ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
29 July 2008
Application code:
NOC08002
Application category:
Import into Containment any New Organism under
section 40(1)(a) of the Hazardous Substances and New
Organisms (HSNO) Act 1996.
Applicant:
Ministry of Health
Purpose:
To import into containment human medicines which
contain 'new organisms' for storage purposes
Date application received:
28 March 2008
Consideration date:
Considered by:
16 July 2008
A Committee of the Environmental Risk Management
Authority (the Authority)
1
1.1
Summary of Decision
The application to import into containment the following organisms contained in
human medicines for storage purposes, is approved, with controls, having being
considered in accordance with the relevant provisions of the Hazardous Substances
and New Organisms Act 1996 (the Act) and the HSNO (Methodology) Order 1998
(the Methodology):
“Any live new microorganism, that is not genetically modified, contained in a
licensed human medicine, as defined in section 3 of the Medicines Act 1981. These
organisms will have the biological characteristics of Risk Group 1 or Risk Group 2
microorganisms as defined in the Australian/New Zealand Standard 2243.3:2002 –
Safety in laboratories Part 3: Microbiological aspects and containment facilities
(AS/NZS 2243.3:2002).
2
Legislative Criteria
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,
as specified in more detail below. Unless otherwise stated, references to clause
numbers in this decision refer to clauses of the Methodology.
3
Application Process
Application Receipt
3.1
Application NOC08002 was determined to comply with section 40(2) of the Act and
was formally received on 28 March 2008.
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, the application was not publicly notified
(following ERMA New Zealand guidelines) because the importation into containment
of human medicines containing ‘new organisms’ is not expected to be of significant
public interest, nor is it likely that public notification would result in additional
information relevant to the consideration of this application.
3.3
In accordance with section 58(1)(c) of the Act and clauses 2(2)(e) and 5 of the
Methodology, the Ministry of Agriculture and Forestry Biosecurity New Zealand
(MAFBNZ) was notified and provided with an opportunity to comment on the
application. MAFBNZ did not raise any issues with this application and provided
advice on the containment controls.
Decision Making Committee
3.4
The application was considered by a Committee of the Authority appointed in
accordance with section 19(2)(b) of the Act. The Committee comprised of the
following members: Dr Max Suckling (chair), Dr Kieran Elborough and
Dr Val Orchard.
Information Available for Consideration
3.5
The information available for the consideration of the application by the Committee
included:


Application NOC08002 (Form NO2N), including the operation manual for the
storage facility (Appendix 1- confidential).
A memorandum from the Agency to assist and support the Committee’s decision
making.
3.6
Recognised techniques were used in identifying, assessing, and evaluating the relevant
information, as required under clause 24. Techniques for identifying and preparing
information on risks, costs and benefits were based on procedures specified in the
ERMA New Zealand Technical Guides.
3.7
The Committee requested further information on the 29 April 2008, as provided for
under section 58. The requested information was whether the proposed storage
facility was registered to the appropriate MAF/ERMA New Zealand containment
standard, and MAFBNZ requirements for auditing the proposed storage facility. The
information was received and checked on the 16 June 2008.
Environmental Risk Management Authority Decision: Application NOC08002 Page 2 of 17
3.8
4
A timeframe waiver under section 59 was applied for on 24 June 2008, to allow for
the convening of the Committee.
Sequence of the Consideration
4.1
In accordance with clause 24, the approach to the consideration adopted by the
Committee was first to examine the scope and purpose of the application, and the
organisms applied for, then to look sequentially at identification, assessment and
evaluation of risks, costs and benefits. Those risks identified as potentially significant
were assessed in accordance with clause 12. Costs and benefits were assessed in
accordance with clause 13. Qualitative scales were used by the Committee to measure
likelihood and magnitude of risks, costs and benefits.
4.2
Interposed with the assessment of risks, costs and benefits was the consideration of
the adequacy of the proposed containment regime, and the ability of the organisms to
escape and establish self-sustaining populations (as required by sections 37 and 44
and clause 10(e)). 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 provide satisfactorily 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 and section 6(e).
4.4
Finally, taking account of the risk characteristics established in accordance with
clause 33, 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 the memorandum from the Agency.
5
Purpose of the Application
5.1
This application is to allow the Ministry of Health (MoH) to import into containment
live new microorganisms (not genetically modified) contained in licensed human
medicines for storage purposes only.
5.2
In accordance with section 45(1)(a)(i), the Committee was satisfied that the
application was for a valid purpose under section 39(1)(h) of the HSNO Act being
“such other purposes as the Authority thinks fit”.
6
6.1
Adequacy of Containment Regime
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 likelihood of the risks, costs and benefits alongside each other and in an
integrated fashion. This is because the magnitude interacts with the likelihood as
recognised in clause 12(d) of the Methodology and in section 45(1)(a)(ii) of the Act.
Environmental Risk Management Authority Decision: Application NOC08002 Page 3 of 17
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:

the biological characteristics of the organisms;

the containment regime; and

the potential pathways for escape of the organisms from the containment facility.
(i) Biological characteristics of the organisms
6.3
Live vaccines are a group of medicines that contain attenuated (weakened)
microorganisms that stimulate an immune response in the recipient to protect against
the development of disease caused by the virulent form of the microorganism. The
microorganisms may retain the ability to multiply and produce immunity, but do not
usually cause illness in healthy individuals.
6.4
The organism description excludes genetically modified organisms and limits the
microorganisms approved for importation to those that have biological characteristics
belonging to Risk Group 1 and Risk Group 2 microorganisms as defined in the
AS/NZS 2243.3:2002. The Committee notes the following definitions for these risk
groupings:

Risk Group 1 microorganisms are those that are unlikely to cause disease in
humans, animals, plants or fungi.

Risk Group 2 microorganisms are those that may cause disease in humans,
animals, plants, or fungi but are unlikely to be a serious hazard to laboratory
personnel, the community, animals or the environment and for which there are
effective treatment and preventive measures with respect to any infections that
they may cause. Furthermore, Risk Group 2 microorganisms present a limited
risk for the spread of infection.
6.5
The Committee notes that any vaccines to be imported under this approval will be
licensed for human use, and must therefore conform to international safety, quality,
efficacy and manufacturing standards such as those set out by the World Health
Organization (WHO). Any commercially-produced and licensed vaccine containing
live microorganisms will be very well characterised and proven safe for human use
(Buckland, 2005).
6.6
The Committee notes that section 20(2)(b) requires the Authority to keep a register
that uniquely identifies each organism. Therefore, the Committee imposes a control
(Additional control 6.3, Appendix 1), requiring that, on application for a permit to
import, the applicant provide MAFBNZ with a description that uniquely identifies
each organism to be imported, and evidence that each of the organisms to be imported
meets the approved organism description.
6.7
In the application, two examples of diseases for which live microorganisms contained
in a human medicine may be imported are given, Japanese encephalitis (JE) and
Environmental Risk Management Authority Decision: Application NOC08002 Page 4 of 17
Tularaemia. The Committee has not specifically assessed these examples as it was
considered that these form a small part of the range of organisms that may be
imported under this approval.
6.8
The Committee considered the biological characteristics of vaccines from vector
borne diseases to those vaccines transmitted by passive immunization such as the oral
polio vaccine (OPV). The examples discussed are not necessarily new organisms but
represent a range of biological characteristics that the vaccine microorganisms
covered under this approval may have.
6.9
An example of a vaccine microorganism transmitted by passive immunization is the
live attenuated oral polio vaccine (OPV). OPV is a live attenuated vaccine, produced
by the passage of the disease causing virus through non-human cells to produce
spontaneous mutations in the viral genome. OPV can still replicate in the gut but
unlike the disease causing strain does not replicate in the nervous system. An
individual immunized with OPV will develop long-lasting protective immunity to all
known forms of poliovirus. Previous studies have shown that OPV (like the disease
causing agent) can spread from person to person through stools (faeces) and saliva.
However, OPV does not persist for long in the environment upon removal of the
vaccine from the immunization schedule in developed countries with temperate
climates. Therefore, the ability of OPV to spread and form a self-sustaining
population is limited.
6.10
The attenuated Yellow fever YF 17D strain has been extensively used as a vaccine
since the 1930s and is available in New Zealand under the trade name of StamarilTM.
The project team notes that while Yellow Fever was determined to not be a “new
organism” under the HSNO Act (S2605001), this vaccine was used as a typical
example of vaccine for a vector-spread disease. After inoculation with the YF 17D
vaccine, only short term and low magnitude viremia is seen (Monath et al, 2004) and
to prevent sustained infection or unintentional spread of this vaccine, this vaccination
is not given to pregnant women or to patients with impaired or compromised immune
systems or to children under 6 months (Medsafe, 2007).
6.11
The project team notes that the spread of a vaccine virus derived from vector-borne
viruses would require spread by a susceptible mosquito vector or direct contact with
the virus through an open wound. For YF 17D, there is no evidence that the mosquito
species that normally spreads YF (eg, Aedes aegypti, Aedes albopictus) have
established in New Zealand to date (Hearnden et al 1999; Landcare Research, 2004).
6.12
Even if the appropriate vectors were present, the project team notes that YF-17D is
restricted in its ability to grow and be transmitted by Aedes aegypti and Aedes
albopictus. The failure to infect and replicate orally-dosed mosquitoes showed that
the virus is not maintained in susceptible insects (Bhatt et al 2000). This fact, with the
low level transient viraemia may explain the documented lack of spread of this
vaccine virus within a population throughout its long history of use.
(ii) Containment regime
6.13
The Committee notes that this approval allows for the storage of human medicines
which contain new organisms and does not allow either the use of, or research on, the
new organisms contained in the medicines (Additional control 6.2, Appendix 1).
Environmental Risk Management Authority Decision: Application NOC08002 Page 5 of 17
6.14
The vaccine store that the applicant proposes to use to store human medicines which
contain new organisms is not currently approved as a containment facility under an
appropriate MAF/ERMA New Zealand Containment Facility Standard, but operates to
comply with the following standards: AS/NZS 2243.3:2002; AS/NZS ISO 9001, the
New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution
of Therapeutic Goods; and national standards provided in the Immunisation Advisory
Centre (IMAC) Vaccine Storage and Distribution National Standards (Immunisation
Advisory Centre, 2002).
6.15
The Committee notes that the vaccine store is able to meet the requirements of the
MAF/ERMA New Zealand Standard Facilities for Microorganisms and Cell
Cultures: 2007a1 and requires that the storage facility be registered to this standard at
the level of physical containment 1 (PC 1) (control 1.2, Appendix 1). Under this
standard, microorganisms held in containment for storage must be adequately labelled
and stored securely to prevent unauthorised access. The standard also requires that
contingency plans are in place to deal with any spillage and breach of containment.
6.16
To ensure that the organisms are adequately contained, the Committee has limited this
approval to MoH. However, the vaccines may be stored in other facilities that meet
the containment requirements of this approval provided a contractual arrangement to
do so is arranged with MoH (Additional control 6.1, Appendix 1).
(iii)Potential pathways for escape of organisms from the containment facility
6.17
The Committee considered the potential significant pathways of escape of the
organisms contained in these vaccines to be:




escape during transportation eg, from the border to the containment facility;
escape by intentional removal by staff or unauthorised persons;
escape by accidental or unintentional removal by staff or unauthorised persons,
eg:

via infection of personnel working in the vaccine store;

through passive vectoring (eg on clothing or skin of personnel);

through contaminated material leaving the vaccine store; and
Escape following natural disaster (such as flood and earthquakes) or fire.
6.18
The Committee notes the potential for inspection at the border to result in accidental
release of the organisms. Additional control 6.4 (Appendix 1) places requirements on
users of the approval to label packages with the ERMA New Zealand application code
and a clearly visible direction that the package should only be opened in a registered
containment facility.
6.19
The Committee considers that the most likely route of escape would be through a
breakage of vaccine vials followed by exposure of facility personnel, either through
the inhalation of the vaccine microorganisms, or through a skin wound. The
Committee considers that it is highly improbable that vaccine microorganisms could
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by
ERMA New Zealand.
1
Environmental Risk Management Authority Decision: Application NOC08002 Page 6 of 17
escape through this route for the following reasons. The number of doses and volume
per vial is limited and would most likely result in an immune response in the exposed
person. The operational procedures in place require that vaccine vials remain
unopened during storage in their original packets or packaging, and that there are
contingency plans in place for cleaning up breakages and spillages of biohazard
materials and inactivation of any live vaccines.
6.20
The Committee concluded that escape of the organisms via the above pathways is
highly improbable.
6.21
This conclusion was formed on the basis of the containment provisions imposed in the
controls on this approval particularly those relating to packaging of the organisms for
transport, waste disposal, management of the facility (including access to the facility
and staff training) and contingency plans. To ensure that staff are aware of these
controls the Committee has imposed control 1.4 (Appendix 1) that requires the person
responsible for the operation of the containment facility to ensure that all staff are
aware of the containment controls for this approval.
Conclusion on adequacy of the containment regime
6.22
7
The Committee has considered the ability of the organisms to escape containment
given their biological characteristics, the proposed containment regime and the
potential pathways of escape. Taking all of these considerations into account the
Committee concluded that it is highly improbable that the organisms would be able
to escape from containment and that the proposed containment regime is adequate to
contain these organisms.
Ability of the Organism to Establish an undesirable Self-Sustaining
Population
7.1
In accordance with sections 44 and 37 and clause 10(e) the Committee considered the
ability of the vaccine microorganisms to form an undesirable self-sustaining
populations should they escape containment, and the ease of eradication of such
populations.
7.2
The Committee considers that for the vaccine microorganisms to be able to establish a
self-sustaining population there must be suitable hosts for the microorganisms to
multiply within. Growth (multiplication) could occur either through the deliberate
administration of the vaccine to humans (not allowed under this application), or
escape from containment followed by infection of a suitable host. The infected host
would then need to come into contact with, and transmit the vaccine microorganism
to, other susceptible hosts, through ‘passive’ immunization.
7.3
The Committee notes that the attenuated vaccine microorganisms that are the subject
of this approval are weakened or related strains of the disease causing microorganism.
The vaccine microorganisms are still able to multiply in humans, but at a much slower
rate than the disease causing strains, and can be easily eradicated by the immune
system. Therefore the Committee considers that it is highly improbable that a selfsustaining population could form.
Environmental Risk Management Authority Decision: Application NOC08002 Page 7 of 17
7.4
8
If a self-sustaining population were to form, then for that population to become
undesirable, an immunocompromised person must be exposed to the vaccine
microorganism to develop disease. However, given the containment measures and the
contingency plans in place, the Committee considers that it is highly improbable that
an undesirable self-sustaining population could form.
Identification and assessment of potentially significant adverse and
beneficial effects (risks, costs and benefits)
8.1
The Committee considered the potential risks, costs and benefits relating to the
application. In accordance with sections 5 and 6 and clause 9(c) the Committee has
categorised the potentially significant adverse effects into environmental, human
health, Māori culture, market economy and social categories.
8.2
The potential risks, costs and benefits assessed here are those identified as potentially
significant, having regard for those matters set out in clauses 9 and 10, which reflect
sections 5, 6, 8 and 44. These effects have been considered in terms of the
requirements of clauses 12, 13, and 14 including the probability of occurrence and the
magnitude of adverse effects, whether or not they are monetary, and the distribution
of costs and benefits over time, space and groups in the community. Risk
characteristics are considered in terms of clause 33. The degree of uncertainty
attached to evidence is taken into account, as required under clauses 25, 29 and 30.
Potentially significant adverse effects
Human health and safety
8.3
The Committee considered the potential for vaccine microorganisms to have an
adverse effect on human health and safety as a result of occupational exposure to an
infectious dose of a vaccine microorganism, through an accidental spillage.
8.4
The Committee notes that the approval is limited to the import of licensed human
vaccines. Therefore, these vaccines would have been tested in a series of clinical
trials as a prerequisite of licensing and would have had to undergo a series of safety
and quality testing including testing for reversion to virulence, and confirmation of
genetic identity.
8.5
The Committee noted that the potential for occupational exposure is limited as this
approval allows for storage of vaccines containing live microorganisms that conform
to the organism description and does not approve the use of, or research with, these
microorganisms.
8.6
The Committee considers that the dominant pathway for occupational exposure is
through a spillage of the vaccine microorganisms. However, this is considered highly
improbable given the containment system and the contingency measure in place
(control 3.3, Appendix 1).
8.7
If occupational exposure were to result, then it will cause an immune response in the
individual exposed. The Committee considers this to be a minimal effect since the
vaccine microorganisms have either Risk Group 1 or Risk Group 2 biological
characteristics.
Environmental Risk Management Authority Decision: Application NOC08002 Page 8 of 17
8.8
There for the Committee concludes that the risk of occupational exposure due to a
spill of vaccine microorganism is negligible.
The environment
8.9
Given the range of vaccine microorganisms that may be imported under this approval,
there is a possibility that some of these microorganisms may cause disease in animals.
However, given the containment system in which the vaccine microorganisms are to
be held, there is no significant exposure pathway to result in animal disease.
Therefore the Committee has not identified any significant effects on the environment
resulting from the import of these vaccine microorganisms.
Māori and their culture and traditions
8.10
The Committee considered the potential Māori cultural effects of these applications in
accordance with clauses 9(b)(i) and 9(c)(iv) of the Methodology and sections 6(d) and
8 of the Act. In addition, the Committee used the assessment framework contained in
the ERMA New Zealand User Guide “Working with Māori under the HSNO Act
1996”, and the ERMA New Zealand revised protocol “Incorporating Māori
perspectives in Part V Decision-making”, as guides in assessing the information
contained in these applications.
8.11
Taking into account the assessment of the potential adverse human health effects
associated with this application, the Committee considers that this application presents
negligible risk to Māori culture or traditional relationships with ancestral lands, water,
sites, wāhi tapu, valued flora and fauna or other taonga.
The market economy
8.12
The Committee considered the potential for vaccine microorganisms to have an
adverse effect on the market economy. The Committee considered that any adverse
effect on the market economy would result from adverse effects on the environment,
such as if a vaccine microorganism used to prevent zoonoses (any disease and/or
infection which is naturally transmissible from vertebrate animals to man), escaped
from containment, infected native or valued animals leading to disease spread and
stock losses.
8.13
However, given the containment system in which the vaccine microorganisms are to
be held, there is no significant exposure pathway to result in animal disease.
Therefore the Committee has not identified any significant effects on the market
economy resulting from the import of these vaccine microorganisms.
Society and community
8.14
The Committee considered that there are no adverse effects on society and the
community associated with approving the importation of vaccine microorganisms for
storage.
Environmental Risk Management Authority Decision: Application NOC08002 Page 9 of 17
9
Identification and Assessment of Potentially Significant Beneficial
Effects
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(c), 10, 13,
and 14 of the Methodology.
9.2
The Committee considered that there are no direct beneficial effects to the
environment, human health and safety, Maori culture and traditions or the market
economy of approving the importation of vaccine microorganisms for storage.
Potentially significant beneficial effects
Society and community
9.3
The Committee considered the potentially significant beneficial effects to society and
the community of planning a response for dealing with disease epidemics and the
ability to rapidly deploy vaccines should the need arise. These potential benefits are
in line with the initiatives of the Global Outbreak Alert and Response Network
(WHO) in combating the international spread of disease outbreaks, and MoH’s
planning for public health matters.
9.4
The Committee noted that a direct benefit of this application would be enabling MoH
in planning and preparing for vaccine preventable disease epidemics by purchasing
and stockpiling vaccines. This would provide the capacity to rapidly deploy vaccines
to the Pacific region should a disease outbreak occur, and thus fulfil part of New
Zealand’s obligation as a signatory to the International Health Regulations 2005, to
respond rapidly to matters of public health of international concern.
9.5
The Committee considers that this is a major benefit as a stockpile would enable
early intervention at the start of an epidemic in an attempt to contain it, and protection
of essential personnel such as health care staff in the initially affected countries. The
Committee considers that the benefits associated with increased preparedness for a
disease epidemic are very likely to be realised, and hence significant.
9.6
The Committee notes however that MoH will not be able to use these vaccines in New
Zealand unless a further HSNO Act approval is obtained. Therefore, the potential
benefits arising from the use of the vaccines microorganisms have not been
considered as they fall outside the scope of this approval.
Environmental Risk Management Authority Decision: Application NOC08002 Page 10 of 17
10 Overall evaluation of risk, costs and benefits
Precautionary approach
10.1
Section 7 of the Act requires the Committee to take into account the need for caution
in managing adverse effects where there is scientific and technical uncertainty about
those effects. The Committee used scenarios to set upper and lower bounds on the
assessment of risks and the evaluation was based on the higher value of the risk.
Clause 29 of the Methodology notes that where there is scientific and technical
uncertainty the Authority must considered the materiality of the uncertainty to the
decision. Since none of the risks was assessed as being non-negligible, the
Committee concluded that this uncertainty was not material to the decision.
Approach to risk
10.2
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 applications
clause 33 is influenced by the applications being “in containment” and the conclusion
that the containment provisions and controls will reduce risks to a negligible level.
10.3
The Committee considered that as the identified risks were assessed as being
negligible, caution in addition to that required by section 7 of the Act is not warranted.
Aggregation and comparison of risks, costs and benefits
10.4
The overall evaluation of risks, costs and benefits was 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.
10.5
The Committee has assessed the potential adverse effects (risks and costs) of
importing these organisms into containment as being negligible if the proposed
containment regime and the controls in Appendix 1 are adhered to.
10.6
The Committee considers that the beneficial effects (benefits) are significant.
10.7
The Committee has concluded that the establishment of undesirable self-sustaining
populations of the vaccine microorganisms in New Zealand, should they escape, is
highly improbable. The proposed containment regime, as outlined in Appendix 1 is
considered to be adequate considering the risks posed by the organisms. Additionally,
it is considered highly improbable that the organisms would be able to escape from
containment.
10.8
The Committee considered all of the controls, set out in Appendix 1, taking into
account the cost effectiveness of the controls in preventing the escape of the
organisms and effectively managing any risks. The Committee, having regard to
these matters, is satisfied that the organisms can be adequately contained, and that it is
Environmental Risk Management Authority Decision: Application NOC08002 Page 11 of 17
evident that the (beneficial effects) benefits of the application outweigh the adverse
effects (risks and costs).
10.9
The Committee was unable to find common units of measurement with which to
combine risks, costs, and benefits in accordance with clause 34(a) and there were no
dominant sources of risk (clause 34(b)). Because the risks individually and as a whole
are negligible, the decision is made in accordance with clause 26 (not clause 27) of the
Methodology.
11 Associated Approvals
11.1
The Committee noted that commercially manufactured live vaccines intended for
human use will require a permit to import from MAFBNZ since they are likely to
contain organisms that are, or may be associated with, risk goods.
11.2
Commercially manufactured antibiotics, medicines and vaccines intended for human
use from any country may be given clearance. The Committee noted however, that,
depending on the nature of these goods and the purpose of import, MAFBNZ may
impose conditions on a permit to import directing such goods to a transitional or
containment facility. Such goods (eg live vaccines containing new organisms) will
require further approval from MAFBNZ to receive clearance.
11.3
The Committee also notes that any vaccines imported under this approval will require
the following additional approvals prior to being used in New Zealand:



HSNO Act approval to release a ‘new organism’ from containment;
Biosecurity clearance from MAFBNZ; and
Consent from MEDSAFE to distribute a ‘new medicine’
12 Decision
12.1
Pursuant to section 45(1)(a)(i) of the Act, the Committee is satisfied that this
application is for one of the purposes specified in section 39(1) of the Act, being
section 39(1)(h): such other purposes as the Authority thinks fit.
12.2
Having 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
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 adverse effects (risks and costs) associated with the importation
into containment of these organisms are outweighed by the beneficial effects
(benefits).
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 applied the balancing tests in 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:
Environmental Risk Management Authority Decision: Application NOC08002 Page 12 of 17




12.5
The Committee has also applied the following criteria in the Methodology:













12.6
section 44 additional matters to be considered;
section 45 determination of application;
section 37 additional matters to be considered; and
the Third Schedule-Part 2, matters to be addressed by containment controls for
new organisms.
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 - the risks are negligible and it is evident benefits outweigh costs;
clause 29 and 32 – considering uncertainty;
clause 33 – the risk characteristics; and
clause 34 – the aggregation and comparison of risks, costs and benefits.
The application to import into containment cultures of the following organisms:
“Any live new microorganism, that is not genetically modified, contained in a
licensed human medicine, as defined in section 3 of the Medicines Act 1981. These
organisms may be Risk Group 1 or Risk Group 2 microorganisms as defined in the
Australian/New Zealand Standard 2243.3: 2002 – Safety in laboratories Part 3:
Microbiological aspects and containment facilities (AS/NZS 2243.3:2002).”
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.
___________________________
29 July 2008
Date
Chair of the Committee
Approval code: NOC002524
Environmental Risk Management Authority Decision: Application NOC08002 Page 13 of 17
References:
1. Bhatt, TR, Crabtree, MB, Guirakhoo,F, Monath, TP, Miller, BR 2000. Growth
characteristics of the chimeric Japanese Encephalitis virus vaccine candidate,
ChimeriVaxTM-JE (YF/JE SA14-14-2), in Culex tritaeniorhynchus, Aedes albopictus,
and Aedes aegypti mosquitoes. American Journal of Tropical Medicine and Hygiene
62: 480-484. http://www.ajtmh.org/cgi/content/abstract/62/4/480; retrieved 17 June
2008.
2. Biosecurity New Zealand (BNZ) 2005. Import Health Standard for the Importation
into New Zealand of Specified Animal Products and Biologicals.
http://www.biosecurity.govt.nz/files/imports/animals/standards/ineproic.all.pdf;
retrieved 21 April 2008.
3. Buckland, BC 2005. The process development challenge for a new vaccine.
Nature medicine supplement 11: S16-S19.
4. Hearnden, M, Skelly, C, Weinstein, P 1999. Improving the surveillance of mosquitoes
with disease-vector potential in New Zealand. New Zealand Public Health Report 6:
25-32. http://www.moh.govt.nz/moh.nsf/Files/phr0499/$file/phr0499.pdf; retrieved
17 June 2008.
5. Immunisation Advisory Centre 2002. Immunisation Advisory Centre (IMAC)
Vaccine Storage and Distribution National Standards, 2nd edition. IMAC,
University of Auckland.
http://www.immune.org.nz/site_resources/Professionals/Cold%20Chain/IMAC_Vacci
ne_Storage_&_Distribution_National_Standards_May_2002.pdf; retrieved 18 April
2008.
6. Medsafe 2007. STAMARIL® Data Sheet – Yellow Fever Vaccine (Live), Stabilised.
http://www.medsafe.govt.nz/Profs/Datasheet/s/Stamarilvac.htm; retrieved 17 June
2008.
7. Landcare Research (2004). Keys to the Mosquitoes of New Zealand.
http://www.landcareresearch.co.nz/research/biocons/invertebrates/mosquitoes/Mosqui
toes%20of%20New%20Zealand/html/generalInfo.htm; retrieved 17 June 2008.
8. Ministry of Health 2006. Pandemic response: functions. In: New Zealand pandemic
influenza action plan 2006. Ministry of Health.
http://www.moh.govt.nz/moh.nsf/pagesmh/5180/$File/part-b-two.pdf; retrieved 17
April 2008.
9. Monath, TP, Guirakhoo, F, Pugachev, K 2004. Vaccines against flavivirus
hemorrhagic fevers. Conference Abstract for Vaccines 3: Frontiers in Vaccine
Development Euroconference 7-8 October 2004, Paris France.
http://www.pasteur.fr/applications/euroconf/vaccines3/15_Monath_Abstract_.pdf;
retrieved 17 June 2008.
Environmental Risk Management Authority Decision: Application NOC08002 Page 14 of 17
10. World Health Organization 2005. Guidelines on the international packaging and
shipping of vaccine. Immunization, Vaccines and Biologicals. Department of
Immunization, Vaccines and Biologicals, WHO Document Production Services,
Geneva, Switzerland. http://www.who.int/vaccines-documents/DocsPDF06/818.pdf;
retrieved 10 April 2008.
11. World Health Organisation 2006. Development of new vaccines. Factsheet No 289.
http://www.who.int/mediacentre/factsheets/fs289/en/index.html; retrieved 17 April
2008.
Environmental Risk Management Authority Decision: Application NOC08002 Page 15 of 17
Appendix 1: Controls Required by the 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 a containment facility that complies with
these controls.
1.2 The construction, operation, and management of the organism containment facility for
the import of new organism shall be in accordance with the:
 MAF/ERMA New Zealand Standard Facilities for Microorganisms and Cell
Cultures: 2007a2;
 Australian New Zealand Standard AS/NZS 2243.3:20023 Safety in Laboratories:
Part 3: (Microbiological aspects and containment facilities); and
 Physical Containment level 1 (PC1) requirements of the above Standards.
1.3 Microorganisms held for storage under this standard must be adequately labelled and
stored securely to prevent unauthorised access.
1.4 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.
1.5 The containment facility shall be approved by Ministry of Agriculture and Forestry
(MAF), in accordance with section 39 of the Biosecurity Act.
2
To exclude unauthorised people from the facility:
2.1 The identification of entrances, numbers of and access to entrances, and the security
requirements for the entrances and the facility shall comply with the standards listed in
Control 1.2 of this decision document.
3
To control the effects of any accidental release or escape of an organism:
3.1 Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.2 relating to the control of the effects of
any accidental release or escape of an organism.
2
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by
ERMA New Zealand.
3
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: Application NOC08002 Page 16 of 17
3.2 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.
3.3 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 included in the
containment manual in accordance with the requirements of standards listed in
control 1.2.
3.4 The applicant shall comply with the requirements of the standards listed in control 1.2
listed above relating to the maintenance of records demonstrating compliance with the
standards, as required by the quality assurance programme, and documented in the
containment manual.
4
Inspection and monitoring requirements for containment facilities:
4.1 The inspection and monitoring requirements for the containment facility shall comply
with the standards listed in control 1.2 of this document.
4.2 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.
5
Qualifications required of the persons responsible for implementing these controls:
5.1 The training of personnel working in the facility shall comply with the standards listed in
control 1.2.
6
Additional Controls:
6.1 Importations under this approval are limited to MoH. However, vaccines may be stored
in other facilities that meet the controls on this approval, under a contractual arrangement
with MoH.
6.2 The vaccines can only be stored under this approval. Vaccine vials must remain
unopened during storage in their original packets or packaging.
6.3 The individual responsible for exercising this approval (whether that be the Operator or
an individual designated to carry out the requirements of this approval) shall provide
MAFBNZ on each application for a permit to import, a description that uniquely
identifies the organism to be imported and evidence that the organism fits within the
organism description in this approval.
6.4 All packages of organisms imported in accordance with this approval shall be clearly
labelled with the ERMA New Zealand application code and the direction that the
package should not be opened at the border, and shall only be opened within the
containment facility. The package should also be accompanied by the appropriate
documentation specifying this direction and attached to the package in such a way that
the package does not have to be opened to access the documentation.
Environmental Risk Management Authority Decision: Application NOC08002 Page 17 of 17