ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

Amended under s67A on 6 September 2007 and 30 August 2011

3 March 2004 Application code: NOC03001 Application category: Import into Containment any New Organism under section 40(1)(a) of the Hazardous Substances and New Organisms (HSNO) Act 1996 Applicant: AgResearch Applicant contact: Dr Travis Glare Purpose: To import into containment a nucleopolyhedrovirus of the painted apple , anartoides, from Australia to test the environmental safety of the strain as a possible biocontrol agent for use in New Zealand. Date application received 24 March 2003 Consideration date: 28 January 2004 Considered by: Committee of the Authority

1 Summary of Decision

The application to import into containment the following organism is approved, with controls (as detailed in Appendix 1 of this decision), having being considered in accordance with the relevant provisions of the Hazardous Substances and New Organisms (HSNO) Act 1996 (the Act) and the HSNO (Methodology) Order 1998 (the Methodology):

Orgyia anartoides single nucleopolyhedrovirus (OranSNPV)

2 Legislative Criteria for Application

The application was lodged pursuant to section 40(1)(a) of the Act. The decision was determined in accordance with section 45, having regard to the matters specified in section 44 and other 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.

Consideration of the application followed the relevant provisions of the Methodology, as specified in more detail below. Unless otherwise stated, references to clause numbers in this decision refer to clauses of the Methodology.

Application Process

The application was lodged pursuant to section 40(1)(a) of the Act. It was formally received and verified on 24 March 2003. In accordance with section 52 of the Act the Authority requested further information from the applicant on 7 April 2003, on the outcome of consultation with Māori regarding the proposed use of native for testing. Sufficient information was received to satisfy this requirement on 14 November 2003.

Under section 53(2) of the Act the Authority has discretion as to whether to publicly notify an application to import into containment any new organism. In this case, the application was not publicly notified. The application was referred to the Chief Executive and the Chair of the Non-GMO New Organisms Standing Committee of the Authority who determined that this application does not exhibit exceptional circumstances warranting public notification in that:

There is a high degree of reported specificity to the host (pest) . The application is to import into containment. Any subsequent application for release from containment of the organism that is the subject of the present application must be publicly notified. In accordance with section 59(5) of the Act the Authority extended the time limit under section 59(1)(d) for consideration of the application by a further 15 working days. This was to provide for adequate evaluation of the application. The consent of the applicant to this waiver was obtained. Consideration of the application commenced on 28 January 2004.

In accordance with section 58(1)(c) of the Act and clauses 2(2)(e) and 5 of the Methodology, the Department of Conservation (DoC) and the Ministry of Agriculture and Forestry (MAF) Biosecurity Authority were notified and provided with an opportunity to comment on the application. Their comments and the applicant‟s responses to those comments are included in the Evaluation and Review (E&R) Report prepared by the Agency.

Information Available for Consideration

The documents available for the consideration of the application by ERMA New Zealand were:

Application NOC03001 (form 2N);

Scientific references cited in the application;

Containment manuals:

o A Quarantine Manual for the HortResearch Mt. Albert Research Centre Containment Facility for Microorganisms. Version 2, October 2000;

o Containment and Transitional Facility for Microorganisms and Uncleared Biological Products, University of Otago, Dunedin Campus, Containment and Quarantine Manual. Version 2.2, February 2002;

o Containment Manual for the AgResearch, Lincoln, Biocontrol Containment Facilities for Microorganisms in accordance with MAF Standard 154.03.02. Version 3.4, March 2003;

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Evaluation and Review (E&R) Report prepared by the Agency to assist and support the Committee's decision-making.

Comments from DoC on the application.

Recognised techniques were used in identifying, assessing, and evaluating the relevant information, as required under clause 24 of the Methodology. Techniques for identifying and preparing information on risks, costs and benefits were based on internal procedures as specified in the ERMA New Zealand Technical Guide publications.

Decision Making Committee

The application was considered by a sub-Committee of the Non-GM New Organisms Standing Committee of the Authority appointed in accordance with section 19(2)(b) of the Act. The Committee comprised the following members: Dr Lin Roberts (Chair) and Associate Professor Marie Dziadek. In addition, Dr Max Suckling advised the Committee on insect biology and insect viruses.

3 Sequence of the Consideration

In accordance with clause 24 of the Methodology, the approach adopted by the Committee was to look sequentially at identification, assessment and evaluation of risks, costs and benefits. Interposed with this was the consideration of the adequacy of the proposed containment regime, and the ability of the organism to escape and to form self-sustaining populations. Management techniques were considered in relation to the identified risks (clauses 24) and those risks identified as significant were assessed (clause 12). Costs and benefits were assessed in accordance with clause 13 of the Methodology.

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.

4 Purpose of the Application

The Committee was satisfied that the purpose of the application fell under section 39(1)(h) of the Act 1996: The importation of any new organism into containment for such other purposes as the Authority thinks fit.

The purpose of this work is to conduct host specificity testing of OranSNPV as a possible biological control agent for the painted apple moth (Teia anartoides) in New Zealand. It is proposed to undertake insect testing at two facilities based at AgResearch, Lincoln and at HortResearch, Auckland. A third facility, at the University of Otago, would be used for virus identification.

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5 Identification of the Significant Risks, Costs and Benefits of the Organism

The Committee considered the potential risks, costs and benefits relating to the application, identified in the E&R Report. In accordance with sections 5 and 6 of the Act, and clause 9 of the Methodology, the potential adverse and beneficial effects of this application were categorised and considered in terms of their area of impact on the environment, on human health and safety, and on Māori and their culture and traditions. No potential adverse effects on the economy, society or the community were identified.

The Committee considered the following potential adverse effects in accordance with clauses 9 and 10 of the Methodology that reflect sections 5, 6, 8 and 44 of the Act:

POTENTIAL ADVERSE ENVIRONMENTAL EFFECTS

Potential for the virus to have non-target effects through infection and subsequent death of organisms other than the painted apple moth.

Potential for ecosystem disruption by viral infection and destruction of organisms.

Potential for adverse effects on water, soil and air quality.

Potential for adverse effects on New Zealand‟s viral genetic diversity.

Potential for the development of new viruses, which may have altered virulence or host range, through recombination.

POTENTIAL ADVERSE EFFECTS ON HUMAN HEALTH AND SAFETY

Potential for the virus to have adverse effects on human health through pathogenic, allergenic or toxic effects on humans.

POTENTIAL ADVERSE EFFECTS ON MAORI AND THEIR CULTURE AND TRADITIONS

Potential for the virus to have adverse effects on Māori and their taonga by infecting native or valued introduced flora and fauna in New Zealand.

The Committee considered the beneficial effects associated with the application, in accordance with sections 5 and 6(e) of the Act and clauses 9, 10, 13, and 14 of the Methodology. The following beneficial effects were identified:

POTENTIAL BENEFICIAL EFFECTS ASSOCIATED WITH THE IMPORT INTO CONTAINMENT OF THE ORGANISM

An increase in knowledge about the environmental safety (in particular the host range) of the OranSNPV virus.

Satisfaction of the necessary host range testing that is a prerequisite for the possible release of a biocontrol agent for painted apple moth.

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Gain of experience in host specificity testing of nucleopolyhedroviruses on insects.

Facilitation of scientific collaboration and improved profile of New Zealand scientific research.

6 Adequacy of the Proposed Containment Regime

In carrying out its consideration the Committee considered the adequacy of containment in accordance with section 45(1)(a)(iii) of the Act, and the magnitude and probability of the risks, costs and benefits alongside each other and in an integrated fashion. This is because the former interact with the latter and this is recognised in clause 12(d) of the Methodology and in section 45(1)(a)(ii) of the Act. For convenience in setting out the decision the adequacy of containment is discussed first.

Ability to adequately contain the organisms

In considering the ability of the organisms to escape from containment, the Committee considered the:

i. biological characteristics of the organism;

ii. potential pathways for escape of organisms from the containment facility;

iii. proposed containment regime; and

iv. ability of the organism to establish a self-sustaining population.

(i) Biological characteristics of the organism

The biological characteristics of the OranSNPV are described in section 4.6 of the E&R Report. In summary; the virus is transmitted from insect to insect through ingestion of contaminated plant material. The infective units (polyhedra) are stable and persist in the soil for many years. Viral transmission requires direct contact with infected material followed by ingestion of polyhedra. The polyhedra are inactive until they are solubilised within the alkaline pH of the larval gut which releases infectious virus to colonise and replicate within insect cells.

(ii) Potential pathways for escape of organisms from the containment facility

The possible routes by which the virus could escape from containment are removal of the virus, removal or loss of infected insects, or removal of other experimental material (e.g. plant material inoculated with virus used to test insects or insect waste) that has come in contact with the virus. This may occur by escape in transit, accidental removal from the containment facility or through removal by unauthorised persons gaining entry to the facility.

The Committee considers that in view of the containment Standards and the proposed controls the likelihood of the organisms escaping during transit is very low.

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The ability of the virus to escape containment by association with persons or other organisms is dependent upon direct contact between viral particles and humans or other organisms that traffic through the facility. This could occur through incorrect handling of experimental material or equipment by personnel. Alternatively accidental escape could occur through incorrect disposal of laboratory waste and biological material that has been in contact with the virus.

The Committee also considered the possibility of intentional removal of the virus from the containment facilities. This is considered to be very unlikely because the facilities are located on private property and access is restricted to authorised personnel only and the entrances to each facility shall be kept locked except when in active use. These measures are required by the Standard (control 1.2). Further, it is considered very unlikely that strong public interest will be generated by this organism as it is not genetically modified; therefore intentional release of the virus is improbable. The Committee also notes that unauthorised release of the virus from containment would be unlikely to have any impact on the painted apple moth because of the small quantities of the virus being used for these studies.

Barriers to the escape of the virus by these pathways are instituted by the operation of the facilities in accordance with the MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.02. (Control 1.2) The Standard specifies the use of procedures to ensure that no accidental or unintended removal of microorganisms from the facility occurs. These procedures cover all aspects of laboratory management including waste disposal, dealing with spills and staff training.

Section 4.6 of the Standard requires all biological waste and culture material to be disposed of in accordance with AS/NZS Standard 2243.3:2002 Safety in laboratories Part 3 Microbiological aspects and containment facilities. Under this regime infectious material must be sterilised before disposal.

The Committee considered that, given the design and management of the containment facility, as well as the experience of the operators, it was very unlikely that the virus would be accidentally removed from the facility.

The Committee considered the contingency plan for escapes from containment within the facility, or to the outside, and found it to be acceptable.

In order to enhance the efficacy of these containment measures the Committee specified the following additional controls:

Larvae and feeding material for host specificity testing must be kept in sealed containers from which the larvae cannot escape (control 1.5).

All insects, plants and experimental material that has come in contact with the virus must be decontaminated (e.g. autoclaved) within the containment facility prior to disposal (control 1.6).

At all times while any of the species of insects is being tested in the containment facility no organisms, other than those directly connected with the testing of that species, are to be in the same part of the containment facility (control 1.7).

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The Committee considers an escape of the virus from the facility to be improbable, based upon an assessment of the containment measures discussed above, the additional proposed controls, the biological characteristics of the virus and the pathways by which the virus could escape.

The Committee consider that, since no flight stages will be infected with the virus and only larval stages will be used, the measures proposed by the applicant, and specified in the controls set by this decision, to contain infected larvae are adequate.

(iii) Proposed containment regime

The virus will be imported into three laboratories:

AgResearch, Lincoln, MAF Number 480,

HortResearch, Auckland, MAF Number 108, and

University of Otago, MAF Number 2767.

Each laboratory is a registered containment facility operated according to MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.02, „Containment Facilities for Microorganisms‟ (the Standard) and MAF Standard 154.02.17.02 (biological products). The containment facilities are maintained at physical containment level 2 (PC2) in accordance with those Standards and with the AS/NZS Standard 2243.3.2002. „Safety in Laboratories Part 3: Microbiological aspects and containment facilities‟. (Refer to controls 1.1 and 1.2.)

The pathogenicity of the virus will be tested on insects within these containment facilities. Therefore the Committee considered the containment of insects within these facilities in addition to containment of the virus alone. The MAF/ERMA New Zealand Standard 154.03.02 specifically addresses the exposure of experimental organisms to microorganisms (section 4.2.3). This requires the experimental organisms that have been exposed to a microorganism to be held according to the minimum containment requirements of the relevant MAF Standard to ensure no escape from containment.

In order to contain the virus the applicant has proposed the following procedures. Painted apple moth larvae will be transferred from the insect quarantine facility to the containment facilities in sealed containers (either larval rearing boxes or individually in plastic pottles) within sealed plastic bags. The virus will be pipetted onto blocks of artificial diet in pottles or into the wells of microtest plates within a laminar flow hood. The larvae will be maintained within an incubator in the laboratory and monitored daily until death or pupation. All insects will be frozen when they die or pupate. All frozen insects not required further will be sterilized by autoclaving. Frozen material (insects that died from the viral infection) required for further analysis at the University of Otago or AgResearch at Lincoln, will be couriered to these laboratories under a MAF transfer approval. All artificial diet or leaf material, used to deliver the virus to the larvae, and dead insects and containers will be decontaminated by autoclaving at the end of the experiments.

The virus will be tested on insect larvae only. Therefore it is highly improbable that the virus could be accidentally carried out of containment by inoculated insects. For the purpose of

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further reducing the likelihood of loss of experimental insects from the containment facilities the Committee have determined the following additional controls:

No adult flight stages of insects shall be used in the host specificity testing (control 1.4).

At all times while host-testing of the approved organism is being conducted in the containment facility the windows shall be closed (control 1.8).

(iv) Ability of the organism to establish a self-sustaining population

OranSNPV is an obligate pathogenic virus of insects that occurs naturally where suitable hosts are available. The ability of the virus to form a self-sustaining population is therefore entirely dependant upon the presence of a suitable host organism. The Committee accepts the evidence that indicates that this virus appears to be restricted to its known host organism, the painted apple moth, and, possibly, to related Lymantriidae family members. This evidence is listed in sections 6.33 – 6.35 of the E&R Report.

OranSNPV can not establish a self-sustaining population without a suitable host species because the virus cannot replicate outside of a host organism. The only known host present in New Zealand is the painted apple moth which has been targeted by MAF Biosecurity for eradication. No other members of the Lymantriidae family are present in New Zealand.

The Committee considers the establishment of the virus, should it escape from containment, to be unlikely because of the lack of available Lymantriid hosts for the virus and the evidence that indicates that OranSNPV is restricted to Lymantriid hosts. The Committee recognises that there is a small degree of uncertainty concerning this assumption because the host specificity of OranSNPV has not been extensively tested on New Zealand species. This uncertainty will be addressed by the host-specificity testing that is the purpose of this application to import OranSNPV.

The Committee considers that eradication of the virus if it became established within a susceptible host population would be unlikely, given that the virus can persist for long periods in the environment.

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7 Assessment of the Risks, Costs and Benefits

The potential risks and costs assessed here are those identified as significant, having regard for those matters set out in clauses 9 and 10 of the Methodology. Risks were considered in terms of the requirements of clause 12 of the Methodology, including the assessment of consequences and probabilities, the impact of uncertainty and the impact of risk management. Costs were considered in terms of clause 13 of the Methodology.

The evidence available was scientific in nature and was considered in terms of clause 25(1) of the Methodology. This evidence comprised principally that provided by the applicant and additional evidence set out in the E&R Report.

Potential for the virus to infect organisms other than Painted Apple Moth including beneficial species with detrimental effect on those non-target hosts

The potential for OranSNPV to infect, and cause adverse effects such as damage to reproductive ability or death of, non-target species has been considered. The virus can only cause these adverse effects if it infects a susceptible host and forms a self-sustaining population. The evidence concerning host specificity is that detailed in sections 6.33-6.35 of the E&R Report.

Information on the susceptibility of New Zealand Lepidopteran species to OranSNPV is currently incomplete and is the main purpose for which the applicant wishes to import this virus. The Committee has considered the current information relevant to the susceptible host- range of OranSNPV and views it as highly likely that OranSNPV can not infect any species present in New Zealand other than painted apple moth (a Lymantriid). The reasons for this are:

the absence from New Zealand of known host species (except painted apple moth), and

the absence from New Zealand of any species closely related to that host (other Lymantriidae), and

the evidence indicating that OranSNPV can only infect insects within the Lymantriidae family (refer to paragraphs 6.33-6.35 of the E&R Report).

The Committee considers that it is improbable that OranSNPV can infect other insects outside of the Lymantriidae family. However, there is a small degree of uncertainty concerning the full extent of the host range of OranSNPV in the absence of testing of New Zealand insect species. The purpose of this application is to conduct the host testing necessary to provide this information and these studies need to be done in New Zealand.

If the virus was able to infect a non-target organism such as a native or valued Lepidopteran species the magnitude of the adverse effects could range from moderate to major depending on whether significant loss of organisms occurs.

The pathway by which adverse effects on non-target host organisms could occur requires the escape from containment of the OranSNPV and the subsequent infection of a susceptible host.

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The Committee conclude that, in the improbable event that the OranSNPV virus escaped from containment, the subsequent infection of a susceptible host organism is highly improbable due to the narrow host range of the virus. However, the magnitude of adverse effects if a non-target species became infected with the virus could be moderate to major. There is only a small degree of uncertainty over whether a non-target species could become infected therefore this risk is considered to be insignificant.

Potential for ecosystem disruption by viral infection and destruction of organisms

Infection of non-target species may be detrimental to those populations and to ecosystems if those non-target species are beneficial insects such as predatory insects or pollinators. There is uncertainty concerning whether beneficial non-target insects would be susceptible to infection and adversely affected by OranSNPV.

The potential effects of OranSNPV on the ecosystem following an escape from containment have a small degree of uncertainty as they are dependent on whether target or non-target species are destroyed by the virus. However, given the conclusion drawn above that infection of non-target organisms would be highly improbable, and given the containment measures proposed, the Committee considers that this risk is insignificant.

Potential for adverse effects on water, soil and air quality

The Committee considered the risk of adverse effects to water, soil and air quality from the virus. The Committee accepts the evidence that the virus is rapidly degraded in the air by UV irradiation1 and is unlikely to persist in aquatic environments (OECD Consensus Document 2002). However, the virus is able to persist in soil environments. The Committee accepts the evidence that the OranSNPV viral particles are inert and inactive until in contact with the gut of a susceptible host insect2, and the likelihood of infection of a susceptible host has been assessed above as insignificant. Therefore, in the likely absence of a host, the risk of any adverse effect on the physical environment is considered to be negligible.

Potential for adverse effects on New Zealand’s viral genetic diversity

The Committee considers that it is highly probable there are no other viruses that infect Lymantriidae family members present in New Zealand because there are no Lymantrids here (other than painted apple moth) and because no known Lymantriidae family viruses have been demonstrated to be able to infect other families. Therefore, it is highly improbable that OranSNPV would displace or recombine with a related nucleopolyhedrovirus to cause a reduction in viral genetic diversity.

1 Maddox, J.V. (1994) Insect pathogens as biological control agents. In: Metcalf & Luckmann (ed.) Introduction to insect pest management. John Wiley & Sons, Inc.

2 Section 7.16 – 7.17 of the E&R Report.

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Potential for development of new viruses through recombination which may infect non-target hosts with detrimental effect

The Committee considers that the escape of the virus and subsequent recombination to generate a novel virus that has altered host range or increased virulence is improbable for the reasons specified in sections 7.19 – 7.24 of the E&R Report. However, it notes that the magnitude of the adverse effects that could happen if a recombinant virus developed is uncertain. Taking account of this uncertainty, in accordance with clause 12(e) of the Methodology, and the likelihood of novel viruses developing and infecting non-target hosts, the Committee considers this risk to be negligible.

Potential for the virus to have adverse effects on human health through pathogenic, allergenic or toxic effects on humans.

The Committee considered the potential adverse human health effects and risks in accordance with Section 6(c) of the Act and clauses 9(c)(iii), 10(c) and (g), and 12 of the Methodology. This included consideration of the potential harm to personnel working with the organisms, and any effects on public health that the OranSNPV might have. The potential for the virus to have adverse effects on public health through pathogenic, allergenic or toxic effects on people was considered.

The Committee conclude that there are no public health risks associated with OranSNPV as it is not a human pathogen. This is because there are no documented observations in the scientific literature of this type of virus infecting humans or vertebrate or of unintended effects. In safety tests involving over 51 entomopathogenic viruses, no adverse health effects were observed (OECD Consensus Document 2002).

The Committee concludes that it is improbable that the virus would have any adverse effects on human health or safety so the overall risk to human health is negligible.

Potential for the virus to have adverse effects on Māori and their taonga by infecting native or valued introduced flora and fauna in New Zealand.

The Committee considers that the import into containment of the virus is unlikely to cause adverse effects on the relationship of Māori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga in accordance with sections 6(d) and 8 of the Act and clauses 9(b)(i) and 9(c)(iv) Methodology. However, the Committee has identified that the research may use native or valued species for testing and that the escape of the virus could result in uncertain and potentially significant adverse effects on native or valued species, therefore posing risk to Māori and their taonga.

The Committee considers these risks to be minimal as it has been concluded above in this decision that it is highly improbable OranSNPV would have an adverse effect on other organisms outside the known host; painted apple moth.

The effects of exposing OranSNPV to native insects in the course of host-testing was considered, and the applicant consulted with iwi representatives in the proposed sites for conducting host testing (Te Kawerau a Maki - Auckland and Ngāi Tahu –Lincoln). The Committee notes that Te Kawerau a Maki have supported the application and have stated their interest in continuing to monitor the research and any future painted apple moth eradication programme. Environmental Risk Management Authority Decision: Application NOC03001 Page 11 of 18

As the applicant could not confirm the sites from which native species will be collected from for use in the host-testing, the potential effects to Māori outside of the Auckland and Lincoln areas is uncertain.

No other environmental effects of importing OranSNPV that may affect the relationship of Māori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga, have been identified.

On considering the information regarding containment and consultation outlined in the E&R Report, the Committee considers that the risks to Māori culture and their taonga are minimal. However, to further mitigate any potential adverse effects, the Committee have determined that the applicant shall be required to provide regular research updates to Te Kawerau a Maki and Ngāi Tahu throughout the duration of the project and to consult further with them before determining any future use of the virus (Control 6.1).

Assessment of Costs

A “cost” is defined in clause 2 as “the value of a particular adverse effect expressed in monetary or non-monetary terms”. The Committee did not identify any costs that would be incurred by the approval of the application other than those to the applicant. The potential costs associated with the potential adverse effects described above were not able to be quantified. However, the Committee notes that if the virus escaped and adversely affected native insects then the costs would be distributed over a wider group than the applicant alone.

Assessment of benefits (beneficial effects)

A “benefit” is defined in clause 2 as “the value of a particular positive effect expressed in monetary or non-monetary terms”. Benefits that may arise from any of the matters set out in clauses 9 and 10 were considered in terms of clause 13.

The Committee considered the following benefits that may be derived from an approval of this application:

New knowledge from host specificity testing of OranSNPV.

Gain of essential knowledge required for possible use of OranSNPV as a biocontrol agent for the painted apple moth.

The Committee considers that the increase in knowledge about the environmental safety of the virus in New Zealand to be gained from this testing is very important and of moderate to high value. A positive effect of doing this work is the completion of the necessary testing required before OranSNPV could be used as a biocontrol agent of painted apple moth.

The results of the testing will be an essential part of any future application to release OranSNPV. The painted apple moth is a serious threat to the New Zealand environment and economy, particularly to horticulture and native forests. It has quickly adapted to feeding on and destroying several native and introduced plants common in New Zealand and is likely to adapt to many more plants. MAF Biosecurity has estimated that if the moth is not wiped out that it could cost the country $350 million over the next 20 years . There are currently no viable alternatives to aerial spraying of insecticides which are controversial for public health and environmental reasons. Environmental Risk Management Authority Decision: Application NOC03001 Page 12 of 18

The Committee considers that the new knowledge from the host specificity tests may lead to the provision of a new biocontrol agent for painted apple moth. The likelihood of this occurring is difficult to assess before the results of the host-specificity testing is known. If eradication of painted apple moth fails, for any reason, limiting the damage that this pest insect causes will be very important. Beneficiaries of biological control of painted apple moth would include regional and territorial local authorities, DoC and private land-owners. Therefore the potential future benefits of undertaking the host-specificity testing of OranSNPV may be moderate to major. In the event that an application is made to release OranSNPV as a biological control agent for painted apple moth in New Zealand the results of the proposed host-specificity testing will be essential supporting evidence.

Benefits that may accrue to AgResearch from the proposed tests include non-monetary and monetary benefits:

Gain of experience in host specificity testing of nucleopolyhedroviruses on insects, and

Facilitation of scientific collaboration and improved profile of New Zealand scientific research.

The specific benefits derived from a raised national and international profile in biological control research are assessed as of moderate value. The new knowledge may lead to monetary benefits from new contracts for biological control research from agencies in New Zealand and overseas.

8 Establishment of the Approach to Risk in the Light of Risk Characteristics

Clause 33 of the Methodology requires the Authority to have regard for the extent to which a specified set of risk characteristics exist when considering applications. This provision provides a route for determining how cautious or risk averse the Authority should be in weighing up risks and costs against benefits. In the present application clause 33 is influenced by the application being “in containment” and the conclusion that the containment provisions and other controls will reduce most biological and physical risks to a low level.

In relation to the biological and physical risks considered (and the risks to human health), the containment measures limit the extent to which exposure to the risks is involuntary. The Committee also consider that there are no significant risks which are not known or understood by the general public. It is considered that the risks that may be difficult to control and which may be persistent and irreversible are dependant upon escape from containment of the virus and its establishment in an alternate valued insect population. Given the Committee's finding that the risk of this occurring is insignificant, the extent to which these risk characteristics are present does not warrant caution additional to that required by section 7 of the Act.

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9 Overall Evaluation of Risk, Costs and Benefits

The overall evaluation of risks, costs and benefits set out below was carried out having regard to clauses 22 and 34 and in accordance with the tests in clause 27 and in section 45.

The Committee was unable to find common units of measurement with which to combine risks and costs in accordance with clause 34(a). Therefore, it identified the dominant risk as potential adverse effects on non-target organisms infected by the virus. This risk was found to be insignificant because escape from containment of the virus is considered to be improbable, and should the virus escape from containment it is very unlikely that infection of susceptible host organisms would occur or that a self-sustaining population would establish.

However, the Committee notes that in the improbable event of OranSNPV escaping from containment and establishing a self-sustaining population, there is uncertainty about the risks to New Zealand native species and other valued species. A purpose of this application is to address these uncertainties.

Because the risks as a whole are negligible, the decision is made in accordance with clause 26 (not clause 27) of the Methodology.

The Committee considered all of the controls, set out in Appendix 1, and did so in the context both of preventing the escape of the organisms and of effectively managing any risks. The Committee, having taken regard of these matters, is satisfied that the organism can be adequately contained, and that the benefits of the application outweigh the costs.

10 Decision

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)(h): Such other purposes as the Authority thinks fit.

2. Having considered all the possible effects in accordance with sections 45(1)(a)(ii) and section 44 and pursuant to clause 26 of the Methodology, and based on consideration and analysis of the information provided and taking into account the application of risk management controls specified in this decision, the view of the Committee is that the risks (or costs) of adverse effects associated with the importation into containment of the following organism are outweighed by the benefits: Orgyia anartoides single nucleopolyhedrovirus (OranSNPV).

3. The Committee is satisfied that the proposed containment regime, as set out in Appendix 1, will adequately contain the organism as required by section 45(1)(a)(iii) of the Act.

4. In accordance with clause 36(2)(b) of the Methodology the Committee records that, in reaching this conclusion, it has applied the balancing tests in section 45 of the Act and Environmental Risk Management Authority Decision: Application NOC03001 Page 14 of 18

clause 26 of the Methodology and has relied in particular on the criteria set out in the following sections of the Act: section 44 additional matters to be considered; section 45 determination of application; section 37 additional matters to be considered; the Third Schedule-Part 2 matters to be addressed by containment controls for new organisms.

5. 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 26 - the risks are negligible and costs are outweighed by benefits; clause 33 – the risk characteristics; and clause 34 – the aggregation and comparison of risks, costs and benefits.

6. The application for importation into containment of the Orgyia anartoides single nucleopolyhedrovirus (OranSNPV) is thus approved, with controls, as set out in Appendix 1.

______3 March 2004 Dr Lin Roberts Date Chairperson of Decision-making Committee

Approval code: NOC002281

Amendment: November 2006 Changes to controls:

Addition of footnotes to the containment facility references and the Australian/New Zealand containment facility references to “future proof” the decision Standardise the wording of the breach of containment control Removal of the control regarding inspection of facilities by the Authority, its agent or enforcement officers

______Date: 6 September 2007

Dr Max Suckling Chair, New Organisms Standing Committee

Environmental Risk Management Authority Decision: Application NOC03001 Page 15 of 18

Amendment: August 2011 Removal of the requirement to report to ERMA New Zealand for control 6.1.

30 August 2011 Richard Woods Date Chair, Decision Making Committee Environmental Protection Authority

Environmental Risk Management Authority Decision: Application NOC03001 Page 16 of 18

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 organisms3of the Act, and other matters in order to give effect to the purpose of the Act (section 45(2)), the approved organism is subject to the following controls:

1 To limit the likelihood of any accidental release of any organism or any viable genetic material4:

1.1 The approved organism shall be imported into, and maintained within, a containment facility which complies with these controls.

1.2 The construction, operation, and management of the containment facility shall be in accordance with the: a) Ministry of Agriculture and Forestry (MAF)/ERMA New Zealand Standard 154.03.025. Containment Facilities for Microorganisms. b) Australian New Zealand Standard AS/NZS 2243:3 20025 Safety in Laboratories: Part 3: (Microbiological aspects and containment facilities). c) Physical Containment Level 2 (PC2) requirements of the above Standards.

1.3 The person responsible for a particular research area and/or the person responsible for the operation of the containment facility shall inform all personnel involved in the handling of the organisms of the Authority‟s controls.

Additional controls:

1.4 No adult flight stages of insects shall be used in the host specificity testing.

1.5 Larvae and feeding material for host specificity testing must be kept in sealed containers from which the larvae can not escape.

1.6 All insects, plants and experimental material that has come into contact with the virus must be decontaminated (e.g. autoclaved) within the containment facility prior to disposal.

1.7 At all times while any of the species of insects is being tested in the containment facility no organisms, other than those directly connected with the testing of that species, are to be in the same part of the containment facility.

3 Bold headings refer to matters to be addressed by containment controls for new organisms excluding genetically modified organisms, specified in the Third Schedule (Part II) of the HSNO Act 1996.

4 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, eg when organisms or parts thereof are sublethally damaged by being frozen, dried, heated, or affected by chemical.

5 Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA New Zealand.

Environmental Risk Management Authority Decision: Application NOC03001 Page 17 of 18

1.8 At all times while host-testing of the approved organism is being conducted in the containment facility the windows shall be closed.

2 To exclude unauthorised people from the facility:

2.1 The identification of entrances, numbers of and access to entrances, and the security requirements for the entrances and the facility shall be in compliance with the standards listed in Control 1.2.

3 To control the effects of any accidental release or escape of an organism:

3.1 Construction and operation of the containment facility shall comply with the requirements of the standards listed in Control 1.2 relating to the control of the effects of any accidental release or escape of an organism.

3.2 If a breach of containment occurs, the facility operator must ensure that the MAF Inspector responsible for supervision of the facility has received notification of the breach within 24 hours.

3.3 In the event of any breach of containment of the organism, the contingency plan for the attempted retrieval or destruction of any viable material of the organism that has escaped shall be implemented immediately. The contingency plan shall be included in the containment manual in accordance with the requirements of standards listed in Control 1.2.

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 1.2.

4.2 The containment manual shall be updated, as necessary, to address the implementation of the controls imposed by this approval, in accordance with Ministry of Agriculture and Forestry (MAF)/ERMA New Zealand Standard 154.03.025 „Containment Facilities for Microorganisms.‟

5 Qualifications required of the persons responsible for implementing those controls:

5.1 The training of personnel working in the facility shall be in compliance with the standards listed in Control 1.2.

6 Additional controls:

6.1 Reports on the outcomes of the host specificity tests are to be provided to Te Kawerau a Maki and Ngāi Tahu upon conclusion of the insect testing regime and if an application is made in the future for general release of the virus.

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