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NOC03001 NOC03001 Decision S67a July 2011.Pdf 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 moth, Teia 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 insects 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) insect. 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; Environmental Risk Management Authority Decision: Application NOC03001 Page 2 of 18 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. Environmental Risk Management Authority Decision: Application NOC03001 Page 3 of 18 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. Environmental Risk Management Authority Decision: Application NOC03001 Page 4 of 18 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
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