ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Date Signed: 7 August 2007
Application code:
NOC06008
Application category:
Import into Containment any New Organism under section
40(1)(a) of the Hazardous Substances and New Organisms
(HSNO) Act 1996
Applicant:
Central Tree Crops Research Trust
Applicant contact:
Date application received:
Mark Christensen
To import into containment Selaginella lepidophylla for research
on the treatment of Huntington’s disease.
23 May 2007
Consideration date:
03 July 2007
Considered by:
A Committee of the Environmental Risk Management
Authority (the Committee)
Application Purpose:
1
Summary of Decision
1.1
Application NOC06008 to import into containment the following organism is
approved, with controls (as detailed in Appendix 1 of this decision), having being
considered in accordance with the relevant provisions of the Hazardous
Substances and New Organisms (HSNO) Act 1996 (the Act) and the HSNO
(Methodology) Order 1998 (the Methodology):
Selaginella lepidophylla (Hooker & Greville) Spring.
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 40(1)(a) of the Act. The
application was determined in accordance with section 45, having regard to the
matters specified in section 44 and 37 and other matters relevant to the purpose of
the Act, as specified in Part II of the Act. Unless otherwise stated, references to
section numbers in this decision refer to sections of the Act.
2.2
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.
3
Application Process
Application receipt
3.1
Application NOC06008 was determined to be in compliance with section 40(2) of
the Act and was formally received on 23 May 2007.
Notification
3.2
Under section 53(2) of the Act, the Environmental Risk Management Authority
(the Authority) has discretion as to whether to publicly notify an application to
import into containment any new organism. In this case (following ERMA New
Zealand guidelines), the application was not publicly notified as the associated
potential risks are expected to be low and there was unlikely to be significant
public interest resulting in additional information relevant to the consideration.
3.3
In accordance with section 58(1)(c) of the Act and clauses 2(2)(e) and 5 of the
Methodology, the Department of Conservation (DOC) and the Ministry of
Agriculture and Forestry (MAF) were notified and provided with an opportunity
to comment on the application. Both DOC and MAF did not raise any concerns
with this application pending the comments suggested below (section 3.4).
3.4
Comments from MAF suggested that the organism be contained in a PC2 facility
and DOC suggested that because of its unique characteristics, this organism may
be listed in CITES in the future.
Decision Making Committee
3.5
The application was considered by a Committee of the Authority (the Committee),
appointed under a delegation from the Authority under section 19(2)(b) of the Act
and appointed in accordance with clause 43 of the First Schedule to the Act. The
Committee comprised the following members: Dr Max Suckling (Chair), Dr
Kieran Elborough and Dr Manuka Henare. The consideration was undertaken by
teleconference on 03 July 2007.
Information Available for Consideration
3.6
The documents available for the consideration of the application by the
Committee were:

The application (Form NO2N) prepared by the applicant;

The Evaluation and Review (E&R) Report prepared by the Agency to assist and
support the Committee's decision-making.
3.7
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.
4
Sequence of the Consideration
4.1
In addition to clause 24 of the Methodology, the approach to the consideration
adopted by the Committee was to first examine the scope and purpose of the
application, and the range of organisms applied for, then to look sequentially at
identification, assessment and evaluation of risks, costs and benefits. Those risks
identified as significant were assessed in accordance with clause 12 of the
Methodology. Costs and benefits were assessed in accordance with clause 13 of
the Methodology. 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.
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4.2
The adequacy of the proposed containment regime (section 45(a)(iii)), and the
ability of the organisms to escape and establish self-sustaining populations (as
required by sections 37 and 44 and clause 10(e)) were also taken into
consideration. Management techniques were considered in relation to the
identified risks. 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 II) of the Act and additional controls were
considered in relation to residual risks that required further consideration.
4.3
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 Act.
4.4
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. The approach to the consideration
followed the decision path outlined in Appendix 2 of the E&R Report.
5
Purpose of the Application
5.1
To import into containment S. lepidophylla for research on the treatment of
Huntington’s disease.
5.2
In accordance with section 45(1)(a)(i) of the Act, the Committee determined that
this purpose falls within the scope of section 39(1)(f) of the Act: “maintaining a
new organism in containment to produce…biopharmaceuticals…for release”.
6
Adequacy of the Containment Regime
6.1
In carrying out its consideration the Committee considered the adequacy of
containment in accordance with section 45(1)(a)(iii) of the Act, and the magnitude
and probability of the risks, costs and benefits alongside each other and in an
integrated fashion. This is because the former interact with the latter and this is
recognised in clause 12(d) of the Methodology and in section 45(1)(a)(ii) of the
Act. For convenience in setting out the decision the adequacy of containment is
discussed first.
Ability to adequately contain the organisms
6.2
In considering the adequacy of the containment regime and the ability of the
organisms to escape from containment, the Committee considered the following:
i. the biological characteristics of the organisms;
ii. the containment regime; and
iii. potential pathways for escape of the organisms from the containment facility.
i. Biological characteristics of the organism
6.3
The Committee noted the specialised characteristics of this organism and that it
occurs in desert regions which are not likely to be represented in New Zealand
year round.
6.4
The Committee noted that this species is capable of vegetative propagation as well
as reproducing via spores. However, the Committee notes the production of
spores is infrequent. In addition the Committee considered the establishment of
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heterosporous (two spore types) plants is further reduced as both spore types must
escape at the same time and then come in contact in order for fertilisation to
occur.
6.5
The Committee noted that the applicant intends to further contain sporulation and
vegetative fragmentation by housing specimens within cloches (see additional
controls in Appendix 1 section 1.17).
6.6
The Committee noted that there are no known inseparable organisms associated
with S. lepidophylla.
ii. Containment regime
6.7
The Committee noted that S. lepidophylla will be imported into a containment
facility registered to the Ministry of Agriculture and Forestry (MAF) Biosecurity
Authority/ERMA New Zealand Standard 155.04.091: Containment Facilities for
New Organisms (including genetically modified organisms) of plant species at
Physical Containment level 2 (PC2) and run in accordance with the Australian New
Zealand Standard AS/NZS 2243:3 1 2002 Safety in Laboratories: Part 3:
(Microbiological aspects and containment facilities).
6.8
The Committee considered that the containment issues raised by MAF were
addressed by the containment regime and in the additional controls.
6.9
The Committee considered that the controls in Appendix 1 of this decision are
sufficient to contain any spores produced.
iii. Potential pathways for escape of organisms from the containment facility
6.10 The Committee considered the potential pathways for escape of S. lepidophylla as:

escape during transport from the border to containment facilities and between
containment facilities;

escape from containment by accidental or deliberate removal by staff or
unauthorised persons;

escape from containment following natural disaster (such as flood and
earthquake) or fire; and

escape of spores, both mega and microspores, via the extraction fan.
6.11 Taking in to consideration the containment regime, the associated regulatory
Standards (set out in Appendix 1) and the additional controls required by this
approval (see Appendix 1 section 1.16). The Committee considers that an escape
through the above pathways to be highly improbable.
Conclusion on adequacy of the containment regime
6.12 The Committee has considered the proposed containment regime (that is physical
facilities, operational procedures and the additional controls), the biology of the
organisms and the potential pathways for escape from containment outlined
above.
Any reference to this standard in these controls refers to any subsequent version approved or
endorsed by ERMA New Zealand
1
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6.13 Taking all of these considerations into account the Committee considers that the
organisms will be adequately contained in a containment facility registered to
Standard 155.04.092 at PC2, and run in accordance with the AS/NZS 2243:3 2002
standard, and the additional controls of this approval.
7
Ability of the Organism to Establish a Self-Sustaining
Population and Ease of Eradication
7.1
In accordance with sections 44 and 37 and clause 10(e) the Committee considered
the ability of the organisms to form self-sustaining populations should they escape
containment, and the ease of eradication of such populations.
7.2
The Committee considers that the formation of a self-sustaining population would
be dependent on escape from containment. Self-sustaining populations could
potentially establish outside the containment facility if vegetative fragments are
carried out of the facility and deposited in a suitable habitat or if both mega and
microspores come into contact with each other in a suitable habitat that favours
the development of both the megagametophyte (female reproductive structure)
and the sporophyte (the subsequent plant that forms from sexual reproduction).
Successful sexual reproduction further requires water for the transfer of sperm
contained within the microgametophyte to fertilise the megagametophyte, and
warm dry conditions for the development of the subsequent sporophyte.
7.3
The probability of forming a self-sustaining population outside of the containment
facility via spores is reduced as both micro and megaspores must first escape
containment, secondly be deposited in the same site, and thirdly come into contact
in a suitable habitat.
7.4
In addition, the Committee noted that the specialised habitat requirements of this
species are not well represented in New Zealand and if self sustaining populations
arise they would be easily identified, temporal and easily eradicated with common
herbicides.
7.5
The Committee considers it highly improbable that S. lepidophylla could survive to
form self-sustaining populations outside the containment facility.
8
Identification and assessment of significant adverse
effects (risks and costs)
8.1
The Committee considered the potential risks and costs relating to the application;
taking into account sections 5, 6 and 8 of the Act and clauses 9 and 10 of the
Methodology. The following adverse effects were categorised and considered in
terms of their area of impact on the environment, on human health and safety, and
on Māori and their culture and traditions, on the market economy and on society
or the community (clause 9(c)).
8.2
These adverse effects have been considered in terms of the requirements of
clauses 12, 13, and 14 of the Methodology. Risk characteristics are considered in
terms of clause 33 of the Methodology. The degree of uncertainty attached to
Any reference to this standard in these controls refers to any subsequent version approved or
endorsed by ERMA New Zealand
2
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evidence is taken into account, as required under clauses 25, 29 and 30 of the
Methodology.
Potential adverse effects on the environment
Potential for the imported organisms to be detrimental to plants or pathogenic to
animals in New Zealand
8.3
The Committee considered the potential for S. lepidophylla to be detrimental,
pathogenic or toxic to plants or animals in New Zealand after an escape from
containment and the formation of a self-sustaining population.
8.4
The Committee concluded that S. lepidophylla is not known to be pathogenic or
toxic to plants or animals and identified no potential adverse effects on the
environment.
8.5
The Committee considered a minimal effect highly improbable for S. lepidophylla
to be detrimental, pathogenic or toxic to plants or animals in New Zealand and
thus any potential effects negligible and no further consideration was warranted.
Potential for S. lepidophylla to cause disruption to New Zealand’s flora.
8.6
There are no New Zealand native species in the family Selaginellaceae or genus
Selaginella.
8.7
The Committee thus considered a minimal effect highly improbable that
S. lepidophylla could hybridise with New Zealand native species and thus any
potential effects negligible and no further consideration was warranted.
Potential adverse effects on human health and safety
Potential for imported organisms to be pathogenic or toxic to humans
8.8
The Committee considered the potential of imported organism to have adverse
effects on human health and safety by being allergenic to humans.
8.9
The Committee considered that there was no evidence to suggest any potential
adverse effects of S. lepidophylla on human health and safety and that a minimal
effect was highly improbable and thus negligible and no further consideration
was warranted.
Potential adverse effects on Māori and their culture and traditions
8.10 The Committee considered the potential Māori cultural effects of this application
in accordance with clauses 9(b)(i) and 9(c)(iv) of the Methodology and sections
6(d) and 8 of the Act, and the assessment framework contained in the ERMA New
Zealand User Guide “Working with Māori under the HSNO Act 1996”.
8.11 The Committee noted that the potential adverse effects on the mauri of native
flora and fauna species is dependent on escape from containment, development of
a self-sustaining population and the capacity of S. lepidophylla to out compete native
species, cause population deterioration of native valued taonga species or to
damage the environment and health and well being of communities or valued
taonga species.
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8.12 The risk also encompasses the ability of Iwi/Māori to exercise their kaitikitanga
over their native and valued taonga species, traditions and customs and health and
well being of the mauri of their taonga should the highly unlikely event of escape,
development of self-sustaining population and adverse effects on native or valued
taonga flora and fauna species occur.
8.13 The Committee considered the potential exposure pathways for cultural risks to be
triggered. In light of the containment facility regulations, conditions and controls,
and trained staff handling the species in containment, the committee considered it
highly improbable that the potential risks to Māori will be triggered and result in
adverse impacts to the mauri of Iwi/Māori taonga.
8.14 The Committee considered the potential adverse effects on the relationship of
Māori and their culture and traditions with their ancestral lands, water, sites, waahi
tapu, valued flora and fauna and other taonga to be minimal, highly improbable
and thus negligible.
Potential adverse effects on the market economy
8.15 The Committee did not identify any potential adverse effects of S. lepidophylla on
the market economy and thus no further consideration was warranted.
Potential adverse effects on society and communities
8.16 The Committee did not identify any potential adverse effects of S. lepidophylla on
society or the community and thus no further consideration was warranted.
9
Identification and assessment of potentially significant
beneficial effects (benefits)
9.1
The Committee considered the potential beneficial effects associated with the
application, in accordance with sections 5 and 6(e) of the Act and clauses 9, 10, 13,
and 14 of the Methodology. The Committee identified the following direct
beneficial effects:

The potential for increased scientific knowledge of Huntington’s disease cures
through research.
9.2
The Committee adopted a precautionary approach as the application contained
limited scientific evidence to support any potential benefits.
9.3
The Committee discussed the applicant’s identification that there would be an
alleviation of lost annual income of Huntington’s disease sufferers if this research
were to succeed and considered this benefit unlikely as the application did not
identify any specifics regarding the intended medical research.
9.4
The Committee agreed that the level for the beneficial effect of increased scientific
knowledge of Huntington’s disease cures through research should be assigned a
minor level of magnitude and a likelihood of unlikely that would give a
significant beneficial level of C. .
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10
Establishment of the Approach to Risk in Light of Risk
Characteristics
10.1 Clause 33 of the Methodology requires the Authority to have regard for 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 organisms being “in containment” and
the conclusion that the containment provisions and other controls will reduce
most biological and physical risks to a low level.
10.2 In relation to the biological and physical risks considered (and the risks to human
health), the containment measures limit the extent to which exposure to the risks
is involuntary. The Committee also considers that there are no significant risks
which are not known or understood by the general public. It is considered that
the potentially significant risks are dependent upon escape from containment of
the organism and the establishment of an undesirable self-sustaining population.
Given the Committee's finding that an escape from containment is highly
improbable and the establishment of a self-sustaining population 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.
11
Overall Evaluation of Risk, Costs and Benefits
11.1 The overall evaluation of risks, costs and benefits set out below were carried out in
accordance with section 45 of the Act and clause 26 of the Methodology, having
regard to clauses 22 and 34 of the Methodology.
11.2 The Committee has assessed the potential risks of importing these organisms into
containment including potential risks to the environment; human health and
safety; Maori and their culture and traditions; society and the community; and the
market economy.
11.3 The benefits include increasing scientific knowledge of Huntington’s disease cures.
11.4 The Committee concluded that an escape from containment would be highly
improbable and the establishment of self-sustaining populations of the organisms
is considered highly improbable.
11.5 Because the risks as a whole are considered negligible, the decision is made in
accordance with clause 26 (not clause 27) of the Methodology.
11.6 The Committee considered all of the controls, set out in Appendix 1, and did so in
the context of both preventing the escape of the organisms and effectively
managing any risks, taking into account the cost effectiveness of the controls. The
Committee, having regard to these matters, is satisfied that the organisms can be
adequately contained, and that it is evident that the benefits of the application
outweigh the costs.
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12
Decision
12.1 In accordance with section 45(1)(a)(i) of the Act, the Committee determined that
this purpose falls within the scope of section 39(1)(f) of the Act: “maintaining a
new organism in containment to produce…biopharmaceuticals…for release”.
12.2 On making a decision, the Committee have considered all the possible effects in
accordance with sections 45(1)(a)(ii), 45(4) and 44 and pursuant to clause 26 of the
Methodology, and based on the consideration and analysis of the information
provided and taking into account the application of risk management controls
specified in this decision, the Committee have not identified any non-negligible
effects.
12.3 The Committee is satisfied that the containment regime, as set out in Appendix 1,
will adequately contain the organisms as required by section 45(1)(a)(iii) of the Act.
12.4 In accordance with clause 36(2)(b) of the Methodology the Committee records
that, in reaching this conclusion, it has considered section 45 of the Act 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; and

the Third Schedule-Part II, matters to be addressed by containment controls for
new organisms.
12.5 The Committee has 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 20 – information produced from other bodies;

clause 21 – the decision accords with the requirements of the Act 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 – negligible risks;

clause 29 and 32 – considering uncertainty;

clause 33 – the risk characteristics; and

clause 34 – the aggregation and comparison of risks, costs and benefits.
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12.6 The application to import into containment Selaginella lepidophylla (Hooker &
Greville) Spring is approved, with controls, in accordance with section 45(1)(a)
of the Act. As required under section 45(2) the approval is subject to the controls
listed in Appendix 1 of this decision.
___________________________
7 August 2007
Dr Max Suckling (Chair)
Date
Chair, New Organisms Standing Committee
Approval code: NOC002508
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Appendix 1: Controls Required by this Approval
In order to satisfactorily address the matters detailed in the Third Schedule Part II:
Containment controls for new organisms excluding genetically modified organisms, of the Act,
and other matters in order to give effect to the purpose of the Act, the approved
organisms are subject to the following controls:
1
To limit the likelihood of any accidental release of any organism
or any viable genetic material:
1.1
The approved organisms shall be imported into and maintained within a
containment facility which complies with these controls.
1.2
The construction, operation, and management of the containment facility for the
import of new organism shall be in accordance with the:
1.2.1
MAF Biosecurity Authority/ERMA New Zealand Standard 155.04.092:
Containment Facilities for New Organisms (including genetically modified
organisms) of plant species.
1.2.2
Australian New Zealand Standard AS/NZS 2243.3:20022 Safety in
Laboratories: Part 3: (Microbiological aspects and containment facilities).
1.2.3
Physical Containment Level 2 (PC2) requirements of the above Standards.
1.3
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.
1.4
The containment facility shall be approved by Ministry of Agriculture and Forestry
(MAF), in accordance with section 39 of the Biosecurity Act.
1.5
All biological waste will be disposed of using validated techniques, eg incineration,
or be provided to a MAF inspector for appropriate disposal as addressed in the
Plant Standard listed in control 1.2.
To exclude unauthorised people from the facility:
1.6
The identification of entrances, numbers of and access to entrances, and the
security requirements for the entrances and the facility shall be in compliance with
the standards listed in control 1.2.
To control the effects of any accidental release or escape of an
organism:
1.7
Construction and operation of the containment facility, relating to the control of
the effects of any accidental release or escape of an organism, shall comply with
the requirements of the standards listed in control 1.2.
1.8
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.
1.9
In the event of any breach of containment of the organism, 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
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included in the containment manual in accordance with the requirements of
standards listed in control 1.2.
1.10 The applicant shall comply with the requirements of the standards listed in control
1.2 relating to the maintenance of records demonstrating compliance with those
standards, as required by the quality assurance programme, and documented in the
containment manual.
Inspection and monitoring requirements for containment facilities:
1.11 The inspection and monitoring requirements for the containment facility shall be
in compliance with the standards listed in control 1.2.
1.12 The containment manuals shall be updated, as necessary, to address the
implementation of the controls imposed by this approval, in accordance with
standards listed in control 1.2.
Qualifications required of the persons responsible for implementing
these controls:
1.13 The training of personnel working in the facility shall be in compliance with the
standards listed in control 1.2.
Additional Controls:
1.14 Any person using this approval for the first time shall notify ERMA New Zealand
and the MAF Inspector responsible for the supervision of the facility of their
intention to do so in writing.
1.15 All packages of organisms imported in accordance with this application shall be
clearly labelled with the relevant ERMA New Zealand approval code and the
direction that the primary package should not be opened at the border, and shall
only be opened within a registered PC2 containment facility. This documentation
should be attached to the package in such a way that the primary package does not
have to be opened to access the documentation and the contents of the primary
package should be visible through the packaging material.
1.16 All living specimens of S. lepidophylla will be contained within cloches except when
specimens are being maintained (ie watering, re-potting etc).
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