratory.
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