ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 6 September 2007
24 May 2006
NOC04012
Application code:
Application category: To import into containment new organisms for maintaining them for diagnostic
purposes.
The Investigation and Diagnostic Centre (IDC), Ministry of Agriculture and
Applicant:
Forestry (MAF).
To import and maintain in containment for diagnostic purposes strains of
Purpose:
microorganisms that may cause disease to animals involved in New Zealand’s
primary industries.
19 April 2005
Date received:
30 March 2006
Hearing date:
24 May 2006
Decision date:
A Committee of the Environmental Risk Management Authority
Considered by:
1
1.1
Summary of decision
Application NOC04012 to import into containment for diagnostic purposes
microorganisms that may cause disease of significance to animals involved in New
Zealand’s primary industries is approved with controls (specified in Appendix 1of this
Decision), having been considered in accordance with the relevant provisions of the
Hazardous Substances and New Organisms (HSNO) Act 1996 and of the HSNO
(Methodology) Order 1998.
2
Legislative criteria for application
2.1
The application was lodged by the Ministry of Agriculture and Forestry’s (MAF)
Investigation and Diagnostic Centre (IDC) (formerly the National Centre for Disease
Investigation (NCDI)) located in Wallaceville, Upper Hutt, pursuant to section
40(1)(a) of the Hazardous Substances and New Organisms Act (HSNO) Act 1996 (the
Act). The Decision was made in accordance with section 45 of that Act taking into
account additional matters to be considered under sections 37 and 44, and matters
relevant to the purpose of the Act, as specified under 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 Hazardous
Substances and New Organisms (Methodology) Order 1998 (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 clauses in
this Decision refer to clauses of the Methodology.
3
Application Process
Application Receipt
3.1
The application was formally received on 19 April 2005. Further information was
sought from the applicant in accordance with section 58(1)(a) of the Act about the
containment facility and procedures followed by the applicant in operating the
facility.
Notification
3.2
The application was publicly notified on 4 May 2005 in accordance with section
53(2)(a) of the Act 1996. Notification was made in accordance with clause 7 of the
Methodology and the method of public notification was that determined by the
Authority pursuant to section 53A of the HSNO Act 1996. Notice of the public
notification was placed on the ERMA New Zealand website (on 4 May 2005) and
published in The Dominion Post, The New Zealand Herald, The Press and The Otago
Daily Times (on 11 May 2005). The Minister for the Environment was notified of
receipt of the application on 4 May 2005 in accordance with section 53(4)(a) of the
Act.
Decision Making Committee
3.3
In accordance with section 19(2)(b) of the Act and clauses 42 and 43(2)(b) of the
First Schedule to the Act, the Environmental Risk Management Authority (the
Authority) appointed a committee (“the Committee”) of its members to hear and
determine the application. The Committee comprised: Dr Max Suckling (Chair), Ms
Helen Atkins and Dr Kieran Elborough.
Submissions
3.4
Public submissions closed on 16 June 2005. Submissions conforming to sections
54(2)(a) and (b) of the Act were received from Federated Farmers of New Zealand
(Inc)and Meat & Wool New Zealand Ltd, who both supported the application, the
Poultry Industry of New Zealand (Inc) (PIANZ) and the Egg Producers Federation of
New Zealand (a joint submission), who opposed the import of infectious bursal
disease virus (IBDV) and Mr NK Wierzbecki who opposed the application.
Federated Farmers, PIANZ, and Mr Wierzbecki indicated that they wished to be
heard, in accordance with section 54(2)(c) of the Act.
Consultation with government departments
3.5
In accordance with section 53(4) of the Act and clause 5 of the Methodology, and for
the purpose of section 58(1)(c) of the Act, the Department of Conservation (DoC) and
the Ministry of Agriculture and Forestry (MAF) were notified of the receipt of the
application. Submissions were received from both DoC and MAF.
Experts
3.6
In accordance with section 58(1)(a) of the Act and clauses 17 and 18 of the
Methodology, the Authority appointed Dr AJ Robinson, Canberra, Australia, to
review the information provided with the application, the submissions received on the
application, other advice with respect to the application, and the Evaluation and
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Review (E&R) report prepared by ERMA New Zealand. Dr Robinson provided
ERMA New Zealand with written reports on his findings.
Information available for the consideration
3.7
The information available for the consideration comprised:


the application NOC04012 (Form NO2N) and appendices;
the E&R Report prepared by the ERMA New Zealand project team to assist
and support decision-making, and incorporating:
 information provided by the applicant to ERMA New Zealand in
response to requests for further information;
 the submissions received in response to public notification of the
application, and from DoC and MAF;
 responses by the applicant to those submissions.
Hearing
3.8
In accordance with section 60(a) of the Act and clause 2(b) of the Methodology, a
public hearing was held at the Bay Plaza Hotel, Oriental Parade, Wellington on 30
March 2006.
3.9
Dr Hugh Davies, Director, MAF Biosecurity New Zealand’s Investigation and
Diagnostic Centres, made a presentation at the hearing on behalf of the applicant.
3.10
In response to a request from the Committee to MAF Biosecurity New Zealand,
presentations were made at the hearing by Mr Peter Webb, National Programme
Manager, MAF Quarantine Service, and by Mr Kevin Corrin, Team Manager,
Operational Standards, MAF Biosecurity New Zealand Pre Clearance Directorate.
3.11
Presentations were also made at the hearing in respect to their submissions by Mr
Wierzbecki, Ms Natalie Gerber, Executive Officer, Technical, PIANZ and the Egg
Producers’ Federation, and Mr Charlie Pederson, National President of Federated
Farmers.
3.12
DoC notified ERMA New Zealand by email on 3 March 2006, that it considered that
all their concerns had been addressed adequately in the E&R report, and therefore
they no longer wished to be heard in regard to the application.
3.13
Mr Shaun Slattery, Programme Manager, New Organisms, made a presentation in
regard to the E&R report on behalf of ERMA New Zealand.
4
Sequence of the consideration
4.1
In accordance with clause 8 of the Methodology, and immediately following the
hearing on 30 March 2006, the Committee considered the information provided by the
sources listed in 3.7 above and presented at the hearing. The approach adopted by the
Committee was to look sequentially at identification, assessment and the combined
evaluation of risks and of costs and benefits. Identification of potential risks and costs
took into account the matters in clauses 9 and 10 of the Methodology. Integral to this
was consideration of the proposed containment regime and the operation of the
containment facility. Controls were considered in relation to the identified risks; these
risks were assessed according to clause 12 of the Methodology. Costs and benefits
were assessed in accordance with clause 13 of the Methodology.
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4.2
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 ability of the
organisms to escape from containment and form self-sustaining populations. Controls
were imposed to satisfactorily provide for the matters in Schedule 3, Part II of the Act.
4.3
Risk characteristics were then established, in accordance with clause 33 of the
Methodology. Finally, taking account of the risk characteristics established in
accordance with clause 33 of the Methodology, the combined impact of risks, costs
and benefits was evaluated in accordance with clause 34.
5
Purpose of application
5.1
The Committee is satisfied that the purpose of this application is to maintain new
organisms in containment for diagnostic purposes in conformity with section 39(1)(g)
of the Act.
6
Adequacy of the containment regime
6.1
The Committee considered the adequacy of containment for the purpose of section
45(1)(a)(iii) of the Act, and the magnitude and probability of the risks, costs and
benefits at the same time and in an integrated fashion. This is because the former
interact with the latter and this is recognised in clause 12 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 assessing the ability of organisms to escape from containment, the Committee
considered the:
 Biological characteristics of the organisms;
 Proposed containment regime; and the
 Potential pathways for the escape of the organisms from the containment
facility.
Biological characteristics of the organisms
6.3
The biological characteristics of the organisms were defined in the application, and
assessed in the E&R report, as Risk Group 1, Risk Group 2 or Risk Group 3
microorganisms (as defined by the Australian/New Zealand Standard 2243.3:2002 –
Safety in laboratories Part 3: Microbiological aspects and containment facilities);
these organisms are capable of being contained within a PC3 containment facility.
Risk Group 4 microorganisms were excluded from the application, and by a control
imposed by this Decision (Appendix 1).
6.4
The Committee considered that all of the organisms should be considered hazardous
to the environment and agriculture in New Zealand because of their potential to cause
enzootic disease in sheep, cattle, goats, pigs, horses, rabbits, deer, bats, rodents, other
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mammals; birds; fish; crustaceans; or other animals. A subset of these organisms is
zoonotic (transmissible from animals to humans) and therefore poses a threat to public
health.
6.5
The Committee noted that organisms differ in the routes by which they may cause
infection in susceptible species. Some of the organisms are highly contagious and can
be transmitted via direct contact with infected animals or material; others are
infectious by oral, respiratory and conjunctival exposure, particularly by inhalation of
aerosols (suspensions in air of finely dispersed solids or liquids).
6.6
The Committee noted also that the microrganisms organisms differ in the length of
time they will survive in the environment outside of a susceptible host or culture
medium. Some are very stable in the environment, but others rapidly die or lose their
pathogenicity when exposed to environmental conditions outside of a host animal.
6.7
The applicant specifically excluded from the application viruses that cause vesicular
diseases of cattle, pigs and horses, specifically: foot-and-mouth disease virus, swine,
vesicular disease virus, vesicular stomatitis viruses, and vesicular exanthema of swine
virus, also known as swine vesicular exanthema virus.
6.8
According to the applicant, the microorganisms listed in section 6.7 above were
excluded from this application, not on the basis of their Risk Group classification
(none are Risk Group 4), but because of high political and social sensitivity of the
farming community to these particular diseases.
6.9
The Committee accepts the applicant’s decision to exclude from the application
organisms listed in 6.7 above. The Committee considers that these viruses are unique
in their potential to impact on the New Zealand economy and that it is very unlikely
that any other Risk Group 3 organisms would have comparable economic risk
profiles.
6.10
The Committee considered the joint submission from the Poultry Industry Association
of New Zealand (PIANZ) and the Egg Producers Federation of New Zealand that
infectious bursal disease virus (IBDV) should be excluded from an approval. The
Committee notes that IBDV has the biological characteristics of a Risk Group 3
organism, and is therefore capable of being contained within a PC3 containment
facility. Furthermore, the Committee notes that IBDV was last detected in New
Zealand in 1999 and that MAF Biosecurity New Zealand has declared IBDV an
endemic disease. On the evidence provided, the Committee does not consider that
IBDV has been eradicated from New Zealand and therefore considers IBDV not to be
a new organism in terms of the Act. The Committee also notes that IBDV is an
unwanted organism under the Biosecutity Act 1993 and restrictions under that Act to
the importation of unwanted organisms apply to IBDV. For these reasons the
Committee does not consider that there is a basis on which to exclude IBDV from an
approval of the present application.
6.11
The Committee notes that section 20(2)(b) of the Act requires the Authority to keep a
register that uniquely identifies each organism, and notes DoC’s submission that the
identity of organisms and their degree of pathogenicity should be known before they
are imported into containment. Although the Committee recognises that there are
precedents for approving importation of unidentified organisms into containment, it
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imposes a control (Appendix 1), recommended in the E&R report, requiring that the
applicant provides MAF Biosecurity New Zealand, on application for a Permit to
Import, with a description that uniquely identifies each organism to be imported, and
evidence that each of the organisms to be imported have the biological characteristics
of Risk Group 1, Risk Group 2 or Risk Group 3 microorganisms (as defined by the
Australian/New Zealand Standard 2243.3:2002 – Safety in laboratories Part 3:
Microbiological aspects and containment facilities).
Containment regime
Structure of the containment facility
6.12
The Committee notes that the structure has been built in accordance with the best
international practices and in some respects exceeds the requirements for a PC3
facility as defined in the Australian/New Zealand Standard 2243.3:2002 – Safety in
laboratories Part 3: Microbiological aspects and containment facilities. The PC3
facility is located in a building that is designed for maximum earthquake resistance, a
category 1 structure, the highest category in the structure design code. All windows to
the facility are sealed and made from double-glazed laminated safety glass that is
strengthened to reduce the chance of a containment breach through accidental
breakage. The building structure is designed to form a physical barrier for
microorganisms, where the concept of containment is a sealed building in which
individual rooms are maintained at different negative air pressures in relation to the
external environment.
6.13
The Committee considers that IDC’s PC3 facility is the only place in New Zealand to
which an approval should apply, not only because of the structure of the facility, but
also because of the manner of its operation and the training of its staff, detailed in
IDC’s Standard Operating Procedures. This Decision imposes a control that this
approval is limited to use at MAF’s Investigation and Diagnostic Centre (IDC) PC3
containment facility, Wallaceville, Upper Hutt (Appendix 1).
Treatment, decontamination and disposal of material
6.14
The Committee notes the E&R report’s conclusion that the laboratory ventilation
system at IDC’s PC3 laboratory, the procedures for decontamination of materials
(including equipment and clothing) for continued use, the treatment of wastewater,
and other procedures for the disposal of biological waste meet the requirements
specified in the Australian/New Zealand Standard 2243.3:2002 – Safety in
laboratories Part 3: Microbiological aspects and containment facilities). The
Committee agrees with the E&R report’s conclusion that it is highly improbable that
the organisms would escape from containment via these pathways.
Security in the event of foreseeable hazards
6.15
The Committee has considered the security of containment in the event of foreseeable
hazards such as fire, spills and mechanical failure of equipment. The E&R report
noted that IDC has emergency plans and training schedules for potential emergencies,
including fire, earthquake, biohazard or chemical spill, gas leak, security threat or
medical emergency. These procedures are designed to minimise any breach of
containment and potential release of infectious agents into the environment, without
putting human life at risk.
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6.16
The E&R report notes that when a fire is detected within the PC3 facility the building
management system will automatically shut down the air handling system. The fire
suppression system uses INERGEN gas. The exhaust fans shut down before the
INERGEN gas discharge but the high volumes of gas flooding the zone will force air
out of the building through the air locks and the intake fans. In the highly improbable
event of the gas flooding coinciding with a centrifuge accident that created an
infectious aerosol, containing for example an influenza virus, the contaminated air
would be forced from the laboratory. However, the E&R report noted that because
contaminated air released from a point source would not contain sufficient virus to
infect animals at 250 metres, the increased dilution resulting from inert gas discharge
forcing air out at multiple sites would further ensure that there is negligible risk to
animals or people in the local area..
6.17
The Committee reviewed IDC’s procedures, outlined in the E&R report, for dealing
with biohazards and spills within the PC3 facility. The Committee considers that they
adequately address any risks of escape of organisms following accidental release or
spillage of microorganisms within the PC3 facility, and meet the requirements of the
MAF ERMA Standard: Containment facilities for microorganisms: Standard
154.03.02.
6.18
The Committee also examined the potential for escape of microorganisms following
mechanical failure of risk mitigation features in IDC’s PC3 containment facility. The
Committee notes that the E&R report presented a detailed risk assessment of a worst
case scenario: escape of an aerosol of influenza viruses resulting from an ultracentrifuge failure. Taking that assessment into account, the Committee considers that
it is highly improbable that such an event would occur, and if it did, it is highly
improbable that an infectious dose of organisms would escape containment.
6.19
The Committee notes that the E&R report concluded that IDC’s has comprehensive
Standard Operating Procedures, contingency plans and emergency procedures for
dealing with spills, fire, mechanical failure of equipment, earthquake, or other natural
disasters. These adequately meet the requirements of the Australian/New Zealand
Standard 2243.3:2002 – Safety in laboratories Part 3: Microbiological aspects and
containment facilities, and the MAF ERMA Standard: Containment facilities for
microorganisms: Standard 154.03.02. Taking account of these procedures, the
Committee considers it highly improbable that a breach of containment would occur
during or following such events.
Access of persons to the facility
6.20
The Committee notes that access to the facility is restricted by security doors at all
points. To enter the facility a confidential PIN number must be used and in addition
an electronic access card with the appropriate level of authorisation swiped. The
Committee notes that all staff with access to the facility are subject to a security
clearance carried out by MAF and the New Zealand Security Intelligence Service.
6.21
The E&R report noted that unauthorised access is monitored by motion sensors within
the building which activate a monitored alarm system. The windows of the PC3
laboratory are reinforced; if someone did manage to break in the alarms would sound.
There are also security patrols of the grounds of the Wallaceville campus. The
Committee notes that that IDC’s procedures to control access to the PC3 facility meet
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and exceed the requirements specified in MAF Biosecurity Authority/ERMA New
Zealand: Containment Facilities for Microorganisms. Standard 154.03.02, and
considers it improbable that unauthorised persons would succeed in gaining access to
and removing organisms from the facility.
Monitoring and quality assurance procedures
6.22
The Committee notes that IDC has a fully operational quality assurance programme
that is accredited to ISO 17025: general requirements for the competence of testing
and calibration laboratories. The E&R report noted that IDC has measures in place to
ensure that it conducts internal audits in compliance with the requirements of the
MAF/ERMA Standard: Containment facilities for microorganisms: Standard
154.03.02.
6.23
The Committee notes that IDC’s PC3 facility has been operating without serious
incident since 2000, and that the facility has a number of features and practices of a
PC4 containment facility. These include clothing change on entry, shower on exit, all
material decontaminated before it leaves the containment facility, the availability of
positive personal hoods if required, and the containment laboratory being located in a
separate building. The Committee considers that these features should continue to be
part of IDC’s normal practices and covered by IDC’s containment facility manual.
The Committee notes that ‘PC3+’ is not recognized as a level of containment in the
Australian/New Zealand Standard 2243.3:2002 – Safety in laboratories Part 3:
Microbiological aspects and containment facilities, and there are no ‘PC3+’ standards
against which the facility could be audited. Consequently it would be inappropriate to
apply the term ‘PC3+’ in any controls imposed by this Decision.
6.24
This Decision imposes a control (Appendix 1) requiring IDC to review all of its
Standard Operating Procedures for its PC3 facility at least every three years, and
amend and update them and its containment facility manual to take account of the
outcomes of the reviews. Furthermore the control stipulates that these procedures
shall be no less stringent than those at the time of this approval.
6.25
The Committee noted that several submissions, including that from Federated
Farmers, considered that an external audit of the facility, to be carried out by people
from an organisation other than MAF, was needed. At the hearing, Dr Davies,
informed the Committee that MAF Biosecurity New Zealand had decided to contract
an Australian auditor, experienced in auditing PC3 facilities in Australia, to undertake
an annual audit of IDC’s PC3 containment facility in conjunction with MAF
Biosecurity New Zealand’s Quarantine Service auditors. This would provide on-site
supervision and training for the New Zealand auditors. Dr Davies said that when the
Australian auditor was satisfied that competence of the New Zealand auditors was of
an appropriately high standard, the frequency of the Australian auditor’s participation
would be reduced, for example to once every three years.
Staff training and experience
6.26
In its submission, Federated Farmers stated that they considered that IDC’s staff may
have insufficient experience in PC3 facilities. The Committee considers experience in
other PC3 facilities to be invaluable for IDC’s staff, and notes that a number of IDC’s
staff have experience in leading containment laboratories in North America and
Europe. The Committee notes the E&R report’s conclusion the IDC has procedures
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that ensure that only appropriately trained and qualified staff have access to the PC3
laboratory.
Potential pathways for escape of the organisms from containment
6.27
The Committee identified potential pathways for escape from containment as:
 escape as a result of interference with structural integrity of facility (e.g. via
natural disaster or criminal activity);
 escape during transportation (between the border and the facility);
 deliberate removal of microorganisms from the facility (eg by unauthorised
persons);
 inadvertent removal of microorganisms from the facility, e.g. via:

infection of personnel working with the microorganisms;

passive vectoring (e.g. on clothing or skin of personnel);

contaminated liquid or solid waste;

air discharged.
Escape as a result of structural interference with the facility
6.28
Taking account the structure of the facility, the internal and external security
monitoring and systems of the facility, and the control of access of persons to the
facility, the Committee considers that it is highly improbable that organisms would
escape from the facility as a result of interference with the structural integrity of the
facility.
6.29
The Committee noted the statement by Dr Davies at the hearing that, even if the
containment laboratory was demolished by a severe earthquake, it is probable that the
protective casing of the vials containing the organisms would remain intact,
preventing the organisms escaping containment. The Committee considers that while
there was no supporting evidence for these claims it is reasonable to conclude that the
primary containers holding the organism within the facility would provide an
additional level of containment security.
Transport and packaging of organisms
6.30
The Committee has given close attention to potential pathways for escape of the
organisms during their transport from the New Zealand border to IDC’s PC3
containment facility. In particular the Committee notes MAF’s submission that details
of the means of transport from the border to IDC should be documented and approved
by MAF.
6.31
The E&R report noted that the Australian/New Zealand Standard 2243.3:2002 –
Safety in laboratories Part 3: Microbiological aspects and containment facilities and
the MAF Biosecurity Authority/ERMA New Zealand: Containment Facilities for
Microorganisms. Standard 154.03.02 require that all materials that are infectious or
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thought to be infectious to humans or animals shall be packaged according to the
Packaging Instruction No. 602 of the International Air Transport Association (IATA)
Dangerous Goods Regulation. However, the packaging requirements described in the
MAF Biosecurity Authority/ERMA New Zealand: Containment Facilities for
Microorganisms. Standard 154.03.02 only apply to organisms that are transported out
of containment facilities registered under that standard. When the samples are
imported from overseas laboratories an applicant is not obliged to ensure that the
above packaging requirements are met.
6.32
6.33
To addresses these issues, this Decision imposes a number of controls (Appendix 1),
including the following regarding packaging and labelling within New Zealand:

All organisms shall be transported to and within New Zealand in packages
complying with the packaging (Packing Instruction No 602) and labelling
requirements of the most recent version of the IATA Dangerous Goods
Regulations and the packaging requirements of MAF Biosecurity Authority
/ERMA New Zealand Standard 154.03.02 Containment Facilities for
Microorganisms and Australian/New Zealand Standard 2243.3: 2002 - Safety
in laboratories Part 3: Microbiological aspects and containment facilities.

Documentation from the exporting facility shall fully describe the identity and
Risk Groups of the organisms being transported to and within New Zealand,
and shall be prominently and securely attached to and accompany each
package.

Each package shall be clearly labelled that it shall not be opened in transit to
New Zealand from its point of origin in the exporting facility, or at the New
Zealand border, or in transit within New Zealand to IDC’s PC3 containment
facility at Wallaceville, Upper Hutt. The inner sealed package shall be opened
only within a Class II biological safety cabinet within IDC’s PC3 containment
facility at Wallaceville, Upper Hutt, in the presence of a scientist with
knowledge and expertise in managing the biological safety requirements of the
organisms within the package.
In regard to documentation and approvals of transport between the New Zealand
border and IDC, this Decision also imposes additional controls, viz:

IDC shall notify in writing MAF Biosecurity New Zealand Quarantine Service
(MAF QS) for its approval, details of the proposed means and schedule of
transport of each package of organisms from the New Zealand border to IDC,
Wallaceville, at least one calendar month before the date of each expected
importation (unless an alternative date is agreed with MAF QS).

MAF QS shall notify IDC, and confirm in writing, every approval of the
means and schedule of transport of each package from the New Zealand
border to IDC Wallaceville. The dispatch of packages from the border shall
proceed only after IDC acknowledges in writing MAF QS’s notification of the
approval.
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6.34

IDC shall arrange for a trained member of IDC staff, or a MAF QS staff
member, or an approved courier, e.g. World Courier, with expertise in secure
transport of biological material, to oversee the movement of each package
from the border to IDC’s PC3 facility at Wallaceville, Upper Hutt, according
to the approval notified by MAF QS.

IDC shall notify MAF QS immediately by telephone of arrival of each
package within IDC’s PC3 containment facility, and confirm in writing with
MAF QS, within 24 hours, the arrival of each package, and that each package
arrived within the facility intact, undamaged and unopened.

Both MAF QS and IDC shall each maintain written records of the dates and
times of dispatch of each package from the border and arrival of each package
within the PC3 facility at Wallaceville, Upper Hutt. MAF QS and IDC shall
ensure that their records are identical.

These controls shall apply also to the transport of any the organisms from
IDC, Wallaceville within New Zealand, including to the border for export.
The Committee notes that the MAF Biosecurity Authority /ERMA New Zealand
Standard 154.03.02 Containment Facilities for Microorganisms stipulates that the
facility operator must keep records of authorisations for movement and biosecurity
directions for a minimum of five years. The Committee also observes that
Government departments and agencies such as MAF are required to keep and
permanently archive all such records. The Committee therefore considers it
unnecessary to impose an additional control specifying the length of time records
must be kept.
Deliberate removal of the organism from the facility
6.35
The Committee notes that all staff with access to the facility are subject to security
clearance by MAF and the New Zealand Security Intelligence Service, and considers
that IDC’s security procedures are adequate to prevent the unauthorised access to the
facility. The Committee considers it improbable that organisms would be removed
illegally from the containment facility by authorised or unauthorised persons.
Inadvertent removal of organisms from the facility
6.36
Based on the IDC’s laboratory operating procedures, the training staff receive, the
diagnostic nature of the work proposed in the application and the controls imposed by
this Decision, the Committee considers that it is highly improbable that escape from
containment would occur by inadvertent removal by laboratory workers or other
persons (eg on skin, clothing, or via infection).
6.37
The Committee notes the E&R report’s conclusion that IDC’s laboratory ventilation
system and its laboratory procedures ensure that all air, infectious waste , equipment
and clothing is decontaminated in accordance with the requirements of the
Australian/New Zealand Standard 2243.3:2002 – Safety in laboratories Part 3:
Microbiological aspects and containment facilities, before leaving the containment
facility, and considers it highly improbable that the organisms would escape from
containment via these pathways.
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Overall assessment of the adequacy of containment
6.38
Taking account of the structure and operation of the facility, the training,
qualifications and experience of IDC staff, IDC’s comprehensive Standard Operating
Procedures, the monitoring and auditing systems for the PC3 facility, and the
proposed controls, the Committee considers that it is highly improbable that the
organisms will escape from containment. The Committee is satisfied that the
organisms proposed to be imported under this approval can be adequately contained
in accordance with section 45(1)(a)(iii) of the Act.
7
Ability of the organisms to establish an undesirable selfsustaining population
7.1
In accordance with sections 37 and 44 of the Act and clauses 10(e) and (f) of the
Methodology, the Committee considered the ability of the organisms to escape
containment and to establish an undesirable self-sustaining population, and the ease
with which the organisms could be eradicated if undesirable self-sustaining
populations were established.
7.2
The Committee considered it appropriate to adopt a ‘worst case scenario’ approach,
by, for example, assuming that vectors may be present in New Zealand (for
microorganisms that require vectors for transmission between hosts) at the time of any
escape even though they may not be present now.
7.3
The Committee notes and accepts the evidence presented by the applicant that there is
an extremely low likelihood that susceptible host animals would be near the PC3
facility at Wallaceville at the time of any escape and be exposed to a dose of any
pathogen sufficient to lead to a viable, self-sustaining infection.
7.4
The Committee agrees with the assessment in the E&R report that escape leading to
pathogenic infection of terrestrial animals is highly improbable, and is very likely to
be detected at an early stage and eradicated by control measures. The Committee
considers that escape of viable aquatic microorganisms and subsequent establishment
of self-sustaining populations in aquaculture or other aquatic species to be highly
improbable, taking account IDC’s procedures for preventing entry of viable
microorganisms into wastewater and their treatment of wastewater before it is
discharged into the sewage system.
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8
Identification of the potentially significant adverse effects
(risks and costs) of the organisms
8.1
Potentially significant risks and costs identified for assessment and evaluation are set
out in the following sections, following clauses 9 and 10 of the Methodology, which
incorporate sections 5, 6 and 8 of the Act. The Committee noted and agreed with the
analyses presented in the E&R report of other adverse effects identified as not
potentially significant, and considered that no further consideration of them was
necessary.
8.2
In accordance with sections 5 and 6 of the Act and clause 9 of the Methodology, the
Committee categorised the potential adverse effects, risk and costs of this application
under the headings of the environment, human health and safety, communities and
society, and the market economy.
8.3
In regard to sections 6(d) and 8 of the Act, concerning the relationship of Māori and
their culture and traditions with taonga, and the Treaty of Waitangi, the Committee
agreed with the project team’s conclusions in the E&R report, that the pathways of
exposure of native species and their associated mauri and the mauri ora of human
health from the adverse effects of the microorganisms to be the same as those
identified in regard to the environment, human health and safety, communities and
society, and the market economy. They were not, therefore, considered separately.
8.4
The following potentially significant adverse effects were identified under each
category:
8.5
Potentially significant adverse effects on the environment:



8.6
Potentially significant adverse effects on human health and safety:


8.7
Adverse effects on native and other valued terrestrial fauna resulting from
escape of the organisms from containment in aerosols.
Adverse effects on native fish and other valued aquatic fauna resulting from
escape of organisms in wastewater.
Deterioration of ecosystems if an escaped pathogenic organism could not be
eradicated from the environment and caused loss of genetic diversity
Adverse effects on human health and safety due to occupational exposure of
people within the containment facility to zoonotic microorganisms.
Adverse effects on public health and safety in the event of escape of
organisms from containment through infection of laboratory workers by
zoonotic microorganisms.
Potentially significant adverse effects on communities and society:

Adverse effects in terms of loss of reputation, loss of confidence in the
facility, and loss of confidence in science in the event of escape of organisms
from containment.
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8.8
Potentially significant adverse effects on the market economy:

Economic impacts of the infection of animals and/or people in the event of
escape of organisms from containment.
9
Identification of the potentially significant beneficial effects
(benefits) of the organisms
9.1
Potentially significant benefits of maintaining the organisms in containment for
diagnostic purposes were identified for assessment and evaluation, following clauses
9 and 10 of the Methodology, which incorporates sections 5, 6 and 8 of the HSNO
Act, were as follows:
9.2
Potentially significant beneficial environmental effects:



9.3
Potentially significant beneficial effects on human health and safety:

9.4
10
Improved control of human disease by more rapid and thorough diagnostic
testing for the suspected presence of zoonotic organisms in New Zealand.
Potentially significant beneficial effects on communities and society:

9.5
Improved and more rapid diagnoses and responses to disease of native and
other valued animals, including farmed animals and aquaculture species.
More rapid elimination of disease threats diagnosed as negative.
More rapid detection of pathogenic organisms that may be new to science or
pathogenic mutant strains of previously benign organisms.
Upskilling of the workforce, scientific benefits and new technologies.
Potentially significant beneficial effects on the market economy:

Enhanced accuracy of responses (eg through elimination of false positives) to
biosecurity threats.

Enhanced speed of responses to biosecurity threats, resulting, for example, in
fewer animals needing to be quarantined or destroyed and less damage to
overseas markets.

Enhanced responses to criminal activity involving pathogenic organisms.
Assessment of the potentially significant adverse effects
(risks and costs)
Approach and coverage
10.1
The risks and costs assessed below are those identified as potentially significant,
having regard for those matters set out in clauses 9 and 10 of the Methodology. Risks
were considered in terms of the requirements of clause 12 of the Methodology,
including especially the assessment of consequences and probabilities, the impact of
uncertainty and the impact of risk management. Costs were considered in terms of
clause 13 of the Methodology. Evidence available to the Committee was evaluated in
accordance with clause 25 of the Methodology.
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10.2
For each risk the Committee addressed the following considerations, as set out in the
Methodology, as far as is reasonably practicable considering the particular nature of
each risk.






10.3
The nature of the adverse effect (clause 12(a)).
An assessment and evaluation of likelihood and consequence (clause 12(b)).
Where possible, an assessment of the level of risk as a combination of the
likelihood of occurrence and the magnitude of the adverse effect (clause
12(c)).
The risk management proposals and their effect on both the risk and the
uncertainty associated with the risk (clause 12(d)).
An assessment of what all the effects of the organisms should the organisms
escape containment, (section 45).
An explicit consideration of the uncertainty bounds on the estimates (clause
12(e)). How uncertainty affects the assessment of the risk (clause 25 scientific and technical uncertainty, clause 29 - materiality of uncertainty,
and clause 30 - need for caution where not resolved).
A “cost” is defined in the Methodology as “the value of a particular adverse effect
expressed in monetary or non-monetary terms”. Each risk will have an associated
cost, which is the reason for linking costs and risks together. The Methodology and
the Act both call for consideration of monetary and non-monetary costs (clause 13
and section 9). Explicit consideration of the uncertainty associated with the estimate
(clause 25: scientific and technical uncertainty, clause 29: materiality of uncertainty
and clause 30: need for caution where not resolved) may also be required.
Potentially significant adverse effects on the environment
Potential for adverse effects on native fauna and valued introduced species from
escape from containment of pathogenic microorganisms
10.4
The Committee notes the risk assessments prepared by the applicant and discussed in
the E& R report and the two potentially significant exposure pathways via aerosols
and wastewater as discussed in paragraphs 6.27- 6.38.
Risks to native and valued terrestrial fauna
10.5
In the highly improbable event of escape of microorgansms in aerosols, for an adverse
environmental effect to occur, native terrestrial fauna (or other valued terrestrial
species) would then need to be infected, develop disease, die and/or suffer other
adverse effects such as reduced fertility in response to the infection. The likelihood of
a succession of such improbable events occurring is remote, but given the wide range
of microorganisms covered by this generic application, there is uncertainty about the
range of potential adverse effects. Taking a worst case scenario, such as the escape
and development of a self-sustaining population of a pathogen with a broad host range
including rare native species, the magnitude of adverse effects could range from
moderate to massive. Examples of worst case scenarios would be escape and
subsequent wide dispersal throughout New Zealand of organisms pathogenic to kiwis,
bats or parrots, with a potential to adversely affect remaining populations of the little
Environmental Risk Management Authority Decision: Application NOC04012
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spotted kiwi (Apteryx owenii), lesser short-tailed bat (Mystacina tuberculata) or
kakapo (Strigops habroptilus).
10.6
The exposure analysis suggests that the likelihood of moderate adverse effect is at
worst highly improbable, while the likelihood of massive adverse effect is
effectively zero, given the controls in place and the expectation that any escape would
be speedily detected and remediated. For this reason the Committee has determined
that the highest realistic magnitude of adverse effect would be moderate, and thus the
overall level of adverse effect on the environment is B. The Committee concludes
that the risk is negligible.
Risks to native and valued aquatic species
10.7
For organisms pathogenic to native fish, aquaculture species and other valued aquatic
species, escape via contaminated wastewater is the most like pathway. The Committee
notes that wastewater is treated with sodium hypochlorite at dosage levels known to
be bactericidal, sporicidal, and virucidal before being discharged into the sewage
system. Such water would then pass through the sewage treatment system and be
massively diluted before being discharged into the sea, so that the likelihood of a
susceptible aquatic species coming into contact with an infectious dose of a
microorganism is infinitesimal.
10.8
The Committee considers that it is highly improbable that this would occur and, if it
did, the magnitude of the effect would not exceed moderate. The overall level of any
adverse effect would thus be B. The Committee concludes that the risk is negligible.
Potential for deterioration of ecosystems if an escaped pathogenic organism
could not be eradicated from the environment and caused loss of genetic
diversity
10.9
The occurrence of this potential adverse effect is also dependent on a cumulative
sequence of events. Each step is improbable and the Committee considers that it is
highly improbable that a full sequence would be completed. The Committee
considers that the magnitude of the adverse effects of such a sequence of events,
should it be completed, would be moderate. The Committee observes that there is a
lack of empirical evidence that any of the microorganisms will infect native species,
but a precautionary approach requires that it should be assumed that some of the
microorganisms might cause disease in native species. The Committee assesses the
level of risk as B. The Committee concludes that the risk is negligible.
Potentially significant adverse effects on human health and safety
Adverse effects on human health and safety due to occupational exposure of
people within the containment facility to zoonotic microorganisms.
10.10 Laboratory-associated infections are both a potential pathway for the escape of a
zoonotic microorganism from containment and for potential adverse effects on human
health and safety. The Committee noted that the probability that an accidental
exposure will contain an infective dose of an organism is broadly related to the titre of
the organism in the material being handled. The likelihood is therefore increased in
experiments requiring handling of bacterial or viral isolates propagated to high titres
in culture or in animals, as compared with diagnostic tests involving clinical
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specimens and other samples which may containing fewer organisms. A control
imposed by this Decision (Appendix1) restricts the use of the approval to the
importing and maintaining in containment organisms for diagnostic and testing
purposes. Laboratory staff should therefore be routinely working with low
concentrations (titres) of the microorganisms, reducing their risk of exposure.
10.11 The Committee notes IDC has appropriate health and safety measures in place
including procedures dealing with medical emergencies and staff training. The
Committee considers that the applicant has well documented, comprehensive
Standard Operating Procedures to ensure compliance with health and safety
requirements and guidelines of the Australian/New Zealand Standard (2002), with
training requirements of the MAF/ERMA Standard 154.03.02 (2002), and with
relevant provisions of the Health and Safety in Employment Act 1992. The
Committee considers that provided these procedures are observed and the proposed
controls implemented, the health and safety of laboratory workers in the PC3 facility
will be adequately protected.
10.12 Based on the applicant’s Standard Operating Procedures for handling pathogenic
organisms, the diagnostic nature of the work proposed, and the proposed controls, the
Committee considers it is it is highly improbable that IDC staff would become
infected with pathogenic zoonotic microorganisms. Should that occur, the effects
would be minimal to major; this reflects the potentially serious hazard some of the
organism may pose to laboratory workers in the highly improbable event of their
infection. The level of risk is A - C (Appendix 2). The Committee concludes that the
risk is non-negligible.
Adverse effects on public health and safety in the event of escape of organisms
from containment through infection of laboratory workers by zoonotic
microorganisms.
10.13 The Committee notes the information provided in the E&R report indicating that
person-to-person transmission of zoonotic diseases is rare. The Committee agrees
with the applicant’s contention that because only Risk Groups 1, 2 or 3 organisms will
be imported, by definition this means that any zoonotic disease in humans can be
treated with appropriate antibiotics or antiserum, or that preventive measures such as
vaccination are available. The Committee considers that early detection of any escape
and rapid implementation of preventive and therapeutic measures in human
populations at risk is highly probable.
10.14 The Committee observes that for infection of members of the general public to occur,
laboratory workers would first need to be infected, and then the disease be transmitted
from them to members of the public. The Committee considers that this would be
highly improbable; if it did occur, the magnitude of any adverse effects resulting
from person-to-person spread of zoonotic disease could range from minimal to
major. The level of risk is therefore assessed as A to C. The Committee concludes
that the risk is non-negligible.
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Potentially significant adverse effects on communities and society
Adverse effects in terms of loss of reputation, loss of confidence in the facility,
and loss of confidence in science in the event of escape of organisms from
containment
10.15 The Committee considers that there could be a wide range of possible effects,
including loss of reputation, loss of confidence in the facility, and loss of confidence
in science. The severity of any impact will depend on the circumstances leading to a
breach in containment, the organisms involved and their impacts on the environment,
public health, and the primary sector. The magnitude of any effects could range from
moderate to major, although the Committee considers their occurrence to be highly
improbable. The level of risk is therefore B – C (Appendix 2). The Committee
concludes that the risk is non-negligible.
Potentially significant adverse effects on the market economy
Economic impacts of the infection of animals and/or people in the event of escape
of organisms from containment
10.16 The Committee considers that, in the event of organisms escaping from the facility
and infecting local animals and/or people, there would be adverse economic and
financial effects on the export trade, the farming industry and individual farmers.
There could also be indirect adverse effects on tourism. The Committee observes that
the way in which the media deals with an escape could influence the severity of
adverse economic impacts. No information or data on the potential range of size of
these effects is available; this would depend on how quickly a response was
organised, and the degree to which an outbreak could be contained.
10.17 The Committee notes the scenario analysis and discussion in the E&R report and
considers that some weight needs to be given to the likelihood that a breach of
containment would be quickly detected and response measures implemented
immediately. These actions would serve to reduce the magnitude of any economic
effect, but the Committee acknowledges that, depending on the organism involved,
even a geographically restricted and short duration event could have major economic
implications. Taking into account the sequence of events required for this scenario to
eventuate the Committee is satisfied that the likelihood is highly improbable. This
results in an overall level of adverse effect of C. The Committee concludes that the
risk is non-negligible
10.18 If the scenario is one of deliberate sabotage and criminal release of organisms, the
Committee considers the likelihood to be improbable, but the magnitude of adverse
effects could be massive, leading to an overall level adverse effect of E. The
Committee concludes that the risk is non-negligible.
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11
Assessment of potentially significant beneficial effects
(benefits)
Approach and coverage
11.1
The beneficial effects assessed below are those identified as potentially significant,
having regard for those matters set out in clauses 9 and 10 of the Methodology. A
“benefit” is defined in the Methodology as “the value of a particular positive effect
expressed in monetary or non-monetary terms”. Benefits were considered in terms of
the requirements of clause 13 of the Methodology, including especially the
assessment of the nature of the beneficial effects (whether monetary or nonmonetary), the magnitude or expected value of the benefits (including the uncertainty
bounds on the value), and the distributional effect of the benefits.
11.2
Consideration of benefits includes:

an estimate of the magnitude of the benefits (clause 13(b));

where relevant an assessment of the likelihood of occurrence (clause 13(b));

whether a benefit is monetary or non-monetary (clause 13(a)); and

the distributional effects over times, space and groups in the community
(clause 13(c)).
Explicit consideration of the uncertainty associated with the estimate (clause 29
(materiality of uncertainty) and clause 30 (need for caution where not resolved)) may
also be required.
Potentially significant beneficial environmental effects
Improved protection of native species and other valued species from exotic
diseases due to enhanced capability within New Zealand
11.3
The Committee considers that the spillover benefits of improved and more rapid
diagnoses and responses to diseases affecting native fauna and other valued non-farm
animals are potentially significant. Rapid implementation of response measures is
highly likely to restrict the spread of any disease and increase the likelihood of its
early eradication. This would provide improved protection of native and other valued
species. The Committee considers that such benefits would be moderate and it is
likely that they will eventuate. The level of benefit is therefore assessed as E. The
Committee concludes that this benefit is significant.
More rapid elimination of disease threats diagnosed as negative
11.4
The Committee considers that the benefits of being able to eliminate disease threats
by prompt negative diagnoses are potentially significant. Rapid elimination of
negatives would avert unnecessary implementation of control measures that might
unnecessarily harm farmed animals, as well as native and valued non-farm animal
species, for example unnecessary culling of animals. This would avert potential for
unnecessary harm to populations and communities of native animals, and their
ecosystems, and to valued introduced species, such as song birds, salmon or trout.
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The Committee considers that such benefits would be moderate and it is likely that
they will eventuate. The level of benefit is therefore assessed as E. The Committee
concludes that this benefit is significant.
More rapid detection of potentially new to science pathogenic organisms, or
pathogenic mutant strains of previously benign organisms
11.5
The Committee considers the possibility of enhanced detection of pathogenic
organisms that might be potentially new to science or pathogenic mutant strains of
previously benign organisms. This would allow more rapid implementation of
measures to restrict the spread of any disease, and increase the probability of early
eradication. This would provide improved protection of native and other valued
species. The Committee considers that the magnitude of such benefits would be
moderate but that such a benefit is unlikely to eventuate. The level of benefit is
therefore assessed as E. The Committee concludes this benefit is significant but of
lesser significance that those benefits discussed in 11.3 and 11.4.
Potentially significant beneficial effects on human health and safety
Improved control of human disease by more rapid and thorough diagnostic
testing for the suspected presence of zoonotic organisms in New Zealand
11.6
The availability within New Zealand of an enlarged reference collection of zoonotic
organisms will provide more rapid and more comprehensive diagnostic testing for
zoonotic infections. This will allow for more rapid implementation of therapeutic,
preventive and control measures if found to be necessary. Negative diagnoses would
lead to avoidance of unnecessary introduction of such measures.
11.7
The Committee considers that the benefits to be gained from more rapid and
comprehensive diagnostic testing for the suspected presence of zoonotic diseases in
New Zealand and the timely implementation of appropriate responses to diagnoses
would be moderate and that such benefits would be probable to be realised. The
level of benefit would be C. The Committee concludes that this benefit is not
significant.
Potentially significant beneficial effects on communities and society
Upskilling of the workforce, scientific benefits and new technologies
11.8
The presence of the organisms in the laboratory would have beneficial effects to
science and knowledge in New Zealand through upskilling of the workforce, the
ability to retain skilled staff, and through increased scientific knowledge (from
research on the organisms). The magnitude of this effect is considered by the
Committee to be minor and it is very likely. Thus the level of beneficial effect is E.
The Committee concludes that this benefit is significant.
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Potential significant beneficial effects on the market economy
Diagnostic capability
11.9
The Committee noted that a range of potentially significant effects on the market
economy related to an enhanced ability for New Zealand to respond to both
biosecurity and bioterrorism threats including:

Improved import and export testing facilities.

Reduced reliance on overseas laboratories; ability to repeat tests promptly;
and, greater control over the testing regime (reduced problems from samples
going astray or being delayed).

Assurance to exporters and overseas customers that New Zealand is able to
detect and respond to any outbreaks of diseases in the approved categories.

The ability to develop and implement improved surveillance programmes, and
a consequential enhanced ability to meet international trade reporting
requirements (in particular with other OIE linked countries).
11.10 The Committee considered these potentially significant beneficial effects as one
overall benefit relating to the presence of the organisms and capacity to undertake
diagnostic activities. Their magnitude is considered to be moderate to major, and it
is very likely that these benefits will be realised. Therefore the level of effect is
estimated as F. The Committee concludes that this benefit is highly significant.
Enhanced speed of response
11.11 Speed of response is considered separately because of the importance of obtaining fast
test results so that appropriate remediation procedures can be initiated. Faster
diagnoses could result in fewer animals needing to be quarantined or destroyed, and
less damage resulting from restricted access to overseas markets. This effect is
considered to be additive to the enhanced response effects assessed above.
11.12 This effect can be assessed in terms of the reduction in damage. However, there is
very little data available to support the analysis.
11.13 The application notes that the outbreak of a serious exotic disease such as foot and
mouth has been estimated as potentially costing $6 billion in one year in terms of lost
GDP, plus ancillary costs. This is not directly relevant since the application does not
include foot-and-mouth disease virus; however, it provides an estimate of the
maximum level of adverse effect of an outbreak.
11.14 At best it can be concluded that in the instance of another disease outbreak the
magnitude of the effect would be less than this amount, and the magnitude of effect
for reducing the impact would again be smaller. However, even a conservative
estimate of magnitude of the marginal reduction would be described as massive, and
if an outbreak were to occur this would be likely. The chance of an outbreak
Environmental Risk Management Authority Decision: Application NOC04012
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occurring for any one of the relevant diseases in any one year is very low and
therefore the Committee considers that the likelihood of the effect occurring in the life
of the laboratory is likely. The level of beneficial effect is therefore F. The
Committee concludes that this benefit is highly significant.
Enhanced response in case of bioterrorism
11.15 The importance of the organisms proposed in the application for use as diagnostic
reagents will make it likely that MAF IDC will be able to fulfil this role in the event
of a bioterrorism event. In the event of bioterrorism activity, the ability to respond
promptly would significantly reduce the magnitude of adverse effects. The magnitude
of such a beneficial effect is difficult to predict as it will depend on the specific
microorganism deployed in a bioterrorism event and the time taken by IDC to confirm
a diagnosis but may range from minimal to major if measures are rapidly
implemented to prevent the spread of the organism and limit its effects on the
environment, human health and the economy. Assessing the lower bound for the
beneficial effect, the Committee considers that the likelihood of the combination of
such an event occurring and a major benefit being realised is highly improbable
(since it requires a combination of an improbable event and an enhanced response)
resulting in a level of beneficial effect of C. The Committee concludes that this
benefit is not significant.
12
Establishment of the approach to risk in the light of risk
characteristics
12.1
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
provides guidance on how cautious or risk averse the Authority should be in weighing
up risks and costs against benefits. In the case of the present application, the relevance
of clause 33 is influenced by the organisms being held in PC3 level containment and
that they will be used only for diagnostic purposes. The Committee has concluded that
the containment regime and the controls imposed by this Decision will reduce
biological and other risks to a low level. In terms of the key risks assessed in section
10 of this Decision, the Committee considers that:
(a)
(b)
(c)
Risks that may be difficult to control and which may persist over time or be
irreversible, or be subject to uncontrollable spread could only occur as a result
of a highly improbable cumulative sequence of events, each improbable in
itself, leading to escape of microorganisms and establishment of undesirable
self-sustaining populations.
The containment regime limits the extent to which exposure to the
environmental risks and to public health risks is involuntary. Exposure of
laboratory workers to health risks is voluntary; the Committee notes that
IDC’s operating procedures reduce the magnitude of occupational risks to
laboratory workers to a low level.
The microorganisms are defined by their biological risk characteristics as
organisms capable of being contained in PC3 level containment, and because
of that the Committee considers that there are no significant risks that are not
known or understood by the general public.
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12.2
Section 7 of the Act requires the Authority to take into account the need for caution in
managing adverse effects where there is scientific or technical uncertainty about those
risks. The Committee notes that there is a degree of uncertainty associated with the
potentially significant risks that have been identified. However, the uncertainty was
considered to be low because the estimated levels of risks were similar to the ranges
of estimates for the proposed scenarios. The Committee did not consider therefore
that additional caution was required. In respect to Clause 29(a) of the Methodology,
the Committee did not consider the uncertainty about the adverse effects to be
material to the Decision.
13
Aggregation and comparison of adverse and beneficial effects
13.1
The overall evaluation of risks and costs (incorporating adverse effects) and benefits
(incorporating beneficial or positive effects) set out below was carried out having
regard to clauses 22 and 34 of the Methodology. The Committee considers some of
the risks associated with the application to be non-negligible. The Committee
therefore considered the application according to Clause 27(1) of the Methodology.
13.2
In combining adverse effects (risks and costs) in accordance with clause 34 of the
Methodology, the Committee was unable to find common units of measurement. The
dominant adverse effects were considered to be the adverse economic impacts of
escape from containment either as a result of an accidental release or through
deliberate sabotage and a consequential infection of either people or animals. The
Committee assessed the level of effect as C in the case of accidental release and E for
deliberate sabotage. While the magnitude of the consequence is the same in both
bases, the likelihood of the effect (i.e. infection) via sabotage is higher than for an
accidental release. Other non-negligible estimated levels of adverse effects are:
potential adverse effects on public confidence in the facility and confidence in science
ranging from B to C; and the level of potential adverse effect in human health
resulting from occupational exposure or transmission to the general public through
exposure of a laboratory worker ranging from A to C.
13.3
In combining beneficial effects (benefits) in accordance with clause 34, the
Committee was also unable to find common units of measurement which could be
used. However, the dominant potential benefits were considered to be the enhanced
responses to biosecurity threats through more accurate and speedy diagnoses
(Diagnostic capability and speed of response) measured in terms of effect on the
market economy. These benefits were assessed as F. Other significant benefits were
considered to be the environmental benefits of more rapid diagnoses and responses to
disease in native and other values animals and the more rapid elimination of disease
threats diagnosed as negative. Also the expected benefits from an increase in
scientific capability within New Zealand were considered significant. All these
benefits were assessed as E.
13.4
The benefits, risks and costs were then weighed up in accordance with clause 27 of
the Methodology. The Committee considers the benefits taken as a whole to be
sufficient to outweigh the combined risks and costs of the application.
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14
Decision
14.1 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(s) 39(1)(g): maintaining new organisms in containment for diagnostic
purposes.
14.2
Having considered all the possible effects in accordance with sections 45(1)(a)(ii) and
any inseparable organisms, including the effects on the matters in sections 44 and 37,
and pursuant to clause 27 of the Methodology, and based on consideration and
analysis of the information provided, and taking into account the application of risk
management controls specified in this Decision, the view of the Committee is that the
risks (or costs) of adverse effects are outweighed by the benefits associated with
importation into containment of the following organisms:
Any microorganisms that may cause disease of significance to animals
involved in New Zealand’s primary industries or wildlife, and that have the
biological characteristics of Risk Group 1, Risk Group 2, or Risk Group 3
microorganisms as defined in the Australian/New Zealand Standard
2243.3:2002 – Safety in laboratories Part 3: Microbiological aspects and
containment facilities, and are therefore capable of being contained within a
PC3 level containment facility.
14.3
Excluded from the application, and therefore from this approval, are viruses that cause
vesicular diseases of cattle, pigs and horses, specifically:
a)
b)
c)
d)
Foot-and-mouth disease virus (ICTV code 00.052.0.05.001; FMDV;
Genus: Aphthovirus; Family: Picornaviridae).
Swine vesicular disease virus (ICTV code 00.052.0.01.004.02.005) is a
synonym of the Human coxsackievirus B 5 (CV-B5) serotype of the
species Human enterovirus B (ICTV code 00.052.0.01.004; HEV-B;
Genus: Enterovirus; Family: Picornaviridae).
Vesicular stomatitis viruses: Vesicular stomatitis Alagoas virus (ICTV
code 01.062.0.01.007; VSAV), Vesicular stomatitis Indiana virus
(ICTV code 01.062.0.01.001; VSIV) and Vesicular stomatitis New
Jersey virus (ICTV code 01.062.0.01.009; VSNJV; Genus:
Vesiculovirus; Family: Rhabdoviridae; Order: Mononegavirales).
Vesicular exanthema of swine virus (ICTV code 00.012.0.01.001;
VESV; Genus: Vesivirus; Family: Caliciviridae) is also known as
Swine vesicular exanthema virus.
14.4
The Committee is satisfied that the proposed containment regime, as set out in
Appendix 1, will adequately contain the organisms as required by section 45(1)(a)(iii)
of the Act.
14.5
In accordance with clause 36(2)(b) of the Methodology the Committee records that, in
reaching this conclusion, it has applied the weighing up in section 45 of the Act and
clause 27 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 NOC04012
Page 24 of 36



section 44 additional matters to be considered;
section 45 determination of application;
Schedule 3 – Part II of the Act: Matters to be addressed by containment
controls for new organisms excluding genetically modified organisms.
14.6
The Committee has also applied the following criteria in the Methodology:
 clause 9 - equivalent of sections 5, 6 and 8;
 clause 10 - equivalent of sections 36 and 37;
 clause 12 – evaluation of assessment of risks;
 clause 13 – evaluation of assessment of costs and benefits;
 clause 21 – the decision accords with the requirements of the 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 27 - the risks and costs are outweighed by benefits;
 clause 33 – the risk characteristics; and
 clause 34 – the aggregation and comparison of risks, costs and benefits.
14.7
The application is thus approved, with controls, as set out in Appendix 1.
_____________________
24 May 2006
Dr Max Suckling
Date:
Chair of the Decision-making Committee
Approval code: NOC002475
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 Max Suckling
Chair, New Organisms Standing Committee
Environmental Risk Management Authority Decision: Application NOC04012
Date: 6 September 2007
Page 25 of 36
Appendix 1: Controls
In order to satisfactorily address the matters detailed in the Third Schedule Part II:
Containment controls for new organisms excluding genetically modified organisms1of the
Act, and other matters in order to give effect to the purpose of the Act (section 45(2)), 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 material2:
Purpose of the approval
1.1
This approval is restricted to use of microorganisms for the purpose of diagnosis and
testing for the presence of disease in animals.
Laboratory registration requirements
1.2
The person responsible for a particular diagnosis and testing 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.
1.3
The approval is limited for use only at the Ministry of Agriculture and Forestry’s
Investigation and Diagnostic Centre (IDC) PC3 containment facility, located in
Wallaceville, Upper Hutt.
1.4
The construction, operation and management of the containment facility shall be in
accordance with the:
a) MAF/ERMA New Zealand Standard 154.03.023 ‘Containment Facilities for
Microorganisms’.
b) Australian/New Zealand Standard AS/NZS 2243.3:20023: Safety in
laboratories: Part 3: Microbiological aspects and containment facilities; and
c) Physical Containment level 3 (PC3) requirements of the above Standards.
Scope of organisms approved
1.5
The scope of organisms is limited to: any microorganisms that may cause disease of
significance to animals involved in New Zealand’s primary industries (eg cattle, sheep,
goats, horses, pigs, poultry, rabbits, deer, bees, fish, molluscs or crustaceans) or
wildlife, and that have the biological characteristics of Risk Group 1, Risk Group 2, or
1
Bold headings in Arial font 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.
2
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.
3
Any reference to this standard in these controls refers to any subsequent version approved or endorsed
by ERMA New Zealand
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Risk Group 3 microorganisms as defined in the Australian/New Zealand Standard
2243.3:20023 – Safety in laboratories Part 3: Microbiological aspects and containment
facilities, and therefore are capable of being contained within a PC3 level containment
facility. This generic description includes animal pathogens on MAF’s unwanted
organism register and emerging animal pathogens of significance to New Zealand’s
primary industries that meet the Risk Group classification requirements.
Exclusions
1.6
Excluded from this approval are viruses that cause vesicular diseases of cattle, pigs and
horses, specifically:
a) Foot-and-mouth disease virus (ICTV code 00.052.0.05.001; FMDV; Genus:
Aphthovirus; Family: Picornaviridae).
b) Swine vesicular disease virus (ICTV code 00.052.0.01.004.02.005) is a
synonym of the Human coxsackievirus B 5 (CV-B5) serotype of the species
Human enterovirus B (ICTV code 00.052.0.01.004; HEV-B; Genus: Enterovirus;
Family: Picornaviridae).
c) Vesicular stomatitis viruses: Vesicular stomatitis Alagoas virus (ICTV code
01.062.0.01.007; VSAV), Vesicular stomatitis Indiana virus (ICTV code
01.062.0.01.001; VSIV) and Vesicular stomatitis New Jersey virus (ICTV code
01.062.0.01.009; VSNJV; Genus: Vesiculovirus; Family: Rhabdoviridae; Order:
Mononegavirales).
d) Vesicular exanthema of swine virus (ICTV code 00.012.0.01.001; VESV;
Genus: Vesivirus; Family: Caliciviridae) is also known as Swine vesicular
exanthema virus.
1.7
Excluded from this approval are any organisms that fall within Risk Group 4 of the
Australian/New Zealand classification of risk groups, contained in Australian/New
Zealand Standard 2243.3:20023 - Safety in laboratories Part 3: Microbiological aspects
and containment facilities.
Identification of organisms
1.8
IDC shall notify ERMA New Zealand in writing as soon as practically possible of the
taxonomic classification of all microorganisms identified that are imported or
transferred in accordance with this approval so they can be added to ERMA New
Zealand’s Register.
1.9
IDC shall provide MAF Biosecurity New Zealand on each application for a Permit to
Import, at least one calendar month before any importation (unless an alternative date is
agreed with MAF), a description that uniquely identifies each organism to be imported,
and evidence that each of the organisms to be imported have the biological
characteristics of Risk Group 1, Risk Group 2 or Risk Group 3 microorganisms as
defined in Australia /New Zealand Standard 2243.3:20023 - Safety in laboratories Part
3: Microbiological aspects and containment facilities, and are therefore capable of
being contained within a PC3 containment facility.
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Sources
1.10 All organisms shall be imported directly from either internationally recognised expert
laboratories or from reputable type culture collections.
1.11 All microorganisms to be imported shall be pure cultures, supplied as frozen or
lyophilised liquid cultures or culture supernatants or as bacteria or fungi growing on
agar slopes. The organisms shall have been purified as part of their isolation and
identified in the source laboratory.
Transport, packaging and labelling
1.12 IDC shall notify, in writing, MAF Biosecurity New Zealand Quarantine Service (MAF
QS) for its approval, details of the proposed means and schedule of transport of each
package of organisms from the New Zealand border to IDC, Wallaceville, at least one
calendar month before the date of each expected importation (unless an alternative date
is agreed with MAF QS).
1.13 MAF QS shall notify IDC, and confirm in writing, every approval of the means and
schedule of transport of each package from the New Zealand border to IDC
Wallaceville. The dispatch of packages from the border shall proceed only after IDC
acknowledges in writing MAF QS’s notification of the approval.
1.14 IDC shall arrange for a trained member of IDC staff, or a MAF QS staff member, or an
approved courier, e.g. World Courier, with expertise in secure transport of biological
material, to oversee the movement of each package from the border to IDC’s PC3
facility at Wallaceville, Upper Hutt, according to the approval notified by MAF QS.
1.15 All organisms shall be transported to and within New Zealand in packages complying
with the packaging (Packing Instruction No 602) and labelling requirements of the most
recent version of the IATA Dangerous Goods Regulations and the packaging
requirements of MAF Biosecurity Authority /ERMA New Zealand Standard
154.03.023 Containment Facilities for Microorganisms and Australian/New Zealand
Standard 2243.3: 20023 - Safety in laboratories Part 3: Microbiological aspects and
containment facilities.
1.16 Documentation from the exporting facility shall fully describe the identity and Risk
Groups of the organisms being transported to and within New Zealand, and shall be
prominently and securely attached to and accompany each package.
1.17 Each package shall be clearly labelled that it shall not be opened in transit to New
Zealand from its point of origin in the exporting facility, or at the New Zealand border,
or in transit within New Zealand to IDC’s PC3 containment facility at Wallaceville,
Upper Hutt. The inner sealed package shall be opened only within a Class II biological
safety cabinet within IDC’s PC3 containment facility at Wallaceville, Upper Hutt, in
the presence of a scientist with knowledge and expertise in managing the biological
safety requirements of the organisms within the package.
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1.18 IDC shall notify MAF QS immediately by telephone of arrival of each package within
IDC’s PC3 containment facility, and confirm in writing with MAF QS, within 24 hours,
the arrival of each package, and that each package arrived within the facility intact,
undamaged and unopened.
1.19 Both MAF QS and IDC shall each maintain written records of the dates and times of
dispatch of each package from the border and arrival of each package within the PC3
facility at Wallaceville, Upper Hutt. MAF QS and IDC shall ensure that their records
are identical.
1.20 Controls 1.12 – 1.19 shall apply also to the transport of any of the organisms from IDC,
Wallaceville within New Zealand, including to the border for export.
Operating procedures
1.21 IDC shall ensure that its documented Standard Operating Procedures address all
matters listed in Schedule 3, Part II of the Act: Matters to be addressed by containment
controls for new organisms excluding genetically modified organisms.
1.22 IDC shall review all of its Standard Operating Procedures for its PC3 facility at least
every three years, and amend and update them and its containment facility manual to
take account of the outcomes of the reviews. The Standard Operating Procedures shall
be no less stringent than those at the time of this approval.
1.23 Any laboratory animals in the same rooms within the facility as the microorganisms
covered by this approval shall be held within a containment unit (cage) in which the air
intakes and exhausts are HEPA filtered to prevent any likelihood of infection should
there be an accidental release in the laboratory.
1.24 This approval specifically excludes using the organisms to deliberately infect live
animal hosts.
Storage
1.25 Organisms subject to this approval shall be stored only within IDC’s PC3 facility at
Wallaceville, Upper Hutt, according to best practices for each of the particular
organisms. Written verification of the storage methods used for each of the organisms,
including assurance that these are referenced to international best practices, shall be
provided to MAF Biosecurity New Zealand when each application for a Permit to
Import is submitted. IDC shall notify MAF Biosecurity New Zealand and ERMA New
Zealand, in writing, of any changes to the storage methods used.
2
2.1
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 1.4 above.
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3
To control the effects of any accidental release or escape of an organism:
3.1
Control of the effects of any accidental release or escape of the organism shall be in
compliance with the standards listed in control 1.4 above.
3.2
In the event of any breach of containment the contingency plan for the attempted
retrieval or destruction of any viable material of the organism that have escaped shall
be implemented immediately. The contingency plan shall be included in the
containment manual in accordance with the standards listed in control 1.4 above.
3.3
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. Appropriate, up-to-date contact details for MAF Biosecurity
New Zealand and ERMA New Zealand shall be appended to the containment manual
for the facility.
4
Inspection and monitoring requirements for containment facilities:
4.1
The inspection and monitoring requirements for containment facilities shall be in
compliance with the standards listed in control 1.4 above.
4.2
The approval holder must provide access for inspection with notice at any reasonable
time.
4.3
A register will be kept of all organisms imported under this approval, to include a
record of the date of arrival of each package imported, the identity of the organisms in
each package, the name and location of the laboratory from which the organisms were
imported (including origin or source, country of origin), in accordance with the
standards listed in control 1.4 above.
5
5.1
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 1.4 above.
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Appendix 2: Qualitative scales for describing adverse
effects
Qualitative Risk Assessment
Risks and benefits are assessed by estimating the magnitude of the possible effects and the
likelihood of their occurrence. For each effect, the combination of these two components
determines the level of that effect, which is a two dimensional concept. Risk assessment may
be qualitative or quantitative. Qualitative assessment is informed by quantitative data where
this is available.
Qualitative matrices are used to prioritise risks (and benefits), and to identify any risks that
are unacceptable. The measure of the level of risk (combination of magnitude and
likelihood) is specific to the application therefore measures of level of risk should not be
compared between applications. However, the measures (descriptors) for different types of
risk (human health, ecological etc) should be established so that they represent relative orders
of magnitude.
Magnitude of effect
The magnitude must be a measure of the endpoint (specified by the Act and the
Methodology), and is described in terms of the element that might be affected. The
magnitude of the effect is not the same as the effect itself. The qualitative descriptors for
magnitude of effect are surrogate measures that should be used to gauge the end effect or the
‘what if’ element.
Tables 1 and 2 contain generic descriptors for magnitude of adverse effects (risks and costs)
and beneficial effects (benefits). These descriptors are examples only, and their generic
nature means that it may be difficult to use them in some particular circumstances. They are
included here simply to illustrate how qualitative tables may be used to represent levels of
risk.
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Table 1
Magnitude of adverse effect
Descriptor
Examples of descriptions
Minimal
Mild reversible short term adverse health effects to individuals
in highly localised area
Highly localised and contained environmental impact, affecting
a few (less than ten) individuals members of communities of
flora or fauna, no discernible ecosystem impact
Low dollar cost of containment/cleanup/repair (<$5,000)
No social disruption4
Minor
Mild reversible short term adverse health effects to identified
and isolated groups5
Localised and contained reversible environmental impact, some
local plant or animal communities temporarily damaged, no
discernible ecosystem impact or species damage
Dollar cost of containment/cleanup/repair in order of $5,000$50,000
Potential social disruption (community placed on alert)
Moderate
Minor irreversible health effects to individuals and/or reversible
medium term adverse health effects to larger (but surrounding)
community (requiring hospitalisation)
Measurable long term damage to local plant and animal
communities, but no obvious spread beyond defined
boundaries, medium term individual ecosystem damage, no
species damage
Dollar cost of containment/cleanup/repair in order of $50,000$500,000,
Some social disruption (e.g. people delayed)
Major
Significant irreversible adverse health effects affecting
individuals and requiring hospitalisation and/or reversible
adverse health effects reaching beyond the immediate
community
Long term/irreversible damage to localised ecosystem but no
species loss
Dollar cost of containment/cleanup/repair in order of $500,000$5,000,000
Social disruption to surrounding community, including some
evacuations
Massive
Significant irreversible adverse health effects reaching beyond
the immediate community and/or deaths
Extensive irreversible ecosystem damage, including species
loss
4
The concept of social disruption includes both physical disruption, and perceptions leading to
psychological disruption. For example, some chemicals may have nuisance effects (through odour)
that result in communities feeling threatened.
5
Note that the reference to ‘groups’ and ‘communities’ in the context of human health effects
includes the notion of groups defined by health status.
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Dollar cost of containment/cleanup/repair greater than
$5,000,000
Major social disruption with entire surrounding area evacuated
and impacts on wider community
The economic effects category has been given a surrogate magnitude. This is for
demonstration as a means of illustrating the type of magnitudes that might be encountered.
Table 2
Magnitude of beneficial effect
Descriptor
Examples of descriptions
Minimal
Mild short term positive health effects to individuals in highly
localised area
Highly localised and contained environmental impact,
affecting a few (less than ten) individuals members of
communities of flora or fauna, no discernible ecosystem
impact
Low dollar benefit (<$5,000)
No social effect
Minor
Mild short term beneficial health effects to identified and
isolated groups
Localised and contained beneficial environmental impact, no
discernible ecosystem impact or species damage
Dollar benefit in order of $5,000-$50,000
Minor localised community benefit
Moderate
Minor health benefits to individuals and/or medium term
health impacts on larger (but surrounding) community and
health status groups
Measurable benefit to localised plant and animal communities
expected to pertain to medium term.
Dollar benefit in order of $50,000-$500,000,
Local community and some individuals beyond immediate
community receive social benefit.
Major
Significant beneficial health effects to localised community
and specific groups in wider community
Long term benefit to localised ecosystem(s)
Dollar benefit in order of $500,000-$5,000,000
Substantial social benefit to surrounding community, and
individuals in wider community.
Massive
Significant long term beneficial health effects to the wider
community
Long term, wide spread benefits to species and/or ecosystems
Dollar benefit greater than $5,000,000
Major social benefit affecting wider community
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Likelihood of effect occurring
Likelihood in this context applies to the composite likelihood of the end effect, and not either
to the initiating event, or any one of the intermediary events. It includes:

the concept of an initiating event (triggering the hazard), and

the exposure pathway that links the source (hazard) and the area of impact (public
health, environment, economy, or community).
The likelihood term applies specifically to the resulting effect or the final event in the chain,
and will be a combination of the likelihood of the initiating event and several intermediary
likelihoods6. The frequency or probability solely of the initial incident or hazard event
should not be used (as it sometimes is in the safety discipline).
The best way to determine the likelihood is to specify and analyse the complete pathway of
the “chain of events” from source to the final environmental impact or effect. Each event in
the chain is dependent upon the previous event occurring in the first place.
Likelihood may be expressed as a frequency or a probability. While frequency is often
expressed as a number of events within a given time period, it may also be expressed as the
number of events per head of (exposed) population. As a probability the likelihood is
dimensionless and refers to the number of events of interest divided by the total number of
events (range 0-1).
Table 3
1
2
3
4
5
6
7
Likelihood (adverse effect)
Descriptor
Description
Highly improbable
Almost certainly not occurring but cannot be
totally ruled out
Improbable
Only occurring in very exceptional
(remote)
circumstances.
Very unlikely
Considered only to occur in very unusual
circumstances
Unlikely
Could occur, but is not expected to occur under
(occasional)
normal operating conditions.
Likely
A good chance that it may occur under normal
operating conditions.
Very likely
Expected to occur if all conditions met
Extremely likely
Almost certain
Table 3 provides an example of a set of generic likelihood descriptors for adverse and
beneficial effect. Note that when estimating these likelihoods, the impact of default controls
should be taken into account.
The table is not symmetrical. This is to allow for classification of very low probability
adverse effects.
6
Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.
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In practical terms, where the exposure pathway is complex, it may be conceptually difficult to
condense all the information into a single likelihood. For any risk where the likelihood is
other than ‘highly improbable’ or ‘improbable’, then an analysis of the pathway should
include identifying the ‘critical points’; the aspects that are the most vulnerable, and the
elements where controls might be used to ‘cut’ the pathway.
Calculating the level of risk
Using these qualitative descriptors for magnitude of effect and likelihood of the event
occurring, an additional two-way table representing a level of risk (combined likelihood and
measure of effect) can be constructed as shown in Table 4, where six levels of effect are
allocated: A, B, C, D, E and F. These terms have been used to emphasise that the matrix is a
device for determining which risks (benefits) require further analysis to determine their
significance in the decision making process. Avoiding labels such as ‘low’, ‘medium’, and
‘high’ removes the aspect of perception.
The lowest level (A) may be deemed to be equivalent to ‘insignificant’. In this table ‘A’ is
given to three combinations; minimal impact and an occurrence of improbable or highly
improbable, and minor impact with a highly improbable occurrence. In some cases where
there is high uncertainty it may be preferable to split this category into A1 and A2, where
only A1 is deemed to equate to insignificant.
For negative effects, the levels are used to show how risks can be reduced by the application
of additional controls. Where the table is used for positive effects it may also be possible for
controls to be applied to ensure that a particular level of benefit is achieved, but this is not a
common approach.
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Table 4
Calculating the level of risk (benefit)
Magnitude of effect
Likelihood
Minimal
Minor
Moderate Major
Massive
Highly improbable A
A
B
C
D
Improbable
A
B
C
D
E
Very unlikely
B
C
D
E
E
Unlikely
C
D
E
E
F
Likely
D
E
E
F
F
Very likely
E
E
F
F
G
Extremely likely
E
F
F
G
G
The table presented here is symmetric around an axis from highly improbable and minimal to
massive and extremely likely, however, this will not necessarily be the case in all
applications.
Impact of uncertainty in estimates
Uncertainty may be taken into account in two ways. Firstly, when describing a risk a range
of descriptors may be used. For example, a risk may be allocated a range of very unlikelyimprobable, and minor-major. This would put the range of the risk as B through E.
Alternatively, the level of risk (or benefit) may be adjusted after it has been estimated on the
grounds of uncertainty.
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