ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under s67A on 22 August 2007
8 June 2004
Application code:
GMD04026
Application
category:
Develop in Containment any New Organism under the Hazardous
Substances and New Organisms (HSNO) Act 1996
Applicant:
Genesis Research and Development Corporation Limited
Purpose:
To develop in containment mammalian cells or mice expressing
recombinant viral vectors containing mammalian DNA fragments from
immune cells, in order to identify the factors that regulate immune cell
development
Date application
received:
26 March 2004
Consideration
period:
10 May 2004
Considered by:
A Committee of the Genetically Modified Organisms Standing
Committee of the Environmental Risk Management Authority (the
Committee).
1
Summary of Decision
1.1
Application GMD04026 to develop in containment cell lines and rodents
expressing recombinant adenoviral and lentiviral vectors that contain
mammalian genes which function in the immune system 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: Organism description for ERMA New Zealand’s Register.
Host Organism modified by
the vector and Donor DNA
opposite
Homo sapiens cell lines (293FT,
293A, 911, PER.C6)
(GMD04026)
Vector and Donor DNA

Modified by recombinant mammalian expression plasmids and lentiviral or
adenoviral plasmids containing genetic material1 from human2 or mouse
involved in cell survival, cell proliferation, cell differentiation/maturation and
regulation of immune cell function, including:
1.
chemokines
2.
cytokines
3.
growth factors
4.
receptors
5.
transcription factors
6.
adaptor molecules
7.
cytoplasmic enzymes
8.
cytoskeletal molecules
9.
other genes involved in regulating the proliferation, differentiation and
survival of the cells of the immune system

Colourimetric and fluorescent reporter genes

Selectable markers

The cDNA sequences described above may have regulatory or localisation
sequences fused to them, such as:
1.
Protein tags including: green fluorescent protein (GFP), hemagglutinin
(HA), histidine (His), FLAG, c-myc, glutathione S-transferase (GST),
maltose binding protein (MBP), calmodulin binding peptide (CBP), V5
and IgG binding peptide.

Promoters including: CMV, RSV, chicken beta-actin, rat, mouse and
human U6 and H1 promoters, IL-12p35, IL-12p40, IL-13, IgE, IL-4, IL18, IL-23, IL-4, NFB, TNF-, STAT 1-6, HLA-DR
3.
Regulatory elements/systems including: polyadenylation signals, internal
ribosomal entry sites, Cre/LoxP recombinase system, TOPO DNA sites,
Gateway® DNA sites, tetracycline regulated system, tamoxifen inducible
system, PEST sequences.
4. 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.
Environmental Risk Management Authority Decision: GMD04026
Page 2 of 13
Host Organism modified by
the vector and Donor DNA
opposite
Mus musculus cell lines
(primary and immortalised)
(GMD04026)
Homo sapiens cell lines
(primary and immortalised)
(GMD04026)
Mus musculus (GMD04026)
Vector and Donor DNA

Modified by lentiviral or adenoviral vectors containing genetic material 3 from
human4 or mouse involved in cell survival, cell proliferation, cell
differentiation/maturation and regulation of immune cell function, including:
1.
chemokines
2.
cytokines
3.
growth factors
4.
receptors
5.
transcription factors
6.
adaptor molecules
7.
cytoplasmic enzymes
8.
cytoskeletal molecules
9.
other genes involved in regulating the proliferation, differentiation and
survival of the cells of the immune system

Colourimetric and fluorescent reporter genes

Selectable markers

The cDNA sequences described above may have regulatory or localisation
sequences fused to them, such as:
1.
Protein tags including: green fluorescent protein (GFP), hemagglutinin
(HA), histidine (His), FLAG, c-myc, glutathione S-transferase (GST),
maltose binding protein (MBP), calmodulin binding peptide (CBP), V5
and IgG binding peptide.

Promoters including: CMV, RSV, chicken beta-actin, rat, mouse and
human U6 and H1 promoters, IL-12p35, IL-12p40, IL-13, IgE, IL-4, IL18, IL-23, IL-4, NFB, TNF-, STAT 1-6, HLA-DR
3.
Regulatory elements/systems including: polyadenylation signals, internal
ribosomal entry sites, Cre/LoxP recombinase system, TOPO DNA sites,
Gateway® DNA sites, tetracycline regulated system, tamoxifen inducible
system, PEST sequences.
4.
Other commercially available promoter or regulatory elements.
Rattus norvegicus
(GMD04026)
3
Sense cDNAs, sense constructs containing nucleotide substitution or deletions (to determine functional
domains), antisense and RNA interference sequences.
4
Non-Māori only.
Environmental Risk Management Authority Decision: GMD04026
Page 3 of 13
1.2
2
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”.
Legislative Criteria for Application
2.1
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.
2.2
Consideration of the application followed the relevant provisions of the 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.
3
Application Process
Application Receipt
3.1
Application GMD04026 was formally received and verified on 26th March
2004 as having adequate information for processing.
3.2
The purpose of the research is to develop in containment mammalian cells or
mice expressing recombinant viral vectors containing mammalian DNA
fragments from immune cells, in order to identify the factors that regulate
immune cell development
3.3
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
3.4
The information available for the consideration were as follows:
a)
The application prepared by the applicant.
b) The E&R report 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 the Methodology.
Recognised techniques were used in identifying, assessing, and evaluating
the relevant information, as required under clause 24 of the Methodology.
Environmental Risk Management Authority Decision: GMD04026
Page 4 of 13
These techniques are based on internal procedures as specified in the
ERMA New Zealand Technical Guides. The documents available for the
preparation of the E&R report were the application (including the
containment manual) and published references as cited in the application
and comments provided by those agencies notified of the application.
Notification
3.5
It was considered there was unlikely to be significant public interest in this
application. Therefore, the application was not publicly notified, in
accordance with ERMA New Zealand policy.
Decision Making Committee
3.6
4
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: Dr Marie Dziadek (Chair)
and Dr Colin Mantell.
Consideration
Purpose of the Application
4.1
Genesis Research and Development Corporation Limited sought approval to
develop in containment mammalian cells or mice [and rats] expressing
[modified by] recombinant viral vectors containing mammalian DNA
fragments from immune cells, in order to identify the factors that regulate
immune cell development
4.2
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
4.3
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 2 of
the E&R report.
Environmental Risk Management Authority Decision: GMD04026
Page 5 of 13
In assessing risks and costs, issues affecting the adequacy of the containment
regime and 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 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.
4.4
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
4.5
The scope of the organisms subject to the approval is limited to that
described in Table 1 above.
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 lentiviral vectors in
mammalian cell lines (PC2, Schedule 1(e) under HSNO (Low-Risk
Genetic Modification) Regulations 2003)
 Genetic modification of mammalian 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)
4.6
5
The Committee notes that this application is from a biotechnology company
who intend to identify new classes of molecules and genes that regulate
immunological function. The Committee considered the broader implication
on risks with this application due to the proposed use of genes of unknown
immunological function.
Identification of Risks, Costs and Benefits
5.1
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.
5.2
The Committee considered section 4 of the E&R report when carrying out
the identification of potential adverse and beneficial effects (risks, costs and
benefits).
Environmental Risk Management Authority Decision: GMD04026
Page 6 of 13
Potential Adverse Environmental Effects
5.3
The Committee consider the risks to the environment in accordance with
clauses 9(a)-9(c) and 10 of the Methodology. The Committee accepts the
conclusions reached in the application and E&R Report that the development
and use of the viral vectors, cell lines and rodents in containment is very
unlikely to pose significant environmental risks. Therefore, these effects will
not be considered further.
Potential Adverse Effects on Human Health and Safety
5.4
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. This is
further discussed in sections 7.2 - 7.7 of this decision.
Potential Adverse Effects to the Economy
5.5
The Committee records that adverse effects to 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 no
further consideration of these aspects was warranted.
Potential Adverse Effects to Māori Culture
5.6
6
The Committee considered the potential adverse Māori cultural effects and
noted sections 4.3-4.5 and 6.36-6.40 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 Whatua and the Hauraki Māori Trust Board. 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. Given this no
further consideration of these effects were warranted.
Containment
6.1
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.
Environmental Risk Management Authority Decision: GMD04026
Page 7 of 13
Ability to Escape from Containment
6.2
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.
Ability of Organism to Establish a Self-sustaining Population and the Ease of
Eradication
6.3
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.
6.4
The Committee considers that with the containment controls it has imposed
(refer to Appendix 1 of this decision); it is very unlikely for the cell lines or
rodents modified with viral vectors to escape or be removed inadvertently
from containment and establish self-sustaining populations.
7
Assessment of Risks, Costs and Benefits
7.1
In section 5 above, the Committee identified a potential significant adverse
effect on human health and safety from viral vectors infecting laboratory
workers via accidental injection or aerosolation. What follows is the
assessment of those adverse effects.
Infection of Laboratory Workers
7.2
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.
7.3
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. The Committee considered that even in the
worst case scenario of tumour cells developing on the site, the health cost to
the individual would be minimal due to monitoring and treatment
possibilities. Further the Committee considered that any effect on the
immune system will be very limited, where only a few cells will be infected
and the effect of the infected cells will be diluted out by millions of healthy
Environmental Risk Management Authority Decision: GMD04026
Page 8 of 13
cells. Therefore, the Committee consider that the effect of accidental
infection on the immune system is likely to be minimal.
7.4
The Committee agrees with the E&R report (section 5.13) that the oversight
of the experiments proposed in this application by an a scientist experienced
with the use of recombinant viral vectors will reduce the occupational health
risk to staff (additional control 8.1, Appendix 1 of this document).
7.5
The Committee agreed with the E&R report (section 5.31) 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.
7.6
The Committee agreed with the E&R report (section 5.37) 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).
7.7
The Committee agreed with the E&R report (section 5.45) 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.
Identification and Assessment of Benefits
7.8
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:
7.9
The Committee agreed with the E&R report (section 6.41) and considers that
the direct benefits of this application are those of gains in scientific
knowledge and scientific reputation and standing for the researchers. The
Committee considers that these benefits are very likely to occur based on the
applicant’s track record in securing grants and funding from private
investors and their publications in top-tier peer-reviewed scientific journals.
Also the Committee considers 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.
7.10
The Committee considers that potentially the research could have significant
non-monetary benefits for human health in the long-term if the applicant was
able to develop novel strategies for treatment of immunological diseases3.
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 of
3
Including multiple sclerosis, rheumatoid arthritis, type I diabetes and asthma.
Environmental Risk Management Authority Decision: GMD04026
Page 9 of 13
uncertainty surrounding expected long-term non-monetary benefits, as it
depends on how successful the research is and on a number of other factors.
8
Other Matters
8.1
9
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)).
International and Related Matters
9.1
10
The Committee considered international obligations relevant to this approval
in accordance with clause 9(c)(vi) of the Methodology and section 6(f) of the
HSNO Act.
Overall Evaluation of Risks, Costs and Benefits and of
the Adequacy of Containment
10.1
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):
10.2
The application has been considered in the context of the purpose and
principles of the HSNO Act (sections 4-8 inclusive).
10.3
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.
10.4
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. Thus, the Committee considered the application under clause
26 of the Methodology.
10.5
As indicated in the foregoing text, 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.
10.6
As assessed in sections 7.8 - 7.10 of 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.
Environmental Risk Management Authority Decision: GMD04026
Page 10 of 13
10.7
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.
10.8
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).
10.9
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
11.1
Decision
The application to develop in containment cell lines and rodents that are
genetically modified with recombinant viral vectors that express genes
involved in the development and function of the immune system, (as
described in Table 1 of this decision) is approved in accordance with section
45(1)(a) of the HSNO Act. As required under section 45(2) the approval is
subject to controls (as listed in Appendix 1 of this decision).
Dr Marie Dziadek
Date: 8 June 2004
Chair, GMO Standing Committee of the Authority
Approval codes: GMD003165 - GMD003169
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: GMD04026
Date: 22 August 2007
Page 11 of 13
Appendix 1: Controls Required by this Approval
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:
Containment 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 recombinant 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 genetically modified 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
2.1
3
To exclude unauthorised people from the facility:
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.
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
Environmental Risk Management Authority Decision: GMD04026
Page 12 of 13
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 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 shall be included in
the containment manual in accordance with the Standards.
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
6.1
7
7.1
8
Inspection and monitoring requirements for containment facilities:
The inspection and monitoring requirements for containment facilities shall be
in compliance with the standards listed in control 1.2 and 1.3 of this document.
Qualifications required of the persons responsible for
implementing those controls:
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.
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.
Environmental Risk Management Authority Decision: GMD04026
Page 13 of 13